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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nPh II Cabazitaxel DD Liposarcoma\n\n**Clinical Trial Summary:**\n\nSoft tissue sarcomas (STS) are a rare group of malignant heterogenous tumors (> 50 histological subtypes, including liposarcoma, the commonest subtype of STS) with distinct genetic, pathological and clinical profiles, and varying patterns of tumor spread. The optimal cytotoxic treatment for this group of patients remains uncertain. Single agents which are most effective include doxorubicin and ifosfamide, but objective response rates and progression-free survival times remain modest. There is clearly a need to improve treatment options for liposarcoma. Eribulin, a antimicrotubule agent that targets the protein tubulin in cells, interfering with cancer cell division and growth , has demonstrated activity in STS. Therefore, it is reasonable to explore whether other anti-microtubule agent like cabazitaxel have a role in STS. Cabazitaxel has been shown to be a relatively safe, effective and tolerated. This drug has been approved by FDA for prostate cancer. The main objective of this trial is to determine whether cabazitaxel or prolonged infusional ifosfamide demonstrate sufficient antitumor activity for liposarcoma.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Local diagnosis of dedifferentiated liposarcoma\n - Age 18-70 yrs\n - WHO performance status 0-1\n - Radiological or histological diagnosis of inoperable locally advanced or metastatic disease, with evidence of disease progression within the past 6 months\n - Clinically and/or radiographically documented measurable disease within 21 days prior to randomization.At least one site of disease must be unidimensionally measurable according to RECIST 1.1.\n - One previous chemotherapy regimen for locally advanced or metastatic dedifferentiated liposarcoma (this could include pre-operative chemotherapy for primary disease if subsequent complete resection was not achieved).\n - Adequate organ functions\n - Birth control measures\n - Written informed consent\n Exclusion Criteria:\n - More than 1 prior molecularly targeted therapy (e.g. CDK4 inhibitor). Any prior such therapy must be completed at least 4 weeks before randomization.\n - Symptomatic CNS metastases\n - Previous encephalopathy of any cause or other significant neurological condition\n - Concurrent or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4/5\n - Pregnancy\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nAn Open Label Study of BIBW 2992/Afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib\n\n**Clinical Trial Summary:**\n\nAdvanced lung cancer (non-small cell lung cancer) with a mutation in the EGFR (epidermal growth factor receptor) gene, which have disease progression after treatment with an EGFR inhibitor (erlotinib or gefitinib), and have progression of disease also after treatment with chemotherapy will be recruited. The trial has only one arm, of afatinib daily treatment. Blood and exhaled breath samples will be collected for investigations aiming to identify factors that predict response to afatinib.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Advanced NSCLC\n - EGFR mutation or six months or longer benefit from EGFR TKIs\n - Disease progression on chemotherapy, or inability to receive chemotherapy for medical reasons.\n - Disease progression on EGFR TKI, or the presence of an EGFR mutation that does predicts for poor response to first generation EGFR TKIs.\n Exclusion Criteria:\n - Inability to take oral drugs\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)\n\n**Clinical Trial Summary:**\n\nThe purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Histologically or cytologically confirmed carcinoma of the breast\n - Locally advanced breast cancer that is not amenable to curative radiation or surgical cure and/or metastatic disease appropriate for systemic single cytotoxic chemotherapy\n - Documentation of a deleterious, suspected deleterious, or pathogenic germline BRCA1 or BRCA2 mutation from Myriad Genetics or other laboratory approved by the Sponsor\n - No more than 3 prior chemotherapy-inclusive regimens for locally advanced and/or metastatic disease (no limit on prior hormonal therapies or targeted anticancer therapies such as mechanistic target of rapamycin (mTOR) or CDK4/6 inhibitors, immune-oncology agents, tyrosine kinase inhibitors, or monoclonal antibodies against CTL4 or VEGF)\n - Prior treatment with a taxane and/or anthracycline in the neoadjuvant, adjuvant, locally advanced, or metastatic setting unless medically contraindicated\n - Have measurable or non-measurable, evaluable disease by the revised response evaluation criteria in solid tumors (RECIST) v.1.1\n - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n Exclusion Criteria:\n - First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy unless the Investigator determines that one of the 4 cytotoxic chemotherapy agents in the control arm would otherwise be offered to the subject\n - Prior treatment with a PARP inhibitor (not including iniparib)\n - Not a candidate for treatment with at least 1 of the treatments of protocol-specific physician's choice (ie, capecitabine, eribulin, gemcitabine, vinorelbine)\n - Subjects who had objective disease progression while receiving platinum chemotherapy administered for locally advanced or metastatic disease; subjects who received low-dose platinum therapy administered in combination with radiation therapy are not excluded\n - Subjects who have received platinum in the adjuvant or neoadjuvant setting are eligible; however, subjects may not have relapsed within 6 months of the last dose of prior platinum therapy\n - Cytotoxic chemotherapy within 14 days before randomization\n - Radiation or anti-hormonal therapy or other targeted anticancer therapy within 14 days before randomization\n - HER2 positive breast cancer\n - Active inflammatory breast cancer\n - CNS metastases\n - Exception: Adequately treated brain metastases documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids (except prednisone ≤ 5 mg/day or equivalent) for management of CNS symptoms. A repeat CT or MRI following the identification of CNS metastases (obtained at least 2 weeks after definitive therapy) must document adequately treated brain metastases.\n - Subjects with leptomeningeal carcinomatosis are not permitted\n - Prior malignancy except for any of the following:\n - Prior BRCA-associated cancer as long as there is no current evidence of the cancer\n - Carcinoma in situ or non-melanoma skin cancer\n - A cancer diagnosed and definitively treated ≥ 5 years before randomization with no subsequent evidence of recurrence\n - Known to be human immunodeficiency virus positive\n - Known active hepatitis C virus, or known active hepatitis B virus\n - Known hypersensitivity to any of the components of talazoparib\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nRecombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nThis pilot clinical trial studies the effect of recombinant interferon gamma on tissue in treating patients with soft tissue sarcoma. Interferon gamma may interfere with the growth of tumor cells.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\n I. To determine whether systemic administration of interferon (IFN) gamma (recombinant interferon gamma) will increase class I major histocompatibility complex (MHC) expression in synovial sarcoma (SS) and myxoid/round cell liposarcoma (MRCL) tumors.\n SECONDARY OBJECTIVES:\n I. To determine whether systemic administration of IFN gamma will increase class II MHC expression in SS and MRCL tumors.\n II. To examine changes in the immune response to MRCL and SS by examining changes in the immune infiltrates, antibody response and antigen specific T cell response before and after IFN gamma treatment.\n OUTLINE:\n Patients receive recombinant interferon gamma subcutaneously (SC) every 7 days for 4 weeks before surgery or thrice weekly for 2 weeks before surgery.\n After completion of study, patients are followed up at 2 weeks post-surgery.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - A diagnosis of synovial sarcoma and myxoid/round cell liposarcoma\n - A superficial tumor easily and safely accessible for a research biopsy or are being considered for resection or biopsy of their tumor as part of standard of care and have recent pathology\n - Zubrod performance status of '0-2' or Karnofsky score > 60%\n - No treatment with systemic anti-cancer treatment (chemotherapy or biologics) within 2 weeks of starting interferon gamma\n - Patients with a history of coronary artery disease must have had a normal stress test within 180 days of starting IFN gamma\n - Must have been off metformin for at least 2 weeks prior to starting IFN gamma\n - No use of full dose, therapeutic anti-coagulation; however, low dose warfarin for catheter prophylaxis or acetylsalicylic acid are acceptable\n - No thrombotic event within 6 months (deep vein thrombosis, pulmonary embolism) of starting IFN gamma\n Exclusion Criteria:\n - Active infection requiring oral or intravenous antibiotics\n - Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within two weeks prior to entry\n - Serum creatinine > 1.5 mg/dL or glomerular filtration rate < 50\n - Serum glutamic oxaloacetic transaminase (SGOT) > 150 IU or > 3 x upper limit of normal\n - Bilirubin > 1.6 mg/dL\n - Prothrombin time > 1.5 x control\n - Known central nervous system (CNS) metastasis; once CNS metastasis have been treated these patients may participate if they are otherwise good trial candidates\n - Current treatment with steroids (must be discontinued 1 week before starting IFN gamma)\n - Hemoglobin A1C > 8.5%\n - Uncontrolled hypertension, blood pressure (BP) > 150/100 mmHg; patients with elevated BP may enroll once BP is corrected\n - Cancer/testis antigen 1B (NY-ESO-1) specific T cell therapy within 1 year of starting on the trial\n - New (< 6 months) cardiac arrhythmia (electrocardiogram [EKG] should be performed within 2 weeks of starting IFN gamma)\n - History of clinically significant congestive heart failure\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nPhase 1b Study of PD-0332991 in Combination With T-DM1(Trastuzumab-DM1)\n\n**Clinical Trial Summary:**\n\nStandard of care:\n Treatment with Trastuzumab\n Experimental:\n 21-Day Cycle of Combination therapy with T-DM1 intravenously on Day 1 and oral PD-0332991 on Days 5-18\n Study Design and Methodology:\n This is a phase 1B inter-patient dose escalation study of PD-0332991 in combination with T-DM1 in patients with recurrent or metastatic HER2-positive breast cancer after prior trastuzumab or other HER2-directed therapies.\n The subjects will be administered T-DM1 by intravenous infusion at 3.6 mg/kg for 90 minutes on day 1 of each 21 day cycle. Infusion timing may vary from 30-90 minutes depending on how well the subject tolerates the treatment.\n A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts.The dosing of PD-0332991 will be divided into 3 cohorts, the subjects will receive PD-0332991 on days 5-18 of each 21 day cycle.\n Cohort 1 : PD-0332991 - 100 mg daily (oral) Cohort 2 : PD-0332991 - 150 mg daily (oral) Cohort 3 : PD-0332991 - 200 mg daily (oral)\n The 3+3 design entails that if one patient out of the first three patients has a DLT, up to three additional patients will be entered at that dose level\n Treatment cycles will continue until disease progression or withdrawal from study.\n\n**Clinical Trial Detailed Description:**\n\nThis is a phase 1B inter-patient dose escalation study of PD-0332991 in combination with T--DM1 in patients with recurrent or metastatic HER2-positive breast cancer after prior trastuzumab or other HER2-directed therapies. A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts. The 3+3 design entails that if one patient out of the first three patients has a dose-limiting toxicity (DLT), three additional patients will be entered at that dose level. The PD-0332991 dose levels will start at 100 mg po daily; the second cohort will receive 150mg po daily; the third cohort 200mg po daily. Patients receive PD-0332991 on days 5-18 of each 21 day cycle. T-DM1 will be given intravenously at 3.6 mg/kg on day 1 of each 21 day cycle.\n Toxicity will be assessed using the Common Terminology Criteria of Adverse Events (CTCAE) version 4.0 grading scale. Dose- limiting toxicity-DLT is defined as any drug-related grade 3 non-hematologic toxicity or grade 4 hematologic toxicity lasting >28 days after the last day of therapy. If two patients experience drug-related DLT, the maximal tolerated dose (MTD) for the combination in HER2-positive breast cancer patients has been exceeded, enrollment to that dose will stop, and the next lower dose will be designated the MTD. An additional 15 patients will be treated at the MTD or the maximal 200mg po daily PD-0332991 dose in combination with T-DM1 to confirm safety. Treatment cycles will continue until disease progression or withdrawal from study.\n Study End-points:\n 1. To evaluate and assess Dose Limiting Toxicities (DLT).\n 2. To determine the toxicity profile.\n 3. To determine the clinical response rate.\n 4. To determine the duration of response.\n 5. To evaluate baseline HER2 positivity biomarkers by analyzing pretreatment tumor Ki67, phospho-RB, cleaved caspase 3, phospho-histone H3, cycline E, MCM7, HER2, p27Kip1.\n 6. To evaluate post-treatment Ki67, phospho-RB, cleaved caspase 3, phospho-histone H3, cyclin E, MCM7, HER2, p27Kip1, Rb, p16ink4c, CDK4, CDK6 in order to establish biomarker response to treatment.\n 7. To evaluate pharmacokinetic (PK) parameters for PD-0332991 and T-DM1 including Cmax, AUC, t1/2\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - 1.All subjects must be informed about the study and have signed a current IRB (Institutional Review Board) approved informed consent.\n 2. All subjects must have recurrent or metastatic HER2-positive breast cancer. diagnosed by biopsy.\n 3. All subjects must have previously received trastuzumab or other HER2 targeted therapies.\n 4.Tumor must be HER2-positive and RB-proficient. RB (Retinoblastoma protein)-proficiency is determined by tumor biopsy demonstrating RB normal and p16in4a low by immunohistochemistry. RB proficiency means that there is an intact RB pathway indicative of responsiveness to PD-0332991. RB staining is scored on an absent (no nuclear staining), weak (nuclear staining less than observed in endothelial cells and stromal cells surrounding the tumor), positive (nuclear staining at or above surrounding tissue) (0, 0.5, 1 respectively). P16ink4a is a routine clinical stain that is scored using absent, weak, positive, strong (0,1,2,3 respectively). Tumors will be scored using [p16]/[RB], where a score of less than 3 is required for inclusion. RB loss is expected to occur in less than 15% of cases.\n 5. Subjects must have a performance status of ≤ 2 on the ECOG (Eastern Cooperative Oncology Group)Performance scale.\n 6. Subjects must have bilirubin <1.5 mg/dl, transaminases <2.5x upper limit of normal, albumin >3gm/dl, creatinine <1.3mg/dl, adequate cardiac reserve (EF>50%), ANC (Absolute neutrophil count) >1,000/mcL (microliter), and Platelets >100,000/mcL.\n 7. Must be willing to be treated at the University of Texas Southwestern Hospital, University of Pennsylvania and affiliated clinics.\n 8. Subjects must be willing to use an approved form of birth control while on this study and for 90 days after completion.\n 9. Age > 18 years. 10. Subject must be able to swallow capsules and have no surgical or anatomic condition that will preclude the subject from swallowing and absorbing oral medications on an ongoing basis.\n Exclusion Criteria:\n - 1. Chemotherapy, radiotherapy or hormonal therapy within 3 weeks ( 6 weeks for nitrosoureas, mitomycin C or bevacizumab), or who have not recovered from the adverse events to < grade 2 due to previous agents administered more than 4 weeks prior to Study Day 1.\n 2. Subjects less than 4 weeks post major surgery. 3. Known active CNS metastases or carcinomatous meningitis. Subjects with CNS (Central Nervous System) metastases including brain metastases who have completed a course of radiotherapy are eligible for the study provided they are clinically stable. However, oral corticosteroids for control of CNS symptoms are not allowed.\n 4. Known documented or suspected hypersensitivity to the components of the study drug(s) or analogs.\n 5. Uncontrolled systemic illness, including but not limited to ongoing or active infection.\n 6. Symptomatic congestive heart failure, unstable angina pectoris, stroke or myocardial infarction within 3 months.\n 7. Baseline neuropathy >grade 1. 8. Known positive for human immunodeficiency virus (HIV). Baseline HIV screening is not required.\n 9. Pregnant or breast-feeding subjects. 10. Subjects who are unable or unwilling to abide by the study protocol or to cooperate fully with the investigator or designee.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Pilot Study on ALK Gene Mutations in Neuroblastoma\n\n**Clinical Trial Summary:**\n\nNeuroblastoma (NB) originates from the sympathetic nervous system and is one of the most common cancers in infants and children. In our hospital, nearly 70% of patients are diagnosed with stage 4, metastatic disease with a poor prognosis, despite the use of multimodal therapy including chemotherapy, surgery, autologous stem cell transplantation, radiation therapy, and differentiation therapy. To improve the survival rate and patient care, our NB Study Group has devoted to the research on NB-specific molecular imaging, biomarkers, and target therapy. We have confirmed studies in cancer genetics by showing that N-myc gene (MYCN) amplification and segmental abnormalities on overall genomic profiling both have an adverse effect on treatment outcome. Therefore, there is an unmet need for the development of novel molecular target therapy in NB. Recently, the anaplastic lymphoma kinase (ALK) oncogene has been found to play an important role in the pathogenesis of NB, as well as serving as the driver mutations in approximately 10% of high-risk NB. The availability of ALK inhibitors also enables ALK as a treatment target in NB. In this proposal, we plan to utilize gene sequencing, array-comparative hybridization, and multiplex ligation-dependent probe amplification methods to evaluate the frequencies and characteristics of ALK mutations and amplifications in patients with NB. The gene and protein expression of ALK will also be evaluated by quantitative polymerase chain reaction(PCR) and immunohistochemistry, respectively, and compared with ALK genotype. The overall genomic pattern, clinical characteristics, histopathology, and treatment outcome of ALK-mutated NB patients will be analyzed. The results from this study may serve as the first report on ALK mutations of NB in Taiwan and will be used for the development of standardized genetic diagnosis protocols, as well as the design of future clinical trials targeting ALK.\n\n**Clinical Trial Detailed Description:**\n\n- purpose Despite the advance of modern multimodal therapy including surgery, chemotherapy, autologous stem cell transplantation, radiation therapy, and differentiation therapy, most children with NB are diagnosed with metastatic diseases and suffer from a dismal outcome. There is an unmet need for the development of novel target therapy in NB. Among all recently identified targets, ALK gene mutations have been found in approximately 10% of high-risk NB patients and are the treatment target of several promising agents that have already been tested in clinical trials, including crizotinib, which is to be available in Taiwan soon. This study aims to evaluate the prevalence of mutations and copy number aberrations of the ALK oncogene in prospective and previously treated NB patients' tumor sample (from surgical specimens) and germ-line (peripheral blood lymphocytes). The messenger ribonucleic acid(mRNA) and protein expression levels of ALK will also be analyzed. The results will be correlated with the clinical characteristics and pathological findings of this NB cohort.\n - technique Prospective cases: Cryopreservation of tumor samples Retrospective cases: Archived tumor Sequencing: point mutation array-based comparative genomic hybridization(aCGH) & MLPA（multiplex ligation-dependent probe amplification）：analyze copy number alterations (CNAs) compare to clinical data\n - expected results The results from this study may serve as the first report on ALK gene mutations of NB in Taiwan. We anticipate that 5-15% of NB tumors carry with common ALK mutations. Genome-wide CNAs profiling by aCGH can help us to categorize the genomic types of NB patients based on published guidelines, while the presence of ALK mutation or amplification may or may not be associated with subtypes with worse outcome. Some patients may have high ALK expression level without bearing common mutations on ALK gene locus, and we may identify novel mutation points in this patient cohort. Finally, we will probably find significant prognostic value of ALK gene mutation, which may be independent from other known risk factors, such as age, stage, MYCN amplification, and genomic pattern.\n Based on these results, we are able to develop standardized protocol for diagnosing ALK mutations for Taiwanese NB patients. With the development of ALK genetic testing, a phase II clinical trial of an ALK inhibitor in high-risk NB patients with relapsed or refractory disease may subsequently be conducted and may improve the treatment outcome of the patients.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Diagnosed by clinical criteria(one of below)\n Proved or maybe as Neuroblastoma by :\n 1. pathological section\n 2. Bone meta with 24 hrs urine Vanillylmandelic acid(VMA)or Homovanillic acid(HVA) elevated\n 3. CT or MRI found tumor around adrenal gland or Neuroblastic tumor\n 2. Have tumor or blood samples to analyze ALK gene：\n 1. will operation to remove tumor or biopsy, and will preserve tumor sample；or\n 2. after operation and have tumor sample preserved；or\n 3. after operation without tumor sample, but agree to take blood sample to analyze ALK mutation\n 3. Signed Inform Consent Form\n Exclusion Criteria:\n (1) After informed but still not consent\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nPrognostic Value and Clinical Pathology of c-MET Expression and Amplification in Gastric Carcinoma\n\n**Clinical Trial Summary:**\n\nThe MET oncogene encodes the receptor tyrosine kinase (RTK) for hepatocyte growth factor (HGF) and controls genetic programs leading to cell growth, invasion and protec¬tion from apoptosis. Although the definitive role of MET oncogene is yet to be determined in carcinogenesis of gastric cancer, overexpression and amplification of c-Met has been demonstrated in gastric cancer cell lines. In addition, approximately 10-20% of gastric cancer tissues and up to 40% of the scirrhous histological subtype were shown to harbor increased MET gene copy numbers. Importantly, PHA-665,752, a selective c-Met kinase inhibitor showed significant reduction of established tumor mass in mouse xenografts with GTL16, a gastric cancer cell line with >10-fold MET amplification. Another pivotal study showed that gastric cancer cells with MET amplification were extremely sensitive to PHA-665,752 and implicated a potential role of c-Met protein in developing theranostics in gastric cancer. More and more data indicated that c-Met was an important prognostic factor in gastric cancer.\n Gastric cancer is a heterogeneous disease. Does the expression and amplification of c-Met in the primary lesion differ from the metastatic disease? Does the expression and amplification of c-Met in the early disease differ from advanced disease? Till now there is no related report.\n Purposes:\n - Compare the expression and amplification of c-Met between primary lesion and metastatic lesion together with clinical characteristic, to explore the relationship of c-Met expression and metastatic pattern\n - Compare the expression and amplification of c-Met between early stage and metastatic stage, and to explore the role of c-MET in the development of carcinoma\n\n**Clinical Trial Detailed Description:**\n\nWe retrospectively collect the metastatic gastric cancer patients who received a surgical resection of both primary diseases and metastatic lesions during January 2006 and December 2012. Patients are collected based on the following criteria: (1) pathology proven advanced gastric adenocarcinoma; (2) the paraffin-embedded tissues of the primary and metastatic lesions were available (3) full information of follow-up. There are 100 patients suitable for the analysis. c-MET protein expression and amplification are assessed in paraffin-embedded tissues of the primary and metastatic diseases obtained from 100 patients by immunohistochemistry (IHC) and Fluorescence in situ hybridization (FISH). The clinical pathologic data of the patients are also collected for analysis, including: gender, age, Karnofsky performance score (KPS), chemotherapy regimens, tumor locations, Lauren classification, histology subtypes, metastatic sites.\n In order compare c-Met expression and amplification between early and advanced stage, we will match 100 early stage (stage I and stage II) patients based on the following criteria (1) pathology proven gastric adenocarcinoma with radical resection; (2) the paraffin-embedded tissues of the primary lesions is available (3) full information of follow-up MET IHC will employ the Dako MET IHC assay and supplied assay protocol and pathology scoring guideline.\n MET FISH will also employ the Dako MET FISH assay supplied assay protocol and pathology scoring guideline.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. For metastatic gastric cancer patients (1) pathology proven advanced gastric adenocarcinoma; (2) the paraffin-embedded tissues of the primary and metastatic lesions were available; (3) full information of follow-up\n 2. For early stage gastric cancer patients (1) pathology proven gastric adenocarcinoma with radical resection; (2) the paraffin-embedded tissues of the primary lesions is available; (3) full information of follow-up\n Exclusion Criteria:\n 1. Older than 70 years old or younger than 18 years old\n 2. without paraffin-embedded tissue\n 3. without information of follow-up\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nEffect of Acid Suppression Medication on Pediatric Microbiome\n\n**Clinical Trial Summary:**\n\nThe colonic microbiome is essential in health and disease, and is highly dynamic during the first several years of life. Proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) are widely used in children, but the effects of PPIs and H2RAs on the pediatric colonic microbiome are unknown. This study will determine whether acid suppression with these medications affects the microbiome of otherwise healthy children who are prescribed acid suppression for gastroesophageal reflux disease (GERD), and determine the duration and magnitude of microbiome changes.\n\n**Clinical Trial Detailed Description:**\n\nOtherwise healthy children age 0-4 years old who are being considered for acid suppressive therapy for GERD will be eligible for this study. Subjects donate samples before and after being treated with PPIs or H2RAs (must donate at least 2 baseline pre-PPI samples to be eligible for final analysis). 30 total children who complete the study (anticipated 10 who receive lifestyle modification and 20 who receive PPIs or H2RAs). All children will donate 6 stools on or about weeks 0, 4, 12, 20, 38, and 64. The primary outcome will be a significant change in the overall diversity of the colonic microbiome after 8 weeks of PPIs or H2RAs (i.e., from week 12 to week 4), compared to after 4 weeks of lifestyle management.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Zero to 4 years old\n - Being considered for PPI or H2RA treatment for refractory GERD\n - Parent is able to give informed consent\n Exclusion Criteria:\n - Prevalent C. difficile infection (excluded via stool PCR at week 0)\n - Use of systemic antibiotics within the past 90 days\n - Use of acid suppression medications within the past 90 days (antacids allowed if none within the last 7 days)\n - Increased risk for fracture due to vitamin D deficiency or other causes\n - Chronic gastrointestinal disease (e.g. inflammatory bowel disease, celiac disease, microscopic colitis, malabsorptive conditions, short gut syndrome)\n - Congenital deficiency in immunity (e.g., such as IgA deficiency)\n - Cystic fibrosis\n - Significant dynamic or uncontrolled comorbidity such as HIV or malignancy\n - Use of medications with potential interaction with PPIs\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nPALBOCICLIB + PD-0325901 for NSCLC & Solid Tumors\n\n**Clinical Trial Summary:**\n\nThis research study is evaluating the experimental drug palbociclib in combination with another experimental drug PD-0325901 as a possible treatment for cancers with KRAS mutations, particularly for those which started in the lung.\n\n**Clinical Trial Detailed Description:**\n\nThis will be an open label Phase I/II dose escalation study evaluating the combination of the CDK4/6 inhibitor palbociclib (PD-0332991) and the MEK inhibitor PD-0325901. To determine the maximally tolerated dose (MTD) and recommended phase 2 dose (RP2D), a 3+3 dose escalation protocol will be undertaken. Once the RP2D has been determined, the study will then evaluate, in a randomized phase II study design, the combination of palbociclib and PD-0325901 compared to PD-0325901 alone and palbociclib alone in KRAS mutant NSCLC.\n - Phase 1: The investigators are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have cancer, not everyone who participates in this research study will receive the same dose of the study drug. The dose the participant receives will depend on the number of participants who have been enrolled in the study before and how well the dose has been tolerated.\n - Study Drug(s): The participant will be given a study drug-dosing calendar for each treatment cycle. Each treatment cycle lasts 4 weeks during which time you will be taking the study drug for 3 weeks at a time. The participant will take Palbociclib by mouth once a day, every day for 3 weeks. The participant will take PD-0325901 by mouth twice a day, every day for 3 weeks.\n - Clinical Exams: During all cycles the participant will have a physical exam and will be asked questions about general health and specific questions about any problems that they might be having and any medications they may be taking.\n - Scans (or Imaging tests): The investigators will assess the participant's tumor by either a CT scan or MRI\n - Blood Tests: These are special tests to check the amount of drug and the amount of tumor DNA in the participant's blood at specific points in time.\n Phase II Outcomes:\n - Determine the response rate, as determined by RECIST 1.1, of the combination of palbociclib and PD-0325901 to that of palbociclib or PD-0325901 as single agents in patients with advanced KRAS mutant NSCLC\n - Further evaluate the safety, tolerability and side effect profile for the combination of palbociclib and PD-0325901 Phase II Secondary Outcomes\n - Determine the rate of progression free survival ≥ 4 months and the median PFS for the combination of palbociclib and PD-0325901 compared to palbociclib or PD-0325901 as single agents in KRAS mutant NSCLC\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Dose-escalation/MTD cohorts, participants must have histologically confirmed malignancy with a RAS mutation that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. For the randomized phase 2 component of the study, participants must have histologically confirmed NSCLC with a confirmed KRAS mutation (via any CLIA-certified method)\n - For the dose-escalation component, participants are required to have only evaluable disease. For the MTD cohort and phase 2 component of the study, participants must have measurable disease.\n - Participants enrolled to the MTD cohort must agree to pre and on-treatment tumor biopsies if assessable disease is identified.\n - Age ≥18 years.\n - ECOG performance status ≤ 2 (see Appendix A).\n Participants must have normal organ and marrow function as defined below:\n - Absolute neutrophils count ≥ 1,500/mcL\n - Platelets ≥100,000/mcL\n - total bilirubin within normal institutional limits\n - AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal (≤ 5.0 X institutional upper limit of normal permitted if hepatic metastases present)\n - Creatinine within 1.5x the ULN institutional limits.\n - Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Ability to understand and the willingness to sign a written informed consent document.\n - QTc ≤480 msec.\n - The availability of archival tissue to evaluate retrospectively the participant's Rb status\n - Patients must have recovered to ≤ Grade 1 in terms of toxicity from prior treatments (excluding neuropathy which can be ≤ Grade 2).\n Exclusion Criteria:\n - Participants who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.\n - Participants may not be receiving any other study agents concurrently with the study drugs.\n - Participants with symptomatic brain metastases that require chronic steroids are excluded. Patients with a history of brain metastases are permitted to enroll as long as they have been treated, off of steroids and have been stable for one month on imaging.\n - Concurrent use with strong CYP3A4 inhibitors/inducers is prohibited due to drug-drug interactions with palbociclib.\n - Due to potential drug interactions between warfarin and PD-0325901, warfarin use is excluded. Other anticoagulants are permitted.\n - Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n - Pregnant women are excluded from this study because the study agents have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with the study agents, breastfeeding should be discontinued.\n - For Part II only: Individuals with a history of a different malignancy are ineligible except if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.\n - HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions.\n - Evidence of visible retinal pathology on screening ophthalmologic examination that places the participant at an unacceptable risk for ocular toxicity, such as risk factors for retinal vein occlusion, related to PF-0325901.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** possibly relevant"
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possibly relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nEffects of Non-Nutritive Sucking on Gastroesophageal Reflux and Related Apneas in Symptomatic Preterm Infants\n\n**Clinical Trial Summary:**\n\nGastro-esophageal reflux (GER) is a common condition among preterm infants, due to several physiological promoting factors. To limit the potentially harmful widespread of pharmacological treatment, a step-wise approach, which firstly applies conservative strategies, is currently considered the best choice to manage GER in the preterm population. Among the most common conservative strategies, postural measures seem to represent an effective measure to reduce GER features in symptomatic preterm babies, whereas feed thickening is almost ineffective. Non-nutritive sucking (NNS) is a care strategy largely applied in the Neonatal Intensive Care Unit (NICU) settings. The act of swallowing is both reported to trigger the onset of transient lower esophageal sphincter relaxations (TLESRs), thereby eliciting to GER episodes, and to promote the esophageal clearance of refluxate. Hence, a possible effect of NNS on GER features might be hypothesized.\n This observational, prospective and explorative study primarily aims to explore the effect of NNS, applied by means of a pacifier, on acid and non-acid GER features, evaluated in symptomatic preterm infants (gestational age ≤32 weeks) undergoing a diagnostic combined pH and multiple intraluminal impedance (pH-MII). The secondary aim of this study is to evaluate, in the subgroup of patients with recurrent GER-related apneas, the effect of NNS on cardiorespiratory events, defined as bradycardias and total, central, obstructive, mixed apneas and detected by a simultaneous polysomnographic monitoring.\n\n**Clinical Trial Detailed Description:**\n\nDue to several promoting factors related to the physiological immaturity of the gastro-intestinal tract, gastro-esophageal reflux (GER) is a frequent condition among preterm infants.\n GER clinical presentation may vary within a wide range of symptoms, being vomiting, regurgitations and cardiorespiratory events, such as apnoeas or bradycardia, the most common in the preterm population. Particularly, apneic episodes are inversely related to the gestational age (GA) and might be associated with such pathological events as hypoxia, hypercapnia or pressure variability, which seem to negatively affect the long-term neurological development of preterm babies.\n Combined pH and multiple intraluminal impedance (pH-MII) is currently considered the best choice for GER diagnosis in preterm infants. While pH monitoring is limited to the detection of acid reflux, combined pH-MII effectively identifies both acid and non-acid GER, which is predominant in preterm babies. Moreover, thanks to its multichannel probe, combined pH-MII allows to evaluate the height reached by the refluxate within the esophageal lumen and to distinguish retrograde fluid bolus movements (reflux) from the anterograde ones (swallows).\n In the last decade, GER pharmacological treatment has increasingly widespread in NICUs. The provision of anti-histamine2 (H2) blockers and proton pump inhibitors (PPI) in the preterm population, however, might lead to such adverse effects as an increased incidence of necrotizing enterocolitis and infections. Hence, to avoid a useless and potentially harmful pharmacological overtreatment, a step-wise approach, firstly promoting conservative strategies, is currently considered the most advisable choice for GER management in symptomatic preterm infants.\n Postural and dietetic interventions represent the most common conservative strategies and their efficacy in improving GER symptoms and features has been largely investigated.\n As we assessed in a previous pH-MII study, both prone and left-side positions were more effective than the right-side or the supine ones to determine a significant improvement in both acid and non-acid GER features.\n Feed thickening is widely employed to reducing vomiting and regurgitations in symptomatic term infants; with regard to the preterm population, however, little data is currently available. We have previously investigated the efficacy of thickened fortified human milk on preterm infants suffering from GER symptoms (frequent regurgitations, desaturations, bradycardia), observing no benefits. Furthermore, standard human milk fortification itself has been shown to increase GER frequency in preterm infants.\n With regard to anti-regurgitation (AR) formulas, we have recently evaluated the effectiveness of a specific AR formula, thickened with amylopectin and specifically tailored for preterm infants' nutritional needs; the tested thickened formula effectively reduced the number of acid GERs, but no difference was observed in the frequency of non-acid GERs and in the mean esophageal acid exposure, which is known to be the main determinant for the development of gastro-esophageal reflux disease (GERD). Thus, according to these preliminary data, feed thickening seem to be almost ineffective in improving GER symptoms and features in preterm infants.\n Non-nutritive sucking (NNS) is part of the routine neonatal care, being widely applied in NICU settings. NNS has been showed to positively influence gastric secretion, gut motility and to improve the digestive process. NICU hospitalization and the need for respiratory support, however, might delay the transition from tube feeding to full oral feeding, thereby increasing the length of hospital stay and negatively affecting the mother-neonate relationship. Over two decades ago, in their meta-analysis Schwartz et al. showed beneficial effects of NNS in reducing time to attain full oral feeding as well as the length of hospitalization. These results have been further confirmed in a recent review by Harding.\n The role of NNS on GER, however, has not been yet clarified. It has been previously shown that the swallowing enhances the occurrence of lower oesophageal sphincter relaxations, which are known to represent a trigger stimulus for reflux episodes. On the other hand, the act of swallowing appears to promote the esophageal clearance of refluxate; hence, a possible influence of NNS on GER might be hypothesized. In a pH-metric study, performed by Orenstein et al. on infants younger than 6 months, NNS seemed to have a worsening effect on GER when applied in the prone posture, whereas in the seated position was associated with an ameliorative outcome; this controversial result, however, cannot be extended to the preterm population. To date, the efficacy of NNS by means of a pacifier on preterm infants symptomatic for GER has been preliminary evaluated only by Zhao et al., reporting an improvement of overall GER features (number of refluxes, reflux index, total time at pH<4) and a faster time of gastric emptying in the NNS group. However, this study was performed by pH monitoring, so that the effect of NNS on non-acid GER has not been evaluated yet.\n Due to the buffering effect of milk feeding on gastric pH, and being the acidity of gastric juice GA-dependent, non-acid GERs represent a major percentage (70%) of the overall reflux episodes in the preterm population. Moreover, as we have recently observed, non-acid reflux is the main responsible for the occurrence of GER-related apneas. Hence, a beneficial effect on GER-related apneas and subsequent hypoxic episodes, potentially harmful for preterm infants, could be supplied by conservative strategies effective in decreasing non-acid GERs features.\n The primary aim of this observational, prospective, exploratory study is to evaluate the effect of NNS on GER pH-MII features in preterm infants (GA ≤32 weeks) symptomatic for GER (i.e. suffering from frequent regurgitations, feeding difficulties, failure to thrive and/or post-prandial desaturations) for which a 24-hour pH-MII monitoring for GER diagnostic evaluation has been scheduled.\n The secondary aim of this study is to assess, by means of a simultaneous non-invasive 6-hour polysomnographic recording, the effect of NNS on total, central, obstructive, mixed apneas and on cardiorespiratory events within the subgroup of patients with recurrent desaturations.\n Overall thirty preterm infants (GA ≤32 weeks) will be enrolled if suffering from moderate/severe GER symptoms and if a diagnostic 24-hour pH-MII monitoring has been scheduled to evaluate GER features, according to our clinical practice.\n During the 24-h pH-MII monitoring each infant will receive eight meals, four of which will be followed by NNS treatment with a pacifier. The sequence of NNS application will be consecutively alternated in study participants. For each evaluation, a minimum of 2 hours of NNS post-prandial treatment is required. The healthcare assistants (i.e. medical staff and nurses) will inspect the correct application of NNS, recording the effective time of pacifier usage and regularly checking the pacifier position in relation to the pH-MII probe and polysomnographic flow sensor, to avoid possible interferences. Due to their immaturity, the enrolled patients might show an ineffective sucking, potentially losing the pacifier. In this case, the healthcare assistants will offer the pacifier to the babies up to a maximum of four times for each postprandial period; measures to fix the pacifier will be avoided.\n The pH-MII device in use for this study (Comfortec pH-MII Sandhill Scientific) is a nasogastric probe with seven rings, composed by six dipolar impedance channels and one antimony electrode responsible for pH detection and placed in the middle of the distal impedance dipole. Due to these characteristics, pH-MII is able to measure the esophageal height reached by refluxate and to identify the direction of esophageal bolus movements, thereby distinguish between a retrograde flow (reflux) and an anti-retrograde flow (swallow). Esophageal probe length will be determined using Strobel's formula: [baby length (cm) x 0.252 + 5)] - 13%.\n Impedance monitoring detects a GER episode (MII-GER) if there is a sequential drop in impedance values to less than 50% of the baseline, starting distally and propagating retrogradely to at least the next two more proximal measuring segments (about 4.5 cm above the lower esophageal sphincter (LES)). A GER episode is then defined as acid or non-acid according to its pH: the MII episodes with a pH lower than 4 are defined as acid MII-GERs, whereas the MII episodes with a pH≥4 are defined as non-acid MII-GERs. GERs migration height is the maximum distance from the LES reached by the esophageal refluxate. An acid GER episode is recorded by pH monitoring as a pH drop to less than 4; to be detected by the pH sensor, the pH drop has to last at least 5 s. The total percent time of esophageal exposure to a pH <4 is named Reflux Index (RIpH).\n Data from the pH-MII recording will be automatically acquired on a portable Sleuth Sandhill Scientific system and then stored in a personal computer containing a specific software (BioVIEW Analysis Sandhill Scientific, version 5.0.9). Data analysis will be performed by the aforementioned software and confirmed by direct visual evaluation.\n In the subgroup of patients with recurrent desaturations, a simultaneous non-invasive 6-hour polysomnographic monitoring, comprehensive of two meals (one followed by NNS and the other not), will be performed to evaluate a possible effect of NNS on apneic episodes (total, central, obstructive, mixed) and cardiorespiratory events.\n The polysomnographic device in use for this study (System Plus, Micromed, Mogliano Veneto, Italy) measures the oral/nasal airflow by a flow transducer placed below the nostrils, whereas abdominal movements are detected by a band placed around the abdomen which is connected to a respiratory inductance plethysmography. Each oral/nasal flow cessation ≥5 seconds will be considered an apneic episode; apneas are then classified as central (CA: absence of both oral/nasal flow and movements of the abdominal wall), obstructive (OA: abdominal movements with an inadequate oral/nasal flow) and mixed (MA: components of both CA and OA). Apneas included in periodic breathing patters will be ruled out from the analysis. Systemic oxygen saturation is recorded by means of a pulse oximeter sensor, placed on the infant's foot. Cardiorespiratory events will be characterized as hypoxic episodes, defined as the occurrence of SatO2 <80%, and/or bradycardia, defined as pulse rate <100 bpm. The polysomnographic recording is automatically acquired in a computer connected to the polysomnographic device. The number of total apneas, CA, OA, MA and cardiorespiratory events will be traced down and visually analyzed by the sub-investigators.\n Statistical analysis will be performed by SPSS 20 (Statistical Package for the Social Sciences, SPSS Inc., Chicago, IL, USA) for Windows. Differences between NNS and control periods in terms of GER frequency and features, number of apneic and bradycardic episodes will be tested by Wilcoxon Signed Ranks Test. The level of significance is set at 0.05.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Preterm newborns (GA ≤ 32 weeks) able to sustain a feeding of at least 100 ml kg-1 day-1 of fortified human milk or standard preterm formula, affected by severe/moderate GER symptomatology (recurrent regurgitations, feeding difficulties, failure to thrive and/or post-prandial desaturations) which usual treatment includes 24h pH-MII diagnostic evaluation.\n - Preterm newborns able to sustain pacifier usage for at least 2h, as scheduled in our study plan.\n - Weight ≥ 1100 g at the time of enrollment\n - Obtained written parental consent.\n Exclusion Criteria:\n - Newborns with serious chronic pathology.\n - Ongoing pharmacological treatment which could interfere with gastro-enteral motion functions (pro-kinetics) and/or with acid gastric secretion (H2 antagonists; proton pump inhibitors).\n - Major congenital malformations (e.g. congenital heart diseases, gastrointestinal abnormalities, malformation syndromes).\n - Neonatal necrotizing enterocolitis (NEC).\n - Ongoing infections.\n - Patients with severe clinical conditions which can hinder his/her participation in this trial (e.g. patent ductus arteriosus, intra-ventricular hemorrhage, hemodynamic instability).\n - Administration of experimental medication treatment during the previous two weeks.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Study of Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer\n\n**Clinical Trial Summary:**\n\nThis research study is evaluating a drug called Palbociclib in combination with endocrine therapy as a possible treatment for hormone receptor positive breast cancer.\n - Palbociclib is a drug that may stop cancer cells from growing. Palbociclib blocks activity of two closely related enzymes (proteins that help chemical reactions in the body occur), called Cyclin D Kinases 4 and 6 (CDK 4/6). These proteins are part of a pathway, or a sequence of steps which is known to regulate cell growth. Laboratory testing has suggested palbociclib may stop the growth of hormone receptor positive breast cancer.\n - Endocrine therapy prevents breast cancer cell growth by blocking estrogen stimulation. During this study endocrine therapy will either be tamoxifen or an aromatase inhibitor. It is standard of care for premenopausal women to take tamoxifen and for postmenopausal women to take either an aromatase inhibitor or tamoxifen after a diagnosis of hormone receptor positive breast cancer.\n\n**Clinical Trial Detailed Description:**\n\nAfter the screening procedures confirms that the participant is able to participate in the study. The participant will be given a dosing diary for each treatment cycle. Each treatment cycle lasts 28 days, during which time the participant will take Palbociclib once a day on days 1-21 of each 28 day cycle and the aromatase inhibitor that the participant is already taking once a day every day. The diary will also include special instructions for taking the study drug(s).\n All participants participating in the research study will receive the same dose of Palbociclib.\n While participating in the research study the participant will have the following tests and procedures:\n - Clinical Exams: The participant will have a physical exam on the first day of the month for first three months of therapy. After that, the participant will have a physical exam every other month until the end of the first year of therapy. After the first year, the participant will have a physical exam every 3 months during the second year of therapy. During the physical exam, the participant will be asked questions about their general health, questions about any problems that they may be experiencing, and any medications they are taking.\n - Blood tests: The participant will have blood drawn on the first and fifteenth days of the first three months of therapy. After that, the participant will have blood drawn every month for the remainder of the first year of treatment and the every other month until the end of therapy. These tests will be used to determine if the participant is having any side effects related to the study drug.\n - Electrocardiograms (EKG): The participant will have an EKG performed on the first day of the first three months of therapy. After that, the participant will have an EKG every other month until the end of the first year of therapy. After the first year of therapy, the participant will have an EKG every 3 months during the second year of therapy.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Participants must have histologically confirmed hormone receptor positive (HR+) HER2 negative stage II (except T2N0) or stage III invasive breast cancer. Evaluation for metastatic disease is not required in the absence of symptoms.\n - Men and both pre- and postmenopausal women are eligible.\n - Prior Treatment:\n - Participants may have received (neo)adjuvant chemotherapy, but must be at least 30 days after last dose, with no more than grade 1 residual toxicity at time of screening.\n - Participants may have received adjuvant radiotherapy, but must be at least 30 days after last dose , with no more than grade 1 residual toxicity at the time of screening.\n - If most recent therapy was surgery, participants must be at least 30 days out from definitive surgery with no active wound healing complications.\n - Participants must have demonstrated ability to tolerate endocrine therapy by prior successful completion of at least 1 month of tamoxifen or aromatase inhibitor (AI) therapy without significant adverse events, and in the opinion of the treating physician any ongoing toxicity does not preclude ability to continue on tamoxifen or AI for at least a projected 2 year continuous duration. Ongoing use of any endocrine therapy, including tamoxifen, letrozole, anastrozole, or exemestane, is allowed. Patients may enroll within 2 years of beginning endocrine therapy, as long as there is a plan for at least 2 more years of adjuvant endocrine therapy.\n - ECOG performance status 0-1\n - Age ≥18 years.\n - Normal organ and marrow function\n - Baseline QTc ≤ 480 ms\n - The effects of palbociclib on the developing human fetus are unknown. Women who might become pregnant must use adequate contraception\n - Ability to understand and the willingness to sign a written informed consent document\n Exclusion Criteria:\n - Concurrent therapy with other investigational agents.\n - Prior therapy with any CDK4/6 inhibitor.\n - History of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib.\n - Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A isoenzymes are ineligible.\n - Current use of drugs that are known to prolong the QT interval\n - Subjects with organ allograft requiring immunosuppression.\n - Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n - Pregnant women are excluded from this study. Breastfeeding should be discontinued prior to entry onto the study.\n - Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.\n - No ongoing combination antiretroviral therapy\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nPP-Gemcitabine & External Beam Radiation-Sarcomas\n\n**Clinical Trial Summary:**\n\nThe goal of this clinical research study is to find the highest safe dose of gemcitabine that can be given with radiotherapy before surgery to treat sarcoma. This study will also look at how well this treatment controls sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nBefore the start of treatment, participants will have a physical exam, blood tests, a MRI scan, and a chest x-ray. A PET scan may be done if thought necessary.\n Participants will receive the drug gemcitabine by vein along with radiation therapy on Days 1, 8, 22, 29, 43, and 50. Radiation treatments will be given 5 days a week for 5 weeks. The gemcitabine and radiotherapy will be given on an outpatient basis. Chemotherapy and/or radiotherapy may be stopped if side effects become severe.\n About 4 to 6 weeks after the final dose of gemcitabine, surgery will be done to remove the tumor or to remove any previous surgical scar and leftover tumor.\n During the combined treatment, participants will be seen weekly by the doctor in charge of radiotherapy or by the study nurse. Blood tests will be done every week during treatment. A MRI scan and a chest x-ray will be done within 14 days before surgery. A PET scan will be done if thought necessary.\n After the surgery is done, participants will return to M. D. Anderson for follow-up visits every 4 months for the first 2 years, every 6 months for 3 years, and then yearly from then on. An ultrasound and MRI scan (of the extremity or trunk) will be done 3 months after completion of all treatment. Ultrasound scans will be performed at each visit. A MRI scan will only be done again at later visits if needed.\n This is an investigational study. Gemcitabine is approved for use by the FDA. Its use together with radiation therapy in this study is experimental. About 36 individuals will take part in the study. All will be enrolled at M. D. Anderson.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Patients with cytologic or histologic proof of Grade II or III resectable soft tissue sarcoma of the extremity or trunk.\n 2. Patients with both measurable and non-measurable disease. Patients who are S/P pre-referral excision will be eligible.\n 3. Inclusion of patients with a prior history of malignancy will be at the discretion of the Study Chairman.\n 4. Patients must have a Zubrod Point Scale of 0 or 1.\n 5. Absolute neutrophil count must be > 1,500 cells/mm; platelet count greater than or equal to 100,000 platelets/ml; serum creatinine less than or equal to 1.8 mg/dl, serum glutamate oxaloacetate transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) less than or equal to 3 x normal, total bilirubin less then or equal to 1.5 mg/dl.\n 6. Patients must have no uncontrolled coexisting medical conditions.\n 7. Women of childbearing potential must not be pregnant or breast feeding and must practice adequate contraception.\n 8. All patients must sign an informed consent.\n Exclusion Criteria:\n 1) Patients with a history of prior radiotherapy in the area of the primary tumor or those in whom the anticipated radiation field would include the perineum, scrotum, or vaginal introitus will not be eligible.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nSARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Refractory Liposarcoma, Osteogenic Sarcoma, and Ewing Sarcomas\n\n**Clinical Trial Summary:**\n\nAlthough regorafenib was approved for use in patients who had progressive GIST despite imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been examined in a systematic fashion in patients with other forms of sarcoma.\n Given the activity of sorafenib, sunitinib and pazopanib in soft tissue sarcomas, and evidence of activity of sorafenib in osteogenic sarcoma and possibly Ewing/Ewing-like sarcoma, there is precedent to examine SMOKIs (small molecule oral kinase inhibitors) such as regorafenib in sarcomas other than GIST. It is also recognized that SMOKIs (small molecule oral kinase inhibitors)such as regorafenib, sorafenib, pazopanib, and sunitinib have overlapping panels of kinases that are inhibited simultaneously. While not equivalent, most of these SMOKIs (small molecule oral kinase inhibitors) block vascular endothelial growth factor and platelet derived growth factors receptors (VEGFRs and PDGFRs), speaking to a common mechanism of action of several of these agents.\n\n**Clinical Trial Detailed Description:**\n\nAlthough regorafenib was approved for use in patients who had progressive GIST despite imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been examined in a systematic fashion in patients with other forms of sarcoma.\n Given the activity of sorafenib, sunitinib and pazopanib in soft tissue sarcomas, and evidence of activity of sorafenib in osteogenic sarcoma and possibly Ewing/Ewing-like sarcoma, there is precedent to examine SMOKIs (small molecule oral kinase inhibitors) such as regorafenib in sarcomas other than GIST. It is also recognized that SMOKIs (small molecule oral kinase inhibitors)such as regorafenib, sorafenib, pazopanib, and sunitinib have overlapping panels of kinases that are inhibited simultaneously. While not equivalent, most of these SMOKIs (small molecule oral kinase inhibitors) block vascular endothelial growth factor and platelet derived growth factors receptors (VEGFRs and PDGFRs), speaking to a common mechanism of action of several of these agents\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patients must have histologically or cytologically confirmed advanced/metastatic liposarcoma, osteogenic sarcoma, or Ewing/Ewing-like sarcoma of soft tissue or bone. This study will accept the diagnosis made at the investigator's center.\n - WHO Performance Status 0, 1 or 2. A maximum of 1/3 of patients in cohorts A & B may be WHO performance status 2.\n - At least one prior line of systemic therapy for the sarcoma diagnosis (neoadjuvant, adjuvant or metastatic disease).\n - All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v 4.0 Grade 1 or less (except alopecia) at the time of signing the Informed Consent Form (ICF).\n - Subject must be able to swallow and retain oral medication.\n - At least one site of measurable disease on x-ray/CT/MRI scan as defined by RECIST 1.1. Baseline imaging must be performed within 28 days of Day 1 of study.\n - Adequate organ function within 14 days of registration INR (International Normalized Ratio) : patients with no prior evidence of underlying abnormality in coagulation parameters exists, according to the written documentation of the treating physician\n - Evidence of progression of disease as defined by RECIST 1.1 (i.e. new disease sites or 30% growth of index lesions) within 6 months of registration\n - Patients with central nervous system disease are eligible for enrollment if they have received prior radiotherapy or surgery to sites of CNS (central nervous system) metastatic disease and are without evidence of clinical progression for at least 12 weeks after therapy.\n Exclusion Criteria:\n - Patients with documentation of well differentiated liposarcoma only (of the well differentiated/dedifferentiated liposarcoma family) are specifically excluded, owing to its characteristically slow growth. If high grade areas are suspected (dedifferentiation), but not proved by pathology analysis (e.g. after primary resection of a well-differentiated liposarcoma), a biopsy must be performed to demonstrate the high-grade dedifferentiated disease.\n - Prior systemic therapy with a small molecule oral kinase inhibitor, including but not limited to: pazopanib, sunitinib, sorafenib, everolimus, sirolimus, vemurafenib, dasatinib.\n - Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study. Patients who progress on placebo are specifically allowed to enroll on the treatment arm of the study if they meet all other entry criteria.\n - Concurrent, clinically significant, active malignancies within 12 months of study enrollment\n - Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol.\n - Major surgery within 28 days prior to study registration or those patients who have not recovered adequately from prior surgery\n - Patients who have received wide field radiotherapy ≤ 28 days (defined as > 50% of volume of pelvis bones or equivalent) or limited field radiation for palliation < 14 days prior to study registration or those patients who have not recovered adequately from side effects of such therapy.\n - Patients who have received prior systemic therapy < 14 days prior to study registration or have not recovered adequately from toxicities to CTCAE v. 4.0 grade 1 or less; prior investigational therapy may not have been given < 5 half-lives of last dose of treatment, or < 14 days, whichever is greater.\n - Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v 4.0] on repeated measurement) despite optimal medical management.\n - Active or clinically significant cardiac disease including: Congestive heart failure-New York Heart Association (NYHA) > class II, Active coronary artery disease, Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, Unstable angina (anginal symptoms at rest), new onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization3.2.11\n - Evidence or history of bleeding diathesis or coagulopathy\n - Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to study registration\n - Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment\n - Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.\n - Ongoing infection > Grade 2 NCI-CTCAE v 4.0\n - Presence of a non-healing wound, non-healing ulcer, or benign bone fracture (patients with stress insufficiency fractures e.g. from osteoporosis or pathological fracture from tumor are eligible for study)\n - Patients with seizure disorder requiring medication\n - Persistent proteinuria: Grade 3 NCI-CTCAE v 4.0 (> 3.5 g/24 h, measured by urine protein:creatinine ratio on a random urine sample)\n - Interstitial lung disease with ongoing signs and symptoms at the time of informed consent\n - Pleural effusion or ascites that causes respiratory compromise (≥ NCI-CTCAE version 4.0 Grade 2 dyspnea)\n - History of organ allograft (including corneal transplant).\n - Known or suspected allergy or hypersensitivity to regorafenib, or excipients of the formulations given during the course of this trial.\n - Any malabsorption condition.\n - Women who are pregnant or breast-feeding.\n - Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.\n - Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.\n - Inability to comply with protocol required procedures.\n - Use of any herbal remedy (e.g. St. John wort [Hypericum perforatum]).\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nAssessment of GERD Knowledge Level Among Patients With it in Korea\n\n**Clinical Trial Summary:**\n\n- 1. Research topic: How much do patients with GERD know about their own disease in Korea? (multicenter survey)\n - 2. Questionnaires for multicenter survey:\n 1. Questionnaire 1 - include items for basic characteristics of participant patients\n 2. Questionnaire 2 - modification of GERD knowledge test which was used in BMC Health Services Research 2008;8:236 (Prof. Jorgen Urnes)\n - 3. Subjects: patients with GERD in secondary or tertiary hospital\n - 4. Participant institutes: GERD club members, The Korean Society of Neurogastroenterology and Motility\n\n**Clinical Trial Detailed Description:**\n\nValidation process to produce Korean version of GERD knowledge test\n 1. Forward Translation of GERD knowledge test of prof. Jorgen Urnes: through certified translation company\n 2. Expert's review of the forward translated knowledge test : among members of GERD club,\n 3. Pilot survey among nurses and some patients\n 4. Korean Version, provisional\n 5. Backward translation: through certified translation company\n 6. Consultation with Prof. Jorgen Urnes about backward translated knowledge test\n 7. Korean Version, final\n 8. Print and distribution\n 9. Study start\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patients who were diagnosed as GERD by doctors\n Exclusion Criteria:\n - Patients without GERD\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Dose Finding Study Followed by a Safety and Efficacy Study in Patients With Advanced Solid Tumors or Multiple Myeloma With FGF/FGFR-Related Abnormalities\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine the safety of TAS-120 and determine the most appropriate dose for the subsequent phase 2 safety and efficacy study in patients with advanced solid tumors and multiple myeloma with genetic abnormalities.\n The progression of cancers is caused by a complex series of multiple genetic and molecular events leading to changes in the patients DNA. The fibroblast growth factor/fibroblast growth factor receptor (FGF/FGFR) signaling pathway is important for normal organ, vascular and skeletal development. However, FGFR gene abnormalities have been linked to various cancers.\n TAS-120 is a highly potent, selective small molecule inhibitor of FGFR and is therefore is being studied as a therapy for cancer.\n\n**Clinical Trial Detailed Description:**\n\nBackground and rationale for study:\n - Activating fibroblast growth factor receptor (FGFR) gene abnormalities are reported in various cancers including non-small cell lung cancer (NSCLC) (FGFR1 amplification), breast (FGFR1 and 2 amplification), gastric (FGFR2 amplification), bladder (FGFR3 activating mutation or gene translocation), endometrial (FGFR2 activating mutation), multiple myeloma (FGFR3 gene translocation), and rhabdomyosarcoma (FGFR4-activating mutation).\n - TAS-120 is a novel, highly potent and selective small molecule FGFR inhibitor.\n Phase 1 Dose Escalation:\n Primary\n • To investigate the safety and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of TAS-120 in patients with advanced solid tumors with or without FGF/FGFR abnormalities for whom no available therapy is likely to convey clinical benefit.\n Secondary\n - To investigate the clinical pharmacokinetics (PK) of TAS-120.\n - To investigate the clinical pharmacodynamics of TAS-120.\n - To determine any preliminary antitumor activity observed with TAS-120.\n Phase 1 Expansion and Phase 2:\n Primary •To investigate the efficacy of the TAS-120 RP2D in patients with advanced solid tumors or multiple myeloma, with FGF/FGFR abnormalities for whom no available therapy is likely to convey clinical benefit.\n Secondary\n •To investigate the safety of TAS-120.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n Provide written informed consent.\n Is ≥18 years of age.\n Patients with confirmed advanced metastatic solid tumor(s) with or without abnormalities of FGF/FGFR who have failed all standard therapies or for whom standard therapy does not exist.\n Patients with confirmed multiple myeloma with amplification, mutation or translocation or other associated abnormalities of FGF/FGFR who have failed all standard therapies or for whom standard therapy does not exist.\n Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n Women of child-bearing potential must have a negative pregnancy test\n Exclusion Criteria:\n History of endocrine alteration of calcium-phosphorus homeostasis.\n History of ectopic mineralization/calcification\n Current evidence of corneal disorder/keratopathy\n History or current evidence of cardiac arrhythmia and/or conduction abnormality.\n QTc > 470 msec on ECG conducted during Screening period\n Treatment with any of the following within the specified time frame prior to the first dose of TAS-120:\n 1. Major surgery within the previous 4 weeks\n 2. Radiotherapy for extended field within 4 weeks\n 3. Any noninvestigational anticancer therapy within 3 weeks\n 4. Any medication administered within 7 days prior to first dose of TAS-120 that is known to affect QT interval\n 5. Any investigational agent received either concurrently or within the previous 30 days.\n A serious illness or medical condition(s)\n Known hypersensitivity to TAS-120 or any drugs similar to it in structure or class.\n Pregnant or lactating female.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nNY-ESO-1 Specific T Cells After Cyclophosphamide in Treating Patients With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma\n\n**Clinical Trial Summary:**\n\nThis phase I trial studies the side effects and best way to give NY-ESO-1 specific T cells after cyclophosphamide in treating patients with advanced synovial sarcoma or myxoid/round cell liposarcoma. Placing a gene that has been created in the laboratory into white blood cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving NY-ESO-1 specific T cells with cyclophosphamide may kill more tumor cells.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\n I. To confirm the safety and efficacy of cancer-testis antigen (NY-ESO-1) specific T cells (autologous NY-ESO-1-specific cluster of differentiation [CD]8-positive T lymphocytes) in patients with advanced synovial sarcoma and myxoid/round cell liposarcoma following conditioning with high dose cyclophosphamide.\n SECONDARY OBJECTIVES:\n I. To confirm the persistence of NY-ESO-1 tetramer positive cells in the peripheral blood at 10 weeks after T cell infusion for synovial sarcoma and myxoid/round cell liposarcoma patients receiving NY-ESO-1 specific T cells following cyclophosphamide conditioning but not post-infusion interleukin (IL)-2.\n OUTLINE:\n Patients receive cyclophosphamide intravenously (IV) on days -3 and -2 and NY-ESO-1 specific T cells IV over 60 minutes on day 0. Patients may receive additional infusions at the discretion of the Principal Investigator (PI).\n After completion of study treatment, patients are followed up for up to 12 weeks.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n INCLUSION CRITERIA FOR SCREENING:\n - Medical history including histopathological documentation of sarcoma\n - Informed consent and Health Insurance Portability and Accountability Act (HIPAA) signing\n CRITERIA FOR LEUKAPHERESIS:\n - NY-ESO-1 expression in tumor by immunohistochemistry (IHC) is not required prior to screening consent; however, patients must have NY-ESO-1 expression to proceed with the leukapheresis; additionally patients must also meet the following criteria to proceed with leukapheresis (any exceptions to this will require prior approval by the Apheresis director and Principal Investigator):\n - Physical exam and Karnofsky performance status\n - Laboratory evaluation:\n - Complete blood count (CBC), differential and platelet count\n - Basic metabolic and hepatic function panels\n - Puget Sound Blood Center Recipient Donor Battery Panel\n - Pregnancy test for females of child-bearing potential\n - Pulse > 45 and < 120\n - Weight >= 45 kg\n - Temperature =< 38 Celsius (C) (=< 100.4 Fahrenheit [F])\n - White blood cell (WBC) >= 2,000\n - Hematocrit (HCT) >= 30%\n - Platelets >= 75,000\n - Research blood including 40 mL of blood in a heparinized tube for peripheral blood mononuclear cell (PBMC) collection and 10 mL of blood for serum collection (generally in a red top tube) within 30 days of leukapheresis collection\n INCLUSION CRITERIA FOR TREATMENT:\n - A diagnosis of synovial sarcoma or myxoid/round cell liposarcoma\n - Patients must have \"advanced disease\"; usually, this will mean metastatic disease; this may also be multiply recurrent disease or locally advanced disease; locally advanced disease is defined for this study as disease where a mutilating surgery is required and the patient is more likely than not to die of their disease despite an aggressive operation; patients with metastatic disease that has been resected or radiated are allowed to participate; Response Evaluation Criteria in Solid Tumors (RECIST) evaluable disease is not necessary for participation\n - NY-ESO-1 positive by IHC (for this study, even a small level of positivity is acceptable); for patients with < 5% NY-ESO-1 by IHC positivity, the level of staining should be discussed with the patient and they should be informed that this will likely effect the efficacy of the therapy; this conversation must be documented in the patient's medical chart\n - Human leukocyte antigen (HLA)-A0201 or HLA-A2402\n - Zubrod performance status of '0-1'\n - All patients must have an electrocardiogram (ECG) within 2 weeks of starting conditioning\n - All patients must have a stress test within 6 months of starting treatment showing no evidence of cardiac ischemia\n - All patients must have an echo or multi gated acquisition scan (MUGA) scan showing ejection fraction (EF) > 50% and normal troponin and creatine kinase (CK) myoglobin binding (MB) (echo may be done at the time of stress test as a stress echo); within 6 months of starting treatment; however if the patient has received cardiotoxic chemotherapy such as Adriamycin, they must have had an echo or MUGA scan since completing this treatment\n - If there is a patient with an NY-ESO-1 expressing soft tissue sarcoma who would be otherwise eligible for the trial, which is either not synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCL) or there is controversy about the diagnosis, eligibility will be decided by the PI\n - Patients must have NY-ESO-1 specific cells already produced or in production; these cells may be either in the process of their final expansion (for fresh infusion) or expanded and frozen at the time of enrollment\n Exclusion Criteria:\n - Patients for whom we are unable to generate NY-ESO-1 specific cells\n - Pregnant women, nursing women, and men and women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within two weeks prior to study entry\n - Serum creatinine > 1.6 mg/dL or glomerular filtration rate < 50\n - Serum glutamic oxaloacetic transaminase (SGOT) > 150 IU or > 3 x upper limit of normal\n - Bilirubin > 1.6 mg/dL\n - Prothrombin time > 1.5 x control\n - Active symptomatic congestive heart failure\n - Clinically significant hypotension (systolic blood pressure [SBP] < 80 mm HG or symptomatic)\n - Newly diagnosed cardiac arrhythmia; patients with an arrhythmia that has been stable for at least 6 months will be allowed to participate\n - Known untreated central nervous system (CNS) metastasis; patients with CNS metastasis will be allowed on study once treated\n - Patients with active systemic infections requiring antibiotics or chronic maintenance/suppressive therapy; once the infection in question has resolved and patient is off antimicrobial treatment, patients may participate\n - Systemic anticancer treatments (including chemotherapy and biologics) less than 3 weeks prior to T cell therapy; locally directed therapy (e.g. radiation) 2 weeks prior to cell infusion\n - Known clinically significant autoimmune disorders requiring systemic immunosuppression for control\n - Patients who are known to be human immunodeficiency virus (HIV) positive are not eligible for this study\n - Current treatment with steroids\n - Known infection with hepatitis B virus (HBV) and hepatitis C virus (HCV); (if a patient was not tested at the time of their leukapheresis, they must be tested prior to receiving T cell infusion; if testing was done for leukapheresis, this is adequate and does not need to be repeated)\n - Patients with a known history of proven myocarditis, pericarditis, and/ or endocarditis\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Anti-Cancer Activity of Trametinib in Combination With Palbociclib in Subjects With Solid Tumors\n\n**Clinical Trial Summary:**\n\nThis is a dose-escalation, Phase I/II, open-label, three-part study. Part 1 is designed to determine the recommended dose and schedule for the orally administered MEK inhibitor trametinib, given together with the CDK4/6 inhibitorpalbociclib in subjects with solid tumors. Multiple dose levels of each inhibitor will be tested to determine the recommended dose and schedule. Part 2 will evaluate the effect of the combination on tumor biomarkers safety, and anti-cancer activity in subjects with cutaneous melanoma that do not have a change at BRAFV600. Approximately 100-200 subjects will be enrolled. All subjects will receive trametinib and/or palbociclib until disease progression, death, consent withdrawal or unacceptable adverse event (AE).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Inclusion Criteria for Part 1 and Part 2\n - Subjects >=18 years old.\n - Signed written informed consent.\n - All prior anti-cancer treatment-related toxicities (except alopecia and laboratory values as listed in the protocol) must be <=grade 1 according to the Common Terminology Criteria for Adverse Events version 4 (CTCAE version 4.0) at the time of randomization.\n - Able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.\n - Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception as defined in the protocol.\n - Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception as described in the protocol.\n - An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n - Adequate baseline organ function as defined in the protocol.\n - Other Inclusion criteria for Part 1\n - Histologically or cytologically confirmed diagnosis of solid tumor malignancy that is not responsive to standard therapies or for which there is no approved or curative therapy.\n - Subjects with cutaneous melanoma must provide either a fresh or archived tumor sample for genetic analysis including determination of or confirmation of BRAF and NRAS genetic status based on local laboratory results. To ensure prompt delivery of tumor samples, tissue shipment tracking information must be provided before administration of study treatment can be initiated.\n - Other Inclusion criteria for Part 2\n - Measurable disease (i.e., present with at least one measurable lesion per RECIST, version 1.1).\n - Histologically or cytologically confirmed diagnosis of advanced or metastatic cutaneous melanoma that is determined to be BRAFV600 wild type and either NRAS wild type or NRAS mutation type. Note: Subjects with a melanoma of unknown primary origin may be allowed to enrol if all other types of melanoma (e.g., uveal, mucosal, or acral) can be reasonably ruled out.\n - Must provide either a fresh or archived tumor sample for genetic analysis.\n - Accessible tumor for biopsy and willingness to provide pre-dose tumor biopsies on Days 1 and Day 15.\n - Inclusion Criteria for Part 3\n - The inclusion criteria for Part 3 will be based on emerging data from Parts 1 and 2 and will be specified in an amendment.\n Exclusion Criteria:\n - Prior treatment with a MEK inhibitor or a CDK4/6 inhibitor.\n - BRAFV600 mutation positive.\n - For Part 1, subjects may have had any number of prior systemic anti-cancer treatments, but may not have received more than 2 schedules of myeloablative chemotherapy. For Parts 2 and 3, more than two prior systemic anti-cancer treatment (chemotherapy, immunotherapy, biologic therapy, vaccine therapy, or investigational treatment) for Stage IIIC (unresectable) or Stage IV (metastatic) melanoma are not permitted. Prior systemic treatment in the adjuvant setting is allowed. (Note: Ipilimumab treatment must end at least 8 weeks prior to Study Day 1 (Parts 1 and 2) or randomization (Part 3.)\n - Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to Study Day 1 (Parts 1 and 2) or randomization (Part 3), or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to Study Day 1 (Parts 1 and 2) or randomization (Part 3).\n - Taken an investigational drug within 28 days or 5 half-lives (minimum 14 days), whichever is shorter, prior to Study Day 1 (Parts 1 and 2) or randomization (Part 3).\n - Current use of a prohibited medication as described in the protocol.\n - History of another malignancy (Part 3 only). Exception: Subjects who have been disease-free for 3 years, or subjects with a history of completely resected, non-melanoma skin cancer, or subjects with indolent second malignancies are eligible. T1a melanoma and melanoma in situ are permitted. Consult GlaxoSmithKline (GSK) Medical Monitor if unsure whether second malignancies meet requirements specified above.\n - Any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that could interfere with the subject's safety, obtaining informed consent, or compliance with study procedures.\n - Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (subjects with laboratory evidence of cleared HBV and HCV infection will be permitted).\n - History of leptomeningeal disease or spinal cord compression secondary to metastasis.\n - Brain metastasis, unless previously treated with surgery or stereotactic radiosurgery and the disease has been confirmed stable (i.e., no increase in lesion size, and stable or decreased doses of corticosteroids) for at least 6 weeks with two consecutive scans prior to Study Day 1 (Parts 1 and 2) or randomization (Part 3). (Enzyme inducing anticonvulsants are not allowed while subjects are on study treatment. Prior whole-brain radiation as adjuvant treatment is allowed.)\n - A history or evidence of cardiovascular risk including any of the following: A QT interval corrected for heart rate using the Fridericia's formula (QTcF) >=480 millisecond (msec); A history or evidence of current clinically significant uncontrolled arrhythmias; Exception: Subjects with atrial fibrillation controlled for >30 days prior to Study Day 1 (Parts 1 and 2) or randomization (Part 3); History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to Study Day 1 (Parts 1 and 2) or randomization (Part 3); A history or evidence of current >=Class II congestive heart failure as defined by the New York Heart Association (NYHA) guidelines; Treatment refractory hypertension defined as a blood pressure of systolic>140 millimeters of mercury (mmHg) and/or diastolic >90 mmHg which cannot be controlled by anti-hypertensive therapy; Patients with intra-cardiac defibrillators or permanent pacemakers; Known cardiac metastases.\n - A history or current evidence/risk of Retinal Vein Occlusion (RVO) or Central Serous Retinopathy (CSR) including: History of RVO or CSR, or predisposing factors to RVO or CSR (e.g. uncontrolled glaucoma or ocular hypertention, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes); or Visible retinal pathology as assessed by ophthalmic examination that is considered a risk factor for RVO or CSR such as: Evidence of new optic disc cupping; Evidence of new visual field defects; Intraocular pressure >21 mmHg as measured by tonography.\n - Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study treatments, their excipients, and/or dimethyl sulfoxide (DMSO).\n - History of interstitial lung disease or pneumonitis.\n - Females who are nursing.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** possibly relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nTrabectedin First Line Therapy In Unfit Sarcoma Study\n\n**Clinical Trial Summary:**\n\nPhase II, non-randomized, two-stage study according to Bryant & Day The study enroll patients with Metastatic and locally advanced soft tissue sarcoma unfit to receive standard chemotherapy (doxorubicin/epirubicin and/or ifosfamide)\n\n**Clinical Trial Detailed Description:**\n\nSoft tissue sarcomas are a group of rare and aggressive disease, comprising more than a hundred different histological subtypes and mainly originating from the embryonic mesoderm. Today, they represent less than 1% of all adult cancers, with an incidence of 3/100000/year and a median age at diagnosis of 65 years. Despite the progress done in the last decade, approximately 50% of STS patients still develop distant metastases within 3 years from the diagnosis and die from their disease. Doxorubicin (or epirubicin) and ifosfamide have been proved to be active in the treatment of STS and they are widely used, alone or in combination, as a first line therapy for locally advanced and metastatic patients. However, the response rate to the combination regimen in non-pretreated patients does not exceed 30-40%, and large randomized clinical trials failed to demonstrate any advantage in survival for the combination compared to single-agent treatment. Trabectedin (Yondelis®) is a marine-derived anticancer agent that has been approved in the European Union as a single agent for the treatment of STS patients after failure of standard chemotherapy (doxorubicin and/or ifosfamide) or for those unsuited to receive these agents. Even if the response rate in soft tissue sarcoma does not exceed 10%, trabectedin can provide a significant clinical benefit, by arresting disease progression in almost 50% of treated patients, with a progression-free survival rate of 20% at 6 months. Trabectedin was found to be particularly active in the treatment of myxoid liposarcoma and uterine leiomyosarcoma, for which better results have been obtained in terms of response rate and survival, suggesting an histotype driven activity. The toxicity profile of trabectedin given as second line therapy has been widely assessed in clinical studies and was largely manageable, with the majority of adverse events being grade 1 or 2 toxicities, generally reversible, dose or time dependent and noncumulative. The good tolerability profile observed in the trials seems to be confirmed also in everyday clinical practice. Conversely, few data are available at the moment about tolerability profile for those patients treated with trabectedin as first line because of medical conditions contraindicating the use of standard agents. The aim of this phase II study is to assess and describe trabectedin toxicity profile in this subset of negatively selected advanced inoperable STS patients.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria\n - Adult patients (≥18 years), who, in the judgment of the clinician, is deemed not suitable to receive an anthracycline and/or ifosfamide based chemotherapy;\n - Pathological diagnosis of soft tissue sarcoma\n - Inoperable, locally advanced or metastatic tumor;\n - Unsuited to receive doxorubicine and ifosfamide: ie stable arrhythmia, previous myocardial infarction; age≥80 years\n - Eastern Cooperative Oncology Group Performance Status 0-2\n - Glomerular filtration rate ≥30 mL per min\n - Adequate hematologic function: Hemoglobin ≥9 g/dL; Absolute neutrophil count ≥1,500/μL, and Platelet count ≥100,000/microliter\n - Creatinine phosphokinase < 2.5 Upper Normal Limit\n - Adequate hepatic function: total bilirubin < Upper Normal Limit, total alkaline phosphatase < 2.5 Upper Normal Limit, or if > 2.5 Upper Normal Limit consider alkaline phosphatase liver fraction or gamma-glutamyltransferase or 5' nucleotidase must be < Transminase <2.5 x Upper Normal Limit, Albumin > 20 g/L.\n - Patient´s written informed consent\n Exclusion criteria\n - Prior exposure to Trabectedin\n - Performance status ≥2.\n - Prior treatment with anthracyclines and or ifosfamide.\n - History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission for 5 or more years and judged of negligible potential of relapse.\n - Active viral hepatitis or chronic liver diseases, which in the judgement of the primary investigator represents a clinical contraindication to the therapy.\n - Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within 6 months before enrolment, uncontrolled arterial hypertension or arrhythmias, left ventricular ejection fraction <40%\n - Active major infection.\n - Other serious concomitant illnesses\n - Pregnant subjects or breast feeding, or planning to become pregnant within 6 months after the end of treatment All sexually active female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to enrollment and must agree to use highly effective contraception during treatment and for 6 months after the end of treatment.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nDose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas\n\n**Clinical Trial Summary:**\n\nTo study the feasibility of reducing the dose of preoperative radiotherapy in MLS (Myxoid Liposarcomas) from 50 Gy to 36 Gy while maintaining comparable clinicopathological responses.\n\n**Clinical Trial Detailed Description:**\n\n- A Bayesian approach is considered for the analysis of this trial. The aim is to provide a stopping rule for inefficacy of the new dose.\n - Two aspects are important to elucidate the mechanism of this treatment: dynamic investigations of perfusion and vasculature. Apart from participation to the dose reduction paragraphs of this study, patients will be also asked to undergo, at clinically relevant dose points, dynamic contrast enhanced (DEC) MRI scans and separately tumor biopsies.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Age above or equal to 18 years\n 2. Biopsy proven MLS (including the reciprocal chromosomal translocation t(12;16)(q13;p11); A the primary sarcoma in case of non-metastatic disease for management is with curative intent (regimen to be chosen = 18 x 2 GY) B in case of oligometastatic patients, the metastasis may also be irradiated to a dose of 36 GY in order to postpone the time interval to next systemic chemotherapy. These patients are usually not operated upon and the total dose may also be reached in 12 times 3 Gy, for convenience purposes (see paragraph 10 for radiobiological considerations).\n 3. ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) 0-2\n 4. Patients must be able (physically, mentally and socially) to complete a series of RT, followed by an observation period of 4-6 weeks and undergo surgery.\n 5. Written informed consent\n Exclusion Criteria:\n 1. Prior radiotherapy to the target area.\n 2. Anticoagulant medication of any kind; especially Ascal®(and derivates), coumarines (Sintrom® and Marcoumar®), all heparin and heparin-like formulations. (Note: this exclusion criterion only applies for patients consenting to the translational research part of the study; patients on anticoagulant medication as described above may take part in the dose reduction part of the study, but the repeat biopsies may not be taken.)\n 3. Pregnancy -\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nStudy of Doxorubicin and Trabectedin in First Line Treatment on Patients With Metastatic Leiomyosarcoma\n\n**Clinical Trial Summary:**\n\nUterine leiomyosarcomas and soft tissues are rare tumors with a poor prognosis when metastatic or locally advanced. They have an average chemosensitivity mainly to doxorubicin, ifosfamide, cisplatin, gemcitabine and trabectedin but response rates in combination in first line does not exceed 55% for uterine leiomyosarcomas and 35% for leiomyosarcomas of soft tissue.\n The trabectedin is a new cancer drug that has obtained marketing authorization after failure of anthracyclines and ifosfamide in the treatment of soft tissue sarcomas (STM) in Europe. It has especially shown efficacy in myxoid liposarcomas, leiomyosarcomas and synoviosarcoma.\n This study aims to evaluate the usefulness of the combination of trabectedin with doxorubicin in first-line treatment of uterine or soft tissue leiomyosarcoma.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Metastatic leiomyosarcoma (uterus or soft tissue) in inoperable relapse with no previous chemotherapy\n - At least one measurable lesion according to RECIST criteria before inclusion. At least one of the target is in a none irradiated area\n - Aged >/= 18 years and physiological age </= 70 years\n - PS </= 2\n - Normal hematological function (Polymorphonuclear Neutrophils >/= 1500/mm3, platelets >/= 100 000/mm3)\n - Normal kidney function (creatinine < 1.5xN)\n - Creatinine phosphokinase </= 2.5xN\n - Normal hepatic function (total bilirubin </= 1xN; transaminase </= 2.5xN and alkaline phosphatase </= 1.5xN)\n - Cardiac function: normal echography and/or isotopic ventriculography (FR>30%, FEVG > 50%)\n - Patients able to procreate must use a birth control device during treatment and during 3 months after treatment for women; 5 months for men\n - Signed informed consent\n - Patient under affiliated to a system of care\n Exclusion Criteria:\n - Any other histological type of uterus sarcoma (carcinosarcoma...) or soft tissue\n - Specific contraindication to the treatment\n - Previous or evolutive mental disease\n - Previous cancer\n - Symptomatic or known brain metastasis\n - Previous radiotherapy ont he only measurable lesion\n - Previous allograft or autograft\n - Known positive serology (HIV, HbC, HbS)\n - Pregnant or breastfeeding women\n - Impossibility to follow the treatment for geographical, social or mental reason\n - Patients under legal protection\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nThe Changes of Ryodoraku and HRV After PPI Treatment in GERD Patients\n\n**Clinical Trial Summary:**\n\nGastroesophageal reflux disease(GERD) mainly related to the reflux of stomach content induced by the dysfunction of lower esophageal sphincter. Proton pump inhibitors (PPI) can effectively block gastric acid secretion but the drug reactions and the degree of improvement in symptoms are sometimes unpredictable. The aim of this study is to investigate the association between the clinical efficacy of PPI in patients with GERD and the personal physical status by Ryodoraku and ANSWatch.\n\n**Clinical Trial Detailed Description:**\n\nGastroesophageal reflux disease(GERD) is a common disease, mainly related to the reflux of stomach content induced by the dysfunction of lower esophageal sphincter. The common symptoms of GERD are heartburn, acid regurgitation, chest pain and globus hystericus. The methods to treat GERD are changes of lifestyle, pharmacotherapy, antireflux surgery and endoscopy. Proton pump inhibitors (PPI) can effectively block gastric acid secretion and promote the repair of esophagus, but the drug reactions and the degree of improvement in symptoms are sometimes unpredictable. Recently there are many instruments used to analyze personal physical status. Meridian energy analysis device ( Ryodoraku ) is used to assess the energy of meridian system by analysis of resistance of the skin surface, as well as the wrist-worn heart rate monitor (ANSWatch) used to assess the autonomic nervous system by analysis of heart rate variability. Therefore, the aim of this study is to investigate the association between the clinical efficacy of PPI in patients with GERD and the personal physical status by Ryodoraku and ANSWatch.\n Investigators will recruit 120 patients with GERD in clinic who have to receive PPIs for four weeks and assess each volunteer before and after taking the medication. Assessment methods : 1. ANSWatch to assess the autonomic nervous system, 2. Ryodoraku to assess the energy of meridian system, 3. Upper gastrointestinal endoscopy to assess the grade of reflux esophagitis, 4. gastroesophageal reflux disease questionnaire to assess the severity of GERD. Investigators analysed and compared the database from the assessments between before and after taking the medication.\n Investigators anticipate to substantiate that the changes of Ryodoraku and ANSWatch are good predictors for the clinical efficacy of PPI in patients with GERD.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - male or female\n - age of 20-75 years\n - patients with GERD who have to receive PPIs for four weeks\n Exclusion Criteria:\n - Suffering from peptic ulcer, gallstones, cancer, and Barrett's esophagus\n - previously underwent the esophagus, stomach or duodenum surgery\n - Lactating women or pregnant women\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nS1400 Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer\n\n**Clinical Trial Summary:**\n\nThis screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid \"Master Protocol\" (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a \"non-match\" sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\n Screening component:\n I. To establish a National Clinical Trials Network (NCTN) mechanism for genomically screening large but homogeneous cancer populations and subsequently assigning and accruing simultaneously to a multi-sub-study \"Master Protocol.\" II. To evaluate the screen success rate defined as the percentage of screened patients that register for a therapeutic sub-study.\n Sub-study-specific Objectives:\n Design #1: Phase II/III Design:\n III. To evaluate if there is sufficient evidence to continue to the Phase III component of the sub-study by comparing investigator-assessed progression-free survival (IA-PFS) between investigational therapy versus standard therapy (SoC) in patients with advanced stage refractory squamous cell carcinoma (SCCA) of the lung. (Phase II) IV. To determine if there is both a statistically and clinically-meaningful difference in IA-PFS among advanced stage refractory SCCA of the lung randomized to receive investigational therapy versus SoC. (Phase III) V. To compare overall survival (OS) in patients with advanced stage refractory SCCA of the lung randomized to investigational therapy versus SoC. (Phase III)\n Design #2: Phase II followed by Phase III (Sequential Phase II to Phase III):\n VI. To evaluate the objective response rate (confirmed and unconfirmed, complete and partial). (Phase II) VII. To determine if there is both a statistically and clinically-meaningful difference in IA-PFS among advanced stage refractory SCCA of the lung randomized to receive investigational therapy versus SoC. (Phase III) VIII. To compare overall survival (OS) in patients with advanced stage refractory SCCA of the lung randomized to investigational therapy versus SoC. (Phase III)\n SECONDARY OBJECTIVES:\n Sub-study-specific Objectives:\n Design #1: Phase II/III Design:\n I. To compare response rates (confirmed and unconfirmed, complete and partial responses) among patients randomized to receive investigational therapy versus SoC. (Phase II) II. To evaluate the frequency and severity of toxicities associated with investigational therapy versus SoC. (Phase II) III. To evaluate the duration of response (DoR) among patients who achieve a complete response (CR) or a partial response (PR) by Response Evaluation Criteria In Solid Tumors (1.1). (Phase II) III. To compare the response rates (confirmed and unconfirmed, complete and partial) among patients randomized to receive investigational therapy versus SoC. (Phase III) IV. To evaluate the frequency and severity of toxicities associated with investigational therapy versus SoC. (Phase III)\n Design #2: Phase II followed by Phase III (Sequential Phase II to Phase III):\n V. To evaluate PFS and OS with investigational therapy. (Phase II) VI. To evaluate the DoR among patients who achieve a CR or PR (confirmed and unconfirmed) by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. (Phase II) VII. To evaluate the frequency and severity of toxicities associated with investigational therapy. (Phase II) VIII. To compare the response rates (confirmed and unconfirmed, complete and partial) among patients randomized to receive investigational therapy versus SoC. (Phase III) IX. To evaluate the frequency and severity of toxicities associated with investigational therapy versus SoC. (Phase III)\n TERTIARY OBJECTIVES:\n I. To evaluate the treatment arm randomization acceptance rate (TARAR) within each treatment arm of each sub-study defined as the percentage of patients randomized to a treatment arm that receive any protocol treatment. (Design #1: Phase II/III Design) II. To identify additional predictive tumor/blood biomarkers that may modify response or define resistance to the targeted therapy (TT)/targeted therapy combination (TTC) beyond the chosen biomarker for biomarker-driven sub-studies.\n III. To evaluate potentially predictive biomarkers for non-match therapy (NMT) in the non-match studies.\n IV. To identify potential resistance biomarkers at disease progression. V. To establish a tissue/ blood repository from patients with refractory SCCA of the lung.\n OUTLINE: Patients are assigned to a biomarker-driven targeted therapy phase II study. If the objectives response rate observed is judged sufficient, patients proceed to a randomized phase III trial and are randomized to biomarker-driven targeted therapy or standard of care.\n S1400A: (Closed to accrual 12/2015) Patients with tumors that do not match one of the currently active drug-biomarker combinations or did not meet the eligibility requirements for that bio-marker driven sub-study are assigned to Arm I. Upon evidence of progression following discontinuation of 12 months of treatment, patients may restart treatment for up to 12 months with the same treatment guidelines followed during the initial 12-month treatment period (Arm III).\n ARM I: (Closed to accrual 12/2015) Patients receive anti-B7H1 monoclonal antibody MEDI4736 intravenously (IV) over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity.\n ARM II (CLOSED TO ACCRUAL 4/2015): Patients receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15)\n ARM III: For patients assigned to Arm 1, MEDI4736: Upon evidence of progression following discontinuation of 12 months of treatment, patients may restart treatment with Arm 3, MEDI4736 for up to 12 months with the same treatment guidelines followed during the initial 12-month treatment period. Patients will only be able to restart treatment once; thus a maximum of two 12-month periods will be allowed. Patients receive anti-B7H1 monoclonal antibody MEDI4736 intravenously (IV) over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity.\n S1400B: Patients with tumors positive for phosphoinositide 3-kinase (PI3KCA) are assigned to Arm I. Patients currently on Arm 2, docetaxel will be given the option to re-register to Arm 3, GCD-0032 after disease progression on current treatment (Arm III).\n ARM I: Patients receive taselisib orally (PO) daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n ARM II (CLOSED TO ACCRUAL 12/18/2015): Patients receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #3 12/18/2015)\n ARM III: Re-Registration Treatment with GDC-0032 (Taselisib) Upon progression patients in Arm 2 may be eligible for Re-Registration to receive GDC-0032. Patients receive taselisib orally (PO) daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n S1400C: Patients with tumors positive for cyclin dependent kinase 4 (CDK4), cyclin D1 (CCND1), cyclin D2 (CCND2), and cyclin D3 (CCND3) are assigned to Arm I. Patients currently on Arm 2, docetaxel will be given the option to re-register to Arm 3, palbociclib, after disease progression on current treatment (Arm III).\n ARM I: Patients receive palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n ARM II (CLOSED TO ACCRUAL 12/18/2015): Patients receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #3 12/18/2015)\n ARM III: Re-Registration Treatment with Palbociclib. Upon progression patients in Arm 2 may be eligible for Re-Registration to receive palbociclib. Patients receive palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n S1400D: Patients with tumors positive for fibroblast growth factor receptor (FGFR) 1, FGFR2, and FGFR3 are assigned to Arm I. Patients currently on Arm 2, docetaxel will be given the option to re-register to Arm 3, AZD4547, after disease progression on current treatment (Arm III).\n ARM I: Patients receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n ARM II (CLOSED TO ACCRUAL 12/18/2015): Patients receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #3 12/18/2015)\n ARM III: Re-Registration Treatment with AZD4547. Upon progression patients in Arm 2 may be eligible for Re-Registration to receive AZD4547. Patients receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n S1400E (CLOSED TO ACCRUAL 11/2014): Patients with tumors positive for met proto-oncogene (MET) are randomized to 1 of 2 treatment arms. (permanently closed to accrual on 11/25/14)\n ARM I: Patients receive rilotumumab IV on day 1 and erlotinib hydrochloride PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n ARM II: Patients receive erlotinib hydrochloride PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n S1400I: Patients with tumors that do not match one of the currently active drug-biomarker combinations or did not meet the eligibility requirements for that bio-marker driven sub-study are randomized to 1 of 2 treatment arms.\n ARM I: Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third course. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.\n ARM II: Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.\n After completion of study treatment, all patients are followed up periodically for up to 3 years from date of screening registration.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - SCREENING/PRE-SCREENING REGISTRATION:\n - Patients must have pathologically proven squamous cell carcinoma (SCCA) cancer of the lung confirmed by tumor biopsy and/or fine-needle aspiration; disease must be stage IV SCCA, or recurrent; the primary diagnosis of SCCA should be established using the current World Health Organization (WHO)/International Association for the Study of Lung Cancer (IASLC)-classification of Thoracic Malignancies; the diagnosis is based on hematoxylin and eosin (H&E) stained slides with or without specific defined immunohistochemistry (IHC) characteristic (p40/p63 positive, transcription termination factor [TTF1] negative) if required for diagnosis; mixed histologies are not allowed\n - Patients must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment; patients will either consent to the screening consent or the pre-screening consent, not both; these criteria are:\n - Screening at progression on prior treatment: to be eligible for screening at progression, patients must have received at least one line of systemic therapy for any stage of disease (stages I-IV); at least one of these lines of therapy must have been a platinum-based chemotherapy regimen; patients must have progressed following the most recent line of therapy; for patients whose prior systemic therapy was for stage I-III disease only (i.e. patient has not received any treatment for stage IV disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that patient received that therapy\n - Pre-screening prior to progression on current treatment: to be eligible for pre-screening, current treatment must be for stage IV disease and patient must have received at least one dose of the current regimen; patients must have previously received or currently be receiving a platinum-based chemotherapy regimen; patients on first-line platinum-based treatment are eligible upon receiving Cycle 1, Day 1 infusion; Note: patients will not receive their sub-study assignment until they progress and the S1400 Notice of Progression is submitted\n - Patients must have adequate tumor tissue available, defined as >= 20% tumor cells and >= 0.2 mm^3 tumor volume; the local interpreting pathologist must review and sign off on the S1400 Local Pathology Review Form prior to screening/pre-screening registration; patients must agree to have this tissue submitted to Foundation Medicine for common broad platform Clinical Laboratory Improvement Amendments (CLIA) biomarker profiling; if archival tumor material is exhausted, then a new fresh tumor biopsy that is formalin-fixed and paraffin-embedded (FFPE) must be obtained; a tumor block or FFPE slides 4-5 microns thick must be submitted; bone biopsies are not allowed; if FFPE slides are to be submitted, at least 12 unstained slides plus an H&E stained slide, or 13 unstained slides must be submitted; however it is strongly recommended that 20 FFPE slides be submitted; Note: previous next-generation deoxyribonucleic acid (DNA) sequencing (NGS) will be repeated if done outside this study for sub-study assignment\n - Patients must not have a known epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) fusion\n - Patients must have Zubrod performance status 0-1 documented within 28 days prior to screening/pre-screening registration\n - Patients must also be offered participation in banking for future use of specimens\n - Patients must be willing to provide prior smoking history as required on the S1400 Onstudy Form\n - As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n - Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines\n - SUB-STUDY REGISTRATION:\n - Patients whose biomarker profiling results indicate the presence of an EGFR mutation or echinoderm microtubule-associated protein-like 4 (EML4)/ALK fusion are not eligible\n - Patients must have progressed per RECIST 1.1 following the most recent line of therapy\n - Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration; patients must have recovered (=< grade 1) from any side effects of prior therapy; localized palliative radiation therapy is allowed for symptom management, provided treatment is completed >= 14 days prior to sub-study registration; all other types of radiation must be completed >= 28 days prior to sub-study registration\n - Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI); the CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality; measurable disease must be assessed within 28 days prior to sub-study registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to sub-study registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form; patients whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration\n - Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study registration; patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 1 day prior to sub-study registration\n - Patient must have fully recovered from the effects of prior surgery at least 14 days prior to sub-study registration\n - Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable\n - Absolute neutrophil count (ANC) >= 1,500/mcl obtained within 28 days prior to sub-study registration\n - Platelet count >= 100,000 mcl obtained within 28 days prior to sub-study registration\n - Hemoglobin >= 9 g/dL obtained within 28 days prior to sub-study registration\n - Serum bilirubin =< institutional upper limit of normal (IULN) within 28 days prior to sub-study registration; for patients with liver metastases, bilirubin must be =< 5 x IULN\n - Either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN within 28 days prior to sub-study registration (if both ALT and AST are done, both must be =< 2 IULN); for patients with liver metastases, either ALT or AST must be =< 5 x IULN (if both ALT and AST are done, both must be =< 5 x IULN)\n - Serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50 mL/min using the following Cockcroft-Gault Formula within 28 days prior to sub-study registration\n - Patients must have Zubrod performance status 0-1 documented within 28 days prior to sub-study registration\n - Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia\n - Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection\n - Patients with a known history of human immunodeficiency virus (HIV) seropositivity must: 1) have undetectable viral load using standard HIV assays in clinical practice, 2) have cluster of differentiation (CD)4 count >= 400/mcL, 3) not require prophylaxis for any opportunistic infections (i.e., fungal, Mycobacterium avium complex [mAC], or pneumocystis jiroveci pneumonia [PCP] prophylaxis), and 4) not be newly diagnosed within 12 months prior to sub-study registration\n - Prestudy history and physical exam must be obtained within 28 days prior to sub-study registration\n - No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years\n - Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures\n - As part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the system\n - Patients with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)\n - Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nOvarian Cancer Treatment Platinum-sensitive Relapse - Cohort Study (PROSPECTYON)\n\n**Clinical Trial Summary:**\n\nThe French cooperative group GINECO proposes to implement an observational study to describe a real situation, in daily practice tolerance and methods of administration of trabectedin (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®, in ovarian platinum sensitive cancer relapse.\n\n**Clinical Trial Detailed Description:**\n\nPopulation : Patients aged 18 years and older with an epithelial ovarian cancer, fallopian tube or primary peritoneal with platinum-sensitive recurrent witch it was decided to initiate a treatment with trabectedin (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patients aged 18 years and over,\n - Patients with an epithelial ovarian cancer, fallopian tube or peritoneal who will receive Yondelis®-Caelyx® in relapse platinum-sensitive\n - Patients should be informed of the study orally and should not have any objection their data to be processed\n Exclusion Criteria:\n - Patient participation in a clinical trial\n - Patient non-affiliated to a social security scheme.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nRadiation Therapy With or Without Combination Chemotherapy or Pazopanib Hydrochloride Before Surgery in Treating Patients With Newly Diagnosed Non-Rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery\n\n**Clinical Trial Summary:**\n\nThis randomized phase II/III trial studies how well pazopanib hydrochloride, combination chemotherapy, and radiation therapy work and compares it to radiation therapy alone or in combination with pazopanib hydrochloride or combination chemotherapy in treating patients with newly diagnosed non-rhabdomyosarcoma soft tissue sarcomas that can be removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy works better when given with or without combination chemotherapy and/or pazopanib hydrochloride in treating patients with non-rhabdomyosarcoma soft tissue sarcomas.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\n I. To identify the dose of pazopanib (pazopanib hydrochloride) that is feasible when given in combination with radiation or chemoradiation in pediatric and adult patients newly diagnosed with unresected intermediate- and high-risk non-rhabdomyosarcoma soft tissue sarcomas (NRSTS).\n II. To compare the rates of near complete pathologic response (> 90% necrosis) with the addition of pazopanib to preoperative chemoradiation versus preoperative chemoradiation alone for potentially resectable > 5 cm, grade 3 intermediate to high risk chemotherapy-sensitive NRSTS in the phase II portion of the study for this cohort.\n III. To compare the rates of near complete pathologic response (> 90% necrosis) with the addition of pazopanib to preoperative radiotherapy versus preoperative radiotherapy alone for potentially resectable intermediate to high risk adult and pediatric NRSTS in the phase II portion of the study for this cohort (using a phase II decision rule to go onto the phase III portion of the study).\n IV. To compare the rates of event-free survival (EFS) with the addition of pazopanib to preoperative radiotherapy versus preoperative radiotherapy alone for localized intermediate to high risk adult and pediatric NRSTS in the phase III portion of the study for this cohort if the phase II decision rule is passed.\n SECONDARY OBJECTIVES:\n I. To estimate the rates of local failure, regional failure, distant metastasis free survival, disease-free survival, and overall survival with the addition of pazopanib to preoperative chemoradiation or preoperative radiation in intermediate to high risk adult and pediatric NRSTS.\n II. To compare the pattern of recurrence (local, regional and distant) between preoperative chemoradiation or radiation with the addition of pazopanib for adult and pediatric NRSTS.\n III. To define the toxicities of ifosfamide and doxorubicin (doxorubicin hydrochloride) chemotherapy and radiation when used in combination with pazopanib in intermediate to high risk adult and pediatric NRSTS.\n IV. To define the toxicities of preoperative radiotherapy when used in combination with pazopanib in intermediate to high risk adult and pediatric NRSTS.\n TERTIARY OBJECTIVES:\n I. To gain insight into the disease biology of childhood and adult NRSTS through analysis of actionable mutations and whole genome sequencing.\n II. To determine if microvessel density and circulating tumor deoxyribonucleic acid (DNA) predict response to pazopanib and outcome.\n III. To determine the effect of pazopanib on doxorubicin exposure in children and adults with NRSTS.\n IV. To evaluate change in fludeoxyglucose F 18 (FDG) positron emission tomography (PET) maximum standard uptake value (SUVmax) from baseline to week 10 or 13 in patients with unresected tumors and to correlate this change with pathologic response and EFS.\n V. To compare the rate of response by standard imaging and pathologic assessment to determine which correlates better with local tumor control, distant tumor control, EFS, and overall survival.\n OUTLINE: This is a dose-escalation study of pazopanib hydrochloride.\n CHEMOTHERAPY COHORT: Patients eligible for chemotherapy cohort are randomized to 1 of 2 treatment regimens.\n REGIMEN A:\n INDUCTION PHASE: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on weeks 1-12, ifosfamide intravenously (IV) over 2-4 hours on days 1-3 on weeks 1, 4, 7, 10, and doxorubicin hydrochloride IV over 1-15 minutes on days 1-2 on weeks 1 and 4. At least 24 hours after the completion of week 4 doxorubicin hydrochloride, patients undergo radiation therapy on weeks 4-10.\n SURGERY: Patients undergo surgery on week 13.\n CONTINUATION PHASE: Patients receive pazopanib hydrochloride PO QD on weeks 16-25, ifosfamide IV over 2-4 hours on days 1-3 on weeks 16 and 19, and doxorubicin hydrochloride IV over 1-15 minutes on days 1-2 on weeks 16, 19, and 22. At least 24 hours after the completion of doxorubicin hydrochloride, if required, patients undergo radiation therapy on weeks 16-25 for a total of 45 Gy. Patients with impaired wound healing within 6 weeks of the date of surgery, have week 16 chemotherapy postponed until radiation therapy (if needed) begins. Patients with impaired wound healing within 8 weeks of the date of surgery, are removed from protocol therapy effective the date 8 weeks after week 13 surgery.\n REGIMEN B:\n INDUCTION PHASE: Patients receive ifosfamide IV over 2-4 hours on days 1-3 on weeks 1, 4, 7, 10 and doxorubicin hydrochloride IV over 1-15 minutes on days 1-2 on weeks 1 and 4. At least 24 hours after the completion of week 4 doxorubicin hydrochloride, patients undergo radiation therapy on weeks 4-10.\n SURGERY: Patients undergo surgery on week 13.\n CONTINUATION PHASE: Patients receive ifosfamide IV over 2-4 hours on days 1-3 on weeks 16 and 19 and doxorubicin hydrochloride IV over 1-15 minutes on days 1-2 on weeks 16, 19, and 22. At least 24 hours after the completion of doxorubicin hydrochloride, if required, patients undergo radiation therapy on weeks 16-25 for a total of 45 Gy. Patients with impaired wound healing within 6 weeks of the date of surgery, have week 16 chemotherapy postponed until radiation therapy (if needed) begins. Patients with impaired wound healing within 8 weeks of the date of surgery, are removed from protocol therapy effective the date 8 weeks after week 13 surgery.\n NON-CHEMOTHERAPY COHORT: Patients eligible for non-chemotherapy cohort are randomized to 1 of 2 treatment regimens.\n REGIMEN C:\n INDUCTION PHASE: Patients receive pazopanib hydrochloride PO QD on weeks 1-9. Patients undergo radiation therapy on weeks 1-7.\n SURGERY: Patients undergo surgery on week 10.\n CONTINUATION PHASE: Patients receive pazopanib hydrochloride PO QD on weeks 13-25. Patients undergo radiation therapy on weeks 13-16 for a total of 50 Gy. Patients with impaired wound healing within 8 weeks of the date of surgery, are removed from protocol therapy effective the date 8 weeks after week 10 surgery.\n REGIMEN D:\n INDUCTION PHASE: Patients undergo radiation therapy on weeks 1-7.\n SURGERY: Patients undergo surgery on week 10.\n CONTINUATION PHASE: Patients undergo radiation therapy on weeks 13-16 for a total of 50 Gy. Patients with impaired wound healing within 8 weeks of the date of surgery, are removed from protocol therapy effective the date 8 weeks after week 10 surgery.\n After completion of study treatment, patients are followed up at 6, 12, 18, 24, 30, 36, 48, and 60 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Newly diagnosed and histopathologically confirmed, potentially resectable NRSTS of the extremity and trunk will be eligible for the chemotherapy or non-chemotherapy cohort based on:\n - Evidence of chemotherapy sensitivity of the histologic sarcoma subtype based on existing evidence from prior clinical trials\n - Sufficient risk of metastatic disease to warrant chemotherapy based on size and grade and\n - Medically deemed able or unable to undergo chemotherapy\n - Notes: an incisional biopsy or core biopsy is preferred; fine needle aspiration biopsy is not acceptable to establish the diagnosis\n - ELIGIBLE SITES:\n - Extremities: upper (including shoulder) and lower (including hip)\n - Trunk: body wall\n - INELIGIBLE SITES: Head and neck, visceral organs (with the exception of embryonal sarcoma of the liver), retroperitoneum, peritoneum, pelvis within the confines of the bony pelvis\n - ELIGIBILITY FOR CHEMOTHERAPY COHORT:\n - Stage T2a/b (> 5 cm) and grade 2 or 3 AND\n - One of the following chemosensitive histologies as defined in the World Health Organization (WHO) classification of soft tissue tumors (with some evidence of good response to chemoradiation and of sufficient high risk of metastases, or clear evidence of metastases):\n - Unclassified soft tissue sarcomas that are too undifferentiated to be placed in a specific pathologic category in the WHO classification (often called \"undifferentiated soft tissue sarcoma\" or \"soft tissue sarcoma not otherwise specified [NOS]\")\n - Synovial sarcoma\n - Angiosarcoma of soft tissue\n - Adult fibrosarcoma\n - Mesenchymal (extraskeletal) chondrosarcoma\n - Leiomyosarcoma\n - Liposarcoma (excluding myxoid liposarcoma)\n - Undifferentiated pleomorphic sarcoma\n - Embryonal sarcoma of the liver\n - Patients meeting the above criteria (histology, size, and grade) with the EXCEPTION of histologies noted above may enroll on the chemotherapy cohort or the non-chemotherapy cohort at the discretion of the enrolling investigator; patients meeting these criteria with the EXCEPTION of histologies noted above but medically deemed unable to receive chemotherapy or who elect not to receive chemotherapy are eligible for the non-chemotherapy cohort\n - Patients with the following histologies are only eligible for the chemotherapy cohort and cannot enroll on the non-chemotherapy cohort:\n - Unclassified soft tissue sarcomas that are too undifferentiated to be placed in a specific pathologic category in the WHO classification (often called \"undifferentiated soft tissue sarcoma\" or \"soft tissue sarcoma NOS\") in patients < 30 years of age\n - Synovial sarcoma\n - Embryonal sarcoma of the liver\n - ELIGIBILITY FOR NON-CHEMOTHERAPY COHORT:\n - Patients with any size of grade 2 or 3 of the following \"intermediate (rarely metastasizing)\" or \"malignant\" tumors, as defined in the WHO classification of soft tissue tumors for which we have consensus data of chemotherapy-resistance are eligible only for the non-chemotherapy cohort:\n - So-called fibrohistiocytic tumors - plexiform fibrohistiocytic tumor, giant cell tumor of soft tissues\n - Fibroblastic/myofibroblastic tumors - solitary fibrous tumor, malignant solitary fibrous tumor, inflammatory myofibroblastic tumor, low grade myofibroblastic sarcoma, myxoinflammatory fibroblastic sarcoma, atypical myxoinflammatory fibroblastic tumor, myxofibrosarcoma, low grade fibromyxoid sarcoma, sclerosing epithelioid fibrosarcoma\n - Tumors of uncertain differentiation - epithelioid sarcoma, alveolar soft part sarcoma, clear cell sarcoma of soft tissue, angiomatoid fibrous histiocytoma, ossifying fibromyxoid tumor, myoepithelioma, myoepithelial carcinoma, extraskeletal myxoid chondrosarcoma, neoplasms with perivascular epithelioid cell differentiation (PEComa), intimal sarcoma, atypical fibroxanthoma, mixed tumor NOS, phosphaturic mesenchymal tumor, malignant ossifying fibromyxoid tumor, malignant mixed tumor, malignant phosphaturic mesenchymal tumor\n - Chondro-osseous tumors - extraskeletal osteosarcoma\n - Pericytic (perivascular) tumors - malignant glomus tumor\n - Nerve sheath tumors - malignant peripheral nerve sheath tumor, malignant granular cell tumor, epithelioid malignant peripheral nerve sheath tumor, malignant Triton tumor\n - Undifferentiated sarcomas (with a specific pathologic category in the WHO classification) - undifferentiated round cell sarcoma, undifferentiated epithelioid sarcoma, undifferentiated spindle cell sarcoma\n - Patients meeting the criteria (histology, size, and grade) with the EXCEPTION of histologies noted above may enroll on the non-chemotherapy cohort at the discretion of the enrolling investigator; patients meeting these criteria with the EXCEPTION of histologies noted above but medically deemed unable to receive chemotherapy or who elect not to receive chemotherapy are eligible for the non-chemotherapy cohort; Note that tumors arising in bone are NOT eligible for this study\n - Extent of disease:\n - Patients with non-metastatic and metastatic disease are eligible\n - Initially unresectable patients, with or without metastatic disease, are eligible as long as there is a commitment at enrollment to resect the primary tumor\n - Sufficient tissue and blood must be available to submit for required biology studies\n - Lansky performance status score >= 70 for patients =< 16 years of age\n - Karnofsky performance status score >= 70 for patients > 16 years of age\n - Absolute neutrophil count >= 1500/uL; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility\n - Platelet count >= 100,000/uL; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility\n - Hemoglobin >= 8 g/dL for patients =< 16 years of age; >= 9 g/dL for patients > 16 years of age; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility\n - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or normal serum creatinine based on age/gender as follows:\n - 2 to < 6 years; 0.8 mg/dL male; 0.8 mg/dL female\n - 6 to < 10 years; 1 mg/dL male; 1 mg/dL female\n - 10 to < 13 years; 1.2 mg/dL male; 1.2 mg/dL female\n - 13 to < 16 years; 1.5 mg/dL male; 1.4 mg/dL female\n - >= 16 years; 1.5 mg/dL male; 1.4 mg/dL female\n - Total bilirubin =< 1.5 x upper limit of normal (ULN) for age\n - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate transaminase [AST]) or serum glutamate pyruvate transaminase [SGPT] (alanine transaminase [ALT]) < 2.5 x upper limit of normal (ULN) for age\n - Shortening fraction of >= 27% by echocardiogram OR ejection fraction of >= 50% by radionuclide angiogram\n - Corrected QT interval (QTc) < 480 msec\n - No evidence of dyspnea at rest, no exercise intolerance, and a resting pulse oximetry reading > 94% on room air if there is clinical indication for determination\n - Patients on low molecular weight heparin or Coumadin (with a stable international normalized ratio [INR]) are eligible\n - Patient must have a life expectancy of at least 3 months with appropriate therapy\n - All patients and/or their parents or legal guardians must sign a written informed consent\n - All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met\n Exclusion Criteria:\n - Patients with grade 1 NRSTS tumors of any size are not eligible\n - Patients with known central nervous system (CNS) metastases are not eligible; Note: brain imaging is not an eligibility requirement\n - Patients with evidence of active bleeding or bleeding diathesis will be excluded (Note: patients aged > 17 years with excess of 2.5 mL of hemoptysis are not eligible)\n - Patients with gross total resection of the primary tumor prior to enrollment on ARST1321 are NOT eligible; patients who have experienced tumor recurrence after a gross total tumor resection are NOT eligible\n - Patients with uncontrolled hypertension are ineligible; uncontrolled hypertension is defined as follows:\n - Patients aged =< 17 years: greater than 95th percentile systolic and diastolic blood pressure based on age and height which is not controlled by one anti-hypertensive medication\n - Patients aged > 17 years: systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg that is not controlled by one anti-hypertensive medication\n - Prior Therapy:\n - Patients must have had no prior anthracycline (eg, doxorubicin, daunorubicin) or ifosfamide chemotherapy\n - Patients must have had no prior use of pazopanib or similar multi-targeted tyrosine kinase inhibitors (TKI)\n - Patients must have had no prior radiotherapy to tumor-involved sites\n - Note: patients previously treated for a non-NRSTS cancer are eligible provided they meet the prior therapy requirements; patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are excluded\n - Other types of invasive malignancy that are not disease free within 3 years except for non-melanoma skin cancer, lentigo maligna, any carcinoma-in-situ or prostate cancer with low risk factors\n - CYTOCHROME P450 3A4 (CYP3A4) substrates WITH narrow therapeutic indices: patients chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices within 7 days prior to study enrollment, including but not limited to pimozide, aripiprazole, triazolam, ergotamine and halofantrine are not eligible; Note: the use of fentanyl is permitted\n - CYP3A4 Inhibitors: patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to itraconazole, clarithromycin, erythromycin many non-nucleoside reverse-transcriptase inhibitors (NNRTIs), diltiazem, verapamil, and grapefruit juice are not eligible\n - CYP3A4 Inducers: patients chronically receiving drugs that are known potent CYP3A4 inducers within 14 days prior to study enrollment, including but not limited to carbamazepine, phenobarbital, phenytoin, rifampin, and St. John's wort are not eligible (with the exception of glucocorticoids)\n - Certain medications that are associated with a risk for QTc prolongation and/or Torsades de Pointes, although not prohibited, should be avoided or replaced with medications that do not carry these risks, if possible\n - Subjects with any condition that may impair the ability to swallow or absorb oral medications/investigational product including:\n - Any lesion, whether induced by tumor, radiation or other conditions, which makes it difficult to swallow capsules or pills\n - Prior surgical procedures affecting absorption including, but not limited to major resection of stomach or small bowel\n - Active peptic ulcer disease\n - Malabsorption syndrome\n - Subjects with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including:\n - Active peptic ulcer disease\n - Known intraluminal metastatic lesions\n - Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or other gastrointestinal conditions which increase the risk of perforation\n - History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to beginning study treatment\n - Subjects with any of the following cardiovascular conditions within the past 6 months\n - Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\n - Cardiac arrhythmia\n - Admission for unstable angina\n - Cardiac angioplasty or stenting\n - Coronary artery bypass graft surgery\n - Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks\n - Arterial thrombosis\n - Symptomatic peripheral vascular disease\n - Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; a subject who has a history of class II heart failure and is asymptomatic on treatment may be considered eligible\n - History of serious or non-healing wound, ulcer, or bone fracture\n - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n - Patients who are unable to swallow whole tablets are not eligible\n - Patients with a body surface area < 0.5 m^2 are not eligible\n - Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are ineligible\n - Patients who are receiving any other investigational agent(s)\n - Pregnancy and breast feeding:\n - Female patients who are pregnant are ineligible\n - Lactating females are not eligible unless they have agreed not to breastfeed their infants during treatment and for a period of 1 month following completion of treatment\n - Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained\n - Unwillingness to use an effective contraceptive method for the duration of their study participation and for at least 1 month after treatment is completed if sexually active with reproductive potential\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nCeritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)\n\n**Clinical Trial Summary:**\n\nThe purpose of this signal seeking study is to determine whether treatment with ceritinib demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patient has a confirmed diagnosis of a select solid tumor (except ALK+ NSCLC) or hematological malignancy and is in need of treatment because of radiologic progression or relapse.\n - Patient must have been pre-identified as having a tumor with an ALK or ROS1 positive mutation, translocation, rearrangement or amplification. The qualifying alteration must be assessed and reported by a CLIA-certified laboratory. ALK positivity as assessed by IHC or FISH are allowed.\n - Patient must have received at least one prior treatment for recurrent, metastatic and/or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.\n - Patient has progressive and measurable disease as per RECIST 1.1 or other appropriate hematological guidelines.\n - Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.\n Exclusion Criteria:\n - Patient has received prior treatment with ceritinib.\n - Patients with symptomatic CNS metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.\n - Patient has received chemotherapy or anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, monoclonal antibodies or mitomycin-C) prior to starting study drug.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nLEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)\n\n**Clinical Trial Summary:**\n\nThe purpose of this signal seeking study is to determine whether treatment with LEE011 demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic malignancies to warrant further study.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patient has a confirmed diagnosis of a select solid tumor (except breast cancer (however, triple negative will be included), liposarcoma, CRPC, melanoma and teratoma) or hematological malignancy (except mantle cell lymphoma).\n - Patient must have been pre-identified as having a tumor with CDK4 amplification or mutation, CDK6 amplification or mutation, Cyclin D1 (CCND1) amplification, Cyclin D3 (CCND3) amplification, or p16 (CDKN2A) mutation\n - Patient has received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.\n - Patient has progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines.\n - Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1\n Exclusion Criteria:\n - Patients has received prior treatment with LEE011.\n - Patient has clinically significant resting bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval > 109 msec, or QTcF > 450 msec.\n - Patients has primary CNS tumor or CNS tumor involvement\n - Patient has received chemotherapy or anticancer therapy ≤ 4 weeks prior to starting study drug\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** possibly relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nGanetespib and Ziv-Aflibercept in Refractory Gastrointestinal Carcinomas, Non-Squamous Non-Small Cell Lung Carcinomas, Urothelial Carcinomas, and Sarcomas\n\n**Clinical Trial Summary:**\n\nBackground:\n - Some people have cancers that don t respond to standard treatments. In these cases, doctors may try to use drugs to slow the growth of the cancer.\n Objectives:\n - To test the safety and efficacy of the drug combination of ganetespib and ziv-aflibercept.\n Eligibility:\n - Adults age 18 and over with advanced cancer of the colon, lung, urinary tract, and sarcomas.\n Design:\n - Participants will be screened with medical history, blood tests, and scans to measure their tumors.\n - Participants will have one or two eye exams, with dilating eye drops.\n - Participants will get the study drugs at the clinic as an infusion in a vein. Ganetespib will be given once a week on the same day for 3 weeks in a row, followed by a 1-week rest period. Ziv-aflibercept will be given once every other week. The drugs will be given in 28-day cycles.\n - Participants may have a small piece of their tumor collected once or twice. This is done using a small needle during computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound scan.\n - Participants will have their blood pressure checked at each visit. They will check it at home every day of the study.\n - Participants may have one or more whole-body PET scans with 89Zr-panitumumab. A small amount of a radioactive chemical will be injected through a tube in an arm. Participants will lie on a bed that slides in and out of the donut-shaped PET scanner. They will have small amounts of blood drawn.\n - Participants may stay in the study as long as they are tolerating the drugs and their tumor is not getting worse.\n\n**Clinical Trial Detailed Description:**\n\nBACKGROUND:\n - Ganetespib is a non-geldamycin synthetic inhibitor of Hsp90 that has demonstrated activity against multiple cancer cell lines and tumor xenografts in preclinical models. Inhibiting the Hsp90 chaperone complex results in the recruitment of ubiquitin ligases, polyubiquination, and proteosomal degradation of Hsp90 client proteins, including transcription factors and proteins involved in angiogenesis (VEGF, VEGFR, HIF-1, STAT-3); growth factor independence (RAF, EGFR,Her2, IGFR); resistance to anti-growth signals (CDK4); tissue invasion and metastases (MET, MMP2); and avoidance of apoptosis (AKT, RIP, Survivin, Bcl-2).\n - HIF-1 activation has been implicated in mediating resistance to anti-angiogenic therapy; recent evidence implicates a greater role for Hsp90 in direct modulation of VEGF signaling.\n - Combining Hsp90 inhibition with ganetespib and anti-angiogenic therapy with Ziv-Aflibercept, a soluble fusion protein with high binding affinity for VEGF-A, VEGF-B, and PIGF, presents a rational novel strategy for improving upon and overcoming resistance to anti-angiogenic therapy\n PRIMARY OBJECTIVE:\n - To establish the safety, tolerability, and maximum tolerated dose (MTD) of the combination of ganetespib and Ziv-Aflibercept in patients with refractory gastrointestinal carcinomas, non-squamous non-small cell lung carcinomas, urothelial carcinomas, and sarcomas\n SECONDARY OBJECTIVE:\n - To assess modulation of HIF1 as a pharmacodynamic marker of therapy with the combination of ganetespib and Ziv-Aflibercept\n - To assess modulation of EGFR expression using 89Zr-labeled, EGFR-targeting antibody panitumumab PET/CT imaging of tumor lesions prior to and following treatment with study drugs\n ELIGIBILITY:\n - Adult patients with histologically confirmed metastatic gastrointestinal carcinomas, non-squamous non-small cell lung carcinomas, urothelial carcinomas, and sarcomas with disease progression after at least one line of standard therapy\n - Participants in the expansion phase must demonstrate EGFR expression on archival tumor samples and have disease amenable to biopsy with willingness to undergo pre- and post-treatment biopsies\n - No major surgery within 4 weeks prior to study enrollment, no radiation or chemotherapy within 3 weeks prior to enrollment; patients must have recovered from toxicities of prior therapies to at least eligibility levels prior to enrollment.\n STUDY DESIGN:\n - Ganetespib will be administered intravenously weekly on days 1, 8, and 15 of a 28-day cycle. Ziv-Aflibercept will be administered intravenously every 2 weeks, on days 1 and 15, during a 28-day cycle.\n - The escalation portion of the trial will follow a standard 3+3 design, whereby patients are dose-escalated in cohorts of 3 until dose-limiting toxicity is observed.\n - Once the MTD is established, 10 additional patients will be enrolled to the expansion phase, at the MTD, and tumor biopsies will be obtained to assess pharmacodynamic endpoints. During cycle 1 of the expansion phase, ganetespib will be administered intravenously weekly, on days 8 and 15 with omission of day 1 treatment to accommodate a baseline biopsy pre-ganetespib but after administration of Ziv-Aflibercept. For all subsequent cycles, ganetespib will be administered days 1, 8, and 15. Ziv-Aflibercept will still be administered intravenously every 2 weeks, on days 1 and 15, of a 28-day cycle.\n - PET/CT imaging with 89Zr-labeled panitumumab will be performed to evaluate tumor distribution prior to and following treatment with study agents.\n\n**Clinical Trial Eligibility Criteria:**\n\n- INCLUSION CRITERIA:\n Patients must have histologically confirmed recurrent or metastatic gastrointestinal carcinomas, non-squamous non-small cell lung carcinomas, urothelial carcinomas, and sarcomas with disease progression after at least one line of standard therapy. Disease should have progressed following all treatments known to prolong survival, unless a given treatment is contraindicated.\n - Patients with colorectal carcinoma must have progressed through at least two lines of standard chemotherapy in the metastatic setting.\n - Patients with non-small cell lung cancer with known sensitizing EGFR mutation and/or ALK rearrangement should have received prior erlotinib and/or crizotinib, respectively.\n - Patients with urothelial carcinoma will have progressed on prior platinum-based therapy or for which platinum-based therapy is contraindicated.\n - Patients enrolled on the expansion phase of the protocol must demonstrate EGFR expression by immunohistochemistry on archival tumor samples prior to undergoing (89) Zr-panitumumab PET/CT scans.\n Age greater than or equal to 18 years of age.\n ECOG performance status < 2.\n Life expectancy > 3 months.\n Patients must have normal organ and marrow function as defined below:\n absolute neutrophil count greater than or equal to 1,500/mcL\n platelets greater than or equal to 100,000/mcL\n total bilirubin less than or equal to 1.5 times institutional upper limit of normal\n AST(SGOT)/ALT(SGPT) less than or equal to 3 times institutional upper limit of normal\n creatinine less than or equal to 1.2 times institutional upper limit of normal\n OR\n creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal\n urine protein/creatinine < 1 mg/mg\n INR < 1.5\n Cardiac function within institutional normal limits on echocardiogram.\n Patients must have blood pressure no greater than 140 mmHg (systolic blood pressure) and 90 mmHg (diastolic blood pressure) for eligibility. Initiation or adjustment of antihypertensive medications is permitted prior to study entry provided that the average of three blood pressure measurements at enrollment visit is less than 140/90 mmHg.\n The effects of ganetespib on the developing human fetus are unknown. For this reason and because anti-angiogenic agents similar to ziv-aflibercept are known to be teratogenic, women of child-bearing potential and men must agree to use two forms of contraception (hormonal or barrier method of birth control; abstinence; sterilization) prior to study entry, for the duration of study participation, and for 3 months after completing study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use two forms of contraception prior to the study, for the duration of study participation, and for 3 months after completion of administration of both ganetespib and ziv-aflibercept.\n Ability to understand and the willingness to sign a written informed consent document.\n During the escalation phase of the protocol, patients may have evaluable or measurable disease. During the expansion phase of the protocol, patients must have 1) measurable disease, 2) disease amenable to biopsy and 3) willingness to undergo pre- and post-treatment biopsies.\n EXCLUSION CRITERIA:\n Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.\n Patients who are receiving any other investigational agents.\n Patients with known active brain metastases or carcinomatous meningitis are excluded from this clinical trial. Patients whose brain metastatic disease status has remained stable for greater than or equal to 4 weeks following treatment of brain metastases are eligible to participate at the discretion of the principal investigator.\n Uncontrolled intercurrent illness including, but not limited to, ongoing or active untreated infection, or psychiatric illness/social situations that would limit compliance with study requirements.\n Patients with known serious cardiac illness or medical conditions, including but not\n limited to:\n - Clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, unstable angina or history of myocardial infarct within 6 months prior to enrollment, or indwelling temporary pacemaker\n - Ventricular tachycardia or a supraventricular tachycardia that requires treatment with antiarrhythmic agents\n - Second- or third-degree atrioventricular block unless treated with a permanent pacemaker\n - Complete left bundle branch block\n - History of long QT syndrome or a family member with this condition\n No major surgery within 4 weeks prior to enrollment or history of gastrointestinal bleeding within 3 months prior to enrollment. No signs or symptoms of active bleeding or nonhealing ulcer will be permitted at study entry. Patients with central pulmonary tumors with evidence of bronchial invasion, or presenting with hemoptysis will be excluded.\n QTc > 470 msec on electrocardiogram (by Bazett s; average of triplicate recordings at the discretion of the PI) will exclude patients from entry on study. Medications that are known to cause QTc interval prolongation are prohibited for patients entering on trial. Patients for whom a given medication that may cause QTc interval prolongation cannot be discontinued, may be eligible at the discretion of the study PI, provided QTc interval criteria is met at enrollment. A comprehensive list of agents with the potential to cause QTc prolongation can be found in Appendix C and at http://crediblemeds.org.\n Pregnant women and women who are breastfeeding are excluded from this study because the effects of the study drugs on the developing fetus are unknown.\n HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ganetespib and zivaflibercept. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.\n Substrates of CYP3A4 or CYP2C19\n Preliminary results of a clinical drug-drug interaction study, examining the effect of ganetespib on the pharmacokinetics of the CYP2C19-sensitive probe omeprazole,show a modest (20%) increase in omeprazole exposure when coadministered with ganetespib. In vitro data implies expectation of greater interaction with CYP2C19substrates than with CYP3A4 substrates. Caution is advised when sensitive narrow therapeutic range CYP3A4 or CYP2C19 substrates are concomitantly administered.\n Inhibitors of P-Glycoprotein Efflux Transporters\n Concomitant medications that are strong inhibitors of P-glycoprotein efflux transporters should be used with caution during the study; examples of these medications include ritonavir, cyclosporine, verapamil, erythromycin, ketoconazole, itraconazole, quinidine, and elacridar.\n Concurrent anticoagulation will be permitted providing the patient is receiving a stable dose of anticoagulants before study entry. Patients receiving anticoagulants will be eligible for this trial. Evidence of clinically significant bleeding diathesis or underlying coagulopathy (e.g., INR > 1.5 without vitamin K antagonist therapy) will not be permitted.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nEfficacy Study on Trabectedin in Retroperitoneal Leiomyosarcoma and Well Differentiated/Dedifferentiated Liposarcoma\n\n**Clinical Trial Summary:**\n\nThis is an Italian, multicentre, single arm, phase II study, with an intra-patient comparison end point. This study aims at confirming the activity of the drug trabectedin as second/further line treatment in retroperitoneal leiomyosarcoma and well differentiated/dedifferentiated liposarcoma expressed in terms of slowing down tumour growth.\n Another objective is to investigate this peculiar benefit of trabectedin in typical retroperitoneal sarcomas may be exploited to help multidisciplinary clinical decision-making in the management of retroperitoneal sarcomas\n\n**Clinical Trial Detailed Description:**\n\nRetroperitoneal soft-tissue sarcomas (R-STSs) are rare neoplasms, accounting for 10% to 15% of Soft Tissue Sarcomas (STSs), which represent 1-3% of all cancers. They may show different histological types, but the predominant ones in the retroperitoneal region are: leiomyosarcoma, liposarcoma. The most commonly encountered in the retroperitoneum is the well differentiated/dedifferentiated liposarcoma.\n First-line chemotherapy usually consists of doxorubicin and/or ifosfamide. These two drugs are the most active agents in adult STSs, with a dose-response relationship and response rates between 20% and 50%. However, the sarcoma community is currently doubtful as to the activity of ifosfamide in the subgroup of leiomyosarcomas.\n Trabectedin has been found to be mainly active in leiomyosarcoma and liposarcoma and is approved by European Medicines Agency (EMA) as second-line chemotherapy for STSs. Although the response rate observed in pre-registration studies did not exceed 10%, trabectedin provided disease control, with progression arrest rates exceeding 50% and Progression Free Survival (PFS) rates exceeding 20% at 6 months.\n Since so far no phase II studies tested the activity of trabectedin in retroperitoneal sarcomas, this is the specific aim of this study.\n Target population: Patients with previously treated, histologically confirmed, retroperitoneal leiomyosarcoma and well differentiated/dedifferentiated liposarcoma. Patients may be either unamenable to surgery or amenable but in whom the addition of medical treatment is considered clinically advisable.\n Translational studies will be performed, with the aim of characterising the tumour biological features associated with different response patterns to trabectedin. These assessments will be done in 15-20 patients who will undergo surgery after trabectedin, comparing tumour tissue specimens collected before and after treatment.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Persistent or locally relapsed and/or metastatic disease (in case of local disease, surgery may be technically feasible or not, but the clinical judgment must be that medical therapy is indicated)\n - Pathology specimens available for centralized review\n - Age ≥ 18 years\n - European Eastern Cooperative Oncology Group Personal Status (ECOG PS) ≤ 2\n - One or more previous systemic treatments employing anthracyclines and ifosfamide (unless one or both are clinically contraindicated)\n - Measurable disease, as defined by Response Evaluation Criteria In Solid Tumors (RECIST)\n - A minimum of 3 weeks since any previous medical therapy\n - Recovery from toxic effects of prior therapies to National Cancer Institute Common Toxicity Criteria (NCI CTC) Grade 1 or lower\n - Adequate haematological, renal and liver functions\n - Ability and willingness to provide informed consent\n Exclusion Criteria:\n - Pregnant or breast-feeding women\n - Prior exposure to trabectedin\n - Peripheral neuropathy, Grade 2 or higher\n - History of other malignancies (except for basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission for 5 years or more and judged of negligible potential of relapse\n - Known central nervous system (CNS) metastases\n - Active viral hepatitis or chronic liver disease\n - Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias\n - Active major infection\n - Other serious concomitant illnesses\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nDouble Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma.\n\n**Clinical Trial Detailed Description:**\n\nThis study will evaluate the safety and efficacy of a Food and Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors). The fat in the lipoma is like normal fat except that it is enclosed in a balloon-like structure which is made of collagen (fibrous tissue). Treatment of the lipoma with an injection of XIAFLEX (a protein that breaks down collagen fibers) may dissolve the collagen/fibrous strands thereby decreasing the size of the lipoma or removing it. Each subject must have two lipomas; one lipoma to be treated with placebo and one lipoma to be treated with study drug, both to be observed similarly throughout the trial.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - 18-75 years of age, of either sex or any race\n - Clinical history of at least 2 lipomas for at least one year\n - Lipomas diagnosed as benign\n - Two lipomas on distinctly separate parts of the body, or on the torso if 30 cm apart, with easily definable edges\n - Each lipoma is a single mass with easily definable edges\n - Lipomas are 5 to 24 cm squared\n - Women of childbearing potential must use an acceptable method of birth control\n Exclusion Criteria:\n - Lipomas on the head, neck, hand or foot, or female breast\n - Women who are nursing or pregnant\n - Multi-lobular lipomas\n - Subjects who have received an investigational drug within 30 days before receiving the first dose of study drug in this study\n - Subjects with a known allergy to collagenase or any of the inactive ingredients in XIAFLEX\n - Subjects with uncontrolled diabetes, hypertension, or thyroid disease, or any medical condition that would make the subject unsuitable for enrollment\n - Subjects having prior treatment or trauma of the lipoma that could interfere with study assessments\n - Subjects with a history of connective tissue diseases, rheumatological diseases\n - Subjects taking anticoagulants or planning to receive anticoagulants (except for lo dose aspirin and over-the-counter nonsteroidal anti-inflammatory drugs) within 7 days of injection of study drug\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nActivity of Trabectedin or Gemcitabine + Docetaxel in Uterine Leiomyosarcoma\n\n**Clinical Trial Summary:**\n\nThe management of patients with uterine leiomyosarcomas poses many difficulties. Despite 60% of women present with disease limited to the uterus, cure rates range from 20 to 60%. Patients with metastatic disease at diagnosis or who recur after initial treatment have a dismal prognosis and, except for a subset of selected patients with completely resectable disease, the median survival is less than one year. Treatment options for recurrent/metastatic uterine leiomyosarcoma are limited. The most active drugs are doxorubicin ± ifosfamide and gemcitabine + docetaxel (GD) with response rate of 25-55% and 27-53%, respectively. Both these regimens have been increasingly used in the last years also in the adjuvant setting. For relapsed patients other drugs have been tested as single agent but negligible activity was observed.\n Trabectedin (Yondelis® -T) is a marine-derived cytotoxic approved by EMEA. It is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide or who are unsuitable to receive these agents. Among STS, activity has been mainly detected in synovial sarcoma, liposarcoma and leiomyosarcoma. Although the response rate did not exceed 10%, T was demonstrated to provide disease control, with progression arrest rates exceeding 50% and progression-free survival rates exceeding 20% at 6 months. So far no phase II studies tested the activity of T in uterine leiomyosarcoma specifically. This study is aimed at evaluating the activity of T (arm A) in advanced uterine leiomyosarcomas, having GD (arm B) as an internal control In parallel translational studies will be performed to identify factors predictive of the activity of T in this specific histotype.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Histologically proven uterine leiomyosarcoma.\n 2. Persistent or locally relapsed and/or metastatic disease.\n 3. At least one previous systemic treatment with an anthracycline ± ifosfamide or gemcitabine ± docetaxel.\n 4. Measurable disease, as defined by RECIST criteria.\n 5. ECOG PS <=2.\n 6. Age >= 18 years.\n 7. A minimum of 3 weeks since prior tumor directed therapy\n 8. Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or lower.\n 9. Adequate haematological function.\n 10. Adequate renal function.\n 11. Adequate liver function.\n 12. Signed informed consent.\n Exclusion Criteria:\n 1. Prior exposure to Trabectedin.\n 2. Peripheral neuropathy, Grade 2 or higher.\n 3. History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission from 5 years or more and judged of negligible potential of relapse.\n 4. Known CNS metastases.\n 5. Active viral hepatitis or chronic liver disease.\n 6. Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias.\n 7. Active major infection.\n 8. Other serious concomitant illnesses\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nEfatutazone Dihydrochloride in Treating Patients With Previously Treated Myxoid Liposarcoma That Cannot Be Removed by Surgery\n\n**Clinical Trial Summary:**\n\nThis phase II trial studies how well efatutazone dihydrochloride works in treating patients with previously treated myxoid liposarcoma that cannot be removed by surgery. Drugs used in chemotherapy, such as efatutazone dihydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\n I. To determine the confirmed response rate for efatutazone dihydrochloride (efatutazone) in patients with advanced myxoid liposarcoma whose disease has progressed on at least one prior therapy.\n SECONDARY OBJECTIVES:\n I. To assess the progression free survival (PFS), overall survival (OS), and adverse event rates for efatutazone treated patients with advanced myxoid liposarcoma whose disease has progressed on at least one prior therapy.\n TERTIARY OBJECTIVES:\n I. To assess the predictive value of peroxisome proliferator-activated receptor (PPAR) and retinoid X receptors (RXR) tumor expression from archived patient tumor samples.\n II. To assess the predictive value of the expression of PPARgamma-regulated markers of adipocytes differentiation.\n III. To assess the predictive value of the expression of PPARgamma-regulated cell cycle proteins.\n IV. To assess the effects of efatutazone treatment on serum adiponectin levels.\n OUTLINE:\n Patients receive efatutazone dihydrochloride orally (PO) twice daily (BID) continuously. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n After completion of study treatment, patients are followed up every 12 weeks for 2 years and then every 6 months for up to 5 years.\n\n**Clinical Trial Eligibility Criteria:**\n\n- Patients must have a formalin-fixed, paraffin-embedded (FFPE) tumor block OR 1 representative hematoxylin and eosin (H&E) and 20 unstained myxoid liposarcoma tissue slides available for submission to central pathology review; this review is mandatory prior to registration to confirm eligibility\n - Measurable disease\n - Progression on at least one prior systemic chemotherapy for advanced, unresectable or metastatic disease; prior adjuvant or neoadjuvant therapy is not included as prior systemic chemotherapy unless treatment occurred within the 6 months prior to study enrollment\n - There is no limit to the number of prior lines of treatment a patient has received\n - No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before study registration; no treatment with nitrosourea or mitomycin =< 42 days before study registration\n - Patients should have resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, grade 1 or less\n - New disease progression prior to enrollment, defined as a growth in the sum of the greatest diameter of the index lesions by at least 20% as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 over a period of 6 months or less\n - No history of the following:\n - Class III or IV congestive heart failure (CHF)\n - Grade 3 or 4 thromboembolic event =< 6 months\n - Pericardial effusion =< 12 months (any grade)\n - Pericardial involvement with tumor\n - Grade 2 or higher pleural effusion =< 6 months\n - No symptomatic, untreated, or uncontrolled brain metastases present\n - Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required; a female of childbearing potential is a sexually mature female who:\n - Has not undergone a hysterectomy or bilateral oophorectomy; or\n - Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)\n - Patients with diabetes mellitus requiring concurrent treatment with insulin or thiazolidinedione (TZD) oral agents are not eligible\n - Patients with known hypersensitivity to any TZD oral agents are not eligible\n - Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n - Absolute neutrophil count (ANC) >= 1,000/mm^3\n - Platelet count >= 75,000/mm^3\n - Creatinine =< 1.5 mg/dL x upper limits of normal (ULN) OR calculated (calc.) creatinine clearance >= 30 mL/min\n - Bilirubin =< 1.5 x ULN; for subjects with liver metastases =< 3 x ULN is allowed\n - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x ULN; for subjects with liver metastases, SGOT (AST) and SGPT (ALT) < 5 x the upper normal limit of institution's normal range is allowed\n - Eligible patients must have histopathologically confirmed myxoid liposarcoma with confirmation of DDIT3 rearrangement\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nEfficacy and Safety Study of GPX-150 to Treat Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nThis study will assess the safety and efficacy of GPX-150 administered intravenously every 3 weeks in the treatment of patients with soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nThis is an open-label, single arm study of GPX-150 in patients with soft tissue sarcoma. Approximately 22 patients will be treated in this study. The population for this study is adult patients with histologically proven advanced and/or metastatic malignant soft tissue sarcoma of intermediate or high histologic grade.\n All patients who meet all entry criteria will receive GPX-150 at a starting dose of 265 mg/m2 every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity or subject withdrawal.\n Prior to initiation of treatment, subjects will undergo screening and baseline evaluations. During all study visits, subjects will be evaluated for safety. The dose of GPX-150 may be reduced when subjects meet specified dose reduction safety criteria. Subjects will be evaluated regularly for safety and tolerability. Tumor measurements will be calculated at baseline (within 28 days prior to treatment initiation), then at regular intervals while receiving treatment for up to 1 year. After discontinuing the treatment phase of the study, safety assessments and tumor measurements will be performed 3 weeks after the last dose of study drug.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Age ≥18 years.\n 2. Histological documentation of soft tissue sarcoma (biopsy may be historical and may have been obtained from primary tumor or a metastatic site).\n 3. Advanced and/or metastatic malignant soft tissue sarcoma of intermediate or high histologic grade. Excluded are the following sarcoma subtypes:\n - Well-differentiated liposarcoma or atypical lipomatous tumor\n - Embryonal or alveolar rhabdomyosarcoma\n - Ewing sarcoma of soft tissue or bone\n - Gastrointestinal stromal tumor (GIST)\n - Dermatofibrosarcoma protuberans\n - Alveolar soft part sarcoma\n - Solitary fibrous tumor\n - Clear cell sarcoma\n - Kaposi sarcoma\n - Extraskeletal myxoid chondrosarcoma\n - PEComa (perivascular epithelial cell tumor)\n - Myoepithelioma / mixed tumor\n 4. Measurable disease as per RECIST 1.1.\n 5. Subject has received either:\n - No prior chemotherapy for current sarcoma, or\n - A single course of gemcitabine and/or docetaxel as adjuvant therapy that was completed at least 6 months prior to planned first dose\n 6. ECOG Performance Status of 0 - 2.\n 7. Adequate cardiac function:\n - LVEF above the institution's lower limit of normal\n - QTcF ≤ 450 msec for males or 470 msec for females.\n 8. Willing and able to provide written informed consent.\n 9. Male and female subjects must agree to use a highly reliable method of birth control for the duration of the study.\n 10. Women of childbearing potential must have a serum pregnancy test performed within 28 days prior to the first day of study drug dosing.\n Exclusion Criteria:\n 1. Sarcomas arising from bone or cartilage, e.g. chondrosarcoma, osteosarcoma, chordoma.\n 2. Subject is eligible for a potentially curative therapy.\n 3. Prior primary chemotherapy.\n 4. Prior radiotherapy to > 25% of bone marrow volume.\n 5. Treatment within 28 days prior to Dose 1 with:\n - Palliative surgery or radiotherapy.\n - Approved anticancer therapy including chemotherapy or immunotherapy.\n - Contraindicated treatments noted in the product labelling for doxorubicin, including trastuzumab and inhibitors and inducers of CYP3A4, CYP2D6, or P-gp.\n - An investigational therapy.\n - Any major surgery (e.g. requiring general anesthesia).\n 6. Inadequate bone marrow, liver, and renal function, as assessed by the following laboratory parameters:\n 1. Absolute neutrophil count (ANC) < 1,500/mm3.\n 2. Platelet count < 100,000/mm3.\n 3. Total bilirubin > 1.5×ULN (upper limit of normal).\n 4. ALT and AST > 2.5×ULN. For patients with documented liver metastases, ALT and AST > 5×ULN.\n 5. Serum creatinine > 1.5 x ULN.\n 6. International Normalized Ratio (INR) and activated partial thromboplastin time [PTT] ≥ 1.5×ULN, if not therapeutically anticoagulated.\n 7. Serum albumin < 3.0 gm/dL.\n 7. Congestive heart failure > Class II New York Heart Association Functional Classification, current pericarditis, myocardial infarction within 6 months, or symptomatic coronary artery disease.\n 8. Unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a patient and/or their compliance with the protocol.\n 9. Active infection requiring systemic antibacterial/antibiotic, antifungal, or antiviral therapy.\n 10. Documented metastases to brain or meninges.\n 11. Any malignancy other than soft tissue sarcoma within the last 5 years prior to screening, with the exception of cervical carcinoma in situ, basal cell carcinoma, or superficial bladder tumors that have been successfully and curatively treated with no evidence of recurrent or residual disease.\n 12. Body surface area (BSA) ≥ 2.4 m2.\n 13. Currently pregnant or nursing.\n 14. Known allergy to any of the study drugs or their excipients.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nPhase I-II Trial, Multicenter, Open, Exploring Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients\n\n**Clinical Trial Summary:**\n\nPhase I-II trial that combines trabectedin plus radiotherapy for tumor reduction response measure in two cohorts of patients:\n Cohort A: Patients with diagnosis of non-operable or unresectable or not oncologically recommended metastasectomy of limited to lung metastases soft tissue sarcoma.\n Cohort B: Patients with locally advanced resectable Myxoid Liposarcoma. Phase I: escalating dose of 1.3 or 1.5 mg/m2. Radiotherapy for cohort A: 30Gy in 10 fractions (3Gy/fraction) Radiotherapy for cohort B: 45Gy in 25 fractions (1.8Gy/fraction) A translational substudy is developed to analyse different biomarkers predictive value.\n\n**Clinical Trial Detailed Description:**\n\nIn this study investigators plan to measure tumor response (RECIST and Choi criteria) when administering trabectedin standard dose or inferior with simultaneous radiotherapy treatment. The hypothesis states that administering trabectedin at 1.3mg/m2 or ≤1.5mg/m2 plus Radiotherapy 30-45Gy shows synergic activity that turns into tumor shrinkage.\n A phase I trial (dose escalation level of 1.3 or 1.5 mg/m2) will provide the proper dose level to perform a phase II trial to measure RECIST and Choi response, progression free survival, overall survival and register safety and quality of life details.\n To cohorts are indicated for this trial, A: Patients with diagnosis of non-operable or unresectable or not oncologically recommended metastasectomy of limited to lung metastases soft tissue sarcoma and cohort B: Patients with locally advanced resectable Myxoid Liposarcoma. Unlimited cycles of chemotherapy are considered to be beneficial for cohort A patients, whereas cohort B only 3 cycles are indicated. About radiotherapy treatment, 30Gy will be given to cohort A patients, whereas cohort B will receive 45Gy. TCs and MRI are selected for imaging purposes.\n Several biomarkers are selected to perform FFPE tumor assays in relation to prediction\n\n**Clinical Trial Eligibility Criteria:**\n\nCohort A: STS\n Inclusion Criteria:\n 1. The patient must sign voluntarily the informed consent form before any study test is conducted that is not part of routine patient care.\n 2. Aged between 18 and 70.\n 3. Patients must have a diagnostic of Soft Tissue Sarcoma with metastasis limited to lung, and not suitable for metastasectomy or surgery resection or not oncologically recommended metastasectomy\n 4. Patients must have documentation of disease progression within 6 months prior to study entry.\n 5. The patient must have been considered eligible for systemic chemotherapy. A maximum of two previous lines for advanced/metastatic disease are allowed as long as trabectedin has not been included.\n 6. The following histological subtypes can be included:\n - Undifferentiated pleomorphic sarcoma (previously, malignant fibrous histiocytoma)\n - Leiomyosarcoma\n - Angiosarcoma/ epithelial hemangioendothelioma\n - Liposarcoma and its variants (well differentiated, dedifferentiated, myxoid/round cells, pleomorphic)\n - Synovial sarcoma\n - Fibrosarcoma and its variants (epithelial fibrosarcoma/low grade fibromyxoid sarcoma)\n - Hemangiopericytoma/solitary fibroid tumor\n - Neurogenic sarcoma (Malignant peripheral nerve sheath tumor, MPNST)\n - Myxofibrosarcoma\n - Epithelioid Sarcoma\n - Unclassified sarcoma (spindle cell/epithelioid/pleomorphic/myxoid)\n 7. Measurable disease, according to RECIST V 1.1 criteria\n 8. Performance status ≤1 (ECOG).\n 9. Adequate respiratory functions: FEV1 >1L\n 10. Adequate bone marrow function (hemoglobin > 10 g/dl, leukocytes ≥ 3.000/mm3, neutrophils ≥ 1.500/mm3, platelets ≥ 100.000/mm3). Patients with plasma creatinine ≤ 1,6 mg/dl, transaminases ≤ 2.5 times the UNL, total bilirubin ≤ UNL, CPK ≤ 2.5 times UNL, alkaline phosphatase ≤ 2.5 times the UNL are acceptable. If the increase of alkaline phosphatase is > 2.5 times the UNL, then the alkaline phosphatase liver fraction and/or 5' nucleotidase and/or GGT must be ≤ UNL.\n 11. Men or women of child bearing potential should be using an effective method of contraception before entry into the study and throughout the same and for 6 months after ending the study. Women of childbearing potential must have a negative urine pregnancy test before study entry.\n 12. Normal cardiac function with a LVEF ≥ 50% by echocardiogram or MUGA.\n 13. Disease distribution in lungs allows meeting with normal tissue constraints of radiation therapy. Radiation oncologist must confirm this point.\n 14. It should be performed HBV and HCV serologies prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If a potential patient is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the patient should NOT be included in the study (if a qualitative PCR cannot be performed then patient will not be able to enter the study)\n 15. Patient must have a Central Venous Catheter for treatment\n Exclusion Criteria:\n 1. Previous treatment with trabectedin or radiotherapy involving any lung field.\n 2. Performance status ≥ 2 (ECOG).\n 3. Metastases out of those located in lungs.\n 4. Plasma bilirubin > UNL.\n 5. Creatinine > 1.6 mg/dL.\n 6. History of other neoplastic disease with the exception of basal cell carcinoma or in situ cervical cancer adequately treated.\n 7. Severe COPD or other severe pulmonary diseases.\n 8. Significant cardiovascular disease (for example, dyspnea > 2 NYHA)\n 9. Significant systemic diseases grade 3 or higher on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity.\n 10. Uncontrolled bacterial, mycotic or viral infections.\n 11. Known positive test for infection by human immunodeficiency virus (HIV).\n 12. Women who are pregnant or breast-feeding.\n 13. Psychological, familial, social or geographic circumstances that limit the patient's ability to comply with the protocol or informed consent.\n 14. Patients participating in another clinical trial or receiving any other investigational product.\n 15. Patients who had participated in another clinical trial and/or had received any other investigational product in the last 30 days prior to inclusion.\n 16. Histologies other than those described in inclusion criteria.\n Cohort B: ML\n Inclusion criteria:\n 1. The patient must sign voluntarily the informed consent form before any study test is conducted that is not part of routine patient care.\n 2. Aged between 18 and 70.\n 3. Pathological diagnosis of Myxoid Liposarcoma, deep located and more than 5 cm or superficial more than 10 cm.\n 4. Tumor must be resectable and without evidence of regional or distal spread after adequate staging procedure. Tumor must be located in limbs or superficial trunk wall.\n 5. Disease distribution allows meeting with normal tissue constraints of radiation therapy. Radiation oncologist must confirm this point.\n 6. Measurable disease, according to RECIST V 1.1 criteria\n 7. Performance status 0-1 (ECOG).\n 8. Adequate bone marrow function (hemoglobin > 10 g/dL, leukocytes ≥ 3.000/mm3, neutrophils ≥ 1.500/mm3, platelets ≥ 100.000/mm3). Patients with plasma creatinine ≤ 1,6 mg/dL, transaminases ≤ 2.5 times the UNL, total bilirubin ≤ UNL, CPK ≤ 2.5 times UNL, alkaline phosphatase ≤ 2.5 times the UNL are acceptable. If the increase of alkaline phosphatase is > 2.5 times the UNL, then the alkaline phosphatase liver fraction and/or 5' nucleotidase and/or GGT must be ≤ UNL.\n 9. Men or women of child bearing potential should be using an effective method of contraception before entry into the study and throughout the same and for 6 months after ending the study. Women of childbearing potential must have a negative urine pregnancy test before study entry.\n 10. Normal cardiac function with a LVEF ≥ 50% by echocardiogram or MUGA.\n 11. It should be performed HBV and HCV serologies prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA HBV+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If a potential patient is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the patient should NOT be included in the study (if a qualitative PCR cannot be performed then patient will not be able to enter the study).\n 12. Patient may have had one previous chemotherapy line.\n 13. Patient must have a Central Venous Catheter for treatment.\n Exclusion criteria:\n 1. More than one previous chemotherapy treatment for local disease including trabectedin.\n 2. Radiotherapy involving the tumoral bed.\n 3. Performance status ≥ 2 (ECOG).\n 4. Presence of metastases or lymph node involvement by the tumor.\n 5. Location other than limb or superficial trunk wall.\n 6. Plasma bilirubin > UNL.\n 7. Creatinine > 1.6 mg/dL.\n 8. History of other neoplastic disease with the exception of basal cell carcinoma or in situ cervical cancer adequately treated.\n 9. Significant cardiovascular disease (for example, dyspnea > 2 NYHA)\n 10. Significant systemic diseases grade 3 or higher on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity.\n 11. Uncontrolled bacterial, mycotic or viral infections.\n 12. Known positive test for infection by human immunodeficiency virus (HIV).\n 13. Women who are pregnant or breast-feeding.\n 14. Psychological, familial, social or geographic circumstances that limit the patient's ability to comply with the protocol or informed consent.\n 15. Patients participating in another clinical trial or receiving any other investigational product.\n 16. Patients who had participated in another clinical trial and/or had received any other investigational product in the last 30 days prior to inclusion.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nEsomeprazole Plus Alginate vs. Esomeprazole Alone for Treatment of Nighttime Reflux Symptom and Sleep Disturbances\n\n**Clinical Trial Summary:**\n\nAmong those patients experienced GERD symptoms, up to 89% report nocturnal symptoms, resulting in poor sleep quality. Sodium alginate oral suspension (Alginos) is a medication indicated for the relief of gastroesophageal reflux symptoms. This multi-center, open-label, randomized trial intends to compare the addition of one dose Alginos (50mg/ml, 20ml) at bed time (Nexium plus Alginos), with no additional alginate treatment (Nexium alone), in erosive GERD patients taking Nexium (40mg/tablet) daily for 4 weeks. Efficacy endpoints include percentage of patients with relief or complete resolution of nighttime heartburn (or regurgitation), percentage of patients with relief or complete resolution of GERD-related sleep disturbance, the percentage of nights without nighttime heartburn (or regurgitation) over treatment period, change from baseline of the Pittsburgh Sleep Quality Index (PSQI) questionnaire total score, and change of the percentage of patients with relief of nighttime heartburn (or regurgitation) at post-treatment visit as compared to final visit in test group (Nexium plus Alginos). Safety endpoint is incidence of adverse events. The study hypothesis is that sodium alginate plus esomeprazole is superior to esomeprazole alone in relieving nighttime reflux symptoms and sleep disturbance in erosive GERD patients.\n\n**Clinical Trial Detailed Description:**\n\nThis multi-center, open-label, randomized trial aims to compared the efficacy and safety profiles of sodium alginate oral suspension (50mg/ml) 20ml at bedtime with that of esomeprazole (40mg/tablet) 1 tablet once daily for the treatment of erosive GERD patients in Taiwan. Patients will be enrolled into study if they are diagnosed as GERD (grade A~D); with history of heartburn (or regurgitation) for ≥ 3 months before entering study; with history of GERD-related sleep disturbances for ≥ 1 month before entering study; with nighttime heartburn (or regurgitation) graded as moderate, or severe, on ≥ 3 nights in the last 7 days of screening period; with GERD-related sleep disturbances on ≥ 3 nights in the last 7 days of screening period; with the global PSQI score >5; and have signed the informed consent. Patients will be excluded if they are diagnosed as non-erosive GERD, Barrett's esophagus or esophageal stricture; with any conditions other than GERD that could be the primary cause of sleep disturbance; with active esophageal, gastric or duodenal ulcers; with history of esophageal, gastric or duodenal surgery; with active cancers of any kind; female patients who are pregnant or lactating; who were allergy to any of the study drugs; taking a proton pump inhibitor (PPI) within 7 days, or any prokinetic agent, H2-blocker, alginate preparations or antacid within 2 days before screening; with a history of drug addiction or alcohol abuse within the past 12 months; or with any other conditions or diseases that investigator considers it is not appropriate to enter the study. The primary efficacy endpoint is the percentage of patients with relief of nighttime heartburn (or acid regurgitation). The secondary efficacy endpoints are percentage of patients with complete resolution of nighttime heartburn (or regurgitation); percentage of patients with relief of GERD-related sleep disturbance; percentage of patients with complete resolution of GERD-related sleep disturbance; percentage of nights without nighttime heartburn (or regurgitation) over treatment period; change from baseline of the Pittsburgh Sleep Quality Index questionnaire total score (global PSQI score) at the end of study; and change of the percentage of patients with relief of nighttime heartburn (or acid regurgitation) at post-treatment visit (V4) as compared to final visit (V3) in test group (Nexium plus Alginos). The safety endpoint is incidence of adverse events. This study aims to prove that sodium alginate plus esomeprazole is superior to esomeprazole alone in relieving nighttime reflux symptoms and sleep disturbance in erosive GERD patients.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Out -patients with age of 20-80 years old (inclusive) in Taiwan of both genders\n - Patients who had been previously diagnosed as erosive GERD (i.e. grade A~D according to the modified Los-Angeles Classification. Endoscopic examination results within 21 days before randomization visit (V2) are acceptable.\n - Patients with history of heartburn (or regurgitation) for ≥ 3 months before entering study\n - Patients with history of GERD-related sleep disturbances for ≥ 1 month before entering study\n - Patients with nighttime heartburn (or regurgitation) graded as moderate, or severe, on ≥ 3 nights in the last 7 days of screening period\n - Patients with GERD-related sleep disturbances on ≥ 3 nights in the last 7 days of screening period\n - Patients with the global PSQI score >5\n - Patients have signed the informed consent form\n Exclusion Criteria:\n - Patients with non-erosive GERD, Barrett's esophagus or esophageal stricture\n - Patients with any conditions other than GERD that could be the primary cause of sleep disturbance (e.g. sleep apnoea, obstructed airway, severe depression, severe anxiety, panic attacks, chronic obstructive pulmonary disease requiring oxygen therapy)\n - Patients with active esophageal, gastric or duodenal ulcers\n - Patients with history of esophageal, gastric or duodenal surgery\n - Patients with active cancers of any kind\n - Female patients who are pregnant or lactating\n - Patients who were allergy to any of the study drugs\n - Patients taken a proton pump inhibitor (PPI) within 7 days, or any prokinetic agent, H2-blocker, alginate preparations or antacid within 2 days before screening\n - Patients with a history of drug addiction or alcohol abuse within the past 12 months\n - Patients with any other conditions or diseases that investigator considers it is not appropriate to enter the study\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nStudy of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer.\n\n**Clinical Trial Summary:**\n\nThis is a Phase Ib/II study of the ALK inhibitor ceritinib in combination with the CDK4/6 inhibitor LEE011 in patients with ALK-positive non-small cell lung cancer.\n The purpose of the study is to determine the MTD/RP2D of the LEE011 and ceritinib combination and evaluate whether the combination is safe and has beneficial effects in ALK-positive advanced non-small cell lung cancer patients.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patients must be diagnosed with ALK-positive advanced NSCLC. The tumor must be ALK-positive as determined by ALK rearrangement in ≥15% of cells (as measured by FISH using the Vysis break-apart ALK probe) or by using the Ventana ALK IHC test. The analysis may be performed locally.\n - Eastern cooperative oncology group (ECOG) performance status ≤ 2.\n - Measurable disease as per RECIST v1.1\n - Availability of tumor sample:\n For ALK inhibitor naïve patients:\n o A representative tumor sample must be submitted. An archival tumor specimen is acceptable\n For patients after progression on an ALK inhibitor:\n o A new tumor biopsy is required unless a biopsy performed after progression on the patient's most recent ALK inhibitor is available for submission For all patients a newly obtained tumor specimen must be submitted if no appropriate archival sample is available. In the event that no sample is available and a new biopsy cannot be obtained, enrollment may be considered after discussion with the sponsor.\n Exclusion Criteria:\n - For Phase I part:\n o Patients who have not previously received at least one line of therapy for ALK-positive NSCLC\n - For Phase II part:\n - Group A: prior therapy with any ALK inhibitor is not permitted.\n - Group B: progression following any ALK inhibitor(s) other than ceritinib is required and the last dose of the ALK inhibitor must be no more than 60 days prior to the first dose of study drug. Prior ceritinib is not permitted.\n - Group C: progression following ceritinib is required and the last dose of ceritinib must be no more than 60 days prior to the first dose of study drug.\n - Patients who have previously been unable to tolerate ceritinib, in the opinion of the investigator. Exceptions to this exclusion include nausea, vomiting and diarrhea in patients taking ceritinib under fasted conditions.\n - Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids or local CNS-directed therapy to control their CNS disease\n - Patients with abnormal laboratory values during screening and on day 1 of pre-dose\n - Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of ceritinib or LEE011\n - Patients who are currently receiving treatment (that cannot be discontinued at least 1 week prior to the initiation of the study) with agents that are known to be any of the following: strong inducers or inhibitors of CYP3A4/5; sensitive substrates of CYP3A; substrates of CYP3A4/5 or CYP2C9 with a narrow therapeutic index.\n - Patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.\n - Patient with impaired cardiac function or any clinically significant uncontrolled cardiac disease, and/or, cardiac repolarization abnormality, including any of the following:\n Clinically significant heart disease such as CHF requiring treatment (NYH grade ≥ 2), history of angina pectoris, myocardial infarction, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry, documented cardiomyopathy, or left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated acquisition scan (MUGA) or echocardiogram (ECHO).\n Uncontrolled systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg, with or without anti-hypertensive medication. Initiation or adjustment of antihypertensive medication (s) is allowed prior to screening, Systolic blood pressure (SBP) <90 mmHg Standard 12-lead ECG values defined as the mean of the triplicate ECGs and assessed by central laboratory\n - QTcF interval at screening >450 msec (using Fridericia's correction)\n - Resting heart rate <50 bpm or > 90 bpm\n Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:\n - Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia\n - Concomitant medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued or replaced by safe alternative medication (e.g. within 5 half-lives or 7 days prior to starting study drug)\n - Inability to determine the QTcF interval Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block).\n Other protocol-defined inclusion/exclusion criteria may apply.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, Non-small Cell Lung Cancer, or Melanoma That Has Spread to the Brain\n\n**Clinical Trial Summary:**\n\nThe main purpose of this study is to evaluate the safety and effectiveness of the study drug known as abemaciclib in participants with hormone receptor positive breast cancer, non-small cell lung cancer (NSCLC), or melanoma that has spread to the brain.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Have brain metastases secondary to hormone receptor positive breast cancer, NSCLC, or melanoma.\n - Have either human epidermal growth factor receptor 2 positive (HER2+) (Study Part A) or HER2- (Study Part B) breast cancer.\n - Participants in Study Part C must have HR+ breast cancer, NSCLC, or melanoma with brain lesions clinically indicated for surgical resection as well as consent to provide tissue for drug concentration determination after 5 to 14 days of study drug dosing.\n - Participants in Part D must have NSCLC of any subtype.\n - Participants in Part E must have melanoma of any subtype.\n - Participants in Part F must have HR+ breast cancer, NSCLC, or melanoma with leptomeningeal metastases.\n - For Parts A, B, D, and E: Must have at least 1 measurable brain lesion ≥10 millimeters (mm) in the longest diameter (LD).\n - For Part C (surgical): Have metastatic brain lesion(s) for which surgical resection is clinically indicated.\n - Have completed local therapy (surgical resection, WBRT, or SRS) ≥14 days prior to initiating abemaciclib and recovered from all acute effects.\n - If receiving concomitant corticosteroids, must be on a stable or decreasing dose for at least 7 days prior to the baseline Gd-MRI.\n - Have a Karnofsky performance status of ≥70.\n - Have a life expectancy ≥12 weeks.\n - For HR+ breast cancer participants in part A, B, C, and F: If currently receiving endocrine therapy, a participant may continue to receive the same endocrine therapy provided that extracranial disease is stable for at least 3 months and central nervous system (CNS) disease progression has occurred while on this endocrine therapy. If these conditions are not met, participants must discontinue endocrine therapy prior to initiation of abemaciclib.\n - For HER2+ breast cancer participants in parts A, C, and F: participants may receive concurrent treatment (ongoing or initiated simultaneously with abemaciclib) with IV trastuzumab.\n - For NSCLC participants in parts C, D, and F: if currently receiving gemcitabine or pemetrexed (single-agent or in combination with another therapy), a participant may continue to receive 1 of these 2 therapies provided that extracranial disease is stable for at least 6 weeks and CNS disease progression has occurred while on this therapy.\n - Have adequate organ function.\n Exclusion Criteria:\n - Require immediate local therapy, including but not limited to WBRT, SRS, or surgical resection, for treatment of brain metastases.\n - Are taking concurrent enzyme-inducing antiepileptic drugs (EIAED).\n - Have evidence of significant (ie, symptomatic) intracranial hemorrhage.\n - For Parts A, B, C, D, E: Have evidence of leptomeningeal metastases. Note: discrete dural metastases are permitted.\n - Have experienced >2 seizures within 4 weeks prior to study entry.\n - For Parts A, B, D, E, and F: Have previously received treatment with any cyclin dependent kinase 6 (CDK6) inhibitor. For Part C participants may have received prior palbociclib or ribociclib, but not abemaciclib treatment.\n - Have known contraindication to Gd-MRI.\n - Have a preexisting chronic condition resulting in persistent diarrhea.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nStudy of Palbociclib in MLL-rearranged Acute Leukemias\n\n**Clinical Trial Summary:**\n\nDiagnosis: Acute myeloid leukemia; Acute lymphoblastic leukemia Age ≥ 18 years, no upper age limit Study drug: Palbociclib Phase Ib/IIa, open-label\n - Phase Ib: Based on previous experience with 125 mg palbociclib once daily for 21 days followed by 7 days of rest in patients with breast cancer, liposarcoma, non-small cell lung cancer, hepatocellular carcinoma, ovarian cancer, mantle-cell lymphoma, and glioblastoma, this regimen will be chosen for the first dose to be evaluated in the phase Ib. Based on a 3 + 3 modified Fibonacci design, the tolerable dose of palbociclib for the phase IIa is defined.\n - Phase IIa: single-agent palbociclib using the tolerable dose defined in the phase Ib part of the study is administered once daily for 21 days followed by 7 days of rest. Based on the optimal two-stage design of Simon, 21 patients are treated in the first stage. If results are positive, 29 additional patients will be recruited into the second stage of the study. An efficacy of the investigational therapy will be rejected in the first stage of 21 treated patients if two or less patients achieve complete remission (CR), CR with incomplete blood count recovery (CRi), partial remission (PR), or anti-leukemic effect (ALE). If three or more patients achieve CR, CRi, PR, or ALE during this first stage, the trial is intended to be continued in the second stage with a total sample size of 50 patients.\n Start of recruitment: July 2015 End of recruitment: July 2017 End of study (last patient out): July 2018 The treatment duration of an individual patient is estimated to be 2-6 months, but may be unlimited in patients with sustained response (\"case-by-case decision\").\n Observation time per patient after entry into the study (incl. treatment) is at least 12 months.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patients with confirmed diagnosis of acute leukemia with MLL rearrangement according to the 2008 WHO Classification\n - Patients with MLL-rearranged leukemia who are refractory to standard induction therapy and not immediate candidates for allogeneic HSCT (bridge to transplant is allowed)\n - Patients with MLL-rearranged leukemia who relapsed after standard first-line treatment and are not immediate candidates for allogeneic HSCT (bridge to transplant is allowed)\n - Patients with newly diagnosed MLL-rearranged leukemia who are not eligible for intensive first-line therapy\n - Genetic/histologic/immunohistologic assessment in one of the central laboratories\n - Age ≥ 18 years, no upper age limit\n - WHO performance status of ≤ 2\n - No prior chemotherapy two weeks before study entry except hydroxyurea to control hyperleukocytosis\n - Non-pregnant and non-nursing. Women of child-bearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 72 hours prior to registration (WOCBP is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 months).\n - Female patients in the reproductive age and male patients must agree to avoid getting pregnant or to father a child while on therapy and for three months after the last dose of therapy.\n - Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control (IUD, tubal ligation, or partner's vasectomy). Hormonal contraception is an inadequate method of birth control.\n - Men must agree not to father a child and must use a latex condom during any sexual contact with WOCBP while receiving therapy and for three months after therapy is stopped, even if they have undergone successful vasectomy.\n - Signed written informed consent\n Exclusion Criteria:\n - Prior treatment with palbociclib\n - Performance status > 2 according to WHO criteria\n - Organ insufficiency: creatinine > 1.5 x upper normal serum level; bilirubin, AST, or AP > 2.5 x upper normal serum level; heart failure NYHA III/IV; uncontrolled hypertension; unstable angina; serious cardiac arrhythmia; severe obstructive or restrictive ventilation disorder\n - Uncontrolled infection\n - Patients with a \"currently active\" second malignancy other than non-melanoma skin cancer. Patients are not considered to have a \"currently active\" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year.\n - Severe neurologic or psychiatric disorder interfering with ability of giving informed consent\n - Known or suspected active alcohol or drug abuse\n - Known positivity for HIV, active HAV, HBV, or HCV infection\n - Bleeding disorder unrelated to leukemia\n - Uncontrolled CNS involvement (treatment for CNS-involvement prior to inclusion is allowed)\n - QTc > 470 msec (based on the mean value of triplicate ECGs), family or personal history of long or short QT syndrome, Brugada syndrome, or known history of QTc prolongation or Torsade de Pointes\n - Uncontrolled electrolyte disorders that can aggravate the effects of a QTc-prolonging drug (e.g., hypocalcemia, hypokalemia, hypomagnesemia)\n - No consent for registration, storage, and processing of individual disease characteristics, information on the course of the disease, and information obtained from the family physician and/or other physicians involved in the treatment of the patient about study participation\n - No consent for biobanking\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nDeciphering Antitumour Response and Resistance With INtratumour Heterogeneity\n\n**Clinical Trial Summary:**\n\nDARWIN II is a multi-arm non-randomised phase II trial, Eligible patient will be those who relapse with NSCLC (clinical trials.gov ref. NCT02183883),\n The trial will investigate assess if intra-tumour heterogeneity (clonal vs subclonal actionable mutation) is associated with PFS.\n Patients 1) without an actionable mutation and PDL1 positive or 2) without an actionable mutation and PDL1 negative following first line cytotoxic chemotherapy, will receive MPDL3280A a monoclonal antibody targeting anti-PDL1.\n Patients with BRAFV600 mutations, Her2 Amplification, ALK/RET gene rearrangements will be enrolled into arms treating with vemurafenib, trastuzumab emtansine and alectinib respectively.\n DARWIN II will include extensive exploratory biomarker analysis to investigate a number of genomic and immune markers that may predict response to MPDL3280A and help guide future clinical trial design.\n\n**Clinical Trial Detailed Description:**\n\nDARWIN II is an exploratory phase II study examining the role of intra-tumour heterogeneity and predicted neo-antigens on the anti-tumour activity of anti-PDL1 immunotherapy.\n It will examine how clonal dominance and intratumour heterogeneity influence outcomes after treatment, offering a unique opportunity to decipher mechanisms of resistance to immunotherapy with anti-PDL1. These data will help improve future study design by developing greater understanding of patient selection for immunotherapies in patients with NSCLC. The relationship between intratumour heterogeneity and cfDNA/CTCs will also be explored in DARWIN II, which may develop tools for patient selection and monitoring to be examined further in future studies. Results from DARWIN II will help to identify a biomarker for anti-PD-L1 therapy which could be used for patient stratification in future phase III trials of molecules targeting this T-cell inhibitory checkpoint. DARWIN II will also provide preliminary data on efficacy of MPDL3280A, which could be used to design randomised studies.\n This is a multicentre non-randomised phase II study based on patients with relapsed NSCLC, who have provided a biopsy sample at the time of relapse.\n The study arms:\n - Arm 1: Patients either 1) without an actionable mutation and PDL1 positive or 2) without an actionable mutation and PDL1 negative following first line cytotoxic chemotherapy - MPDL3280A\n - Arm 2: BRAFV600 - vemurafenib\n - Arm 3: ALK/RET gene rearrangement - alectinib\n - Arm 4: Her2 Amplification - trastuzumab emtansine\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Multi-region sequencing data of the primary tumour available\n - Subjects must be willing to have a biopsy of relapsed disease. Consent will be obtained through the TRACERx study. (TRACERx patients) or using the DARWIN2 trial entry biopsy consent form (non-TRACERx patients). Procurement of the biopsy sample is not necessary at the time of trial registration. However, patients must undergo a biopsy prior to commencement of any trial treatment.\n - Arm1:\n - Absence of any actionable mutation and PDL1 positive. OR\n - Absence of any actionable mutation and PDL1 negative following first line cytotoxic chemotherapy\n - Arm2: Presence of BRAFV600 mutation\n - Arm3: Presence of ALK/RET gene fusion and ALK IHC+/RET FISH\n - Arm4: Presence of HER2 amplification and HER2 IHC2+/3+\n - Absence of sensitising EGFR mutation (tested according to local protocol). The only exception will be patients who progress on DARWIN1 or on EGFR TKi off-study (if agreed following prior discussion with the CI & UCL CTC)\n - Written Informed consent for DARWIN2.\n - ECOG PS 0-2 for arms 1-3, ECOG PS 0-1 for arm 4.\n - No previous chemotherapy the advanced setting (exception if PDL1 negative an received first line cytotoxic chemotherapy)\n - Measurable disease by RECIST v1.1. See Appendix 4\n - At least 18 years of age.\n - Anticipated life expectancy of at least three months.\n - Able to swallow and retain oral medication for arms 2 & 3.\n - Adequate organ function as defined by the following baseline values:\n - Absolute neutrophil count (ANC) ≥1.5x10^9/L\n - Platelets ≥100x10^9/L\n - Serum bilirubin ≤1.5 x upper limit of normal (ULN). (In case of Gilberts syndrome discuss with TMG)\n - Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≤3xULN or ≤5x ULN if liver metastases are present).\n - Creatinine clearance must be >30mL/min calculated or measured.\n - Women with child-bearing potential, or men who are able to father a child, must be willing to practice acceptable methods of birth control during the trial and for 7 months after the end of treatment.\n - Women of childbearing potential must have a negative pregnancy test within 14 days before the first dose of trial medication.\n Exclusion Criteria:\n - Suitable for radical radiotherapy.\n - Palliative radiotherapy within 1 week prior to registration.\n - Patients with current or pre-existing interstitial lung disease.\n - Patients with pre-existing autoimmune disease (some exceptions allowed).\n - Known hypersensitivity to study IMP or to any of the excipients\n - Inability to understand or to comply with the requirements of the trial, trial protocol or to provide informed consent.\n - Anti-cancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic therapy, or major surgery within 14 days prior registration.\n - Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti−tumor necrosis factor (TNF) agents) within 2 weeks prior to registration, or anticipated requirement for systemic immunosuppressive medications during the trial (Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enroled in the trial after discussion with CTC. The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed. Low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed).\n - Known human immunodeficiency virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection. Subjects with evidence of hepatitis B virus clearance may be enrolled.\n - History of other malignancy; Exception: (a) Subjects who have been successfully treated and are disease-free for 3 years, (b) a history of completely resected non-melanoma skin cancer, (c) successfully treated in situ carcinoma, (d) CLL in stable remission, or (e) indolent prostate cancer requiring no or only anti-hormonal therapy with histologically confirmed tumour lesions that can be clearly differentiated from lung cancer target and non-target lesions are eligible.\n - Patients with symptomatic brain metastases.\n - The following cardiac abnormalities:\n - Corrected QT (QTc) interval ≥480 msecs\n - Arm 4: LVEF <50%\n - History of acute coronary syndromes (including unstable angina) within the past 6 months\n - Coronary angioplasty, or stenting within the past 24 weeks\n - Class III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system\n - History of known arrhythmias (except sinus arrhythmia) within the past 6 months\n - History of myocardial infarction within the past 6 months\n - Patients taking medicines known to prolong QT interval 2 weeks prior to registration. Use also not permitted while on trial\n - Arm 3 - Use of potent inhibitors and inducers of CYP3A, 2 weeks or 5 half-lives (whichever is longer) prior to registration. Use also not permitted while on trial.\n - Uncontrolled medical conditions (i.e., diabetes mellitus, hypertension, uncorrectable electrolyte abnormalities (including magnesium etc), psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol.\n - Pregnant, lactating or actively breastfeeding females\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nPhase II Trial of Palbociclib in Patients With Metastatic Urothelial Cancer After Failure of First-Line Chemotherapy\n\n**Clinical Trial Summary:**\n\nThis multicenter phase II trial will evaluate palbociclib (PD-0332991) in patients with metastatic urothelial carcinoma (UC) with cyclin-dependent kinase inhibitor 2A (CDKN2A) (also referred to as p16) loss and positive Retinoblastoma (Rb) expression after failure of first-line chemotherapy.\n\n**Clinical Trial Detailed Description:**\n\nThis multicenter phase II trial will evaluate palbociclib (PD-0332991) in patients with metastatic urothelial carcinoma (UC) with cyclin-dependent kinase inhibitor 2A (CDKN2A) (also referred to as p16) loss and positive Retinoblastoma (Rb) expression after failure of first-line chemotherapy. The study will enroll up to 40 patients to identify 36 evaluable patients, using a Simon's two-stage design, with a primary endpoint of progression free survival (PFS) at 4 months (PFS4). Secondary objectives include estimating median PFS, overall survival (OS), response rate (RR) and exploratory objectives include an evaluation of molecular predictors of response and resistance.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Age ≥ 18 years\n - ECOG Performance status of ≤ 2 (see section 11.1, Appendix A)\n - Histologically confirmed UC of the bladder, urethra, ureter or renal pelvis with Rb+/CDKN2A- based on immunohistochemistry (IHC) of tissue blocks or unstained slides performed within a CLIA-certified laboratory at UNC; if stage I of original cohort indicates futility, molecular requirement for eligibility will change to Rb+/CCND1 overexpression (also based on IHC); see statistical section, section 8.0)\n - Metastatic disease that is not amenable to curative surgery or radiation\n - Prior treatment with ≤ two prior cytotoxic regimens; prior therapy must have consisted of at least one of the following: cisplatin, carboplatin, paclitaxel, docetaxel or gemcitabine. If the only prior cytotoxic therapy was administered in the perioperative i.e. neoadjuvant or adjuvant settings, patient is eligible provided the interval from end of therapy to the diagnosis of metastatic disease is less than one year.\n - Progressive disease during or after treatment with at least one of the agents listed above\n - At least one measurable disease site (as defined by RECIST1.1) that has not been previously irradiated\n - No prior therapy with a CDK 4/6 inhibitor; prior anti PD1 and anti PD-L1 therapy is permitted\n - Washout period should be at least 2 weeks for prior chemotherapy or radiation therapy 3.1.10 Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, surgery to ≤ grade 1 per NCI CTCAEv4 except neuropathy which may be ≤ grade 2\n - No active brain metastases\n - Adequate bone marrow, liver and renal functions as assessed by the following:\n - Hemoglobin ≥ 8 g/dL;\n - Absolute neutrophil count ≥ 1,500/uL;\n - Platelets ≥ 75,000 g/uL;\n - Total bilirubin ≤ 1.5 times upper limit of normal (ULN);\n - ALT and AST ≤ 2.5 times ULN;\n - serum creatinine ≤ 2.5 times ULN;\n - Negative serum pregnancy test in women of child-bearing potential within 7 days of D1 of treatment\n - If fertile, agree to use effective contraception (condom or other barrier methods, oral contraceptives, implantable contraceptives, intrauterine devices) during trial\n - Life expectancy greater than 3 months\n - Subject must be able to give written IRB approved informed consent and be able to follow protocol requirements\n Exclusion Criteria:\n - Any prior treatment with any investigational drug within the preceding 4 weeks\n - Any concurrent active malignancy requiring treatment (other than basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder tumors, other malignancies curatively treated > 3 years prior to study entry) or patients with adenocarcinoma of the prostate that has been surgically treated and with a post-treatment PSA that is non-detectable.\n - Unstable systemic disease or active uncontrolled infection\n - Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to study entry\n - Not willing to avoid grapefruit, grapefruit juices, grapefruit hybrids, Seville oranges, pummelos, and exotic citrus fruits from 7 days prior to the dose of study medication and during the entire study due to potential CYP3A4 interaction with the study medication. Orange juice is allowed.\n - Intake of any herbal preparations or medications (including, but not limited to, Saint John's Wort and ginkgo biloba) and dietary supplements within 7 days prior to first dose of study drug\n - Unable or unwilling to discontinue use of any drug known to be a strong or moderate inhibitor or inducer of CYP3A4 (prohibited inducers and inhibitors must be discontinued within 2 weeks prior to first dose of study drug; see section 11.2 Appendix B); unable or unwilling to discontinue use of any proton pump inhibitor; see section 11.2, Appendix B\n - Any malabsorption problem that, in the investigator's opinion, would prevent adequate absorption of the study drug\n - Inability to swallow oral medications\n - Pregnant or breast-feeding\n - Substance abuse, or medical, psychological or social conditions that may interfere with the patient's participation in the study or the evaluation of the study results\n - Other serious, ongoing, non-malignant disease or infection that would compromise protocol objectives\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nSafety and Clinical Activity of Lapatinib in Patients With HER2-positive Refractory Advanced Cancer\n\n**Clinical Trial Summary:**\n\nAlthough anti-HER2 (human epidermal growth factor receptor 2) therapy is currently approved for breast, gastric, and gastroesophageal cancers overexpressing the HER2 protein or amplified for the HER2 gene, HER2 aberrations (gene amplification, gene mutations, and protein overexpression) are reported in other diverse malignancies. Indeed, about 1-37% of tumors of the following types harbor HER2 aberrations: bladder, cervix, colon, endometrium, germ cell, glioblastoma, head and neck, liver, lung, ovarian, pancreas, and salivary duct.\n Lapatinib is an orally active, reversible, small molecule TKI that potently inhibits both ErbB1 and ErbB2 tyrosine kinase activity. Data suggest that a dual ErbB1 and ErbB2 inhibitor may provide improved therapeutic benefit compared with inhibitors that target only one or the other receptor.\n Therefore, this phase 2 study is designed to evaluated the activity of lapatinib in patients with HER2-positive refractory cancer.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Age > 19\n - Written informed consent\n - ECOG 0-2,\n - Histologically confirmed HER2-positive Refractory solid tumor(IHC 3+ alone, or IHC 2+ with FISH amplification) and/or specific sensitivity to Lapatinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.\n - The presence of measurable disease as defined by the Response (Evaluation Criteria in Solid Tumors (RECIST) version 1.1)\n - Adequate organ function\n Exclusion Criteria:\n - Uncontrolled symptomatic brain metastasis,Uncontrolled active infection\n - Uncontrolled systemic illness (DM, CHF, unstable angina, hypertension or arrhythmia)\n - Prolonged QT interval in ECG (QTc >450 msec)\n - Pregnant, lactating women\n - Prior treatment with lapatinib,Malabsorption syndrome, any disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication\n - Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nStudy of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma\n\n**Clinical Trial Summary:**\n\nTo determine the MTD/RP2D of the HDM201 and LEE011 combination and evaluate whether the combination is safe and has beneficial effects in patients with liposarcoma.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patients with histologically documented, locally advanced or metastatic WD/DD liposarcoma who have received at least one prior systemic therapy\n - Patients with radiologic progression, defined by RECIST v.1.1, occurring while on/or within 6 months after last systemic treatment, prior to enrollment\n - ECOG performance status of 0-1\n Exclusion Criteria:\n - Prior treatment with compounds with the same mode of action\n - Patients with TP53 mutated tumors, if the molecular status is known\n - Symptomatic central nervous system metastases\n - Inadequate organ function\n - Previous and concomitant therapy that precludes enrollment, as defined by protocol\n Other protocol-defined inclusion/exclusion criteria may apply.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nAdult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas\n\n**Clinical Trial Summary:**\n\nThis study is to evaluate the efficacy and safety of ABT-414 alone or with temozolomide versus temozolomide or lomustine alone in participants with recurrent glioblastoma multiforme.\n The study includes a Pediatric sub-study to evaluate safety, tolerability and pharmacokinetics of ABT-414 in a pediatric population.\n Adult enrollment has been completed and the study is now only recruiting for pediatric participants.\n\n**Clinical Trial Detailed Description:**\n\nThe pediatric sub-study is an uncontrolled, open-label, single-arm global study. This sub-study is to evaluate the safety, tolerability, and pharmacokinetics of ABT-414 in a pediatric population less than 18 years of age as well as to assess the effect of ABT-414 on tumor response per Response Assessment in Neuro-Oncology (RANO) criteria.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n Adult participants (greater than or equal to 18 years old):\n - Histologically confirmed de novo (primary) Glioblastoma Multiforme with unequivocal tumor progression or recurrence.\n - In case of testing at the time of first progression: either at least 3 months after the end of radiotherapy or have tumor progression that is clearly outside the radiation field or have tumor progression unequivocally proven by surgery/biopsy\n - Absence of any psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule; such conditions should be assessed with the patient before registration in the trial.\n - Availability of adequate biological material (formalin-fixed paraffin embedded [FFPE] tumor) for central testing of Epithelial Growth Factor Receptor (EGFR) amplification\n - Presence of EGFR amplification confirmed by central assessment; participants with undetermined EGFR status are excluded\n - World Health Organization (WHO) Performance status 0 - 2\n - No more than one line of chemotherapy (concurrent and adjuvant Temozolomide based chemotherapy including in combination with another investigational agent is considered one line of chemotherapy). Chemotherapy must have been completed at least 4 weeks prior to randomization.\n - Post surgery MRI within 48 hours following surgery, however an MRI scan has to be done within 2 weeks prior to randomization.\n - Surgery completed at least 2 weeks before randomization and patients should have fully recovered as assessed by investigators.\n Pediatric sub-study participants (less than 18 years old):\n - Histologically proven high grade glioma (HGG: WHO grade III glioma [e.g anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma], grade IV glioma [e.g glioblastoma, gliosarcoma] or diffuse intrinsic pontine glioma [DIPG]).\n - Must either have recurrent/progressive tumor or, if newly diagnosed, have completed any planned radiation therapy at least 4 weeks prior to first dose of ABT-414.\n - The tumor tissue must have been determined to have EGFR amplification, performed either by local or central laboratory. If EGFR amplification is identified by local laboratory, the results from central confirmation of EGFR amplification are not necessary before enrollment of the patient in the study.\n - Participant has sufficiently recovered from previous therapy.\n Exclusion Criteria:\n Adult population (greater than or equal to 18 years old):\n - Prior treatment with nitrosoureas\n - Prior treatment with bevacizumab\n - Previous exposure to Epithelial Growth Factor Receptor (EGFR) targeted agents, including EGFRvIII targeting agents\n - Prior discontinuation of temozolomide chemotherapy for toxicity reasons\n - Prior Radiation Therapy (RT) with a dose over 65 Gy, stereotactic radiosurgery or brachytherapy unless the recurrence is histologically proven\n - Previous other malignancies, except for any previous malignancy which was treated with curative intent more than 5 years prior to randomization, and except for adequately controlled limited basal cell carcinoma of the skin, squamous carcinoma of the skin or carcinoma in situ of the cervix\n - Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to randomization.\n - No history of wheat allergies and Coeliac disease.\n - No EIAED, patients who require anti-convulsant therapy must be taking non-enzyme inducing antiepileptic drugs (non-EIAED). Patients previously on EIAED must be fully switched to non-EIAED at least 2 weeks prior to randomization.\n Pediatric sub-study (less than 18 years old):\n - (For recurrent disease) No prior RT with a dose over 65Gy to the brain, stereotactic radiosurgery or brachytherapy unless the recurrence is histologically proven\n - No current or recent (within 4 weeks or 5 half-lives (whichever is shorter) before enrollment) treatment with another investigational drug\n - Female participants of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to randomization.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nEarly-Phase Study to Assess Inhibitor Ribociclib in Patients With Recurrent Glioblastoma or Anaplastic Glioma\n\n**Clinical Trial Summary:**\n\nThis is a single-institution, open-label, early-phase study to assess the ability of ribociclib (LEE011) to inhibit CDK4/CDK6/Rb/E2F signaling and cell proliferation/viability in core and infiltrating tumor tissues obtained from patients with recurrent glioblastoma or anaplastic glioma compared to the baseline/primary pathologic tumor specimen. Abundant preclinical evidence indicates that Rb-deficient cancer cells are resistant to CDK4/6 inhibition and ongoing trials with CDK4/6 inhibitors exclude patients with Rb-deficient tumors. The investigators will evaluate 10 patients with Rb-positive glioblastoma or anaplastic glioma in this study. Given that a minority of glioblastomas ha Rb loss the investigators anticipate enrolling a maximum of 20 patients, to meet our goal of 10 patients with Rb-positive tumors.\n\n**Clinical Trial Detailed Description:**\n\nPreliminary evaluation of efficacy and determination of the ribociclib safety profile in patients with brain tumors will be studied. All patients will be treated with ribociclib (600 mg/day) for 8-21 days before surgical resection of the recurrent tumor. Rb status of the recurrent tumor will be determined by immunohistochemistry within 2 weeks after surgery. Patients with Rb-positive tumors will continue treatment with ribociclib (21 days on, 7 days off) after surgery. Patients will be treated until unacceptable toxicity is observed, or until disease progression as assessed by radiographic or clinical metrics. We will determine whether molecular markers associated with changes induced by ribociclib treatment in tumors (matching initial vs. recurrent tumors) correlate with progression-free survival.\n Approximately 20% of patients with recurrent high-grade glioma will undergo surgical resection of their tumor typically at the time of first recurrence. These patients will be eligible for this study. An extra 10 mL of blood will be collected during a routine clinical procedure prior to initiation of ribociclib treatment (i.e., baseline blood sample), separated into plasma and buffy coat fractions, and frozen for pharmacokinetic (PK) analysis. Patients will be treated with ribociclib for 8-21 days prior to surgery to identify drug effects on tumor cells, and to determine drug PK. The last presurgical dose of ribociclib will be administered on the day of surgery at 4-8 hours prior to surgery to allow sufficient time for the drug to enter tumor cells, inhibit CDK4/6, and modulate downstream effectors. Blood will be acquired within 1 hour before surgery (as close to the time of surgery as possible). Blood will be separated into plasma and buffy coat fractions, and frozen. During surgery, samples of brain tumor core and infiltrating brain tumor will be acquired. Tissue samples will be frozen or fixed in paraffin embedded blocks and histology for PK and molecular analyses.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria:\n - Written informed consent must be obtained prior to any screening procedures\n - Patients age 18-85 are eligible for study participation\n - History of grade III or IV glioma (GBM or AG) with archived FFPE and/or frozen tumor tissue available\n - Patient must be a candidate for surgical resection of recurrent high-grade glioma\n - Karnofsky Performance Scale score ≥ 70.\n - Life expectancy of 4 months or longer.\n - Received at least 1 prior systemic therapy for glioma.\n - A sufficient interval must have elapsed between the last dose of prior anti-cancer therapy (including cytotoxic and biological therapies and major surgery) and enrollment, to allow the effects of prior therapy to have abated\n - Patients must have adequate organ function\n - For continued ribociclib treatment after surgery, immunohistochemical (IHC) confirmation of Rb expression in ≥50% of malignant tumors cells in at least 1 tumor specimen is\n Exclusion criteria:\n - Impairment of gastro-intestinal (GI) function or GI disease that may significantly alter the absorption of ribociclib such as patients with a history of GI surgery which may result in intestinal blind loops and patients with clinically significant gastroparesis, unresolved nausea, vomiting, or diarrhea of CTCAE grade > 1\n - Impaired cardiac function or clinically significant cardiac diseases\n - Patients who are currently receiving treatment (within 5 days prior to starting study drug) with agents that are metabolized predominantly through CYP3A4 and that have a narrow therapeutic window. Agents including vitamins, supplements, and herbal supplements that are either (i) metabolized solely through CYP3A4/5, CYP1A2 or BSEP and have a narrow therapeutic window or (ii) are strong inhibitors of CYP3A4/5, CYP1A2 or BSEP. Agents that are known strong inducers or inhibitors CYP3A4 are prohibited. Patients must avoid consumption of grapefruit, Seville oranges or products containing the juice of each during the entire study and for 7 days before the first dose.\n - Patients with concurrent severe and/or uncontrolled concurrent medical conditions that the investigator believes could compromise participation in the study (e.g., uncontrolled hypertension and/or diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection)\n - Pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).\n - Women of childbearing potential, defined as all women physically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Effective contraception must be used by both sexes (female patients and their male partners) during study treatment and for 30 days after the last dose of study medication\n - Fertile males must be willing to use contraception. Fertile males must use condom with spermicide (double barrier method). Effective contraception, as defined above, must be used by both sexes (male patients and their female partners) during study treatment and for 30 days after the last dose of study medication. A condom is required to be used by vasectomized men in order to prevent delivery of the study drug via seminal fluid.\n - Patients unwilling or unable to comply with the protocol\n - Known diagnosis of human immunodeficiency virus (HIV) or hepatitis C (testing is not mandatory)\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nEfficacy and Safety of Trabectedin (Yondelis®) in Patients With Advanced Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nEfficacy and safety of trabectedin in real-life practice, routinely used for the management of advanced sarcoma after failure of anthracyclines and ifosfamide or patients unsuited to receive these drugs in Germany.\n Trabectedin is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.\n\n**Clinical Trial Detailed Description:**\n\nThis is a non-interventional, observational and prospective study to evaluate efficacy and safety of trabectedin in routine practice. Patients are assigned to a therapeutic strategy within current practice, not according to a trial protocol. The prescription of the medicine is separated from the decision to include the patient in the study. Diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy.\n There are no dose regimens or medical procedures defined within this study plan. Every medical decision and course of treatment with trabectedin will reflect exclusively the decision of the Investigator in a routine clinical situation according to SmPC. The concept of this non-interventional study and its documentation procedure will not affect in any way the routine treatment situation.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patients must comply with all of the following criteria in order to be enrolled into the study:\n - Histologically diagnosed advanced STS\n - Female or male aged 18 years or above\n - Signed written informed consent\n - Suitable to undergo treatment with trabectedin according to SmPC\n - Progress after therapy with anthracyclines and ifosfamide has failed, or if patients are unsuited to receive these agents\n Exclusion Criteria:\n - Patients presenting contraindications for the use of trabectedin as defined in the SmPC will be excluded from participating in the study.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nPost-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan.\n\n**Clinical Trial Summary:**\n\nThe primary objective of the study is to clarify factors affecting the incidence of peripheral neuropathy in patients treated with HALAVEN. A total of 590 patients will be enrolled in this study with 295 patients in the treatment group of primary or secondary chemotherapy and 295 patients in the treatment group of tertiary or later chemotherapy.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria:\n Patients with HER2-negative inoperable or recurrent breast cancer.\n Exclusion criteria:\n Patients with high-grade bone marrow depression (absolute neutrophil count less than 1,000 /mm^3, absolute platelet count less than 75,000 /mm^3).\n Patients with a history of hypersensitivity to the ingredients of HALAVEN. Women who are pregnant or may be pregnant. Patients with a history of use of HALAVEN.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nMetformin for Rising PSA Remote Trial\n\n**Clinical Trial Summary:**\n\nClinical trials are critical to informing the care of patients with cancer. However, only 3-5% of patients with cancer enroll in clinical trials. Poor accrual to trials has major implications with regards to the pace of progress, the cost of clinical cancer research, and the generalizability of results. The investigators have recently shown in an analysis of 7,776 cancer clinical trials registered on clinicaltrials.gov that approximately 20% of cancer clinical trials fail to complete enrollment at all; the most often cited reason was poor accrual.\n Prior research has identified barriers to cancer clinical trial accrual that can be generally categorized in the domains of availability, awareness, and acceptance. Much attention has been paid to the barriers involvement awareness and acceptance - however, trial availability is likely a \"rate limiting step\". This pilot study is the first in a series of planned steps to attempt to shift the current paradigm of \"bringing patients to trials\" to \"bringing trials to patients.\" With the integration of telemedicine visits, the investigators aim to decrease the burden of participation for patients, begin to address geographic barriers, and ultimately improve trial accrual. In this study, men with biochemically recurrent prostate cancer (a rising PSA after definitive local therapy) will receive the antidiabetic drug, metformin. Patients will require a single on-site visit for study enrollment. The remainder of the 6 month study will be conducted via a HIPPA secure telemonitoring system (monthly visits conducted via telemedicine with tablet computers provided to each patients).\n\n**Clinical Trial Detailed Description:**\n\nMen with an isolated PSA recurrence after local therapy are an ideal population for the evaluation of novel therapies given the minimal disease burden, generally indolent natural history, and patients' preference to avoid the adverse effects of androgen deprivation therapy. Metformin has shown anti-prostate cancer activity in preclinical models and cohort studies. Metformin, a biguanide oral antihyperglycemic agent, abrogates hyperinsulinemia in individuals with and without diabetes and has shown promising anti-prostate cancer activity in preclinical models, epidemiologic studies, and retrospective cohorts. Several epidemiologic/retrospective studies have shown that metformin has a positive impact on overall survival among men with prostate cancer.\n These nonclinical and clinical studies have led to calls for prospective studies of metformin in patients with prostate cancer. This is a pilot telemedicine study of metformin in patients with a rising PSA (\"biochemical recurrence\") after definitive local therapy for prostate cancer.\n The current study is supported by the following rationale:\n - A large proportion of clinical trials close prematurely due to poor accrual.\n - Geographic inaccessibility is a barrier to clinical trial participation.\n - Metformin is a safe and inexpensive medication that has demonstrated anti-prostate cancer activity in nonclinical and epidemiologic studies. Importantly, metformin has been shown to be safe in non-diabetic patients (e.g., patients with polycystic ovary disease) and does not cause hypoglycemia.\n - Use of novel technologies may facilitate clinical trial accrual and minimize the burden of participation for patients. Ultimately, these approaches may also decrease the cost of drug development and increase the pace of progress.\n In the absence of prohibitive toxicities or disease progression (defined in 4.4), patients may continue treatment for the 6-month study period. This study will include a baseline visit for study enrollment at Mount Sinai. The remainder of the visits will be telemedicine visits conducted using secure video conferencing.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Histologically confirmed adenocarcinoma of the prostate. (*in situations where pathology reports documenting prostate cancer are no longer available such as when the initial biopsy or prostatectomy was performed in the remote past, a documented history of prior prostate cancer and prostate cancer treatment in prior medical records will be sufficient)\n - Biochemical disease progression after radical prostatectomy and/or radiation therapy (external-beam radiation therapy and/or brachytherapy), and no radiographic evidence of metastases.\n - Men with history of radical prostatectomy are required to have baseline PSA > 0.5 ng/mL (Prior treatment with neoadjuvant, adjuvant, or salvage radiation therapy is allowed, again, with screening PSA greater than or equal to 0.5 ng/mL required for eligibility).\n - Men treated with primary radiation therapy are required to have baseline PSA ≥ 1.0 ng/mL above their post radiation nadir for men who were treated with primary radiation therapy (external beam and/or brachytherapy). Men who had primary radiation therapy followed by salvage prostatectomy are eligible if screening PSA is greater than or equal to 0.5 ng/mL.\n - Men with previous neoadjuvant adjuvant hormone therapy are eligible if testosterone level at screening is non-castrate (≥ 50 ng/dl). Men previously treated with intermittent hormonal therapy are also eligible if level of testosterone at screening is non-castrate (≥ 50 ng/dl).\n - Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).\n - Subjects must have normal organ as defined below:\n - AST(SGOT)/ALT(SGPT) less than or equal to 1.8 X institutional upper limit of normal\n - Serum bilirubin ≤ ULN (except for subjects with Gilbert's Disease who are eligible despite elevated serum bilirubin level)\n - Creatinine ≤ 1.5 mg/dL and/or creatinine clearance > 60 ml/min\n - English speaking\n Exclusion Criteria:\n - Concurrent use of other investigational agents or other prostate cancer therapies (e.g., androgen deprivation therapy)\n - Currently taking metformin, sulfonylureas, thiazolidinedione, insulin, or other antidiabetic drugs for any reason.\n - Known hypersensitivity or intolerance to metformin\n - Condition associated with increased risk of metformin-associated lactic acidosis:\n - New York Heart Association Class III or IV Heart Failure\n - Intake of 3 or more alcoholic beverages per day\n - Known history of lactic acidosis\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Phase 1b Safety Study of CMB305 (Sequentially Administered LV305 and G305) in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1\n\n**Clinical Trial Summary:**\n\nThis is a Phase 1b, open label, multi-center study of CMB305 (sequentially administered LV305 [a dendritic cell-targeting viral vector expressing the NY-ESO-1 gene] and G305 [NY-ESO-1 recombinant protein plus GLA-SE]) in patients with melanoma, sarcoma, ovarian cancer, or non-small cell lung cancer that express NY-ESO-1.\n CMB305 is a novel in vivo approach designed to stimulate the body's immune system to fight the spread and growth of cancer for patients whose tumors express the NY-ESO-1 protein. LV305 will be given in a prime-boost approach with G305 to induce a synergistic immunotherapeutic response.\n\n**Clinical Trial Detailed Description:**\n\nThis study is designed to investigate and examine the safety and immunogenicity of the combinatorial regimen called CMB305, where intradermal LV305 is administered sequentially with intramuscular G305 over three months. During Part 1, a dose escalation design will be utilized in patients with melanoma, NSCLC, ovarian cancer, or sarcoma. After completion of Part 1, the study will be expanded in Part 2 and will enroll patients with NSCLC, ovarian cancer, synovial sarcoma or myxoid/round cell liposarcoma.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Locally advanced, relapsed, and/or metastatic cancer with low or minimal tumor burden, which may or may not be measureable (see Appendix A for descriptions)\n 2. Tumor histology consistent with one of the following: In Part 1, Dose Escalation - melanoma, NSCLC, ovarian cancer (including fallopian tube carcinoma), or sarcoma (any subtype). In Part 2, Patient Expansion - NSCLC, ovarian cancer (including fallopian tube carcinoma), or the sarcoma subtypes, synovial sarcoma or myxoid/round cell liposarcoma\n 3. Tumor specimen positive for NY-ESO-1 expression by IHC and/or RT-PCR\n 4. If ovarian cancer, cancer antigen 125 (CA-125) must be ≥ 40 U/mL (unless patient has measureable disease that cannot be followed by CA-125); if melanoma, LDH must be ≤ ULN\n 5. Inadequate response, relapse, and/or unacceptable toxicity with one or more prior systemic, surgical, or radiation cancer therapies, and for whom curative standard therapy is not an option (except patients with NSCLC who must have experienced either an inadequate response, relapse, and/or unacceptable toxicity with two or more prior systemic, surgical, or radiation cancer therapies)\n 6. ≥ 18 years of age\n 7. Life expectancy of ≥ 6 months per the investigator\n 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n 9. ECG without evidence of clinically significant arrhythmia or ischemia\n 10. If female of childbearing potential (FCBP), willing to undergo pregnancy testing and agrees to use at least one highly effective or two effective contraceptive methods during the dosing period and for three months after last CMB305 injection\n 11. If male and sexually active with a FCBP, must agree to use highly effective contraception such as latex condom during the dosing period and for three months after last CMB305 injection\n Exclusion Criteria:\n 1. Investigational therapy within 3 weeks prior to CMB305 dosing\n 2. Prior administration of other NY-ESO-1-targeting immunotherapeutics\n 3. Significant immunosuppression from:\n 1. Concurrent, recent (≤ 4 weeks ago) or anticipated treatment with systemic corticosteroids at any dose, or\n 2. Other immunosuppressive medications such as methotrexate, cyclosporine, azathioprine (antihistamines, non-steroidal anti-inflammatory drugs and aspirin permitted) or conditions such as common variable hypogamma-globulinemia or exposures such as large field radiotherapy\n 4. Cancer therapies, including chemotherapy, radiation, biologics or kinase inhibitors, G-CSF or GM-CSF within 3 weeks prior to the first scheduled CMB305 dosing\n 5. Psychiatric, other medical illness or other condition that in the opinion of the PI prevents compliance with study procedures or ability to provide valid informed consent\n 6. Significant autoimmune disease with the exception of alopecia, vitiligo, hypothyroidism or other conditions that have never been clinically active or were transient and have completely resolved and require no ongoing therapy\n 7. Myocardial infarction within 6 months of study initiation, active cardiac ischemia or New York Heart Association (NYHA) Grade III or IV heart failure\n 8. Inadequate organ function including:\n 1. Marrow: Peripheral blood leukocyte count (WBC) < 3000/mm3, absolute neutrophil count ≤ 1500/mm3, platelets < 75000/mm3, or hemoglobin < 10 gm/dL\n 2. Hepatic: alanine aminotransferase (ALT), and aspartate aminotransferase (AST) > 2.5 x ULN, total serum bilirubin > 1.5 x ULN (patients with Gilbert's Disease may be included if their total bilirubin is ≤3.0 mg/dL)\n 3. Renal: Creatinine > 1.5x ULN\n 4. Other: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x ULN\n 9. History of other cancer within 3 years (except non-melanoma cutaneous malignancies and cervical carcinoma in situ).\n 10. Active tuberculosis or recent (< 2 week ago) clinically significant infection or evidence of active hepatitis B, hepatitis C or HIV infection\n 11. Uveal melanoma\n 12. Brain metastases considered unstable as:\n 1. Without confirmed stability over 60 days in patients previously treated with prior surgery or radiation; OR\n 2. Associated with symptoms and/or findings; OR\n 3. Requiring corticosteroids or anticonvulsants in the prior 60 days\n 13. Pregnant or nursing\n 14. Known allergy(ies) to any component of CMB305, including egg lecithin\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nPREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to characterize the pharmacokinetics (PK) and safety of intravenous (iv) pantoprazole in patients 1 to 16 years old who are candidates for acid suppression therapy.\n\n**Clinical Trial Detailed Description:**\n\nIn hospitalized pediatric subjects, age 1 to 16 years who in the judgment of the investigator are candidates for acid suppression therapy, the following are the objectives of this trial:\n Primary Objectives To characterize the PK profile of single and repeated IV doses of pantoprazole in pediatric subjects aged 1 < to less than 2 years old.\n To characterize the PK profile of single and repeated IV doses of pantoprazole in pediatric subjects aged 2 to 16 years old.\n Secondary Objectives To determine the safety and tolerability of single and multiple doses of IV pantoprazole in each of the independent age cohorts over 7 days.\n To assess the CYP2C19 genotype in pediatric subjects receiving IV pantoprazole, to determine the presence of the gene for the major enzyme responsible for metabolism of pantoprazole.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Hospitalized subjects 1 to 16 years who in the judgment of the investigator are candidates for acid suppression therapy (ie, those with a presumptive diagnosis of GERD, a clinical diagnosis of suspected GERD, symptomatic GERD, or endoscopically proven GERD)\n - Body weight > 5th percentile for age\n - Y-site or dedicated IV line for administration of pantoprazole\n - Expected survival for at least 30 days\n - Male and female subjects of childbearing potential at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment.\n Exclusion Criteria:\n - Participation in other studies involving investigational drug(s) or treatment with an investigational drug within 30 days or 5 half lives before the first dose of the investigational product and/or during study participation.\n - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n - Pregnant females; breastfeeding females; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after last dose of investigational product.\n - Serum CK levels >3x ULN.\n - Known history of HIV or clinical manifestations of AIDS.\n - History or presence of upper GI anatomic or motor disorders, including:\n - Esophageal strictures, webs, or diverticulae.\n - GI strictures of any kind.\n - Esophageal or gastric motor disorders.\n - Barrett's esophagus.\n - Peptic ulcer disease, erosive gastritis and/or erosive duodenitis.\n - Known eosinophilic esophagitis by histology.\n - GI malabsorption.\n - Known active H. pylori infection.\n - Known hypersensitivity to PPIs or to any substituted benzimidazole or to any of the excipients.\n - History of treatment with any PPI within 2 weeks (14 days) before Day 1.\n - Use of H2RAs, sucralfate, misoprostol, or prokinetic agents, and bismuth preparations within 2 weeks (14 days) before Day 1.\n - Any disorder requiring chronic (every day) use of warfarin, carbamazepine, or phenytoin, methotrexate, atazanavir or nelfinavir, clopidogrel, and potent inhibitors and inducers of CYP2C19.\n - Chronic (daily) use of glucocorticoids. Steroid inhalers and topical steroids may be used.\n - Active malignancy of any type, or history of a malignancy (Subject with a history of malignancies that have been surgically removed or eradicated by irradiation or chemotherapy and who have no evidence of recurrence for at least 5 years before Screening are acceptable).\n - Diagnosed as having or has received treatment for esophageal, gastric, pyloric channel, or duodenal ulceration within 30 days before Screening.\n - ALT or BUN >2.0 ULN or estimated creatinine >1.5 X ULN for age or any other laboratory abnormality considered by the Investigator to be clinically significant within 14 days before Screening.\n - In the Investigator's opinion, a chronic condition (eg, diabetes, epilepsy), which is either not stable or well controlled and may interfere with the conduct of the study.\n - History of sensitivity to heparin or heparin induced thrombocytopenia.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nOpen Label Study of Single Agent Oral RG7388 in Patients With Polycythemia Vera and Essential Thrombocythemia\n\n**Clinical Trial Summary:**\n\nThis research looks at two conditions, Essential Thrombocythemia (ET) and Polycythemia Vera (PV). ET causes people to produce too many blood cells called platelets and PV causes too many platelets and red blood cells to be made. Platelets are particles which circulate in the blood stream and normally prevent bleeding and bruising. Having too many platelets in the blood increases the risk of developing blood clots, which can result in life threatening events like heart attacks and strokes. When the number of red blood cells is increased in PV this will slow the speed of blood flow in the body and increase the risk of developing blood clots.\n The purpose of Part A of this study is to test the safety and tolerability of drug RG7388 patients and identify the recommended phase II dose in a single agent dose escalation study. The investigators want to find out what effects, good and/or bad it has on the disease.\n The purpose of Part B of this study is to test the safety and tolerability of the combination of RG7388 and Pegylated Interferon Alfa-2a or Pegasys in PV/ET patients from Part A who did not achieve at least a partial response by the end of three cycles of single agent RG7388.\n Essential Thrombocythemia (ET) and Polycythemia Vera (PV) have been difficult diseases to treat. RG7388 is a selective inhibitor of the p53-MDM2 binding that frees p53 from negative control and activates the p53 pathway in cancer cells, leading to cell cycle arrest and apoptosis in vitro and in vivo. It has been used to treat solid tumors and Acute Myelogenous Leukemia (AML) in clinical trials. Pegasys is a drug that is the standard of care for patients who have Chronic Hepatitis B (CHB).\n RG7388 is a drug that is not yet approved by the Federal Drug Administration (FDA) for the treatment of patients with essential thrombocythemia or polycythemia vera. Pegasys is a drug that is approved by the FDA for the treatment of CHB. The use of RG7388 alone and in combination with Pegasys is experimental.\n\n**Clinical Trial Detailed Description:**\n\nThe Philadelphia chromosome-negative chronic myeloproliferative neoplasms (MPNs) are a group of hematopoietic stem cell malignancies that include polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF). PV and ET can evolve into myelofibrosis, termed post PV/ET MF. ET, PV and PMF have variable tendencies to transform to blast phase disease with a dismal prognosis. JAK2V617F is a point activating mutation resulting in the constitutive activity of the JAK-STAT pathway within hematopoietic cells in approximately 96%, 50%, and 50% of patients with PV, ET, and MF, respectively.\n Polycythemia Vera is characterized by an absolute increase in red cell mass. Patients with PV have a median survival if untreated of approximately 18 months from the time of diagnosis and treated of approximately 18 years. PV-related symptoms include headache, weakness, dizziness, epigastric distress, and pruritus. PV-related signs include hypertension, gout, left upper abdominal quadrant pain, high hematocrit, leukocytosis, and thrombocytosis. Major causes of reduced survival include thrombosis (29%), bleeding (7%), evolution to myelofibrosis (3%), transformation to acute leukemia (23%), and solid tumors (16%). PV patients are stratified for risk of thrombosis by age >60 and history of prior thrombotic events. Therapy for low risk PV includes low dose aspirin and therapeutic phlebotomy to maintain a hematocrit <45% in a man and 42% in a woman. Cardiovascular risk factor modification such as weight loss, control of hypertension and hypercholesterolemia, and smoking cessation are also important adjunctive approaches to all patients with PV. High risk patients are also treated with cytoreductive therapy in the form of hydroxyurea to further reduce the risk of thrombotic complications.\n Essential Thrombocythemia is characterized by persistent isolated thrombocytosis and tendency for arterial and venous thrombosis. A similar pattern of symptoms as noted above with PV are also seen in patients with ET. The median survival of patients with ET is similar to that of age and sex matched cohort and in some patients is limited by thrombotic complications (22%), evolution to MF (10%), and acute leukemia (2%) (Barbui. J Clin Oncol. 2011; 29(23):3179). Risk stratification for occurrence of thrombosis is based on age >60 years and/or history of thrombosis. Additionally, cardiovascular risk factors and persistent thrombocytosis >1.5 x 109/L are believed to influence thrombotic risk and leukemic transformation has been shown to be associated with anemia, older age, and leukocytosis. JAK2V617F is present in approximately 50% of cases and helps establish a diagnosis of a clonal thrombocytosis, and has been shown in some studies to predict for a higher risk of thrombosis and potential for transformation to PV. Management is aimed at reducing thrombotic risk with the use of low dose aspirin in low risk patients (no risk factors) and cytoreductive therapy in high risk patients (at least one risk factor). Hydroxyurea, anagrelide, and interferon (IFN) have all been used to maintain a platelet count below 400 x 109/L in patients with a history of thrombosis (secondary prophylaxis). Currently, hydroxyurea is considered standard of care for high risk ET patients based on the results of the PT-1 study which demonstrated superiority of hydroxyurea over anagrelide in arterial thrombosis risk reduction and worsening marrow reticulin fibrosis in patients receiving anagrelide (Harrison N Engl J Med. 2005;353(1):33). Hydroxyurea is associated with a risk of oral and skin ulcers, rash, and unacceptable myelosuppression that can sometimes limit use in patients with ET/PV. Additionally, some patients are unable to achieve adequate control of blood counts at doses below 2000 mg/daily and this has been termed \"resistance\". Importantly, although a theoretical concern of leukemogenic potential of hydroxyurea exists, based on the mechanism of action of this chemotherapeutic agent, there are no definitive prospective studies clearly documenting an increased risk of leukemic transformation.\n More recently, a renewed interest in interferon-α for the treatment of PV as an alternative therapeutic approach has led to the evaluation of pegylated interferon-α 2a (Pegasys, Roche) in several phase II studies. Pegasys has an improved toxicity profile over intron-a and can be self-administered by the patient on a weekly basis. Currently, Pegasys is being evaluated in two large international trials within the myeloproliferative disorder research consortium (MPD-RC). The MPD-RC 111 study is a phase II study intended to evaluate the response by European LeukemiaNet (ELN) criteria in patients with high risk ET/PV who are intolerant or resistant to hydroxyurea therapy treated with Pegasys. In addition, patients with documented JAK2V617F and splanchnic vein thrombosis are also eligible for this clinical trial. MPD-RC 112 is a phase III study for newly diagnosed high risk PV/ET patients in which patients are randomized to either Pegasys or hydroxyurea with a primary endpoint of response rate comparison between the two treatment arms.\n The use of intron-a (rIFN-α) and Pegasys has been extensively studied in patients with PV and reported rates of discontinuation in the first year of therapy range from 14-40%. Objective hematologic responses are seen in approximately 80% of treated patients and achievement in complete phlebotomy free state in 60% of PV patients. Trials of Pegasys in the treatment of PV have further demonstrated major molecular responses of 19% and complete eradication of JAK2V617F in 14-24% of patients. Although hematologic remission can often be achieved within months of starting rIFN-α treatment, molecular responses require longer term administration and are rarely seen before completion of 12 months of therapy. Additionally, sustained molecular remissions have been documented in patients that have discontinued therapy for up to 30 months of follow up. In a retrospective review of 118 MPN patients receiving Pegasys throughout multiple MPN centers included 55 PV patients with an ORR of 87% (54% CR, 33% PR) by ELN criteria [21]. In this review, the most common non-hematologic toxicities were Grade 1-3 fatigue in 24 patients (20%), Grade 1 liver function test (LFT) elevation in 7 (6%), and Grade 1-2 skin/allergic reaction in 6 (5%). Adverse effects leading to discontinuation were primarily non-hematologic, although one patient (<1%) discontinued Pegasys therapy due to Grade 2 anemia.\n Although the biological mechanism of recombinant IFN in the treatment of PV is not completely understood, evidence to suggest promotion of immunoregulatory cell function, inhibition of angiogenesis, induction of pro-apoptotic gene expression, alteration of the bone marrow microenvironment, suppression of hematopoietic progenitor cells, and increase cycling of hematopoietic stem cells (HSC) has been reported.\n In the last several years, oral small molecule tyrosine kinase inhibitors of JAK2 have been tested in both pre-clinical and clinical trials of patients with MPNs including PV/ET. These agents have demonstrated remarkable responses in terms of reduction in splenomegaly and correction of leukocytosis, erythrocytosis, and thrombocytosis. However, mature follow up of PV patients treated with JAK2 inhibitors evaluating reduction in thrombotic risk and evolution to MF is not known. Currently, Ruxolitinib (Jakafi) is being evaluated in a phase III study in patients with high risk PV that are refractory/intolerant to hydroxyurea [Response trial: NCT01243944].\n The tumor suppressor p53 plays an integral role in the regulation of the cell cycle, apoptosis, DNA repair, and senescence. Fifty percent of cancers are found to have inactivating mutations of p53. Although, inactivating mutations of p53 are uncommon in the chronic phases of MPNs, they increase in frequency in the blast phase of MPNs. The p53 pathway can also be down-regulated in MPN cells that express wild-type p53 through alternative pathways. Over-expression of the ubiquitin ligase murine double minute 2 (MDM2; HDM2 in humans) is a regulator of wild type p53 through a variety of different mechanisms. MDM2 1) promotes proteosomal degradation and 2) inhibits p53 transcription, and 3) inhibits transactivation 4) facilitates export from the nucleus. Inhibition of MDM2 is expected to release the negative regulation of p53 and ultimately promote tumor suppressor function. MDM2 overexpression can be a consequence of gene amplification, increased transcription, and increased translation. It has previously been shown that in primary hematopoietic cells from patients with JAK2V617F PV, reduced expression of p53 is a result of increased La autoantigen expression leading to increased translation of MDM2. It would appear that JAK2V617F induces this ribonucleoprotein and furthermore, La protein expression can be down-regulated by in vitro JAK2 inhibitor treatment. Lu et al demonstrated increased MDM2 expression and reduced p53 levels in JAK2V617F-positive PV CD34+ cells. The physical structure and interaction of p53 and MDM2 is known and has allowed for the development of small molecule inhibitors of MDM2-p53 interaction. Nutlin-3, a small molecule antagonist of MDM2, was shown to inhibit the proliferation of PV CD34+ cells through increased p53 mediated apoptosis. Moreover, in vitro combination of low doses of Pegasys with nutlin-3 resulted in selective and significant inhibition of JAK2V67F-positive CD34+ PV colony formation compared to normal colony formation. Thus, MDM2 appears to be a novel therapeutic target in JAK2V617F-positive PV and ultimately may prove to be most effective when used in combination with Pegasys.\n RG7388 is an MDM2-p53 binding cell cycle inhibitor (antiproliferative) and is expected to be myelosuppressive at sufficiently high doses. Nonclinical safety findings with RG7388 that may have potential clinical relevance include thrombocytopenia and neutropenia, as well as general pancytopenia, and effects on liver function parameters.\n Clinical experience to date suggests a dose relationship for RG7388 and gastrointestinal AEs with increased incidence of nausea, vomiting, and diarrhea at higher dose levels; gastrointestinal prophylaxis with anti-emetics is recommended. Cytopenias, manifesting as thrombocytopenia and neutropenia, occurring at higher dose levels appear to be related to exposure.\n Iancu-Rubin et al have investigated the biological effect of RG7112 (first generation MDM2 inhibitor) induced p53-MDM2 disruption on megakaryopoiesis and platelet production in order to better elucidate the mechanism of treatment associated thrombocytopenia (ASH 2012). Bone marrow derived CD34+ cells exposed to RG7112 for 7 days generated fewer viable cells, fewer CFU-MK colonies as compared to untreated cells. Based on these findings, it would appear that RG7112 impacts megakaryopoiesis by two potential mechanisms: 1) Impairing the ability of CD34+ cells to generate MK precursors due to increased apoptosis; 2) Limiting DNA synthesis and polyploidization during the late stages of MK development due to pharmacological activation of p53. A combination of these two effects may provide an explanation for thrombocytopenia observed in patients receiving this drug and suggests that p53 plays an important role in normal human thrombocytopoiesis.\n Study NP27872 is a multi-center, open-label, first-in-human, Phase I dose-escalation study of single agent RG7388, a small molecule MDM2 antagonist, administered orally in patients with advanced malignancies except leukemia. The first patient received RG7388 on 15 November 2011. As of 13 September 2012, 51 patients have been enrolled in the study.\n Evaluable PK data is available for 22 patients in Study NP27872. There has been no evidence of significant accumulation (defined as a mean ratio of area under the curve [AUC]τ [on Day 15 or 5] to AUCinf [on Day 1] > 2) observed in the study thus far, except for one patient who exhibited a long half-life (t½) and consequently had an accumulated drug exposure that increased 5-fold from Day 1 to Day 5. This was possibly due to concomitant controlled-release oxycodone, as opioids are known to cause delayed gastric emptying and decreased intestinal motility. In addition, data from the study demonstrate an approximately linear dose-exposure (Day 1 maximum plasma concentration [Cmax]) relationship in RG7388 with moderately high inter-patient variability without an absorption plateau to date.\n Macrophage inhibitory cytokine (MIC-1, a secreted protein that is strongly induced by activated p53) serum levels has been used to assess pharmacodynamic (PD) effects in this Phase I study. Analysis of patients on 100 to 800 mg/day of RG7388 showed that the minimum level for p53 induction occurs at a dose of 100 mg/day or a corresponding plasma level of 500 ng/mL of RG7388. Preliminary analysis of PK and safety data showed that there is an apparent PK/PD relationship between an AUC per cycle and Cycle 1 platelet nadir.\n At the data cutoff of 13 September 2012, 51 patients with advanced malignancies had received R05503781 in Study NP27872. Fifty patients experienced at least 1 adverse event (AE) and 11 patients experienced at least 1 serious adverse event (SAE).\n Thirteen SAEs in patients (white blood cell count decreased, platelet count decreased, 2 cases of neutrophil count decreased, febrile neutropenia, 5 cases of thrombocytopenia, 2 cases of neutropenia, and diarrhea) were considered by the investigator to be probably related to study treatment; 4 SAEs (2 cases of febrile neutropenia, urinary tract infection, and anemia) were considered possibly related; 1 SAE (lung infection) was considered remotely related; and the other 6 SAEs (infection, sciatica, non-cardiac chest pain, dyspnea, wrist fracture, and neutropenia) were considered unrelated. Three patients died due to disease progression.\n Eleven patients across all groups and schedules had at least 1 event considered a dose limiting toxicity (DLT): a treatment-related SAE of Grade 3 febrile neutropenia, a treatment-related SAE of Grade 4 febrile neutropenia, a treatment-related SAE of Grade 4 platelet count decreased, 3 cases of treatment-related SAEs of Grade 4 thrombocytopenia, a treatment-related AE of Grade 4 thrombocytopenia, 3 cases of treatment-related AEs of Grade 4 thrombocytopenia, a treatment-related AE of Grade 4 neutropenia, a treatment-related SAE of Grade 4 neutropenia, a treatment-related AE of Grade 3 diarrhea, 2 cases of treatment-related AEs of Grade 3 nausea, and a treatment related AE of Grade 3 vomiting. Six patients experienced 8 AEs that led to withdrawal from treatment: 1 (Grade 3 AE of cataracts) was considered remotely related to study treatment, 4 (Grade 4 AE of thrombocytopenia/Grade 3 SAE of febrile neutropenia, Grade 2 AE of neutropenia, Grade 3 SAE of febrile neutropenia) were considered possibly related to study treatment, and 3 (Grade 4 SAE of neutropenia, Grade 4 SAE of thrombocytopenia/Grade 4 SAE of neutrophil count decreased) were considered probably related to study treatment.\n RG7388 is representative of an entirely new branch of the nutlin family of MDM2 antagonists and the second agent with this mechanism of action sponsored by Roche. As with the lead compound (RO5045337), RG7388 binds selectively to the p53 site on the surface of the MDM2 molecule in vitro with high affinity and can effectively displace p53 from MDM2, leading to stabilization and accumulation of p53 protein and activation of the p53 pathway. RG7388 is from a different chemical series compared to the lead compound and binds with higher potency and selectivity to the MDM2 protein. This follow-on compound has substantially improved pharmacological properties. Preclinical models predict superior efficacy of RG7388 in the clinic at lower doses and exposures. Compared to the lead molecule, lower variability may be seen given that RG7388 does not have significant pH dependent solubility (fasted and fed-state simulated intestinal fluid solubilities are similar). RG7388 at 0.3 μM has equivalent apoptotic activity to RO5045337 at 10-fold higher (3 μM) concentration and at 25 mg/kg has equivalent efficacy to RO5045337 at 4-fold higher dose (100 mg/kg) and better potency when given once weekly.\n RG7388 exhibits improved in vitro and in vivo potency against tumor cell lines and xenografts, improved CYP inhibition profile, and 2.5- to 20-fold lower projected human efficacious dose. Preclinical studies have indicated that tumors expressing wild-type p53 may respond to this novel therapeutic strategy that releases p53 from MDM2 inhibition, and tumors with wild-type p53 and MDM2 over-expression or amplification are likely to be the most sensitive. Results from preclinical safety and toxicology studies support further exploration of this compound in cancer patients. In view of the existing unmet medical need in advanced cancers expressing the above molecular signature, RG7388 is believed to be a promising agent that may offer a new therapeutic option.\n The use of Pegasys in combination with other targeted agents for the treatment of PV/ET would allow for the administration of lower doses of Pegasys, thereby reducing dose dependent toxicities. Preclinical studies by Lu et al. have demonstrated preferential inhibition of PV CD34+ cell proliferation and colony formation at subtherapeutic doses of Pegasys in combination with Nutlin-3 [33]. Pegasys increases p53 expression through enhanced transcriptional activity via the p38 Map kinase pathway and Nutlin-3 prevents p53 degradation via interruption of the MDM2-p53 interaction [34]. Due to the common downstream target effect of increased tumor suppressor p53 expression with combination Pegasys and Nutlin-3, lower doses of each agent can be used together in PV patients. Thus, the use of RG7388 alone or in combination with Pegasys would be anticipated to enhance p53 expression by different mechanisms and presents a novel approach to the treatment of PV/ET.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n (Patient should meet all the criteria)\n - JAK2V617F-positive PV or JAK2V617F-positive ET (confirmed by WHO diagnostic criteria)\n - High risk ET/PV [age >60; history of thrombosis] or low risk disease with symptoms [recurrent headaches, paresthesias, pruritus]\n - Previously treated with at least one other agent [hydroxyurea, interferon, anagrelide] and determined to be either intolerant/resistant\n -≥18 years of age\n - Eastern Cooperative Oncology Group (ECOG) Performance status 0-2\n - Acceptable pre-study organ function during screening as defined as: Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) unless due to Gilbert's disease or hemolysis, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN, Serum creatinine ≤ 1.5 x ULN\n - Women of childbearing potential and males must agree to use adequate contraception (i.e., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a female subject become pregnant or suspect she is pregnant while participating in this study, she should inform the treating physician immediately\n - Ability to understand and willingness to sign a written informed consent document.\n Exclusion Criteria:\n - Meets the criteria for post ET/PV MF as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)\n - Blast phase disease (>20% blasts in the marrow or peripheral blood)\n - Acute thrombosis within 3 months of screening\n - Uncontrolled intercurrent illness including, but not limited to hepatitis, human immunodeficiency virus (HIV) - positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nRibociclib and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors or Lymphoma\n\n**Clinical Trial Summary:**\n\nThis phase I trial studies the side effects and best dose of ribociclib and gemcitabine hydrochloride in treating patients with solid tumors or lymphoma that have spread to other places in the body and usually cannot be cured or controlled with treatment. Ribociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib together with gemcitabine hydrochloride may work better in treating patients with solid tumors or lymphoma.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\n I. To describe the dose-limiting toxicities and identify the maximum tolerated dose (MTD) and recommended Phase II dose of the combination of LEE011 (ribociclib) and gemcitabine (gemcitabine hydrochloride) in patients with advanced solid tumors or lymphoma.\n SECONDARY OBJECTIVES:\n I. To describe the safety and tolerability of the combination of LEE011 and gemcitabine.\n II. To describe the pharmacokinetic (PK) of LEE011 in combination with gemcitabine.\n III. To describe preliminary evidence of efficacy of the combination of LEE011 and gemcitabine.\n IV. To evaluate the correlation of cyclin-dependent kinase (CDK) amplification (testing by fluorescence in situ hybridization [FISH]), retinoblastoma (RB) and P16 expression (by immunohistochemistry) in archived and biopsied tumor tissue with treatment response.\n OUTLINE: This is a dose-escalation study.\n Patients receive ribociclib orally (PO) on days 1-14 and gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n After completion of study treatment, patients are followed up at 30 days.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patients must have advanced/metastatic solid malignancy or lymphoma for which no standard treatment option exists that will confer clinical benefit\n - Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n - Patients enrolled in the dose expansion phase must have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria for solid tumors or measurable nodal disease at baseline as defined by Cheson criteria for lymphoma\n - Written informed consent must be obtained prior to any screening procedures and according to local guidelines\n - Life expectancy of >= 12 weeks\n - Absolute neutrophil count >= 1.5 × 10^9/L\n - Platelets >= 100 × 10^9/L\n - Hemoglobin >= 9 g/dL\n - Potassium above lower limit normal range for the institution; supplementation may be given before the first dose of study medication\n - Total calcium (corrected for serum albumin if albumin abnormal) above lower limit normal range for the institution; supplementation may be given before the first dose of study medication\n - Magnesium above lower limit normal range for the institution; supplementation may be given before the first dose of study medication\n - Sodium above lower limit normal range for the institution; supplementation may be given before the first dose of study medication\n - Phosphorus above lower limit normal range for the institution; supplementation may be given before the first dose of study medication\n - International normalized ratio (INR) =< 1.5\n - Serum creatinine =< 1.5 mg/dL or creatinine clearance >= 50 mL/min (calculated by Cockcroft Gault equation)\n - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 upper limit of normal (ULN) or =< 5 x ULN if liver metastases are present\n - Total bilirubin =< ULN; or total bilirubin =< 3.0 x ULN with direct bilirubin =< 1.5 ULN n patients with well documented Gilbert's syndrome\n - Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of study drug\n - Must be able to swallow ribociclib capsules\n Exclusion Criteria:\n - Previous anti-cancer chemotherapy, immunotherapy or investigational agents < 4 weeks prior to the first day of study defined treatment\n - Patient who has received radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom >= 25% of the bone marrow was irradiated\n - Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered as major surgery)\n - Active clinically serious infections or other serious uncontrolled medical conditions\n - Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)\n - Patient has baseline neuropathy of > grade 2\n - Patient has known hypersensitivity to any of the excipients of ribociclib\n - Patient has a known history of human immunodeficiency virus (HIV) infection (testing not mandatory)\n - Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria:\n - At least 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment\n - Clinically stable CNS tumor at the time of screening and not receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases\n - Clinically significant, uncontrolled heart disease and/ or a history of cardiac dysfunction including any of the following:\n - History of unstable angina pectoris, symptomatic pericarditis, myocardial infarction, coronary artery bypass grafting or coronary angioplasty within 12 months prior to study entry\n - History of documented congestive heart failure (New York Heart Association functional classification III-IV)\n - Documented cardiomyopathy\n - Patient has a left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)\n - History of clinically significant ventricular arrhythmia and/or conduction delays within 12 months of screening\n - Systolic blood pressure > 160 mmHg or < 90 mmHg\n - Congenital long QT syndrome or family history of long QT syndrome\n - Bradycardia (heart rate < 50 at rest) by electrocardiogram (ECG) or pulse at screening.\n - On screening, inability to determine the Fridericia corrected QT interval (QTcF) interval on the ECG (i.e.: unreadable or not interpretable) or QTcF > 450 msec (using Fridericia's correction); all as determined by screening ECG (mean of triplicate ECGs)\n - Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g., chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial, or viral infections etc.)\n - Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to starting study drug (for details):\n - Known strong inducers or inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges\n - Those have a narrow therapeutic window and are predominantly metabolized through CYP3A4\n - Those have a known strong risk to prolong the QT interval or induce Torsades de Pointes\n - Herbal preparations\n - Patient is currently receiving or has received systemic corticosteroids (=< 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment)\n - The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular)\n - Patient has a history of non-compliance to medical regimen or inability to grant consent\n - Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed\n - Participation in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer\n - Patient has not recovered from all toxicities related to prior anticancer therapies to grade 1 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study)\n - Patient with a Child-Pugh score B or C (for cirrhosis patients only)\n - Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test\n - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for 8 weeks after study drug discontinuation; highly effective contraception methods include:\n - Total abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n - Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\n - Male sterilization (at least 6 months prior to screening); for female patients on the study, the vasectomized male partner should be the sole partner for that patient\n - Combination of any of the 2 following (a+b or a+c or b+c)\n - a. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception\n - b. Placement of an intrauterine device (IUD) or intrauterine system (IUS)\n - c. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository\n - In case of use of oral contraception, women should have been stable on the same pill before taking study treatment\n - Note: oral contraceptives are allowed but should be used in conjunction with a barrier method of contraception\n - Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential\n - Sexually active males unless they use a condom during intercourse while taking the drug and for 21 days after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** possibly relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nT790M Mutation on ctDNA in Patients With NSCLC After EGFR-TKI Failure\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to compare the frequency and abundance of T790M mutation among the different Clinical modes of EGFR-TKI failure.\n\n**Clinical Trial Detailed Description:**\n\nAn observational, non-interventional, multi-central study of comparison of the frequency and abundance of T790M mutation using both amplification refractory mutation system (ARMS) and digital droplet PCR (ddPCR) methods among the different Clinical modes of non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) failure\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Histologically confirmed stage IIIB/IV NSCLC.\n - Investigator confirmed progression according RECIST 1.1 during EGFR-TKI treatment within 28 days of the enrollment\n - Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting ≥ 6 months\n - Patient must be able to comply with the protocol\n Exclusion Criteria:\n - Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 defined disease progression for more than 28 days while on previous EGFR-TKI treatment.\n - Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.\n - Histologically confirmed small cell lung cancer or other metastatic tumors\n - Patient with no histologic or cytological diagnosis.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** possibly relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nEffects of Diet on Reflux and Dyspepsia\n\n**Clinical Trial Summary:**\n\nReflux and dyspeptic symptoms are common affecting 10-20% of the population on a regular basis. Reflux symptoms such as heartburn and regurgitation are caused by the return of acid or non-acid gastric contents into the esophagus. Dyspeptic symptoms are caused by abnormal gastric relaxation (impaired accommodation) or increased sensitivity of the stomach to distension during the meal.\n The effects of diet on gastrointestinal function are debated and the efficacy of dietary management for digestive symptoms has not been established. Epidemiological studies suggest an effect; however, it is not possible to distinguish the effects of fat intake and total energy (i.e. calorie) intake in this work. This issue has been addressed by small physiological studies. The results show that esophageal acid exposure was related to total calorie intake but not to fat content. In contrast, the number of reflux symptoms was 40% higher after the high-fat than the low-fat meals. Similar findings were found for the relationship between gastric distension, fullness and dyspeptic symptoms by Magnetic Resonance Imaging. Thus, it appears that fat does not cause digestive dysmotility but heightens sensitivity to visceral events and so increases the number and severity of symptoms reported by patients. As yet, these findings have not been confirmed in larger, more representative surveys.\n Similar to the effects of food, there are inconsistent findings regarding the effects of alcohol on gastro-esophageal reflux (GER) and gastric function. Physiological studies have noted delayed gastric emptying and an increase in reflux events when alcohol is taken with food. However, larger surveys have not confirmed that alcohol triggers reflux or dyspeptic symptoms.\n The proposed observational, dietary study with cross-over design will assess the independent effects of energy intake (i.e. calorie load) and fat intake on gastric fullness, the number and severity of reflux and dyspeptic symptoms after meals. The effect of alcohol on symptoms after the high calorie, high fat meals will also be documented. The study population of senior academics attending a conference are likely to have a relatively high prevalence of risk factors for gastro-esophageal reflux disease (GERD) being predominantly male, with an older age and a larger waist circumference than average in the general community. This will increase study power and relevance of the findings.\n The results will provide new information concerning the impact of dietary factors and alcohol on digestive symptoms after meals. This data will inform future guidelines for the dietary management of patients with reflux and dyspeptic symptoms after meals which will be relevant in both primary and secondary care.\n\n**Clinical Trial Detailed Description:**\n\nThis is an observational, dietary study with cross-over design. Restaurant style meals and beverages are provided to faculty and delegates attending the Ascona II conference that agree to participate and provide written consent. Approximately 120 participants are expected to be recruited.\n On four consecutive days the evening meal served will vary in calorie load and fat content using the established, partially balanced study design applied in previous studies. On the first three days fruit juice will be served, whereas, on the final day, an alcoholic beverage with the same acidity and number of calories will be served. All meals will have the same size and salt content. Controlling for all these parameters will reduce possible confounding factors in the analysis.\n 1. High calorie (1200 kcal), High fat (50% energy), 400 ml juice (230 kcal)\n 2. High calorie (1200 kcal), Low fat (20% energy), 400 ml juice (230 kcal)\n 3. Low calorie (600 kcal), Low fat (20% energy), 400 ml juice (230 kcal)\n 4. High calorie (1200 kcal), High fat (50% energy), 300 ml wine (40 g alcohol, 230 kcal), 100 ml water Note: The order of meals on day 1-3 will be fixed, but not necessarily in the order above. Meal constituents will not be disguised.\n Note: Testing digestive symptoms in response to diet on successive days is possible because clinical physiological studies have shown no evidence of a sequence effect in previous studies using similar test meals.\n An alginate-antacid preparation will be available as required for acute relief of any reflux or dyspeptic symptoms (Gaviscon Liquid, Reckitt Benckiser (available across-the-counter for this indication in Switzerland)). No participant is required to take this preparation.\n The occurrence and severity of fullness, reflux and dyspeptic symptoms will be recorded contemporaneously by participants for three hours after each of the four test meals using a mobile application (SymTrack, Gastric Imaging & Analysis GmbH, Zürich, Switzerland). Paper forms will be made available for those without a mobile device. Three hours is the period of time during which reflux and dyspeptic symptoms are most often reported after meals. Positive reporting bias will be minimized by automatic reminders sent to the participants by the SymTrack every 30 minutes for three hours to remind participants to document the severity of symptoms including, if appropriate, an absence of symptoms. The use of the rescue medication to treat reflux and dyspeptic symptoms during the study will also be documented on the SymTrack. Symptoms and use of the rescue medication that occur after this three hour period up to 12 hours (i.e. the following morning) will be documented as part of safety follow-up data; however these will not contribute to primary or secondary outcomes.\n All faculty and delegates will be invited to participate in this observational, dietary study. The investigators expect to recruit all, or nearly all, of those attending. The fixed menu provided every night by the restaurant will be the same whether the attendee does or does not participate in the study (unless specific dietary requirements are present). Involvement of almost all attendees will reduce selection bias; however, selection bias will remain because the group of clinical academics is not wholly representative of the general population. Note that the study population is predominantly male, with an older age and a larger waist circumference than the average in the community. These are all risk factors for reflux disease. This should increase study power to show treatment effect and the clinical relevance of findings.\n All those attending the Centro Stefano Franscini conference centre in Ascona take their evening meal together. The cost of these meals is included in the registration package. This is a fixed menu with non-alcoholic drinks (alcohol is available to purchase). No other food is available on site except for individuals that have registered special dietary requirements. If other food is wanted, then this is available nearby in the town of Ascona. This local organizational arrangement with the provision of fixed meals free of charge will encourage compliance with the diet.\n If the participants do not adhere to the meal and beverages set out in the study protocol then this can be documented using the SymTrack. To assess compliance, the participant will respond to the questions \"did the patient consume the study meal?\", \"did the patient take additional food?\", \"did the patient consume the study beverage?\", and \"did the patient take additional alcoholic drinks?\". Failure to comply with study procedures will not preclude the individual from participating on the following days.\n The primary study analysis will investigate associations between number symptoms and caloric and fat content of the meals. It will be expressed as odds ratio. There will be a qualitative description of the deviation from study protocol. For example if participants report drinking alcohol during or after the meal on days 1-3 this will be expressed as a percentage deviation.\n The primary and secondary variables plus other outcomes of interest will be documented using a mobile application (SymTrack; Gastric Imaging and Analysis GmbH, Zürich, Switzerland). Paper symptom diaries will be available for those participants without access to a smartphone.\n On arrival at the meeting each attendee that agrees to participate and signs Written Informed Consent will be given personal instructions as to the operation of the mobile application. Should any difficulties remain then investigators, including those involved in the development of the app, will be on hand to assist participants.\n Once the Written Informed Consent is signed the participants will be given a unique username and password to allow them to log into the SymTrack and start entering screening information and symptoms. This username will allow the identification of study participant as data is entered and ensure effective monitoring of data.\n The primary analysis will be performed following study completion. The primary outcome is the number of reflux or dyspeptic symptoms. Odds ratio will be computed to describe the association of the number of symptoms with the meal calorie load and fat content.\n Secondary outcomes are the severity of reflux and the severity of dyspeptic symptoms as well as sensation of fullness after each test meal. Analogue to the primary outcome an odds ratio will be computed to describe the association of these outcomes with the meal calorie load and fat content.\n An odds ratio will be computed to describe the association of the primary and secondary outcomes with the ingestion of alcohol after the meal.\n An additional analysis will be performed to identify factors - other than composition of the test meal - that increase the likelihood of reporting reflux and dyspeptic symptoms after meals (e.g. age, gender, BMI and low quality of life score).\n Control questions that describe the study compliance will be described using descriptive statistics.\n The majority of data acquired in this study originates from electronic sources. Screening data and symptoms entered via the smartphone are immediately transferred over an encrypted channel to the server and stored in a MySQL-database. Both the server application and the database are hosted on a professional application hosting provider located in Switzerland. The server application and the database design are developed and tested by Gastric Imaging & Analysis GmbH. The software version used during this study will be tested using semi-automated functional tests and load tests. Study principal investigator (Mark Fox) is responsible for all data stored in the database.\n To ensure that the study is conducted in accordance with ethical principles, internal monitoring will be carried out regularly throughout the study. At the screening the internal monitor will review the protocol, and the database and all other aspects of the study with the investigator and other staff. Monitoring will be carried out early in the study and again after the last subject has completed the study. During monitoring, the monitor will verify compliance with the protocol and amendment(s), review the signed informed consent forms, diverse logs and all other source data. Direct access to all study-related site and source data/documents is mandatory for the monitoring review. Study team staff must be made available to answer any queries during the monitoring process.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Participants will be faculty and delegates attending the \"Ascona II: Advances in clinical measurement of gastrointestinal motility and function\" conference.\n Exclusion Criteria:\n - Age < 18,\n - special dietary requirements incompatible with meals served at congress hotel restaurant,\n - participation in another study with investigational drug within the 30 days preceding and during the present study (purely diagnostic studies are acceptable),\n - individuals unwilling to provide written informed consent,\n - inability to follow the procedures of the study, e.g. due to language problems (all study documents in English).\n Participants with a history of alcohol dependency or medical conditions that may be exacerbated or affected by alcohol intake are allowed to participate but are instructed not to drink the alcohol provided with the high calorie, high fat test meal on day 4.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nStudy of LEE011plus Cetuximab in Patients With a Cancer of the Head and Neck\n\n**Clinical Trial Summary:**\n\nIn this trial, the investigators would like to investigate the activity of LEE011 associated with cetuximab (standard of care for the SCCHN patients at this stade of the disease).\n\n**Clinical Trial Detailed Description:**\n\nIn the mammalian cell cycle, entry into S phase is achieved by cyclin-dependent kinases 4 and 6 (CDK4/6), which activate a family of E2F transcription factors by phosphorylating and deactivating the retinoblastoma protein (pRb). LEE011 is an orally, highly selective small molecule inhibitor of CDK4/6 that potently induces G1 arrest with sub-micromolar IC50's in a variety of pRb-positive cancer cells. A recent study showed that an inhibitor of the CDK4-CCND1 complex showed promising results in SCCHN pre-clinical models. There is a strong rationale to investigate CDK inhibitors in this disease. In phase Ib/II study as a single agent, the major toxicities observed were Grade 3 and 4 fatigue (53.8%), nausea (50.8%), neutropenia (47.7%), anemia (37.1%), leukopenia (46.2%), thrombocytopenia (34.1%), diarrhea (32.6%), vomiting (34.8%), lymphocytes count decreased (30.3%), anorexia (21.2%), hyperglycemia (21.2%), constipation (19.7%), hypoalbuminemia (18.9%), dyspnea (18.2%) and cough (16.7%).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Recurrent and/or metastatic head and neck squamous cell carcinoma not amenable to curative treatment with surgery and/or chemotherapy and/or radiation.\n 2. HPV negative tumors\n 3. Previous treatment with anti-EGFR based therapy is allowed\n 4. Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria (Tumor lesions previously irradiated or subjected to other locoregional therapy will only be considered measurable if disease progression at the treated site after completion of therapy is clearly documented).\n 5. Progressive disease within 1 year after first line platinum-based chemotherapy given either as a part of the multimodal curative treatment or in the palliative setting or patients non-eligible for platinum therapy.\n 6. Tumor easily accessible for a biopsy\n 7. ECOG performance status 0-1, in stable medical condition\n 8. Patients must have an expected survival of at least 3 months.\n 9. Paraffin-embedded tumor tissue available for immunohistochemistry\n 10. Patients must be over 18 years old and must be able to give written informed consent.\n 11. Women of child-bearing age or sexually active female patients with reproductive potential must have a negative pregnancy test (serum or urine within the 7 days prior to enrollment).\n 12. Patients able to swallow ribociclib capsules / tablets\n 13. Patient has adequate bone marrow and organ function as defined by the following laboratory values :\n 1. Absolute neutrophil count ≥ 1.5 × 109/L.\n 2. Platelets ≥ 100 × 109/L.\n 3. Hemoglobin ≥ 9 g/dl.\n 4. Potassium, total calcium (corrected for serum albumin), magnesium, sodium and phosphorus within normal limits for the institution or corrected to within limits with supplements before first dose of study medication.\n 5. INR ≤ 1.5.\n 6. Serum creatinine ≤ 1.5 × mg/dL or creatinine clearance ≥50 mL/min.\n 7. In the absence of liver metastases, Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤ 2.5x ULN. If the patient has liver metastases, ALT and AST < 5 x ULN.\n 8. Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤1.5 x ULN in patients with well documented Gilbert's Syndrome.\n 14. Signed informed consent prior to beginning protocol specific procedure.\n Exclusion Criteria:\n 1. Non-squamous head and neck cancer\n 2. Nasopharynx cancer\n 3. Patient who received any CDK4/6 inhibitor.\n 4. Patient has a known hypersensitivity to any of the excipients of LEE011 (ribociclib) or combination drug\n 5. Patient is concurrently using other anti-cancer therapy.\n 6. Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered as major surgery).\n 7. Patient who has not had resolution of all acute toxic effects of prior anti-cancer therapy to NCI CTCAE version 4.03 Grade <1 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study).\n 8. Patient who has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia) and/or from whom ≥ 25% (R. E. Ellis 1961) of the bone marrow was irradiated.\n 9. Patient has a concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.\n 10. Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria:\n - At least 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment\n - Clinically stable CNS tumor at the time of screening and not receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases.\n 11. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)\n 12. Patient has a known history of HIV infection (testing not mandatory)\n 13. Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections etc.)\n 14. Patient has active cardiac disease or a history of cardiac dysfunction including any of the following:\n - History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting) or symptomatic pericarditis within 12 months prior to screening.\n - History of documented congestive heart failure (New York Heart Association functional classification III-IV)\n - Documented cardiomyopathy\n - Patient has a Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)\n - History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months of screening.\n - On screening, any of the following cardiac parameters: bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval >109 msec, or QTcF >450 msec.\n - Congenital long QT syndrome or family history of long QT syndrome\n - Systolic blood pressure >160 or <90 mmHg at screening\n - Bradycardia (heart < 50 at rest), by ECG or pulse, at screening\n 15. On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF >450 msec (using Fridericia's correction). All as determined by screening ECG (mean of triplicate ECGs)\n 16. Patient with a Child-Pugh score B or C\n 17. Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to the start of the treatment (see Appendix 1 for details):\n - That are known strong inducers or inhibitors of CYP3A4/5. including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges\n - That have a known risk to prolong the QT interval or induce Torsades de Pointes.\n - That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.\n - Herbal preparations/medications, dietary supplements\n 18. Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment.\n • The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular)\n 19. Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed.\n 20. Participation in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer\n 21. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for 8 weeks after study drug discontinuation. Highly effective contraception methods include:\n - Total abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n - Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\n - Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient\n - Combination of any of the two following (a+b or a+c or b+c)\n 1. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception\n 2. Placement of an intrauterine device (IUD) or intrauterine system (IUS)\n 3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository In case of use of oral contraception, women should have been stable on the same pill before taking study treatment.\n Note: Oral contraceptives are allowed but should be used in conjunction with a barrier method of contraception due to unknown effect of drug-drug interaction.\n Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.]\n 22. Sexually active males unless they use a condom during intercourse while taking the drug and for 30 days after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.\n 23. Patient has a history of non-compliance to medical regimen or inability to grant consent.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nStudy of AZD6094 (Volitinib) in Advanced Gastric Adenocarcinoma Patients With MET Amplification as a Third-line Treatment\n\n**Clinical Trial Summary:**\n\nVolitinib is a potent and selective small molecule c-Met kinase inhibitor. Volitinib was found to inhibit c-Met kinase at the enzyme and cell levels with IC50s of 4 nM for both enzyme and Met phosphorylation in the cell. Consistent with its potent enzyme and cell activity, volitinib was found to inhibit cell growth in vitro against tumors with c-Met gene amplification in the absence of HGF stimulation with IC50s generally below 10 nM. It also potently inhibited HGF-stimulated cell proliferation against tumors with c-Met overexpression or carrying a HGF/c-Met autocrine loop.\n This study is a single-arm, phase II study of votilinib in patients with advanced gastric adenocarcinoma harboring MET amplification as a third line treatment Volitinib 800 mg will be administered orally once a day for 21 days as one cycle.\n To investigate the efficacy of volitinib in patients with advanced gastric adenocarcinoma harboring MET amplification.\n\n**Clinical Trial Detailed Description:**\n\nsame as above\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Provision of fully informed consent prior to any study specific procedures.\n 2. Patients must be ≥20 years of age.\n 3. Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after second-line therapy.\n - Both fluoropyrimidine and platinum agent need to be contained in the prior chemotherapies\n - Prior adjuvant or neoadjuvant therapy is counted as 1 regimen, provided that disease progression occurs within 6 months after the completion of adjuvant or neoadjuvant therapy.\n 4. Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1\n 5. Patients with MET amplification.\n 6. Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.\n 7. Eastern Cooperative Oncology Group performance status 0-1.\n 8. Patients must have a life expectancy ≥ 3 months from proposed first dose date.\n 9. Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to administration of study treatment as defined below:\n - Haemoglobin ≥9.0 g/dL (transfusion allowed)\n - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L\n - White blood cells (WBC) > 3 x 109/L\n - Platelet count ≥100 x 109/L (transfusion allowed)\n - Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (does not include patients with Glibert's disease)\n - AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN\n - Serum creatinine ≤1.5 x institutional ULN\n 10. At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and following up visits.\n 11. Negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1. for women of childbearing potential.\n 12. Provision of consent for mandatory biopsy at progression (fresh frozen will be mandatory if clinically feasible)\n 13. Provision of archival or fresh tissue sample at baseline (fresh frozen will be mandatory if clinically feasible)\n Exclusion Criteria:\n 1. Are currently enrolled in, or discontinued within the last 21 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.\n 2. Any previous treatment with MET inhibitors\n 3. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.\n 4. HER2 positive patients (defined by HER2 3+ by immunohistochemistry or HER2 SISH +)\n 5. Patients unable to swallow orally administered medication.\n 6. Treatment with any investigational product during the last 21 days before the enrollment (or a longer period depending on the defined characteristics of the agents used).\n 7. Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 3 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates or denusomab for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment.\n 8. With the exception of alopecia, any ongoing toxicities (>Common Toxicity Criteria for Adverse Effects grade 1) caused by previous cancer therapy.\n 9. Intestinal obstruction or Common Toxicity Criteria for Adverse Effects grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment.\n 10. Resting ECG with measurable QTcB > 480 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.\n 11. Patients with cardiac problem as follows: uncontrolled hypertension (BP ≥150/95 mmHg despite medical therapy) Baseline Left ventricular ejection fraction below the LLN of <55% measured by echocardiography or institution's LLN for MUGA, Atrial fibrillation with a ventricular rate >100 bpm on ECG at rest , Symptomatic heart failure (NYHA grade II-IV), Prior or current cardiomyopathy, Severe valvular heart disease, Uncontrolled angina (Canadian Cardiovascular Society grade II-IV despite medical therapy), Acute coronary syndrome within 6 months prior to starting treatment\n 12. Female patients who are breast-feeding or child-bearing and Male or female patients of reproductive potential who are not employing an effective method of contraception\n 13. Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses or renal transplant, including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV)\n 14. Patients currently receiving (or unable to stop use at least 2 weeks) prior to receiving the first dose of AZD6094, medications known to be potent inhibitors of CYP1A2 or CYP3A4, potent inducers of CYP3A4 or CYP3A4 substrates with a narrow therapeutic range.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nSingle-arm Study to Evaluate the Safety and Efficacy of Pazopanib, in Subjects With FGFR2 Amplification, FGFR2 Mutation Refractory Solid Tumors\n\n**Clinical Trial Summary:**\n\nThis is a pilot study of Pazopanib in patients with FGFR2 Amplification or FGFR2 mutation Refractory solid tumors.\n This study is a single-arm, pilot study of Pazopanib in subjects with Refractory solid tumors harboring FGFR2 Amplification or FGFR2 mutation Pazopanib 800mg will be administered orally once a day 28 days.Study treatment will be continued until objective disease progression.\n To investigate the efficacy of Pazopanib in subjects with Refractory solid tumors harboring FGFR2 Amplification or FGFR2 mutation.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Provision of fully informed consent prior to any study specific procedures.\n 2. Patients must be ≥20 years of age.\n 3. FGFR2 amplification or FGFR2 mutation Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.\n 4. ECOG performance status 0-2.\n 5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.\n 6. Adequate Organ Function Laboratory Values\n - Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 x 109/L\n - bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)\n - creatinine ≤1.5 x UNL\n 7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.\n 8. Adequate heart function.\n Exclusion Criteria:\n 1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.\n 2. Has known active central nervous system (CNS) metastases.\n 3. Has an active infection requiring systemic therapy.\n 4. Pregnancy or breast feeding\n 5. Patients with cardiac problem.\n 6. Any previous treatment with Pazopanib.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Validation Study of the Dx-pH Probe in Children for the Detection of Extra-oesophageal Reflux\n\n**Clinical Trial Summary:**\n\nGastro-oesophageal reflux (GORD) and its extraoesophageal manifestations present with a variety of symptoms in both adult and paediatric populations. In children the effects of refluxate above the upper oesophageal sphincter (UES) has been implicated as a contributory factor in the underlying pathological processes of a number of conditions including apnoea, asthma, chronic cough, subglottic stenosis, chronic rhinosinusitis and otitis media. The absence of typical symptoms in addition to the inability to obtain a formal symptom history from a young paediatric population contributes to the difficulty in establishing a diagnosis. At present there are no studies or data directly measuring extraoesophageal reflux and its correlation to oesophageal pH monitoring in children.\n The use of twenty-four hour oesophageal pH monitoring is regarded as the established technique for diagnosis of GORD, however this technique has been less reliable for detecting extra-oesophageal reflux. The investigators intend to use the Dx-pH Measurement system, a sensitive and minimally invasive transnasal device, to assess the feasibility and validate its use in a paediatric population.\n\n**Clinical Trial Detailed Description:**\n\nGastro-oesophageal reflux (GORD) and its extraoesophageal manifestations present with a variety of symptoms in both adult and paediatric populations. In children the effects of refluxate above the upper oesophageal sphincter (UES) has been implicated as a contributory factor in the underlying pathological processes of a number of conditions including apnoea, asthma, chronic cough, subglottic stenosis, chronic rhinosinusitis and otitis media.\n The absence of typical symptoms in addition to the inability to obtain a formal symptom history from a young paediatric population contributes to the difficulty in establishing a diagnosis.\n At present there are no studies or data directly measuring extraoesophageal reflux and its correlation to oesophageal pH monitoring in children. As a result there is no baseline data for a paediatric population and subsequently no measureable definition of a significant extraoesophageal reflux event. There is a poor correlation between reflux events measured with an oesophageal probe and extra-oesophageal symptoms of reflux. Studies have demonstrated that 51% of patients without pharyngeal reflux had abnormal distal oesophageal pH studies.\n This is secondary to both technical concerns regarding the ability of such probes in detecting aerosolized and vapour forms of reflux in the pharynx and due to the inadequacy of the definition of a significant reflux event above the upper oesophageal sphincter. Moving cephaled (upwards) within the upper aerodigestive tract will result in shorter, higher pH events that may not be recognised using traditional oesophageal analysis, which define a pH<4 as defining a significant oesophageal reflux event.\n The use of twenty-four hour oesophageal pH monitoring is regarded as the established technique for diagnosis of GORD, however this technique has been less reliable for detecting extra-oesophageal reflux.\n The Dx-pH Measurement system (Dx-pH; Respiratory Technology Corp., San Diego, CA) is a sensitive and minimally invasive transnasal device for detection of aerosolized extra-oesophageal acid reflux in the posterior oropharynx.\n The investigators intend to use the Dx-pH measurement system and the Peptest salivary pepsin assay (RBiomed, UK) in children already undergoing oesophageal pH studies. The investigators aim to assess the feasibility of these systems in a paediatric population,to provide baseline data and to validate its use in measuring extra-oesophageal reflux events in children. These results will be correlated against symptom questionnaire scores and the results of the 24 hour oesophageal pH study results.\n The investigators' results will guide further interventional studies in this area, with the eventual aim of improving diagnosis and guided treatment for the extra-oesophageal manifestations of GORD\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - All children between the age of 1 year old and 16 years old consecutively referred for outpatient 24 hour oesophageal pH / impedance monitoring will be invited to participate in the study. This is regardless of the underlying diagnosis, aetiology and manifestation of symptoms.\n Exclusion Criteria:\n - Children under the age of 1 year old. Children under 1 year old will be excluded due to the technical difficulty of placing both the pH / impedance monitoring probe and the Dx-pH probe into the same nostril. Firstly, this is due to the size restriction of placing 2 probes into one nostril. Secondly, the non-pathologic high incidence of regurgitation and positing in below the age of 1 will make data difficult to interpret.\n - Children with an nasogastric feeding tube in situ will be excluded. Firstly due to the difficulty in placing and securing the nasogastric, oesophageal pH and Dx-pH probe (3 tubes / probes) through the nostrils, with resultant bilateral nasal obstruction. Secondly, the nasogastric tube causes increased iatrogenic reflux within the pharynx, making data more difficult to interpret and creating artificial reflux events.\n - Children with cleft palate prior to surgical repair will be excluded as the Dx-pH probe will be difficult to locate in the oropharynx and may displace into the oral cavity.\n - Children requiring pH monitoring as inpatients during an acute medical admission. Children will be excluded from the study if their condition has necessitated an acute hospital admission, therefore participation in the study will not affect other ongoing investigations, treatment or their acute condition.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nPatients With Refractory, Metastatic Cancer Harboring KIT Mutation or Amplification to Investigate the Clinical Efficacy and Safety of Imatinib Therapy\n\n**Clinical Trial Summary:**\n\nKIT is a receptor tyrosine kinase that binds to stem-cell factor (SCF), activating a series of downstream effector pathways. KIT is an established therapeutic target in cancer with activating mutations of KIT, such as gastrointestinal stromal tumors (GIST), and significant benefit is achieved with various small molecule inhibitors of KIT such as imatinib mesylate. Moreover, there is increasing evidence implicating KIT mutations as tractable therapeutic targets in melanoma. Additional information is required to characterize the functional role of low-frequency mutations in KIT and to determine whether amplification of wild type KIT is a real driver that can be targeted therapeutically. Except GIST and melanoma, other solid cancers were reported to have KIT mutation even in low frequency. A molecular profiling of the tumors of patients referred to the phase I clinic at the M.D. Anderson Cancer Center showed KIT mutation in 7 patients in total of 431 patients (2%).\n Hence, the investigators planned this study to apply the molecularly targeted agent, imatinib to various types of cancers harboring KIT mutation or amplification.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. age ≥ 20\n 2. advanced, refractory cancer patients who failed standard of care (SOC)\n 3. KIT aberration: defined as mutation in exons 9, 11, 13, 17 or 18, or nanostring CNV by quantitative PCR (greater than 3 copies) or subject with specific sensitivity (Z-score<-1) to imatinib by Avatar scan whose disease has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy\n 4. ECOG performance status of 0~2\n 5. measurable or evaluable lesion per RECIST 1.1 criteria\n 6. adequate marrow, hepatic, renal and cardiac functions\n - Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN), or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy\n - Total serum bilirubin ≤ 1.5 x ULN\n - Absolute neutrophil count(ANC) ≥ 1,500/uL\n - Platelets ≥ 100,0000/uL\n - Hemoglobin ≥ 9.0 g/dL\n 7. provision of a signed written informed consent\n Exclusion Criteria:\n 1. severe co-morbid illness and/or active infections\n 2. pregnant or lactating women\n 3. history of major surgery or radiotherapy within 4 weeks\n 4. active CNS metastases not controllable with radiotherapy or corticosteroids (however, CNS metastases (except for leptomeningeal seeding) are allowed if controlled by gamma knife surgery or surgery or radiotherapy or steroid)\n 5. known history of hypersensitivity to study drugs\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nSurvey on the Treatment Reality of Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Non-small Cell Lung Cancer(NSCLC)\n\n**Clinical Trial Summary:**\n\nAccording to the recent report using EGFR tyrosine kinase inhibitors (EGFR-TKI), there is all over survival of the EGFR gene mutation-positive NSCLC in a tendency to extension. However, the real situation and the reason are not clarified.This observational study collects the data of EGFR gene mutation-positive NSCLC approximately 2,000 from the medical record of approximately 20 facilities in Japan and observes the treatment reality of EGFR gene mutation-positive NSCLC.\n\n**Clinical Trial Detailed Description:**\n\nStudy Site(s), number of subjects and countries planned Approximately 2000, Advanced Non Small Cell Lung cancer (aNSCLC) patients who fulfil the inclusion/exclusion criteria will be recruited by 10 to 20 investigational sites in Japan.\n Total planned Study period Estimated date of first subject in June , 2015 Estimated date of last subject in November , 2015 Estimated date of data base lock December, 2015 Estimated date of first subject in for investigation of survival January, 2016 Estimated date of last subject in for investigation of survival March, 2016 Estimated date of data base lock for investigation of survival March, 2016\n Medicinal Products (type, dose, mode of administration) and concomitant medication Not applicable Study Rationale As its benefits in EGFR mutation-positive patients have been reported, EGFR-TKI is now recommended by guidelines as standard first-line therapy for EGFR mutation-positive patients. Back then when concomitant use of platinum medication and 3rd-generation cytocidal drug was the standard therapy, treatment was of very poor prognosis, 8 to 10 months in terms of median overall survival, and a 1-year survival rate of 30% to 35%. Then, gefitinib was approved in July 2002. Takano et al. reported that survival among patients with EGFR mutation-positive non-small cell lung cancer has been getting longer after approval of gefitinib. The overall survival of patients with EGFR mutation-positive non-small cell lung cancer was 27.7 months in gefitinib group of Study North East Japan (NEJ) 002 reported by Inoue et al. in 2013, 34.8 months in gefitinib group of Study West Japan Oncology Group (WJOG) 3405 reported by Yoshioka et al. in 2014, 36.3 months in patients receiving erlotinib in Study Japan Oncology (JO) 22903 reported by Katakami et al. in 2014, and 46.9 months in afatinib group and 35.8 months in chemotherapy group of the Japanese subset in Study Lux-Lung3 reported by Kato. According to recent reports, overall survival tends to be prolonging, but the actual situation and the reason for such tendency has not been revealed.\n Thus, we planned the present study, which clarify the prognosis, patient characteristics and treatment regimen of the patients with EGFR mutation positive NSCLC to provide useful information in order to promote individualized therapy for the patients with EGFR mutation positive NSCLC.\n Study Objectives The primary objective of this study is intended to reveal the characteristics of and reality of the treatment and survival among patients with EGFR mutation-positive advanced/recurrent non-small cell lung cancer. The primary objective, secondary objective and exploratory objective of the study are as follows.\n Primary objective of the study is:\n - To estimate overall survival of the patients\n Secondary objectives of the study are:\n - To estimate overall survival by patient background\n - To estimate overall survival by treatment sequence\n - To calculate treatment time and exposure rate by treatment category (Sum of all treatment time for the patients with each treatment category/Sum of all treatment time for all patients)\n - To estimate efficacy of Gefitinib treatment\n Exploratory objectives of the study are:\n - To explore any factors for which an impact on prognosis among patients\n - To explore the relationship between treatment sequences and prognosis among patients Study Design This is a domestic, multicenter, retrospective and non-interventional diagnostic study. The data for the subjects with EGFR mutation-positive advanced/recurrent NSCLC will be collected at least 2000 cases from 10 to 20 sites.\n Target subject population The patients with EGFR mutation-positive advanced/recurrent non-small cell lung cancer.\n Survey items\n 1. Patient characteristics i) Date of NSCLC diagnosis ii) Gender (Male/Female) iii) Age at the time of diagnosis iv) Histological type (adenocarcinoma/squamous cell carcinoma/large cell carcinoma/others) v) Clinical staging at the initial diagnosis (IIIB /IV, post-operative relapse) vi) Performance Status(PS) (0/1/2/3/4), *Eastern Cooperative Oncology Group(ECOG) Performance Status vii) Smoking history (Yes/No) viii) Smoking exposure(pack year) xi) Type of EGFR mutation x) Distant metastasis organ\n 2. Survival status as of the end of December 2014, date of death or date of last follow-up of survival. A death with disease progression should be noted in Electronic Data Capture (EDC), but not be reported as serious adverse events unless the disease progression is greater than anticipated in the natural course of the disease. Survival status as of the end of December 2015, date of last follow-up of survival will be investigated.\n 3. NSCLC treatment provided for each line of treatment Name of drug category ( (i) EGFR-TKI (Gefitinib or other), (ii) Singlet Chemo, (iii) Doublet Chemo, (iv) EGFR-TKI+Chemo) The date treatment was commenced The date of last dose PS at the commencement of therapy given for each line of treatment *ECOG Performance Status Best response for each therapy (based on clinical evaluation) Total numbers of treatment cycle conducted (chemotherapy) The date on which Progressive Desease (PD) was confirmed\n - The date on which PD was evaluated by Response Evaluation Criteria in Solid Tumors（RECIST） (ver1.1)\n - The date on clinical PD is defined as disease progression met one of the any conditions below (Modified from original source)\n - Occurrence of clinical symptom by Disease Progression\n - Decreasing PS by Disease Progression\n - Occurrence of threatening condition in main organ (lymphangiosis carcinomatosa, bone marrow metastasis, carcinomatous meningitis, liver metastasis with liver disorder, etc)\n - Aggravation of the lesion in multiple organ with or without the symptom\n Source :Paul A. Bunn EGFR and Anaplastic Lymphoma Kinase (ALK) TKI Therapy in Advanced NSCLC: Molecular Basis and When and Why to Stop or Change. Molecular Testing for Non-Small Cell Lung Cancer: Critical Questions, 2012 Chicago Multidisciplinary Symposium in Thoracic Oncology\n Statistical methods Data collected will be analyzed using a method appropriate for the descriptive statistics in epidemiological studies. Patient characteristics will be summarized using descriptive statistics. Statistical Analysis Plan (SAP) will be prepared before database lock.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - 1. EGFR mutation-positive progress recurrent non-small cell lung cancer subject.\n - 2. Subjects who commenced on first-line treatment between January, 2008 and December 2012.\n Exclusion Criteria:\n - 1. Patients has a treatment history with the drug which was not approved for marketing authorization as of 31th December , 2014\n - 2. Person who were planning and/or getting involved in this survey. (applies to both AstraZeneca staff and/or staff at the study site)\n - 3. Previous enrolment in the present study.\n - 4. Patient was not evaluated to be appropriate for study enrolment by the investigators\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nNeonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial\n\n**Clinical Trial Summary:**\n\nThe overall purpose of the investigator's study is to evaluate the causes of and treatment for feeding difficulty in infants with Gastro-esophageal Reflux Disease (GERD). New treatments can be possible only if the cause is known. Many infants have GERD and feeding difficulties, such as sucking and swallowing problems, vomiting, or delayed emptying of the stomach. Some of these infants have difficulty in protecting their airway during feeding or during reflux, and as a result can breathe fluid into their lungs or hold their breath. Most GERD treatments are done based on experience, but there is no scientific proof that these methods work for infants. GERD and feeding difficulties can lead to longer hospitalization and more stress for the family.\n In this clinical trial, the investigators are developing new methods to help with diagnosis as well as defining better treatment strategies in relieving GERD and GERD complications.\n\n**Clinical Trial Detailed Description:**\n\nGastroesophageal reflux disease (GERD) and its troublesome complications constitute serious diagnostic and management challenges to the development of safe feeding and airway protection strategies among infants convalescing in the neonatal intensive care units; thus contributing to prolonged lengths of stay, recurrent hospitalizations, and death. GERD is frequently diagnosed by inadequate criteria, and the relative risks, benefits and indications of GERD therapies are unclear. Significant gaps in knowledge exist in understanding the complex causal or adaptive aerodigestive protective reflex mechanisms implicated in GERD in infants. The long-term goal is to improve digestive health, nutrition, and infant development through the design of simplified personalized treatment paradigms by better understanding the pathophysiology of aerodigestive reflexes.\n The current objective is to conduct a prospective single center randomized blinded controlled trial comparing the short term effects of the investigators innovative feeding strategy bundle (study approach) versus standard feeding approach (conventional approach).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Hospitalized infants with aerodigestive or GERD symptoms\n - Gestational age ≤42 weeks\n - Premature infants are eligible at 34 weeks postmenstrual age (PMA)\n - Enteral or Oral Fed\n - Average daily total feeding volume ≥ 150ml/kg/day\n - Room air or supplemental oxygen of ≤1 liter/minute (LPM) and/or ≤ 35% by nasal cannula\n Exclusion Criteria:\n - Known genetic, metabolic or syndromic disease\n - Neurological diseases such as Grade 3 or 4 intraventricular hemorrhage (IVH) or intracranial hemorrhage (ICH) and perinatal asphyxia\n - Gastrointestinal malformations and surgical gastrointestinal conditions\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nPalbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer\n\n**Clinical Trial Summary:**\n\nAs part of the global clinical development program for Palbociclib, studies are planned in cancer patients in China. An assessment of Palbociclib pharmacokinetics in Chinese patients, as required by the Chinese Health Authorities, is therefore warranted. In addition, safety and efficacy will be also evaluated.\n The single and multiple 125 mg oral dose pharmacokinetics of Palbociclib will be characterized.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - ER(+), HER2(-), postmenopausal adult (ages 18-65 years, inclusive) Chinese women with proven diagnosis of adenocarcinoma of the breast with evidence locoregionally recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.\n a. Postmenopausal women: i. Prior bilateral surgical oophorectomy; or ii. Medically confirmed post-menopausal status defined as spontaneous cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause b. Documentation of histologically or cytologically confirmed diagnosis of: i. ER(+) breast cancer. c. Documentation of HER2(-) breast cancer. d. Previously untreated with any systemic anti cancer therapy for their locoregionally recurrent or metastatic ER+ disease.\n - Measurable disease as defined per RECIST v.1.1 or bone-only disease. - Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if disease progression at the treated site after completion of therapy is clearly documented.\n Exclusion Criteria:\n - HER2-positive tumor as defined by documentation of erbB-2 gene amplification by FISH (as defined by a HER2/CEP17 ratio ≥2) or chromogenic in situ hybridization (CISH, as defined by the manufacturer's kit instruction) or documentation of HER2 overexpression by IHC (defined as IHC3+, or IHC2+ with FISH or CISH confirmation) based on local laboratory results\n - Patients with advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement).\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nCrizotinib in Pretreated Metastatic Non-small-cell Lung Cancer With MET Amplification or ROS1 Translocation (METROS)\n\n**Clinical Trial Summary:**\n\nPhase II, two arms, parallel, non comparative study with crizotinib in patients with ROS 1 translocation or MET amplification\n\n**Clinical Trial Detailed Description:**\n\nThis is a phase II, prospective, two arms, parallel, non comparative study with crizotinib in pretreated NSCLC patients with ROS1 translocation or MET amplification. Patients with locally advanced or metastatic NSCLC, pretreated with at least one previous chemotherapy line and with at least one measurable tumor lesion will be considered eligible for the trial. All potentially eligible patients will be evaluated for MET and ROS1 by FISH to detect MET amplification or ROS1 translocation After evaluation of inclusion and exclusion criteria, and after signature of informed consent form, all MET amplified or ROS1 translocated eligible patients will receive crizotinib 250 mg BID p.o until disease progression, unacceptable toxicity or patient refusal.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Histologically confirmed diagnosis of NSCLC\n - Availability of tumor tissue for ROS1 and MET analyses\n - Patient positive for ROS1 translocation or MET amplification\n - At least one radiological measurable disease according to RECIST criteria (Response Evaluation Criteria in Solid Tumors )\n - At least 1 previous standard chemotherapy regimen\n - Performance status 0-2 (ECOG)\n - Patient compliance to trial procedures\n - age ≥ 18 years\n - Written informed consent\n - Adequate BM function (ANC ≥ 1.5x109/L, Platelets ≥ 100x109/L, HgB > 9g/dl)\n - Adequate liver function (bilirubin <G2, transaminases no more than 3xULN/<5xULN in present of liver metastases).\n - Normal level of alkaline phosphatase and creatinine.\n - If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of approved contraceptive method [intrauterine contraceptive device (IUD), birth control pills, or barrier device] during and for ninety(90) days after end of treatment.\n Exclusion Criteria:\n - No tumor tissue available or patient negative for ROS1 translocation or MET amplification\n - Absence of any measurable lesion\n - For ROS1+ patients: Previous therapy with crizotinib or any anti-ALK agent\n - For MET amplified patients: Evidence of MET amplification in tumor tissue collected in EGFR mutant patient at time of EGFR-TKI acquired resistance occurrence. An EGFR mutant patient is eligible if MET amplification is detected in a tumor specimen collected before starting an EGFR-TKI\n - No previous chemotherapy\n - Concomitant radiotherapy or chemotherapy.\n - Previous radiotherapy on the target lesion(s). If all sites were included in radiotherapy fields patient is eligible only if there is evidence of progressive disease after completion of radiotherapy.\n - Symptomatic brain metastases\n - Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uteri and squamous cell carcinoma of the skin\n - Pregnancy or lactating\n - Other serious illness or medical condition potentially interfering with the study\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nThe Primary Symptoms of GERD(Gastroesophageal Reflux Disease) in Chinese Outpatients in Gastroenterology Department\n\n**Clinical Trial Summary:**\n\nConsecutive patients aged 18-65 years who go to the gastroenterology clinic presented with upper gastrointestinal discomfort would be included. All patients underwent upper endoscopy or an ambulatory 24-h pH(Potential Of Hydrogen) monitoring.Pathologic esophageal acid reflux was defined as the percentage total time for which a pH value < 4 was >4.2 % in the distal esophagus. Then, patients were treated with esomeprazole 20 mg twice daily for 28 days. The symptom scores were measured by the frequency score multiplied by the severity scores of the predominant symptom before and at the end of the treatment, and the \" PPI test \" was defined as positive if the overall scores of the predominant dyspeptic symptom in the fourth week decreased by >50 % compared with those of the baseline.\n GERD is defined by either 24-hour impedance-pH monitoring or positive PPI(proton pump inhibitor) test or positive result from endoscopy. The percentage of each symptom of GERD in the symptom questionnaire in Chinese outpatients in Gastroenterology department will be calculated. The symptom of the highest percentage will be the primary symptom.\n\n**Clinical Trial Detailed Description:**\n\nPrimary Objective：To define the primary symptom of GERD in Chinese outpatients in Gastroenterology department Secondary Objective：1. To investigate the symptom distribution of patients who present with symptoms originated from upper gastrointestinal tract and have pathologic esophageal reflux established by 24-hour impedance-pH monitoring, upper endoscopy, or proton pump inhibitor test.\n 2. To evaluate the life quality of patients with atypical GERD symptoms (symptoms except heartburning and regurgitation) 3. To investigate the diagnostic value of proton pump inhibitor trial to diagnose GERD with atypical reflux symptoms 4. To investigate the predictive value of Gerd Q to diagnose GERD with atypical reflux symptoms with heartburn or regurgitation\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Consecutive patients aged 18-65 years who go to the gastroenterology clinic presented with upper gastrointestinal discomfort, such as heartburn, regurgitation, dysphagia, substernal pain, epigastric pain, epigastric burning, early satiety, postprandial fullness.\n - Whose previous symptoms should last for at least 3 months and be at least 3 days per week in frequency with moderate severity.\n - Able to fill in the questionaires.\n Exclusion Criteria:\n - gastric or duodenal ulcers, upper GI neoplasms on upper endoscopy\n - severe cardiac or pulmonary diseases, diabetes or rheumatic diseases\n - history of operations in the upper GI tract\n - renal failure or abnormal liver function\n - use of non-steroidal anti-inflammatory drugs (NSAIDs)\n - allergy to esomeprazole\n - Pregnancy or lactating mother\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Phase 1 Study of BLU-554 in Patients With Hepatocellular Carcinoma\n\n**Clinical Trial Summary:**\n\nThis is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of BLU- 554 administered orally in patients with hepatocellular carcinoma (HCC). The study consists of 2 parts, a dose-escalation part (Part 1) and an expansion part (Part 2) exploring both a once daily (qd) and twice daily (bid) dosing schedule.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nKey Inclusion Criteria:\n - Confirmed diagnosis of HCC by histological examination or by non-invasive criteria according to European Association for the Study of the Liver (EASL) or American Association for the Study of Liver Disease (AASLD) guidelines. Patient has unresectable disease and has been previously treated with sorafenib, has declined treatment with sorafenib, or does not have access to sorafenib.\n OR\n - In Part 1 only, confirmed diagnosis of a relapsed or refractory advanced solid tumor other than HCC that has evidence of aberrant FGF19/FGFR4 pathway activity [e.g. tumor or blood/plasma alterations including, but not limited to, 11q13.1 locus (FGF19/CCND1 (cyclin D1)) amplification/copy number gain]\n - Child-Pugh class A with no clinically apparent ascites\n - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n - For Part 1, willing to provide archived tumor tissue (if available) and willing to undergo pre- and on-treatment tumor biopsy (if considered safe and medically feasible by the treating investigator)\n - For Part 2, all patients must have an FGF19 IHC result available. Only FGF19 IHC positive HCC patients will be eligible for Part 2 of the bid dosing schedule.\n Key Exclusion Criteria:\n - Central nervous system metastases\n - Platelet count <75,000/mL\n - Absolute neutrophil count <1000/mL\n - Hemoglobin <8 g/dL\n - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5x the upper limit of normal (ULN)\n - Total bilirubin >2.5 mg/dL\n - International normalized ratio (INR) >2.3 or prothrombin time (PT) >6 seconds above control\n - Estimated (Cockroft-Gault formula) or measured creatinine clearance <40 mL/min\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nElectrical Stimulation Therapy (EST) of the Lower Esophageal Sphincter (GERD)\n\n**Clinical Trial Summary:**\n\nThe investigational device that will be used in this trial is the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System.\n The purpose of this trial is to evaluate the safety and the effectiveness of electrical stimulation therapy (EST) on the lower esophageal sphincter (LES) in the treatment of subjects with gastroesophageal reflux disease (GERD).\n The study population will consist of subjects diagnosed with pathological GERD as defined by abnormal pH and who complain of heartburn, regurgitation or both for > 6 months, on a daily PPI use.\n\n**Clinical Trial Detailed Description:**\n\nStudy Design:\n Multicenter, randomized, double-blind, sham-controlled study. All subjects undergo screening and baseline visits, followed by system implantation, and randomization after 2 weeks to either a treatment Group (stimulation) or Control Group (delayed stimulation).\n Randomized subjects complete a 10-week, double-blind phase. At the 14-week visit, subjects are unblinded, control group subjects begin receiving stimulation, and all subjects are followed for an additional 9-month open-label treatment phase.\n Subjects continue receiving stimulation for an extended follow-up phase involving annual visits through 5 years.\n Study Visits:\n Screening and baseline visits. Laparoscopic implantable pulse generator (IPG) and lead implant procedure. Post-implant follow-up office visits at 2 weeks/randomization, 6, 10, 14, 24 and 48 weeks, followed by annual visits through 5 years.\n Sample Size and Scope:\n Forty-six subjects will be implanted and followed to 12 months after stimulation treatment at 3 investigational sites.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Subject able and willing to provide written informed consent\n - Subject able and willing to comply with required study procedures and follow-up schedule\n - Typical symptoms of GERD (regurgitation and/or heartburn) for longer than 6 months, heartburn responding to PPI therapy. Subject may also complain of atypical symptoms of GERD that may persist on PPI\n - Daily dose of PPI or other acid neutralization drugs because of PPI intolerance\n - Baseline visit GERD-HRQL score ≥ 20 following 14 days off-PPI and at least 10 points higher than their on-PPI (or other acid-neutralization drugs) GERD-HRQL score recorded during the Screening Visit\n - Excessive lower esophageal acid exposure during pH monitoring (defined as distal esophageal pH < 4 for > 5.0% of the monitoring time) performed after 14 days off PPIs\n - Subject is a suitable surgical candidate able to undergo general anesthesia and laparoscopic surgery.\n Exclusion Criteria:\n - Previous EndoStim LES System implant and/or implant attempt\n - Previous esophageal surgery, including Nissen fundoplication\n - Previous endoscopic intervention for the treatment of GERD and/or Barrett's esophagus\n - Hiatal hernia larger than 2 cm as determined by any diagnostic investigation (i.e., endoscopy, manometry or laparoscopic visualization)\n - Gastroparesis\n - Any non-GERD esophageal motility disorders\n - Esophageal stricture or significant esophageal anatomic abnormalities\n - Barrett's epithelium or any grade of dysplasia\n - Documented history of esophagitis Grade C or D (LA Classification)\n - History of suspected or confirmed esophageal or gastric cancer\n - Esophageal or gastric varices\n - Symptoms of dysphagia more than once per week within the last 3 months\n - Suspected or known allergies to titanium, platinum, iridium, stainless steel, silicone, epoxy, or nylon\n - Body mass index (BMI) > 35 kg/m2\n - Any significant multisystem diseases\n - Autoimmune or a connective tissue disorder (scleroderma, dermatomyositis, Calcinosis-Raynaud's-Esophagus Sclerodactyly Syndrome (CREST), Sjogren's Syndrome, Sharp's Syndrome, etc.) requiring therapy in the preceding 2 years\n - Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus (T2DM) defined as HbA1c > 9.5 in the previous 6 months or at screening/baseline, or has T2DM for > 10 years\n - Significant cardiac arrhythmia or ectopy or significant cardiovascular disease (i.e. unstable angina pectoris, hemodynamically significant valvular disease, severe congestive heart failure), or cardiac therapeutic intervention within the last 6 months.\n - Significant cerebrovascular event within the last 6 months\n - Existing implanted electrical stimulator (pacemaker, implantable cardioverter defibrillator, deep brain stimulator (DBS), bone growth or pelvic floor stimulators, drug pumps, etc.)\n - Chronic anticoagulant therapy\n - Female subject of child-bearing potential and is pregnant or nursing, or intends to become pregnant during the trial period, who is not using a reliable form of birth control\n - Subject is currently enrolled in other potentially confounding research\n - Active infection as determined by the investigator\n - History of any malignancy in the last 2 years\n - Life expectancy less than 3 years\n - Diagnosed major psychiatric disorder (bipolar, schizophrenia, etc.)\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nSafety and Efficacy of PD0332991 (Palbociclib), a Cyclin-dependent Kinase 4 and 6 Inhibitor, in Patients With Oligodendroglioma or Recurrent Oligoastrocytoma Anaplastic With the Activity of the Protein RB Preserved\n\n**Clinical Trial Summary:**\n\nThis multicenter, open-label, phase II trial aims to assess the safety and efficacy of palbociclib in adult patients with Oligodendroglioma or recurrent oligoastrocytoma anaplastic with the activity of the protein RB preserved.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Ability to understand and sign the informed consent approved by the Ethic Committee.\n 2. Men or women aged greater than or equal to 18.\n 3. Patients with oligodendroglioma anaplastic or oligoastrocytoma anaplastic according to WHO classification and histologically confirmed. Note: It can be included patients with oligoastrocytoma or oligodendroglioma G2 only if they have suffered a recurrence in which the diagnosis of the resection were G3.\n 4. Patients in relapse after radiotherapy and one or two lines of chemotherapy. Note: Both previous radiotherapy and chemotherapy could be received in adjuvant therapy or previous recurrences. It is also accepted to be received concurrent chemoradiotherapy. In the secondary oligodendrogliomas or oligoastrocytomas anaplastic, the patients could have received chemotherapy and radiotherapy when the tumor was G2.\n 5. All patients have to present positivity in immunohistochemical study for the RB protein in the tumor samples sent to the central lab.\n 6. The cases must have 10 slides or a tumor block available from a biopsy or surgery.\n 7. All patients have to show disease progression in a cerebral nuclear magnetic resonance.\n 8. Interval of at least one week between the previous intracranial biopsy and the inclusion.\n 9. Interval of at least 12 weeks between radiotherapy and the inclusion, unless: a) Recurrent tumor confirmed histologically b) recurrency showed in the NMR out of radiotherapy.\n 10. Patients should have been recovered from previous therapies: 28 days since the end of any investigational product and since the end of any cytotoxic treatment.\n 11. ECOG≤2\n 12. Stable or decreasing dose of corticoids during the five days prior to the inclusion\n 13. patients who have been suffered from a tumor resection in the last recurrence are eligible if:\n - A good surgery recover\n - there is a measurable or evaluable disease after surgery\n 14. Good bone marrow function:\n - Neutrophils ≥ 1500/mm3 (1.5x10e9/L)\n - Platelet ≥ 100.000/mm3 (100 x 10e9)\n - Hemoglobin ≥ 9 g/dL\n - Seric creatinine ≤ 1.5 x LSN of the site or estimated clearance ≥ 60 ml/min calculated.\n - Bilirubin ≤ 1.5 x LSN (if Gilbert's syndrome ≤ 3 xLSN) AST (SGOT) and/or ALT ≤ 3 x LSN; alkaline phosphatase ≤ 2.5 x LSN.\n 15. Nor pregnant women nor breast-feeding women. Women with heterosexual activity should have a negative pregnant test before the inclusion in the study. Both women and men should use an accepted contraceptive method during the study treatment and 1 month after treatment completed.\n Exclusion Criteria:\n 1. Presence of meningeal carcinomatosis disseminated.\n 2. Concomitant treatment with other investigational products\n 3. Previous treatment wih an investigational product that could be active for CDK4/6\n 4. Any kind of surgery in the previous 2 weeks\n 5. Presence of any clinically significant gastrointestinal abnormality that can affect oral administration, transit or absorption of study drug, such as the inability to take medication by mouth as tablets.\n 6. Presence of any psychiatric or cognitive disorder that limits the understanding or the signature of informed consent and / or jeopardize the fulfillment of the requirements of this protocol.\n 7. In the 7 days prior to the beginning of the treatment, to have received a treatment with: - Drugs inhibitor of the CYP3A4 - Drugs inductors of the CYP3A4 - Drugs that extends the QT interval\n 8. QTc interval >480 msec, familiar history or personal of QT large Syndrome, QT short Syndrome, Brugada syndrome, QTc extension or Torsade de Pointes history\n 9. Electrolyte disorder that may affect the QTc interval\n 10. Significant or uncontrolled cardiovascular disease, including:\n - Myocardial infarction within the previous 12 months\n - Uncontrolled angina within the previous 6 months\n - Congestive heart failure in the previous 6 months\n - History of clinically significant ventricular arrhythmias of any type (as ventricular tachycardia, ventricular fibrillation or torsades de pointes)\n - History of second or third grade heart block (these patients may be eligible if you currently have a pacemaker)\n - Ictus\n - Pulmonary embolism\n 11. History of any cancer, except for the following circumstances:\n - Patients with a history of other malignancies are eligible if they have been free of disease for at least the last 3 years, and at the discretion of the investigator, there is low risk of disease recurrence.\n - Patients with the following cancers are eligible even if they are diagnosed and treated in the last 3 years: carcinoma in situ of the cervix and basal cell or basal cell skin carcinoma. Patients are ineligible if there is evidence of any neoplastic disease that required therapy other than surgery in the past 3 years.\n 12. Patients positive for HIV\n 13. Inflammatory bowel disease, chronic diarrhea, short gut syndrome or any upper gastrointestinal surgery including gastric resection.\n 14. History of allergic reactions to Palbociclib\n 15. Another acute or chronic serious medical condition, uncontrolled intercurrent illness or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of test results and that,investigator's discretion, make the patient inappropriate for entry into this trial. Uncontrolled intercurrent illness including, but are not limited to, ongoing or active infection or psychiatric illness / social situations that limit the compliance of study requirements.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nPotential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study\n\n**Clinical Trial Summary:**\n\nThis is a prospective randomized clinical trial that aims to evaluate the potential effects of the first dose of rotavirus vaccines on gastrointestinal motility and anatomy and blood and stool cytokine responses. It will also assess the association between these outcomes and the pattern of the shedding of vaccine strain rotavirus in the stool. Infants will be randomized to one of four arms: monovalent rotavirus vaccine (Rotarix®, RV1) alone, RV1 with other recommended vaccines, pentavalent rotavirus vaccine (RotaTeq®, RV5) alone, or RV5 with other recommended vaccines. Data derived from the pilot study will be used to assess the feasibility of conducting a larger scale study.\n\n**Clinical Trial Detailed Description:**\n\nHealthy infants 6-13 weeks of age will be randomized (1:1:1:1) to receive either, RV1 alone, RV1 with Advisory Committee on Immunization Practices (ACIP) routinely recommended immunizations (Diphtheria, Tetanus and Pertussis (DTaP), Haemophilus influenza type b (Hib), pneumococcal conjugate (PCV13), Hepatitis B (HBV) and inactivated polio (IPV)), RV5 alone or RV5 with ACIP routinely recommended immunizations. Imaging study personnel and parents will be blinded to the rotavirus vaccine type; parents will be informed about the rotavirus vaccine type at the completion of the study. Up to 100 infants will be enrolled.\n Recruitment and enrollment will occur prior to the first clinic visit. There will be four study visits including the recruitment/enrollment visit and three clinic visits. Infants will be randomized to either RV1, RV1 plus other immunizations, RV5 alone, or RV5 plus other immunizations. Clinic Visit 1 (day 0) will include blood, saliva, stool and breast milk collection . The MRI and ultrasound will be performed prior to vaccination. Children will receive the immunizations to which they are randomized. Imaging personnel and parents will be blinded to rotavirus vaccine type; they will be informed about other vaccines administered. A second MRI and ultrasound will be performed at Clinic Visit 2 (day 5) and blood and stool samples collected. Parents will be unblinded at the completion of Clinic Visit 3 (day 14). Arrangements will be made to get remaining doses of same rotavirus vaccine. Daily stool samples will be collected at home during the 15 day study period (on vaccination day 0 and for next 14 days). A memory aid will be completed to collect reactogenicity data on days 0 and for the next 14 days. Remaining stools and reactogenicity data from parents will be collected at Visit 3.\n The investigators will assess blood and stool cytokine responses and intestinal anatomy and motility after rotavirus vaccination by comparing pre-vaccination with post-vaccination responses in the study infants. Cytokines and intestinal anatomy and motility will be assessed at baseline (Visit 1, the day of vaccine receipt) and 5 days after vaccination (Visit 2). For both blood and stool, the following cytokines will be tested: IL-2, IL-6, IL-7, IL-8, IL-15, INF-γ and TNF-α. Additional biomarkers may be studied.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. healthy infant 6 to 13 weeks (12 weeks and 6 days) of age at day of rotavirus vaccine administration\n 2. free of obvious health problems as established by medical history and confirmed with infant's primary physician prior to Visit 1\n 3. parent/legal guardian willing to have infant feed from a bottle for contrast\n 4. parent/legal guardian willing and capable of signing informed consent\n 5. parent/legal guardian and infant expected to be available for entire study\n 6. parent/legal guardian can be reached by telephone\n 7. parent/legal guardian expresses willingness to complete study procedures and receive 2 month immunizations, according to recommended schedule\n Exclusion Criteria:\n 1. gestational age of <37 weeks\n 2. infant unable to fast for 4 hours prior to MRI procedure\n 3. receipt of any vaccine except initial HBV (must have at least 28 days between HBV and Visit 1 to be included)\n 4. history of severe allergic reaction to HBV vaccine\n 5. contraindications for any of the routine vaccines\n 1. Severe Combined Immune Deficiency\n 2. history of intussusception\n 6. precautions for either RV1 or RV5 (may interfere with study outcomes)\n a. altered immunocompetence i. infants with primary and acquired immunodeficiency states, cellular immunodeficiency, hypogammaglobulinemic and dysgammaglobulinemic states ii. infants with blood dyscrasias, leukemia, lymphomas, or other malignant neoplasms affecting the bone marrow or lymphatic system iii. infants on immunosuppressive therapy (including high-dose systemic corticosteroids) iv. infants who are HIV-exposed or infected b. acute gastroenteritis c. moderate or severe acute illness with or without fever d. pre-existing chronic gastrointestinal diseases (e.g., congenital malabsorption syndromes, Hirschsprung's disease, or short-gut syndrome) e. infants with spina bifida or bladder exstrophy (latex rubber is contained in the RV1 oral applicator)\n 7. sensitivity to latex (latex rubber is contained in the RV1 oral applicator)\n 8. febrile illness within previous 14 days (axillary temperature of 100.4◦ F or higher)\n 9. history of vomiting (forceful expulsion of partially digested milk/food) and/or diarrhea (3 watery stools) within 14 days of Visit 1\n 10. receipt of any steroids, immunoglobulins, other blood products/transfusion\n 11. receipt of non-steroidal anti-inflammatory drugs in previous 72 hours (may affect cytokine response)\n 12. receipt of an antipyretic medication (acetaminophen or ibuprofen) within 72 hours prior to the first dose of rotavirus vaccine or is already planning to administer a prophylactic antipyretic medication on the day of and the day following vaccination (this exclusion does not apply if the caretaker indicates he/she might administer antipyretics after vaccination to reduce a fever)\n 13. is enrolled or plans to enroll in another clinical trial with an investigational product while participating in this study (observational studies are allowed)\n 14. any condition which, in the opinion of the investigators, may post a health risk to the subject or interfere with the MRI or vaccine evaluation\n 15. currently receiving medication for gastroesophageal reflux (GERD) or any other gastrointestinal condition including colic\n 16. infant who is a relative of any research study personnel\n 17. allergy to barium\n 18. failed newborn hearing screening\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Phase II Study Assessing Efficacy & Safety of Ribociclib in Patients With Advanced Well/Dedifferentiated Liposarcoma\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine whether ribociclib are effective and safe in the treatment of progressive well/dedifferentiated liposarcoma (WDL/DDL).\n\n**Clinical Trial Detailed Description:**\n\nThe expected duration of this study is 36 months (24 months accrual period and 12 month follow up period). Enrollment into the screening or treatment phase of the study will be stopped when the actual subject numbers have been achieved.\n This single arm single institution, open label, prospective, phase II trial will evaluate the efficacy and safety of oral 600mg/daily in 28 day cycles of ribociclib in advanced well-differentiated liposarcoma (WDL) and de-differentiated liposarcoma (DDL) patients. Number of patients in the study will reflect the reconciliation between statistical requirements and incidence.\n Treatment will continue until disease progression, development of unacceptable toxicity, noncompliance or withdrawal of consent by the patient or investigator decision.\n All screening requirements must be completed within 28 days of the visit (except for CDK4/6 amplification and pRb, p16 and cyclin D staining status which may be completed in advance). Patients will be examined on cycle 1 day-1 and every 2 weeks, including complete blood count (CBC) and chemistry, for the first 8 weeks of treatment, and thereafter every month until disease progression. CT/MRI imaging (contrast) will be performed every 8 weeks for response evaluation. Clinical benefit as well as individual categories of response (complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) will be determined using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST). Response duration endpoints, including PFS, PFS at 12 weeks and OS will be assessed using the Kaplan-Meier method. Toxicity (AEs) will be recorded using the NCI- Common Toxicity Criteria for Adverse Effects v 4.03 (NCI-CTCAE). Screening procedures will include quantitative analysis of CDK4 gene copy number using FISH, immunostaining for p16 and cyclin D1 all using formalin fixed paraffin embedded (FFPE) tissue sections. In addition tumor DNA, extracted from FFPE tissue (after choosing optimal area by a Pathologist), will be submitted to a next generation sequencing analysis (\"ion ampliseq\" cancer panel v2©) for a later exploratory analysis.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Written informed consent\n 2. Age ≥ 18 years\n 3. Histological confirmed diagnosis of WDL/DDL with metastatic or locally advanced disease not amenable to complete resection.\n 4. WDL/DDL patients must have documentation of disease progression within 6 months prior to study entry.\n 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n 6. Measurable disease by RECIST v1.1 criteria. At least one measurable lesion located outside of a previously irradiated area.\n 7. Formalin fixed paraffin embedded tumor blocs and representative hematoxylin/eosin slides (preferably both) should be provided for immunohistochemistry staining and molecular analysis of 50 gene signature panel and must have increased CDK4 gene copy number (at least >/=3) and proficient Rb gene.\n 8. Patient has adequate bone marrow and organ function.\n 9. Must be able to swallow ribociclib capsules/tablets.\n Exclusion Criteria:\n 1. A known hypersensitivity to ribociclib or any of its excipients.\n 2. A concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.\n 3. Patients with central nervous system (CNS) involvement at least 4 weeks from prior therapy completion\n 4. Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening)\n 5. On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF >450 msec\n 6. Participation in a prior investigational study within 30 days prior to enrollment\n 7. Patient has had major surgery within 14 days prior to starting study drug\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** definitely relevant"
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definitely relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification\n\n**Clinical Trial Summary:**\n\nThis study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) prolongs progression free survival (PFS) and overall survival (OS) in participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification.\n In addition, this is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in subjects with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Must have a clinical diagnosis of Glioblastoma (GBM)\n 2. Must have a confirmed Epidermal growth factor receptor amplification in tumor tissue\n 3. Must have a Karnofsky Performance Status (KPS) performance score of 70 - 100 (N/A to the sub-study)\n 4. Must have recovered from effects of surgery, postoperative infection and other complications of surgery\n 5. Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the subject must have adequate bone marrow and renal function and have mild-to-moderate hepatic impairment)\n Exclusion Criteria:\n 1. Multifocal, recurrent or metastatic Glioblastoma (GBM) or gliomatosis cerebri (For the sub-study, the subject can have multifocal GBM and gliomatosis cerebri but can't have recurrent or metastatic GBM )\n 2. Prior chemo therapy or radiosensitizer for head and neck cancer.\n 3. Prior radiotherapy to the head or neck in overlap of radiation fields.\n 4. Prior therapy for glioblastoma or other invasive malignancy.\n 5. Prior, concomitant or planned treatment with Novo-TTF, EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nGERD and Anti-Reflux Therapy Between Able-bodied and SCI Individuals\n\n**Clinical Trial Summary:**\n\nRespiratory dysfunction, esophageal dysmotility, and a gastroesophageal reflux disease (GERD) have been demonstrated to be highly prevalent in persons with SCI. GERD has been linked to respiratory symptoms and conditions such as asthma, chronic cough, and an increased rate of respiratory infections in the general population. In persons with asthma, respiratory symptoms and dependency on asthma medications have been reduced by treatment with anti-reflux medication. Possible mechanisms have been proposed for this link, including the microaspiration of reflux materials, which may result in airway acidification and aspiration pneumonia, or the stimulation of the vagus nerve through acid-sensitive receptors in the esophagus with associated esophageal inflammation and reflex bronchoconstriction. Investigators propose to study the effects of anti-reflux therapy (proton pump inhibition) in persons with SCI on objective and subjective symptoms of respiratory function to determine the underlying mechanisms of airway inflammation due to GERD.\n\n**Clinical Trial Detailed Description:**\n\nComplete or partial loss of respiratory muscle innervation in individuals with cervical (C1-8) and high thoracic (T1-6) injuries leads to inadequate ventilation and inability to effectively clear secretions, often prompting supportive ventilation following initial injury. Development of atelectasis, pneumonias and respiratory failure are the most common respiratory complications observed during the acute phase of injury. The role of chronic airway inflammation on pulmonary function in persons with SCI is unknown, although the investigators' recent work has shown that individuals with cervical SCI have elevated levels of exhaled nitric oxide (NO), comparable to those seen in mild asthma. It is now widely believed that in the airways of asthmatic patients, the release of NO represents a physiological mechanism to counteract the bronchoconstriction caused by various stimuli. In persons with cervical SCI, bronchoconstriction may represent a consequence of unopposed parasympathetic influence, but alternative mechanisms, such as recurrent infections secondary to impaired cough effectiveness, systemic inflammatory response following SCI, or extra-esophageal manifestations of underlying esophageal dysmotility and/or GERD need to be evaluated. In general population, it has been long recognized that esophageal dysmotility and/or GERD may lead to extra-esophageal manifestations. Reflux can affect both upper and lower respiratory systems leading to the variety of extra-esophageal manifestations, such as reflux asthma, chronic cough, hoarseness, chronic sinusitis, laryngitis, loss of dental enamel, idiopathic pulmonary fibrosis, recurrent pneumonia, chronic bronchitis, etc. 2 possible mechanisms of these complications have been identified: the direct aspiration of reflux content and indirectly, stimulation of vagally-mediated reflexes. Regardless of the underlying mechanisms, treatments with acid-reducing therapies have shown improvement in GERD and extra-esophageal manifestations of the disease the general population. Investigators propose to study the effects of anti-reflux therapy (proton pump inhibition) in persons with SCI on objective and subjective symptoms of respiratory function to determine the underlying mechanisms of airway inflammation due to GERD.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Subjects with Tetraplegia (Level of SCI C4-8);\n - Subjects with High Paraplegia (Level of SCI T1-T7);\n - Subjects with Low Paraplegia (Level of SCI T8 or below);\n - Able-Bodied Subjects (non SCI)\n - Duration of injury ≥ 1 year; and\n - Chronological age between 18-75 years.\n Exclusion Criteria:\n - Smoking, active or history of smoking < 6 months;\n - Any history of blast injuries to the chest;\n - Active respiratory disease or recent (within 3 months) respiratory infections;\n - Use of medications known to alter airway caliber (i.e. beta 2 agonists or anticholinergic agents);\n - Use of Protein Pump Inhibitors < 8 weeks before testing;\n - Use of H2 receptor blockers <8 weeks before testing;\n - History of gastrectomy;\n - History of esophageal malignancy and/or resection\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nTrial of Nilotinib and Adriamycin as Treatment in Liposarcomas and Leiomyosarcomas of Retroperitoneum\n\n**Clinical Trial Summary:**\n\nPhase I/II multicenter and prospective trial of nilotinib and adriamycin as neoadjuvant treatment in liposarcomas and leiomyosarcomas of retroperitoneum.\n The main objective of this study is to improve relapse-free survival (RFS)and overall survival (OS) decreasing from 50% to 30% the relapse percentage at 5 years in patients with resected sarcoma of retroperitoneum.\n Secondary objectives include the analysis of antitumoral activity through response rate (RECIST and tissular changes), the assessment of positive correlation between biomarkers and clinical results, the study of long term overall survival, and the analysis of the safety profile of the nilotinib-adriamycin combination.\n The trial hypothesis is that the nilotinib-adriamycin combination is synergistic and therefore better response results are expected (from 20% as P0 to 40% as P1). The study seeks to find a positive correlation between biomarkers and clinical results in retroperitoneal liposarcoma and leiomyosarcoma treated with the mentioned combination.\n The study involves the participation of 20 hospitals of the Spanish Sarcoma Group (GEIS). The treatment consists of 4 neoadjuvant cycles of nilotinib-adriamycin on patients with resectable retroperitoneal sarcoma. The research comprises a robust translational study as well as histological and radiological reviews.\n\n**Clinical Trial Detailed Description:**\n\nThe nilotinib-adriamycin combination will be given in 4 cycles of 21 days. In each cycle, nilotinib will be administered at fixed dose of 400 mg/12h orally during 6 consecutive days (1-6) and endovenous adriamycin (20 minutes) on day 5 at three levels (in phase I, dosage of 60 mg/m2, 65 mg/m2, and 75 mg/m2 will be tested to determine the recommended dose for phase II).\n Phase I includes patients with retroperitoneal liposarcoma, retroperitoneal leiomyosarcoma and chondrosarcoma. Phase II is focused on retroperitoneal liposarcoma and leiomyosarcoma only.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patients with histological diagnosis of well differentiated liposarcoma, dedifferentiated liposarcoma or primary leiomyosarcoma of retroperitoneum and resectable. In phase I the study will recruit patients with high-grade chondrosarcoma of non-mesenchymal type.\n - Age: 18-70 years.\n - Measurable disease, according to RECIST criteria.\n - Functional status: 0-1 (ECOG).\n - Baseline medullar function (hemoglobin > 10 g/dL, leukocytes ≥ 3.000/mm3, RAN≥ 1,5 x 109 /l, granulocytes ≥ 1.500/mm3, platelets ≥ 100.000/mm3). Patients with alteration of transaminases ≤ 2.5 times the normal limits, bilirubin total ≤ LSN, CPK≤ 2.5 times the normal limits, alkaline phosphatase ≤ 2.5 times more the normal limits or creatinine values ≤ 1.6 mg/dL, are accepted.\n - Cardiac function (LVEF) normal, considering the normal ranges of the institution.\n - The patient must voluntarily sign the informed consent before any trial test, knowing that he/she can leave the trial at any time, without any consequence for his/her posterior medical attention.\n - Patients in fertile age (both male and female) must use an effective contraceptive method before the entry in the study and during the trial. Moreover, women must maintain contraceptive measures up to 5 months after the treatment. Pregnancy must be ruled out though urine test (negative pregnancy test) for study enrolment.\n Exclusion Criteria:\n - Patients having received previous chemotherapy.\n - Patient having been irradiated on the tumoral disease.\n - Functional status > 1 (ECOG).\n - Metastasis in any location.\n - Bilirubin values over the normal level. Creatinine over 1.6 mg/dL.\n - History of another oncological disease except basalioma or in situ cervical carcinoma adequately treated.\n - Serious cardiovascular diseases (dyspnea >= 2 NYHA, ie.)\n - Systemic pathologies limiting survival to less than 2 years, limiting patient availability, or those that, by clinical judgement, may interfere significantly with treatment toxicity.\n - Bacterial, viral, or uncontrolled mycotic infectious diseases.\n - Pregnant or lactating patients.\n - Psychological, family, sociological or geographical situations not allowing protocol fulfilment or informed consent signature.\n - Patients currently involved in other clinical trials receiving any other agent under investigation.\n - Patient having participated in a clinical trial and/or having received an agent under investigation in the 30 days prior to enrolment.\n - Patients requiring treatments with prolongation of QT interval as amiodarone, disopyramide, procainamide, quinidine, and sotalol.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nStudy of AZD2014 and Palbociclib in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer\n\n**Clinical Trial Summary:**\n\nThis dose finding/extension study consists of three parts: Part A will identify the MTD of the AZD2014/palbociclib combination on a background of fulvestrant (referred to as the triplet) in postmenopausal women with locally advanced/metastatic estrogen receptor positive (ER+) breast cancer. Part B will further characterize safety, tolerability, PK, and preliminary efficacy in single-arm dose expansion groups. Part C will investigate the efficacy of the triplet combination in a double-blind, placebo-controlled, stratified, parallel group extension.\n\n**Clinical Trial Detailed Description:**\n\nThis is a Phase I/II international, multicenter study of the combination of AZD2014 and palbociclib on a background of 500 mg fulvestrant (referred to as the triplet) in postmenopausal women with locally advanced/metastatic estrogen receptor positive (ER+) breast cancer. The study consists of three parts:\n Part A is a Phase I triplet-dose finding investigation in 3-6 patients per cohort to determine the maximum tolerated dose (MTD) of the triplet.\n Part B will comprise Phase I single arm expansions approx 27 patients evaluable for response to define the recommended Phase II dose (RP2D).\n Part C will investigate the efficacy of the triplet combination at the RP2D in a randomized, double-blind, placebo-controlled, stratified, parallel group extension. Part C will include ER+, locally advanced and/or metastatic breast cancer patients who have progressed following prior non-steroidal aromatase inhibitor (NSAI) endocrine therapy. Patients in Part C will be randomized to receive either the triplet combination (AZD2014 + palbociclib + fulvestrant) or the doublet (matching AZD2014 placebo + palbociclib + fulvestrant). Patients will be stratified according to hormone sensitivity, presence of visceral metastases, and prior CDK inhibitor treatment. Part C will be opened if indicated by emerging data\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion:\n Postmenopausal women >= 18 WHO/ECOG perf. status 0-1 Histologically or cytologically proven diagnosis of breast cancer with evidence of locally advanced or metastatic disease not amendable to resection or radiation ER+ and HER2 negative Parts A: Must be eligible for fulvestrant. A maximum of 3 prior lines of chemotherapy are allowed Parts B and C: Postmenopausal with locally advanced or metastatic ER+ breast cancer and refractory to aromatase inhibitors (AIs), defined as: disease recurrence while on, or within 12 months of end of adjuvant treatment with letrozole, anastrazole, or exemestane; or disease progression while on, or within one month of end of letrozole, anastrazole, or exemestane, or exemestane treatment for locally advanced or metastatic breast cancer.\n At least 1 lesion (measurable or non measurable) that can be accurately assessed at baseline with CT or MRI and which is suitable for accurate repeated measurement\n Exclusion:\n Prior chemotherapy, biological or radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents, or any investigational drug or corticosteroids within 14 days Prior radiotherapy to >= 25% of bone marrow regardless of when it was received Unresolved toxicity from prior therapy > CTCAE grade 1 Exposure to potent or moderate inhibitors or inducers of CYP3A4/5, CYP2C8, Pgp (MDR1) or BCRP if taken within the stated washout period prior to start of treatment Exposure to sensitive or narrow therapeutic range substrates of the drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K within the appropriate wash-out period (a minimum of 5 x reported elimination half-life) before the first dose of study treatment Previous treatment with AZD2014, AZD8055 or other mTORC1/2 inhibitor, Part C: Prior treatment with fulvestrant, or everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway Prior treatment with CDK4/6, or everolimus or any PI3K-mTOR pathway Major surgery or significant trauma within 4 weeks or anticipated need for major surgery during the study, or minor surgery within 2 weeks of study entry Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease, as indicated by clinical symptoms, cerebral edema, and/or progressive growth. History of CNS metastases or cord compression are eligible if they have been definitively treated (e.g. radiotherapy, stereotactic surgery) and are clinically stable, off anticonvulsants and steroids for at least 4 weeks. Not eligible if they have spinal cord compression and/or brain metastases unless they are asymptomatic or treated and stable off steroids for at least 4 weeks.\n Any evidence of severe or uncontrolled systemic disease as judged by the Investigator.\n Any other malignancy within 3 years prior to study treatment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.\n Any of the following currently or within 12 months: coronary/peripheral artery bypass graft, angioplasty, vascular stent, MI, angina, CHF (NYHA Grade >=2), ventricular arrhythmias requiring continuous therapy, supraventricular arrhythmias including atrial fibrillation, symptomatic pulmonary embolism, haemorrhagic or thrombotic stroke, including TIA or any other CNS bleeding Abnormal ECHO or MUGA at baseline (LVEF <50%) Mean resting QTc > 470 msec, family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes within 12 months Any clinically important abnormality in rhythm, conduction, or morphology of resting ECG, e.g. complete left bundle branch block, third degree heart block.\n Concomitant medications known to prolong QT, or with factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, family history of unexplained sudden death under age 40.\n Inadequate bone marrow reserve or organ function as demonstrated by any of the following: ANC <1.5 x 109/L, platelets <100x109/L, haemoglobin <90g/L, ALT >2.5 x ULN or >5 x ULN in the presence of liver metastases, total bilirubin >1.5 x ULN or >3 x ULN in patients with Gilbert's Syndrome, serum creatinine >1.5 x ULN concurrent with creatinine clearance <= 50 mL/min.\n Part A Only: Individual cohorts may have specific baseline ANC ranges for patients to be enrolled within the limits of the above exclusion. These sub-groups are defined as follows\n - Low ANC Patients: ANC between 1.5 x 10^9/L and 3.0 x 10^9/L\n - High ANC Patients: ANC between 3.0 x 10^9/L and above Pre-existing renal disease including glomerulonephritis, nephritic syndrome, Fanconi Syndrome or renal tubular acidosis.\n Refractory nausea and vomiting, chronic GI diseases, inability to swallow the product, or previous significant bowel resection that would preclude adequate absorption of AZD2014 or palbociclib.\n History of hypersensitivity to active or inactive excipients of AZD2014, palbociclib or fulvestrant, or drugs with a similar chemical structures Patients with Diabetes Type I or uncontrolled Type II Patients with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term including patients with massive uncontrolled effusions (pleural, pericardial, peritoneal), pulmonary lymphangitis, and over 50% of liver involvement in metastases.\n Prior hematopoietic stem cell or bone marrow transplant Patients receiving regular coumadin therapy (LMW heparin is allowed) Known coagulation abnormalities Erythropoietin, G-CSF, and GM-CSF are not allowed within 2 weeks prior to study. The primary prophylactic use of G-CSF is not permitted but it may be used to treat treatment-emergent neutropenia.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nSelinexor in Advanced Liposarcoma\n\n**Clinical Trial Summary:**\n\nThis is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 245 total patients will be randomized to study treatment (selinexor or placebo).\n\n**Clinical Trial Detailed Description:**\n\nIn the Phase 2 portion of the study, approximately 50 patients will be randomized to selinexor (60 mg) or placebo at a 1:1 allocation ratio.\n In the Phase 3 portion of the study, approximately 195 patients will be randomized to selinexor (60 mg) or placebo with a 2:1 allocation ratio.\n Patients who progress during the blinded portion of the study will be unblinded and if receiving:\n - placebo, may cross over to open-label selinexor (60mg twice weekly)\n - selinexor, will be withdrawn from further treatment and followed for survival\n Study treatment will be given twice weekly on Day 1 and Day 3 during Weeks 1-6 of each six-week (42 day) cycle until disease progression or intolerability.\n Treatment will continue until one or more of the following occurs:\n - Disease progression, as defined by WHO criteria\n - Clinical progression, as determined by the treating physician\n - Unacceptable AEs or failure to tolerate study treatment\n - Patient withdrawal\n - Patient discontinuation due to non-compliance\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Patients ≥12 years of age\n 2. Body surface area (BSA) ≥ 1.2 m2\n 3. Histologic evidence of DDLS at any time prior to randomization AND current evidence of DDLS requiring treatment\n 4. Must have measurable disease by the bidimensional WHO Response Criteria\n 5. Radiologic evidence of disease progression within 6 months prior to randomization. If the patient received other intervening therapy after documented disease progression, further disease progression must be documented after the completion of the intervening therapy\n 6. Must have had at least one (1) prior line of systemic therapy for liposarcoma (no maximum number)\n 7. If patient received any previous systemic therapy, the last dose must have been ≥ 21 days prior to randomization (or ≥ 5 half-lives of that drug - whichever is shorter) with all clinically significant therapy- related toxicities having resolved to less than or equal to Grade 1\n Exclusion Criteria:\n 1. Patients with pure WDLS, myxoid/round cell or pleomorphic tumor histologic subtypes.\n 2. Known active Hepatitis B (HepB), Hepatitis C (HepC) or human immunodeficiency virus (HIV) infection.\n 3. Known central nervous system metastases\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nProton Pump Inhibitor Empirical Treatment in Management of Outpatients With Gastroesophageal Reflux Disease.\n\n**Clinical Trial Summary:**\n\nChina Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients with Gastroesophageal Reflux Disease\n\n**Clinical Trial Detailed Description:**\n\nTo estimate the overall responder rate after 4 weeks of Proton Pump Inhibitor empirical treatment This will be a multicenter prospective observational study carried out in China. Investigator will collect data in a pre-specified Case Report Form from the outpatient. Informed consents will be needed. Investigator will provide patient diary card to each patient for them to note down the symptom frequency every day. Main data from each outpatient will include demographics, Gerd Q, symptom frequency and Proton Pump Inhibitor empirical treatment. Data from each outpatient will be collected on the screening day, 2 weeks and 4 weeks.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Female or male, and any race, Age ≥ 18 years and≤ 65 outpatients.\n - Gastroenterologists already prescribe PPI standard dose bid as empirical treatment.\n - GerdQ≥8\n - The subject will not have endoscopy within 4 weeks after enrolment.\n - Ability to provide informed consent, adhere to the study visit schedule, and complete all study assessments and complete the patient diary by his/herself.\n Exclusion Criteria:\n - If participating in any interventional clinical trial.\n - Patient with alarm symptom of oncology(weight loss, recurrent dysphagia, anemia, hematemesis, melena).\n - Continuous application of nonsteroidal anti-inflammation drugs or acid suppressive drug within 2 weeks before screening.\n - The need for H2-receptor antagonists (H2RA) including cimetidine, ranitidine and famotidine or sucralfate, antacids, traditional Chinese medicine and prokinetics during the upcoming 4 weeks (study duration).\n - Previous gastroesophageal surgery.\n - Upper gastrointestinal malignancy, achalasia, and esophageal spasm or stricture.\n - Peptic ulcer\n - Diabetes\n - Cerebral vascular disease\n - Zollinger-Ellison syndrome\n - Scleroderma\n - Hiatus hernia women\n - Pregnant or lactating women\n - Any other subjects were not suitable to this study in the opinion of the investigator.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nTrial of CMB305 and Atezolizumab in Patients With Sarcoma\n\n**Clinical Trial Summary:**\n\nThis is an open-label Phase 2 randomized study that will examine the use of the study agents, CMB305 (sequentially administered LV305 [a dendritic cell-targeting viral vector expressing the NY-ESO-1 gene] and G305 [NY-ESO-1 recombinant protein plus GLA-SE]) in combination with atezolizumab or atezolizumab alone, in patients with locally advanced, relapsed or metastatic sarcoma (synovial or myxoid/round cell liposarcoma) expressing the NY-ESO-1 protein.\n CMB305 is a novel approach designed to stimulate the body's immune system to fight the spread and growth of cancer in patients whose tumors express the NY-ESO-1 protein. LV305 will be given in a prime-boost approach with G305 to induce a potentially synergistic immunotherapeutic response in combination with atezolizumab.\n\n**Clinical Trial Detailed Description:**\n\nThis study is designed to investigate and examine the time to progression for CMB305 in combination with atezolizumab or atezolizumab alone in the treatment of patients with sarcoma expressing NY-ESO-1 protein.\n\n**Clinical Trial Eligibility Criteria:**\n\nSelected Inclusion Criteria:\n - Locally advanced, relapsed, or metastatic sarcoma with measurable tumor burden following therapy, as defined by RECIST v1.1; the total of all lesions must be ≤12 cm (for synovial sarcoma) or ≤15 cm (for myxoid/round cell liposarcoma [MRCL]).\n - Tumor histology consistent with synovial sarcoma or MRCL.\n - Tumor specimen positive for NY-ESO-1 expression by IHC.\n - Inadequate response, relapse, and/or unacceptable toxicity with ≥ 1 prior systemic, surgical, or radiation cancer therapies.\n - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n Selected Exclusion Criteria:\n - Investigational therapy within 4 weeks prior to CMB305 dosing\n - Prior administration of other NY-ESO-1-targeting immunotherapeutics.\n - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti PD-1, and anti PD-L1 therapeutic antibodies, or any other antibody or drug targeting T-cell costimulation.\n - Treatment with systemic immunostimulatory agents (including but not limited to interleukin-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to first dose.\n - Significant immunosuppression.\n - Other cancer therapies, including chemotherapy, radiation, biologics or kinase inhibitors within 3 weeks prior to the first scheduled dosing.\n - History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis\n - History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), risk of pulmonary toxicity, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n - History of other cancer within 3 years.\n - Evidence of active tuberculosis or recent (<1 week prior to first scheduled dosing) clinically significant infection requiring systemic therapy.\n - Evidence of active hepatitis B (HepB), hepatitis C (HepC), or Human Immunodeficiency Virus (HIV) infection.\n - Known active or untreated central nervous system (CNS) metastases. - Pregnant, planning to become pregnant within 6 months of treatment, or nursing.\n - Known allergy(ies) to any component of CMB305, atezolizumab, or severe allergic reactions to monoclonal antibodies, fusion proteins, or CHO cell products.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nAfatinib vs Erlotinib as 2nd TKI After Failure to 1st TKI and Chemotherapy for Metastatic NSCLC\n\n**Clinical Trial Summary:**\n\nThe investigators prospectively evaluated in this study the efficacy and safety profiles of afatinib as 3rd or 4th line treatment after prior failure to systemic chemotherapy and first-generation EGFR-TKI under a Boehringer Ingelheim sponsored Compassionate Use Program (CUP), with comparison of our historical cohort who received erlotinib after previous failure to systemic chemotherapy and first-generation EGFR-TKI.\n\n**Clinical Trial Detailed Description:**\n\nStudy background The investigators prospectively evaluated the use of afatinib as 3rd or 4th line treatment after progression to one line of first-generation EGFR-TKI therapy and at least one line of systemic chemotherapy under this CUP. All patients had documented EGFR activating mutations before the start of afatinib. Determination of EGFR mutation analysis of all patients was described previously. Formalin-fixed paraffin-embedded tumor biopsies before starting 1st TKI therapy were retrieved. Briefly, tumor enrichment was performed by micro-dissection under light microscopy. Genomic DNA was extracted using QIAmp DNA FFPE Tissue kit (Qiagen, Hilden, Germany), followed by polymerase chain reaction (PCR) amplification of EGFR exons 18 to 21 using intron-based primers and sequenced in both forward and reverse directions.\n Study population Patients who had EGFR-mutated metastatic NSCLC with prior documented objective response to first-generation TKI (gefitinib or erlotinib) for 6 months and prior treatment of at least 1 line of systemic chemotherapy were eligible to join the CUP offered by Boehringer-Ingelheim Pharma GmbH, Ingelheim, Germany. Patients who had received anti-vascular endothelial growth factor antagonist but not anti-EGFR monoclonal antibody in their previous courses of treatment, either alone or in combination with systemic chemotherapy were allowed to join this CUP. They all had baseline computed tomography scan of the brain, thorax and abdomen with at least 1 evaluable lesion and adequate serum hematological, hepatic and renal function as defined by LUX-Lung1 study.\n Treatment The treating physicians then decided the starting dose of afatinib of either 50 mg, 40 mg or 30 mg once daily continuously. After commencement of afatinib, they had regular clinical follow up every 2 weeks for 4 weeks then every 4 weeks until permanent discontinuation of afatinib or death. They also had regular imaging with CT scan every 8-10 weeks for tumor response evaluation by Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1 [16]. Treatment interruption was needed for those who developed grade >= 3 adverse event until it was returned to grade 1 or less. Then afatinib could be resumed but at a one lower dose level. Those who received afatinib 30 mg daily as the initial starting dose would discontinue afatinib permanently if they developed grade >=3 events.\n Assessment of efficacy and treatment-related toxicities All treatment-related toxicities were collected and graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Objective response (OR) included complete response and partial response while disease control (DC) included complete response, partial response and stable disease according to RECIST 1.1. Survival outcomes included progression-free survival (PFS, defined as time from start of afatinib to first of date of objectively determined progressive disease or death from any cause) and overall survival (OS, time from start of afatinib to date of death from any cause). Time to progression (TTP) started from the date of afatinib commencement to the date of objectively determined progressive disease. All these parameters in those who received afatinib in this study were compared to a historical cohort of patients who received erlotinib after prior failure to gefitinib and at least one line of systemic chemotherapy. All patients in the historical cohort received erlotinib at 150 mg once daily, with the same treatment response evaluation, survival and toxicity assessment as for those who received afatinib.\n Statistical analysis Mann-Whitney U was used for comparison of non-parametric variables and chi-square tests were performed for discrete variables. Kaplan-Meier methods with log-rank tests were employed for comparison of survival outcomes and Cox proportional hazard models were used for prognostic factors for PFS after afatinib or erlotinib in univariate and multivariate analyses, with afatinib versus erlotinib, age, sex, performance status, smoking status, histology, TTP for 1st TKI therapy, time interval between 1st TKI and afatinib or erlotinib, TTP for all lines of prior chemotherapy, time interval between last chemotherapy and afatinib or erlotinib as covariates. All statistical analyses were performed by Statistical Package for Social Sciences (SPSS) version 20.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patients with stage IV epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer who were previously responsive to one line of EGFR tyrosine kinase inhibitor and at least one line of systemic chemotherapy\n - Adequate hematological function (ANC >=1.5 x 10^9/l, Hb >=9.0 x 10^9/l, plt >=100 x 10^9/l)\n - Adequate renal function (with estimated creatinine clearance >=50ml/min as determined by Cockcroft-Gault formula)\n - Adequate liver function (ALT/AST <2.5 x upper normal limit or ALT/AST <5 x upper normal limit in the presence of liver metastasis)\n - Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2\n - Evaluable target lesions according to RECIST 1.1 for tumour response assessment\n - Patients able to give written consent\n Exclusion Criteria:\n - Symptomatic brain metastases requiring steroids/surgery/radiation therapy within 4 weeks of commencement of study medication\n - Significant cardiovascular abnormalities\n - Significant psychiatric disorders\n - Patients who have documented history of interstitial lung disease\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nStudy of Crenolanib in Recurrent/Refractory Glioblastoma With PDGFRA Gene Amplification\n\n**Clinical Trial Summary:**\n\nThis is a proof of concept, single-arm study to investigate crenolanib monotherapy in patients with recurrent/refractory glioblastoma with PDGFRA gene amplification by assessing the progression-free survival (PFS) at 6 months. Crenolanib will be given orally starting at 100 mg TID continuously until disease progression, unacceptable toxicity, or consent withdrawal.\n\n**Clinical Trial Detailed Description:**\n\nThis is a proof of concept, single-arm study to investigate crenolanib monotherapy in patients with recurrent/refractory glioblastoma with PDGFRA gene amplification. Eligible patients include those with recurrent/refractory glioblastoma after prior therapy including surgery, radiation, and temozolomide. The trial is designed to assess the anti-tumor activity of crenolanib in recurrent/refractory glioblastoma with PDGFRA gene amplification based on the estimation of progression-free survival (PFS) at 6 months. Symptom burden will be evaluated using the M.D. Anderson Symptom Inventory-Brain Tumor (MDASI-BT).\n Crenolanib will be administered orally continuously at 100 mg TID on a 28-day cycle basis . Patients are allowed to receive crenolanib for a maximum of 26 cycles if clinical benefit has been observed.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Patients (male or female) ≥ 18 years of age.\n 2. Histopathologically confirmed glioblastoma or gliosarcoma (WHO Grade IV) confirmed by local pathology tissue screening.\n 3. Radiologic evidence of first recurrence after initial treatment (including surgery, radiation, and temozolomide) or tumor refractory to initial treatment without subsequent treatment in glioblastoma or gliosarcoma (WHO Grade IV). Transformation from a lower grade glioma previously treated with radiation and/or temozolomide to glioblastoma will be considered first recurrence for the purpose of this trial\n 4. Tumor tissue available from original diagnosis and/or recurrence; a minimum of 1 FFPE archival tumor tissue block (preferred) or a minimum of 20 FFPE unstained slides from initial and/or most recent pre-registration biopsy or resection. It is recommended that at least 1 cm^2 of tissue composed primarily (defined as greater than 85%) of tumor is present.\n 5. Confirmed PDGFRA amplification in the tumor tissue at the time of diagnosis or time of recurrence. Central confirmation of PDGFRA amplification will be performed by FISH in CLIA certified lab (ProPath). Signal quantitation will be used to generate a PDGFRA/centromere 4 ratio. PDGFRA to Centromere 4 ratios will be interpreted as follows: 1.8 to 2.2, borderline for amplification; 2.2 to 5.0, low-level amplification; and greater than 5.0 or clustered signals that are too numerous to count would be considered highly amplified. Tumor samples with PDGFRA to Centromere 4 ratios of 2.2 or higher will be considered amplified and therefore eligible for this trial. For patients with local CLIA testing demonstrating PDGFRA amplification by Next Generation Sequencing (Foundation Medicine, CMS400), central testing will not be required.\n 6. Patients must have adequate organ function at baseline as defined below:\n • Adequate liver function (within 7 days of crenolanib commencement), as determined by:\n - Serum ALT, AST ≤ 2 × ULN\n - Normal serum total bilirubin (lower and upper limits of local Laboratory)\n - Adequate renal function assessed by: serum creatinine ≤ 1.5 × ULN\n 7. KPS ≥ 60\n 8. Recovered (returned to ≤ grade 1 as per CTCAE v4.03) from prior treatment-related toxicity.\n 9. A minimum of 3 weeks must have elapsed from last intake of prior standard chemotherapy treatment.\n 10. A minimum of 6 weeks must have elapsed from the last dose of nitrosoureas.\n 11. A minimum of 5 half-lives of last dose of investigational agent must have elapsed prior to C1D1.\n 12. More than 12 weeks from completion of chemoradiation, unless RANO criteria for early progression within 12 weeks of chemoradiation are met (See 18.1)\n 13. Non-pregnant and non-nursing women of childbearing potential must have a negative serum or urine pregnancy test within 3 days of crenolanib commencement (\"Women of childbearing potential\" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months).\n 14. Women of childbearing potential and men must agree to use adequate contraception (simultaneous use of 2 methods of birth control) prior to study entry, for the duration of study participation and for 90 days following completion of therapy.\n 15. Patient able and willing to provide informed consent.\n 16. Ability to understand and willingness for follow-up visits.\n Exclusion Criteria:\n 1. Pre-existing liver diseases (i.e., cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, and sclerosing cholangitis, etc.)\n 2. Known positive for HIV\n 3. Patients previously treated with bevacizumab.\n 4. NYHA Class III-IV heart failure, myocardial infarction <6 months prior to study entry, and/or serious arrhythmia requiring anti-arrhythmic therapy\n 5. Patients receiving concurrent anti-cancer treatment (chemotherapy, investigational agents, immunotherapy, endocrine therapy, or Optune®…)\n 6. Patients with any other severe and/or uncontrolled concurrent disease affecting the cardiovascular system, liver, kidneys, hematopoietic system or else considered as clinically important by the investigator and that could be incompatible with patient's participation in this trial or would likely interfere with study procedures/results or compromise compliance with the protocol.\n 7. Pregnant or breast-feeding women.\n 8. Patients unable to swallow pills.\n 9. Patients who are allergic to MRI contrast medium or unable to undergo MRI for any other reason.\n 10. Patients unable to provide informed consent.\n 11. Patients on EIADs are not eligible, unless the antiepileptic drug can be safely tapered and discontinued before C1D1.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nStudy of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ H2N- Advanced Breast Cancer\n\n**Clinical Trial Summary:**\n\nThis is a randomize trial for patients with metastatic HR-positive HER2-negative breast cancer who have progressed on an aromatase inhibitor plus a CDK4/6 inhibitor (either palbociclib or ribociclib) to either fulvestrant alone or fulvestrant with ribociclib. The purpose of the trial is to determine whether there is continued benefit for patients to remain on a CDK4/6 inhibitor at the time of switching anti-estrogen therapy. As ribociclib and palbociclib have a similar toxicity and drug profile and mechanism of action, we feel that it is appropriate for patients to receive either drug with an aromatase inhibitor prior to randomization.\n\n**Clinical Trial Detailed Description:**\n\nDespite advances in early detection and therapeutic options, unresectable or metastatic breast cancer remains incurable and is one of the leading causes of cancer-related mortality. Breast cancer is a molecularly heterogeneous disease. This study will be evaluating estrogen receptor (ER) expression positivity and/or progesterone receptor (PgR) positivity of breast cancer with the absence of over-expression or amplification of HER2.\n Inhibitors of the cyclin dependent kinases 4 and 6 (CDK4/6) have been developed and demonstrated impressive activity in patients with ER-positive HER2-negative breast cancer with marked improvements in progression free survival. This question is asking whether CDK 4/6 inhibition should be continued with hormone therapy in patients who will be switching their hormone therapy in the metastatic breast cancer setting.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Men or women at least 18 years of age with histologically or cytologically confirmed adenocarcinoma of the breast with unresectable or metastatic disease.\n 2. Most recent tumor biopsy or surgical resection specimen must be either ER positive, PgR positive, or both, as defined by immunohistochemistry (IHC) ≥1% (as per the ASCO-CAP guidelines).\n 3. HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+ (i.e. indeterminate), a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing. (as per the ASCO-CAP guidelines).\n 4. Postmenopausal status or receiving ovarian ablation with a GnRH agonist such as goserelin. Postmenopausal status is defined by any one of the following criteria:\n - Prior bilateral oophorectomy.\n - Age ≥60 years.\n - Age <60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH, LH, and estradiol in the postmenopausal range per local normal.\n If the patient does not meet criteria for postmenopausal status but is receiving ovarian ablation therapy with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin, the patient is eligible for this study, provided that the GnRH agonist is started at least 2 weeks prior to C1D1 of anti-estrogen therapy.\n 5. Have evidence of measurable or unmeasurable disease.\n 6. Eastern Cooperative Group (ECOG) performance status of 0 or 1.\n 7. Scenario 1: No prior cdk 4/6 inhibitor. If patient has not previously received letrozole, letrozole will be supplied by Novartis. If previously progressed on letrozole, another aromatase inhibitor that the patient has not previously received is allowed, per standard of care (anastrazole or exemestane, not supplied by study). Ribociclib will be supplied by Novartis. If patient has previously received letrozole, anastrazole, and exemestane, (s)he is not eligible. No prior fulvestrant allowed.\n 8. Scenario 2: the patient must have received an aromatase inhibitor plus palbociclib as standard of care or received a CDK4/6 inhibitor (palbociclib or ribociclib) as part of a clinical trial, and demonstrated evidence of disease progression. If the patient was enrolled in a randomized clinical trial involving ribociclib or palbociclib (such as the MONALEESA or PALOMA series of trials), then it must be known after study discontinuation and unblinding that the patient received the investigational drug and not placebo. Documentation of progression and duration of response on aromatase inhibitor plus CDK 4/6 inhibitor should be provided whenever possible. No prior fulvestrant allowed.\n 9. Adequate baseline laboratory studies (hematologic and chemistry), including the following parameters:\n - Absolute neutrophil count ≥ 1500 per microliter, Platelets ≥ 75,000 per microliter, Hemoglobin level ≥ 8.0 gm/dL on screening complete blood count\n - Potassium, sodium, total calcium (corrected only in the case of hypoalbuminemia), magnesium, and phosphorus within normal limits of the local laboratory (Screening values can be rechecked after electrolyte repletion and before the first dose of study medication, if necessary.)\n - Serum creatinine level ≤ 1.5 mg/dL or estimated glomerular filtration rate > 50 mL/min.\n - In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be below 2.5 × the upper limit of normal (ULN). If the patient has liver metastases, ALT and AST should be < 5 × ULN.\n - Total bilirubin ≤ 1.5 x ULN. (In patients with well documented Gilbert's Syndrome, total bilirubin ≤ 3 × ULN with direct bilirubin within normal range.)\n - INR ≤ 1.5\n 10. a) Written informed consent and HIPAA authorization obtained from the subject/legal representative prior to performing any protocol-related procedures b) Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study\n 11. Must be able to swallow ribociclib and oral aromatase inhibitor, such as letrozole\n Exclusion Criteria:\n 1. Prior selective estrogen receptor downregulator use (SERD), including fulvestrant\n 2. Patient has a known hypersensitivity to any of the excipients of ribociclib, aromatase inhibitors (such as letrozole) or fulvestrant\n 3. Active central nervous system (CNS) disease. History of CNS metastases or cord compression is allowable if the patient has been clinically stable for at least 4 weeks since completion of definitive treatment and is off systemic steroids. In the case of brain metastases, the patient must have stable or improved imaging at least 4 weeks after completion of definitive treatment. If there is evidence of active leptomeningeal disease, the patient is ineligible.\n 4. Identified as having visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis. Visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease.\n 5. Received more than 1 prior systemic chemotherapy in the unresectable or metastatic setting. If the patient received 1 prior systemic chemotherapy, the patient is eligible. To clarify, this prior line can be single agent or combination (example, carboplatin/gemcitabine given concurrently). Patients do not need to have demonstrated disease progression on chemotherapy to be eligible. Having received prior targeted therapies for breast cancer (such as everolimus or experimental agents) does not affect eligibility for this study, with the exception of patients who have received the investigational CDK4/6 inhibitor abemaciclib (LY2835219). If the patient has previously received abemaciclib, the patient is not eligible for this study.\n 6. Completion of major surgery or radiation within 14 days prior to starting investigational drug or has not recovered from major side effects.\n 7. Residual acute toxic effects of prior anti-cancer therapy that have not resolved to CTCAE v.4 Grade ≤1 (except alopecia or other grade II or above toxicities not considered a safety risk for the patient at investigator's discretion).\n 8. Presence of a concurrent malignancy or malignancy diagnosed within 5 years of randomization, with the exception of basal or squamous cell carcinoma, non-melanomatous skin cancer, curatively resected cervical cancer, localized prostate cancer treated with curative intent, and stage I colorectal cancer treated with curative resection,\n 9. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n 10. Patient has a known history of HIV infection (testing not mandatory)\n 11. Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including any of the following:\n - History of myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry\n - Documented cardiomyopathy\n - Patient has a known Left Ventricular Fraction (LVEF) <50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO).\n - Long QT syndrome or family history of long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: i. Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesaemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia ii. Concomitant medications(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued or replaced by safe alternative medication (e.g. within 5 half-lives or 7 days prior to starting study drug) iii. Inability to determine the QTc interval\n - Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block)\n 12. Corrected QT interval (QTc) > 480 msec on screening electrocardiogram. If QTc prolongation is felt to be related to electrolyte imbalance, an EKG can be repeated after correction of electrolytes.\n 13. The presence of any other concurrent severe and/or uncontrolled medical condition that would, in the investigator or treating physician's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol. This includes uncontrolled infections that could potentially be exacerbated by anti-neoplastic treatment, active untreated or uncontrolled fungal bacterial or viral infections, etc.\n 14. Currently receiving treatment, including medications and herbal preparations, with known strong inducers or inhibitors of cytochrome p450 enzymes CYP3A4/5 medications that have a narrow therapeutic window and are predominately metabolized through CYP3A4/5 or herbal preparations/medications, dietary supplements, which cannot be discontinued at least one week prior to receiving investigational drug. Anti-retrovirals, anti-microbials, and anti-arrhythmics are the most common medications that interact with these enzymes. Section 5: Pharmaceutical Information and Appendix B for more information and a list of drugs that should not be used concurrently with ribociclib. An additional reference can be the CT scholar tool designed for Novartis Oncology\n 15. Patients who are receiving any other investigational agents concurrently or have received investigational agents within 14 days or 5 half-lives of the compound or active metabolites, whichever is longer before the first dose of the study treatment.\n 16. Subject is pregnant or nursing. Serum or urine Beta-HCG must be checked in all pre- and peri-menopausal patients. (Fulvestrant is pregnancy category D and CDK4/6 inhibitors have demonstrated teratogenicity/fetotoxicity in animal studies.)\n 17. The effects of ribocicilb on the developing human fetus are unknown. For this reason and because the effects of chemotherapy are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 weeks after completion of ribociclib administration.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Randomized, Double-blind, Placebo-controlled,Trial of IW-3718 for 8 Weeks in Patient With Symptomatic GERD\n\n**Clinical Trial Summary:**\n\nThe objectives of this study are to evaluate the safety, efficacy, and dose-response relationship of IW-3718 administered orally to patients who have GERD and continue to experience GERD symptoms while receiving once-daily (QD), standard-dose PPIs\n\n**Clinical Trial Detailed Description:**\n\nThis study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 8-week study, consisting of 3 distinct periods: a screening period, pretreatment period, and treatment period. The study will enroll patients who have GERD and continue to experience GERD symptoms while receiving QD, standard-dose PPI therapy. Eligible patients will continue to take their PPI and will be randomized to placebo or to one of three doses of study drug.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patient is an ambulatory, community-dwelling male or nonpregnant female and is at least 18 years old at the Screening Visit. Lactating females must agree not to breastfeed.\n - Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or regurgitation) on ≥ 4 days per week during the 8 weeks before the Screening Visit while taking standard QD PPI therapy.\n Exclusion Criteria:\n - Patient may not meet any of the excluded conditions specified in the protocol\n - Patient has any alarm symptoms including but not limited to GI bleeding, anemia, vomiting, dysphagia, or unexpected weight loss any time during the Screening or Pretreatment Periods\n - Patient has a history of clinically significant hypersensitivity or allergies to any of the excipients contained in the study medication (active or placebo).\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nManagement of Reflux After Sleeve Using Stretta\n\n**Clinical Trial Summary:**\n\nGastroesophageal reflux disease (GERD) is a frequently seen entity after sleeve gastrectomy. Management of GERD after sleeve is difficult given limited treatment modalities. Stretta is an endoscopic FDA approved device that improves symptoms of GERD, there is minimal information about its use on patients after sleeve. This registry will attempt to get information regarding the treatment of reflux using Stretta after sleeve gastrectomy.\n\n**Clinical Trial Detailed Description:**\n\nGastroesophageal reflux disease (GERD) is a widely prevalent medical disorder in the United States with a spectrum of treatment options ranging from dietary modification, to various pharmacologic treatments, to an array of available surgical and endoscopic procedures. There is a well-described correlation between obesity and symptoms of GERD. The morbidly obese patients undergoing evaluation for bariatric surgery are to characterize any GERD-like symptoms as this will assist in directing surgical therapy. Generally, it is recommended that patients with severe GERD undergo Roux-en-Y gastric bypass(RYGB) rather than a sleeve gastrectomy (SG) as RYGB has proven to be the most effective surgical treatment for GERD in the morbidly obese patient. The number of bariatric procedures performed in the United States has increased significantly in the recent years. Out of all bariatric procedures SG is the most commonly performed in the United States, as it has proven to be a very safe procedure with excellent weight loss. However, the incidence of de novo GERD and the effect of SG on patients with preexisting GERD remain controversial. Although some authors report high incidence of de novo GERD and worsening of previous reflux symptoms, there is also data showing improvement of symptoms post SG. Management of GERD after SG poses an interesting challenge, as traditional invasive procedures like Nissen fundoplication are not available due to an altered gastric anatomy. The alternative is to perform a conversion to RYGB, which represents increased morbidity to patient and significant cost.\n A large number of endoscopic procedures have been introduced in the past for the management of GERD as an alternative to the surgical anti-reflux procedures with various degrees of success. One of the few non-invasive methods for managing GERD that is still available on the market and widely used is Stretta. Stretta delivers Radio Frequency energy (RFe) to the LES resulting in increased LES pressure. In 2000, the FDA approved the Stretta system for treatment of GERD. Stretta allows an alternative for treatment in patients who are not willing or able to undergo surgery. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) published clinical practice guidelines that endorsed Stretta as an appropriate therapy for treatment of GERD in patients >18, with at least 6 months of symptoms partially or completely responsive to pharmacotherapy and who are unable or unwilling to undergo laparoscopic Nissen fundoplication. There are to date no studies evaluating the use of Stretta in management of patients with GERD symptoms after sleeve gastrectomy.\n The investigators will study sleeve gastrectomy patients with GERD symptoms and if considered candidates for Stretta all patients will be enrolled in data collection cohort and followed prospectively with symptom questionnaire and quality of life scores for improvement of symptoms.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Symptomatic reflux: (heartburn, chest discomfort, asthma/chronic cough, laryngitis, nocturnal aspiration or regurgitation)\n 2. On a PPI with GERD-related symptoms\n 3. On a PPI but like to discontinue them\n Exclusion Criteria:\n 1. Age <18 or > 80\n 2. History of a severe psychiatric disorder: including suicidal ideation, or admission to a psychiatric institution.\n 3. Unable or unwilling to consent for an invasive procedure.\n 4. History of intestinal leak after surgery.\n 5. History of revisional bariatric surgery\n 6. Significant sleeve abnormalities such and twist or large fundus\n 7. Hiatal hernia(>2cm)\n 8. Pregnancy\n 9. Inability to comply with study protocols and procedures\n 10. Esophageal stricture, Eosinophilic Esophagitis or Achalasia\n 11. Prior esophageal surgery or therapy for Barrett's Esophagus\n 12. Grades 3 or 4 esophagitis\n 13. Gastric or esophageal varices\n 14. History of obstruction of the small bowel or inflammatory bowel disease\n 15. Pacemaker or implanted cardiac defibrillator\n 16. Coagulopathy or use of anticoagulants\n 17. ASA classification >3\n 18. Scleroderma or other connective diseases\n 19. Use of immunosuppressive medications.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nSF1126 in Recurrent or Progressive SCCHN and Mutations in PIK3CA Gene and/or PI-3 Kinase Pathway Genes\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to test the good and bad effects of an experimental drug called SF1126. This drug is being tested in patients whose cancer has not been controlled by available standard therapies and who have certain genes in their tumor.\n SF1126 is a drug that inhibits a cell protein called phosphatidyl inositol 3 kinase (PI3K). PI3K is part of signaling pathway that tells cancer cells to grow, survive, invade and metastasize. PI3K also has an important role in the development of blood vessels that are required to support tumor growth. SF1126 is being developed by SignalRx Pharmaceuticals, Inc. It is considered an experimental drug because it is not approved by the FDA for any disease treatment.\n\n**Clinical Trial Detailed Description:**\n\nSignalRx Pharmaceuticals has developed a pan isoform specific PI-3 inhibitor called SF1126 to treat patients with advanced or metastatic cancer. SF1126 is a conjugate that contains two components: SF1101 (the active drug) and SF1174 (an inactive tetrapeptide RGD targeting moiety)\n Both components of SF1126 play key roles in the activity of the drug. SF1101 is a selective inhibitor of certain members of the phosphatidyl inositol 3-kinase (PI-3) family and SF1174 binds selectively to receptors known to be present on neovasculature supporting tumors and on some tumor cells themselves. These components result in a drug designed to be both selective in its activity and targeted in its delivery.\n This is an open label Phase II study of SF1126 in adult patients with recurrent or refractory advanced SCCHN with PIK3CA mutation. Treatment cycles (28 days) will consist of SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four cycles and then once weekly for subsequent cycles.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Diagnosis of recurrent or metastatic SCCHN or any site except lip, thyroid, salivary gland, or nasopharynx.\n - No known FDA-approved therapy available that's expected to prolong survival by greater than 3 months.\n - Tumors with at least one of the following known mutations in the PI-3K signaling pathway, via assays performed in a CLIA-approved setting (Foundation Medicine FoundationOne test will be used. This assay uses a cut-off of 5% allele fraction for mutations. Allele fraction will be requested on each sample):\n 1. PIK3CA,\n 2. PIK3CG,\n 3. PIK3R1, PIK3R5 and PIK3AP1 (regulatory subunits),\n 4. AKT and mTOR, or\n 5. PTEN Note: PIK3CA amplification is not eligible.\n - Prior receipt of platinum-containing chemotherapy for recurrent/metastatic disease or a history of progression of disease within 6 months of receiving platinum as part of concurrent chemoradiation.\n - Disease must not be amenable to potentially curative treatment..\n - Has recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy.\n - Myelosuppressive chemotherapy: At least 3 weeks since completion (6 weeks for nitrosourea)\n - Biologic (anti-neoplastic agent): At least 14 days since completion of therapy with a biologic agent.\n - Radiation (XRT):1 week must have elapsed from prior palliative XRT to non-target lesions.\n - Adequate Bone Marrow Function Defined for all subjects (including status post SCT):\n - Peripheral absolute neutrophil count (ANC) 1000/mm3; Note: must be >7 days from use of hematopoietic growth factor or 21 days from pegfilgastrim\n - Platelet count 75,000/ mm3 (transfusion independent for >7 days)\n - Hemoglobin 8.0 g/dL (may receive transfusions)\n - Adequate Renal Function Defined As:\n - Serum creatinine ≤ 1.5 x institution's ULN (upper limit of normal), or\n - Creatinine clearance 50 ml/min\n - Adequate Liver and Pancreatic Function Defined As:\n - Total bilirubin 1.5 x upper limit of normal, and\n - ALT or AST 5 x upper limit of normal, and\n - Albumin 2 g/dL\n - Adequate Central Nervous System Function Defined As:\n - Subjects with seizure disorder may be enrolled if on anticonvulsants and seizures are well controlled.\n Exclusion Criteria:\n - Brain metastases or spinal cord compression, unless treatment was completed at least 4 weeks before study entry, and stable without steroid treatment for at least 4 weeks.\n - Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac [including life threatening arrhythmias], hepatic, or renal disease).\n - Unresolved toxicity ≥ CTCAE Grade 2 from previous anti-cancer therapy except alopecia or long-term radiation toxicity (radiation related toxicity 3 months or greater after radiation exposure).\n - Presence of cardiac impairment defined as:\n - Prior history of cardiovascular disease including heart failure that meets New York Hearth Association (NYHA) class III and IV definitions; OR\n - History of myocardial infarction/active ischemic heart disease within one year of study entry; OR\n - Uncontrolled dysrhythmias; OR\n - Poorly controlled angina.\n - Participation in a trial of an investigational agent within the prior 30 days.\n - Pregnant or breast-feeding females.\n - History of other malignancies except curatively excised carcinoma in situ of the cervix, non-melanomatous skin carcinoma or superficial bladder cancer or other solid tumors curatively treated with no evidence of disease for 3 years. Other cases will be reviewed and possibly allowed if discussed with and approved by the Principal Investigator.\n - Patients receiving therapeutic doses of warfarin.\n - Blood pressure greater than 170/90 or two standard deviations from normal based on age and weight nomogram on three separate measurements.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nMolecular Profiling and Matched Targeted Therapy for Patients With Metastatic Melanoma\n\n**Clinical Trial Summary:**\n\nThis is a patient oriented translational research project aiming to improve clinical outcomes for patients with BRAF and NRAS wild-type unresectable Stage III or Stage IV metastatic melanoma who have progressed on, or are unable to receive standard therapy (in general, immunotherapy). Consecutive patients seen at three major clinics and fitting the broad eligibility criteria will be invited to participate.\n The approach is designed to test the impact of different targeted drugs on different mutations in a single type of cancer. In this project, patients will have tumour tissue genetically profiled to determine which mutation(s) are present, and will then be assigned to receive a matched drug expected to target the mutation(s) in the tumour. Where multiple targets are identified in one patient, or where multiple potential therapies would be appropriate for a single tumour mutation, the treating clinician may determine the appropriate therapeutic approach after consultation with the study team, using the latest version of library of matched therapies.\n\n**Clinical Trial Detailed Description:**\n\nCurrent standard of care testing covers mutations in the BRAF and NRAS genes. The comprehensive gene testing platform to be used in this project is designed to interrogate the entire coding sequence of 315 cancer-related genes plus introns from 28 genes often rearranged or altered in cancer. These genes are known to be somatically altered in solid cancers based on recent scientific and clinical literature. The test panel will be used on melanoma tissue from patients pre-screened as having BRAF and NRAS wild-type melanoma. The extent of testing will be updated to reflect new discoveries in melanoma tumourigenesis and availability of new therapies as the project proceeds. Testing will be performed on formalin-fixed and paraffin-embedded samples of metastatic tissue. Archival tissue from primary or regional recurrent melanoma may be considered if no recent sample is available or possible.\n All new patients with unresectable Stage III or IV melanoma seen at each participating site will be invited to participate. Following written consent, all patients will undergo the standard testing for BRAF and NRAS mutations. Patients found to have mutations in either gene will receive standard treatment with dabrafenib and / or trametinib and no further molecular testing.\n Patients with wild type versions of BRAF and NRAS genes will have tumour tissue sent for the extended gene testing platform. These patients will first receive standard of care therapy for wild type BRAF / NRAS melanoma, where possible. Once standard therapies have been exhausted (because of disease progression or intolerable adverse events), patients will then receive a targeted therapy matched for their genetic result, if applicable. The selection of targeted therapy will be based on clinical evidence of activity in other solid tumours harbouring similar mutations and / or in at least Phase I testing in melanoma. The table of matched therapies will be modified and extended as new findings from clinical research become available. Patients may be included in specific clinical trials of targeted therapies if available, e.g. a MEK inhibitor combined with an MDM2 inhibitor (AMG232) for BRAF and TP53 wild-type melanoma or a MEK inhibitor combined with a CDK4/6 inhibitor for BRAF wild-type melanoma.\n The extensive molecular profiling platform is fully validated and will be conducted by an external provider accredited by an authority with the responsibility to award Laboratory Accreditation at private and public facilities.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria for Inclusion in Molecular Testing Platform:\n 1. Newly diagnosed and treatment naïve unresectable Stage IIIB, IIIC or Stage IV melanoma.\n 2. Archival metastatic tumour tissue available for genetic testing. Archival tissue from primary melanoma may be considered if no recent sample is available.\n 3. Male or female patients aged 18 or over.\n 4. Written informed consent for molecular genetic testing of tumour tissue (for both standard and research tests).\n 5. Standard of care molecular tumour testing which has identified BRAF / NRAS wild type tumour tissue.\n Inclusion Criteria for Matched Targeted Therapy:\n 6. Received available standard therapies for metastatic melanoma and progressed, unable to tolerate standard therapy, or standard therapy contraindicated.\n 7. Written informed consent to receive targeted therapy (if applicable) and clinical follow up.\n 8. ECOG status 0 - 2.\n 9. Adequate haematological, hepatic and renal organ function as defined by:\n 1. White cell count ≥ 2.0 × 109/L\n 2. Neutrophil count ≥ 1.5 × 109/L\n 3. Haemoglobin ≥ 90 g/L\n 4. Platelet count ≥ 100 x 109/L\n 5. Total bilirubin ≤ 3.0 x ULN\n 6. Alanine transaminase ≤ 3.0 x ULN\n 7. Aspartate aminotransferase ≤ 3.0 x ULN\n 8. Serum creatinine ≤ 1.5 x the upper limit of normal (ULN).\n 10. Life expectancy > 30 days.\n 11. Women of child bearing potential (WOCBP) to use contraception to avoid pregnancy.\n 12. Non sterile men with female partners of CBP to use contraception to avoid pregnancy.\n 13. Drug specific inclusions.\n Exclusion criteria for Matched Targeted Therapy:\n 1. An expectation for the need for concurrent radiotherapy (unless safety has been established with the matched drug regimen).\n 2. Any investigational drug or other systemic drug therapy for melanoma within 14 days or 5 half-lives from baseline, whichever is shorter.\n 3. Pregnant or breast feeding females.\n 4. Drug specific exclusions.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nPhase II, Single-arm Study of AZD1775 Monotherapy in Relapsed Small Cell Lung Cancer Patients With MYC Family Amplification or CDKN2A Mutation Combined With TP53 Mutation\n\n**Clinical Trial Summary:**\n\nAZD1775 (previously known as MK-1775 in earlier studies) is an inhibitor of Wee1, a protein tyrosine kinase. Wee1 phosphorylates and inhibits cyclin-dependent kinases 1 (CDK1) and 2 (CDK2), and is involved in regulation of the intra-S and G2 cell cycle checkpoints.\n CDK1 (also called cell division cycle 2, or CDC2) activity drives a cell from the G2 phase of the cell cycle into mitosis. In response to DNA damage, Wee1 inhibits CDK1 to prevent the cell from dividing until the damaged DNA is repaired (G2 checkpoint arrest).\n Inhibition of Wee1 is expected to release a tumor cell from chemotherapeutically-induced arrest of cell replication. In vitro experiments demonstrate that AZD1775 has synergistic cytotoxic effects when administered in combination with various DNA damaging agents that have divergent mechanisms of action. Therefore, the primary objective of the clinical development of AZD1775 is its use as a chemosensitizing drug in combination with a cytotoxic agent (or combination of agents) for treatment of advanced solid tumors.\n CDK2 activity drives a cell into, and through, S-phase of the cell cycle where the genome is duplicated in preparation for cell division. Inhibition of Wee1 is expected to cause aberrantly high CDK2 activity in S-phase cells which, in turn, leads to unstable DNA replication structures and ultimately DNA damage. Therefore, it is anticipated that AZD1775 will have independent anti-tumor activity in the absence of added chemotherapy.\n The tumor suppressor protein p53 regulates the G1 checkpoint. As the majority of human cancers harbor abnormalities in this pathway they become more dependent on S- and G2- phase checkpoints. Thus, S- and G2-checkpoint abrogation caused by inhibition of Wee1 may selectively sensitize p53-deficient cells.\n One hundred percent of SCLC has TP53 mutation, therefore we can expect that most of SCLC have lost G1 checkpoint and has high probability of WEE1 dependency for proper DNA repair and cell cycle progression. For this reason, SCLC could be a good clinical trial target disease for WEE1 inhibitor.\n\n**Clinical Trial Detailed Description:**\n\nThere is only approved drug, topotecan for patients with relapsed small cell lung cancer who have progressed following first-line therapy. In clinical practice, topoisomerase inhibitor, topotecan or irinotecan is commonly used in this setting.\n AZD1775 is a highly selective, adenosine-triphosphate (ATP) competitive, small-molecule inhibitor of Wee1 kinase. Wee1 is a tyrosine kinase involved in regulation of intra-S and G2 cell cycle checkpoints through phosphorylation and inhibition of CDK2 and CDK1, respectively. Because activity of these and other CDKs coordinate progression through the cell cycle, they are inhibited at cell cycle checkpoints, causing transient arrest at the G1-, S-, and G2 phases of the cell cycle.\n P53 is a key regulator of the G1 checkpoint and is one of the most frequently mutated genes in cancer. Therefore, a majority of human cancers lack G1checkpoint but retain the S- and G2-phase checkpoints. As a result of p53 deficiency,cells lacking the G1 checkpoint are predicted to be more dependent on the Wee1-mediated G2 checkpoint. Hence, p53-deficient tumors treated with inhibitors of Wee1 may be particularly susceptible to DNA damage because multiple checkpoints have been lost.\n One hundred percent of SCLC has TP53 mutation, therefore we can expect that most of SCLC have lost G1 checkpoint and has high probability of WEE1 dependency for proper DNA repair and cell cycle progression.\n Therefore, the AZD1775 monotherapy might have some clinical activity as a 2nd line therapy in small cell lung cancer patients.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Provision of fully informed consent prior to any study specific procedures.\n 2. Histologically confirmed SCLC with documented MYC family (MYC, MYCN, MYCL) amplification or CDKN2A mutation combined with TP53 mutation.\n 3. Patients must be ≥20 years of age.\n 4. Small cell lung cancer that has progressed during or after first-line therapy.\n - The 1st line regimen must have contained platinum based regimen.\n - Refractory to first-line chemotherapy or relapse within 6 months since the last dose of first-line chemotherapy\n - If the patient correspond to sensitive relapse (relapse more than 6 months since the last dose of first-line chemotherapy), she/he should get second-line treatment.\n 5. Previous radiotherapy is allowed.\n 6. Provision of tumor sample (from either archival or fresh biopsy)\n 7. Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.\n 8. ECOG performance status 0-2\n 9. Patients must have a life expectancy ≥ 3 months from proposed first dose date.\n 10. Patients must have acceptable bone marrow, liver and renal function measured within 14 days prior to administration of study treatment as defined below:\n - Haemoglobin ≥9.0 g/dL\n - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L\n - White blood cells (WBC) > 3 x 109/L\n - Platelet count ≥100 x 109/L\n - Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n - AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN\n - Serum creatinine ≤1.5 x institutional ULN and a calculated creatinine clearance (CrCl) ≥45 mL/min by the Cockcroft-gault method:\n CrCl = (140-age) x (weight/kg) x (0.85 if female)\n 11. At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and follow up visits.\n 12. Negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1, if woman of childbearing potential\n 13. Female patients who are not of childbearing potential and fertile female patients of childbearing potential who agree to use adequate contraceptive measures, who are not breastfeeding.\n 14. Fertile male patients willing to use at least one medically acceptable form of birth control, and must not donate sperm, for the duration of the study, and for 2 weeks after treatment stops\n Exclusion Criteria:\n 1. More than two prior chemotherapy regimen for the treatment of small cell lung cancer\n 2. Any previous treatment with P53 inhibitors (small molecules)\n 3. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for >2 years.\n 4. Patients unable to swallow orally administered medication.\n 5. Treatment with any investigational product during the last 14 days before the enrollment (or a longer period depending on the defined characteristics of the agents used).\n 6. Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 3 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates or denosumab for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment.\n 7. Concomitant use of known sensitive CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong CYP3A4 inhibitor/inducer which cannot be discontinued to weeks prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study drug, Co-administration of aprepitant or fosaprepitant during this study is prohibitedRefer to the Section 5.9.2 and Appendix H for listing of all prohibited medications.\n 8. With the exception of alopecia, any ongoing toxicities (>CTCAE grade 1) caused by previous cancer therapy.\n 9. Intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment.\n 10. Resting ECG with measurable QTcB > 480 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.\n 11. Patients with cardiac problem as follows: unstable angina pectoris, congestive heart failure, acute myocardial infarction, conduction abnormality not controlled with pacemaker or medication, significant ventricular or supraventricular arrhythmias (patients with chronic rate controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible).\n 12. Female patients who are breast-feeding or child-bearing\n 13. Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses or renal transplant, including any patient known to have human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C\n 14. Major surgical procedures ≤28 days of beginning study treatment, or minor surgical procedures ≤7 days\n 15. Known central nervous system (CNS) disease other than neurologically stable,treated brain metastases - defined as metastasis having no evidence of progression or haemorrhage for at least 2 weeks after treatment\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nTAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer\n\n**Clinical Trial Summary:**\n\nThe purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.\n\n**Clinical Trial Detailed Description:**\n\nThe Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - 18 years of age or older\n - Histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma who is no longer benefiting from standard anti-cancer treatment or for whom, in the opinion of the treating physician, no such treatment is available or indicated\n - Performance status 0-2 (Per Eastern Cooperative Oncology Group (ECOG )criteria)\n - Patients must have acceptable organ function as defined below. However, as noted above, drug-specific inclusion/exclusion criteria specified in the protocol appendix for each agent will take precedence for this and all inclusion criteria:\n 1. Absolute neutrophil count ≥ 1.5 x 106/µl\n 2. Hemoglobin > 9.0 g/dl\n 3. Platelets > 75,000/µl\n 4. Total bilirubin < 2.0 mg/ dl\n 5. Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (SGPT) < 2.5 x institutional upper limit of normal (ULN) (or < 5 x ULN in patients with known hepatic metastases)\n 6. Serum creatinine ≤ 1.5 × ULN or calculated or measured creatinine clearance ≥ 50 mL/min/1.73 m2\n - Patients must have measurable or evaluable disease (per RECIST v1.1 for solid tumor, Lugano criteria for non Hodgkin lymphoma or International Myeloma Working Group criteria for multiple myeloma), defined, per RECIST 1.1, as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral computed tomography (CT) scan, Magnetic Resonance Imaging (MRI), or a subcutaneous or superficial lesion that can be measured with calipers by clinical exam. For lymph nodes, the short axis must be ≥15 mm. Patients who have assessable disease by physical or radiographic examination but do not meet these definitions of measurable disease are eligible and will be considered to have evaluable disease. Patient's whose disease cannot be objectively measured by physical or radiographic examination (e.g., elevated serum tumor marker only) are NOT eligible\n - Results must be available from a genomic test or immunohistochemistry (IHC) test for protein expression performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified, College of American Pathologists (CAP) -accredited, New York State accredited (for labs offering services to residents of NY) laboratory that has registered the test with the National Institutes of Health (NIH) Genetic Test Registry or has established an integration with the TAPUR platform. The genomic or IHC test used to qualify a patient for participation in TAPUR may have been performed on any specimen of the patient's tumor obtained at any point during the patient's care at the discretion of the patient's treating physician. Genomic assays performed on cell-free DNA in plasma (\"liquid biopsies\") will also be acceptable if the genomic analysis is performed in a laboratory that meets the criteria described above.\n - Ability to understand and the willingness to sign a written informed consent document\n - Have a tumor genomic profile for which single agent treatment with one of the FDA approved targeted anti-cancer drugs included in this study has potential clinical benefit based on the criteria described in protocol\n - For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome\n - Because of the risks of drug treatment to the developing fetus, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for four months following completion of study therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study or if she is the partner of a male participant in this study and becomes pregnant while he is participating in this study, she should inform her or her partner's treating physician immediately as well as her obstetrician. Female study patients who become pregnant must immediately discontinue treatment with any study therapy. Male patients should avoid impregnating a female partner. Male study patients, even if surgically sterilized, (i.e. post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or completely abstain from sexual intercourse\n Note: TAPUR does not explicitly exclude any type of solid tumor, but the patient must have measurable and evaluable disease per RECIST v1.1\n Exclusion Criteria:\n - Patients whose disease is not measurable or cannot be assessed by radiographic imaging or physical examination (e.g., elevated serum tumor marker only) are not eligible\n - Patients with primary brain tumors are excluded. Patients with known progressive brain metastases determined by serial imaging or declining neurologic function in the opinion of the treating physician are not eligible. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within the 3 months prior to registration. All patients with previously treated brain metastases must be clinically stable for at least 1 month after completion of treatment and off steroid treatment for one month prior to study enrollment.\n Note: there are additional exclusion criteria that may apply\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** possibly relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nOxidative Stress in Intestinal Metaplasia and Metabolic Syndrome\n\n**Clinical Trial Summary:**\n\nIntestinal metaplasia is generally considered a precancerous lesion. Although it is associated with a very small increase of gastric cancer risk, European Endoscopic Society and other European academic companies highlighted the increased risk of cancer in patients with gastric atrophy and IM and the need for staging in cases with high-grade dysplasia.\n The production of ROS in the gastrointestinal tract (GI) and their role in the pathophysiology and pathogenesis of gastrointestinal diseases have not been studied sufficiently. In the plasma of patients, in the context of the sequence gastro oesophageal reflux-oesophagitis-metaplasia-dysplasia-adenocarcinoma, have been found simultaneous formation of DNA adducts and increased myeloperoxidase concentration, which are associated with oxidative stress, decreased antioxidant capacity (decreased glutathione concentration).These findings support the role of oxidative stress in the pathogenesis and malignant transformation.\n Metabolic Syndrome (MS) has been recognized as a pro-inflammatory, pro-coagulant state associated with increased levels of C reactive protein (CRP), interleukin (IL) 6 and plasminogen activator inhibitor (PAI) 1. It has been reported that the inflammatory and the pro thrombotic markers, which are associated with increased risk for cardiovascular disease and DM2, represent only a part of the relationship between IM and cardiovascular mortality.\n Several factors influence the pathogenesis of MS, as the pro-oxidant condition of such patients may increase the risk for developing symptoms and related chronic diseases such as DM2. Although the exact contribution of oxidative stress on every pathologic condition included in MS is difficult to determine definitively, it is certain that oxidative stress is particularly high in the MS.\n Regarding the relationship between MS and GI diseases, studies have reported that patients with MS are almost twice at risk for developing Barrett's esophagus.The relationship between MS, gastro-esophageal reflux disease (GERD), and the development of IM also requires well designed prospective studies. It seems however, to be a correlation between obesity and GERD, as well as between obesity and gastric adenocarcinoma\n\n**Clinical Trial Detailed Description:**\n\nINTRODUCTION:\n Intestinal metaplasia (IM) is considered a precancerous lesion and is associated with a very small increase of gastric cancer risk. Generally there are no widely accepted guidelines on the IM management. Recently, the European Endoscopic Society and other European academic companies have developed evidence-based guidelines for the management of patients with IM. These instructions highlighted the increased risk of cancer in patients with gastric atrophy and IM and the need for staging in cases with high-grade dysplasia. Risk factors for IM include infection with Helicobacter pylori, high NaCl intake, smoking, alcohol consumption and chronic bile reflux. The four steps sequence of the events for the development of the intestinal type gastric adenocarcinoma include: Non-atrophic gastritis, multifocal atrophic gastritis, IM, and dysplasia.\n Reactive oxygen species (ROS) are produced as by-products of the normal metabolism of the cell. ROS are generated in response to ultraviolet radiation, smoking, alcohol, nonsteroidal anti-inflammatories, ischemia-reperfusion, chronic infections and chronic inflammatory disorders. Disruption of the normal homeostasis of the cell, due to changes in redox homeostasis can lead to the development of cardiovascular diseases, neurodegenerative diseases and cancer. The production of ROS in the gastrointestinal tract (GI) and their role in the pathophysiology and pathogenesis of gastrointestinal diseases have not been studied sufficiently. Despite the protective barrier provided by the digestive mucosa, different molecules which may be present in the content of GI,as well as various pathogens can cause oxidative damage and inflammatory response in the intestinal mucosa and the immune cells. Pathogenesis of various GI diseases, including ulcerative lesions, cancer, and inflammatory bowel diseases are attributable in part to oxidative stress. In the plasma of patients, in the context of the sequence gastro oesophageal reflux-oesophagitis-metaplasia-dysplasia-adenocarcinoma, have been found simultaneous formation of DNA adducts and increased myeloperoxidase concentration, which are associated with oxidative stress, decreased antioxidant capacity (decreased glutathione concentration).These findings support the role of oxidative stress in the pathogenesis and malignant transformation.\n On the other hand, since chronic inflammation has been recognized as an important risk factor for the development of GI tumors, the underlying molecular mechanisms have been studied extensively. Chronic inflammation may induce cell mutations and promote malignant transformation in normal cells of the GI mucosa. The inflammatory reaction generated during carcinogenesis involves the formation of reactive oxygen and nitrogen species (ROS and RNS) derived from mononuclear phagocytes and lymphocytes, as well as the development of immune response, and the production of pro-inflammatory cytokines. Nuclear factor-κB (NF-κB) is considered as the main mediator of the immune response. The activation of NF-κB through phosphorylation leads to translocation of NF-κB in the nucleus, where regulates the transcription of several pro-inflammatory cytokines and chemokines. Furthermore, chronic inflammation can create the appropriate conditions for genomic and epigenetic changes.\n Obesity, particularly abdominal obesity, is associated with insulin resistance in the peripheral tissues and abnormal fatty acid metabolism, often leading to type 2 diabetes mellitus (DM2) development. Insulin resistance, hyperinsulinemia, hypoglycemia and cytokine production by adipocytes (adipokines) can also result in endothelial dysfunction, disorders of the lipid profile, hypertension and vascular inflammation, which promote the development of atherosclerotic cardiovascular disease. In patients with coexistence of metabolic risk factors for DM2 and cardiovascular disease (abdominal obesity, hyperglycemia, dyslipidemia and hypertension) suggested the existence of \"metabolic syndrome\". Metabolic Syndrome (MS) has been recognized as a pro-inflammatory, pro-coagulant state associated with increased levels of C reactive protein (CRP), interleukin (IL) 6 and plasminogen activator inhibitor (PAI) 1. It has been reported that the inflammatory and the pro thrombotic markers, which are associated with increased risk for cardiovascular disease and DM2, represent only a part of the relationship between IM and cardiovascular mortality. Furthermore, no causal relationship between increased levels of CRP levels and MS incidence has been found. The value of several markers for the monitoring of patients with MS remain uncertain.The use of these markers should be made for clinical purposes only, with respect to the determination of cardiovascular risk assessment. The guidelines of the Centers for Disease Control and Prevention (CDC) emphasize that the analysis of CRP still belongs to the optional tests, because the power as an independent predictive remains uncertain.\n Several factors influence the pathogenesis of MS, as the pro-oxidant condition of such patients may increase the risk for developing symptoms and related chronic diseases such as DM2. The reduction of antioxidant capacity in individuals with IM can be explained by the concomitant overproduction of ROS and their metabolites (d-ROMS), the decreased activity of the enzymes that neutralize ROS (SOD, CAT and GPx) and reduction of other antioxidant systems, such as PON1 activity. Recently, γGT has been suggested as a promising biomarker for the diagnosis of MS, and its levels in serum may reflect the response to oxidative stress.\n Moreover, the correlation between the SOD and the various active moieties in MS may indicate that the SOD activity could be a better biomarker of oxidative stress in these patients. The measurement of the SOD activity could be used as a predictive tool for determining the extent of the underlying oxidative stress in the disease. These findings suggest that the study of the oxidative state in the earlier phases of MS may be the starting point for understanding the pathways that contribute to the progress of the MS and its subsequent complications. Although the exact contribution of oxidative stress on every pathologic condition included in MS is difficult to determine definitively, it is certain that oxidative stress is particularly high in the MS. It seems that increased oxidative stress is the main mechanism behind the increased tendency to develop cardiovascular disease, greater severity of cardiovascular disease in younger people and poorer treatment outcomes.\n Regarding the relationship between MS and GI diseases, studies have reported that patients with MS are almost twice at risk for developing Barrett's esophagus. If these findings will be confirmed in prospective studies, patients with MS could form a high-risk group for developing Barett's esophagus and esophageal adenocarcinoma. The prevalence of MS concerning the development of Barett's esophagus and particularly the relationship between the length of damage and changes in the levels of leptin, insulin and proinflammatory markers, indicate that the changes caused by the development of Barrett's esophagus are constant and are affected by metabolic changes caused by adipokines and cytokines. The relationship between MS, gastro-esophageal reflux disease (GERD), and the development of IM also requires well designed prospective studies. It seems however, to be a correlation between obesity and GERD, as well as between obesity and gastric adenocarcinoma.\n AIM OF THE STUDY:\n This study aim the analysis of oxidative stress markers and markers of inflammation in patients with IM and MS, patients with IM alone, and healthy volunteers, as well as the impact of therapeutic protocols, and the association of the markers with the extension of the lesion.\n MATERIALS AND METHODS:\n A group of patients with IM and MS, a group of patients with IM alone, and a group of healthy volunteers. Every group of patients will be divided in subgroups based on age and gender.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Clinical diagnosis of metabolic syndrome, Must be able to undergo gastroscopy,\n - Must be >25 and <75 years old\n Exclusion Criteria:\n - Autoimmune diseases, Malignancy, Chronic kidney disease, Type 2 diabetes complications\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nStudy of the Efficacy of Single Agent BGJ398 in FGFR1-3 Translocated, Mutated, or Amplified Squamous Cell Carcinoma of the Head and Neck\n\n**Clinical Trial Summary:**\n\nThis phase IIa proof-of-concept open-label trial will consist of two cohorts namely, HPV(+) and HPV(-) and will be run across multiple centers through the University of Chicago PCC Consortium. All eligible patients with histologically-confirmed recurrent/metastatic HNSCC and FGFR alteration will receive BGJ398 at 125 mg PO daily. Patients with FGFR1-3 high level amplification, mutation, or translocation will be included.\n\n**Clinical Trial Detailed Description:**\n\nPrimary Objectives\n To assess efficacy of BGJ398 in FGFR altered HPV (-) and HPV (+) HNSCC.\n Secondary Objectives\n 1. To assess efficacy of BGJ398 in relation to specific genetic aberrations in HPV (+) and HPV (-) FGFR altered HNSCC (i.e. FGFR3-TACC3 translocation, FGFR1 high copy number/amplification, FGFR2 mutation, FGFR3 mutation).\n 2. To assess safety and tolerability of BGJ398 in patients with Head and Neck Cancer.\n 3. To assess progression free and overall survival.\n Exploratory Objectives To determine mechanisms of resistance to FGFR inhibition at disease progression.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria\n Must meet all of the following:\n 1. Histologically documented diagnosis of squamous cell carcinoma of the head/neck including nasopharyngeal carcinomas (lymphephithelioma histology is ok if criteria 2 is met).\n a) Patients must have progressed on prior platinum based therapy (or have become intolerant) prior to enrollment on this study.\n 2. FGFR genetic alterations (specifically FGFR1-3 mutation, amplification, or translocation) via DNA or RNA based assay. Prescreening has to be completed prior to enrollment on this study. Commercial or local testing is typically expected, but samples can also be sent to the Univ. of Chicago for testing.\n The following genetic aberrations will be screened for:\n - FGFR1 amplification, FGFR1 somatic mutations, FGFR1 translocations.\n - FGFR2 somatic mutations, FGFR2 translocations, FGFR2 amplification.\n - FGFR3 somatic mutations, FGFR3 translocations, FGFR3 amplification.\n Other genetic FGF/FGFR pathway aberrations may be acceptable should such genetic changes be observed to emerge and require approval per the Lead Investigator for enrollment (e.g. FGF amplification).\n 3. Consent to undergo a fresh biopsy in case of benefit from therapy and subsequent progression\n 4. ECOG performance status ≤1\n 5. Patients must provide written informed consent prior to any screening procedures.\n 6. Age 18 years or older.\n 7. Willing and able to comply with scheduled visits, treatment plan and laboratory tests\n 8. Patient is able to swallow and retain oral medication, unless approval per the manufacturer of other administration routes/methods is provided.\n 9. Recovery from adverse events of previous systemic anti-cancer therapies to baseline or grade 1, except for:\n 1. Alopecia\n 2. Stable neuropathy of ≤ grade 2 due to prior cancer therapy\n 10. HPV status in Oropharyngeal Carcinomas. While HPV status (e.g. via p16) does not have to be known prior to consenting, the HPV status (e.g. using p16 IHC) needs to be established prior to start of therapy.\n 11. Presence of measurable disease by RECIST 1.1\n 12. Availability of tumor tissue (e.g. FFPE) for genomic profile (typically 12 unstained FFPE 5-10 micron slides, minimum of 10).\n Exclusion Criteria:\n 1. History of another primary malignancy except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin or any other curatively treated malignancy that has not been treated in the prior 3 months or expected to require treatment for recurrence during the course of the study.\n 2. Patients with metastatic CNS tumors are allowed provided that they are clinically stable for a period of 30 days prior to study entry and there is not a requirement for steroid (other than close to physiologic doses) or anti-convulsant therapy. Patients with leptomeningeal involvement are excluded.\n 3. Patients who received a prior selective FGFR inhibitor in the recurrent/metastatic disease setting. Prior use of a multikinase inhibitor that includes anti-FGFR activity is acceptable after review by the Lead Investigator\n 4. History and/or current evidence of tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium and lung with the exception of calcified lymph nodes and asymptomatic coronary calcification\n 5. Current evidence of corneal or retinal disorder/keratopathy including, but not limited to , bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjuctivitis, confirmed by ophthalmologic examination\n 6. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral BGJ398 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)\n 7. History and/or current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis, etc unless the lead investigator obtains approval from Novartis.\n 8. Treatment with any of the following anti-cancer therapies prior to the first dose of BGJ398 within the stated timeframes\n - Cyclical chemotherapy (intravenous) within a period of 2 weeks unless there are ongoing side effects > Grade 2.\n - Biological therapy (including small molecules, and/or) within a period of time that is ≤2 weeks prior to starting study drug unless there are ongoing side effects > Grade 2.\n - Any other investigational agents within a period ≤ 2 weeks prior to starting study drug unless there are ongoing side effects > Grade 2.\n - Wide field radiotherapy (including radioisotopes) ≤ 2 weeks prior to starting study drug unless there are ongoing side effects > Grade 2.\n 9. Patients who are currently receiving treatment with agents that are known strong inducers or inhibitors of CYP3A4 are prohibited.\n 10. Enzyme inducing anti-epileptic drugs.\n 11. Consumption of grapefruit, grapefruit juice, pomegranates, star fruits, Seville oranges or products within 7 days prior to first dose.\n 12. Use of medications that are known to prolong the QT interval and/or are associated with a risk of Torsades de Pointes 7 days prior to first dose.\n 13. Use of amiodarone within 90 days prior to first dose.\n 14. Use of medications that increase serum levels of phosphorus and/or calcium.\n 15. Current use of therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulants. Heparin and/or low molecular weight heparins or other anticoagulants are allowed.\n 16. Insufficient bone marrow function\n - ANC <1,000/mm3 [1.0 x 109/L]\n - Platelets < 75,000/mm3 [75 x 109/L]\n - Hemoglobin < 10.0 g/dL\n 17. Insufficient hepatic and renal function\n - Total bilirubin > 1.5x ULN (unless evidence of Gilbert's disease)\n - AST/SGOT and ALT/SGPT > 2.5x ULN\n - Serum creatinine ≥ ULN and/or calculated or measured creatinine clearance < 75% LLN\n 18. Calcium-phosphate homeostasis\n - Inorganic phosphorus outside of normal limits\n - Total and ionized serum calcium outside of normal limits\n 19. Clinically significant cardiac disease including any of the following:\n - Congestive heart failure requiring treatment (NYHA grade ≥ 2), LVEF < 50% as determined by MUGA scan or ECHO, or uncontrolled hypertension (refer to WHO-ISH guidelines)\n - History or presence of clinically significant ventricular arrhythmias, atrial fibrillation, resting bradycardia, or conduction abnormality\n - Unstable angina pectoris or acute myocardial infarction ≤ 3 months prior to starting study drug\n - QTcF > 450 msec (both genders)\n - History of congenital long QT syndrome\n 20. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test\n 21. Known positive serology for HIV, active Hepatitis B, and/or active Hepatitis C infection.\n 22. Study medication cannot be administered through G-tube, unless additional information from the manufacturer becomes available in the future.\n 23. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months following the discontinuation of study treatment must be used by both sexes (=female patients and their male partners). Highly effective contraception methods include:\n - Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n - Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\n - Male sterilization (at least 6 months prior to screening). For female subjects on the study the vasectomized male partner should be the sole partner for that subject.\n - Combination of the following (a+b or a+c, or b+c):\n 1. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception\n 2. Placement of an intrauterine device (IUD) or intrauterine system (IUS)\n 3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\n Note: Oral contraceptives (OC), injected or implanted hormonal methods are not allowed as the sole method of contraception because BGJ398 has not been characterized with respect to the potential to interfere with PK and/or the effectiveness of OCs.\n Post-menopausal women are allowed to participate in this study. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.\n 24. Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after the last dose of the study drug and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nEvaluation of Safety and Effectiveness of the RefluxStop Device in the Management of GERD\n\n**Clinical Trial Summary:**\n\nProspective, open-label, multi-centre, single arm treatment only trial to evaluate the safety and effectiveness of RefluxStop for the treatment of GERD.\n The used medical device \"RefluxStop\" is an implantable single use sterile device to ensure maintenance of gastro oesophageal junction (GEJ) in an intra-abdominal position to reduce or eliminate GERD.\n\n**Clinical Trial Detailed Description:**\n\nProspective, open-label, multi-centre, single arm treatment only trial to evaluate the safety and effectiveness of RefluxStop for the treatment of GERD.\n The used medical device \"RefluxStop\" is an implantable single use sterile device to ensure maintenance of gastro oesophageal junction (GEJ) in an intra-abdominal position to reduce or eliminate GERD.\n The study plan will include a screening/baseline visit, a surgical procedure phase with hospital stay until discharge, and follow-up visits at 6 weeks, 3 months and 6 months after device implantation.\n The study will include a part A (20 patients followed for 6 weeks) and a part B (the first 20 patients assessed at 3 months and 6 months, and the remaining 30 patients assessed at weeks, 3 months, and 6 months).\n An independent Safety Monitoring Board (SMB) will review the results of the first 20 patients after 6 weeks.\n The Board will also meet one month prior to the anticipated inclusion of 50 patients in order to recommend whether an increase of the sample size will be needed for safety documentation purposes.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Subject's age >= 18 years and <= 75 years\n - Subject is able to undergo general anaesthesia and is a suitable laparoscopic surgical candidate\n - Subject is willing and able to participate\n - Subject has provided written informed consent after being informed of the study procedure and risks prior to any study-related events\n - Subject has documented typical GERD symptoms present for > 6 months which respond to PPIs as anti-GERD medication. Typical symptom of GERD is defined as heartburn, which is a burning epigastric or substernal pain\n - Subject requires daily PPI anti GERD medication\n - Subject has a 24-hour pH monitoring proven GERD performed taken off any anti reflux medication or after discontinuation for at least 7 days prior to testing. Total distal oesophageal pH must be <= 4 for >= 4.5% if time during a 24-hour monitoring\n Exclusion Criteria:\n - Subject is currently participating in another study involving investigational drugs or devices\n - Subject has a history of gastro oesophageal surgery, anti-reflux or bariatric procedure\n - Subject has a history of endoscopic anti-reflux intervention\n - Subject has a history or a suspicion of oesophageal or gastric cancer\n - Subject has a history of major psychiatric disorder\n - Presence of a para-oesophageal hernia or sliding hernia of > 3cm determined on endoscopy\n - Presence of an oesophagitis grade C or D according to the Los Angeles classification\n - Presence of oesophageal dysmotility disorder such as but not limited to sclerodermia, achalasia, Nutcracker oesophagus\n - Presence of oesophageal stricture or stenosis\n - Presence of delayed gastric emptying\n - Presence of oesophageal or gastric varies\n - Subject has a body mass index (BMI) > 35kg/m2\n - Female patients who are pregnant or nursing\n - Subjects who are unable to comply with the protocol requirements\n - Subjects with limited life expectancy (< 3 years)\n - Intra-operative findings that may preclude conduct of the study procedures\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nKOREA Study (Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy)\n\n**Clinical Trial Summary:**\n\nThe objectives of this study are to assess the safety and efficacy of single agent Tagrisso (Osimertinib, hereinafter \"the study drug\") in a real world setting in adult patients with advanced or metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or after EGFR tyrosine kinase receptor (TKI) therapy.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - 1. Eligible for, or on active study drug treatment according to the approved label; patients with locally advanced or metastatic, EGFR T790M mutation-positive NSCLC, who have progressed on or after EGFR tyrosine kinase receptor (TKI) therapy\n - 2. Provision of signed and dated written informed consent by the patient or legally acceptable representative\n Exclusion Criteria:\n - 1. History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug\n - 2. Pregnancy and/or breast feeding\n - 3. Current participation in any interventional trial\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors\n\n**Clinical Trial Summary:**\n\nThe main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with other anticancer agents in participants with advanced or metastatic solid tumors.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - For all parts: The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their advanced or metastatic cancer.\n - For dose escalation for all combinations: The participant must have histological or cytological evidence of cancer, either a solid tumor or a lymphoma, which is advanced or metastatic.\n - For Part A dose confirmation: All participants must have histological evidence of advanced or metastatic soft tissue sarcoma or breast cancer. Breast cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.\n - For Part B dose confirmation: All participants must have histological evidence of advanced or metastatic colon cancer or soft tissue sarcoma. Colon cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.\n - For Part C dose confirmation: All participants must have histological evidence of advanced or metastatic breast cancer and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.\n - For Part D dose confirmation: All participants must have histological evidence of cholangiocarcinoma and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway. Participants must not have received >1 line of prior systemic therapy for metastatic or resectable disease (that is, participants may have received adjuvant gemcitabine and then later gemcitabine/cisplatin for recurrent metastatic disease).\n - For Part E dose confirmation: All participants must have histological evidence of locally advanced or metastatic triple negative breast cancer (TNBC) and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway. Participants must not have received >2 lines of systemic treatment for advanced or metastatic TNBC.\n - Have adequate organ function.\n - Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.\n - Have discontinued all previous therapies for cancer.\n Exclusion Criteria:\n - Have current acute leukemia.\n - Have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel disease.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nS1400C Lung-MAP: Palbociclib as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and Positive Biomarker Matches\n\n**Clinical Trial Summary:**\n\nThis phase II trial studies how well palbociclib works in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a sub-study that includes all screened patients positive for the cyclin dependent kinase 4/6 (CDK4/6) biomarker. CDK4/6 can cause tumor cells to grow more quickly. Palbociclib may decrease the activity of CDK4/6 and may be able to shrink tumors.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\n I. To evaluate if there is sufficient evidence to continue to the Phase III component by evaluating the objective response rate (ORR) for cell cycle gene alteration positive patients registered to S1400C treated with palbociclib. (Phase II) II. If the study meets the criteria specified in S1400 Section 11.2a, the study will be amended to include a follow-on randomized Phase III trial. (Phase III)\n SECONDARY OBJECTIVES:\n I. To evaluate investigator-assessed progression-free survival (IA-PFS) and overall survival (OS) in cell cycle gene alteration-positive treated with palbociclib. (Phase II) II. To evaluate the duration of response (DoR) among cell cycle gene alteration positive patients treated with palbociclib who achieve a complete response (CR) or partial response (PR) (confirmed and unconfirmed) by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. (Phase II) III. To evaluate the frequency and severity of toxicities associated with palbociclib. (Phase II)\n TRANSLATIONAL MEDICINE OBJECTIVES:\n I. To identify additional predictive tumor/blood biomarkers that may modify response or define resistance to palbociclib beyond the chosen biomarker for biomarker-driven sub-studies.\n II. To identify potential resistance biomarkers at disease progression. III. To establish a tissue/ blood repository from patients with refractory squamous cell carcinoma (SCCA) of the lung.\n OUTLINE: As of 12/18/2015, patients are assigned to Arm I.\n ARM I: Patients receive palbociclib orally (PO) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n ARM II (CLOSED TO ACCRUAL 12/18/2015): Patients receive docetaxel intravenously (IV) on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, patients may be eligible to re-register to Arm III.\n ARM III: Patients in Arm II eligible for re-registration receive palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n After completion of study treatment, all patients are followed up every 6 months for the first 2 years and then at the end of the year 3 from date of sub-study/re-registration.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)\n - Patients must be assigned to S1400C\n - Patients must not be taking within 7 days prior to sub-study registration, nor plan to take while on protocol treatment, cytochrome p450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and/or strong CYP3A4 inducers; moderate inhibitors or inducers of isoenzyme CYP3A4 should be avoided, but if necessary can be used with caution\n - Patients must not be taking within 7 days prior to sub-study registration, nor plan to take while on protocol treatment drugs that are known to prolong the QT interval\n - Patients must not have QTcF interval > 480msec (based on the mean value of the triplicate electrocardiograms [EKGs]) within 28 days prior to sub-study registration, family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or torsade de pointes\n - Patients must be able to take oral medications; patient may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of palbociclib (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)\n - Patients must also be offered participation in banking for future use of specimens\n - STEP 2 PALBOCICLIB RE-REGISTRATION:\n - Patients must have progressed on Arm 2 (docetaxel) of this sub-study\n - Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to Step 2 Re-registration; patients must have recovered (=< grade 1) from any side effects of prior therapy\n - Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI); the CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality; measurable disease must be assessed within 28 days prior to Step 2 Re-registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to Step 2 Re-registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form; patients whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration\n - Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to Step 2 Re-registration; patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 1 day prior to Re-registration\n - Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable\n - Patients must not have a screening QTcF interval > 480 msec based on the average of triplicate EKGs performed within 28 days prior to Step 2 Re-registration; NOTE: Triplicate EKGs are required at other timepoints; patients must not have any family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes\n - Absolute neutrophil count (ANC) >= 1,500/mcl obtained within 28 days prior to Step 2 Re-registration\n - Platelet count >= 100,000 mcl obtained within 28 days prior to Step 2 Re-registration\n - Hemoglobin >= 9 g/dL obtained within 28 days prior to Step 2 Re-registration\n - Serum bilirubin =< Institutional Upper Limit of Normal (IULN); for patients with liver metastases, bilirubin must be =< 5 x IULN within 28 days prior to Step 2 Re-registration\n - Either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN within 28 days prior to Step 2 Re-registration (if both ALT and AST are done, both must be < 2 IULN); for patients with liver metastases, either ALT or AST must be =< 5 x IULN (if both ALT and AST are done, both must be =< 5 x IULN)\n - Patients must have a serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50 mL/min\n - Patients must have Zubrod performance status of 0-1 documented within 28 days prior to Step 2 Re-registration\n - Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia\n - Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection\n - Patients with a known history of human immunodeficiency virus (HIV) seropositivity: 1. Must have undetectable viral load using standard HIV assays in clinical practice; 2. Must have cluster of differentiation (CD)4 count >= 400/mcL; 3. Must not require prophylaxis for any opportunistic infections (i.e., fungal, mycobacterium avium complex [mAC], or pneumocystis pneumonia [PCP] prophylaxis); 4. Must not be newly diagnosed within 12 months prior to re-registration\n - Pre-study history and physical exam must be obtained within 28 days prior to re-registration\n - No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years\n - Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures\n - As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n - Patients with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)\n - Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nEribulin [Halaven] Use For the Treatment of Advanced Breast Cancer\n\n**Clinical Trial Summary:**\n\nThe purpose of this study was to evaluate the efficacy and safety of eribulin in standard clinical practice in patients with locally recurrent or metastatic advanced breast cancer.\n\n**Clinical Trial Detailed Description:**\n\nThis was an observational, cross-sectional, retrospective, multicenter study conducted in Spain. During the year after authorization of the drug by the European Medicines Agency (EMA), patients in the compassionate use program (public sites) and patients treated in private sites (no purchase restrictions) who received at least 1 dose of treatment with eribulin per approved label at any of the 17 Spanish sites with the highest numbers of treated cases during that period (minimum 3 patients/site) were enrolled in this observational study. Approximately 112 patients will be enrolled in the study.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria:\n 1. Patients diagnosed with locally recurrent or metastatic advanced breast cancer, previously treated with taxanes and anthracyclines, unless these were not indicated.\n 2. Clinical and/or radiological documentation of location and extension of the disease at the time of starting treatment with eribulin. Patients with measurable diseases and those patients who only have non-measurable lesions are eligible.\n 3. Medical history documentation including analytical control data (blood count and serum chemistry including hepatic and renal functions) carried out at least one week before starting treatment with eribulin. (Determining the CA15-3 tumor marker is not indispensable).\n 4. Eribulin monotherapy (at least 1 dose) between April 2011 and March 2012, both inclusive.\n 5. Availability of a medical history allowing monitoring of clinical progression of the patients during and after treatment with eribulin.\n Exclusion criteria:\n 1. Diagnosis of any type of cancer in the last 5 years, except for non-melanoma skin cancer, cervical intraepithelial neoplasia or contralateral breast cancer.\n 2. Patients having received any other anti-tumor treatment, whether conventional or experimental, during the week prior to starting treatment with eribulin. Treatment with bisphosphonate and corticoids is allowed if they are clinically indicated and started 28 days before treatment with eribulin.\n 3. Lack of clinical status documentation after completing treatment with eribulin or, at least, after having been administered 3 initial cycles. This can arise in any of the following cases (they are not excluding):\n 1. Patients whose Medical History does not state the reason and date for interruption of treatment with eribulin and their subsequent clinical progression.\n 2. Patients still undergoing treatment with eribulin on March 31, 2012, for whom there is no data for at least the first 3 cycles.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nUtilizing a Multi-gene Testing Approach to Identify Hereditary Pancreatic Cancer\n\n**Clinical Trial Summary:**\n\nThe primary objective of the study will be to estimate the prevalence of germline mutations in patients who present consecutively within 12 weeks of a confirmed diagnosis of pancreatic ductal adenocarcinoma.\n\n**Clinical Trial Detailed Description:**\n\nThe proposed research is a multi-site prospective and observational plan to investigate the prevalence of germline mutations in patients diagnosed with pancreatic cancer. Thirty two genes will be analyzed, all of which have been associated with an increased risk for cancer. The genes are included on CancerNextTM a multi-gene next generation sequencing and array CGH test. The 32 genes include: APC, ATM, BARD1, BRCA1, BRCA2, BRIP1, BMPR1A, CDH1, CDK4, CDKN2A, CHEK2, EPCAM, GREM1, MLH1, MRE11A, MSH2, MSH6, MUTYH, NBN, NF1, PALB2, PMS2, POLD1, POLE, PTEN, RAD50, RAD51C, RAD51D, SMAD4, SMARCA4, STK11, and TP53 .\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Male and female patients between the ages of 18 and 89 years of age.\n - Diagnosed within the previous 12 weeks with histologically or cytologically confirmed PDAC Stage I to IV.\n - Ability of participant to understand and the willingness to sign a written informed consent document.\n - Participant must agree to sample collection and genetic testing using the 32 gene test, CancerNextTM and allow the test result to be part of their medical record.\n Exclusion Criteria:\n - Diagnosed with intraductal papillary mucinous neoplasms, mucinous cystic neoplasms, pancreatic neuroendocrine tumors or dysplasia without PDAC.\n - Diagnosed with PDAC more than 12 weeks before presenting to the clinical site.\n - Patients meeting the above enrollment criteria who have had CancerNext performed previously.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Multi-center Prospective Observational Biomarker Study on EGFRm+ Non-small Cell Lung Cancer Patients With Leptomeningeal Metastasis\n\n**Clinical Trial Summary:**\n\nLeptomeningeal metastasis (LM) is one of the disastrous events when managing advanced Non-small cell lung cancer (NSCLC) due to a grave prognosis. Although intrathecal (IT) chemotherapy and brain and/or spinal axis irradiation show some effects for LM in advanced NSCLC, the prognosis is still poor with median survival less than 12-14 weeks. Epidermal growth factor (EGFR) tyrosine kinase inhibitors (TKIs) showed to be effective for LM in selected NSCLC patients in some retrospective research. Our single-center prospective research indicated that the incidence of EGFR sensitive mutations (EGFRm+) in NSCLC-LM patients was high and EGFR-TKIs showed a survival benefit for LM in EGFRm+ NSCLC patients. A multi-center prospective observational biomarker study will be started in 11 lung cancer center based on our single-center prospective research result. The aims of the study are to find predictive biomarkers for LM in advanced NSCLC, to establish EGFR-TKIs based comprehensive treatment for appropriate EGFRm+ LM cases, and to establish effective clinical assessment criteria for NSCLC-LM EGFR-TKIs treatment.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. The cytological identification of malignant cells within cerebrospinal fluid (CSF).\n 2. Non-small cell lung cancer patients.\n 3. Tumor specimens or cytology specimens can be used for the EGFR gene mutation detection.\n 4. The entails examining cerebrospinal fluid could be obtained by lumbar puncture.\n 5. Expected survival time is greater than 1 month.\n Exclusion Criteria:\n Patients with radiologic evidence of LM not confirmed by positive CSF cytology.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nAdd-Aspirin: A Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival After Primary Therapy in Common Non Metastatic Solid Tumours\n\n**Clinical Trial Summary:**\n\nAdd-Aspirin aims to assess whether regular aspirin use after standard curative therapy can prevent recurrence and improve survival in individuals with non-metastatic common tumours. The question will be assessed in four different tumour types (breast, colorectal, gastro-oesophageal and prostate) by means of parallel cohorts within an overarching trial protocol.\n Eligible participants will be randomly assigned (double-blind) to either aspirin 100mg, aspirin 300mg or a matched placebo, to be taken daily for at least 5 years. Disease recurrence and survival will be assessed, along with adherence, toxicity, and other potential effects of aspirin (eg. cardiovascular).\n There is a large body of evidence indicating that aspirin has anti-cancer effects. Meta-analyses of cardiovascular trials of aspirin have shown short-term effects on cancer mortality and a decrease in risk of metastases, suggesting a role for aspirin in the treatment as well as prevention of cancer. Additionally, large observational studies of individuals taking aspirin after cancer treatment have shown improved disease-specific and overall mortality for specific tumour types.\n In the treatment setting, the risks of side effects associated with aspirin are expected to be outweighed by potential benefits. However, this has not yet been assessed in a randomised trial.\n As a low cost, generic and widely available drug, which is generally safe, if aspirin is shown to be effective, it could have a huge impact on cancer outcomes globally.\n\n**Clinical Trial Detailed Description:**\n\nA phase III, multi-centre, double-blind, placebo-controlled randomised trial which aims to assess whether regular aspirin use after standard therapy prevents recurrence and prolongs survival in participants with non-metastatic common solid tumours.\n The trial has four parallel tumour site-specific cohorts (breast, colorectal, gastro-oesophageal and prostate cancer). An overarching protocol ensures each cohort is as comparable as possible to allow a combined analysis of overall survival as a co-primary outcome measure in addition to individual tumour site-specific analyses of disease recurrence and survival.\n Participants who have undergone potentially curative treatment (surgery or other radical treatment), including any standard neo-adjuvant or adjuvant therapy for breast, colorectal, gastro-oesophageal or prostate cancer or have participated in any pre-approved trials and satisfy the eligibility criteria.\n Participants will be randomly assigned to 100mg aspirin, 300mg aspirin or matched placebo. All tablets will be enteric-coated to be taken daily for at least five years. Prior to randomisation, all potential participants will take open-label 100mg aspirin daily for a run-in period of approximately 8 weeks to assess tolerability and adherence.\n The trial incorporates a feasibility phase during which recruitment feasibility, treatment adherence, safety and use of the run-in period will be assessed.\n\n**Clinical Trial Eligibility Criteria:**\n\nCOMMON INCLUSION CRITERIA\n - Written informed consent\n - WHO performance status 0, 1 or 2\n - Participants should not be and have no intention of pregnancy or breast feeding during trial treatment\n - Previous or current participants of other primary treatment trials if agreed in advance between trials\n - No clinical or radiological evidence of residual or distant disease\n BREAST COHORT INCLUSION CRITERIA\n - Men or women with histologically confirmed invasive breast cancer\n - Undergone complete primary invasive tumour excision with clear margins\n - Surgical staging of the axilla must have been undertaken by sentinel node biopsy, axillary sampling or dissection\n - In those patients with a positive sentinel node biopsy:\n o If 1, 2 or 3 nodes are positive, subsequent management of the axilla (with surgery, radiotherapy or no further intervention) should be completed prior to registration\n o If 4 or more nodes are involved, patients must have undergone completion axillary node dissection\n - Radiotherapy (RT)\n - Patients who have undergone breastconserving surgery should have received adjuvant RT\n - Patients who have undergone mastectomy should have received RT if they have more than 3 axillary lymph nodes involved\n - Patients who have undergone mastectomy and have T3 tumours and/or 1, 2 or 3 involved lymph nodes may (or not) have received radiation per institutional practice\n - Final histology must fall within at least one of these 3 groups:\n - Node positive\n - Node negative with highrisk features 2 or more of:\n 1. ER negative\n 2. HER2 positive\n 3. Grade 3\n 4. Lymphovascular invasion present\n 5. Age <35\n 6. Oncotype Dx score of >25\n - In patients who have received neoadjuvant chemotherapy, patients are eligible if they have both a hormone receptor negative/HER2 negative tumour, a HER2 positive tumour or a hormone receptor positive grade 3 tumour and did not achieve a pathological complete response with neoadjuvant systemic therapy\n - Known HER2 and ER status\n - Timing of entry\n o If no adjuvant chemotherapy or RT: registration within 12 wks of definitive surgery achieving clear margins\n o Following adjuvant chemotherapy/RT: registration within 8 wks of last therapy.\n - Participants may receive endocrine therapy and trastuzumab. All ER positive patients should be planned to undergo at least 5 yrs of adjuvant endocrine therapy.\n COLORECTAL COHORT INCLUSION CRITERIA\n - Histologically confirmed stage II or III adenocarcinoma of the colon or rectum and patients who have undergone resection of liver metastases with clear margins and no residual metastatic disease\n - Patients with synchronous tumours if one of the tumours is at least stage II or III\n - Serum CEA ideally ≤1.5 x upper limit of normal\n - Have undergone curative (R0) resection with clear margins\n - Timing of entry:\n - If no adjuvant treatment: registration within 12 wks of definitive surgery achieving clear margins\n - Following adjuvant treatment: registration within 8 wks of last therapy GASTROOESOPHAGEAL COHORT INCLUSION CRITERIA\n - Patients with histologically confirmed adenocarcinoma, adenosquamous carcinoma or squamous cell cancer of the oesophagus, gastrooesophageal junction or stomach\n - Have undergone curative (R0) resection with clear margins or primary chemoRT given with curative intent\n - Timing of entry:\n - Following surgery without adjuvant treatment: registration within 12 wks of the definitive surgery achieving clear margins\n - Following primary chemoRT or surgery with adjuvant treatment: registration within 8 wks of last therapy\n PROSTATE COHORT INCLUSION CRITERIA\n - Men with histologically confirmed node negative nonmetastatic adenocarcinoma of the prostate\n - Have undergone curative treatment, either:\n - Radical prostatectomy\n - Radical RT\n - Intermediate or high risk according to D'Amico classification Depending on the curative treatment pathway, participant must additionally satisfy the following (a) Prostatectomy patients\n - Open, laparoscopic or robotic radical prostatectomy\n - Men treated with immediate adjuvant RT\n - Men receiving adjuvant hormone therapy planned for a maximum duration of 3 yrs\n - Timing of entry:\n - If no adjuvant RT: registration within 12 wks of definitive surgery and PSA at ≥6 weeks postsurgery must be <0.1ng/ml\n - Following adjuvant RT: registration within 8 wks of delivery of final fraction of RT\n - Men treated with salvage RT following a rise in PSA\n - Men randomised to RADICALSHD (ISRCTN 40814031) provided all other eligibility criteria are met (b) Radical RT patients\n - Men receiving neoadjuvant and/or adjuvant hormone therapy planned for a maximum duration of 3yrs\n - Timing of registration within 8wks from completion of RT (c) Salvage RT patients after previous Radical Prostatectomy\n - Men treated with salvage RT following a rise in PSA\n - Men receiving neoand/ or adjuvant hormone therapy planned for a maximum of 3yrs\n COMMON EXCLUSION CRITERIA\n • Current or previous regular use of aspirin (at any dose) or current use of another NSAID for any indication.\n - A past history of adverse reaction or hypersensitivity to NSAIDs, celecoxib, aspirin or other salicylates or sulphonamides, including asthma, that is exacerbated by use of NSAIDs.\n - Current use of anticoagulants.\n - Current or longterm use of oral corticosteroids. The treating physician should make the clinical decision whether a patient has been exposed to longterm therapy.\n - Active or previous peptic ulceration\n - Previous gastrointestinal bleeding except where the cause of the bleeding has been surgically removed.\n - Active or previous history of inflammatory bowel disease.\n - History of moderate or severe renal impairment, with eGFR<45ml/min/1.73m2.\n - Previous invasive or noninvasive malignancy except:\n - DCIS where treatment consisted of resection alone. Prostate cancer initially treated with prostatectomy and now being treated with salvage radiotherapy following a rise in PSA.\n - Cervical carcinoma in situ where treatment consisted of resection alone.\n - Basal cell carcinoma where treatment consisted of resection alone or radiotherapy.\n - Superficial bladder carcinoma where treatment consisted of resection alone.\n - Other cancers where the patient has been diseasefree for ≥15 years.\n - Any other physical condition which is associated with increased risk of aspirinrelated morbidity or, in the opinion of the Investigator, makes the patient unsuitable for the trial, including but not limited to severe asthma, haemophilia and other bleeding diatheses, macular degeneration and patients with a highrisk of mortality from another cause within the trial treatment period.\n - Known glucose6phosphate dehydrogenase deficiency.\n - LFTs greater than 1.5x the upper limit of normal unless agreed with TMG.\n - Anticipated difficulties in complying with trial treatment or followup schedules.\n - <16 years old.\n - Participants in other treatment trials where this has not been agreed in advance by both trial teams.\n BREAST COHORT EXCLUSION CRITERIA\n • Metastatic or bilateral breast cancer.\n COLORECTAL COHORT EXCLUSION CRITERIA • Proven (or clinically suspected) metastatic disease (patients who have undergone resection of liver metastases with clear margins and no residual metastatic disease are eligible).\n GASTROOESOPHAGEAL COHORT EXCLUSION CRITERIA\n • Proven (or clinically suspected) metastatic disease.\n PROSTATE COHORT EXCLUSION CRITERIA\n - Biopsy proven or radiologically suspected nodal involvement, or distant metastases from prostate cancer.\n - Adjuvant hormone therapy planned for >3 years.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Trial to Assess the Activity and Safety of Palbociclib in Patients With Well and Moderately Differentiated Metastatic Pancreatic Neuroendocrine Tumors (pNET)\n\n**Clinical Trial Summary:**\n\nA phase II trial to assess the activity and safety of PD0332991 in patients with well- and moderately-differentiated metastatic pancreatic neuroendocrine tumors (pNET) with overexpression of cell cycle markers (Cdk4 and/or phospho-Rb1 and/or cyclin D1)\n\n**Clinical Trial Detailed Description:**\n\nThe purpose of this study is to evaluate the activity and safety of PD0332991 in patients with well- and moderately-differentiated metastatic pancreatic neuroendocrine tumors (pNET) with overexpression of cell cycle markers (Cdk4 and/or phospho-Rb1 and/or cyclin D1)\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Histologically or cytologically proven diagnosis of pancreatic neuroendocrine tumors (pNET) with Ki67 assessment of < or = 20% (well and moderately differentiated) with evidence of unresectable disease or metastatic disease. Locally advanced disease must not be amendable to resection or radiation therapy with curative intent.\n 2. Overexpression of Cdk4 and/or phospho-Rb1 and/or cyclin D1 in tumor tissue sample from tumor biopsy or prior primary tumor resection (Molecular study will be conducted at CNIO and logistic is described later). Therefore availability of paraffin-embedding tumor tissue sample is needed.\n 3. Documented progression of the disease by CT scan, MRI, or Octreoscan within 12 months prior to baseline.\n 4. Previous treatments with chemotherapy, antiangiogenics, or interferon are permitted providing that toxicity has resolved to < grade 1 at study entry and that last treatment was at least 4 weeks prior to baseline assessment. Patients may be treated with somatostatin analogues during the trial. Concomitant interferon treatment is not permitted.\n 5. Measurable disease as per RECIST. Measurable lesions that have been previously radiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.\n 6. Able to swallow oral compound\n 7. Male or female, 18 years of age or older.\n 8. ECOG performance status less than 2.\n 9. Life expectancy greater than 12 weeks.\n 10. The definitions of minimum adequacy for organ function required prior to study entry are as follows. In addition, safety precautions provided in the product labeling for the anticipated control arm chemotherapy must be observed.\n - Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) 2.5 x upper limit of normal (ULN), or AST and ALT 5 x ULN if liver function abnormalities are due to underlying malignancy\n - Total serum bilirubin 1.5 x ULN\n - Serum albumin 3.0 g/dL\n - Absolute neutrophil count (ANC) 1500/L\n - Platelets 100,000/L\n - Hemoglobin 9.0 g/dL\n - Creatinin clearance < 40 mL/min\n 11. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.\n 12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n Exclusion Criteria:\n 1. Prior chemotherapy regimen or biological treatment for locally advanced or metastatic transitional cell carcinoma of the urinary tract.\n 2. Prior treatment on Cdk4 inhibitor under clinical trial.\n 3. Creatinine clearance < 40 ml/min using Cockroft and Gault formula.\n 4. Major surgery, radiation therapy, or systemic therapy within 3 weeks of study randomization except palliative radiotherapy to non-target metastatic lesions.\n 5. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.\n 6. Immunosuppressive drugs such as cyclosporine, tacrolimus, azathioprine, or long-term oral glucocorticoids taken concurrently or within last 3 months prior to randomization\n 7. Prior radiation therapy to >25% of the bone marrow.\n 8. Current treatment on another clinical trial.\n 9. Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease. Patients should have completed surgery or radiation therapy for existing brain metastases, should not have documented increase in size over the previous 3 months prior to first dose of treatment on study and should be asymptomatic.\n 10. Diagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.\n 11. Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus.\n 12. Ongoing cardiac dysrhythmias of NCI CTCAE grade 2, atrial XML File Identifier: 3xAP+CVEwV9UnEoC7xvloFQA/XQ=Page 20/34 fibrillation of any grade, or QTc interval >450 msec for males or >470msec for females.\n 13. Hypertension that cannot be controlled by medications (>150/100mmHg despite optimal medical therapy)\n 14. Current treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).\n 15. Known human immunodeficiency virus infection.\n 16. Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to randomization.\n 17. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nPembrolizumab and Imatinib in Patients With Locally Advanced/Metastatic Melanoma With c-KIT Mutation/Amplification\n\n**Clinical Trial Summary:**\n\nThis phase I/II trial studies the side effects and how well pembrolizumab and imatinib mesylate work in treating patients with melanoma with c-KIT mutation or amplification that has spread to nearby tissue or other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and imatinib mesylate may work better in treating patients with melanoma with c-KIT mutation or amplification that has spread to nearby tissue or other places in the body.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\n I. To assess the best overall response rate (BORR = complete response + partial response) of the combination of pembrolizumab and imatinib for treatment of melanomas harboring c-Kit mutation or amplification.\n II. To evaluate the safety and adverse effect profile of the combination of pembrolizumab and imatinib in patients with melanomas harboring c-KIT aberrations (mutations or amplifications).\n SECONDARY OBJECTIVES:\n I. To assess the median time to progression (TTP), progression free survival (PFS), and overall survival (OS).\n TERTIARY OBJECTIVES:\n I. Assessment of programmed cell death ligand (PD-L)1 expression in melanoma patients with c-KIT aberrations before and after combined therapy.\n OUTLINE:\n Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and imatinib mesylate orally (PO) once daily (QD) on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.\n After completion of study treatment, patients are followed up at 30 days and every 9 weeks for 1 year, and then every 12 weeks thereafter.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patient must have histologically or cytologically confirmed diagnosis of stage III melanoma inoperable/not amenable to local treatment or stage IV melanoma.\n - Patient must have either mutation or amplification of c-KIT gene tested by commercially available molecular or gene sequencing techniques\n - Be willing and able to provide written informed consent/assent for the trial\n - Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n - Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the sponsor\n - Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale\n - Absolute neutrophil count (ANC) >= 1,500 /mcL\n - Platelets >= 100,000 / mcL\n - Hemoglobin >= 9 g/dL or >= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)\n - Serum creatinine =< 1.5 X upper limit of normal (ULN) or measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN\n - Serum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN\n - Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases\n - Albumin >= 2.5 mg/dL\n - International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants\n - Activated Partial Thromboplastin Time (aPTT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n - Female subject of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n - Female subjects of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year\n - Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\n Exclusion Criteria:\n - Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment\n - Has a diagnosis of immunodeficiency or is receiving immunosuppressive therapy within 7 days prior to the first dose of trial treatment; individuals who are receiving systemic steroid therapy at a stable dose less than or equal to 10mg of prednisone per day or its equivalent will be permitted to participate\n - Has a known history of active TB (bacillus tuberculosis)\n - Hypersensitivity to pembrolizumab, imatinib, or any of its excipients\n - Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier\n - Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent\n - Note: subjects with =< grade 2 neuropathy and/or alopecia are an exception to this criterion and may qualify for the study\n - Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy\n - Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer\n - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids at a dose exceeding 10mg of prednisone per day or its equivalent for at least 7 days prior to trial treatment; this exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability\n - Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids exceeding 10 mg prednisone per day or its equivalent, or immunosuppressive drugs); replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n - Has known history of, or any evidence of, active, non-infectious pneumonitis\n - Has an active infection requiring systemic therapy\n - Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n - Has decompensated congestive heart failure as defined by New York Heart Association (NYHA) functional classification III or IV\n - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n - Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment\n - Has received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, or anti-PD-L2 agent\n - Has received prior therapy with imatinib or another tyrosine kinase inhibitor\n - Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)\n - Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)\n - Has received a live vaccine within 30 days of planned start of study therapy\n - Note: seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nMulti-Arm Study to Test the Efficacy of Immunotherapeutic Agents in Multiple Sarcoma Subtypes\n\n**Clinical Trial Summary:**\n\nThe goal of this clinical research study is to learn if the combination of durvalumab and tremelimumab can help to control sarcoma. The safety of this drug combination will also be studied.\n\n**Clinical Trial Detailed Description:**\n\nStudy Drug Administration:\n If participant is found to be eligible to take part in this study, they will receive tremelimumab and durvalumab by vein, over about 1 hour each, every 4 weeks for up to 16 weeks (4 doses). After Week 16, participant may continue to receive durvalumab alone by vein over about 1 hour for an additional 32 weeks (8 doses).\n Study Visits:\n On Day 1 of Week 0:\n - Participant will have a physical exam.\n - Participant will have 3 EKGs in a row.\n - Blood (about 1 tablespoon) and urine will be collected for routine tests. If participant can become pregnant, part of this routine blood and urine sample will be used for a pregnancy test.\n - Blood (about 2½ tablespoons) will be drawn for biomarker and genetic testing. Biomarkers are found in the blood and may be related to participant's reaction to the study drug. The type of genetic testing in this study will be performed to learn how participant's DNA (genetic material) may change how they respond to the study drugs.\n On Day 1 of Weeks 2 and 6, blood (about 3½ tablespoons) will be drawn for routine, genetic, and biomarker testing.\n On Day 1 of Week 4 and then every 4 weeks after that (Weeks 8, 12, 16, and so on) until Week 44:\n - Participant will have a physical exam.\n - Blood (about 1 tablespoon) will be drawn for routine tests.\n - Participant will have imaging scans. Participant will not have these scans at Weeks 16 and 24.\n On Day 1 of Weeks 10 and 14, blood (about 1 tablespoon) will be drawn for routine tests.\n Length of Study:\n Participant may receive up to 4 doses of durvalumab in combination with tremelimumab and up to an additional 8 doses of durvalumab alone. Participant will no longer be able to take the study drug(s) if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions.\n If participant completes 12 months of therapy but the disease appears to get worse, they may be able to re-start treatment. The study doctor will discuss this with participant.\n It is expected that patient's participation in this study may last up to 15 months. Patient's participation on the study will be over after the follow-up visits.\n End-of-Treatment Visit:\n As soon as possible after participant's last dose of study drug(s):\n - Participant will have a physical exam.\n - Participant will have an MRI, CT, or positron emission computed tomography (PET)/CT scan.\n - Blood (about 1 tablespoon) and urine will be collected for routine tests.\n - Blood (about 1 tablespoon) will be drawn for biomarker and genetic testing.\n Follow-Up Visit:\n About 30 days after participant's last dose of study drug(s):\n - Participant will have a physical exam.\n - Blood (about 1 tablespoon) will be drawn for routine tests.\n Long-Term Follow-Up:\n Every 3 months:\n - Participant will have an MRI, CT, or PET/CT scan.\n - Participant may be called to learn how they are doing and if they have started any anti-cancer treatments. If participant is called, it should take about 5-10 minutes.\n This is an investigational study. Durvalumab and tremelimumab are not FDA approved or commercially available. They are currently being used for research purposes only. The study doctor can explain how the study drugs are designed to work.\n Up to 150 participants will be enrolled in this study. All will take part at MD Anderson.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Age: >/= 18 years of age\n 2. Histologically or cytologically confirmed sarcoma that fall into one of the following categories Patients with low-grade tumors are eligible if there is definite evidence of metastasis or progression (defined as at least a 10% increase in the cumulative sum of the longest diameters within a 3 month period): 1. Adipocytic tumors (Well-differentiated/dedifferentiated liposarcoma, myxoid liposarcoma, pleomorphic liposarcoma) 2. Vascular tumors (leiomyosarcoma, angiosarcoma) 3. Undifferentiated pleomorphic sarcoma 4. Synovial sarcoma 5. Osteosarcoma 6. Other sarcoma histologies\n 3. Must have received and have progressed, are refractory or intolerant to standard therapy appropriate for the specific sarcoma subtype, if there is a standard therapy for the subtype (i.e. Progressing well-differentiated liposarcoma, clear cell sarcoma etc do not require prior therapy).\n 4. Subjects must have at least 1 lesion that is measurable by irRECIST a. A previously irradiated lesion can be considered a target lesion if the lesion is well defined, measurable per irRECIST, and has clearly progressed. b. Subjects undergoing fresh tumor biopsies must have additional non-target lesions that can be biopsied at acceptable risk as judged by the investigator or if no other lesion suitable for biopsy, then an irRECIST target lesion used for biopsy must be >/= 2 cm in longest diameter.\n 5. Subjects must consent to provide archived tumor specimens for correlative biomarker studies. Tumor tissue must be identified and availability confirmed prior to initiation of study therapy. In the setting where archival material is unavailable or unsuitable for use, or there have been multiple intervening therapies subjects must consent and undergo fresh tumor biopsy. A tumor lesion planned for biopsy must not be an irRECIST target lesion unless there are no other lesions suitable for biopsy and lesion used for biopsy is >/= 2 cm in longest diameter.\n 6. ECOG performance status of 0 or 1\n 7. Adequate organ function as determined by (lymphocyte count): a. Hematological (without growth factor or transfusion support): i. Absolute neutrophil count >/= 1.5 x 10^9/L (1,500/mm^3) ii. Platelet count >/= 100 × 10^9/L (100,000/mm^3) iii. Hemoglobin >/= 8.0 g/dL within first 2 weeks prior to first dose of investigational product b. Renal: i. Calculated creatinine clearance (CrCl) or 24-hour urine CrCl > 50 mL/min Cockcroft-Gault formula (using actual body weight) will be used to calculate CrCl, except for pts with Osteosarcoma who will be allowed to participate with an estimated creatinine clearance (CrCl) of > 40 mL/min, as calculated by the Cockcroft-Gault equation. c. Hepatic: i. Total bilirubin </= 1.5 × ULN; for subjects with documented/suspected Gilbert's disease, bilirubin </= 3 × ULN ii. AST and ALT </= 2.5 × ULN; for subjects hepatic metastases, ALT and AST </= 5 × ULN\n 8. Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from the time of screening, and must agree to continue using such precautions for 180 days after the final dose of investigational product.\n 9. Life expectancy of at least 6 months.\n 10. Ability to understand the purposes and risks of the study and has signed a written consent form approved by the investigator's IRB/Ethics Committee\n Exclusion Criteria:\n 1. Prior therapy with anti-PD1, anti-PD-L1 or anti-CTLA-4 antibody\n 2. Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener syndrome) within the past 2 years. Subjects with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.\n 3. Untreated central nervous system metastatic disease, leptomeningeal disease, or cord compression. Subjects previously treated central nervous system metastases that are radiographically and neurologically stable for at least 6 weeks and do not require corticosteroids (of any dose) for symptomatic management for at least 14 days prior to first dose of MEDI4736 and tremelimumab are permitted to enroll.\n 4. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study.\n 5. Receipt of any conventional or investigational anticancer therapy not otherwise specified above within 28 days or 5 half-lives of the agent prior to the first dose of durvalumab and tremelimumab.\n 6. Any concurrent chemotherapy, Immunotherapies or biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable. In addition, local treatment (eg, by local surgery or radiotherapy) of isolated lesions for palliative intent is acceptable beyond the first cycle with prior consultation and in agreement with the PI.\n 7. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v4.03 Grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (eg, hearing loss) after consultation with the medical monitor.\n 8. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI4736 or tremelimumab. The following are exceptions to this criterion: a. Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection), b. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent, c. Steroids as premedication for hypersensitivity reactions (eg, computed tomography [CT] scan premedication).\n 9. History of primary immunodeficiency, solid organ transplantation, or previous clinical diagnosis of tuberculosis\n 10. True positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.\n 11. Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational products (NOTE: Subjects, if enrolled, should not receive live vaccine during the study and 180 days after the last dose of investigational products).\n 12. Major surgery (as defined by the investigator) within 4 weeks or thoracotomy for pulmonary metastases within 2 weeks prior to first dose of treatment or if still recovering from prior surgery. Local surgery of isolated lesions for palliative intent is acceptable.\n 13. Other invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured.\n 14. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs from MEDI4736 or tremelimumab, or compromise the ability of the subject to give written informed consent.\n 15. Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.\n 16. Patients with a history of pneumonitis or interstitial lung disease.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nSirolimus and Cyclophosphamide in Metastatic or Unresectable Myxoid Liposarcoma and Chondrosarcoma\n\n**Clinical Trial Summary:**\n\nChondrosarcoma and liposarcoma consists of different subtypes with a wide range of patient survival. Current treatment options consist of wide surgical resection, however for patients with a local recurrence or metastatic disease the outcome is poor. New treatment options being evaluated and mouse models show in vivo that mammilian target of rapamycin (mTOR) inhibition can prevent tumour growth. mTOR is an kinase that is present in two complexes and thereby activates multiple pathways. Aberrant mTOR signalling is known to be involved in cancer cell survival. Several clinical studies for patients with bone or soft tissue sarcoma treated with mTOR inhibitors have been conducted and they show promising results. From these studies the investigators can conclude that the combination of an mTOR inhibitor with cyclophosphamide shows promising results in chondrosarcoma. With the lack of other treatment options for unresectable and metastatic chondrosarcoma or myxoid liposarcoma the Eurosarc consortium (www.eurosarc.eu) decided to treat these patients in a standardised way according to a common protocol with the combination of sirolimus and cyclophosphamide using the growth modulation index for evaluation in the current clinical study protocol.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Pathologically proven conventional chondrosarcoma\n - Or pathologically proven myxoid liposarcoma with PIK3CA mutation or Phosphatase and tensin homolog (PTEN) loss\n - Or pathologically proven mesenchymal or dedifferentiated chondrosarcoma\n - Patient is 18 years and up\n - Documented radiographic progression of disease according to RECIST 1.1 criteria in last 6 months\n - Written signed informed consent\n - Adequate bone marrow function (Hb ≥ 6.0 mmol/L, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥ 80 x 109/L)\n - Availability of archival tumor material for central review or be able to perform a 3 core fresh biopsy\n - Ability to adhere to the study visits and all protocol requirements\n Exclusion Criteria:\n - Previously treated with an mTOR inhibitor\n - Known to be allergic to cyclophosphamide\n - Life expectancy of less than 3 months\n - No measurable lesions according to RECIST 1.1\n - Eastern cooperative oncology group (ECOG) Performance status >2\n - Major surgery less than 4 weeks prior to start of treatment\n - Known human immunodeficiency virus (HIV) positivity\n - A decreased renal function with calculated glomerular filtration rate (GFR) < 30ml/min\n - Systemic anti-cancer therapy within 28 days prior to the first dose of study drug , or radiotherapy to a target lesion within 21 days prior to the first dose of study drug\n - Pregnant or lactating women\n - Other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localised cured prostate and cervical cancer\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nPPI's and SSRI's Therapy for the Management of NCCP\n\n**Clinical Trial Summary:**\n\nNon cardiac chest pain (NCCP) is defined as recurring, angina-like, retrosternal chest pain of non cardiac origin. Annual prevalence of NCCP in the general population of the western world ranges from 25-35%. Of those patients presenting to an emergency room with chest pain, a cardiac etiology is ultimately found in only 11-39%. Several conditions are associated with NCCP, with gastroesophageal reflux disease (GERD) being the most prevalent, constituting up to 60% of cases. However, NCCP is considered a disorder of heterogenous nature and several other conditions, apart of GERD, such as esophageal dysmotility and esophageal hypersensitivity have been implicated.\n Treatment of NCCP remains a real challenge due to the diverse underlying mechanisms responsible for patients' symptoms. Given the fact that GERD is by far the most common etiology, proton pump inhibitor (PPI) therapy has been tried extensively; however, after 6 weeks of treatment complete resolution of symptoms occurs in only 30% of patients, the optimal duration of PPI administration is not known, while the best maintenance dose has never been determined. Although the administration of selective serotonin reuptake inhibitors (SSRIs) could theoretically benefit those patients with esophageal hypersensitivity, the trials that have been published so far have included small number of patients and reported conflicting results, while the co-administration of PPIs with SSRIs has not been evaluated so far. Furthermore, data on treatment of patients with functional chest pain are lacking.\n\n**Clinical Trial Detailed Description:**\n\nWe have therefore designed a prospective study in order to evaluate the effect of PPI and SSRI therapy for different subtypes of NCCP patients using multichannel intraluminal impedance and pH (MII-pH) monitoring.\n METHODS\n Patients with non cardiac chest pain symptoms presenting to the participating centres, will be prospectively screened for entry into the study.\n They should have undergone a comprehensive diagnostic evaluation by cardiologists in order to exclude a cardiac source for their chest pain. Patients recruited in the study should have either a normal coronary angiogram or lack of ischemic heart disease on exercise treadmill or stress thallium testing\n Inclusion criteria i) patients should have at least 3 episodes of chest pain per week in the previous 3 months.\n The exclusion criteria will be:\n i) thoracic, esophageal or gastric surgery ii) primary or secondary esophageal motility disorders iii) use of non-steroidal anti-inflammatory drugs and aspirin iv) presence of Barrett's esophagus, erosive esophagitis, peptic stricture and duodenal or gastric ulcer on upper endoscopy v) eosinophilic esophagitis vi) underlying psychiatric illness vii) pregnancy in women viii) refusal to participate.\n Study protocol\n All subjects who will agree to participate in the study should undergo an upper endoscopy to assess the presence or absence of esophageal mucosal injury. Patients with Barrett's esophagus and erosive esophagitis will not be included in the present study. Furthermore, biopsies will be taken and patients with eosinophilic esophagitis will also be excluded.\n All patients will also be subjected to stationary esophageal manometry and those with motility abnormalities will be excluded. During esophageal manometry the lower esophageal sphincter (LES) will be located.\n Esophageal impedance-pH monitoring will be performed in all participating subjects using an ambulatory multichannel intraluminal impedance (MII) and pH monitoring system (Sleuth; Sandhill Scientific, Inc. Higland Ranch, CO, USA). During the test, each subject will eat three standard meals, while the beginning and ending times of every meal will be indicated in a diary. Subjects will also be instructed to press the event marker button on the data logger whenever they experience chest pain. Data recording will be concluded after 24 hours, when patients will return to the endoscopy unit for the catheter removal.\n The impedance and pH data will be used to determine in each patient the number and type of reflux episodes and the total 24-hour esophageal acid exposure, defined as the total time at pH below 4 divided by the time monitoring. Total distal esophageal acid exposure (i.e., % time pH < 4) less than 4.2% over 24 hours will be considered normal.\n In each patient we will calculate the symptom index (SI) for chest pain. Bioview analysis software will be used for the calculation of SI. According to the setting of this software the symptoms will be considered as being related to reflux if they occur within a 2-min time window after the onset of the reflux episode. SI will be defined as the number of symptoms associated with reflux divided by the total number of symptoms. A positive SI is declared if ≥ 50% (i.e, at least half of the symptoms are associated with reflux).\n Treatment\n Patients will abnormal distal acid esophageal exposure will receive PPI twice daily for 8 weeks .\n Patients with positive symptom index for chest pain will receive citalopram 20 mg once daily and PPI once daily for 8 weeks.\n Patients with a negative symptom index for chest pain will receive citalopram 20mg once daily for 8 weeks.\n All patients will be evaluated at the end of the 8-week period and will be asked about the presence or absence of chest pain. Treatment success will be defined as the complete disappearance of the chest pain, while the presence of mild or infrequent symptoms will be considered as treatment failure.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n Patients should have at least 3 episodes of chest pain per week in the previous 3 months. Meanwhile they should have undergone a comprehensive diagnostic evaluation by cardiologists in order to exclude a cardiac source for their chest pain. Patients recruited in the study should have either a normal coronary angiogram or lack of ischemic heart disease on exercise treadmill or stress thallium testing.\n Exclusion Criteria:\n The exclusion criteria will be: i) a history of thoracic, esophageal or gastric surgery, ii) primary or secondary esophageal motility disorders, iii) use of non-steroidal anti-inflammatory drugs and aspirin, iv) presence of Barrett's esophagus, erosive esophagitis, peptic stricture and duodenal or gastric ulcer on upper endoscopy, v) eosinophilic esophagitis, vi) underlying psychiatric illness, vii) pregnancy in women, viii) refusal to participate.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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[
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"role": "assistant",
"content": "**Answer:** not relevant"
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nRandomized Short-term Pre-surgical Study to Assess the Effects of Abemaciclib (LY2835219) in Early Breast Cancer Patients\n\n**Clinical Trial Summary:**\n\nCyclins CDK4 / 6 are extensively involved in the proliferation and growth of numerous cancers including breast cancer. The objective of this study is to identify if a new preoperative oral treatment, abemaciclib directed against the CDK / 6 compared to no treatment, inhibits tumor growth or induced senescence (aging) tumor.\n This early study is offered to women who are going to be operated on for breast cancer with expression of hormone receptor (ER and / or PR). These women will have 3 chances to receive one for up to 14 days in the waiting period of their surgery abemaciclib as tablets. Other patients do not receive treatment. The decision to receive or no treatment will be done by a random computer draw.\n The drug's effectiveness will be evaluated primarily on the biological parameters of the tumor itself when comparing surgery to before treatment. These results biomarkers will allow us to better know how this treatment and eventually will be used in future to identify patients for whom treatment with abemaciclib more efficiency.\n Patients treated in the protocol will then receive treatment entirely conventional in their breast cancer within the parameters of their tumors: their participation is very limited in time.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Signed written informed consent\n 2. Female patients aged 18 years or older.\n 3. Histologically or cytologically confirmed untreated invasive carcinoma of the breast\n 4. Candidates for initial breast surgery with a minimum tumor size of 11 mm measured by breast ultrasound. Bilateral and multifocal tumors are allowed, assuming tumor evaluations and pre- and post-treatment biopsies are performed in the same target lesion.\n 5. HR-positive (defined as either ER and or PR expression >10% by immunohistochemistry or by PCR) irrespective of HER2 status.\n 6. No evidence of metastatic disease.\n 7. Eastern Cooperative Oncology Group (ECOG) performance status 0/1.\n 8. Left ventricular ejection fraction (LVEF) of at least 50%\n 9. Negative pregnancy test in women of childbearing potential within 14 days prior to treatment initiation (premenopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilization).\n 10. For women of childbearing potential who are sexually active, agreement to use a highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception during and for at least 6 months post-treatment.\n 11. Patients must be affiliated to a social security system\n Exclusion Criteria:\n 1. Patients non-candidate for upfront breast surgery or candidate for neoadjuvant chemotherapy or hormonotherapy.\n 2. Patients receiving another concomitant anticancer treatment like chemotherapy, immunotherapy, endocrine treatment, or radiotherapy for the currently diagnosed tumor.\n 3. Known hypersensibility to abemaciclib or any of its components.\n 4. Difficulty to swallow oral medication.\n 5. Serious uncontrolled concomitant disease that would put the patient at high risk for treatment-related complications.\n 6. Patients whose general clinical condition does not consider postponing surgery.\n 7. Inadequate organ function, evidenced by the following laboratory results:\n - Absolute neutrophil count <1,500 cells/mm3\n - Platelet count <100,000 cells/mm3\n - Hemoglobin <8 g/dL\n - Total bilirubin greater than 1,5 times the upper limit of normal (ULN) (unless the patient has documented Gilbert's syndrome)\n - Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) >3 x ULN\n - Serum creatinine >2 mg/dL and/or clearance creatinine <50mL/min (calculated by Cockcroft-Gault method)\n 8. Patients with serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis).\n 9. Patients with a personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.\n 10. Patients assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.\n 11. Pregnant or breastfeeding patients\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nEffect of Tube Feeding on Gastroesophageal Reflux in Preterm Infants\n\n**Clinical Trial Summary:**\n\nDue to several promoting factors, gastro-esophageal reflux (GER) is very frequent in preterm infants. To limit the potentially harmful widespread of pharmacological treatment, a step-wise approach, which firstly undertakes conservative strategies, is currently considered the best choice to manage GER in the preterm population. Among the most common conservative strategies, postural measures seem to effectively reduce GER features in symptomatic preterm babies, whereas feed thickening is almost ineffective.\n Due to their prematurity, preterm infants <34 weeks gestation are often unable to coordinate sucking, swallowing and breathing, thus requiring a feeding tube to ensure adequate enteral intakes. Continuous feeding and boluses are the most common techniques of enteral tube feeding in Neonatal Intensive Care Units; at present, however, the effects of these techniques on GER features have not been clearly established.\n This observational, prospective and explorative study primarily aims to evaluate the effect of different techniques of enteral tube feeding on GER frequency and features in symptomatic preterm infants (gestational age ≤33 weeks) undergoing a diagnostic combined pH and multiple intraluminal impedance (pH-MII) for GER evaluation.\n\n**Clinical Trial Detailed Description:**\n\nDue to several promoting factors related to the physiological immaturity of the gastro-intestinal tract, gastro-esophageal reflux (GER) is a frequent condition among preterm infants.\n GER clinical presentation may vary within a wide range of symptoms, being vomiting, regurgitations and cardiorespiratory events the most common in the preterm population.\n Combined pH and multiple intraluminal impedance (pH-MII) is currently considered the best choice for GER diagnosis in preterm infants. While pH monitoring is limited to the detection of acid reflux, combined pH-MII effectively identifies both acid and non-acid GER, which is predominant in preterm infants. Moreover, it allows to evaluate the height reached by the refluxate within the esophageal lumen and to distinguish retrograde fluid bolus movements (reflux) from the anterograde ones (swallows).\n In the last decade, GER pharmacological treatment has increasingly widespread in Neonatal Intensive Care Units (NICUs). The provision of anti-histamine2 blockers and proton pump inhibitors in the preterm population, however, might lead to such adverse effects as an increased incidence of necrotizing enterocolitis and infections. Hence, to avoid a useless and potentially harmful pharmacological overtreatment, a step-wise approach, firstly promoting conservative strategies, is currently considered the most advisable choice for GER management in symptomatic preterm infants.\n Postural and dietary interventions are the most common conservative strategies and their efficacy in improving GER symptoms and features has been largely investigated.\n As previously assessed by pH-MII, both prone and left-side positions were more effective than the right-side or supine ones to significantly improve both acid and non-acid GER features.\n Feed thickening is widely employed to reduce vomiting and regurgitations in symptomatic term infants; with regard to the preterm population, however, little data is currently available. The efficacy of thickened fortified human milk on preterm infants with GER symptoms has been previously investigated, observing no benefits. Furthermore, standard human milk fortification itself has been shown to increase GER frequency in preterm infants.\n With regard to anti-regurgitation (AR) formulas, the effectiveness of a specific AR formula, thickened with amylopectin and specifically tailored for preterm infants' nutritional needs, has been recently evaluated; the tested thickened formula effectively reduced the number of acid GERs, but no difference was observed in the frequency of non-acid GERs and in the mean esophageal acid exposure, which is known to be the main determinant for the development of gastro-esophageal reflux disease (GERD). Thus, according to these data, feed thickening seem to be almost ineffective in improving GER symptoms and features in preterm infants.\n Due to their prematurity, preterm infants <34 weeks gestation are unable to coordinate sucking, swallowing and breathing; thus, to ensure adequate enteral intakes, they are usually fed via an intragastric tube. Continuous and bolus feeding are the most common techniques of enteral tube feeding in NICU settings.\n The latter is shown to stimulate cyclical surges of gastrointestinal hormones, thus being considered more physiological. It entails the administration of the meal by gravity or through an infusion pump for a total duration of about 10 minutes, after which the feeding tube could be removed. However, the short time elapsing between the tube insertion for bolus administration and its subsequent removal might provoke a vagal response, characterized by bradycardia and temporary reduction of cardiac output. Moreover, the rapid gastric distension following bolus administration could increase the pressure of lower esophageal sphincter (LES), thus contributing to the refluxate of gastric contents into the esophageal lumen.\n On the other hand, continuous feeding allows administering enteral feeds over a longer period (e.g. 2 or 3 hours), at a slower flow rate. It has been associated with better absorption of nutrients and faster gastric emptying, thus it may be preferable in case of delayed gastric motility, gastric residuals and abdominal distension. Moreover, its slow rate of infusion prevents a rapid gastric distension; however, this feeding method requires the permanence of the feeding tube through the LES for the whole feeding period, and this could predispose to the occurrence of gastro-esophageal reflux.\n The effect of bolus and continuous feeding on cardio-respiratory events, which could represent clinical atypical manifestations of GER, has been recently evaluated, observing a slight but significant increase of apneic episodes during continuous feeding.\n A recent systematic review has aimed to evaluate which of these tube-feeding methods could be more suitable in low birth weight infants with GER symptoms; however, current data are scarce and controversial and do not allow to draw any definitive conclusion.\n The aim of this study is to evaluate the effect of different enteral tube feeding modalities, such as bolus and continuous feeding, on pH-MII GER features in tube-fed preterm infants ≤33 weeks gestation, undergoing a diagnostic pH-MII evaluation.\n Overall, thirty preterm infants ≤33 weeks gestation will be enrolled if suffering from moderate/severe GER symptoms and if a diagnostic 24-hour pH-MII monitoring has been scheduled to evaluate GER features, according to our clinical practice.\n During the 24-h pH-MII monitoring, each infant will receive his meals (usually 8) according to the following sequence:\n - 1st meal: optional modality (not considered for statistical analysis);\n - 2nd meal: continuous feeding over 3 hours;\n - 3rd meal: bolus feeding; the feeding tube remains in place for the whole post-prandial period;\n - 4th meal: bolus feeding; the feeding tube is removed after feed administration;\n - 5th: continuous feeding over 3 hours;\n - 6th : bolus feeding; the feeding tube remains in place for the whole post-prandial period;\n - 7th: bolus feeding; the feeding tube is removed after feed administration;\n - 8th: optional modality (not considered for statistical analysis). Healthcare assistants will inspect the correct application of this sequence.\n The pH-MII device in use for this study (Comfortec pH-MII Sandhill Scientific®) is a nasogastric probe with seven rings, composed by six dipolar impedance channels and one antimony electrode responsible for pH detection and placed in the middle of the distal impedance dipole. Due to these characteristics, pH-MII is able to measure the esophageal height reached by refluxate and to identify the direction of esophageal bolus movements, thereby distinguish between a retrograde flow (reflux) and an anti-retrograde flow (swallow).\n The distance between the infant's nose and LES will be determined with Strobel's formula: [baby length (cm) x 0.252 + 5)] - 13%. After placement, the probe's position will be radiographically confirmed.\n Data from the pH-MII recording will be automatically acquired on a portable Sleuth Sandhill Scientific system and then stored in a personal computer containing a specific software (BioVIEW Analysis Sandhill Scientific, version 5.0.9). Data analysis will be performed by the aforementioned software and confirmed by direct visual evaluation.\n Statistical analysis will be performed by SPSS 20 (Statistical Package for the Social Sciences, SPSS Inc., Chicago, IL, USA) for Windows. Differences between the different modalities in terms of GER frequency and features will be tested by Friedman test (level of significance: p <0.05).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Preterm newborns (≤ 33 weeks gestation), able to tolerate at least 100 ml kg-1 day-1 of fortified human milk or standard preterm formula, affected by severe/moderate GER symptoms (recurrent regurgitations, feeding difficulties, failure to thrive and/or post-prandial desaturations), whose usual treatment includes a 24-h pH-MII diagnostic evaluation.\n - Need for tube feeding at the time of pH-MII\n - Weight ≥ 1100 g at the time of enrollment\n - Obtained written parental consent.\n Exclusion Criteria:\n - Newborns with serious chronic pathology.\n - Ongoing pharmacological treatment that could interfere with gastro-enteral motion functions (pro-kinetics) and/or with gastric acidity (H2 antagonists; proton pump inhibitors; sodium alginate).\n - Major congenital malformations (e.g. congenital heart diseases, gastrointestinal abnormalities, malformation syndromes).\n - Neonatal necrotizing enterocolitis.\n - Ongoing infections.\n - Patients with severe clinical conditions that can hinder their participation in this trial (e.g. patent ductus arteriosus, intra-ventricular hemorrhage, hemodynamic instability).\n - Administration of experimental medication treatments during the previous two weeks.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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