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100	[ { "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\nClinical Trial Title:\n\nPanitumumab and Irinotecan as Third-Line Therapy in Treating Patients With Metastatic Colorectal Cancer\n\nClinical Trial Summary:\n\nRATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving panitumumab together with irinotecan may kill more tumor cells.\n PURPOSE: This phase II clinical trial is studying giving panitumumab together with irinotecan to see how well it works as third-line therapy in treating patients with metastatic colorectal cancer.\n\nClinical Trial Detailed Description:\n\nOBJECTIVES:\n Primary\n - To assess the objective response rate when panitumumab is administered in combination with irinotecan hydrochloride as third-line therapy in patients with advanced metastatic colorectal cancer without KRAS mutation (wild type) previously treated with FOLFOX or XELOX chemotherapy with or without bevacizumab and irinotecan hydrochloride alone or FOLFIRI or CAPIRI chemotherapy with or without bevacizumab.\n Secondary\n - To assess the efficacy in terms of disease control rate, duration of response, time to response, progression-free survival, time to progression, time to treatment failure, and duration of stable disease.\n - To assess the efficacy and safety of this regimen, followed by panitumumab alone in patients who discontinue third-line irinotecan hydrochloride due to toxicity.\n Tertiary\n - To correlate this regimen with EGFR expression, detection of the functional genetic polymorphisms of the EGFR gene, EGFR gene amplification (FISH), EGFR activation detection, EGFR downstream protein and gene expression parameters, proteomics, and epigenetics.\n OUTLINE: This is a multicenter study.\n Patients receive panitumumab IV over 30-90 minutes and irinotecan hydrochloride IV over 90 minutes on day 1. Patients who discontinue irinotecan hydrochloride may receive panitumumab monotherapy. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.\n Archived tumor tissue specimens are obtained at baseline for correlative laboratory studies. Tissue samples are analyzed for EGFR amplification status by chromogenic in situ hybridization and fluorescence in situ hybridization, KRAS and KRAF mutations, and STAT3 expression.\n After completion of study therapy, patients are followed at approximately 56 days.\n\nClinical Trial Eligibility Criteria:\n\nDISEASE CHARACTERISTICS:\n - Histologically confirmed colorectal adenocarcinoma\n - Metastatic disease\n - Wild type KRAS (no mutation) by allelic discrimination on tumor DNA\n - Measurable disease (≥ 10 mm) per modified RECIST criteria\n - Previously treated for metastatic disease with oxaliplatin and fluorpyrimidines (i.e., fluorouracil/folinic acid or capecitabine) with or without bevacizumab, and irinotecan hydrochloride alone or in combination with fluorpyrimidines (i.e., fluorouracil/folinic acid or capecitabine) with or without bevacizumab\n - Must have paraffin-embedded tissue or unstained tumor slides from primary or metastatic tumor available for correlative studies\n - Must be registered with a national health care system (CMU included)\n - No CNS metastases unless previously treated or asymptomatic, provided patient has been off steroids for at least 30 days prior to study treatment\n PATIENT CHARACTERISTICS:\n - WHO performance status of 0-2\n - ANC ≥ 1,500/mm³\n - Platelet count ≥ 100,000/mm³\n - Hemoglobin ≥ 9 g/dL\n - Creatinine < 150 μmol/L or creatinine clearance > 30 mL/min\n - AST ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)\n - ALT ≤ 3 times ULN (5 times ULN if liver metastases present)\n - Bilirubin ≤ 1.5 times ULN\n - Magnesium normal\n - No significant cardiovascular disease, including unstable angina or myocardial infarction within the past 6 months\n - No history of treated or untreated ventricular arrhythmia\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective double barrier contraception during and for 6 months after completion of study treatment\n - No other malignant tumors within the past five years except basocellular carcinoma, in situ cancer of the cervix or uterus, or any UDAW cancers for which there has been complete resection for at least three years\n - No known hypersensitivity to an excipient (vehicle) of panitumumab or known hypersensitivity of irinotecan trihydrate chlorhydrate or known hypersensitivity excipient (vehicle) of irinotecan hydrochloride\n - No history of interstitial pneumonitis, pulmonary fibrosis or evidence of interstitial pneumonitis, or pulmonary fibrosis on baseline chest CT scan\n - No active inflammatory bowel disease, other bowel disease causing chronic diarrhea (defined as > 4 loose stools per day), or bowel occlusion\n - No history of Gilbert syndrome\n - No history of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results\n - No known positive test for HIV infection, hepatitis C virus, chronic active hepatitis B infection\n - No comorbid disease that would increase risk of toxicity\n - No disorder that would compromise the patient's ability to give written informed consent and/or comply with study procedures\n - Must be willing and able to comply with study requirements\n - No grade IV toxicity associated with a past treatment with irinotecan hydrochloride\n PRIOR CONCURRENT THERAPY:\n - See Disease Characteristics\n - At least 14 days since prior treatment for systemic infection\n - No prior or concurrent anti-EGFR antibody therapy (e.g., cetuximab) or treatment with small molecule EGFR tyrosine kinase inhibitors (e.g., erlotinib hydrochloride)\n - Patients who discontinued their first dose of anti-EGFR therapy (i.e., cetuximab) because of an infusion reaction are eligible\n - More than 30 days since prior and no other concurrent investigational agent (no delay for non-investigational treatment)\n - More than 14 days since prior CYP3A4 enzyme, including anticonvulsant medication (e.g., phenytoin, phenobarbital, or carbamazepine)\n - More than 14 days since prior rifampicin\n - More than 14 days since prior radiotherapy and recovered\n - More than 7 days since prior and no concurrent ketoconazole\n - More than 28 days since prior and no concurrent major surgical procedure\n - Concurrent topical, oral, or IV antibiotics used to treat skin- or nail-related toxicities are allowed at the investigator's discretion\n - No other concurrent experimental or approved anti-tumor therapies (e.g., bevacizumab), chemotherapy other than irinotecan hydrochloride, non-palliative radiotherapy, or systemic steroids (except when used for symptomatic skin- or nail-related toxicities requiring withholding of the panitumumab dose, as chemotherapy premedication, or for an infusion reaction)\n - No concurrent millepertuis (i.e., Hypericum perforatum)\n - No concurrent phenobarbital, clarithromycin, erythromycin, HIV protease inhibitors, cyclosporine or tacrolimus, or nefazodone\n - Concurrent minor surgery, procedures, or surgery arising as needed or necessary allowed\n - Concurrent elective surgery allowed in patients eligible for surgical resection of metastases as curative therapy\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
101	[ { "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\nClinical Trial Title:\n\nAZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma\n\nClinical Trial Summary:\n\nThis phase II trial is studying how well AZD0530 works in treating patients with recurrent locally advanced, or metastatic soft tissue sarcoma. AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.\n\nClinical Trial Detailed Description:\n\nOBJECTIVES:\n I. To assess the efficacy of AZD0530, in terms of disease control rate (i.e., response rate and stable disease rate), in patients with recurrent locally advanced or metastatic soft tissue sarcoma.\n II. To assess the toxicity, time to progression, and response duration of AZD0530 in these patients.\n OUTLINE: This is a multicenter study.\n Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.\n After completion of study therapy, patients are followed every 8 weeks.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Leukocytes >= 3,000/mcL\n - Histologically or cytologically confirmed soft tissue sarcoma including, but not limited to any of:\n - Malignant fibrous histiocytoma\n - Fibrosarcoma - non infantile\n - Leiomyosarcoma - not uterine\n - Liposarcoma\n - Non-rhabdomyosarcoma soft tissue sarcoma\n - Rhabdomyosarcoma, not otherwise specified\n - Carcinosarcoma of the uterus\n - Dermatofibrosarcoma\n - Endometrial stromal sarcoma\n - Leiomyosarcoma - uterus\n - Recurrent or locally advanced or metastatic disease\n - No more than two prior lines of chemotherapy for metastatic disease (not including adjuvant chemotherapy)\n - Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan\n - Target measurable lesion must not have been in previous radiation portal, unless progression of this lesion after radiotherapy has been documented\n - ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%\n - Life expectancy > 12 weeks\n - Recovered from all prior therapy\n - Platelet count >= 100,000/mcL\n - Hemoglobin > 9 g/dL\n - Total bilirubin =< 1.25 times upper limit of normal (ULN)\n - AST and ALT =< 3 times ULN\n - Creatinine =< 1.5 times ULN OR creatinine clearance >= 50 mL/min\n - Urine protein:creatinine ratio =< 1.0 OR 24-hour urine protein < 1,000 mg\n - ANC >1,500/mcL\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective contraception during and for 8 weeks after completion of study therapy\n - No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530\n - No QTc prolongation (defined as a QTc interval >= to 460 msecs) or other significant ECG abnormalities\n - No poorly controlled hypertension (i.e., systolic blood pressure (BP) >= 140 mm Hg, or diastolic BP >= 90 mm Hg)\n - No condition that impairs a patient's ability to swallow AZD0530 tablets, including any of the following:\n - Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation\n - Prior surgical procedures affecting absorption\n - Active peptic ulcer disease\n Exclusion Criteria:\n - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)\n - No intercurrent cardiac dysfunction including, but not limited to, any of the following:\n - Symptomatic congestive heart failure\n - Unstable angina pectoris\n - Cardiac arrhythmia\n - No history of ischemic heart disease, including myocardial infarction\n - No uncontrolled intercurrent illness including, but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements\n - More than 4 weeks since prior radiotherapy\n - More than 7 days since prior and no concurrent prohibited CYP3A4-active agents or substances\n - No other concurrent investigational agents or commercial agents or therapies\n - No concurrent combination antiretroviral therapy for HIV-positive patients\n - No known brain metastases\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
102	[ { "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\nClinical Trial Title:\n\nLocal Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US\n\nClinical Trial Summary:\n\nThe purpose of this research study is to compare the safety and effectiveness (how well the medicine works) of esomeprazole (study drug) to placebo (a capsule that does not contain any medication) taken daily in relieving nighttime heartburn and problems sleeping in patients with gastroesophageal reflux disease (GERD).\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Prior to the run-in period, a history of heartburn or acid regurgitation for 3 months or longer or any history of EE;\n - Prior to the run-in period, nighttime heartburn averaging at least 2 or 3 times per week;\n - Prior to the run-in period, a history of sleep disturbances associated with GERD for 1 month or more;\n Exclusion Criteria:\n - Any condition other than GERD that is either the primary cause of, or a significant contributor to, the patient's sleep disturbance\n - Sleep medication (including over-the-counter), antihistamine, benzodiazepine, or anti-anxiety medication use that has not been stable (either in dose or regularity) for at least 3 months or is not expected to remain stable during the patient's participation in the study. Patients on a stable regimen, whose regimen is also expected to remain stable throughout the study, are eligible for participation;\n - Proton Pump Inhibitor (PPI) use within 1 week prior to Screening. The only allowable acid modifying rescue medication is GELUSIL® during the run-in period. Only study medication and rescue medication (GELUSIL®) is allowed during the treatment period for treatment of acid mediated symptoms\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
103	[ { "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\nClinical Trial Title:\n\nEffect of Pantoprazole 40mg Daily vs Placebo on Power Spectral Analysis of the Sleep EEG of Patients With GERD.\n\nClinical Trial Summary:\n\nThe purpose of this research study is to determine if treatment with pantoprazole 40 mg daily versus a placebo improves sleep quality in patients with gastroesophageal reflux disease (GERD). Another purpose is to determine if treatment with pantoprazole 40 mg once daily versus a placebo improves sleep outcomes in patients with gastroesophageal reflux disease using spectral analysis of sleep electroencephalogram (EEG).\n\nClinical Trial Detailed Description:\n\nIt appears that the presence of intraesophageal stimuli alone may not be sufficient to elicit symptoms of heartburn. Most acid reflux events (>80%-90%) do not reach conscious level and thus are not perceived.[3] It is yet to be determined what factors enhance our perception of esophageal stimuli and may help to elevate them to the conscious level. In recent years, central and peripheral factors that may enhance our perception of intraesophageal stimuli have been evaluated. Intraduodenal fat infusion was shown to enhance perception of intraesophageal acid in patients with GERD.[4] This study suggested that fat is an important modulator of postprandial GERD symptoms. Central factors, such as stress and psychological comorbidity, also appear to have an important role in symptom generation in patients with GERD, regardless if esophageal inflammation is present or absent.[5-8] Thus, by modulating brain-gut interactions, perception of pathological and probably physiological events in the esophagus of patients with GERD may be altered.\n Poor sleep is a central factor that may enhance perception of intraesophageal stimuli and thus elevate them to the conscious level. Several studies have demonstrated that patients with fibromyalgia or irritable bowel syndrome report increased symptoms due to sleep abnormalities.[9, 10] Similar reports in patients with GERD are not available. A subset of patients with GERD experience nocturnal heartburn that may awaken them during the night. In others, despite lack of nocturnal symptoms, sleep abnormalities may occur due to acid reflux events. In both cases, GERD leads to poor sleep, and that in turn may enhance perception of intraesophageal stimuli, leading to reports of increased frequency and severity of perceived GERD symptoms. Thus, poor sleep may be a crucial factor in symptom generation and exacerbation of patients with GERD.\n Recently, we have used a novel technique, power spectral analysis of the sleep electroencephalogram (EEG), to assess patients with heartburn and erosive esophagitis and those with heartburn but without erosive esophagitis.[11] We were able to show that among heartburn patients with GERD, EEG spectral power during sleep is shifted towards higher frequencies as compared to heartburn patients without GERD despite similar sleep architecture.\n Several recent therapeutic trials in GERD patients have failed to demonstrate improvement in polysomnographic studies despite improvement in GERD-related symptoms and subjective reports of sleep quality.[12] Spectral analysis of the sleep EEG might be a more sensitive tool than polysomnographic study in assessing objective improvement of sleep in patients receiving antireflux treatment.\n In summary, sleep disturbances in patients with GERD are poorly recognized and rarely elicited during clinic visits despite their significant impact on patients' quality of life and probably perception of disease severity. Several studies have demonstrated improvement of subjective reports of sleep quality in patients with GERD receiving antireflux treatment. However, the effect of potent antireflux therapy on objective sleep parameters has yet to be demonstrated.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - 18 to 80 yrs of age\n - 2 to 3 episodes of GERD/week\n - erosive esophagitis or abnormal 24 hr pH\n - able to read and understand, complete questionnaires\n Exclusion Criteria:\n - barrett's esophagus or peptic stricture on endoscopy\n - normal EGD and normal 24 hour pH\n - previous upper GI surgery\n - comorbidity (cardiovascular, respiratory, renal, hepatic)\n - use of narcotics or pain medication on regular basis\n - insomnia, shift work sleep disorder, sleep apnea, restless leg syndrome\n - diabetes, scleroderma or neuromuscular disorders\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
104	[ { "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\nClinical Trial Title:\n\nA Comparative Study of Proton-pump Inhibitor Tests for Chinese Reflux Patients in Relation to the CYP2C19 Genotypes\n\nClinical Trial Summary:\n\nBackgrounds & Aims: Proton-pump inhibitor (PPI) test has been proposed as a valuable tool in the diagnosis of gastroesophageal reflux disease (GERD) in Western populations. We assumed that a higher prevalence of poor metabolizers in Chinese population might affect the diagnostic accuracy of a PPI test.\n Methods: In this open-label, randomized trial, patients with symptoms suggestive of GERD were randomly assigned to receive a 2-week test with daily rabeprazole 40-mg or daily pantoprazole 80-mg after diagnostic endoscopy. Therapeutic response was assessed with a five-grade daily record. Genotypes of cytochrome P450 (CYP) 2C19 polymorphism were determined.\n\nClinical Trial Detailed Description:\n\nAs described above\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Consecutive patients with symptoms suggesting GERD will be enrolled from gastroenterology outpatient clinics in our academic institute. The typical GERD symptom was defined as heartburn and/or regurgitation at least 3 episodes per week in recent 3 months.\n Exclusion Criteria:\n - Those who were under maintenance PPI treatment, have a medical contraindication to PPI therapy, report a history of peptic ulcer disease or gastrointestinal surgery, malignancy proven by endoscopy, or unwilling or unable to provide informed consent.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
105	[ { "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\nClinical Trial Title:\n\nStudy of TS-1 or TS-1 + PSK for Gastric Cancer Patients\n\nClinical Trial Summary:\n\nSince it is not uncertain about efficacy of combination therapy with PSK and TS-1 in gastric cancer, in this study, we compare efficacy and safety of postoperative adjuvant therapy using TS-1 or TS-1+PSK in the stage II or III gastric cancer patients.\n\nClinical Trial Detailed Description:\n\nTS-1 is an oral anticancer drug approved in Japan consisting of tegafur (a pro-drug of fluorouracil, 5-FU), gimeracil and oteracil potassium. The response rate of TS-1 in the untreated advanced gastric cancer patients was 44.6% in the late phase II study. In 2007, efficacy of the adjuvant therapy using TS-1 in the resected gastric cancer patients was demonstrated by ACTS-GC study group conducted in Japan. PSK is an oral anticancer drug approved in Japan consisting of protein-bound polysaccharide extracted from mycelium of Trametes (Coriolus) versicolor, a kind of mushroom. Even though survival benefit by PSK in combination with adjuvant chemotherapy using 5-FU or tegafur in the postoperative gastric cancer patients was already demonstrated, it is not uncertain about efficacy of combination therapy with PSK and TS-1 in gastric cancer. In this study, we compare efficacy and safety of postoperative adjuvant therapy using TS-1 or TS-1+PSK in the stage II or III gastric cancer patients.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Patient who is pathologically confirmed as gastric cancer\n - Patient who has received surgery with D2 or more lymph node dissection and whose final curability of surgical resection is grade A or B\n - Patient whose final stage is II (except for T1), IIIA, or IIIB\n - Patient without liver, peritoneal and distant metastasis, and who is negative in peritoneal cytological diagnosis\n - Patient whose age at the registration is ranging between 20 and 80 years old\n - Patient who has not received any preoperative therapy including radiotherapy, chemotherapy and immunotherapy\n - Patient who has received surgery for gastric cancer within six weeks before the registration, and is judged to be capable of oral administration\n - Patient who has no serious concurrent complications, and satisfies the following criteria\n - White blood cell count: > LLN or > 4,000 /mm3\n - Platelet count: > 100,000 /mm3\n - Serum total bilirubin: < 1.5 mg/dL\n - Serum AST (GOT), ALT (GPT): < 2.5 * ULN\n - Serum creatinine: < ULN\n - Patient who has received an explanation of this study by assent documents, and has given written informed consent to participate in this study\n Exclusion Criteria:\n - Patient with metachronous or synchronous multicancer\n - Patient who contraindicates to TS-1\n - Patient who requires continuous use of flucytosine, phenytoin or warfarin potassium\n - Patient who has experienced serious drug allergy over grade 3 in the past\n - Patient with serious complications including paralysis of intestine, ileus, interstitial pneumonitis, fibroid lung, uncontrollable diabetes mellitus, heart insufficiency, renal insufficiency or hepatic insufficiency\n - Patient with diarrhea (watery stool)\n - Patient who is pregnant or in lactation, or wish to become pregnant during this study\n - Male patient who intends to make someone pregnant during this study\n - Patient with HIV positive\n - Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
106	[ { "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\nClinical Trial Title:\n\nGastroesophageal Reflux Disease (GERD) Segmentation: Document How Swiss General Practitioners (GPs) Allocate Their GERD Patients to the Three GERD Patient Segments\n\nClinical Trial Summary:\n\nDocument how Swiss GPs allocate their GERD patients to the three GERD patient segments (according to King et al.) and how treated GERD patients are affected by their GERD treatment\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Previously diagnosed GERD patients\n - on treatment for at least 2 weeks\n Exclusion Criteria:\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
107	[ { "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\nClinical Trial Title:\n\nNational Survey on Gastroesophageal Reflux Disease (GERD) Patients\n\nClinical Trial Summary:\n\nThe purpose of this observational study is to assess the impact of abdominal fat on severity and frequency of GERD symptoms .\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Male or female > or = 18 years old\n - Patient with symptomatic GERD\n - Without PPI or H2 antagonist treatment during the 3 previous months\n - Agree to take part in this study\n Exclusion Criteria:\n - Pregnant women\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
108	[ { "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\nClinical Trial Title:\n\nWaist Circumference Versus Body Mass Index to Predict Severity of Gastroesophageal Reflux Disease\n\nClinical Trial Summary:\n\nGastroesophageal reflux disease (GERD) is a common and important disorder. Previous studies have demonstrated the association of obesity with GERD, and now obesity is regarded as a risk factor for GERD. Moreover, body mass index (BMI), an indicator of general obesity, correlates with severity of symptoms and degree of erosive esophagitis. Waist circumference, an indicator of abdominal obesity, has stronger correlation with intra-abdominal pressure and low-grade inflammatory state when compared with BMI. Nevertheless the association of waist circumference with severity of GERD has not been studied.\n The primary aim of this study is to compare BMI with waist circumference for their independent association with severity of GERD. The secondary aim is to evaluate independent risk factors of severity of GERD.\n\nClinical Trial Detailed Description:\n\nThis is a cross-section observational study. Outpatients presenting with acid reflux or heart burn are interviewed with standardized questionnaire to quantify severity of symptoms. The eligible patients undergo upper endoscopy to diagnose erosive esophagitis and further classify the degree of erosions according to Los-Angels classification. Enrolled patients receive anthropometric measurements to record body weight, body height and waist circumference on the day of enrollment.\n Two outcomes are studied: the severity of GERD symptoms and the Los-Angels Classification of erosive esophagitis.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - age more than 20 years old and less than 70 years old\n - typical gastroesophageal reflux symptoms (heart burn and acid reflux)\n - outpatient\n - complete upper gastrointestinal endoscopy\n Exclusion Criteria:\n - age less than 20 years or more than 70 years old\n - receive medication for reflux disease (including proton pump inhibitor, histamine type 2 receptor blocker, prokinetic agents) in previous one month\n - pregnant women\n - history of abdominal surgery\n - severe comorbidity with cirrhosis, end-stage renal disease, heart failure\n - no written informed consent\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
109	[ { "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\nClinical Trial Title:\n\nA New Method for Determining Gastric Acid Output Using a Wireless Capsule\n\nClinical Trial Summary:\n\nBackground:\n - Acid-related gastrointestinal disorders are numerous and may require chronic treatment and maintenance, but they are often difficult to diagnose and treat. Gastric analysis is a critical tool for diagnosing and treating acid-related disorders; however, at present it requires a technically difficult procedure, using a nasogastric tube, that is costly, invasive, and uncomfortable. Recently a new tool, the SmartPill, has been developed that can measure acid levels, temperature, and pressure throughout the stomach, small intestine, and colon by swallowing a small capsule. Researchers are interested in comparing current methods of measuring stomach acid with the SmartPill by studying both healthy volunteers and individuals with acid-related gastrointestinal disorders.\n Objectives:\n - To evaluate the usefulness and accuracy of the SmartPill for gastric analysis, compared with current procedures.\n Eligibility:\n - Phase 1A/1B: Healthy volunteers between 18 and 60 years of age.\n - Phase 2: Individuals at least 18 years of age who have been diagnosed with Zollinger-Ellison Syndrome or acid hypersecretion.\n - Phase 3: Individuals at least 18 years of age who have been diagnosed with refractory gastroesophageal reflux disease, peptic ulcer disease, or idiopathic gastric hypersecretion.\n Design:\n - This study involves a screening visit, a 3-day inpatient study visit, and possible additional outpatient visits.\n - Participants will be screened with a medical history and physical examination, as well as blood and urine samples.\n - Phase 1A/1B: Participants will have a 3-day inpatient study visit with the following procedures:\n - Imaging study of the stomach (simultaneous gastric emptying scintigraphy), followed by a special diet for the next day s test.\n - Gastric analysis using a nasogastric tube to collect stomach acid secretions.\n - SmartPill study, in which participants will ingest a SmartPill and wear a monitor for 24 to 48 hours to collect readings.\n - Participants in Phase 1A will have a second outpatient SmartPill study 7 days after the first SmartPill study. Participants in Phase 1B will not have the second SmartPill study.\n - Phase 2 and Phase 3: Participants will have a 3-day inpatient study visit with the following procedures:\n - Imaging study of the stomach (simultaneous gastric emptying scintigraphy), followed by a special diet for the next day s test.\n - Gastric analysis using a nasogastric tube to collect stomach acid secretions.\n - SmartPill study, in which participants will ingest a SmartPill and wear a monitor for 24 to 48 hours to collect readings.\n - Phase 2 and 3 participants will have outpatient study visits only if directed by the study researchers.\n\nClinical Trial Detailed Description:\n\nAcid related disorders are numerous and often require chronic treatment and maintenance. Many of these diseases are without symptoms and therefore difficult to diagnose and treat. Gastric analysis is the quantitative measurement of gastric acid output and is a critical tool for the diagnosis of acid related disorders and the ongoing assessment of therapy response. At present gastric analysis requires a technically difficult procedure, using gastric aspiration through a nasogastric tube, that is costly, invasive, and uncomfortable for patients. Recently there is introduction of the SmartPill, which is a disposable pill that measures pH, temperature, and pressure throughout the GI tract. We propose a pilot study to validate a new method of gastric analysis with the ingestion of the SmartPill with a meal of a known buffering capacity to measure both the acidity and quantity of acid output in the stomach. We will validate this method by comparing it to the accepted gastric aspiration method under maximally stimulated conditions. We will study healthy volunteers for the validation phase and then study patients with known acid related disorders to assess its usefulness in patients. Interested subjects will report to the NIH outpatient gastrointestinal clinic for evaluation to be followed by a 3 day in-patient admission and 2 subsequent clinic visits. Subjects will have gastric analysis of basal, meal stimulated, and pharmacologically stimulated rates with both the conventional and study methods. Outcomes will include a quantitative measurement of gastric acid output in unit time, normal meal stimulated acid output values in healthy volunteers and patients with acid related disorders, and the assessment of acid suppression in patients treated with a variety of anti-secretory medications.\n\nClinical Trial Eligibility Criteria:\n\n- CURRENTLY ONLY RECRUITING Patients with Zollinger Ellison Syndrome and Hypersecretion AND Patients with Refractory GERD, Peptic ulcer disease, Idiopathic Gastric Hypersecretion\n Phase II, Use in Patients with Zollinger Ellison Syndrome and Hypersecretion\n INCLUSION:\n - Zollinger-Ellison syndrome (ZES) as diagnosed by one of the following criteria: histologic confirmation of gastrinoma, positive provocative testing with secretin (an increase of >200 pg/mL postinjection), gastric acid hypersecretion (BAO > 15) in the presence of hypergastrinemia (fasting serum gastrin > 99)\n - Multiple endocrine neoplasia type-I (MEN1) with suspicion of ZES (hypergastrinemia) undergoing evaluation. MEN-I with ZES\n - Hypergastrinemia (serum gastrin > 99)\n Patients must meet at least 1 of the above inclusion criteria and the following:\n - Ages equal to or greater than 18 years\n - Male, females, all ethnicities\n EXCLUSION:\n - History of gastric surgery (gastrectomy, pyloroplasty)\n - Use of bowel motility medications such as, but not limited to, Reglan, Immodium, and Lomotil\n - Contraindication to SmartPill: history of gastric bezoar, disorders of swallowing, suspected strictures, fistulas, or physiological GI obstruction, GI surgery within the past three months, severe dysphagia to food or pills, Crohn s Disease or diverticulitis, a subject who uses an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump\n - Pregnancy and breastfeeding. Females of childbearing potential must be on an acceptable means of birth control and no intercourse in 2 weeks prior to study enrollment.\n - Lactose intolerance or inability to drink standard meal of Ensure Plus\n - Estabished diagnosis of gastroparesis\n - Significant systemic or major illnesses including, but not limited to, stroke, congestive heart failure, renal failure (creatinine clearance < 50 ml/min), organ transplantation, angina pectoris, active malignancy, and autonomic neuropathy\n - Unstable psychiatric conditions, untreated or uncontrolled depression or generalized anxiety disorder, substance abuse within the past year, in order to prevent feeling of being uncomfortable or to prevent lack of follow-up\n - Use of not-steroidal anti-inflammatory drugs for 2 weeks prior to study enrollment\n Phase IIIA, Use in Patients with Refractory GERD, Peptic ulcer disease, Idiopathic Gastric Hypersecretion\n INCLUSION:\n - Gastric acid hypersecretion (BAO>15 mEq/hr)\n - Conditions with gastric acid hypersecretion including, but not limited to, patients with systemic mastocytosis (SM)\n - Refractory GERD (patients with persistant symptoms despite being on standard medical therapy), PUD, and suspected idiopathic gastric hypersecretion\n Patients must meet at least 1 of the above inclusion criteria and the following:\n - Ages equal to or greater than 18 years\n - Male, females, all ethnicities\n EXCLUSION:\n - History of gastric surgery (gastrectomy, pyloroplasty).\n - Use of bowel motility medications such as, but not limited to, Reglan, Immodium, and Lomotil\n - Contraindication to SmartPill: history of gastric bezoar, disorders of swallowing, suspected strictures, fistulas, or physiological GI obstruction, GI surgery within the past three months, severe dysphagia to food or pills, Crohn s Disease or diverticulitis, a subject who uses an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump\n - Pregnancy and breastfeeding. Females of childbearing potential must be on an acceptable means of birth control and no intercourse in 2 weeks prior to study enrollment.\n - Lactose intolerance or inability to drink standard meal of Ensure Plus\n - Established diagnosis of gastroparesis\n - Significant systemic or major illnesses including, but not limited to, stroke, congestive heart failure, renal failure (creatinine clearance < 50 ml/min), organ transplantation, angina pectoris, active malignancy, and autonomic neuropathy\n - Unstable psychiatric conditions, untreated or uncontrolled depression or generalized anxiety disorders, substance abuse within the past year, in order to prevent feeling of being uncomfortable or to prevent lack of follow-up. Use of non-steroidal anti-inflammatory drugs for 2 weeks prior to study enrollment.\n Phase IIIB, Use in Patients with Medication-Controlled: GERD, Peptic ulcer disease, Idiopathic Gastric Hypersecretion\n INCLUSION:\n -Medication-controlled (patients whose symptoms resolve with medication):GERD, PUD, and suspected idiopathic gastric hypersecretion\n Patients must meet the above inclusion criteria and the following\n - Ages equal to or greater than 18 years\n - Male, females, all ethnicities\n EXCLUSION:\n - Refractory to medication: GERD (patients with persistant symptoms despite being on standard medical therapy), PUD, and suspected idiopathic gastric hypersecretion\n - History of gastric surgery (gastrectomy, pyloroplasty).\n - Use of bowel motility medications such as, but not limited to, Reglan, Immodium, and Lomotil\n - Contraindication to SmartPill: history of gastric bezoar, disorders of swallowing, suspected strictures, fistulas, or physiological GI obstruction, GI surgery within the past three months, severe dysphagia to food or pills, Crohn s Disease or diverticulitis, a subject who uses an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump\n - Pregnancy and breastfeeding. Females of childbearing potential must be on an acceptable means of birth control and no intercourse in 2 weeks prior to study enrollment.\n - Lactose intolerance or inability to drink standard meal of Ensure Plus\n - Established diagnosis of gastroparesis\n - Significant systemic or major illnesses including, but not limited to, stroke, congestive heart failure, renal failure (creatinine clearance < 50 ml/min), organ transplantation, angina pectoris, active malignancy, and autonomic neuropathy\n - Unstable psychiatric conditions, untreated or uncontrolled depression or genralized anxiety disorders, substance abuse within the past year, in order to prevent feeling of being uncomfortable or to prevent lack of follow-up\n - Use of non-steroidal anti-inflammatory drugs for 2 weeks prior to study enrollment\n RECRUITMENT IS CLOSED FOR Phase IA/IB, Validation and Establishment of Nomogram in Healthy Volunteers\n PHASE IA/IB INCLUSION:\n - Healthy volunteers\n - Ages 18-60\n - Males, females, all ethnicities\n PHASE IA/IB EXCLUSION:\n - History of gastric or bowel surgery\n - Use of bowel motility medications such as, but not limited to, Reglan, Immodium, and Lomotil\n - Use of antacid, antisecretory, and anticholinergic medications such as, but not limited to, proton pump inhibitors and histamine 2 receptor antagonists\n - Use of non-steroidal anti-inflammatory drugs for 2 weeks prior to study enrollment\n - Hypersecretory and hyposecretory related conditions including, but not limited to, pernicious anemia, atrophic gastritis, and Zollinger-Ellison syndrome\n - Contraindication to NGT: deviated septum, history of transphenoidal surgery, chronic sinusitis, severe facial trauma (cribriform plate disruption, sustained head trauma, maxillofacial injury, or anterior fossa skull fracture), esophageal stricture, esophageal varices, altered mental status, and impaired airway\n - Contraindication to scintigraphy: allergy to sulfa-colloid\n - Contraindication to pentagastrin: allergy to pentagastrin, active gastrointestinal bleeding, active peptic ulcer disease, active gallbladder and liver disease, pancreatitis, and bowel obstruction\n - Contraindication to SmartPill: history of gastric bezoar, disorders of swallowing, suspected strictures, fistulas, or physiological GI obstruction, GI surgery within the past three months, severe dysphagia to food or pills, Crohns disease or diverticulosis, and implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump\n - Pregnancy and breastfeeding. Females of childbearing potential must be on an acceptable means of birth control and no intercourse in 2 weeks prior to study enrollment.\n - Lactose intolerance or inability to drink standard meal of Ensure Plus\n - Helicobacter pylori infection\n - Gastroparesis\n - History of gastroesophageal reflux disease, peptic ulcer disease, irritable bowel syndrome, or inflammatory bowel disease\n - Significant systemic or major illnesses including, but not limited to, stroke, cardiovascular disease, hypertension, congestive heart failure, renal failure (creatinine clearance < 50 ml/min), organ transplantation, angina pectoris, active malignancy, diabetes, or autonomic neuropathy\n - Unstable psychiatric conditions, depression, generalized anxiety disorder, or substance abuse within the past year, in order to prevent feeling of being uncomfortable or to prevent lack of follow-up\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
110	[ { "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\nClinical Trial Title:\n\nSafety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)\n\nClinical Trial Summary:\n\nThe study is designed to test the safety and efficacy of the Medigus SRS endoscopic stapling system for the treatment of GERD.\n The system allows the operator to staple the stomach to the esophagus,in order to restore the gastroesophageal flap valve. The effect of the stapling is similar to a common operation for GERD (partial fundoplication) but is done through the mouth, and incision into the abdomen is not needed.\n The hypothesis of the study is that the treatment will be effective in improving GERD related quality of life by 50% or more in the majority of the subjects, and that the procedure will be as safe as surgery.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - History of GERD related symptoms for at least 2 years.\n - Recent objective evidence of GERD, demonstrated by a 24h pH acid exposure test.\n - History of daily intake of proton pump inhibitors (PPIs) for at least 6 months, with significant relief of symptoms (i.e., difference in GERD Health Related Quality of Life (GERD HRQL) scores on and off PPI > =6).\n - GERD-HRQL ≥20 off of PPI's\n Exclusion Criteria:\n - Hiatal hernia > 3 cm or a paraesophageal hernia\n - Barrett's esophagus or grade IV esophagitis\n - Esophageal stricture, ring or web causing symptoms of dysphagia\n - Grade I Flap valve according Hill's classification\n - History of co-morbidity\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
111	[ { "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\nClinical Trial Title:\n\nIntravenous (IV) Pantoprazole for Gastroesophageal Reflux Disease (GERD) in Neonates and Infants\n\nClinical Trial Summary:\n\nThe purpose of this study is to determine how the body uses and eliminates pantoprazole, a drug used to treat GERD. This is a pharmacokinetic (PK) study. PK is a measure of how much drug is in the blood and how long it takes to leave the body. It is hypothesized that younger infants will need a lower dose than older children to achieve the same PK measurement.\n The results of this study will be used to determine the best dose of the drug to use in each age group. Pantoprazole is a drug used to decrease acid production. The use of pantoprazole has not been approved for use in children. Pantoprazole is approved for use of acid-related and stomach disorders in adults.\n\nClinical Trial Detailed Description:\n\nGastroesophageal reflux, regurgitation of gastric contents into the esophagus, and gastroesophageal reflux disease, displaying symptoms and complications from regurgitation, are both very common in infants. Daily reflux is present in up to 50% of infants younger than 3 months and in more than 66% at 4 months of age. GERD is primarily attributed to lower esophageal sphincter relaxation. Between 5-9% of infants less than one year of age have GERD and require acid suppression. Complications associated with GERD include failure to thrive, apnea, wheezing, recurrent aspiration, poor feeding, refusal to feed, irritability, and in more severe cases, acute life-threatening events.\n Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production through binding to the H+-K+-ATPase enzyme system at the surface of parietal cells in gastric epithelium. This causes a reduction in acid production regardless of the stimulus presented. Pantoprazole is used as therapy in GERD, erosive esophagitis, gastritis, gastric ulcerations, duodenal ulcerations and prophylaxis of stress gastritis in hospitalized patients. Pantoprazole is metabolized mainly by hepatic cytochrome P-450 CYP2C19 and is hypothesized to be metabolized at a higher rate in children as compared to adults. However, the metabolism of proton pump inhibitors is slower in infants < 10 weeks of age. Clinical studies are ongoing for the use of oral pantoprazole in infants and children.\n Acid suppression is frequently required in hospitalized infants to treat GERD. In children who are critically ill, oral administration of acid suppressive agents is relatively contraindicated therefore an intravenous alternative such as intravenous pantoprazole is imperative. Intravenous pantoprazole has been well tolerated in pharmacokinetic studies in children ages 1 to 16 years. No systematic studies have been done to determine the pharmacokinetics of intravenous pantoprazole in infants less than 1 year of age therefore this study will meet an identified unmet need and address a knowledge deficit in this population. The aim of this study is to determine the pharmacokinetics of pantoprazole sodium for injection and evaluate the safety and tolerability of single and multiple intravenous doses in preterm neonates and infants 0-11 months of age using population pharmacokinetics. In addition, the genotyping for CYP2C19 and CYP3A4 polymorphisms will be performed.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n 1. Signed informed consent and HIPAA documents by parent/legal guardian.\n 2. Hospitalized premature neonates (Post menstrual age (PMA) 28 - < 34 weeks), neonates (PMA 34 to 44 weeks), and infants (PMA > 44 weeks to 11 months).\n 3. Clinical indication for acid suppression or a presumptive diagnosis of GERD based on clinical symptoms and/or objective tests diagnostic of GERD.\n 4. Body weight of at least 750 grams (based on blood volume required for study participation).\n Exclusion Criteria:\n 1. Previous adverse reaction to proton pump inhibitor\n 2. History of gastrointestinal anomalies, eosinophilic esophagitis, unrepaired tracheal esophageal fistula or liver disease\n 3. Unstable cardiovascular, renal, hepatic, hematologic or endocrine disease\n 4. History of acute life-threatening events due to GERD\n 5. History of hepatitis B or hepatitis C\n 6. Use of PPI's within 24 hours before study drug is administered\n 7. Known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome\n 8. Clinically significant laboratory values:\n - Aspartate aminotransferase (AST) or alanine aminotransferase (AST) >2 times the upper limit of normal (ULN) for age\n - Total bilirubin > 2 times ULN for age\n - Alkaline phosphatase > 2 times ULN for age\n 10.Use of histamine-2 receptor blockers (eg. Cimetidine, famotidine, ranitidine, or nizatidine) sucralfate, misoprostol, or prokinetic agents (eg. urecholine, erythromycin, or metoclopramide) and antacids or bismuth preparations within 24 hours before test article administration.\n 11.Any disorder requiring chronic use of warfarin, oxcarbazepine, topiramate, carbamezapine, rifampin or phenytoin.\n 12.Currently participating in another investigational drug trial or have participated in a study within the last 30 days.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
112	[ { "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\nClinical Trial Title:\n\nPrevalence of EED and Quality of Life Evaluated by Gastroesophageal Reflux Disease (GERD)-Q in Korean GERD Patients\n\nClinical Trial Summary:\n\nThe purpose of this study is to asses the EED symptom prevalence in Koran GERD patients with typical reflux symptom and to evaluate quality of life with the scales including Gerd Q.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - GERD patients who have experienced heartburn or acid regurgitation during past 7 days\n - GERD patients who have already undergone endoscopy before enrolment\n Exclusion Criteria:\n - Involvement in the planning and conduct of the programme\n - The person who took the medicine such as PPI or H2RA during the last 7 days\n - Severe systemic disease\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
113	[ { "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\nClinical Trial Title:\n\nADX10059 as an add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD)\n\nClinical Trial Summary:\n\nThe purpose of this study is to evaluate the effect of ADX10059 in patients with gastroesophageal reflux disease who are partial responders to proton pump inhibitors\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - diagnosis of typical GERD\n - partial responder to a stable standard clinical symptoms control dose of PPI therapy\n - body mass index ≤ 32 kg/m2\n Exclusion Criteria:\n - exclusively atypical symptoms of GERD\n - symptoms that have been shown not to be associated with GERD\n - erosive oesophagitis\n - treated with a dose of PPI greater than the dose indicated for clinical symptom control of GERD\n - hiatus hernia > 3 cm\n - current diagnosis of co-existing psychiatric disease\n - known clinical significant allergy or known hypersensitivity to drugs\n - is pregnant or breast-feeding\n - has received sodium valproate or topiramate within 30 days of Screening\n - has a history of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
114	[ { "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\nClinical Trial Title:\n\nGemcitabine and Erlotinib in Treating Patients With Metastatic or Recurrent Pancreatic Cancer\n\nClinical Trial Summary:\n\nRATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with erlotinib may kill more tumor cells.\n PURPOSE: This phase II trial is studying how well giving gemcitabine together with erlotinib works in treating patients with metastatic or recurrent pancreatic cancer.\n\nClinical Trial Detailed Description:\n\nOUTLINE: This is a multicenter study.\n Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15 and oral erlotinib hydrochloride on days 2-5, 9-12, and 16-26. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.\n Archived tumor tissue samples are analyzed for the expression of EGFR, HER3, HER2, downstream signaling molecules, and other molecular markers by immunohistochemistry and RT-PCR. The presence of aberrant gene copy numbers (amplification and polysomy) for EGFR, HER3, and HER2 are determined by FISH. Blood samples are collected at baseline and periodically during study for polymorphism analysis and correlative molecular analysis of surrogate endpoint biomarkers.\n After completion of study therapy, patients are followed every 3 months.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Histologically or cytologically confirmed locally advanced, metastatic or recurrent pancreatic carcinoma\n - Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension\n - No prior chemotherapy for metastatic or recurrent disease is allowed. Prior adjuvant chemotherapy is allowed provided that patients did not receive gemcitabine and the chemotherapy was completed > six months prior to initiation of study therapy. Prior erlotinib therapy is not allowed\n - Available tumor specimen that was obtained at the time of diagnosis and/or prior to study entry is highly encouraged\n - Age ≥ 18 years\n - Life expectancy greater than 3 months\n - Zubrod performance status ≤ 2\n - Patients must have normal organ and marrow function as defined below:\n - leukocytes ≥ 3,000/μL\n - absolute neutrophil count ≥ 1,500/ μL\n - platelets ≥ 100,000/ μL\n - total bilirubin ≤ 1.5 X institutional upper limit of normal\n - AST(SGOT)/ALT(SGPT) ≤ 3 X institutional upper limit of normal, unless the liver is involved with tumor, in which case the AST/ALT must be ≤ 5 X institutional upper limit of normal\n - creatinine clearance ≥ 50 mL/min/1.73 m2, as measured by 24hour collection OR\n - creatinine ≤ 1.5 X institutional upper limit of normal\n - The effects of erlotinib and gemcitabine on the developing human fetus at the recommended therapeutic doses are unknown. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation\n - Ability to understand and the willingness to sign a written informed consent document\n Exclusion Criteria:\n - Patients may not be receiving any other investigational agents.\n - Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.\n - History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib or gemcitabine.\n - Secondary primary malignancy. Concurrent or history of another malignancy < 5 years.\n - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that would limit compliance with study requirements.\n - Pregnant women are excluded from this study because erlotinib and gemcitabine have the potential for teratogenic or abortifacient effects. Breastfeeding should be discontinued if the mother is treated with study drugs.\n - Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
115	[ { "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\nClinical Trial Title:\n\nNational Survey on GERD Patients (Adults and Children)\n\nClinical Trial Summary:\n\nTo describe GERD digestive expression according to ages: - children (from 0 to 23 months) and (24 months and more)- adults (from 18 to 29 years old), (from 30 to 39 years old), (from 40 to 49 years old), (from 50 to 59 years old), (more than 60 years old)\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Adults : - Male or female > or = 18 years old - With at least one GERD typical clinical sign (pyrosis and / or acid regurgitations).- Not receiving any GERD treatment within the 3 previous months.\n - Children :- Male or female < 18 years old - With GERD digestive clinical signs during the consultation (receiving treatment or not)- Whose parents or legal guardian gave oral approval to the child participation in the survey.\n Exclusion Criteria:\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
116	[ { "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\nClinical Trial Title:\n\nA Phase II Study to Evaluate Efficacy and Safety of P276-00 in Relapsed and/or Refractory Mantle Cell Lymphoma\n\nClinical Trial Summary:\n\nThe purpose of this study is to determine whether P276-00 is safe and effective in treatment of Mantle Cell Lymphoma that is recurred after or not responding to at least one previous line of treatment.\n\nClinical Trial Detailed Description:\n\nDespite response rates of up to 97% with first-line standard or high-intensity chemotherapy, with or without stem-cell transplantation, most patients of mantle cell lymphoma (MCL)relapse.Prognosis of MCL after first relapse is very poor with median survival of around 1 to 2 years. Therefore, novel therapies are required for relapsed and/or refractory MCL.Overexpression of Cyclin D1 as a result of t(11;14)(q13;q32) translocation is the hallmark of MCL.It is postulated that Cyclin D1 may also have an oncogenic role independent of pRb in MCL.Therefore, inhibition of Cdk4-Cyclin D1 is a potentially promising target in MCL. P276-00 is a potent Cdk4-Cyclin D1 inhibitor worth exploring for its efficacy in MCL. Hence, this Phase II study is planned to examine the efficacy and safety of P276-00 in the treatment of patients with relapsed and/or refractory MCL.\n This is an open-label, single-arm, 2-stage trial. Approximately 35 patients are planned to be enrolled into the study to obtain a total of 25 efficacy evaluable patients (patients who complete at least 2 cycles of study treatment and have tumor measurements at the end of 2 cycles). A total of 15 efficacy evaluable patients are planned to be treated in Stage I of the study. If ≥1 response (CR or PR) of any duration or ≥2 stable disease (SD) for ≥4 cycles are seen in the Stage I, then the study will continue into Stage II, in which additional patients will be treated until there are 10 additional efficacy evaluable patients.The study is divided into 3 periods: Screening, Treatment, and Follow-up. During the Screening Period, patients will provide written informed consent and be evaluated for inclusion and exclusion criteria. During the Treatment Period, patients will be administered P276-00 as intravenous (iv) infusion on Days 1 to 5 of each 21-day cycle for a minimum of 6 cycles and a maximum of 12 cycles, or until progressive disease (PD) or unacceptable toxicity occurs. Safety and efficacy evaluations will be done on Days 1 to 5 and 11 of each cycle, and on Day 21 of every 2 cycles. Pharmacokinetic (PK) assessments will be done on Cycle 1, Day 1 (pre-dose and post-dose time points), and optional biomarker assessments will be done pre-dose within 4 weeks of Day 1 and post-dose on Day 4 or 5. The End-of-Last-Cycle Visit will occur at the end of Cycle 6, or if the patient continues study treatment beyond Cycle 6, it will occur at the end of the patient's last cycle; if the patient discontinues early, these assessments will be done as an Early Exit Visit. The Follow-up Visit will occur 4 weeks (±1 week) after the End-of-Last-Cycle Visit (or Early Exit Visit) for final safety assessments.Objective response rate is the primary end point for this study. Response evaluation will be performed using the International Working Group (IWG) revised response criteria for malignant lymphoma.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Age ≥18 years\n - Histological diagnosis of MCL and presence of either nuclear Cyclin D1 positivity by immunohistochemistry or t(11;14) by fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), or conventional karyotyping\n - Documented progression or relapse after at least 1 line of prior chemotherapy\n - Presence of measurable disease\n - ECOG performance status 0, 1, or 2\n - Life expectancy of at least 3 months\n - Ability to understand and the willingness to sign a written informed consent document (ICD)\n - Full recovery from all prior treatment toxicities of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1\n Exclusion Criteria:\n - Prior radiation therapy, chemotherapy or biologic/targeted anticancer agents within 4 weeks of study drug administration\n - Prior treatment with monoclonal antibodies or any radio- or toxin- immunoconjugates within 3 months of study drug administration; however, a patient who has had rituximab treatment within 3 months and has had PD after such treatment is allowed in the study.\n - Prior allogeneic stem cell transplantation within 1 year of study drug administration\n - Current or prior CNS lymphoma\n - QTc > 450 msec\n - Unstable angina, myocardial infarction, CHF or stroke within previous 6 months of study drug administration\n - Presence of active and serious comorbidity and uncontrolled illness other than MCL\n - History of other prior malignancies except for properly treated basal cell or squamous cell carcinoma of skin, in situ cervical cancer, in situ breast cancer or early stage prostate cancer\n - Hemoglobin <8.0 gm/dL\n - Absolute neutrophil count <1000/mm3\n - Platelet count <50,000/mm3\n - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >3 × institutional upper limit of normal (ULN) (> 5 × institutional ULN if liver is involved with lymphoma or if patient has Gilbert's Disease)\n - Total bilirubin, >1.5 × institutional ULN (> 3 × institutional ULN if liver is involved with lymphoma or if patient has Gilbert's Disease)\n - Serum creatinine >1.5 × institutional ULN\n - Patients known to be suffering from infection with human immunodeficiency virus (HIV), tuberculosis, Hepatitis C or Hepatitis B\n - Pregnant or lactating women\n - Women of childbearing potential or men not willing to use at least 2 approved methods of contraception (one of which being a barrier method) after signing the ICD, during the entire study and for at least 4 weeks following withdrawal from the study\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
117	[ { "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\nClinical Trial Title:\n\nGENSARC 2008 : Medical Economic Evaluation of the Molecular Detection by FISH (Fluorescent in Situ Hybridization) and by PCR (Polymerase Chain Reaction) of Sarcomas Specific Translocations and Amplifications .\n\nClinical Trial Summary:\n\nThe clinical and histological diagnosis of sarcomas is often very difficult. The identification of chromosomal and molecular anomalies, such as amplifications, deletions or fusion genes is a powerful help for establishing a correct diagnosis of sarcomas and their benign counterparts. However, the cost of the cytogenetic and molecular techniques for the detection of these alterations is often a limitation to their use. The aim of our study is to evaluate the direct cost of the molecular techniques in comparison to the cost that would be generated by an appropriate therapy and care management of the patient in case of an erroneous diagnosis.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - patients with biopsy or excision of sarcoma (suspected or diagnosed)\n - sampling reviewed by pathologists\n - frozen sampling\n - clinical data available\n Exclusion Criteria:\n - opposition of patient\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
118	[ { "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\nClinical Trial Title:\n\nA Pharmacokinetics, Pharmacodynamics and Safety Study of Rabeprazole in New Born Infants With Gastroesophageal Reflux Disease (GERD)\n\nClinical Trial Summary:\n\nThe purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, and the safety of rabeprazole sodium for the treatment of gastroesophageal reflux disease (GERD) in newborns and pre-term infants.\n\nClinical Trial Detailed Description:\n\nThis is a multi-center Phase I study in newborns and pre-term infants (less than 44 weeks at the time of the first dose). The drug being studied is rabeprazole sodium, the active pharmaceutical ingredient in AcipHex. This study will consist of two parts, Part 1 and Part 2. Each part will consist of three phases, a pre-treatment phase (screening of up to 7 days before the start of treatment), a treatment phase (up to 28 days) and a post treatment phase (at least 14 days, but no more than 21 days after the last dose of study drug). The maximum study length for each patient will therefore be up to 8 weeks. Patients will be monitored patients with a presumptive diagnosis of GERD and who need a feeding tube for enteral alimentation (complete or partial) in place and have been admitted to a newborn intensive care unit or step down unit. The population pharmacokinetics (PK) results together with the pharmacodynamics (ie, pHmetry) data, the safety and tolerability data from Part 1 will be assessed to determine the two dose levels to be studied in Part 2 before the start of dosing. Pharmacokinetics explores how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time. Pharmacodynamics (PD) studies the action or effects a drug has on the body. All patients in Part 1 will require pH monitoring for clinical management and undergo a 24-hour PD assessment (intraesophageal and intragastric pHmetry). At least 12 patients in Part 2 (at least 6 patients from each dose group) will require pH monitoring and undergo the same PD assessment as patients in Part 1. Patients participating in the pHmetry assessment must be in need of this assessment for their clinical management in the opinion of the Principal Investigator. The intraesophageal and intragastric 24-hour pH PD assessment in both Part 1 and Part 2 will be performed at baseline (Day -1) and after the first dose (Day 1) and fifth dose (Day 5). Sampling for single dose blood level PK evaluations will be performed post-dose on Day 1. Sampling blood level evaluations at the presumed steady-state during multiple dosing will be performed on Day 5. Patients' safety will be monitored throughout the study. At the end of the study, or if any patient prematurely discontinues his/her participation in the study, a safety evaluation will be performed at least 14 days, but no more than 21 days, after the final rabeprazole sodium dose. During the course of the study, after consent each patient will have medical history, a physical, length, weight, vital signs, blood chemistry, and urinalysis. Safety from baseline to the End of Study visit (post-treatment phase) will be evaluated by examining incidence, severity and relationship to the study drug and type of Adverse Events (AEs), urinalysis, physical examination and vital signs. Patients will receive rabeprazole sodium as a single daily dose for up to 28 consecutive days. Patients participating in Part 1 will receive 1.0 mg rabeprazole sodium administered by a nasogastric tube. After four patients complete Part 1, their rabeprazole plasma levels will be assessed and the dose may be increased to 2.0 mg rabeprazole sodium. The population PK results, together with the PD (ie, pHmetry) data, safety and tolerability data from Part 1 will be assessed to determine 2 doses in Part 2.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Patients must need a feeding tube in place for enteral alimentation (complete or partial) and be in a neonatal intensive care unit or step down unit\n - Patients participating in the pHmetry assessment must be in need of this assessment\n - New born, neonate or pre-term infants less than 44 weeks with a minimum weight of 0.8 kg and with a presumptive diagnosis of GERD\n - Patients who have been treated with, or are currently receiving a proton pump inhibitor (PPI), H2-blockers or antacids\n - Patients should be generally healthy, other than for the presence of GERD.\n Exclusion Criteria:\n - A history of or current clinically significant medical illness (excluding GERD, asthma, reactive airway disease or cystic fibrosis-dependant GERD)\n - Continuous drip tube feeding with formula or breast milk\n - Patients whose mothers are taking PPIs and who are pumping breast milk to be fed to their infants\n - Continuous positive airway pressure (CPAP) delivered via nasal prong or oral mask\n - Serum concentrations of hepatic transaminases > 3-fold higher than the upper limit of normal for age creatinine values = 106 micromoles/L\n - Clinically relevant abnormal laboratory values\n - Treatment with full therapeutic doses of sucralfate or any medication that affects gastrointestinal motility such as baclofen, erythromycin, metoclopramide, cisapride, or domperidone\n - A history of allergy or sensitivity to PPIs or to their inactive ingredients\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
119	[ { "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\nClinical Trial Title:\n\nGranzymes and Perforin at the Onset of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations\n\nClinical Trial Summary:\n\nCOPD exacerbations are characterized by an excessive accumulation and activation of inflammatory cells in the airways. It is not known whether this phenomenon represents a risk for for lung damage via the release in the extracellular environment of potent cytolitic cellular granular contents such as granzymes and perforin.\n The investigators assess the intracellular expression of granzymes and perforin in neutrophils and large granular lymphocytes (LGL) at the onset of exacerbations compared to stable disease.\n The investigators hypothesize that a greater release of intracellular perforin and granzymes from neutrophils and LGL into the extracellular environment occur at exacerbations compared to stable condition and that these changes are more pronounced in COPD patients than in subjects without COPD who undergo respiratory infection.\n\nClinical Trial Detailed Description:\n\nThe course of Chronic Obstructive Pulmonary Disease (COPD) is characterized by exacerbations which lead to significant clinical deterioration and morbidity.COPD exacerbations are characterized by an augmentation of the inflammation that is observed in the airways in stable condition, particularly by excessive accumulation of polymorphonuclear neutrophils and activation of lymphocytes.\n It has been suggested that this abnormal increase of inflammatory cells in the airways of COPD patients during exacerbations, might represent a significant risk for excessive proteolytic activity in the airways via the release of their granule contents into the extracellular environment. Large granular lymphocytes (LGL) which include NK and cytotoxic T- cells and neutrophils contain cytolytic molecules such as, granzymes and perforin. Therefore, the inflammatory process during exacerbations might be potentially toxic to the lung. Notably, it was showed that sputum T-lymphocytes (CD8+) from patients with stable COPD express more perforin and are more cytotoxic compared to normal subjects.\n However, few previous investigations questioned the role of these cytolytic molecules in the pathophysiology of COPD. Moreover, despite the considerable progress that has been made in understanding the underlying mechanisms in COPD, there have been no studies investigating the expression of perforin or granzymes during COPD exacerbations.\n In the present prospective investigation we assess the intracellular expression of granzymes and perforin in neutrophils and LGL cells at the onset of sputum of COPD patients by using flow cytometry.\n Subjects and protocol:\n COPD subjects will be examined at the onset of an exacerbation and in stable condition. The definition of an exacerbation will be based on the criteria described by Anthonisen, requiring either the presence of at least two major symptoms (increase in dyspnea, sputum production, purulence) or of one major symptom in addition to at least one minor (wheeze, cough, nasal discharge, sore throat, fever), for two consecutive days.\n In addition we will assess the expression of granzymes and perforin in neutrophils and LGL cells of subjects without COPD(controls) who will be recruited by consecutive sampling among those subjects who seek medical assistance at the clinic during the study period and they satisfy all the following criteria: i) absence of COPD, Asthma, pneumonia, evidence of lung cancer, bronchiectasis, interstitial lung disease or other respiratory disease ii) initiation of symptoms diagnostic for respiratory infection in the past 72 hours, iii) abstention from any new therapeutic intervention, and iv) absence of any signs suggestive of condition requiring hospitalization. Control subjects will be examined at the onset of respiratory infections and at stable condition. The definition of a respiratory infection require the presence of one of the following symptoms such as dyspnea, sputum production, purulence, cough, ± fever, for two consecutive days. Stable condition for controls will be defined as absence of respiratory infection/exacerbation based on symptoms.\n The study is approved by the Research Ethics Committee of the Hospital . Sputum induction and processing Sputum will be induced at exacerbation or respiratory infection and in stable condition (at least 8 weeks after exacerbation) of the same patient and control subject respectively; samples will be processed for analysis of inflammatory cells and cytokines and microbiology. Sputum will be induced via inhalation of a hypertonic saline solution aerosol (Ultraneb 2000; DeVilbiss; Somerset, PA).\n Antibody labeling:\n The following mouse anti-human monoclonal antibodies will be used for labeling sputum cells: phycoerythrin-conjugated antiCD3 (PE-CD3), phycoerythrin-5-conjugated (antiCD4-PCy5), fluorescein isothiocyanate-conjugated anti-perforin-antibody, (antiperforin-FITC) and fluorescein isothiocyanate-conjugate will be also used for competitive detection of intracellular perforin and granzymes. The \"a intraprep kit\" (Beckman-Coulter Inc Fullerton Ca, USA). Isotyping antibodies mouse antimouse IgG will be used as controls (Immunotech; Marseille, France). For labeling cell surface antigens 1x106 cells in suspension will be incubated with normal bovine serum to block the unspecific binding (blocking reagent), and then the monoclonal antibody/ antibodies will be added in excess (according to manufacturer's instruction) for 45 min at 10°C in the dark and washed three times with PBS plus 10% FCS. For intracellular perforin and granzymes staining, cells will be subsequently incubated in a permeabilization reagent (Intraprep; Beckman Coulter; Fullerton, CA) for 10 min. As a control, unlabeled antiperforin (or antigranzyme) at molar excess will be used after permeabilization and then antiperforin (or antigranzyme) FITC will be added without washing and incubated for 30 min at room temperature (competitive labeling). After staining, the samples will be washed with PBS plus 10% FCS and will be immediately analyzed using flow cytometry.\n Flow Cytometric analysis:\n The sputum samples prepared as described above will be analyzed on a fluorescence activated cytometer (EPICS ELITE; Coultronics; Louton, UK). Cells will be tightly gated by volume and complexity on a forward (0o) and side-light scattering (90o) mode. At least 105 cells were analyzed in each session. PCy-5-conjugated anti-human CD45 monoclonal antibodies (Dako; Ely, UK) will be used as pan-leukocyte stain to exclude non leukocyte events by logical gating. The percentage of one-color, two-color, and three-color positive cells will be measured and the mean channel value as well as the relative fluorescence intensity (RFI) corresponding to the antigen density will be estimated. The QC-Combo Kit (FCSC; San Jun, Puerto Rico) will be used for quantification of antibody binding and day-to-day instrument calibration (amplification and compensation settings of the flow cytometer) will be routinely carried out. Gating will be performed according to forward and side scattering and CD45 expression. Positive cells within the neutrophilic and lymphocytic population will be measured as percentages of each cell population.\n Following the above methodology we will asses the expression of perforin in neutrophils and LGL cells and the expression of granzymes in neutrophils and LGL cells both in exacerbation and in stable COPD.\n\nClinical Trial Eligibility Criteria:\n\nCOPD patients\n Inclusion Criteria:\n - All COPD patients who seek medical assistance at the clinic during the study period will be asked about COPD exacerbation related symptoms-medical history and then they will be included in the study if they satisfied all the following criteria:\n - COPD diagnosis according to the GOLD Consensus Statement\n - initiation of symptoms diagnostic for COPD exacerbation in the past 72 hours\n - abstention from any new therapeutic intervention\n - absence of any signs suggestive of severe exacerbation requiring hospitalization\n Control subjects\n Inclusion Criteria:\n - Subjects who seek medical assistance at respiratory clinic for symptoms suggesting acute bronchitis (dyspnea, sputum production, purulence, wheeze, cough)\n - medical history free of COPD, Asthma, pneumonia, other chronic respiratory disease or congestive cardiac failure,\n - initiation of symptoms in the past 72 hours,\n - abstention from any new therapeutic intervention, and\n - absence of any signs suggestive of clinical condition requiring hospitalization.\n Exclusion Criteria:\n - Patients with Asthma or other respiratory disease will be excluded from this study\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
120	[ { "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\nClinical Trial Title:\n\nStructured Treatment of Gastroesophageal Reflux in a Company Health Care Setting, -Effect on Quality of Life, Symptoms and Productivity\n\nClinical Trial Summary:\n\nThe study aims to evaluate if a GERD treatment programme, in accordance with current regional recommendations, in a company health care setting, has an impact on health related quality of life (HRQoL), symptoms, and productivity in GERD patients.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Female and/or male aged > 18 years\n - Diagnosis of GERD confirmed\n - Prescription of GERD treatment or already receiving GERD treatment\n Exclusion Criteria:\n - Any symptom suggesting a need for further investigation\n - Previous participation in the present study\n - Current participation in a clinical study or participation in a clinical study during the last 30 days\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
121	[ { "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\nClinical Trial Title:\n\nVaccine Therapy in Treating Patients Undergoing Surgery for Recurrent Glioblastoma Multiforme\n\nClinical Trial Summary:\n\nRATIONALE: Vaccines made from a person's tumor cells and dendritic cells may help the body build an effective immune response to kill tumor cells.\n PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients undergoing surgery for recurrent glioblastoma multiforme (GBM).\n\nClinical Trial Detailed Description:\n\nOBJECTIVES:\n Primary\n - To evaluate the feasibility and safety of an autologous brain tumor stem cell messenger ribonucleic acid (mRNA)-loaded dendritic cell vaccine in adult patients with recurrent glioblastoma multiforme.\n Secondary\n - To assess humoral and cellular immune responses to vaccination.\n - To compare the proportion of vaccinated patients alive at 6 months from the time of surgery for recurrent tumor with matched historical cohorts.\n OUTLINE: Patients undergo surgical resection of tumor. Tumor tissue samples are collected to isolate brain tumor stem cells (BTSCs) and for extraction and amplification of BTSC-specific mRNA. Within 4 weeks after surgical resection, patients undergo leukapheresis over 4 hours to generate dendritic cells (DCs). Patients also undergo leukapheresis at 1 week after the third vaccination and then at least every 3 months as needed for generation of additional DCs.\n Patients receive autologous BTSC mRNA-loaded DC vaccine intradermally once weekly for 3 weeks and then once monthly in the absence of disease progression or unacceptable toxicity.\n After completion of study treatment, patients are followed periodically.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Age >18 years of age\n - First recurrence of GBM (WHO Grade IV glioma or astrocytoma) in surgically accessible areas with prior histologic diagnosis of GBM\n - No known contraindications to receiving Avastin\n - Karnofsky Performance Status (KPS) of > 70%\n - Radiation Therapy (RT) with ≥ 45 Gy tumor dose, completed ≥ 8 weeks prior to study entry\n Exclusion Criteria:\n - Contrast-enhancing tumor component crossing the midline, multi-focal tumor, or tumor dissemination (subependymal or leptomeningeal)\n - Clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment\n - Pregnant or need to breast feed during the study period (Negative beta-human chorionic gonadotropin (HCG) test required), or unable to maintain use of contraception while on study\n - Active infection requiring treatment or an unexplained febrile (> 101.5 degrees F) illness\n - Known immunosuppressive disease, autoimmune disease or human immunodeficiency virus infection, Hepatitis B or Hepatitis C\n - Unstable or severe intercurrent medical conditions such as severe heart (New York Association Class 3 or 4) or lung (FEV1 < 50%) disease, uncontrolled diabetes mellitus\n - Prior brachytherapy, carmustine wafer therapy, radiolabeled monoclonal antibodies, or stereotactic radiosurgery\n - Prior inguinal lymph node dissection\n Avastin-Specific Exclusion Criteria\n Subjects meeting any of the following criteria are ineligible for study entry:\n - Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure > 100 mmHg)\n - Prior history of hypertensive crisis or hypertensive encephalopathy\n - New York Heart Association (NYHA) Grade II or greater congestive heart failure\n - History of myocardial infarction or unstable angina within 6 months prior to enrollment\n - History of stroke or transient ischemic attack within 6 months prior to enrollment\n - Significant vascular disease (e.g. aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) (within 6 months prior to enrollment)\n - History of hemoptysis (> or = 1/2 teaspoon of bright red blood per episode) within 28 days prior to enrollment\n - Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)\n - Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment\n - Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to enrollment\n - Serious, non-healing wound, active ulcer or untreated bone fracture\n - Proteinuria as defined by > +1 on urinalysis dipstick\n - Known hypersensitivity to any component of Avastin\n - Pregnant (positive pregnancy test) or lactation\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
122	[ { "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\nClinical Trial Title:\n\nAnal Cancer Screening Study\n\nClinical Trial Summary:\n\nBackground:\n - HIV-positive men who have sex with men (MSM) have rates of anal cancer that approach those of cervical cancer in women. However, unlike cervical cancer, there is no current recommended method of screening that could be used to detect anal precancerous lesions for the prevention of anal cancer in HIV-positive MSM.\n - Infections by human papillomavirus (HPV) are the likely cause of cervical and anal precancer and cancer. Detecting the presence of HPV or related biomarkers has helped to identify women who may be at increased risk of cervical cancer; researchers believe that early detection of HPV or related biomarkers in MSM may be useful for anal cancer screening.\n Objectives:\n - To evaluate the effectiveness of various tests to detect cancer-causing HPV in HIV-positive men who have sex with men.\n Eligibility:\n - HIV-positive MSM that are interested in receiving anal screening for precancer\n Design:\n - HIV-positive MSM will respond to a self-administered risk factor questionnaire, and will undergo a physical exam and a high-resolution anoscopy at the participating clinic.\n - The clinician will then collect to anal Pap specimens from each subject for research on HPV and related biomarkers.\n - Participants will be followed annually for 2 years to collect additional health data for research follow-up.\n\nClinical Trial Detailed Description:\n\nBACKGROUND:\n Human immunodeficiency virus (HIV) positive men who have sex with men (MSM) are at risk of anal cancer that approaches the risk of cervical cancer for unscreened women living in developing countries. There is currently no accepted method for screening HIV positive MSM for anal precancer to reduce the morbidity and mortality due to anal cancer ; in the absence of a standard and effective screening modality, clinics often resort to anoscopy, a diagnostic procedure akin to colposcopy, and directed biopsies on all HIV positive MSM.\n OBJECTIVE:\n Evaluate the clinical performance of detecting carcinogenic human papillomavirus (HPV) DNA and RNA, individual carcinogenic HPV genotypes, cytogenetic markers, p16(INK4a) and Ki-67 immunocytochemistry staining, anal cytology, and combinations of these biomarkers for identifying HIV positive MSM with prevalent, 1 year cumulative, and 2 year cumulative anal precancer and cancer (histologically-confirmed greater than or equal to AIN3) using clinician-collected anal specimens at baseline.\n ELIGIBILITY:\n HIV positive MSM seeking anal cancer screening. Inclusion: 1) KPNC member; 2) documented HIV-positive status; 3) able and mentally competent to provide written, informed consent. Exclusion:A current diagnosis of anal cancer at enrollment.\n DESIGN:\n To address this need and to improve detection of anal precancer and cancer, we propose a screening cohort study of 1,000 HIV positive MSM participating in the Kaiser Permanente Northern California (KPNC) health maintenance program. Under written, informed consent, participating KPNC members will respond to a self-administered risk factor questionnaire and will undergo two anal specimen collections into liquid-based cytology (LBC) medium prior to a digital exam and high resolution anoscopy. Subjects will be asked to self-collect at home into the same LBC buffer and return their specimen in a prepared return envelope to evaluate the utility of self-collection for anal cancer screening. Subjects will be followed annually for two years to collect follow-up clinical data related to outcomes. Baseline clinician-collected specimens will be tested in a masked fashion for the following clinical biomarkers: 1) carcinogenic HPV DNA in aggregate and individual carcinogenic HPV genotypes; 2) carcinogenetic HPV RNA and HPV16/18 RNA; 3) cytogentic changes (3q, 5p, and 20q amplification); and 4) p16(INK4a) and Ki-67 immunocytochemical staining. For reference, clinician-collected specimens will be used to make LBC slides and evaluated by an expert cytopathology laboratory. We will estimate the clinical performance (sensitivity, specificity, positive and negative predictive values, and referral rates) for detection of prevalently-detected, one-year cumulative, and two-year cumulative histologically-confirmed anal precancer (anal intraepithelial neoplasia grade 3) or worse (greater than or equal to AIN3). We will test the self-collected anal specimens by the best molecular test(s) or combination of tests for detection of prevalently-detected greater than or equal to AIN3 as determined from testing the clinician-collected specimens. All MSM will undergo diagnostic procedures at all visits and independent of testing results, which will result in unbiased disease ascertainment.\n\nClinical Trial Eligibility Criteria:\n\n- 2.1 ELIGIBILITY CRITERIA:\n Any male member of KPNC who is 1) identified as HIV positive through the Kaiser HIV registry, 2) 18 years or older, can provide written, informed consent, and 3) is not currently diagnosed with anal cancer (prior to enrollment).\n 2.2 INCLUSION CRITERIA:\n HIV-positive men will be invited to participate, regardless of race and ethnicity, as described below if they meet the eligibility criteria. Other than having been diagnosed with anal cancer prior to enrollment, there will no other disease-based exclusions. Because of the high fraction of HIV-positive men are in fact MSM, we will not prescreen men for their sexual orientation.\n 2.3 EXCLUSION CRITERIA:\n The exclusion criteria will be age less than 18, a current diagnosis of anal cancer rendered prior to enrollment, an unwillingness or inability (evident mental incapacity to understand the informed consent documents) to give informed consent.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
123	[ { "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\nClinical Trial Title:\n\nA Vaccine Study for High Risk Cancers\n\nClinical Trial Summary:\n\nThe purpose of this study is to determine the safety and immunological effects of a vaccine for people diagnosed with high risk neuroblastoma, osteogenic sarcoma, and rhabdomyosarcoma. It is hypothesized that this vaccine could reduce the incidence of relapse.\n\nClinical Trial Detailed Description:\n\nMAGE -A1, MAGE- A3, and NY-ESO-1 are antigens that can be found with significant frequency on neuroblastoma, rhabdomyosarcoma, and osteogenic sarcoma, three relatively common solid tumors that in some cases can be associated with a high risk for relapse. In this study each subject will be screened for the presence of these antigens, and an individualized vaccine will be developed and administered using the subject's own dendritic cells (DC).\n This study consists of two phases: a screening phase and a treatment/vaccine phase. First, eligible individuals will be consented into the screening phase. Tumor specimens will be tested by immunohistochemistry or RT-PCR for the presence of MAGE- A1, MAGE- A3, and NY-ESO-1. Those testing positive for one or more antigen can be consented for the treatment phase of the study. Blood will be drawn for DC culture, and approximately one month later a series of three vaccines will be administered at two week intervals. Subjects will receive a topical medication called imiquimod to the vaccine site prior to and following each injection, to help immune cells travel into the area. Study participation occurs over 18 months and also involves periodic physical examinations and blood draws.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria for Screening Phase:\n Patient 1 to 70 years of age with neuroblastoma, rhabdomyosarcoma, or osteogenic sarcoma, who have one or more of the following high risk features:\n - Neuroblastoma:\n - Stage IV disease\n - Stage III disease with n-myc amplification\n - Osteogenic sarcoma:\n - Presence of metastases\n - Elevated alkaline phosphatase or LDH at diagnosis\n - Primary tumor affecting the axial skeleton\n - Poor histopathological response after completion of pre-surgical chemotherapy (≥10% viable tumor)\n - Rhabdomyosarcoma:\n - Stage IV disease\n - Alveolar histology\n - Positive tumor margins, with lymph node positivity\n Inclusion Criteria for Vaccine Phase:\n - Patient meets all screening criteria and tumor is positive for NY-ESO-1, MAGE- A1, or MAGE-A3 by immunohistochemistry or RT-PCR.\n - Patients who are between 3 months and 2 years following the completion of therapy, and have achieved at least a very good partial response to primary therapy.\n - No chemotherapy is planned for one month following the last vaccination.\n - Bilirubin <2 mg/dL, and SGOT/SGPT <2.5 x normal\n - Creatinine clearance > 50ml/min as estimated by patient's serum creatinine, weight, and age\n - Room air pulse oximetry >94%\n - Patient is not pregnant\n - Male and female sexually active patients of reproductive who wish to participate must agree to use acceptable contraception\n - Patient is not moribund and has a projected life expectancy >6 months\n - Lansky performance scale > 70, ECOG < 2 (Appendix I)\n - Potential subjects will be tested for HIV 1 and 2 antibodies, HTLV 1/2 antibodies, and for HIV 1, hepatitis C and hepatitis B virus by NAT testing. - -Subjects testing positive for any of these pathogens will be ineligible for vaccine.\n - White blood cells ≥ 2.5 K/µL, Hemoglobin ≥ 8 g/dL, Hematocrit > 25%, and Platelets ≥ 70 K/µL\n - Patient does not have central nervous system involvement.\n - Patient does not a have a history of autoimmune disease, specifically inflammatory bowel disease, systemic lupus erythematosis, or rheumatoid arthritis\n - Patient is not receiving concurrent systemic steroid therapy\n - Patient does not have a known systemic hypersensitivity to imiquimod or any vaccine component\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
124	[ { "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\nClinical Trial Title:\n\nGastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass\n\nClinical Trial Summary:\n\nThe hypothesis of this study was that gastric bypass (GBP) ameliorates gastroesophageal reflux disease (GERD) in morbidly obese patients.\n\nClinical Trial Detailed Description:\n\nThe investigators studied the impact of this surgical procedure on GERD in patients with morbid obesity.\n Esophageal syndromes were evaluated according to the Montreal Consensus, where troublesome symptoms were defined as score ≥ 2 on a validated questionnaire of symptoms for Portuguese language along with esophageal syndromes with injury assessed through upper endoscopy.\n Esophageal acid exposure was determined through 24h pH monitoring. Increased acid exposure was characterized when total esophageal pH < 4 for at least 4% of the total monitoring time.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Morbid obesity\n - Acceptance to undergo open gastric bypass\n Exclusion Criteria:\n - Prior gastroesophageal surgery\n - Achalasia\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
125	[ { "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\nClinical Trial Title:\n\nDiagnosis and Response to Treatment Using a Reliable Gastroesophageal Reflux Disease (GERD) Questionnaire: An In Clinical Practice Study\n\nClinical Trial Summary:\n\nThe purpose of the study is to determine the applicability and utility of Gerd Q in the diagnosis of GERD and in the assessment of treatment response.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Patients of either gender aged between 18-79 years of age\n - Patients must be having symptoms of gastroesophageal reflux disease\n Exclusion Criteria:\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
126	[ { "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\nClinical Trial Title:\n\nStudy Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma\n\nClinical Trial Summary:\n\nThe primary objective of the study is to determine the safety profile and overall response rate of IPI 504 in patients with advanced dedifferentiated liposarcoma.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - At least 18 years of age at the time of signing informed consent.\n - Histologic diagnosis of dedifferentiated liposarcoma.\n - Available archival pathology specimen or tissue sample from a new biopsy for confirmation of diagnosis by central pathology reading.\n - At least one prior chemotherapy regimen for dedifferentiated liposarcoma.\n - No more than 2 prior chemotherapy regimens for dedifferentiated liposarcoma. Note: Any number of non-chemotherapy regimens is permitted.\n - Measurable disease on computed tomography (CT) or magnetic resonance imaging (MRI) as defined by RECIST (version 1.1) with at least one measurable lesion.\n - Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.\n - Life expectancy ≥6 months.\n Exclusion Criteria:\n - Prior treatment with any heat shock protein 90 (Hsp90) inhibitor.\n - Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease\n - Patients with prior hepatic resections or hepatic-directed therapy\n - Use of a medication or food that is a clinically relevant CYP3A inhibitor or inducer within 2 weeks prior to dosing.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
127	[ { "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\nClinical Trial Title:\n\nSafety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)\n\nClinical Trial Summary:\n\nThe purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an inhibitor of gastric acid secretion of the protein pump inhibitor (PPI) class, compared with placebo in the treatment of gastrointestinal esophageal reflux disease (GERD) in infants 1 to 11 months of age.\n\nClinical Trial Detailed Description:\n\nRabeprazole sodium belongs to the class of drugs known as proton pump inhibitors, which suppress gastric acid secretion. The drug is approved in the United States for the treatment of adults with GERD and other acid-related gastrointestinal disorders, and has been studied in adolescents (older than 12 years of age) with results similar to those in adults. However, the drug has not been studied in children under the age of 12 years. This study focuses on the efficacy and safety of rabeprazole sodium in infants aged 1 to 11 months, the pediatric group in which the prevalence of GERD-related symptoms is the greatest. This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group withdrawal study to compare the efficacy and safety of 2 doses (0.5 mg/kg or 1.0 mg/kg daily) of rabeprazole with placebo in the treatment of infants aged 1 to 11 months who have a diagnosis of suspected GERD, symptomatic GERD, or endoscopically or histologically proven GERD. The study consists of 3 study periods: a screening period of up to 10 days, an open-label treatment period of up to 3 weeks, and a 5-week double-blind treatment period. Patients who have been receiving GERD therapy before screening will have their GERD therapy discontinued for 3 days before entering the open-label treatment period. Patients who have a positive clinical response according to the Clinical Global Impressions - Improvement (CGI-I) scale at the end of the first or second week of the open-label treatment period will enter the double-blind treatment period; those who do not will be withdrawn from the study. A parent, legal guardian, or other individual experienced in the care of the infant will be the primary caregiver, who is responsible for the daily and weekly assessments and study drug administration. Efficacy assessments consist of the Infant Gastroesophageal Reflux Questionnaire Revised (I GERQ-R) total score, the Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I GERQ-DD) total score, the CGI-I, the Global Treatment Satisfaction Score, and the weight-for-age Z-score. Safety assessments include monitoring of concomitant therapies and adverse events throughout the study; clinical laboratory testing (hematology, clinical chemistry, urinalysis), measurement of vital signs (pulse and respiratory rate, blood pressure, temperature); and physical examination including length and weight. The study hypothesis is that rabeprazole sodium is superior to placebo in the treatment of GERD in infants aged 1 to 11 months. Rabeprazole sodium capsule(s) by mouth once a day, 10.0 milligram (mg)/kilogram (kg) for up to 3 weeks during the open-label treatment period and either 5.0 mg/kg or 10.0 mg/kg during the 5-week double-blind treatment period. To give the study drug to the infants, the contents of the capsule(s) are sprinkled onto a small amount of soft food or, as needed, the contents of the capsule(s) may be given in a small amount (5 milliliter [mL]) of infant formula or expressed breast milk.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Diagnosis of suspected GERD, symptomatic GERD, or endoscopically or histologically proven GERD, based on frequent vomiting or regurgitation, with at least 1 of the following: a) poor weight gain, or b) irritability, excessive crying or disturbed sleep that both the parent(s) and the doctor consider abnormal (but not due to colic)\n - or c) refusal to eat even if hungry or arching of the back during meals\n - weight 2.5 kg to 15.0 kg\n - I-GERQ-R score >16\n - Have only 1 caregiver in addition to the parent(s)\n Exclusion Criteria:\n - History of confirmed acute life-threatening events due to GERD\n - Known narrowing of the opening from the stomach to the small intestines\n - Confirmed diagnosis of cow's milk allergy\n - Have taken PPIs or H2-blockers (a class of drugs that inhibit stomach acid production) or any of several drugs that affect the normal movement of the digestive tract (caffeine, theophylline, antacids, erythromycin, and others) within 3 days before entering the study\n - Have blood or urine test results that are well above or below the normal range for the infant\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
128	[ { "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\nClinical Trial Title:\n\nPhase III Trial to Evaluate the Elortinib vs Gefitinib in Advanced NSCLC With EGFR Exon 19 or 21 Mutations\n\nClinical Trial Summary:\n\nThis is a randomized controlled trial to compare efficacy and safety between erlotinib and gefitinib in advanced NSCLC harboring EGFR exon 19 or 21 mutations.Eligible patients were randomized to receive erlotinib or gefitinib in any line settings.The primary endpoint was progression-free survival (PFS).\n\nClinical Trial Detailed Description:\n\nPatients with stage IV NSCLC who have EGFR exon 19 or 21 mutations will randomized to received oral erlotinib 150mg or gefitinib 250mg once daily until disease progression or unacceptable toxicity. Method of direct DNA sequencing of tumor tissue is used to analysis EGFR mutation status of exons 18-21. The response will be evaluated by RECIST criteria first month,second month and then repeat every 3 months after the beginning of the treatment weeks.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Histologically or cytologically confirmed stage IIIB (wet) or IV NSCLC.\n - Patients with positive EGFR exon19 or exon21 mutation as confirmed by direct sequencing histologically.\n - Signing the informed consent form.\n - The vital organ functions are tolerant to therapy.\n - Have recovered to CTCAE2 grade below from toxicity of previous chemotherapy and radiotherapy\n - PS 0-2 scores.\n - Functional reserve of bone marrow is adequate, e.g. white blood cell count ≥3.0×109/L, planet count ≥90×109/L, and HB≥80×109/L.\n - Serum bilirubin is 2 times less than the upper limit of normal (ULN), ALT and AST are 3 times less than ULN; for liver metastases, ALT and AST need to be 5 times less than ULN; creatinine should be 2 times less than ULN.\n Exclusion Criteria:\n - Informed consent is not provided.\n - Women of pregnancy or breastfeeding.\n - Have difficulty in swallowing.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
129	[ { "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\nClinical Trial Title:\n\nEvaluation of the Safety and Effectiveness of Tailored Transoral Incisionless Fundoplication (TIF) Using EsophyX for the Treatment of GERD\n\nClinical Trial Summary:\n\nObjectives of the Study:\n The primary objective of this study is to evaluate the relative merits, safety and effectiveness of the tailored TIF2 procedure in treating GERD patients who have persistent GERD symptoms despite PPI therapy.\n The secondary objective of the study is to evaluate the effectiveness of the tailored TIF procedure in restoring the antireflux barrier and eliminating GE reflux.\n Type of Study:\n Prospective, non-randomized, uncontrolled Study Duration 12 months Number of Patients 20\n Inclusion Criteria:\n Age 18-70 years, on daily PPIs for > 6 months, persistent GERD symptoms despite PPI therapy, anatomic disruption of the gastroesophageal valve to a Hill Grade II-III, evidence of one of the following while on PPI therapy: (1) erosive esophagitis (erosions or ulcerations during endoscopy); (2) abnormal ambulatory pH study; or (3) biopsy confirmed changes characteristic of reflux esophagitis; acceptable esophageal motility (by either manometry or video esophagogram), hiatal hernia no larger than 2 cm, patient willing to cooperate with post-operative dietary recommendations and assessment tests, signed informed consent\n Exclusion Criteria:\n BMI > 40, hiatal hernia > 2 cm, esophagitis grade D, esophageal ulcer, fixed esophageal stricture, gastric motility disorders, previous splenectomy, pregnancy (female), immunosuppression, ASA > 2, portal hypertension and/or varices, history of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis, active gastro-duodenal ulcer disease, gastric outlet obstruction or stenosis, gastroparesis or delayed gastric emptying, coagulation disorders\n Interventions:\n Treatment: Tailored transoral incisionless fundoplication (TIF2) using EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA)\n Evaluation Criteria:\n Primary Outcome Measure 24 hour pH impedance study: change in Johnson DeMeester scores; GERD-HRQOL scores Secondary Outcome Measures PPI usage, GERD symptoms at 6 and 12 months vs. baseline off PPI's, total number of reflux episodes, and Symptom Association Probability while off PPI.\n Safety: Adverse events will be mapped to standard terms and reported.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Age 18-70 years\n - On daily PPIs for > 6 months\n - Persistent GERD symptoms despite PPI therapy\n - Anatomic disruption of the gastroesophageal valve to a Hill Grade II-III\n - Evidence of one of the following while on PPI therapy:\n - Erosive esophagitis (erosions or ulcerations during endoscopy)\n - Abnormal ambulatory pH study\n - Biopsy confirmed changes characteristic of reflux esophagitis\n - Acceptable esophageal motility (by either manometry or video esophagogram)\n - Hiatal hernia no larger than 2 cm\n - Patient willing to cooperate with post-operative dietary recommendations and assessment tests\n - Signed informed consent\n Exclusion Criteria:\n - BMI > 40\n - Hiatal hernia > 2 cm\n - Esophagitis grade D\n - Esophageal ulcer\n - Esophageal stricture\n - Esophageal motility disorder\n - Prior splenectomy\n - Pregnancy or plans for pregnancy in the next 12 months (in females)\n - Immunosuppression\n - ASA > 2\n - Portal hypertension and/or varices\n - History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis\n - Active gastro-duodenal ulcer disease\n - Gastric outlet obstruction or stenosis\n - Gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment\n - Coagulation disorders\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
130	[ { "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\nClinical Trial Title:\n\nDinaciclib in Treating Patients With Stage III-IV Melanoma\n\nClinical Trial Summary:\n\nThis is a phase I/II trial is studying the side effects and best dose of dinaciclib and to see how well it works in treating patients with advanced melanoma. Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.\n\nClinical Trial Detailed Description:\n\nPRIMARY OBJECTIVES:\n I. To determine the recommended phase 2 dose of SCH727965 administered as a 4-hour infusion every other week in patients with advanced malignant melanoma. (Phase I) II. To determine the 1-year overall survival of patients with malignant melanoma treated with SCH727965 at the dose and schedule derived in the phase 1 part of the study. (Phase II)\n SECONDARY OBJECTIVES:\n I. To characterize the safety profile and toxicities of SCH727965 administered as a 4-hour infusion every other week.\n II. To determine the pharmacokinetics of SCH727965 administered as a 4-hour infusion every other week.\n III. To determine the proportion of patients with malignant melanoma who are alive without progression of disease 6 months after beginning treatment with SCH727965 at the dose and schedule derived in the phase 1 part of the study.\n IV. To determine the objective response rate to SCH727965 of patients with malignant melanoma enrolled to part 2 of the study.\n V. To document cdk2, combined cdk2/1 and cdk9 inhibition in surrogate tissues and tumor.\n VI. To correlate the degree of change of pharmacodynamic parameters in post-treatment compared to pre-treatment samples with clinical outcome.\n VII. To correlate the degree of change of parameters defining cdk2, cdk2/1 and cdk9 inhibition with pharmacokinetic parameters.\n VIII. To correlate pre-treatment cdk2 levels with the degree of change of parameters measuring cdk2 inhibition.\n IX. To correlate pre-treatment cdk2 levels with clinical outcome. X. To correlate tumor p53 status with clinical outcome.\n OUTLINE: This is a phase I dose-escalation study followed by a phase II study.\n Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Patients must have histologically confirmed, unresectable stage III or stage IV malignant melanoma\n - ECOG performance status =< 1\n - Absolute neutrophil count >= 1.5 x 10^9/L\n - Platelets >= 100 x 10^9/L\n - Total bilirubin within normal institutional limits\n - AST(SGOT)/ALT(SGPT =< 1.5 x institutional upper limit of normal\n - Creatinine =< 1.5 mg/dl OR\n - Creatinine clearance >= 50 mL/min for patients with creatinine levels above institutional normal\n - 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 participating in this study, she should inform her treating physician immediately\n - Eligible patients must agree to pre- and post-treatment biopsies of normal skin; in the phase 1 part of the study, patients with cutaneous disease or accessible lymph nodes must also agree to pre- and post-treatment tumor biopsies; in the phase 2 part of the study, tumor biopsies are required of the first 20 patients enrolled who have cutaneous disease or accessible lymph nodes\n - Patients enrolled to the Phase 2 portion of the study must have measurable disease by RECIST criteria\n - Ability to understand and the willingness to sign a written informed consent document\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 may not be receiving any other investigational agents\n - Patients with active CNS metastases are excluded; patients with a history of CNS metastases that have been treated must be stable for 4 weeks after completion of treatment, with image documentation required; patients must not be taking enzyme-inducing anticonvulsants and must be either off steroids or be receiving a stable dose of steroids\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 if the mother is treated with SCH727965\n - HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with SCH727965; 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 - Patients with other currently active malignancies are excluded, except those with an in-situ cancer or basal or squamous cell carcinoma of the skin\n - In the phase 2 part of the study, patients who have received prior investigational treatment with a cdk inhibitor are excluded\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
131	[ { "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\nClinical Trial Title:\n\nPHASE II TRIAL OF THE CYCLIN-DEPEDENT KINASE INHIBITOR PD 0332991 IN PATIENTS WITH CANCER\n\nClinical Trial Summary:\n\nRATIONALE: PD 0332991 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.\n PURPOSE: This phase II trial is studying the side effects and how well PD 0332991 works in treating patients with refractory solid tumors.\n\nClinical Trial Detailed Description:\n\nPRIMARY OBJECTIVES:\n I. To determine the response rates following treatment with PD 0332991 in the following malignancies: 1) Metastatic breast cancer, 2) Metastatic colorectal cancer, 3) Metastatic melanoma with CDK4 mutation or amplification, or 4) Cisplatin-refractory, unresectable germ cell tumors.\n II. To evaluate the safety and tolerability of PD 0332991 administered to subjects with refractory solid tumors.\n SECONDARY OBJECTIVES:\n I. To assess the pharmacodynamic effects of PD0332991 on tumor and non-tumor tissue.\n II. To investigate the relationship between selected biomarkers, PK and/or efficacy and safety outcomes.\n III. To estimate the population pharmacokinetic for PD 0332991 and to correlate PK with efficacy outcomes.\n IV: To perform a Phase II evaluation of PD 0332991 in a population defined as potential responders on the basis of CCND1 gene amplification.\n OUTLINE:\n Patients receive oral PD 0332991 once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Disease Characteristics:\n All Subjects: All subjects treated under this protocol will have histologically documented cancer of one of the following types:\n A. Metastatic breast cancer (7 triple negative, 23 ER+ after the first 15 patients are enrolled on the non-CCND1cohort; in addition 10 HER2+ for combination trastuzumab and PD0332991 therapy) up to 55 total enrollment slots B. Metastatic colorectal cancer that harbors the Kras or BRAF mutation (15-30 enrollment slots) C. Advanced or metastatic esophageal and/or gastric cancer (15-30 enrollment slots) D. Cisplatin-refractory, unresectable germ cell tumors (15-30 enrollment slots) E. Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation, CCND2 amplification OR any other functional alteration at the G1/S checkpoint. (15-30 enrollment slots)\n - Biopsy Requirements: For Subjects with accessible disease amenable to biopsy: A biopsy will be obtained pre-treatment and in during cycle 1 (while patient is receiving drug) for molecular markers of the cell cycle, and its inhibition.\n - Subjects will be > 18 years old\n - The subject has disease that is assessable by tumor marker, physical, or radiologic means.\n - The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n - The subject has adequate organ function, defined as follows A. Bilirubin ≤ 1.5 x the upper limit of normal (ULN) B. Serum creatinine ≤ 1.5 x UNL or calculated creatinine clearance ≥ 60 mL/min, and C. For subjects without liver metastases: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN D. For subjects with liver metastases: alanine aminotransferase (ALT) and aspartate aminotransferase ≤ 5 x ULN\n - All tumors must test positive for Rb expression except:\n A. ER positive metastatic breast tumors (data now shows all to be Rb positive.) B. Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation, CCND2 amplification OR any other functional alteration at the G1/S checkpoint.\n - The subject has adequate marrow function, defined as follows: A. Absolute neutrophil count (ANC) >1500/mm3 B. Platelets >100,000/mm3, and C. Hemoglobin > 9 g/dL\n - The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document.\n - Sexually active subjects (male and female) must use accepted methods of contraception during the course of the study and for 3 months after the last dose of protocol drug(s).\n - Female subjects of childbearing potential must have a negative pregnancy test at screening. Females of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months.\n - However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, or ovarian suppression.\n Exclusion Criteria\n - The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) within 3 weeks (or nitrosoureas or mitomycin C within 6 weeks) before the first dose of PD 0332991. . Patients with HER2-overexpressing tumors may receive trastuzumab up to the date of starting therapy, and may continue to receive trastuzumab while receiving PD0332991.\n - The subject has received any other type of investigational agent within 28 days before the first dose of study treatment.\n - The subject has not recovered from clinically-meaningful toxicity due to prior therapy (i.e., back to baseline or Grade ≤ 1), with the exception of neurotoxicity and alopecia.\n - The subject has untreated or uncontrolled brain metastases or evidence of leptomeningeal involvement of disease unless the subject has a teratoma in which case s/he may be eligible if all other eligibility criteria are met\n - The subject has uncontrolled intercurrent illness including, but not limited to:\n 1. ongoing or active infection\n 2. diabetes mellitus\n 3. hypertension\n 4. symptomatic congestive heart failure, unstable angina pectoris, stroke or myocardial infarction within 3 months\n - The subject has a baseline corrected QT interval (QTc) > 470 ms.\n - The subject is pregnant or breastfeeding.\n - The subject is known to be positive for the human immunodeficiency virus (HIV). Note:\n baseline HIV screening is not required\n - The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
132	[ { "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\nClinical Trial Title:\n\nGastric Bypass After Previous Anti-reflux Surgery\n\nClinical Trial Summary:\n\nThe goal of this study is to describe the clinical presentation, indications, and operative treatment as well as assess the morbidity, mortality, and overall performance of revisional Roux-en-Y gastric bypass (RYGB) after either failed or functional antireflux surgery \"ARS\" in obese patients. With such information, we hope to determine which features might assist us in advancing our knowledge about Gastro-Esophageal Reflux Disease \"GERD\", the best option for primary ARS, and mechanisms of failure in the obese population as well as in identifying predictors of outcome after revisional surgery in this population.\n\nClinical Trial Detailed Description:\n\nThe epidemic of overweight and obesity in the United States of America along with its comorbidities continues to expand. Bariatric surgery has demonstrated to be the most effective and sustained method to control severe obesity and its comorbidities. For instance, type 2 diabetes mellitus was completely resolved in 76.8 percent, systemic arterial hypertension was resolved in 61.7 percent, dyslipidemia improved in 70 percent, and obstructive sleep apnea-hypopnea syndrome was resolved in 85.7 percent. Furthermore, bariatric surgery significantly increases life expectancy (89 percent) and decreases overall mortality (30-40 percent), particularly deaths from diabetes, heart disease, and cancer. Lastly, preliminary evidence about downstream savings associated with bariatric surgery offset the initial costs in 2 to 4 years.\n Since 1998, there has been a substantially progressive increase in bariatric surgery. In 2005, the American Society of Metabolic and Bariatric Surgery \"ASMBS\" reported that 81 percent of bariatric procedures were approached laparoscopically. 205,000 people, in 2007, had bariatric surgery in the United States from which approximately 80 percent of these were Gastric Bypass. Moreover, there is a mismatch between eligibility and receipt of bariatric surgery with just less than 1 percent of the eligible population being treated for morbid obesity through bariatric surgery. Along with the increasing number of elective primary weight loss procedures, up to 20 percent of post RYGB patients cannot sustain their weight loss beyond 2 to 3 years after the primary bariatric procedure. Thus, revisional surgery for poor weight loss and re-operations for technical or mechanical complications will rise in a parallel manner.\n Three systematic reviews and meta-analysis have examined the association between obesity (BMI >30kg/m2) and several GERD-related disorders, including 1) GERD symptoms, 2) erosive esophagitis \"EE\", and 3) esophageal adenocarcinoma \"EA\". Obesity is associated with a 1.5-to-2-fold increased risk of GERD symptoms and EE and a 2- to 2.5-fold increased risk of EA. In two large case-control studies, abdominal diameter (waist-hip ratio), but not BMI, is an independent risk factor for another GERD-related disorder, Barrett´s esophagus \"BE\".\n Current pathophysiological mechanisms of GERD in the obese encompass the following. 1) Mechanical: I) increased intra-gastric pressure: increased intra-peritoneal and abdominal wall fat mass increases the intra-abdominal and peri-gastric pressures with subsequent increased gastroesophageal pressure gradient \"GEPE\" with augmented esophageal acid exposure. Each BMI unit increase corresponds to a 10 percent increase in intra-gastric pressure. II) Hiatal Hernia: \"HH\" disrupts the integrity of the sphincter mechanisms and prolongs esophageal acid clearance. Thin, normal, overweight, and obese subjects have a 1.0, 1.9, 2.5, and 4.2 risk of having HH compared to thin subjects, respectively. 2) Motility: I) Increased Transient LES Relaxation \"TLESR\" are associated with acid reflux during the postprandial period, especially during inspiration. II) Low LES basal pressure: Increased prevalence of abnormally low LES basal pressure in the overweight and obese in comparison to the normoweight subject. III) Esophageal motility abnormality: Jaffin et al, with esophageal manometry, reported 61 percent of patients with altered esophageal motility from which 59 percent had altered visceral pain perception (asymptomatic). IV) Delayed gastric emptying: mostly associated with one of its major comorbidities, diabetes mellitus. 3) Esophageal sensitivity: Mercer et al., with a Bernstein test, found a significant difference between normoweight and obese subjects without clinical evidence of GERD (0 percent vs. 86 percent, respectively) for esophageal hypersensitivity. 4) Hormonal: mostly mediated by estrogen and adiponectin. 5) Environmental (Diet): high-fat, saturated fatty acids, high-cholesterol, and high caloric density diets have been associated with the highest likelihood of perceiving an acid reflux event; fat may confer its sensory effect by activating pain facilitatory pathways or by deactivating pain inhibitory pathways.\n The most recent data is not conclusive on whether increased BMI affects acid-suppressive therapy for GERD. However, MacDougall et al. found that increased BMI was significantly associated with long-term acid suppression therapy. This can be explained based on either a higher prevalence of factors that predispose overweight and obese subjects to severe GERD, such as HH, greater GEPG, increased number of TLESR, or standard doses of PPI´s are suboptimal for patients with increased BMI and GERD.\n Broad indications for antireflux surgery include: 1) Reflux of food associated with HH, 2) despite successful medical treatment or after poor or moderate symptom control on optimized PPI therapy, patient opts for surgery, and 3) Complicated GERD without including severe dysplasia.\n Available traditional ARS are either 1) fundoplication, which is the most commonly performed procedure and can be partial -Toupet, Dor- or complete -Nissen-, or other procedures with limited use such as 2) Hill operation, 3) pyloroplasty, 4) vagotomy with antrectomy, and 5) duodenal switch.\n Long-term control of typical symptoms after primary laparoscopic Nissen fundoplication \"LNF\", in properly selected patients and with an experienced surgical team, is attained in more than 90 percent of patients confirming that LNF is the gold standard for the treatment of severe GERD.\n In a cohort study of 166 patients followed for 11 years, Smith et al found preoperative response to acid-reducing medication, typical symptoms, and BMI < 35 Kg/m2 to predict successful outcome. However, HH size, normal 24-hour pH score, age > 50 years, female gender, and prior abdominal surgery that previous studies found to be associated with poor outcomes were not corroborated by this study. Other risk factors for failure are short esophagus, HH greater than 3 cm, and diaphragmatic stressors such as retching, sports of weight lifting, and high-speed motor vehicle accident among others.\n Another study found increased BMI to be a predictor of poor outcome. Perez et al, in a retrospective cohort analysis of 224 patients undergoing LNF and transthoracic ARS, found a significantly increased recurrence rate of GERD in obese and overweight compared to normoweight patients, regardless of procedure type.\n In contrast, a cohort study of 257 consecutive patients undergoing LNF, D´Alessio et al analyzed outcomes based on BMI (< 25, 25-30, and >30 kg/m2); No significant differences in symptom scores and clinical success rates were found among the different subsets. However, mean BMI for obese patients was 33 kg/m2 (obesity class I) and only three patients were >35 kg/m2.\n Regardless of contradictory data about LNF efficacy in obesity, several studies have shown the effectiveness of RYGB for GERD in morbidly obese patients by symptoms, endoscopic findings, manometry and pH-metry results, and endoscopic biopsy-histopathology.\n There are four retrospective cohort studies assessing mostly early outcomes after converting ARS to RYGB. First, Sarr et al analyzed 19 patients that underwent open conversion to RYGB. Next, Ikramuddin et al described the anatomic findings for fundoplication failure after the laparoscopic conversion to RYGB of 11 patients. Lastly, with seven patients each, Raftopoulos et al and Donnelly et al reported feasibility with a high morbidity rate as well.\n In summary, there is little information about what is the best primary ARS and the best revisional strategy to address intractable or severe reflux after failed fundoplication in the obese population. Also, there is lack of data about the best revisional procedure to address obesity in the patient status post functional or competent ARS. With this pilot retrospective study, we will advance our knowledge and along with the existing literature, we will draw preliminary clinical recommendations.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Status post, either open or laparoscopic, primary Nissen fundoplication with all the following requirements:\n - Met NIH criteria for bariatric surgery\n - With functional or failed antireflux surgery (Nissen fundoplication)\n - Laparoscopic approach for revisional surgery\n Exclusion Criteria:\n - Any other type of revisional bariatric procedure\n - Nonstandard revisional RYGB surgery\n - Open approach for revision surgery\n - Missing records and/or unreachable patients with scant information for analysis\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
133	[ { "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\nClinical Trial Title:\n\nHuman Papillomavirus (HPV) in Squamous Cell Carcinoma of the Head and Neck\n\nClinical Trial Summary:\n\nThe rationale for this study proposal is derived from previous case series demonstrating that up to 60% of patients with HNSCC, especially in the oropharynx are associated with high risk HPV infection.\n In this study, we will characterize the association between HPV infection and HNSCC in Israel and establish a program for its diagnosis and management based on HPV as a biomarker. The rationale for the proposed research is that once it is known which types of HPV are associated with HNSCC, this information can be used to direct diagnosis and screening effort to high risk population. Our approach is based on establishing a multicenter consortium of leading researchers that will establish a joint database of demographic, clinical and biological data from various regions in Israel. For this we have assembled a multidisciplinary research team with the scope and breath (surgical oncology, pathology, virology and molecular biology) needed to complete all phases of the research successfully. The research will be coordinated and performed at the Applied Cancer Research Laboratory, Tel Aviv Sourasky Medical Center. The patients will be recruited from 7 tertiary medical centers in Israel: Ichilov, Bellinson, Hadassa, Rambam, Soroka, Sheba and Nazeret..\n\nClinical Trial Detailed Description:\n\nTo determine the prevalence and classify the high risk human papillomavirus types associated with head and neck cancer in Israel. We will determine the HPV genotype distribution in Israel in order to study the ethnic uniqueness of the region. Many studies have shown HPV 16 to be the most prevalent type in HNSCC (NEJM). In Israeli Jewish women the HPV types 16, 39, 52, and 18 were the most prevalent genotypes found (15). In our aim, we will determine the prevalence of various HPV genotypes in HNSCC specimens.Study population The group will include patients treated with primary surgery or biopsy, with or without adjuvant radiotherapy between 1998 and 2010 for SCC of the oral cavity, oropharynx, hypopharynx, larynx and paranasal sinuses.\n The anatomic site and extent of the primary tumor will be documented. The TNM classification of will be based on the staging system revised by the American Joint Committee on Cancer (AJCC). Patients will be recruited from seven national cancer referral hospitals, including Soroka Medical Center in the Negev (Beer Sheva), Sourasky Medical Center (Tel Aviv), Rabin Medical Center (Petach Tikva), Hadassa Medical (Jerusalem), Rambam Medical Center (Haifa), Sheba medical center (Ramat- Gan) and French Hospital Nazareth (Nazareth). These centers cover almost the entire population in Israel, including Israeli Jews, Bedouins, Druze and Israeli Arab population.\n Data Entry Data will be entered into a commercially available spreadsheet (Microsoft Excel 2000, Microsoft Corporation, Seattle, WA) and statistical analysis will perform using a computerized software package (SPSS). We have previously used a similar system to report the results of 146 patients with skull base sarcomas in an international multicenter study including 17 cancer centers (17).\n Tumor specimens Specimens will be collected retrospectively, and comprise of paraffin sections of primary tumors or biopsies retrived from the pathology department archives at each center. Transportation of paraffin blocks to Tel Aviv for deparaphinization and HPV testing will take place personally by the investigators. Histopathological analysis Primary tumor specimens will be first evaluated by pathologists at each participating cancer. All specimens will be than re-analyzed and evaluated by head and neck pathologist, Dr. Kaplan Ilana. Specimen dissection and tissue sampling of the primary tumor will be in accordance with the current guidelines for the histopathological assessment of head and neck cancer carcinoma.\n HPV detection at the laboratory Tissue sections will be subjected to deparaffinization, heatinduced target retrieval, and digestion with proteinase K (Roche Diagnostics, Indianapolis, IN), as described previously (18). DNA is then purified from paraffin by deparaffinization, proteinase K digestion, phenol/chloroform extraction, and ethanol precipitation. We will use the HPV genotyping system using a PCR based HPV GenoArray test kit for genotyping of 37 HPV taypes (Hybribio Limited, Hong Kong). Specimens are placed into PreservCytR LBC medium (ThinPrep liquid Pap vial; Cytyc Corporation). The Amplicor HPV test kit contains a pool of HPV-specific primers designed to amplify HPV DNA from 13 HR genotypes (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68). According to the manufacturer's specification, the Amplicor HPV test detects HPV genotypes 31, 52, 58, and 59 at 240 copies/ml and HPV genotypes 16, 18, 33, 35, 39, 45, 51, 56, and 68 at 100 copies/ml with a positivity rate greater than 95%. All genotypes are detected with a 100% positivity rate at 480 copies/ml.\n HPV genotyping HPV genotyping is performed by using a commercially available PCR based HPV GenoArray test kit (Hybribio Limited, Hong Kong), which makes use of both DNA amplification and HybriBio's proprietary flowthrough hybridization technique to simultaneously identify 21 HPV genotypes, including 5 low-risk types (types 6, 11, 42, 43, and 44), 14 HR types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68), and 2 intermediate-risk types (types CP8304 and 53).\n The test employs a macroarray format with a nylon membrane onto which HPV genotype-specific oligonucleotides probes have been immobilized. In Situ Hybridization system will be performed with Amplicor HPV test (Roche Molecular Systems) for validation of the results. This kit is designed for the detection and discrimination of human papilloma virus (HPV) DNA in paraffinembedded tissue. An HPV16-positive tumor specimen will be used as a positive control.\n p16 Immunohistochemistry\n The expression status of p16 is strongly correlated with tumor HPV status (19) and therefore we will evaluate the presence of this protein by immunohistochemistry (20). After 5- μ m sections are deparaffinized, antigen retrieval is performed by use of heat-induced epitope retrieval with 10 mM citrate buffer. Immunostaining will be performed with a Ventana automated stainer (Ventana Medical Systems, Tucson, AZ) according to the manufacturer's recommendations. Cervical specimen known to be positive for HPV will be used as positive control and normal tissues as baseline controls. A mouse monoclonal antibody against p16 (MTM Laboratories, Heidelberg, Germany) at 1:500 dilution will be utilized. The p16 antibody is detected using the avidin-biotin-peroxidase technique (Dako LSAB Kit, Dako). On histopathologic review, the pattern of p16 expression is generally dichotomous according to tumor sample, with p16 staining either absent (negative) or present with strong and diffuse nuclear and cytoplasmic staining (positive). Relative protein expression will be estimated using dedicated software (Metamorph, Molecular Devices, Union City, CA), which analyzed the intensity and area of positive staining. Immunohistochemical interpretation will be performed by two investigators blinded to the HPV status and identity of the patient from whom the tumor originated.\n Evaluation the association between HPV status and therapeutic response or survival in patients with oropharyngeal/laryngeal SCC Prospective analyses of case series in the United States and Europe have consistently demonstrated that patients with oropharyngeal SCC which are HPV-positive have a better prognosis than patients whose tumors are HPV negative (21,22). We will evaluate the effect of tumor HPV status on treatment response and survival outcomes among patients with oropharyngeal and laryngeal SCC who were treated with primary chemoradiation or radiation therapy (organ preservation regime).\n Data Collection Each center will collect data from patients charts. The data will include: age, sex, ethnic group, area of birth and residence, religion, education (ever attendance at school, number of years of school attendance, and age at leaving school), longest occupation, use of tobacco in its different forms, alcohol drinking habits, dietary habits, marital status, sexual history (number of lifetime sexual partners, visits to prostitutes, and frequency of oral sex), histories of various diseases, family history of cancer, and oral cavity health. A \"smoker\" is defined as an individual who reports having smoked tobacco daily for at least 1 year, and smokers will be asked about duration of smoking and amount and type of tobacco smoked (cigarettes, cigars, pipes or any form of tobacco chewing). A \"drinker\" is defined as an individual who reports drinking alcoholic beverages at least once a month. Details will be obtained on types of beverages, amounts and duration of habitual drinking. information on tumor-node-metastasis classification and staging will be obtained from the study patients. This classification will be converted into stage according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual. We will evaluate the outcome of each therapy in terms of response (complete response, partial response and progressive disease according to the RECIST classification)\n Statistical analysis Five-year overall survival (OS), disease-specific survive al (DSS) and locoregional control rates will be calculated using the Kaplan-Meier method and the difference in survival rate will be assessed by a log rank test (17). OS will be measured from the date of surgery to the date of death or last follow-up. For DSS, the patients who died from causes other than SCC will be censored at the time of death. The variables that will have prognostic potential suggested by univariate analysis will be subjected to multivariate analysis with the Cox proportional hazards regression model. All statistics will be two-sided. A value of P< 0.05 will be considered to indicate statistical significance. Comparison of HPV/p16 classification (three-class model) will be performed by Kruskal-Wallis analysis followed by Wilcoxon rank sum test with Bonferroni corrections. Comparison of protein expression by HPV/p16 classification will be made using one-way analysis of variance (ANOVA) with post hoc comparisons by Dunnett's T3 test. Comparison of HPV - three class model classification status with specific clinical and pathologic variables (sex, TNM stage, T stage, N stage, histologic grade, management, radiotherapy, chemoradiation, alcohol use, tobacco use and clinical response), will be performed by Fisher's exact test. Clinical response will be recorded as complete response versus no response/partial response after completion of treatment. All calculations and analyses will be performed with the Statistical Package for the Social Sciences version 11.5 for Windows (SPSS Inc, Chicago, IL), by a qualified statistician at Tel Aviv Souraky Medical Center (Esther Shabtai PhD).\n Sample size and its justification The prevalence of HNSCC in Israel is estimated to be 52 oropharyngeal and 250 laryngeal cancer new cases per year (Middle East cancer consorcium, www.mecc.cancer.gov). The medical centers that will participate in this study cover 80% of the population of the State of Israel. we estimate that the participation rate among case patients will be 89% (range from 76 to 99.0%) (REF JNCI International). Therefore it is estimated a study period of 6 months approximately 100 samples will be recruited.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - SCC of the oral cavity, oropharynx, hypopharynx, larynx and paranasal sinuses.\n Exclusion Criteria:\n - pregnancy,\n - age < 18\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
134	[ { "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\nClinical Trial Title:\n\nA Retrospective Study of Biomarkers in Non-Small Cell Lung Cancer\n\nClinical Trial Summary:\n\nThe purpose of this study is:\n 1. To characterize the types and frequency of molecular alterations to the epidermal growth factor receptor (EGFR) pathway, FGFR4 and EML-ALK in Asian patients with non-small cell lung cancer\n 2. To identify candidate biomarkers of importance in the EGFR and estrogen pathways\n Most, if not all, human malignancies including lung cancer are caused by somatic alterations of the genome, leading to activation of oncogenes or inactivation of tumor suppressor genes and their resultant oncogenic effects. In addition to mutations, increased chromosomal copy number (by amplification or polysomy) and DNA methylation are other mechanisms of oncogene activation and tumour suppressor gene inactivation respectively.\n Little is known about the relationship between these oncogenes of the EGFR family and the recently described oncogenes FGFR4 and fusion gene EML4-ALK. Recent data suggests molecularly defined subgroups of non-small cell lung cancer (NSCLC) exist and can be used to predict for sensitivity to targeted agents (erlotinib or gefitinib) or cytotoxic chemotherapy (pemetrexate, gemcitabine, platinum agents). The findings that estrogen receptors are present in lung tumours and that estrogen can stimulate growth and proliferation of lung cancers in vitro and in vivo are provocative. Further studies to evaluate the role of estrogens and other sex hormones in lung cancer are warranted.\n A further understanding of the molecular indicators of lung cancer prognosis and treatment prediction would improve drug development and patient treatment selection.\n Archived paraffin-embedded and fresh frozen NSCLC tumor tissue will be obtained via the Department of Pathology and the National University Tissue Repository respectively. Clinico-pathological characteristics will be obtained from the case records, Pathology and Tissue Repository. DNA will be isolated using standard techniques. Sequencing of genes in the EGFR signaling pathway: EGFR, KRAS, ErbB2, ErbB3, MET, PI3K, and BRAF as well as FGFR4. Unstained slides from the paraffin-embedded tissue will be obtained and subjected to fluoresce in vitro hybridization (FISH) for breakpoints in the EML4 and ALK genes as previously described. For cases that have been snap-frozen, RNA will be extracted and EML4-ALK fusions will be confirmed using RT-PCR and pre-specified primers. To analyse the expression of proteins of putative relevance to EGFR function (such as EGFR, ErbB2, ErbB3, AKT, MET, STAT, ERK, MAPK, cyclin D1, C/EBPa), downstream effects of EGFR: cell proliferation (Ki-67), angiogenesis (CD34, VEGF-A), apoptosis (bcl-2), metastasis, and hormonal influence (oestrogen and progesterone receptors, aromatase), TMA technology will be utilised. The status of the tumor suppressor genes PTEN and C/EBPa will be analysed.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n Exclusion Criteria:\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
135	[ { "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\nClinical Trial Title:\n\nTransoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)\n\nClinical Trial Summary:\n\nThe study objective is to evaluate the safety and efficacy of TIF among a broad range of GERD patients treated in routine clinical practice at multiple centers across the United States.\n\nClinical Trial Detailed Description:\n\nPrimary Effectiveness Endpoint: Typical and atypical GERD symptom elimination (scores ≤ 2 to each question) or clinically significant improvement (≥ 50% reduction in total scores) at 6-month follow-up compared to baseline.\n Secondary Effectiveness Endpoints: GERD symptom elimination or clinically significant improvement at 12-month follow-up, 24-month follow-up and 36-month follow-up; complete discontinuation of PPIs; normalization of esophageal acid exposure; significant reduction in reflux episodes; healing of reflux esophagitis; reduction of hiatal hernia; safety supported by low incidence of serious adverse events.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Age 18-75 years\n - GERD for > 1 year\n - History of daily PPIs use for > 6 months\n - Moderate to severe typical or atypical GERD symptoms off PPIs\n - Complete (responders) or partial (nonresponders) symptom control on PPIs\n - Deteriorated gastroesophageal junction (Hill grade II or III)\n - Proven gastroesophageal reflux by either endoscopy, ambulatory pH or barium swallow testing\n - Willingness to undergo pH/impedance testing, if required\n - Willingness to cooperate with the postoperative diet for 6 weeks\n - Availability for follow up visits at 6 months and 12 months\n - Willingly and cognitively signed informed consent\n Exclusion Criteria:\n - BMI > 35\n - Incompletely reducible hiatal hernia with residual of > 5 mm\n - Esophagitis grade D\n - Barrett's Esophagus > 2 cm\n - Esophageal ulcer\n - Fixed esophageal stricture or narrowing\n - Portal hypertension and/or varices\n - Active gastro-duodenal ulcer disease\n - Gastric outlet obstruction or stenosis\n - Gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study, if patient complains of postprandial satiety during assessment\n - Coagulation disorder\n - History of any of the following: resective gastric or esophageal surgery, antireflux surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis\n - Pregnancy or plans of pregnancy in the next 12 months\n - Enrollment in another device or drug study that may confound the results\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
136	[ { "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\nClinical Trial Title:\n\nAn Epidemiological Study to Describe Symptom Control and Impact of Gastroesophageal Reflux Disease\n\nClinical Trial Summary:\n\nThe purpose of this study is to examine patient's perspective of symptom control and impact of gastroesophageal reflux disease (GERD) on daily life.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Patients with gastroesophageal reflux disease -GERD (disease duration ≤3 years or newly diagnosed) that are currently not treated with a proton pump inhibitor, for whom the general practitioner (GP) has previously decided to initiate or change the tre\n - Patients should be treated for GERD according to current practice (National guideline for treatment of dyspepsia in GP setting)\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
137	[ { "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\nClinical Trial Title:\n\nEfficacy and Safety Assessment of Oral LBH589 in Adult Patients With Advanced Soft TIssue Sarcoma After Pre-treatment Failure\n\nClinical Trial Summary:\n\nThe purpose of this study is to assess efficacy and safety of LBH589 - Panobinostat®, a potent HDACi, in patients with advanced STS who experiment disease progression after or during first-line chemotherapy. The rational is based on the observation of activity of deacetylase inhibitor (DACi) in several pre-clinical models of STS including Synovial sarcoma and Ewing sarcoma.\n\nClinical Trial Detailed Description:\n\nDespite surgical excision and radiation therapy, approximately 50% of patients treated for localised STS will experience local or distant relapse.\n Recurrent STS : current therapeutic strategies Although some patients may be salvaged with surgery, chemotherapy using doxorubicin-based regimens is in most cases indicated for patients with recurrent STS. Progression-free survival (PFS) is in most cases less than or equal to 6 months. Most patients die of their disease within 12-15 months following the diagnosis of advanced disease. Doxorubicin is considered as the standard of care in the first line setting for patients with locally advanced unresectable or metastatic STS. However, only 15-25% of these patients exhibit objective response following this chemotherapy while 30-35% experiment rapid disease progression. Doxorubicin-based combinations have resulted in an inconsistent increase in response rate but no survival advantage versus single-agent doxorubicin. After doxorubicin-based regimens failure, most agents, including other agents approved for the treatment of STS such as dacarbazine, ifosfamide and trabectedin, have shown very low response rates and short PFS. The only approved agent in this setting is trabectedin, which has shown prolonged stabilization in approximately 20% of patients at 6 months in several phase II trials. Gemcitabine-docetaxel combination, although not approved for the treatment of STS has shown interesting response rates in leiomyosarcomas, as well as other STS subtypes . Mechanisms of chemoresistance are poorly understood.\n Place of LBH589:\n LBH589 is postulated to have activity in sarcomas by being able to arrest gene transcription through the inhibition of HDAC, to cause the misfolding of important proteins for sarcoma biology such as fusion proteins or overexpressed genes (HDM2, cdk4, AKT…) via the disruption of HSP90 functioning . Some mechanisms similar to leukemia-associated fusion proteins, which have been shown to recruit HDAC to repress hematopoietic differentiation, might be involved by some translocation-associated sarcomas. The SYT portion of the synovial sarcoma oncoprotein SYT-SSX interacts with trithorax-group proteins and binds directly to the mSin3A HDAC component. SSX associates with polycomb-group proteins, which involve HDAC activity to mediate transcriptional repression; thus, aberrant epigenetic changes in gene expression seem to be a central effect of the fusion oncoprotein in this disease. HDAC inhibitors have been effective against both synovial sarcoma and Ewing sarcoma in preclinical studies . Evidence has also been presented for growth inhibition and induction of differentiation in clear cell sarcoma (Nielsen TO, Vancouver Coastal Health Research Institute, Vancouver, Canada, unpublished data) and chondrosarcoma by HDACi.\n Data from the phase I study involving patients with advanced solid tumors indicate that the MWF every week schedule of LBH589 is pharmacodynamically and clinically active. Histone acetylation was detected in peripheral blood cells for up to 72 hours (the maximum duration between doses on the MWF every week schedule) in 50% of patients at the 20 mg and 30 mg doses and CR and PR were observed in two and three patients respectively, with cutaneous T-cell lymphoma. Grade 3 fatigue was the dose-limiting toxicity (DLT) in 2 patients treated at the 40 mg level and 1 patient treated at the 60 mg level. The 40 mg level seem to be tolerable and is felt to be the most likely to have activity in solid tumors.\n After first-line chemotherapy failure, efficacy of therapeutic alternatives is limited. The purpose of this trial is therefore to investigate the efficacy, safety and tolerability of 40 mg of LBH589 given orally on a twice a week.\n\nClinical Trial Eligibility Criteria:\n\nINCLUSION CRITERIA\n - Age ≥ 18 years.\n - Histologically proven advanced metastatic or unresectable soft tissue sarcoma, excluding osteosarcoma.\n - Prior treatment with a doxorubicin containing regimen whether in the adjuvant setting or for metastatic/advanced disease. If doxorubicin was given as adjuvant therapy patient may be included if relapse occurs within a year of adjuvant therapy. If relapse occurs more than one year after the completion of adjuvant therapy, the patient must have received one prior regimen for metastatic disease. Patient may have received one or more previous line of therapy. Patients with sex cord tumors may be included after prior treatment with a platinum containing regimen (pretreatment with a doxorubicin containing regimen is not required for this patients subgroup).\n - Patient has at least one site of measurable nodal disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan (MRI is allowed only if CT scan can not be performed).\n - ECOG performance status (PS) ≤ 2.\n - Adequate haematological, liver and renal function:\n - Absolute Neutrophil Count (ANC) ≥ 1.5 G/L,\n - Hemoglobin ≥ 9 g/dL,\n - Platelets ≥ 100 G/L,\n - Total calcium (corrected for serum albumin) ≥ lower limit of normal (LLN) or correctable with supplements,\n - Magnesium ≥ LLN or correctable with supplements,\n - Potassium ≥ LLN or correctable with supplements,\n - Phosphorus ≥ LLN or correctable with supplements,\n - Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) (or ≤ 5.0 x ULN if liver metastasis are present),\n - Serum bilirubin ≤ 1.5 x ULN,\n - Serum creatinine ≤ 1.5 x ULN,\n - If the serum creatinine is ≥ 1.5 x ULN, then a 24-hour creatinine clearance must be conducted and the result must be ≥ 50 mL/min.\n - Clinical euthyroidy (patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism).\n - Ability to swallow capsules or tablets.\n - Life expectancy ≥ 12 weeks.\n - Mandatory affiliation with health security insurance.\n - Signed written informed consent.\n EXCLUSION CRITERIA\n - Prior treatment with any HDAC or HSP90 inhibitor drug.\n - Unresolved toxicities (≥ Grade 1) from prior therapy that would, in the opinion of the investigator, compromise patient safety.\n - Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:\n - Impaired cardiac function or clinically significant cardiac diseases, including any one of the following:\n - Left ventricular systolic function (LVEF) determined by MUGA scan or echocardiogram < center normal value,\n - Complete left bundle branch block,\n - Obligate use of a cardiac pacemaker,\n - Congenital long QT syndrome,\n - History or presence of ventricular tachyarrhythmia,\n - Presence of unstable atrial fibrillation (ventricular response > 100bpm),\n - Clinically significant resting bradycardia (< 50 bpm),\n - Mean corrected QT interval (QTcF - n ≥ 3) ≥ 450 msec on screening ECG,\n - Right bundle branch block + left anterior hemiblock (bifasicular block),\n - Angina pectoris ≤ 3 months prior to starting study drug,\n - Acute myocardial infarction (MI) ≤ 3 months prior to starting study drug,\n - History or presence of acute coronary syndrome,\n - Other clinically significant heart disease (e.g.: Congestive heart failure (CHF), uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen),\n - Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of LBH589 (e.g.: ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or extensive small bowel resection),\n - Other concurrent severe and/or uncontrolled medical conditions (e.g.: uncontrolled diabetes, active or uncontrolled infection, chronic obstructive or chronic restrictive pulmonary disease) that could cause unacceptable safety risks or compromise compliance with the protocol.\n - Current treatment with any of the medications listed in appendix 04, if the treatment cannot be discontinued or switched to a different medication prior to starting study drug. The medications listed in appendix 04 have a relative risk of prolonging the QT interval, or inducing Torsades de Pointes, or inhibit CYP3A4/5.\n - Major surgery ≤ 2 weeks prior starting study drug or who have not recovered from side effects of such therapy.\n - History of brain metastases.\n - Absence of at least one metastatic lesion greater than or equal to 2cm on pretreatment CT scan or other radiographic imaging as defined in RECIST criteria (appendix 02).\n - Systemic treatment with any anti-cancer drug, including any investigational drug that is administered on an intermittent schedule if the last dose has not been administered ≥ 4 weeks ago, or if the patient has not recovered from any ongoing toxicity prior to study enrolment.\n - Systemic treatment with any anti-cancer drug, including investigational drug that is administered on a chronic dosing schedule (e.g.: daily dosing, every-other-day dosing, MWF weekly) if ≤ 5 half-lives elapsed since the last dose, or if the patient has not recovered from any ongoing toxicity prior to study enrolment.\n - Women who are pregnant or breast feeding.\n - Women of childbearing potential (WCBP) are excluded unless they have a negative serum pregnancy test ≤ 48 hours prior starting study treatment. All sexually active WCBP and male patients are excluded unless they agree to use adequate contraceptive methods (injectable or implantable hormonal contraceptive, tubal ligation, intra-uterine device, barrier contraceptive with spermacide, or vasectomized partner) throughout the study. Since the potential of LBH589 to induce CYP3A4 is unknown, patients who are using oral contraceptives should use another effective method of contraception.\n - Current immunosuppressive syndrome.\n - History of another malignancy that is currently clinically significant or currently requires active intervention.\n - Refusal or inability to comply with the protocol or follow the instructions given to them by the clinic staff.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
138	[ { "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\nClinical Trial Title:\n\nEfficacy and Safety of Neridronate (Nerixia®)to Treat Osteoporosis in Patients With TM and TI\n\nClinical Trial Summary:\n\nAn Italian Multicentric randomized, open-label therapeutic trial evaluating the efficacy and safety of Neridronate in the treatment of Osteoporosis in patients with Thalassemia Major and Severe Thalassemia Intermedia.\n Efficacy and safety of the drug will be evaluated measuring at every visit this parameters:\n - haematological: Haemochrome\n - blood chemistry: creatinine, BUN, AST, ALT, Ca, P, proteins electrophoresis, total proteins.\n The prevalence of ectopic calcification and pseudoxantoma elasticum (PXE)-like syndrome and their follow-up will be evaluated at the beginning of the study vs 24 months through physical examination, abdominal echography and fundus oculi examination.\n During the trial other known risks factors for osteoporosis will be recorded, including prevalence and incidence of bone fractures and, if executed, Polimorphisms COLIA1.\n At the beginning of the study and at months 12 and 24 morphometry DXA will be performed to evaluate of the presence of bone deformities.\n Furthermore data regarding QOL and symptom pain will be evaluated trough administration of scale SF-36.\n At 12 months an intratrial analisis will be performed on efficacy and safety parameters in order to introduce possible amendments to the study design and to decide the prosecution of the trial\n During the trial all adverse events will be recorded\n\nClinical Trial Detailed Description:\n\nAim of the Study At present, due to the global therapeutic approach, the prognosis of Thalassemia Major and Severe Thalassemia Intermedia is open-ended. Regular transfusional regimens from childhood and early iron chelation therapy prevent bone deformities that in the past characterized this disease even though according to several authors a high percentage of patients suffers from osteopenia-osteoporosis. This persistent complication may be explained by one or more coexistent factors such as anaemia, genetic factors, sex hormones involved in the bone metabolism, iron and chelation therapy, hypothiroidism, low or subnormal concentrations of serum vitamin D, etc.\n Pain resulted to be the only parameter that may be considered to distinguish patients with Thalassemia Major from healthy patients of the same age through a survey about Quality of Life performed in the Center of Genoa. More frequently pain is localized in the lumbar vertebrae, it is often described with invalidant pictures and it has to be referred to osteoporosis of vertebral bodies.\n The incidence of spontaneous fractures observed in the specialistic centers treating these pathologies is increasing.\n Thalassemia Intermedia is an eterogeneous clinical entity including a wide range of phenotypes from mild to severe forms. In the mild forms hemoglobin levels range between 8-9 g/dl, which is stable without the need for regular transfusion therapy unless an intercurrent episode aggravates anemia; no expansion of the bone marrow is observed. By contrast, there are forms in which anemia is persistently more severe (6.5- 7.5 g/dl) with marked ineffective erythropoiesis. In these cases, especially when the diagnosis is made in childhood, patients should receive a transfusional regimen similar to Major forms with similar complications such as osteoporosis.\n For these reasons in patients affected with Severe Thalassemia Intermedia and with Thalassemia Major prevention and early diagnosis of osteoporosis are important as well as treatment of the established disease in order both to improve quality of life and life expectancy.\n In therapeutical trials previously described bisphosphonates have been shown to be effective because of their ability to inhibit bone resorption and their relatively few side effects resulting in an increase bone density. Since all the previous trials were conducted on a small number of patients, we propose a randomized, open label large multicentric trial to test the efficacy of Neridronate. The possibility to administrate this drug every 90 days intravenous makes dosing regimens simple and reduces the frequency of administration. These are important factors to improve adherence to therapy in patients already subjected to an heavy daily therapeutic load.\n Primary Objectives The primary objective of this study is to evaluate the efficacy of Neridronate (an aminobisphosfonate of third generation that has been proved in several clinical trials to have the ability to inhibit osteoclast-mediated bone resorption) to increase Bone Mass Density (BMD) measured through Double X-ray densitometry (DXA). Bone densitometry will be performed at basal screening and then at 6, 12, 18, 24 months from the beginning of the treatment.\n Secondary objectives The effect of Neridronate on bone turn over will be evaluated through bone alcaline phosphatase (BALP) and telopeptide C-terminal of type 1 seric collagen (CTX-s), at screening and then at 6, 12, 18, 24 months from the beginning of the treatment.\n The dosage of the markers will be centralized. Study design An Italian Multicentric randomized, open-label therapeutic trial evaluating the efficacy and safety of Neridronate in the treatment of Osteoporosis in patients with Thalassemia Major and Severe Thalassemia Intermedia.\n Efficacy and safety of the drug will be evaluated measuring at every visit this parameters:\n - haematological: Haemochrome\n - blood chemistry: creatinine, BUN, AST, ALT, Ca, P, proteins electrophoresis, total proteins.\n The prevalence of ectopic calcification and pseudoxantoma elasticum (PXE)-like syndrome and their follow-up will be evaluated at the beginning of the study vs 24 months through physical examination, abdominal echography and fundus oculi examination.\n During the trial other known risks factors for osteoporosis will be recorded, including prevalence and incidence of bone fractures and, if executed, Polimorphisms COLIA1 At the beginning of the study and at months 12 and 24 morphometry DXA for the evaluation of the presence of bone deformities Furthermore data regarding QOL and symptom pain will be evaluated trough administration of scale SF-36.\n During the trial all adverse events will be recorded\n Extension study:\n Objectives of the extension study\n 1. In vitro analysis of the effects of iron overload and chelating molecules on mesenchymal stem cells growth and osteogenic differentiation\n 2. Evaluation of the effects of neridronate on normal and thalassemic MSCs'proliferation and differentiation.\n 3. Phenotypical characterization of MSCs prepared from thalassemic patients treated with or without neridronate Study design A. In vitro analysis of the effects of iron overload and chelating molecules on MSCs growth and osteogenic differentiation B. Evaluation of the effects of neridronate on normal and thalassemic MSCs'proliferation and differentiation.\n C. Phenotypical characterization of MSCs prepared from thalassemic patients treated with or without neridronate A. In vitro analysis of the effects of iron overload and chelating molecules on MSCs growth and osteogenic differentiation\n 1. Preparation of a collection of bone marrow mesenchymal stem cells from normal subjects To isolate and prepare MSCs, we will utilize the protocol described in detail in Oliva et. al. (Molec. and Cell. Biochem., 2003, 247:55-60). The details of MSCs preparation are reported in annexes.\n The cells expressed specific surface markers, such as CD13, CD29, CD44, CD105, CD166, and were negative for hematopoietic cell markers CD14, CD34 and CD45.\n In this way, we are preparing a normal MSCs'bank, on which perform the experimentation. At present, we have already available more than 10 preparations of MSCs from normal subjects.\n 2. Analysis of the effects of iron overload on proliferation and differentiation of MSCs Although it is well known that thalassemic subjects undergo iron overload, no data are available in Literature on the effects of this metal on proliferation and differentiation of MSCs. To this aim we will proceed as indicated below. We will evaluate the proliferation rate and iron and ferritin intracellular levels in MSCs in logarithmic phase incubated with increasing concentrations of iron, starting from physiological hematic amounts, i.e. 2-18 microg/ml, until reaching values 10-fold higher, similar to those occurring in thalassemic patients. We will analyze the effect on growth rate by direct cell count, MTT vitality assay, and 3H-thymidine incorporation (DNA synthesis).\n Successively we will analyze the effects of iron overload on the levels of the main proteic product of MSCs, namely type I collagen, following the protocol reported. Confluent cultures of early passages (0-3) of MSCs, nontreated and treated with iron overload, are tripsinized, counted and centrifuged at 800xg. The pellets are resuspended in 0.5 M acetic acid containing 250 microg/ml pepsin.\n After 16 hours of gentle shaking at 4°C, the insoluble residue is pelleted at 20.000xg for 1 hour, solubilized in run buffer and analyzed by 6% SDS-PAGE. Afterwards, proteins are blotted to a nitrocellulose membrane and incubated with rabbit monoclonal antibodies specific for human type I collagen. The immunoreactive bands are then incubated with horse radish peroxidase conjugated secondary antibodies and detected by means of enhanced chemoluminescent technique (ECL).\n The effects on differentiation will be evaluated analyzing the expression of specific markers of osteoblastic phenotype, namely alkaline phosphatase activity and osteocalcin production. In addition, we will evaluate the osteogenic capacity of MSCs expressed by extracellular matrix mineralization. Confluent cultures are incubated with an osteogenic medium composed of dexametasone 100 nM and beta-glycerophosphate 10 mM. If osteogenic capacity is present, calcification noduli appear within 2-4 weeks. To further confirm the matrix mineralization we will measure calcium levels and finally carry out a specific stain by von Kossa method.\n 3. Analysis of effects of iron chelating molecules on proliferation and differentiation of MSCs We will evaluate the effects of DFO, which represents so far the most used chelating molecule in the therapy of thalassemia in spite of the well known disadvantages and toxicity. MSCs cultures, nontreated or treated with iron overload, will be added with DFO at concentrations similar to those obtained in vivo following drug administration to thalassemic patients. We will analyze the effect of the treatment on growth rate, collagen type I levels, alkaline phosphatase activity, osteocalcin production, as well as the osteogenic capacity.\n 4. Characterization of cell cycle components in MSCs subjected to iron overload and/or DFO It is well known that characterization of cell cycle components represents the basis for the comprehension of pivotal events of proliferation and differentiation processes.\n Thus, cell extracts obtained from both MSCs cell populations treated as described above (i.e. iron, DFO or iron overload and/or desferrioxamine) will be analyzed by immunoblotting employing antibodies against several cycle proteic components. Among them in particular: cyclin D1, D2, and D3, cyclin E, cyclin A; CDK4, CDK6, CDK2 and CDK1; p16, p14, p15, p21, and p27. Moreover, the phosphorylation of the retinoblastoma protein and the cdk activities will be analyzed.\n B. Evaluation of the effects of neridronate on normal and thalassemic MSCs'proliferation and differentiation.\n The objective of this study will be the in vitro analysis of the effects of the neridronate on normal and thalassemic human MSCs. In particular, we will evaluate if the drug, tested at concentrations between 10(-4) M and 10(-6) M being 10(-5) M the therapeutic dose, affect the viability, proliferation, and cellular activity of MSCs. The effects on proliferation will be assessed in terms of 3H-thymidine incorporation, MTT test and cell cycle engine modulation. The action on differentiation will be evaluated analyzing the expression of specific markers, namely type I collagen levels, alkaline phosphatase activity and osteocalcin production. In addition, we will evaluate the osteogenic capacity of MSCs expressed by extracellular matrix mineralization, by the measure of calcium levels and by von Kossa staining.\n C. Phenotypical characterization of MSCs prepared from thalassemic patients treated with or without neridronate The aim of this study will be to investigate whether the treatment of thalassemic patients with neridronate might positively affect the osteoporotic condition and, at the same time, improve the osteogenic capacity of MSCs. Therefore, we will prepare MSCs from thalassemic patients treated or not with neridronate and cultivate them according to standard method. In particular, we will analyze the growth rate, the cell cycle machinery, the collagen levels, the AP activity and the osteocalcin synthesis. Most importantly we will evaluate the extracellular matrix mineralization.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Patients presenting BMD Z score <-2 at the level of the femoral neck or of the lumbar column Regular transfusional regimen in order to mantain pre-transfusional Hb values >9 g/dl.\n Written informed consent by the patient\n Exclusion Criteria:\n Entravenous administration of bisphosphonates within the past 2 years\n Administration of di bisphosphonates per os, unless wash out as it follows:\n 1 year if >8 weeks <48 weeks 6 months if > 2 weeks and <8 weeks Hypoparathyroidism Thalassemia Intermedia if not regularly transfused Pregnancy and breast feeding Impaired renal function (creat. > 1.5 mg/dl) Neoplastic disease Patients with mean levels of alanine aminotransferase ALT > 300 U/l and patients with variations of AST or AST of 300% within the year before randomization. (At least 4 misurations over 12 months) Systemic cardiovascular, renal, hepatic disease etc. which would prevent the patient from undergoing study treatment Known hypersensibility to bisphosphonates. History of non compliance to medical regimens and patients who are considered potentially unreliable and/or not cooperative.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
139	[ { "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\nClinical Trial Title:\n\nNon Small Cell Lung Cancer Evaluation According to Pre-determined Drug-targeting Tumor Markers\n\nClinical Trial Summary:\n\nEvaluate chemotherapy related tumor markers on non small cell lung cancer by fluorescent in situ hybridization and immunohistochemistry, targets to be studied include EGFR, c-MET, topoisomerase II, p53, topoisomerase I, thymidylate synthase, ERCC1, tau, c-myc, RRM1, class III tubulin. These targets have been chosen because they are targets for chemotherapeutic agents that are currently used in clinical management of these diseases. In total 50 specimen will be studied, approximately one third have mutations/deletions of the EGFR gene.To attempt to establish a correlation between the pre-selected tumor markers and response to chemotherapy, and thus to be able to create a clinically useful classification that would provide clinical guidance for selection of the most effective chemotherapy for a individual patient, and thus be able to logically design more effective clinical trials for the future.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Patients with histologically confirmed lung cancer who received standard platinum-containing doublet chemotherapy followed by EGFR tyrosine kinase inhibitors.\n Exclusion Criteria:\n - non\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
140	[ { "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\nClinical Trial Title:\n\nA Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery\n\nClinical Trial Summary:\n\nThis open-label study will evaluate efficacy, safety and tolerability of RO5045337 in patients with liposarcoma who are eligible for debulking surgery. Prior to surgery, patients will receive 2-3 cycles of RO5045337, orally for 10 days followed by 18 days of rest per cycle. Anticipated time on study treatment is 3 months. Patients with an incomplete resection may be treated for an additional 3 cycles with RO5045337.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - adult patients, >/=18 years of age\n - well differentiated and/or dedifferentiated liposarcoma eligible for tumor debulking surgery\n - willing to undergo tumor biopsies before, during and after treatment\n - ECOG performance status 0-1\n Exclusion Criteria:\n - previous chemotherapy and/or radiation for liposarcoma; previous debulking surgery is acceptable\n - patients receiving any other agent or therapy to treat their malignancy\n - patients requiring anticoagulant therapy and/or anti-platelet therapy\n - pre-existing gastrointestinal disorders which may interfere with absorption of drugs\n - history of seizure disorders or unstable CNS metastases\n - clinically significant cardiovascular disease\n - history of long QT syndrome\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
141	[ { "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\nClinical Trial Title:\n\nCan E-cadherin Found in Tissue/Blood be Valuable in Identifying & Monitoring Patients With Post-proton Pump Inhibitor (PPI)-Responsive Heartburn\n\nClinical Trial Summary:\n\nThe purpose of this research study is to determine in heartburn patients with nonerosive disease if detecting the presence of a fragment of the protein e-cadherin in esophageal epithelium or the amount of fragments of e-cadherin in blood can be used to monitor healing of esophagitis treated with a proton pump inhibitor (PPI). The hypothesis is that the presence of fragments of e-cadherin in esophageal epithelium or the amount of fragments of e-cadherin in blood can you useful as a biomarker for the healing of esophagitis in patients successfully treated with a PPI.\n\nClinical Trial Detailed Description:\n\nThe symptom of heartburn was once a reliable indicator of gastroesophageal reflux disease (GERD) and as such patients would predictably respond to acid inhibition. In the post-proton pump inhibitor (PPI) world, neither of these statements is true since many patients presenting with heartburn have symptoms mediated by mechanisms unrelated to esophageal luminal acidity, e.g. functional disease, visceral hypersensitivity or activation of esophageal stretch receptors. Consequently these subjects fail to respond to PPIs[1-3]. Since PPI-responsive and PPI-refractory patients with heartburn are indistinguishable by history, it is difficult to determine which PPI-unresponsive subjects may respond to higher doses of a PPI. Additionally, when subjects do respond to PPI therapy, symptom response may not correlate with lesion healing, making a systemic marker of healing highly desirable. Lesion healing is particularly problematic since the histopathologic lesion that correlates best with heartburn is the presence of dilated intercellular spaces (DIS) within esophageal epithelium, which cannot be detected by with standard endoscopy, and is most reliably demonstrable by performing transmission electron microscopy[4-7]. Consequently, it would be desirable to have an objective marker of acid-mediated injury to esophageal epithelium that could identify those with PPI-responsive heartburn and determine healing of acid-damaged epithelium non-invasively.\n DIS in esophageal epithelium has been established as an early histopathologic feature of gastroesophageal reflux disease (GERD). This electron microscopic lesion is present in both erosive and nonerosive forms of GERD and results from acid damage to the intercellular junctional complex that controls paracellular permeability within esophageal epithelium[8]. Further, it is known that treatment with PPIs results in resolution of DIS along with that of heartburn in patients with both erosive and nonerosive types of GERD[9]. E-cadherin is a protein which forms the intercellular adhesive bridge of the zonula adherens (ZA)[10]; and the ZA plays an integral role in maintaining the integrity of the tight junction between cells such that loss of adhesion between bridging molecules of e-cadherin results in loss of barrier function and increased paracellular permeability[11,12]. Therefore, under conditions where an acidic refluxate is present within the esophageal lumen, a 'leaky' junctional barrier promotes excessive entry of hydrogen ions into and so acidification of the intercellular space, which in turn triggers heartburn by activation of acid-sensitive neurons within the mucosa[13].\n Recently, my lab has found that DIS in non-erosive acid-damage to (rabbit) esophageal epithelium is associated on Western blots with cleavage of the intercellular portion of e-cadherin and that this cleavage occurs by acid activation of an endogenous proteolytic process (unpublished observations). Moreover, this same phenomenon on Western blots is replicated in human esophagus of patients with GERD, i.e. endoscopic biopsies of esophageal epithelium reveal cleavage of e-cadherin in those with both erosive and non-erosive forms of GERD but is not present within the esophageal epithelium of healthy subjects or subjects without signs or symptoms of esophageal disease[14] - see Fig 4 of attached poster presentation. Specifically, cleavage of e-cadherin in GERD patients leaves behind within the esophageal epithelium a cytoplasmic 'C-terminal fragment (CTF)' of the molecule and this CTF is readily detected on Western blot. Interestingly, the size of the CTF is consistent, as in the rabbit model, with cleavage of e-cadherin by an endogenous matrix metalloprotease. Also noteworthy is that the other cleaved extracellular component of e-cadherin is an 'N-terminal fragment (NTF)' and this fragment is absorbed into the blood stream resulting in higher serum levels of NTFs of e-cadherin than healthy subjects as detectable using a commercial ELISA assay[14] - see Fig. 6 of attached poster presentation. Since CTFs on Western blot of endoscopic biopsies and elevated NTFs of e-cadherin by ELISA in serum are a reflection of acid-injured esophageal epithelium, this suggests the tantalizing possibility of a sensitive, minimally invasive (serum) test for esophageal mucosal damage in the GERD subject. We hypothesize that determination of either of the cleaved fragments of e-cadherin (serum or tissue-based) can discriminate between patients with acid-mediated heartburn who are likely to be PPI-responsive and those whose heartburn symptoms are not mediated by acid and so are PPI-refractory.\n The hypothesis will be tested by determining the presence or absence of CTFs of e-cadherin on esophageal biopsy and by measuring the level of NTFs of e-cadherin in serum of endoscopy-negative patients with heartburn and correlating the findings with the patient's (heartburn) response to Kapidex 30 mg for 4 weeks. Based on effective heartburn control on Kapidex or lack thereof, patients will be classified as having PPI-responsive or PPI-refractory disease, respectively, and these classifications correlated with presence or absence of CTFs on pretreatment biopsy and pretreatment serum level of NTFs of e-cadherin. Also, after 4 weeks of Kapidex, repeat serum specimens for NTFs are obtained from all treated patients to determine, as a marker of healing, whether the serum level of NTFs post-treatment are significantly lower than pretreatment serum level of NTFs in those that have PPI-responsive heartburn but not in those that have PPI-refractory heartburn.\n The results of this study are expected to show that patients with PPI-responsive heartburn have CTFs of e-cadherin in tissue and higher levels of NTFs of e-cadherin in serum at baseline, and that these levels decrease after successful PPI therapy. In contrast, because symptoms in PPI-refractory subjects are not acid-mediated, these subjects are expected to lack CTFs in tissue and to have lower levels of NTFs in serum at baseline compared to PPI-responsive patients, and these levels will remain unchanged after PPI therapy. Consequently, such findings would establish detection of cleaved fragments of e-cadherin in tissue and blood as useful biomarkers of disease that can identify those with heartburn that are responsive to standard doses of Kapidex. The results are also expected to show that patients with PPI-responsive heartburn, but not those with PPI-refractory heartburn, have a significant decline in the level of NTFs in serum post-treatment and that this lower level of NTFs is expected to fall within the range of controls. Consequently, such findings would establish that detection of serum NTFs before and after treatment can be useful as a biomarker of (microscopic) lesion healing in those with PPI-responsive heartburn. Such findings might help select sub-groups appropriate for more intensive (higher dose) or long term PPI therapy.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria: (all responses must be Yes)\n - Between 18 and 75 years of age\n - Male or non-pregnant, non-lactating female\n - Willing and able to undergo endoscopy with biopsies and a blood draw\n - Willing and able to discontinue use of PPIs for at least 1 month prior to the study start date\n - Endoscopy-negative heartburn of moderate severity at least 3 times-a-week for 3 months\n Exclusion Criteria:(all responses must be No)\n - History of:\n - Barrett's Esophagus\n - Erosive Esophagus\n - Zollinger Ellison syndrome\n - bleeding disorder\n - upper gastrointestinal bleeding or malignancy\n - esophageal motor disorder\n - esophageal stricture\n - esophageal varices\n - Had the following surgeries:\n - organ transplant\n - gastric or esophageal surgery for the treatment of: Esophageal Cancer, Achalasia, Gastroesophageal Reflux Disease (GERD); i.e. Nissen Fundoplication\n - Have any of the following:\n - Current malabsorption\n - inflammatory bowel disease\n - severe heart-lung-liver or renal cerebrovascular disease\n - known hypersensitivity to PPIs\n - Currently taking any of the following medications:\n - Quinidine\n - quinine\n - benzodiazepines\n - antineoplastic agents\n - dilantin\n - warfarin\n - non-steroidal anti-inflammatory drugs\n - narcotics\n - prostaglandins\n - salicylates (except baby aspirin for cardiovascular protection)\n - H2-receptor antagonists\n - PPIs other than study agent\n - steroids\n - promotability drugs\n - sucralfate\n - KCl\n - anti-tuberculosis medication\n - oral biphosphonates\n - drugs requiring acid for absorption (iron, ampicillin, digoxin and ketoconazole)\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
142	[ { "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\nClinical Trial Title:\n\nVismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma\n\nClinical Trial Summary:\n\nThis randomized phase I/II clinical trial is studying the side effects and best dose of gamma-secretase/notch signalling pathway inhibitor RO4929097 when given together with vismodegib and to see how well they work in treating patients with advanced or metastatic sarcoma. Vismodegib may slow the growth of tumor cells. Gamma-secretase/notch signalling pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vismodegib together with gamma-secretase/notch signalling pathway inhibitor RO4929097 may be an effective treatment for sarcoma.\n\nClinical Trial Detailed Description:\n\nPRIMARY OBJECTIVES:\n I. To determine the maximum-tolerated dose (MTD) of gamma-secretase inhibitor RO4929097 (RO4929097) when given in combination with fixed-dose Hedgehog antagonist GDC-0449 (GDC-0449) which will become the recommended dose for the phase II portion of this study. (Phase Ib) II. To assess the progression-free survival (PFS) of the combination of RO4929097 with and without GDC-0449 in two arms of patients with advanced sarcoma. (Phase II)\n SECONDARY OBJECTIVES:\n I. To describe the tolerability and adverse event profile of daily GDC-0449 administered orally in combination with daily RO4929097 administered orally for 21 consecutive days. (Phase Ib) II. To describe the pharmacokinetics of the combination of the combination of GDC-0449 and RO4929097. (Phase Ib) III. To assess Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 overall response rates (complete and partial response [CR+PR]) for combination therapy. (Phase Ib and II) IV. To conduct pharmacodynamic studies in tissue biopsies (pre- and post-study) for explorative and hypothesis-generating studies. (Phase Ib and II) V. To assess overall survival. (Phase II) VI. To further describe the pharmacokinetics and pharmacodynamics of the combination of GDC-0449 and RO4929097 at the phase II dose at the continuous schedule. (Phase II) V. To conduct pharmacodynamic studies in tissue biopsies (pre- and post- study drug[s]) for explorative and hypothesis generating studies. (Phase II)\n OUTLINE: This is a phase I, dose-escalation study of gamma-secretase/notch signalling pathway inhibitor RO4929097 followed by a phase II study.\n PHASE IB:\n PART A: Patients receive vismodegib orally (PO) once daily (QD) on days 1-21.\n PART B: Beginning within 7 days of finishing part A, patients receive vismodegib PO and gamma-secretase/notch signalling pathway inhibitor RO4929097 PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n PHASE II: Patients are randomized to 1 of 2 treatment arms.\n ARM I: Patients receive gamma-secretase/notch signalling pathway inhibitor RO4929097 PO QD on days 1-21.\n ARM II: Patients receive vismodegib PO and gamma-secretase/notch signalling pathway inhibitor RO4929097 PO QD on days 1-21.\n In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n After completion of study treatment, patients are followed up for 4 weeks.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Patients must have histologically or cytologically confirmed sarcoma\n - All Patients must have measurable disease as defined by RECIST 1.1\n - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)\n - There is a minimum of 1 prior therapy; however, there are no minimum systemic therapy requirements for well differentiated or de-differentiated liposarcoma, clear cell sarcoma, chondrosarcoma, alveolar soft part sarcoma and chordomas which have no effective therapies; for Phase Ib, there are no maximum limits to number of prior therapies; for Phase II, there is a maximum of 5 prior chemotherapy regimens including tyrosine kinase inhibitors (TKI); the last dose of systemic therapy (including TKI) must have been given at least 2 weeks prior to initiation of therapy; patients receiving nitrosourea (such as BCNU) or mitomycin C must have received their last dose of such therapy at least 6 weeks prior to initiation of therapy; patients receiving bevacizumab must wait at least 4 weeks; patients receiving experimental immunotherapy or antibody based therapies must wait a minimum of 4 weeks or 4 half-lives, whichever is longer; this should be discussed with the principal investigator before registration; tumor biopsies should be performed only after meeting these requirements; patients should recover to less than Common Terminology Criteria for Adverse Events (CTCAE) grade 2 toxicities related to previous therapies to be eligible\n - Patients with metastatic or locally advanced (inoperable) gastrointestinal stromal tumor (GIST) must have progressed on imatinib and sunitinib or be intolerant to both drugs; the last dose of tyrosine kinase inhibitors imatinib or sunitinib should be given at least 2 weeks prior to initiation of therapy\n - Patients with brain metastasis that have been treated with definitive surgery or radiation and have been clinically stable for 3 months following the procedure with no neurological signs or symptoms and no requirement for systemic glucocorticoids are eligible for study\n - Patients must not have current evidence of another malignancy except non-melanoma skin cancer and superficial bladder cancer\n - Leukocytes >= 3,000/mcL\n - Absolute neutrophil count >= 1,500/mcL\n - Hemoglobin >= 9 g/dl\n - Platelets >= 100,000/mcL\n - Total bilirubin =< upper limit of normal\n - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 X upper limit of normal\n - Creatinine =< 1.5 or creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above 1.5\n - Patients treated at Memorial Sloan-Kettering Cancer Center may consent to optional tumor biopsies before and after initiation of study drug; tumor biopsies should be obtained after fulfilling requirements\n - Women of child-bearing potential and men must use two forms of contraception (i.e., barrier contraception and one other method of contraception) at least 4 weeks prior to study entry, for the duration of study participation, and for at least 12 months post-treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; women of childbearing potential are required to have a negative pregnancy test (with a sensitivity of at least 25 mIU/mL) within 7 days and within 24 hours prior to the first dose of GDC-0449 and/or RO4929097 (serum or urine); a pregnancy test (serum or urine) will be administered every 3 weeks to all women of childbearing potential, at the start of each drug cycle; a positive urine test must be confirmed by a serum pregnancy test; prior to dispensing GDC-0449 and/or RO4929097, the investigator must confirm and document the patient's use of two contraceptive methods, dates of negative pregnancy test, and confirm that patient understands the teratogenic potential of GDC-0449 and/or RO4929097\n - Female patients of childbearing potential are defined as follows:\n - Patients with regular menses\n - Patients, after menarche with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding\n - Women who have had tubal ligation\n - Female patients may be considered to NOT be of childbearing potential for the following reasons:\n - The patient has undergone total abdominal hysterectomy with bilateral salpingo-oophorectomy or bilateral oophorectomy\n - The patient is medically confirmed to be menopausal (no menstrual period) for 24 consecutive months.\n - The patient is post-menopausal defined by amenorrhea for at least 1 year in a woman > 45 years old\n - Ability to understand and the willingness to sign a written informed consent document\n Exclusion Criteria:\n - Patients may not receive other investigational agents within 2 weeks of enrollment in this study; patients treated with bevacizumab should be off therapy for 4 weeks; other experimental or immuno therapies should wait for 4 half-lives or 4 weeks, whichever is longer; prior exposure to Notch or Hedgehog inhibitors is not allowed; patients who have not recovered to less than CTCAE grade 2 from prior therapies are ineligible\n - History of allergic reactions attributed to compounds of similar chemical or biologic composition to GDC-0449 or RO4929097 used in the study\n - Patients taking medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin®) are ineligible; patients on warfarin may be considered for enrollment after cessation of warfarin and appropriate transition to alternate anti-coagulation agents\n - Preclinical studies indicate that RO4929097 is a substrate of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) and inducer of CYP3A4 enzyme activity; caution should be exercised when dosing RO4929097 concurrently with CYP3A4 substrates, inducers, and/or inhibitors; furthermore, patients who are taking concurrent medications that are strong inducers/inhibitors or substrates of CYP3A4 should be switched to alternative medications to minimize any potential risk; the following medications with strong potential for interaction are not allowed: indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone\n - Caution should be exercised when dosing GDC-0449 concurrently with medications that are substrates of cytochrome P450 family 2, subfamily C, polypeptide 8 (CYP2C8), CYP2C9, and CYP2C19 and have narrow therapeutic windows; caution should be exercised when dosing GDC-0449 concurrently with inhibitors of CYP3A4\n - Patients must be able to swallow pills; patients with malabsorption syndrome or other condition that would interfere with intestinal absorption\n - Patients with clinically active liver disease, including active viral or other hepatitis or cirrhosis, are ineligible\n - Patients with uncontrolled electrolyte abnormalities including hypophosphatemia, hypocalcemia, hypomagnesemia, hyponatremia or hypokalemia or defined as less than the lower limit of normal for the institution, despite adequate electrolyte supplementation are excluded from this study\n - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, a history of torsades de pointes or other significant cardiac arrhythmias that require antiarrhythmics or other medications known to prolong corrected QT interval (QTc); psychiatric illness/social situations that would limit compliance with study requirements\n - Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with GDC-0449 and/or RO4929097\n - Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible\n - Cardiovascular: baseline QTc > 450 msec (male) or QTc > 470 msec (female)\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
143	[ { "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\nClinical Trial Title:\n\nBiomarkers in Tissue Samples From Patients With Breast Cancer Treated With Bevacizumab\n\nClinical Trial Summary:\n\nRATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment.\n PURPOSE: This research study is studying biomarkers in tissue samples from patients with breast cancer treated with bevacizumab.\n\nClinical Trial Detailed Description:\n\nOBJECTIVES:\n Primary\n - To demonstrate that vascular endothelial growth factor-A (VEGFA) haplotypes that are associated with an increased VEGFA expression will predict superior outcome for patients with metastatic breast cancer receiving bevacizumab in ECOG-E2100 (but not for the control arm).\n - To demonstrate that candidate single nucleotide polymorphisms (SNPs) will further improve the predictive capacity of outcome (efficacy and toxicity) in patients enrolled in ECOG-E2100.\n - To demonstrate that tumor VEGFA amplification or borderline amplification (estimated 14% frequency) will predict superior outcome for patients with metastatic breast cancer receiving bevacizumab on ECOG-E2100 whereas those with VEGFA deletion (estimated 11% frequency) will predict inferior outcome.\n - To demonstrate that VEGFA amplification/deletion will not predict outcome in the control arm of ECOG-E2100.\n Secondary\n - To demonstrate that tumor VEGFA amplification will predict increased protein expression as ascertained by IHC.\n - To demonstrate that a combined algorithm calculated from tumor-specific variability (VEGFA amplification/deletion) and host-specific variability (SNPs) will optimally predict outcome (efficacy) with bevacizumab in patients enrolled on ECOG-E2100.\n OUTLINE: This is a multicenter study.\n Previously collected tumor-derived DNA is analyzed for VEGFA amplification/deletion and haplotype as biomarkers for outcome after bevacizumab treatment. Gene expression, polymorphism, protein expression analysis, and IHC are performed on the samples.\n\nClinical Trial Eligibility Criteria:\n\nDISEASE CHARACTERISTICS:\n - Enrolled on ECOG-E2100\n PATIENT CHARACTERISTICS:\n - Not specified\n PRIOR CONCURRENT THERAPY:\n - See Disease Characteristics\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
144	[ { "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\nClinical Trial Title:\n\nA Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Pumosetrag in Patients With Gastroesophageal Reflux Disease (GERD)\n\nClinical Trial Summary:\n\nThe purpose of this study is to determine if pumosetrag is effective in treating Gastroesophageal Reflux Disease (GERD) symptoms in patients who have a history of GERD symptoms and are currently taking an acid suppression therapy, such as a Proton Pump Inhibitor (PPI).\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Patients with history of Gastroesophageal Reflux Disease (GERD) symptoms (heartburn, regurgitation, acid taste in mouth).\n - Between ages of 18 - 70 inclusive.\n - Develop GERD symptoms following ingestion of a refluxogenic meal.\n - Able to take a stable Proton Pump Inhibitor (PPI) regimen for duration of study.\n - Understand and sign the informed consent form.\n Exclusion Criteria:\n - Pregnant or lactating women.\n - Allergic to pumosetrag or formulation excipients.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
145	[ { "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\nClinical Trial Title:\n\nEfficacy of Nilotinib in First or Second Line Treatment of Primary Melanomas Stage III Unresectable Melanomas.\n\nClinical Trial Summary:\n\nNILOMEL is a phase II multicentric uncontrolled open national trial assessing the efficacy of Nilotinib in first or second line treatment of primary melanomas , stage III unresectable melanomas, or Stage IV melanomas with c-KIT mutation or amplification. The primary objective is overall response rate (partial and complete response) according to RECIST 1.1 criteria, assessed using CT-SCAN (stage IV melanoma) or MRI (unresectable melanoma) after 6 months therapy with Nilotinib 800 mg/d. Secondary objectives include:\n - Disease control rate (complete, partial response and stable disease)\n - Metabolic response\n - Tolerance NCI CTCAE Version 3.0\n - Biomarkers associated to response and disease control.\n\nClinical Trial Detailed Description:\n\nNILOMEL is a phase II multicentric uncontrolled open national trial assessing the efficacy of Nilotinib in first or second line treatment of primary melanomas , stage III unresectable melanomas, or Stage IV melanomas with c-KIT mutation or amplification (in case of c-KIT amplification, no B-RAF nor N-Ras mutation should be detected). The primary objective is overall response rate (partial and complete response) according to RECIST 1.1 criteria, assessed using CT-SCAN (stage IV melanoma) or MRI (unresectable melanoma) after 6 months therapy with Nilotinib 800 mg/d. Secondary objectives include:\n - Disease control rate (complete, partial response and stable disease) according to RECIST\n - Metabolic response rate (TEP-SCAN)\n - Tolerance NCI CTCAE Version 3.0\n - Biomarkers associated to response and disease control (evaluated at M0, M1 and M6). Protein analysis of c-KIT, PI3K, MAPK and STAT signalling pathways as well as PDGFR and Ephrin signalling pathways.\n Patients with progressive disease after 3 months therapy will be withdrawn. Patient with stable disease after 3 months will continue Nilotinib until evaluation at 6 months. Patients with stable disease or progressive disease at 6 months will continue Nilotinib until progression.\n The trial has been planned using a one-stage design (Fleming TR) . We considered that a response rate under 7.5% would define the null hypothesis of no efficacy . To detect a response rate of 30% or more with power 90% using a one-sided test at the 0.05 level, 25 patients have to be recruited.\n Accrual for 2.5 years total study duration: 3 years\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Patients with histologically proven melanoma with either c-KIT mutation or C-KIT amplification (without BRAF or NRAS mutation)\n - Unresectable primary or stage III or stage IV melanoma\n - Measurable disease (RECIST)\n - The inclusion of patients with primary tumor or metastasis accessible to sequential biopsies will be favored. If such lesions are present, biopsies are mandatory and not optional\n - No more than 1 previous specific therapy excluding tyrosine kinase inhibitors. 4 weeks wash out will be needed after cytotoxic therapy , 12 weeks wash out after anti -CTLA4 therapy or any immunological treatment\n - No radiotherapy within 4 weeks ; previously irradiated lesion will not be considered as measurable unless progression at inclusion\n - ECOG performance status < 2\n - WBC ≥ 3,000/mm³\n - PNN ≥ 1,500/mm³ (G-CSF allowed)\n - platelets ≥ 100,000/mm³\n - Hb ≥ 9.0 g/dL ( transfusions allowed as well as recombinant erythropoetin)\n - Creatinin clearance > 40ml/mn\n - Normal kalemia\n - Normal magnesemia\n - Total bilirubin <1.5N ; ASAT and ALAT <2.5N\n - PT/INR and PTT normal\n - NYHA class < 3\n - Signed Written Informed Consent\n - Affiliated to the National Health Insurance\n Exclusion Criteria:\n - Patients refusal\n - Age < 18 years\n - Fertile women who do not want or cannot use effective contraception during the study and up to 8 weeks after the end of study\n - Women pregnant or nursing\n - Women with positive pregnancy test at inclusion or before treatment initiation\n - Fertile and sexually active men whose partner are fertile women who do not use effective contraception\n - Clinical and/or radiographic evidence of active cerebral metastases\n - Severe evolutive infection\n - Known HIV infection\n - Concomitant therapy with any other anti-cancer, immunomodulator or immunosuppressing agent or radiotherapy (except palliative care if bone metastases, after acceptance of principal investigator).\n - Previous use of tyrosine kinase inhibitors\n - More than one line of prior systemic therapies of melanoma by anti-cancer agent or immunotherapy.\n - Received experimental treatment within 4 weeks of inclusion\n - Pace-maker\n - Cardiac dysfunction, as evaluated by one of:\n - Ejection fraction < 45% (less than 28 days from inclusion)\n - Congenital prolonged QT\n - QTc > 450 ms\n - Ventricular tachyarrhythmia within the past 6 months\n - Bradycardia at rest < 50/mn\n - Major conduction dysfunction\n - Myocardial infarction within the previous 6 months\n - Unstable angina\n - Uncontrolled hypertension\n - Digestive disease that may inhibited NILITINIB absorption\n - Concomitant medication that may increase QT\n - Taking CYP3A4 inhibitors\n - Eating Sevilla oranges (or Sevilla oranges derivates), grapefruit (or grapefruit juice), grapes (or grapes juice), pomegranate (or pomegranate juice)\n - Hereditary galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
146	[ { "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\nClinical Trial Title:\n\nStudy to Assess the Incidence of Intussusception in Children < 2 Years of Age in Singapore\n\nClinical Trial Summary:\n\nThis prospective study aims to estimate the incidence of intussusception among children < 2 years old through hospital-based surveillance in Singapore.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - A male or female infant aged < 24months at the time of diagnosis of intussusception.\n - Subject is diagnosed with definite, probable, possible, suspected intussusception during the period of at least one year beginning at study start.\n - Written informed consent obtained from the parent or guardian of the subject.\n Exclusion Criteria:\n - A male or female infant ≥ 24 months of age at the time of intussusception diagnosis.\n - The subject has had a radiographically or surgically confirmed case of intussusception prior to the current episode.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
147	[ { "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\nClinical Trial Title:\n\n3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Primary Refractory Neuroblastoma in Bone Marrow\n\nClinical Trial Summary:\n\nThe purpose of this study is to see find out what effects, good and/or bad, the combination of 3F8 and GM-CSF has on the patient and the cancer.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Diagnosis of NB as defined by a) histopathology (confirmed by the MSKCC Department of Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine levels.\n - High-risk NB as defined by risk-related treatment guidelines1 and the International NB Staging System,89 i.e., stage 4 with (any age) or without (> or = to 18 months of age) MYCN amplification or MYCN-amplified stage 4S.\n - Patients have primary refractory disease limited to BM, i.e., high-risk NB (defined above) resistant to standard therapy, as evidenced by incomplete response in BM, but no measurable MIBG-avid soft tissue tumor assessable for response and no progressive disease.\n - Signed informed consent indicating awareness of the investigational nature of this program.\n Exclusion Criteria:\n - Creatinine > 3.0 mg/dL\n - ALT, AST and Alkaline Phosphatase > 5.0 times the upper limit of normal\n - Bilirubin > 3.0 mg/dL\n - Patients with grade 3 or higher toxicities (using the CTCAE v 4.0) related to cardiac, neurological, pulmonary or gastrointestinal function as determined by physical exam. Patients must have normal blood pressure for age.\n - Progressive disease\n - History of allergy to mouse proteins.\n - Active life-threatening infection.\n - Human anti-mouse antibody (HAMA) titer >1000 Elisa units/ml.\n - Inability to comply with protocol requirements.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
148	[ { "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\nClinical Trial Title:\n\nRO4929097 and Erlotinib Hydrochloride in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer\n\nClinical Trial Summary:\n\nThis phase I trial studies the side effects and best dose of gamma-secretase/Notch signalling pathway inhibitor RO4929097 (RO4929097) and erlotinib hydrochloride when given together in treating patients with non-small cell lung cancer that is stage IV or has come back. RO4929097 and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.\n\nClinical Trial Detailed Description:\n\nPRIMARY OBJECTIVES:\n I. To define the maximum-tolerated dose (MTD) and toxicity of RO4929097 combined with erlotinib (erlotinib hydrochloride) in patients with advanced non-small cell lung cancer (NSCLC). (Dose escalation portion) II. To assess whether the probability of detectable tumor shrinkage or response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria correlates with pre-therapy immunohistochemistry (IHC) and reverse phase protein array (RPPA) expression of Notch 1, 2, 3, and 4. (Dose escalation portion) III. A preliminary, exploratory assessment will be performed with respect to percent tumor shrinkage and the probability of response over the first 2 cycles of therapy. (Expansion cohort) IV. A preliminary, exploratory assessment will be performed with respect to change in tumor immunohistochemistry (IHC) scores and reverse phase protein array (RPPA) expression for Notch 1, 2, 3, and 4 over the first 2 cycles of erlotinib. (Expansion cohort)\n SECONDARY OBJECTIVES:\n I. To perform a preliminary exploratory assessment of whether probability of detectable tumor shrinkage/response correlates with pre RO4929097 presence in tumor of an activating epidermal growth factor receptor (EGFR) mutation, the T790M EGFR mutation, met proto-oncogene (c-MET) gene amplification or insulin-like growth factor 1 receptor (IGF-1R) expression or activation or various Notch pathway markers. (Dose escalation portion) II. To perform a preliminary exploratory assessment of whether addition of RO4929097 to erlotinib leads to tumor shrinkage/response in any tumor deposits that had previously exhibited growth on erlotinib alone. (Dose escalation portion) III. Conduct a preliminary exploratory assessment on the expansion cohort with respect to tumor shrinkage/response of the following over the first 2 cycles of erlotinib and RO4929097 treatment with and without the presence of mutation, amplification, and activation of markers: tumor IHC scores and RPPA expression of the Notch ligand jagged 1 (Jag1), and the Notch targets hairy and enhancer of split 1 (HES1), hairy/enhancer-of-split related with YRPW motif protein 1 (HEY1); tumor IHC scores and RPPA expression of putative stem cell markers cluster of differentiation (CD)24 (decreased in stem cells), CD44, CD133, dehydrogenase and of the epithelial to mesenchymal transition (EMT) markers E-cadherin and vimentin; detectability in tumor of EGFR T790M mutations, MET amplification, and IGF-1R expression and activation; and soluble markers of angiogenesis, including stromal cell-derived factor 1 alpha (SDF-1alpha), basic fibroblastic growth factor (bFGF), cryptic epitope of collagen IV, interleukin (IL)-6, IL-8, vascular endothelial growth factor (VEGF). (Expansion cohort) IV. Conduct a preliminary exploratory assessment of whether percent tumor shrinkage/response or time to progression correlates with pre-therapy IHC and RPPA expression of Notch 1, 2, 3 and 4, the above Notch pathway and stem cell markers, with baseline detectability of T790M mutations and MET amplification, and with baseline IGF-1R expression and activation, and with change in these markers from the initial biopsy to the subsequent biopsy. (Expansion cohort) V. In tumor samples collected both during the dose escalation phase and in the expansion cohort, assess if IHC and RPPA expression of Notch, Notch ligand and Notch targets correlates with expression of stem cell markers.\n VI. Assess if percent tumor shrinkage/response, time to progression and baseline and change in IHC and RPPA expression of Notch, Notch ligand, Notch targets and stem cell markers varies with: tumor Notch gene amplification as assessed by fluorescent in situ hybridization (FISH); tumor IHC and RPPA expression of selected members of the Wnt and Hedgehog pathways (since these could lead to stem cell properties in cells that do not express Notch); host (peripheral blood mononuclear cell) polymorphisms for relevant genes in the Notch pathway; tumor micro ribonucleic acid (RNA) levels.\n VII. Trough levels of erlotinib and RO4929097 will be measured in plasma samples of all patients on the dose-escalation portion of the study approximately 24 hours after the cycle 1, day 1 dose and again approximately 24 hours after the cycle 2, day 1 dose. These measurements are being done to permit a preliminary exploratory assessment of whether there is induction of metabolism of one or both drugs that will lead to decreased drug plasma concentrations.\n VIII. In the Expansion Cohort, plasma levels of erlotinib and RO4929097 will be measured approximately 24 hours after the cycle 2, day 21 erlotinib dose (just prior to initiation of cycle 3), and plasma levels of both agents will be measured in plasma approximately 24 hours after the cycle 3, day 1 doses of both agents. These measurements are done to permit a preliminary exploratory assessment of whether: plasma drug levels correlate with % tumor shrinkage/response or with change in tumor biomarkers over the first 6 weeks of therapy; erlotinib plasma concentrations are affected by RO4929097 administration.\n OUTLINE: This is a dose-escalation study.\n Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21 and gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n After completion of study treatment, patients are followed up for 12 weeks.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Dose-escalation portion:\n - Patients must have histologically or cytologically confirmed diagnosis of incurable NSCLC\n - Preference will be given to patients with NSCLC who have been treated with erlotinib, and have either responded initially and then experienced subsequent growth in one or more tumor deposits while continuing erlotinib (acquired resistance) or patients who have been treated with erlotinib and failed to demonstrate any response to it (intrinsic resistance)\n - Expansion cohort: patients must satisfy each of the following criteria:\n - Histologically or cytologically confirmed non-small cell lung cancer that is incurable (stage IV or recurrent)\n - Patients must not have received prior anti-EGFR therapy\n - Patients on both the dose escalation portion of the study and in the Expansion Cohort portion must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 10 mm with computed tomography (CT) scan with cuts at 2.5 or 5 mm\n - Patients on both portions of the study must have tumor amenable to core biopsy (or to incisional, excisional, or punch biopsy) for research purposes; the collaborating interventional radiologists will make the determination whether or not the patient has a tumor amenable to biopsy and whether or not the patient is medically an appropriate candidate for tumor biopsy\n - Any prior anticancer systemic therapy or radiotherapy must have been completed at least 4 weeks prior to initiation of therapy on this study; (Exception: patients may be entered within 2 weeks of radiotherapy if the radiotherapy was restricted to femur below the trochanter, humerus or more distal limb areas)\n - Dose escalation portion:\n - Unlimited prior therapy is permitted (including prior anti-EGFR therapy), with the exception that patients who have received prior therapy with a gamma-secretase inhibitor are not eligible\n - Prior therapy is not required\n - Preference will be given to NSCLC patients who have been treated with erlotinib with evidence of acquired or intrinsic resistance to erlotinib\n - Expansion cohort:\n - Patients may have received an unlimited number of prior systemic regimens for NSCLC (as adjuvant therapy, as therapy for locally advanced disease or as therapy for advanced disease) provided they have not received prior anti-EGFR therapy (small molecule or antibody, etc) or prior gamma-secretase inhibitors\n - Prior therapy is not required\n - Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 60%)\n - Leukocytes >= 3,000/mcL\n - Absolute neutrophil count >= 1,500/mcL\n - Platelets>= 100,000/mcL\n - Hemoglobin >= 9 g/dL\n - Total bilirubin within normal institutional limits\n - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 X institutional upper limit of normal\n - Creatinine =< 1.5 X institutional upper limit of normal\n - International normalized ratio (INR) =< 1.7 X upper limit of normal (ULN) and the patient must not have received aspirin or Coumadin and the patient must not have received aspirin or Coumadin within the previous week or a therapeutic dose of a heparin product within the previous 24 hours\n - Women of childbearing potential must use two forms of contraception (i.e., barrier contraception and one other method of contraception) from at least 2 weeks prior to initiation of therapy on this study, for the duration of study participation, and for at least 2 months post-treatment; should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study and for 2 months after study participation, the patient should inform the treating physician immediately\n - Women of childbearing potential are required to have a negative serum pregnancy test (with a sensitivity of at least 25 mIU/mL) within 14 days prior to the first dose of RO4929097 and a negative serum or urine pregnancy test within 24 hours prior to the first dose of RO4929097; following initiation of therapy with RO4929097, a pregnancy test (serum or urine) will be administered every 3 weeks while on study; a positive urine test must be confirmed by a serum pregnancy test; prior to dispensing RO4929097, the investigator or designate must confirm and document the patient's use of two contraceptive methods, dates of negative pregnancy test, and confirm the patient's understanding of the teratogenic potential of RO4929097\n - Patients with a positive pregnancy test who are unlikely to be pregnant may be considered for entry on this trial if they are deemed to be unlikely to be pregnant by an obstetrician or gynecologist and if the study sponsor is in agreement with their study entry\n - Female patients of childbearing potential are defined as patients who do not fall into either of the categories listed above and to whom any of the following apply:\n - Patients with regular menses\n - Patients, after menarche with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding\n - Women who have had tubal ligation\n - Female patients may be considered to NOT be of childbearing potential for the following reasons:\n - The patient has undergone total abdominal hysterectomy with bilateral salpingo-oophorectomy or bilateral oophorectomy\n - The patient is medically confirmed to be menopausal (no menstrual period) for 24 consecutive months\n - Men participating in the study must also use 2 methods of contraception including 1 barrier method\n - Breastfeeding should be discontinued if the mother is treated with RO4929097\n - Patients with asymptomatic or minimally symptomatic brain metastases will not be required to undergo cranial radiation prior to being considered for this trial, and are eligible provided that it is not anticipated that they will require any of the following over the course of study treatment:\n - Corticosteroids for control of cerebral edema\n - Enzyme-inducing anticonvulsants\n - Radiotherapy, surgery, or other local therapy for the brain metastases\n - Able to swallow oral medications\n Exclusion Criteria:\n - Patients may not have received other systemic therapy or radiotherapy for their cancer within the previous 4 weeks prior to planned first day of therapy on this trial; (Exception: patients may be entered within 2 weeks of radiotherapy if the radiotherapy was restricted to distal limbs such as femur below the trochanter, humerus or more distal limb areas; in addition, patients in the dose escalation portion who have previously received erlotinib may start therapy on this trial as early as 1 week after stopping prior erlotinib provided all other study entry criteria are met)\n - Patients on the expansion cohort may not have received prior anti-EGFR therapy (small molecule tyrosine kinase inhibitor [TKI] or antibody); (Note: this in contrast to the dose escalation portion of the study in which patients with prior anti-EGFR therapy will be eligible)\n - Patients may not be receiving any other investigational agents\n - History of allergic reactions attributed to compounds of similar chemical or biologic composition to RO4929097, OSI-774 or other agents used in the study\n - Patients taking medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin®) are ineligible\n - Caution should be exercised when dosing RO4929097 concurrently with CYP3A4 substrates, inducers, and/or inhibitors; furthermore, patients who are taking concurrent medications (other than erlotinib) that are strong inducers/inhibitors or substrates of CYP3A4 should be switched to alternative medications; if such patients cannot be switched to alternative medications, they will be ineligible to participate in this study; if a patient is taking a strong CYP3A4 inhibitor/inducer other than the 2 study drugs, they should be switched to an alternative drug\n - Patients with malabsorption syndrome or other condition that would interfere with intestinal absorption\n - Diarrhea > grade 1 despite appropriate therapy\n - Patients who are known to be serologically positive for hepatitis A, B or C are ineligible\n - Patients with > grade 1 (by Common Terminology Criteria for Adverse Events [CTCAE] criteria) hyponatremia or hypocalcemia (based on measurement of ionized calcium) despite appropriate medical management are excluded from this study, as are patients with hypophosphatemia (serum phosphate below the lower limit of normal for the institution), hypomagnesemia, (serum magnesium below the lower limit of normal), hypokalemia, or hyperkalemia (serum potassium outside normal limits) despite appropriate medical management\n - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic therapy (with antibiotics, antiviral or antifungal agents), symptomatic congestive heart failure, unstable angina pectoris, angina at rest, a history of torsades de pointes, potentially life-threatening cardiac arrhythmias (patients are permitted to have chronic, stable atrial fibrillation, premature atrial or ventricular contractions, sinus tachycardia, provided the rate is controlled at < 115 per minute, and sinus bradycardia, provided the rate is > 50 per minute), myocardial infarction within the previous 3 months, or psychiatric illness/social situations that would limit compliance with study requirements\n - Pregnant women are excluded from this study\n - Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible\n - Cardiovascular: baseline corrected QT interval using Fridericia's formula (QTcF) > 450 msec (male) or QTcF > 470 msec (female)\n - Patients requiring drugs that are known to cause Torsades de pointes and/or prolonged corrected QT (QTc) intervals are excluded; patients requiring drugs with a possible but unproven association with Torsades de pointes and/or QTc prolongation may be eligible, but will require additional electrocardiogram assessments, as outlined\n - Patients who have not recovered to < CTCAE grade 2 toxicities related to prior therapy are not eligible to participate in this study\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
149	[ { "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\nClinical Trial Title:\n\nBiomarkers of Response in Blood and Tumor Tissue Samples From Patients With Unresectable Stage IV Squamous Cell Cancer of the Head and Neck Previously Treated With Cetuximab, Cisplatin, and Radiation Therapy\n\nClinical Trial Summary:\n\nRATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how patients respond to treatment.\n PURPOSE: This research study is studying biomarkers of response in blood and tumor tissue samples from patients with unresectable stage IV squamous cell carcinoma of the head and neck previously treated with cetuximab, cisplatin, and radiation therapy.\n\nClinical Trial Detailed Description:\n\nOBJECTIVES:\n Primary\n - To expand upon the list of molecular correlates indicated in clinical trial ECOG-E3303, including EGFR expression, EGFR phosphorylation, map kinase, AKT, and STAT3.\n - To correlate the status or expression level of each biomarker with clinical outcome (response, progression-free survival, overall survival).\n OUTLINE: Archived tumor and blood specimens are analyzed for human papilloma virus and p16 status; EGFR gene amplification; levels of ERCC1, XPF, and c-Met proteins; expression and activation of several signaling pathways including PI3 kinase gene and mTOR; levels of ErbB2, ErbB3, P70S6 kinase, S6 , and Akt; expression of amphiregulin (AR), TGF-alpha (TGF-α), heparin-binding EGF-like growth factor (HB-EGF), EGF, epiregulin and c-Met ligand, and hepatocyte growth factor by fluorescence in situ hybridization (FISH), automated in situ quantitative measurements of protein analysis (AQUA), IHC, PCR, and ELISA.\n\nClinical Trial Eligibility Criteria:\n\nDISEASE CHARACTERISTICS:\n - Diagnosis of squamous cell carcinoma of the head and neck\n - Stage IV disease\n - Unresectable disease\n - Treated with cetuximab, cisplatin, and radiotherapy on clinical trial ECOG-E3303\n - Archived blood and tumor tissue samples available\n PATIENT CHARACTERISTICS:\n - Not specified\n PRIOR CONCURRENT THERAPY:\n - See Disease Characteristics\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
150	[ { "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\nClinical Trial Title:\n\nPD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma\n\nClinical Trial Summary:\n\nThe purpose of this study is to find out what effects, good and/or bad, Palbociclib (Ibrance) (formerly known as PD0332991) has on the patient and on the liposarcoma.\n Palbociclib is an investigational drug. An investigational drug is a medication that has not been approved for marketing by the Food and Drug Administration (FDA). Palbociclib blocks a protein called CDK4 which is part of a pathway in liposarcoma cells that is over-active. The investigators hope that blocking CDK4 will shut down this pathway in the liposarcoma cells and stop tumors from growing. Palbociclib is an oral medication.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - A diagnosis of liposarcoma confirmed at MSKCC. Because myxoid / round cell liposarcoma does not have significant CDK4 amplification, patients with this subtype are not eligible.\n - Metastatic and/or locally advanced or locally recurrent disease that is not surgically resectable, with evidence of disease progression, either clinically or radiographically, as determined by the investigator\n - All patients must have measurable disease as defined by RECIST 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be >10 mm when measured by CT, MRI or caliper measurement by clinical exam; or >20 mm when measured by chest x-ray. Lymph nodes must be > 15 mm in short axis when measured by CT or MRI.\n - A minimum of 1 prior systemic regimen for recurrent/metastatic disease. Note: This requirement does not apply to patients enrolled in the Expansion Cohort. The last dose of systemic therapy (include targeted therapies) must have been given at least 2 weeks prior to initiation of therapy. Patients receiving BCNU or mitomycin C must have received their last dose of such therapy at least 6 weeks prior to initiation of therapy.\n - Patients with brain metastasis that have been treated with definitive surgery or radiation and have been clinically stable for 3 months are eligible.\n - Age > or = 18 years.\n - ECOG performance status 0 or 1.\n - Adequate organ and marrow function as defined below (ULN indicates institutional upper limit of normal):\n Absolute neutrophil count ≥ 1.5x109/L Hemoglobin ≥ 9.0 g/dL WBC ≥ 3.0x109/L Platelets ≥ 100x109/L Total bilirubin ≤ 1.5 x ULN except for patients with known Gilbert syndrome AST(SGOT)/ALT(SGPT) ≤ 3 x institutional ULN Serum creatinine ≤ 1.5 x ULN or Creatinine Clearance > 50 mL/min (calculated by Cockcroft-Gault method)QTc interval ≤ 470 msec\n - Patients must not have current evidence of another malignancy that requires treatment.\n - The effects of Palbociclib on the developing human fetus at the recommended therapeutic dose are unknown. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence). Women must not breast feed while on study.\n - Ability to understand and the willingness to sign a written informed consent document.\n - Ability to swallow intact Palbociclib capsules.\n - Patients‟ tumors must express Rb, as assessed using an historical biopsy sample if available or a newly obtained tumor sample. Samples must demonstrate ≥1+ staining for Rb. Patients' tumors must also have evidence of CDK4 amplification by FISH. Note: This does not apply to patients enrolled in the Expansion Cohort.\n Exclusion Criteria:\n - Patients who have not recovered from adverse events of prior therapy to ≤ NCI CTCAEv4.0 Grade 1.\n - Patients receiving any other investigational agents.\n - Patients who have received prior treatment with a selective CDK4 inhibitor\n - History of allergic reactions attributed to compounds of similar chemical or biologic composition to Palbociclib.\n - Uncontrolled intercurrent illness including, but not limited to, known ongoing or active infection, including HIV, active hepatitis B or C, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (specifically, atrial fibrillation or ventricular dysrhythmias except ventricular premature contractions), or psychiatric illness/social situations that would limit compliance with study requirements.\n - Pregnant women and women who are breast-feeding.\n - Patients with a history of long-QT syndrome or documented family history of long-QT syndrome. Patients who must remain on drugs that prolong the QT interval.\n - Palbociclib is a substrate of CYP3A. Caution should be exercised when dosing Palbociclib concurrently with CYP3A inducers or inhibitors. Furthermore, patients who are taking concurrent medications that are strong inducers/inhibitors or substrates of CYP3A4 should be switched to alternative medications to minimize any potential risk. A list of CYP3A4 substrates, inducers and/or inhibitors is provided in Appendix B. The following medications with strong potential for interaction are not allowed: indinavir nelfinavir ritonavir clarithromycin itraconazole ketoconazole nefazodone saquinavir telithromycin carbamazepine phenobarbital phenytoin pioglitazone rifabutin rifampin St. John's wort Troglitazone\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: definitely relevant" } ]	definitely relevant
151	[ { "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\nClinical Trial Title:\n\nA Study of PD 0332991 in Patients With Recurrent Rb Positive Glioblastoma\n\nClinical Trial Summary:\n\nThis study will determine the efficacy of the small molecule CDK4/6 inhibitor PD 0332991 (as measured by progression free survival at 6 months) in patients with recurrent glioblastoma multiforme or gliosarcoma who are Rb positive. A total of 30 patients will be treated; 15 will undergo a planned surgical resection and receive drug for 7 days prior to surgery, followed by drug after recovery from surgery, and the other 15 patients will receive drug without a planned surgical procedure.\n\nClinical Trial Detailed Description:\n\nA total of 30 patients with recurrent Glioblastoma or Gliosarcoma will be treated with PD 0332991 at a dose of 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Of these 30 patients, 15 will receive drug for 7 days prior to an indicated, intended surgical resection for progression, and will then resume drug at the same dose after recovery from surgery. Treatment will be repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients will be given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.\n Following registration, available blocks or slides from a previous surgery must be submitted for diagnosis review (confirmation of Glioblastoma multiforme or Gliosarcoma) and Rb status determination. Only patients with Rb positive tumors can be treated, and Rb tumor status must be known prior to any treatment. Additional tissue from previous surgeries will also be obtained to evaluate molecular abnormalities in the tumor. These studies will be done retrospectively and are not required to be performed prior to registration.\n Monitoring will include a clinical and neurological exam before the beginning of each cycle (every 4 weeks). Complete blood counts with differential will be examined on days 1 and 15 of each cycle. Liver and renal function will be performed every 4 weeks. Toxicity and dose modifications will be based on the NCI CTCAE Version 4. Disease status will be assessed clinically each cycle (every 4 weeks) and radiographically after each second cycle (every 8 weeks).\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Patients 18 years or older with KPS > 60, with life expectancy of > 8 weeks with radiographically proven recurrent, intracranial Glioblastoma multiforme or Gliosarcoma; patients must have documentation of Rb positive disease.\n - All patients must sign an informed consent and must have signed an authorization for the release of their protected health information.\n - Patients must have had prior external beam radiation and temozolomide chemotherapy; there is no limit to the number of prior chemotherapies used; patients may be treated in their first, second or third relapse\n - Patients must have recovered from the toxic effects of prior therapy\n - Patients must have adequate bone marrow function and renal function before starting therapy. A pre-study EKG with a normal QT interval is required for all patients\n - Patients must have shown unequivocal evidence for tumor progression by MRI scan and on a steroid dose that has been stable for at least 7 days.\n - Patients must have an interval of greater than or equal to 42 days from the completion of radiation therapy to study entry.\n - A subset of 15 patients will be enrolled prior to a planned, indicated surgical resection. Patients can be enrolled pre-operatively only if they are surgical candidates, do not have evidence of an acute intracranial hemorrhage and are able to start protocol treatment in a window of 7 days before surgery.\n - Male and female patients with reproductive potential must use an approved contraceptive method. Women of childbearing potential must have a negative beta-HCG pregnancy test\n - Blocks or slides of tumor tissue from a previous surgery must be available to do IHC Rb staining. Patients with negative tumors (Rb negative) will be excluded from the study.\n Exclusion Criteria:\n - Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.\n - Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible.\n - Patients on enzyme-inducing anti-epileptic drugs or other drugs that cause CYP3A enzyme induction or inhibition will not be eligible\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
152	[ { "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\nClinical Trial Title:\n\nConventional Nissen Fundoplication Versus Laparoscopic Nissen Fundoplication\n\nClinical Trial Summary:\n\nThis is a long-term follow-up of a prospective randomized trial comparing open and laparoscopic Nissen fundoplication.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - moderate / severe gastrointestinal reflux disease (GERD) requiring operative treatment\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
153	[ { "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\nClinical Trial Title:\n\nA Trial of LEE011 in Patients With Advanced Solid Tumors or Lymphoma.\n\nClinical Trial Summary:\n\nLEE011 is a new oral drug designed to inhibit the activity of an enzyme known as CDK4/6. CDK4/6 is involved in the process that allows both normal and cancer cells to divide and multiply. Cancer cells are often driven to divide and multiply by abnormalities that increase the activity of CDK4. Hence there is hope that blocking the activity of CDK4 may slow the growth of some cancers. LEE011 has shown anti-cancer activity in several different tumor models in animals.\n Because CDK4 is important in both normal and cancerous cells, LEE011 is expected to decrease the ability of the bone marrow to make white blood cells, platelets, and red blood cells. Although these effects are expected to be reversible, they can increase the risk of infection, bleeding and fatigue.\n The primary purpose of this study is to find the highest dose of LEE011 that can be safely given to adult patients with advanced solid tumors or lymphomas for which no further effective standard treatment is available. It will provide information about the side effects that may occur following treatment. The study will also possibly provide early evidence for LEE011's anti-tumor activity.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n 1. Patients aged ≥18 years with a histologically or cytologically confirmed diagnosis of a solid tumor or lymphoma for which no further effective standard treatment is available\n 2. Patients must have an ECOG performance status of 0 - 1\n 3. Patients enrolled in the dose expansion phase must have at least one measurable lesion as defined by RECIST criteria for solid tumors or Measurable nodal disease at baseline as defined by Cheson criteria for Lymphoma.\n 4. 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 in this study, to allow the effects of prior therapy to have abated:\n - Cytotoxic chemotherapy: ≥ the duration of the cycle of the most recent treatment regimen (a minimum of 2 weeks for all regimens, except 6 weeks for nitrosoureas and mitomycin-C).\n - Biologic therapy (e.g., antibodies): ≥ 4 weeks.\n 5. Patients must have adequate organ function, as defined by the following parameters:\n - Bone marrow: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Hemoglobin (Hgb) ≥ 9 g/dL, Platelets ≥ 100 x 109/L\n - Hepatic function: Serum total bilirubin ≤ 1.5 x ULN (upper limit of normal); AST (SGOT) and ALT (SGPT) ≤ 3 x ULN, except in patients with tumor involvement of the liver who must have AST and ALT ≤ 5 x ULN\n - Renal function: Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 40 ml/min, Serum potassium, magnesium and calcium must be within normal limits\n Exclusion Criteria:\n 1. Patients with primary central nervous system tumors or brain metastases. However, if radiation therapy and/or surgery has been completed and serial evaluation by CT (with contrast enhancement) or MRI over a minimum of 3 months demonstrates the disease to be stable and if the patient remains asymptomatic, then the patient may be enrolled. Such patients must have no need for treatment with steroids or anti-epileptic medications.\n 2. Impairment of gastro-intestinal (GI) function or GI disease that may significantly alter the absorption of LEE011 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 3. Prior hematopoietic stem cell or bone marrow transplantation\n 4. Impaired cardiac function or clinically significant cardiac diseases, including any of the following:\n - LVEF <45% as determined by MUGA or echo\n - Complete left bundle branch block\n - Obligate use of a cardiac pacemaker or implantable cardioverter defibrillator\n - Congenital long QT syndrome or family history of unexpected sudden cardiac death\n - History or presence of ventricular tachyarrhythmia\n - Presence of unstable atrial fibrillation (ventricular response > 100 bpm\n - Clinically significant resting bradycardia\n - QTcF >450 ms for males and >470 ms for females on screening ECG\n - Right bundle branch block and left anterior hemiblock (bifascicular block)\n - Angina pectoris ≤ 3 months prior to dosing with study drug\n - Acute MI ≤ 3 months prior to dosing with study drug\n - Other clinically significant heart disease\n 5. Acute myocardial infarction or angina pectoris ≤ 3 months prior to starting study drug\n 6. Patients with concurrent severe and/or uncontrolled concurrent medical conditions that 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 Known diagnosis of HIV or hepatitis C\n Other protocol-defined inclusion/exclusion criteria may apply\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: possibly relevant" } ]	possibly relevant
154	[ { "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\nClinical Trial Title:\n\nA Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors\n\nClinical Trial Summary:\n\nBackground: Gastroesophageal reflux disease (GERD), which affects at least 20% of adult Americans, may be especially common and severe in Veteran patients. Proton pump inhibitors (PPIs), which block gastric acid production, are the most effective medications for GERD, and the VA spends more than $177 million each year on outpatient PPI prescriptions. PPIs do not prevent the reflux of non-acidic material and do not completely eliminate esophageal acid exposure, however, and bothersome GERD symptoms persist in approximately 40% of patients treated with PPIs. Recent studies using the new technique of esophageal pH/ impedance monitoring, which detects the reflux of both acidic and non-acidic materials, have shown that PPI-resistant GERD symptoms correlate with episodes of reflux (acidic and/or non-acidic) in approximately one-half of patients. For those patients, an antireflux operation might relieve symptoms and obviate the expense of ineffective PPI therapy, but the efficacy of modern, laparoscopic fundoplication in this regard is not clear. For patients with PPI-resistant GERD symptoms, furthermore, the efficacy of medications that that can prevent gastroesophageal reflux (e.g. baclofen) or diminish pain of esophageal origin (e.g. neurotropic agents like desipramine) also is not clear. Study Hypothesis: Laparoscopic antireflux surgery (Nissen fundoplication) is superior to medical therapy (PPIs plus baclofen and desipramine) for GERD patients who, while on PPIs, have persistent episodes of heartburn that are associated with reflux episodes or with abnormal esophageal acid exposure by esophageal pH/impedance monitoring.\n Study Goals: The primary goal is to compare the efficacy of laparoscopic Nissen fundoplication and medical therapy (PPIs plus baclofen and desipramine) for GERD patients who, while on PPIs, have persistent episodes of heartburn that are associated with reflux episodes or with abnormal esophageal acid exposure by esophageal pH/impedance monitoring, and to compare the efficacy of each therapy with placebo. Secondary goals are: 1) To determine the frequency with which non-GERD disorders underlie \"PPI failure,\" 2) To determine the frequency of functional gastrointestinal symptoms, anxiety and depression in patients who have persistent heartburn while on PPIs, 3) To determine whether functional gastrointestinal symptoms, anxiety and depression is associated with the outcomes of medical and surgical therapies, and 4) To determine whether the outcome of Nissen fundoplication is associated with adherence to technical aspects of the operation.\n Study Design: At 15 VA medical centers, there will be a 30-month recruitment period to enroll 393 patients with heartburn that is refractory to PPI therapy. Patients will have their baseline GERD symptoms scored using the GERD Health-Related Quality of Life (GERD-HRQL) index, and will have endoscopy, esophageal manometry and esophageal pH/impedance monitoring while on PPI therapy. Patients who have episodes of heartburn that are associated with reflux episodes or with abnormal esophageal acid exposure by esophageal pH/impedance monitoring will be randomized to one of three treatment groups: Surgical Treatment (laparoscopic Nissen fundoplication), Active Medical Treatment (omeprazole and baclofen initially; desipramine for baclofen failures) or Placebo Medical Treatment (omeprazole, placebo baclofen, placebo desipramine). All patients will have quarterly clinic visits for symptom scoring and laboratory testing. At one year, patients will have a final symptom scoring and repeat endoscopy, esophageal manometry and esophageal pH/impedance monitoring. Treatment success will be defined as 50% improvement in the GERD-HRQL score at 12 months. Patients also will complete the Hospital Anxiety and Depression Scale (HADS), Rome III Functional GI Disorders Questionnaire and the Short-Form Health Survey (SF-36) at baseline and one year. The results will be correlated with treatment outcomes.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Age 18-64 years\n - History of heartburn (defined as a burning sensation in the retrosternal area of the chest) that is refractory to antisecretory medications\n - Initial GERD-HRQL:\n - Total score must be 6 and at least one of the six heartburn questions must be scored 2\n - GERD-HRQL after two weeks of treatment with omeprazole:\n - Total score must be >50% of the initial GERD-HRQL score and at least one of the six heartburn questions must be scored 2\n - Either or both of the following by baseline esophageal pH/multichannel intraluminal impedance (MII) monitoring in patients on omeprazole 20 mg two times a day (BID):\n - Positive symptom association probability (SAP) (>95%) for acid reflux, non-acid reflux or all reflux.\n - Abnormal acid reflux (esophageal pH<4 for 4.2% of the 24-hour monitoring period)\n Exclusion Criteria:\n - Patients who do not have heartburn, defined as a burning sensation in the chest\n - Patients unwilling or unable to provide informed consent\n - Pregnancy or women unwilling to use effective contraception\n - Age <18 or >64 years\n - History of surgery on the stomach or esophagus\n - History of seizure disorder\n - History of heart block\n - History of glaucoma\n - Allergy to or previous inability to tolerate study medications (omeprazole, baclofen, desipramine)\n - Esophageal varices\n - Cirrhosis\n - Co-morbidity of sufficient severity to preclude elective surgery (e.g. pulmonary, cardiac, renal, liver disease)\n - History of disorders that can cause medically-refractory \"GERD symptoms\" (eosinophilic esophagitis, neoplasms of the upper gastrointestinal tract, gastroparesis, achalasia)\n - Myocardial infarction within the past 6 months\n - History of bipolar disorder, schizophrenia or suicidal thoughts or suicide\n - Current use of thioridazine (Mellaril), monoamine oxidase inhibitors, pimozide, tricyclic antidepressants (TCAs), linezolid, metoclopramide\n - Current use of clopidogrel\n - Patients who have a contraindication to a study medication or who require therapy with a medication that has a clinically important drug interaction with study medication (omeprazole, baclofen, desipramine)\n - Patients who, in the judgment of the PI, are not suitable candidates for therapy with a study medication (omeprazole, baclofen, desipramine)\n - Initial GERD-HRQL score: Total score <6 and/or all heartburn scores <2\n - Inability to tolerate omeprazole during the 2-week treatment phase (before randomization)\n - GERD-HRQL after two weeks of treatment with omeprazole: Total score 50% of initial GERD-HRQL score and/or all heartburn scores <2\n - Laboratory abnormalities including:\n - Platelet count <100,000\n - international normalized ratio (INR) >1.5 (off anticoagulants)\n - Serum creatinine >2.0 mg per deciliter\n - Endoscopic abnormalities including:\n - Los Angeles Classification of Oesophagitis (LA grade) C or D reflux esophagitis\n - Active ulceration of the esophagus that is not due to reflux esophagitis\n - Candida esophagitis\n - Esophageal varices\n - Active ulceration of the stomach and/or duodenum\n - Neoplasm of the esophagus, stomach or duodenum\n - Gastric outlet obstruction\n - Eosinophilic esophagitis (15 eosinophils per high power field in any esophageal biopsy specimen)\n - Manometric abnormalities including:\n - Achalasia\n - Complete aperistalsis\n - Negative SAP ( 95%) for acid reflux, non-acid reflux and all reflux on baseline combined esophageal pH/MII monitoring and normal acid reflux (esophageal pH<4 for <4.2% of the 24-hour monitoring period)\n - Study surgeon identifies a contraindication to laparoscopic Nissen fundoplication\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
155	[ { "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\nClinical Trial Title:\n\nContinuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma\n\nClinical Trial Summary:\n\nThis randomization discontinuation trial will allow for concomitant evaluation of the following:\n - Side effects and benefits of immediate continuation of Trabectedin after the sixth cycle\n - Side effects and benefits of a drug holiday\n\nClinical Trial Detailed Description:\n\nSelection part (220 patients):\n Trabectedin (depending on dose reductions : between 1.5 and 1 mg/m²/3 weeks; over 24 hour administration) until progression, intolerance or 6 cycles (according to the SPC of Trabectedin)\n Randomized part (50 patients):\n After the 6 first cycles, if there is not progression or unacceptable toxicity, the patients will be randomly assigned to continuous or \"intermittent/holiday\" therapy with CT-scan evaluation every 6 weeks in both arms\n - Arm A Continuation of Trabectedin (between 1.5 and 1 mg/m²/3 weeks; over 24 hour administration) until progression or intolerance\n - Arm B \"Intermittent/holiday\" therapy. Rechallenge of Trabectedin will be implemented in the event of progression; in this case administration of Trabectedin will occur until the second progression or intolerance\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria (for the selection part):\n - Inoperable or metastatic soft tissue sarcoma and/or uterine sarcoma\n - Measurable lesions (RECIST 1.1)\n - Performance status ≤ 2\n - Age ≥ 18\n - Normal hematological parameters (polynuclear neutrophils ≥ 1500, hemoglobin level ≥ 9 g/dl, platelets counts ≥ 100,000)\n - Adequate biological parameters :\n - Adequate hepatic function (bilirubin ≤ ULN , SGPT/ALT and SGOT/AST ≤ 2.5 x ULN)\n - Alkaline phosphatases ≤ 2.5 x ULN, If Alkaline phosphatases ≥ 2.5 ULN, hepatic isoenzymes 5-nucleotidases or GGT tests must be performed; hepatic isoenzymes 5- nucleotidases and/or GGT must be within the normal range\n - Albumin ≥ 25 g/L\n - Adequate renal function : Serum creatinine ≤ 1.5 x ULN\n - Creatine phosphokinase ≤ 2.5 x ULN\n - Adequate central venous access\n - Pregnant or lactating women or men of reproductive potential must use effective contraceptive methods\n - Patient covered by government health insurance\n - Information sheet given to the patient (Patient information sheet 1)\n Exclusion Criteria (for the selection part):\n - Patients that have received more than one regimen of chemotherapy for metastatic or inoperable soft tissue or uterine sarcoma, after the failure/intolerance of doxorubicin and ifosfamide. Maintenance treatment does not count as treatment line\n - The following histological subtypes : GIST, rhabdomyosarcoma, aggressive fibromatosis, desmoïd tumour, PNET, carcinosarcoma, and all bone sarcomas\n - Single tumour in an irradiated region\n - Other malignant tumour over the past five years (except basal cell carcinoma or cervical carcinoma in situ adequately treated)\n - Currently active bacterial or fungus infection (> grade 2 CTC [CTCAE] Version 4.02). Known HIV1, HIV2, hepatitis B or hepatitis C infections\n - Presence of known leptomeningeal or brain metastasis\n - Patients unable to receive corticotherapy\n - Any circumstance that could jeopardise compliance or proper follow-up during the trial\n - Pregnant or nursing women\n Inclusion Criteria (for the randomized part):\n - Patient registered in the selection part\n - Stable tumour or objective response (CR + PR) after 6 Trabectedin (Yondelis®) cycles, according to local assessment\n - Available copies of thoraco-abdominal and pelvic scan performed prior to the first cycle and after the sixth cycle\n - Performance status ≤ 2\n - Patients receiving at least 1 mg/m²/3 weeks of Trabectedin at the time of the sixth cycle\n - Normal hematological parameters (polynuclear neutrophils ≥ 1500, hemoglobin level ≥ 9 g/dl, platelets counts ≥ 100,000)\n - Adequate biological parameters :\n - Adequate hepatic function (bilirubin ≤ ULN , SGPT/ALT and SGOT/AST ≤ 2.5 x ULN)\n - Alkaline phosphatases ≤ 2.5 x ULN, If Alkaline phosphatases ≥ 2.5 ULN, hepatic isoenzymes 5-nucleotidases or GGT tests must be performed; hepatic isoenzymes 5- nucleotidases and/or GGT must be within the normal range\n - Albumin ≥ 25 g/L\n - Adequate renal function : Serum creatinine ≤ 1.5 x ULN\n - Creatine phosphokinase (CPK) ≤ 2.5 x ULN\n - Adequate central venous access\n - Pregnant or lactating women or men of reproductive potential must use effective contraceptive methods\n - Informed consent form signed by the patient or the patient's legal representative (patient information sheet 2 and informed consent)\n Exclusion Criteria (for the randomized part):\n - Tumour progression (according to RECIST 1.1) during the first six Yondelis cycles\n - Non-availability of baseline scans prior to the first cycle and following the sixth cycle\n - Currently active bacterial or fungus infection (> grade 2 CTC [CTCAE] Version 4.02). Known HIV1, HIV2, hepatitis B or hepatitis C infections\n - Presence of known leptomeningeal or brain metastasis\n - Creatinine clearance less than 30 ml/min\n - Patients unable to receive corticotherapy\n - Any circumstance that could jeopardise compliance or proper follow-up during the trial\n - Pregnant or nursing women\n - Hypersensitivity to Trabectedin or any excipient in prior cycles\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
156	[ { "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\nClinical Trial Title:\n\nA Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma\n\nClinical Trial Summary:\n\nThe purpose of this study is to evaluate whether overall survival for the trabectedin group is superior to the dacarbazine group for patients with advanced L-sarcoma (liposarcoma or leiomyosarcoma).\n\nClinical Trial Detailed Description:\n\nThis is a randomized study (study drug assigned by chance) using a 2:1 randomization. It is an open-label (all people know study drug), active-controlled (comparing to a different drug used for the same condition), parallel-group (different treatment groups continue with separate treatments throughout the study), multicenter study. This study will be divided into 3 phases, screening, treatment, follow-up and optional extension phase (OEP). During screening, potential participants will be assessed for study eligibility after providing signed informed consent. Approximately 570 patients who satisfy all inclusion and exclusion criteria will be randomly assigned in a 2:1 ratio to either the trabectedin (n=380) or dacarbazine (n=190) treatment groups. During the treatment phase, patients will receive study drug once every 3 weeks, until disease progression (defined by Response Evaluation Criteria in Solid Tumors [RECIST] Version 1.1 criteria) or signs of toxicity. Assessments will be performed to evaluate the effectiveness of the drug, and patient safety will be monitored. During the follow-up phase, after the last dose of study drug, clinical outcomes for patients will be evaluated. Trabectedin will be administered at a dose of 1.5 milligram per square meters (mg/m^2) through a catheter into a large vein as a 24-hour intravenous (IV) infusion, once every 3 weeks, until disease progression or signs of toxicity. Dacarbazine will be administered at a dose of 1.0 g/m^2 as a 20-120 minute infusion, once every 3 weeks, until disease progression or signs of toxicity. In the OEP, participants who were previously randomized to the dacarbazine group will have the option to receive trabectedin at the discretion of the investigator.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Histologically proven, unresectable, locally advanced or metastatic liposarcoma (dedifferentiated, myxoid round cell, or pleomorphic) or leiomyosarcoma. Participants must have a pathology report indicating the diagnosis of liposarcoma or leiomyosarcoma that has been reviewed by the sponsor before randomization may occur\n - Treated in any order with at least: an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen\n - Measurable disease at baseline in accordance with RECIST Version 1.1\n - Pathology specimens (example [e.g.], tumor blocks or unstained slides) for potential centralized pathology review and biomarker studies\n - ECOG Performance Status score of 0 or 1\n - Adequate recovery from prior therapy, all side effects (except alopecia) have resolved to Grade 1 or less according to the National Cancer Institute - Common Terminology Criteria of Adverse Events (NCI-CTCAE) Version 4.0\n - Adequate organ function as evidenced by the following peripheral blood counts or serum chemistry values: hemoglobin 9 gram per deciliters (g/dL), absolute neutrophil count (ANC) 1,500/L, platelet count 100,000/L, serum creatinine 1.5the upper limit of normal (ULN), creatine phosphokinase (CPK) 2.5 Upper Limit of Normal [ULN]\n - Adequate hepatic function as evidenced by the following serum chemistry values: total bilirubin, ULN. If total bilirubin is greater than (>) ULN, measure indirect bilirubin to evaluate for Gilbert's syndrome (if direct bilirubin is within normal range, participant may be eligible) ALP 2.5 x ULN; Trabectedin: if the ALP is >2.5 x ULN, then an ALP liver fraction or 5-nucleotidase must be obtained and ULN, AST and ALT 2.5 ULN\n - Negative pregnancy test (urinary or serum beta-HCG) at screening (applicable to women of child bearing potential who are sexually active)\n - Female participants must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent (at the discretion of the investigator), or if sexually active, be practicing an effective method of birth control. Male participants must agree to use an adequate contraception method as deemed appropriate by the investigator (e.g., vasectomy, double-barrier, partner using effective contraception) and to not donate sperm for a minimum of 5 months after treatment discontinuation\n Optional Extension Phase (OEP) Phase:\n - Documentation for inclusion criteria histologically proven, unresectable, locally advanced or metastatic liposarcoma (dedifferentiated, myxoid round cell, or pleomorphic) or leiomyosarcoma. Participants must have a pathology report indicating the diagnosis of liposarcoma or leiomyosarcoma that has been reviewed by the sponsor before randomization may occur and treated in any order with at least: an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen do not need to be reviewed by the Sponsor\n - Collection of the specimen: Pathology specimens (example (e.g.), tumor blocks or unstained slides) for potential centralized pathology review and biomarker studies is not applicable\n - Documentation of inclusion criteria adequate organ function as evidenced by the following peripheral blood counts or serum chemistry values: hemoglobin 9 gram per deciliters (g/dL), absolute neutrophil count (ANC) 1,500/L, platelet count 100,000/L, serum creatinine 1.5the upper limit of normal (ULN), creatine phosphokinase (CPK) 2.5ULN and adequate hepatic function as evidenced by the following serum chemistry values: total bilirubin, ULN. If total bilirubin is greater than (>) ULN, measure indirect bilirubin to evaluate for Gilbert's syndrome (if direct bilirubin is within normal range, participant may be eligible) ALP <= 2.5ULN; Trabectedin: if the ALP is >2.5ULN, then an ALP liver fraction or 5-nucleotidase must be obtained and ULN, AST and ALT 2.5 ULN will be reviewed by the Sponsor before enrollment in the OEP may occur\n Exclusion Criteria:\n - Potential participants who meet any of the following criteria will be excluded from participating in the study: Prior exposure to trabectedin or dacarabazine, less than 3 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or therapy with any investigational agent, other malignancy within past 3 years. Exceptions: basal or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, or Federation Internationale de Gynecologie et d'Obstetrique (FIGO) Stage 1 carcinoma of the cervix\n - Known central nervous system metastasis\n - Known significant chronic liver disease, such as cirrhosis or active hepatitis (potential participants who test positive for hepatitis B surface antigen or hepatitis C antibodies are allowed provided they do not have active disease requiring antiviral therapy)\n - Myocardial infarct within 6 months before enrollment, New York Heart Association Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities\n - Uncontrolled intercurrent illness including, but not limited to, poorly controlled hypertension or diabetes, ongoing active infection, or psychiatric illness/social situation that may potentially impair the participant's compliance with study procedures\n - Unwilling or unable to have a central venous catheter\n - Known allergies, hypersensitivity, or intolerance to trabectedin, dacarbazine, dexamethasone, or their excipients\n - Pregnant or breast-feeding\n - Any condition that, in the opinion of the investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements\n OEP phase:\n - Potential participants who meet any of the following criteria will be excluded from Participating in the study: Prior exposure to trabectedin, less than 3 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or therapy with any investigational agent, other malignancy within past 3 years. Exceptions: basal or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, or Federation Internationale de Gynecologie et d'Obstetrique (FIGO) Stage 1 carcinoma of the cervix does not apply\n - Treated in any order with at least: an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen with less than 3 weeks from last dose of systemic anticancer therapy, radiation therapy, or therapy with any investigational agent\n - Known allergies, hypersensitivity, or intolerance to dacarbazine does not apply\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
157	[ { "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\nClinical Trial Title:\n\nA Clinical Research Study to Determine Whether PD 0332991 May Be Effective in Treating Patients With Liver Cancer\n\nClinical Trial Summary:\n\nThis is a Phase 2 Study of PD-0332991 in the treatment of patients with Advanced Hepatocellular Carcinoma (HCC), a type of adenocarcinoma and the most common type of liver tumor. PD-0332991 is a compound that stops the tumor cell from entering the Synthesis phase of the cell cycle, therefore stopping DNA multiplication and decreased tumor cell copying.\n\nClinical Trial Detailed Description:\n\nHepatocellular carcinoma (HCC) is the fifth most common cancer worldwide and the third most frequent cause of cancer-related mortality. To date, surgical resection and liver transplantation are considered the main curative treatment options for HCC (El-Serag et al. 2006). However, the majority (~75%) of patients present with advanced tumor stage and poor liver function, rendering the patient ineligible for surgical interventions. Until the multikinase inhibitor sorafenib (Nexavar) was approved for the treatment of HCC in patients with unresectable disease (disease that can't be removed by surgery), there were no standard systemic therapies, as classical cell killing drugs (administered singularly or in combination) had not led to reproducible response rates or survival benefit. Despite this, response rates to sorafenib are low with overall benefits modest, and moreover the toxicity profile of the drug limits treatment for many patients. There is still a critical need for additional effective drugs to treat advanced HCC.\n PD-0332991 is an orally available, selective inhibitor of cyclin-dependent kinase 4/6 (CDK4/6), a key regulator of cell growth. Pre-clinical data with PD-0332991 demonstrated potent target-specificity. PD-0332991 demonstrated significant inhibition of tumor cell growth in hepatoma cell lines, as well as animal and xenograft model systems, and was more effective than the currently approved drug, sorafenib in these systems. Initial clinical trials have demonstrated and acceptable toxicity profile for the drug. Thus, PD-0332991 represents an ideal candidate for the treatment of patients with advanced HCC.\n This trial is an open-label non-randomized single-institution study for subjects with inoperable, recurrent/refractory, advanced hepatocellular carcinoma (HCC). Subjects must have failed or be intolerant of standard first line therapy, sorafenib (Nexavar®). Eligible subjects will receive 125 mg PD-0332991 capsules orally once daily, administered on days 1-21 of a 28-day cycle, in repeated cycles. The primary objective of the study is to assess the time to disease progression (TTP). Secondary objectives include assessment of safety and tolerability, and determination of overall survival (OS) and response rate (RR).\n Subjects will be permitted to receive protocol directed therapy until disease progression as determined by modified RECIST (Response Evaluation Criteria in Solid Tumors) guidelines or clinical progression, unacceptable toxicity, withdrawal of consent or death. Tumor response assessment will be performed by the Investigator and will consist of evaluation by CT or MRI every 8 weeks. Subjects who discontinue therapy will still be followed for safety on Day 28 (± 3 days), Day 56 (± 3 days) and every 3 months thereafter from the last administration of protocol-directed therapy or until death.\n Subjects will be continuously assessed for evidence of acute and cumulative toxicity. Vital signs, physical examinations, performance status, laboratory safety tests will be obtained and assessed prior to drug administration at regular intervals throughout the study. Toxicity will be evaluated every 2 weeks during the first 3 cycles and thereafter monthly (once per cycle) by the Investigator according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n 1. Male or female, age > or = 18 years with HCC refractory to currently available therapies.\n 2. Documented HCC by at least 2 out of 3 mentioned criteria and evidence of non-resectability by a multidisciplinary team:\n A. Radiological - MRI with arterial enhancement and rapid venous washout B. Biopsy C. Serum alpha-fetoprotein level > or = 200\n 3. Positive staining for RB-function on tumor biopsy.\n 4. Subject must be able to give written informed consent and be able to follow protocol requirements\n 5. Life expectancy greater than 3 months\n 6. Be Child's-Pugh class A or B\n 7. ECOG Performance status of < or = 2\n 8. If female of childbearing potential must have negative pregnancy test at screening and may not be breast-feeding\n 9. Females of child-bearing potential (< one year post-menopausal with documented FSH greater than 30 IU/L or surgically not sterile), must agree to practice an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device, condom, diaphragm with spermicidal, cervical cap, abstinence or sterile sex partner) from the time informed consent is signed through follow-up. Males must agree to take appropriate precautions to avoid fathering a child from screening through follow-up.\n 10. No other active malignancy requiring treatment in the last 3 years other than adequately treated non-melanomatous skin cancer, adequately treated cervical carcinoma in-situ, superficial adequately treated bladder cancer or prostatic intraepithelial neoplasia without evidence of prostate cancer.\n 11. Adequate bone marrow, liver and renal function as assessed by the following:\n A. Hemoglobin > or = 8 g/dL B. WBC > or = 4,000/uL C. Absolute neutrophil count > or = 1,500/uL D. Platelets > or = 75,000/uL E. Total bilirubin < or = 1.5 times ULN F. ALT and AST < or = 5 times ULN G. Creatinine < or = 1.5 times ULN H. Albumin > or = 2.5 mg/dL\n 12. Subjects who have received previous radiotherapy, loco-regional, or systemic therapy are eligible. A minimum interval of 4 weeks since the last anti-cancer treatment of any kind is required.\n 13. Subjects with brain metastases or a history of previously treated brain metastasis are eligible but must:\n A. Have been treated by surgery or stereotactic radiosurgery (SRS) at least 4 weeks prior to enrollment B. AND have a baseline MRI or CT that shows no evidence of active intercranial disease C. AND be off steroids for at least 1 week prior to study enrollment\n Exclusion Criteria:\n 1. 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, or other malignancies curatively treated > 3 years prior to study entry)\n 2. History of severe cardiovascular disease within the last 12 months: symptomatic congestive heart failure, myocardial infarction, coronary artery disease (CAD), life threatening arrhythmias, uncontrolled hypertension\n 3. Renal failure requiring hemo- or peritoneal dialysis\n 4. Unstable systemic diseases or active uncontrolled infection\n 5. Known history of HIV infection\n 6. Clinically significant gastrointestinal bleeding within 30 days prior to study entry\n 7. Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to study entry\n 8. Child's-Pugh Class C\n 9. Any malabsorption problem that, in the investigator's opinion, would prevent adequate absorption of the study drug\n 10. Presence of any other medical complications that in the investigator's opinion, suggests a survival of < 3 months\n 11. Substance abuse, or medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results\n 12. Patient inability to swallow oral medications\n 13. Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study\n 14. Pregnant or breast-feeding patients\n 15. Being of reproductive potential and unable or unwilling to practice an effective contraceptive method\n 16. Lack of positive staining for RB-function on tumor biopsy.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
158	[ { "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\nClinical Trial Title:\n\nThe Roles of Neutrophil Elastase in Lung Cancer\n\nClinical Trial Summary:\n\nLung cancer is the leading cause of cancer death in Hong Kong. Lung adenocarcinomas is the most common type, accounting for 70% of lung cancer and the molecular target of epidermal growth factor receptor (EGFR) gene mutation at exons 18 - 21 is present in about 50% of lung adenocarcinomas. The v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (K-ras) mutations are commonly present in the other 50% that are EGFR wildtype. EGFR and K-ras mutations are found to be mutually exclusive in the same tumor. EGFR-tyrosine kinase inhibitor (TKI) can be used as treatment for EGFR mutated tumors while no specific targeted therapy can be recommended for EGFR wildtype tumors and these patients often receive chemoirradiation, which is toxic and clinical response is suboptimal. There is a need to find alternative molecular pathways/targets in EGFR wildtype lung adenocarcinomas.\n Even with EGFR mutations, good clinical response to EGFR-TKI is achieved in about 70% of these patients. This would mean suboptimal targeting of the EGFR gene or the presence of alternative pathways mediating tumor progression and susceptibility to therapy. Exploration of molecular pathways in lung cancer may allow for discovery of new molecular targets for therapeutic development.\n Neutrophil infiltration is frequently observed in lung cancer. Recognized similarities between neutrophils and cancer cells include (i) ability to circulate as single cells; (ii) target attachment via vascular system; (iii) target invasion. The major difference is that migrated neutrophils will undergo apoptosis while cancer cells can escape apoptosis.\n This led to the postulation that neutrophils and cancer cells may share similar inflammatory cascades by secreting a similar panel of proteases, and one of these could be neutrophil elastase (NE). Animal studies demonstrated that NE from neutrophils moves into lung tumor cells and mediates lung tumor growth via degradation of Insulin receptor substrate-1 (IRS-1), leading to activation of intracellular phosphoinositide-3-kinase (PI3k) and the v-akt murine thymoma viral oncogene homolog 1 (Akt) signaling pathways and the intracellular tyrosine kinase of the platelet-derived growth factor receptor (PDGFR).\n The aims of this study are to demonstrate NE activities and the subsequent signaling cascades activated in lung cancer cells, and to verify NE and its related pathway activation in clinical lung cancer specimen.\n This study will conclude the roles of NE and the therapeutic potential of NE/IRS-1/PI3K/PDGFR pathways in EGFR wildtype lung adenocarinomas.\n\nClinical Trial Detailed Description:\n\nObjectives\n 1. To demonstrate the presence of NE in vitro and the entrance into lung adenocarcinoma cells\n 2. To identify the intracellular mechanisms through which NE mediates its tumor proliferating effects\n 3. To verify the activation of NE and its related pathway component in clinical lung adenocarcinoma specimens\n Background of research\n Lung Cancer in Hong Kong Lung cancer is the leading cause of cancer death in Hong Kong [1]. Surgical resection for early stage lung cancer is the only curative option and advanced stage lung cancer is treated with chemoirradiation or molecular targeted agents, one of which is Epidermal Growth Factor Receptor - Tyrosine Kinase Inhibitor (EGFR-TKI). Recent advances in molecular biology of lung cancer allowed for development of these targeted therapy. However, treatment response depends on the presence of activating EGFR gene mutation, and the median response period is usually maintained for nine to twelve months, after which the tumor usually become non-responsive or resistant to EGFR-TKI.\n EGFR mutation vs EGFR wildtype lung adenocarcinomas\n In Asian populations including Hong Kong, EGFR mutations at exons 18 - 21 are present in up to 50% of lung adenocarcinomas, while the other 50% are EGFR wild type lung adenocarcinomas and are usually bearing K-ras gene mutations [2]. Even with the presence of activating EGFR gene mutations at exons 18 - 21, clinical response was observed in only 70% of patients with tumors bearing EGFR mutations [3]. It is apparent that in a cohort of lung adenocarcinomas, there can be the following groupings according to their EGFR gene mutation status:\n (i) EGFR mutated lung adenocarcinomas (~50%)\n 1. with response to TKI treatment (~35%)\n 2. but unresponsive to TKI treatment (~15%) (ii) EGFR wildtype lung adenocarcinomas (~50%) The presence of group (i)(b) tumors with EGFR but failed response to treatment would mean suboptimal targeting of EGFR and the presence of group (ii) EGFR wildtype tumors would imply alternative pathways mediating tumor progression and susceptibility to tumor therapy in lung cancer. Exploration of molecular pathways in lung adenocarcinomas may allow for discovery of new molecular targets for therapeutic development in lung cancer.\n Neutrophils vs cancer cells\n Neutrophil infiltration, and hence inflammatory infiltrate, is a frequently observed in lung cancer [4]. Recognized similarities between neutrophils and cancer cells include:\n 1. ability to circulate as single cells\n 2. target attachment via vascular system\n 3. target invasion Neutrophils achieve migration through pulmonary epithelial layers by secreting NE, which is readily balanced by the local action of secretory leukocyte peptidase inhibitor (SLPI). SLPI has also been detected in cancer tissues but the relevant function role in lung cancer has not been defined yet [5]. The major difference between neutrophils and cancer cells lies in the fact that migrated neutrophils will undergo apoptosis while cancer cells can escape apoptosis and are able to proliferate in target organs.\n The possible roles of NE in lung cancer This has led to the speculation that neutrophils and cancer cells may share similar inflammatory cascades by secreting a similar panel of proteases, and one of these had been demonstrated to be neutrophil elastase (NE). The action of NE may happen at different cellular levels: (1) action on extracellular matrix to facilitate migration and tissue invasion; (2) action on cell surface signaling receptors; or (3) intracellular action on signaling pathways following uptake into signaling endosomes. There are recent evidence in animal studies that NE secreted by neutrophils actually moved into lung tumor cells and mediates lung tumor growth via degradation of Insulin receptor substrate-1 (IRS-1) and subsequent effects on the intracellular PI3K signaling pathways acting on the intracellular tyrosine kinase domain of the platelet-derived growth factor receptor (PDGFR)[6]. It is possible that neutrophils infiltrating lung tumor stromal tissues may be acting in collaboration with cancer cells via the direct and indirect actions of NE.\n Work done by others Immunoreactive NE, both in free and in complex forms, can be demonstrated in breast cancer cell lines [7] and lung cancer cell lines [8]. NE activities has been further demonstrated in human breast cancer tissues [9] but not in human lung cancer tissues or normal lung tissues. These showed that NE is present at the tissue level but their intracellular action, whether enzymatically active or signaling active, has not been delineated clearly yet.\n In breast cancer tissues, the higher the amount of extracted tissue NE, the worse was the prognosis [9] and similar prognostic significance was suggested for NE in non-small cell lung cancer [10].\n When lung cancer cells were inoculated into severe combined immunodeficiency (SCID) mice, concomitant administration of NE inhibitor, ONO-5046, will completely suppressed tumor growth and appearance of metastatic foci [11]. The exact mechanism of action of ONO-5046 remains to be clarified.\n NE has also been shown to cleave cell surface epidermal growth factor (EGF) and transforming growth factor-alpha (TGF-α) [12, 13]. This may send aberrant signals to tumor cells EGF receptors and promote cancer cell proliferation in vitro.\n TGF-α also induced NE expression in human cancer cell lines (breast and pancreas)\n There were recent works by Houghton et al [6] demonstrating NE could influence lung cancer growth and development by:\n 1. permeating into lung tumor cells (A549 lung adenocarcinoma cell line with Kras mutation) and, via degradation of IRS-1, mediating tumor cell progression.\n 2. being blocked by specific inhibitors (ONO-5046), leading to aberrant intracellular signaling and then tumor cell growth arrest.\n Work done by our groups NE in airway inflammation Our group had done work related to the roles of NE in airway inflammation and diseases and we have raised cancer and normal bronchial bronchial epithelial cell lines from local patients that would be appropriate models for testing the hypothesis in local patient populations.\n Syndecan-1 was found to be able to bind NE in sputum sol of bronchiectasis, supporting the role of NE complexed with syndecan-1 in balance with antielastase [14]. We have also demonstrated shed syndecan-1 from human lymphoid cell line was able to bind to NE, disturbing the NE and anti-elastase balance in the airway environment, and thus could be playing a role in airway inflammation [15].\n We have tried to unopposed NE in the airway fluids in a cigarette smoke-induced model of COPD in rats. Sulfated maltoheptaose to chelate NE was administered to rats and bronchoalveolar lavage fluid (BALF) and lung tissues were collected 3 days after administration that showed significant declines in NE activity and myeloperoxidase activity as compared to BALF of smoking rats not treated. Significant reduction in neutrophil accumulation was also observed in BALF and lung tissue sections. Airspace enlargement was significantly reduced following the treatment. All these results suggested that sulfated maltohepatose is a potential therapeutic against neutrophilic inflammation in the airways of patients with COPD. (unpublished data).\n We have also tested the NE activity of a lung adenocarcinoma cell line A549 and found that radio-labelled cells migrate into lung cancer cells and is enzymatically inactive (unpublished data) Lung cancer cell lines and normal bronchial epithelial cells and clinical lung cancer tissue bank\n We have recently established primary lung cancer and normal bronchial epithelial cell lines from local Chinese patients and they were characterized with in vitro growth kinetics, morphological and immunohistochemical studies and gene expression profiling [16]. At the moment, we have:\n 1. Four primary lung adenocarcinoma cell lines (HKULC 1 - 4) published [16] and six more newly established in various phase of characterization.\n 2. Two new normal bronchial epithelial cell lines immortalized with standard protocols with cdk4 and hTert infections [17].\n These new cell lines were all derived from clinical specimen from the local Hong Kong Chinese patients and more are becoming established with continued accrual of clinical collection. The clinical data of the patients, including gender and smoking history, from which these primary lung adenocarcinoma cell lines originated were known. Together with 10 other ATCC lung adenocarcinoma cell lines and established normal bronchial epithelial lines (HBEC-KT 1 - 5) from John Minna MD, Tx, USA, these cell lines will provide invaluable materials to test for in vivo effects of NE on cancer cells.\n With the collaboration of Queen Mary Hospital Cardiothoracic Surgical Department, we have also collected 40 pairs of resected lung adenocarcinomas and normal lung tissues that will allow for verification of in vitro findings in clinical specimens. Further collection accrual of clinical specimens is in progress\n The research questions to be addressed (Figure 1) are:\n 1. What are the roles of NE in lung adenocarcinoma proliferation?\n 2. How are such roles of NE mediated at the intracellular signaling level? Is IRS-1/PI3K/PDGFR the most common axis involved in cancer cells? Or there will be 'cross-talk' with pathways such as EGFR or TNF-α in lung adenocarcinoma proliferation?\n 3. Can we verify such roles of NE in cancer proliferation in human lung adenocarcinoma tissues?\n The aims of the study will be:\n 1. To determine the mode of entrance and site of action of labeled NE in lung adenocarcinoma cells\n 2. To study the activation of IRS-1/PI3K/PDGFR in lung adenocarcinoma cells after penetrance by NE and if there will be concurrent activation of other signaling pathways including the EGFR and TNF-α pathways\n 3. To study the effects of blocking NE with specific NE inhibitors on lung adenocarcinoma cell proliferation\n 4. To verify the above mechanisms of actions of NE in clinical lung adenocarcinoma specimens\n Plan of study:\n 1. EGFR mutation profiling of lung adenocarcinoma cell lines and resected lung adenocarcinomas Genomic DNA will be extracted from available lung adenocarcinoma cell lines (20 specimens) as well as microdissected surgical lung adenocarcinoma specimens. Exons 18 - 21 will be PCR-amplified and directly sequenced to read for EGFR mutation in exons 18 - 21. This will characterize available lung adenocarcinomas cell lines and clinical tumor specimens with respect to EGFR gene mutation or EGFR wildtype for subsequent work, where experimental results will be compared between the two groups.\n 2. For aim (1) - (3), the mode of entrance and site of action of NE in lung adenocarcinoma cells will be studied.\n Live cell imaging Live cell imaging technique with Alex-Flour-488-labelled NE will be employed to localize and follow the path of NE entrance into lung adenocarcinoma cells. Eglin C, a proteolytic inhibitor, will be applied at the same time. Normal bronchial epithelial cell lines will be used for comparison. The intracellular location of entrance and possible activated structural changes will be recorded.\n NE-specific reverse transcription PCR cDNA amplified from total RNA will be amplified using RT-PCR with specific primers 5'-GAG GCA ATT CCG TGG ATT AG-3' and 5' ACG ACA TCG TGA TTC TCC AG-3' Western blotting NE-stimulated cells from (1) above will have proteins extracted by standard methods followed by immunoblotting with specific monoclonal antibodies to study related signaling pathways including pAkt, Akt, p85, IRS-1, IRS-2, PDGF, PDGF-α, pPDGF-α, p44/42 MAPK, phosphor-p44/42 MAPK as well as pEGFR and TNF-α. Anti-β-actin will be used as endogenous control. Reaction to individual markers will be done in triplicates Cell growth assay The effect of ONO-5046, a specific NE inhibitor, on cell growth and proliferation will be studied on lung adenocarcinoma cell lines compared to control (no drug administration).\n 3. For aims (4), we would like to study the activation of relevant signaling pathways upon NE stimulation\n 1. Immunohistochemistry Immunohistochemical staining will be performed on clinical lung adenocarcinoma specimens with specific monoclonal antibodies against NE, PDGF, PDGFR, IRS-1 and EGFR. Concordance of staining pattern will be examined between IRS-1 and EGFR or PDGF respectively. The proportion of discordant cases will be compared with the proportion of concordant cases.\n 2. NE assay in clinical lung cancer specimens from human subjects Clinical lung cancer specimens will be collected from patients with lung adenocarcinomas and NE activities assayed.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - All subjects undergoing clinical diagnostic or therapeutic procedures, including:\n 1. Fibreoptic bronchoscopy or pleuroscopy\n 2. Diagnostic or Therapeutic pleurocentesis AND who are mentally fit to give informed consent for donation of clinical specimens\n Exclusion Criteria:\n - Patients who cannot give written informed consent or refuse to give such consent for participation in this study\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
159	[ { "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\nClinical Trial Title:\n\nEffect of GSK962040 on Oesophageal Function\n\nClinical Trial Summary:\n\nGSK962040 is a selective non-peptide motilin receptor agonist which is in development for the treatment of conditions associated with slow rates of gastric emptying. Single ascending doses (1 to 150 mg), and 14-days repeated doses (10 to 125 mg daily) have been investigated in two randomized, placebo-controlled trials. Results show that these doses were well tolerated with few mild to moderate adverse events (AE), and no clinically significant abnormal vital sign measurements, ECG changes or abnormal clinical laboratory findings. GSK962040 exhibited predictable PK with and without food. The mean within subject time for half a [13C]-containing meal to empty from the stomach (GE t½) decreased by 22-43% from placebo with GSK962040 50-150 mg single doses, and shortening of gastric emptying was confirmed at doses of 50 mg and above in the repeat dose study.\n Several studies have shown that motilin agonists increase lower oesophageal sphincter (LOS) pressure and have various dose dependent effects on oesophageal peristaltic amplitudes and propulsive contractions in both healthy volunteers and patients with gastro-oesophageal reflux disease (GORD). The purpose of the present study is to examine the effect of GSK962040 on oesophageal function, using techniques such as high resolution oesophageal manometry, and pH/gastric transit using a wireless motility capsule.\n\nClinical Trial Detailed Description:\n\nMotilin is a peptide found in specific endocrine cells in the epithelia of the upper small intestine . It is released during fasting to act at its own receptor (motilin receptor, previously known as GPR38) resulting in the initiation of Phase III of the migrating motor complex (MMC). MMCs begin in the upper regions of the gut and are usually characterized by three distinct phases (I, a period of near-quiescence; II, short- or non-propulsive contractions at irregular frequency; III, a final burst of high amplitude propulsive contractions), terminating within the distal regions of the small intestine. Phase III activity may help clear the stomach and intestine from any undigested material, prevent bacterial overgrowth in the upper gut and perhaps help develop the sensation of hunger. The association of motilin release with Phase III of the MMC, together with an ability of motilin to mimic the strong propulsive contractions which comprise Phase III, has argued for an involvement of motilin in the regulation of certain functions of the gut during fasting.\n Motilin receptor agonists can increase gastric emptying after ingestion of a meal; this action is mediated via the cholinergic system of the stomach. Erythromycin and motilides (non-peptide derivatives of macrolide antibiotics but devoid of antibiotic activity) are motilin receptor agonists and effective gastroprokinetic agents in patients. Erythromycin has been shown to stimulate gastric emptying in patients with diabetic, idiopathic and post-vagotomy gastroparesis, and in critically-ill patients receiving enteral nutrition, EM574 and KC 11458, and the peptide motilin receptor agonist atilmotin, also increase gastric emptying in humans.\n In addition to effects on gastric emptying, motilin also appears to produce an effect on the oesophageal musculature. In particular, several studies have shown that single doses of motilin agonists (erythromycin in healthy volunteers and in patients with gastro-oesophageal reflux disease (GORD), atilmotin, a peptide motilin agonist, in healthy volunteers) , increase lower oesophageal sphincter (LOS) pressure and have various dose dependent effects on oesophageal peristaltic amplitudes and propulsive contractions in both healthy volunteers and patients with GORD. In addition, there is evidence that reduction of GORD in patients by using a motilin agonist may be useful clinically. For example, in a recent study in patients following lung transplantation, it was demonstrated that azithromycin, a motilin agonist macrolide antibiotic, reduced the number of reflux events and total oesophageal acid exposure as well as reduce the proximal extent to which reflux was regurgitated.\n The clinical trials of promotility agents in GORD have not, however, shown consistent benefit. This may be related to compound characteristics. The dynamics of the relationship between PK and the effect on oesophageal function may be a factor as the most consistent data supporting their role as prokinetics in GORD come from studies which administered the drug intravenously, a route of administration which would not be suitable for a broader GORD population. In addition, if high doses of macrolides are required to have an effect on GORD, there is a risk of overlapping with antibiotic therapeutic doses, which would limit the interest of such approach. Macrolides also induce side effects such as nausea and abdominal, which makes macrolides difficult to tolerate for many patients. Another factor to consider is that repeat administration of macrolides induces desensitization of the motilin receptor reducing their efficacy over time, a phenomenon called tachyphylaxis. A strategy to decrease the tachyphylaxis to stimulation of motilin receptors is to identify agents that do not possess a complex motilide structure like erythromycin. This was the approach taken by GlaxoSmithKline (GSK) by which they identified GSK962040, a small molecule motilin receptor agonist, which is not a motilide.\n GSK962040 was designed using the recombinant human motilin receptor to enhance the specificity for the receptor and potentially decrease the negative characteristics encountered with compounds with complex and non-specific motilide structures. A range of in vitro and in vivo studies have been conducted using GSK962040 to investigate its primary, secondary and safety pharmacology and toxicology. In addition, the pharmacokinetics (PK), absorption, distribution, metabolism and elimination of GSK962040 have been investigated in non-clinical species through a series of oral and intravenous studies.\n The First Time in Human (FTIH) study (MOT107043) of GSK962040 is completed. It was an ascending single dose, randomised, placebo-controlled trial, with doses in the range of 1-150 mg to assess safety and tolerability, PK and pharmacodynamic effects on gastric emptying (GE) in healthy male and female volunteers. Dosing with GSK962040 was well tolerated. The results demonstrated that GSK962040 has an approximate dose proportional PK profile. Single doses of GSK962040 in the range of 1 to 150 mg resulted in mean exposures less than 23 μg.h/mL (AUC). At single doses of 50 mg to 150 mg, the rate of GE measured by the 13C-octanoic acid breath test was significantly increased in healthy volunteers when compared with placebo. Increasing the dose above 50 mg did not result in a greater effect on GE. The mean within subject time for half a [13C]-containing meal to empty from the stomach (GE t½) decreased by 22-43% from placebo with GSK962040 50, 75, 125 and 150 mg single doses (p ≤ 0.02). Increases in the rate of gastric emptying occurred in 85% to 100% of those healthy subjects receiving the 50 to 150 mg doses. The 14-day repeat dose study in healthy volunteers (MOT109681) was an ascending dose, randomised, placebo-controlled trial over the range of 10 mg to 125 mg daily. GSK962040 was well tolerated over the 14- day administration period for the doses tested and exhibited predictable PK, with and without food. The results indicated that GE was enhanced at doses of 50 mg and above, throughout the 14-day dosing. GSK962040 is currently in Phase II clinical development, being investigated in intensive care patients who receive enteral feeding, and in patients with diabetic gastroparesis. The present study will investigate effect of GSK962040 on oesophageal function because a combination of enhanced GE, barrier function (i.e. increase in LOS pressure) and oesophageal clearance would be potentially beneficial in patients with GORD or regurgitation.\n Non clinical and clinical data indicate that a motilin agonist such as GSK962040 may also influence oesophageal function as well as GE. The purpose of the present study is primarily to evaluate the physiological effect of clinical doses of GSK962040 on oesophageal function in healthy volunteers, using established methods (oesophageal manometry, ambulatory pH/Impedance monitoring). GE will also be measured, using wireless motility capsule (WMC) monitoring. Given this is a physiological assessment, the use of healthy volunteers is considered appropriate; in addition, the study population will comprise male volunteers only in order to reduce variability in the measurements and therefore sample size, as GE varies with gender. The information from this study will inform decision making as to whether GSK962040 could have utility in conditions in which lower oesophageal function is deranged such as GORD.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n 1. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.\n 2. Male between 18 and 65 years of age inclusive, at the time of signing the informed consent.\n 3. AST, ALT, alkaline phosphatase and bilirubin = 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).\n 4. Subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication through at least 5 days following the dose of GSK962040.\n 5. Body weight = 50 kg and BMI within the range 18.5-29.9 kg/m2 (inclusive).\n 6. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.\n 7. QTcB or QTcF < 450 msec or QTc<480msec in subjects with Bundle Branch Block based on single or average QTc value of triplicate values obtained over a brief recording period.\n Exclusion Criteria:\n 1. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.\n 2. A positive test for HIV antibody.\n 3. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).\n 4. History of cholecystectomy or biliary tract disease.\n 5. History of major gastrointestinal surgical procedure.\n 6. History of bowel surgery within the 3 months preceeding screening\n 7. History of strictures or adhesions following surgery.\n 8. History of, or current clinically significant gastrointestinal transit condition, ie. Passing of < 1 bowel movement per 48hr period.\n 9. A positive pre-study drug/alcohol screen.\n 10. A previous reaction or allergy to local anesthetic gels or sprays.\n 11. History of regular alcohol consumption within 6 months of the study defined as:\n -an average weekly intake of >21 units. One unit is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.\n 12. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).\n 13. Smoking history that includes regular use of tobacco or nicotine-containing products within 6 months prior to screening.\n 14. Exposure to more than four new chemical entities within 12 months prior to the first dosing day.\n 15. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.\n 16. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.\n 17. Where participation in the study would result in donation of blood or blood products in excess of 500mL within a 90 day period.\n 18. Unwillingness or inability to follow the procedures outlined in the protocol.\n 19. Subject is mentally or legally incapacitated.\n 20. Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the dose of study medication.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
160	[ { "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\nClinical Trial Title:\n\nIs the Neosquamous Epithelium \"Normal\" Following Endoscopic Ablation of Dysplastic Barrett's Esophagus?\n\nClinical Trial Summary:\n\nThe investigators propose a study comparing the morphological and functional aspects of the neosquamous epithelium (NSE) after ablative therapy for dysplastic Barrett's esophagus (BE) to that of native squamous epithelium in normal controls as well as gastroesophageal reflux disease (GERD), non-Barrett's Esophagus (BE) subjects.\n\nClinical Trial Detailed Description:\n\nPurpose: We propose a study comparing the morphological and functional aspects of the neosquamous epithelium (NSE) after ablative therapy for dysplastic Barrett's esophagus (BE) to that of native squamous epithelium in normal controls as well as gastroesophageal reflux disease (GERD), non-BE subjects.\n Participants: Eligible subjects will be women and men between the ages of 18-80, with one of the following:\n 1. Two or greater cm of dysplastic BE, who will undergo or have undergone radiofrequency ablation for BE at UNC, or\n 2. Diagnosed with GERD per a gastrointestinal (GI) physician undergoing upper endoscopy for other indications at UNC, or\n 3. Non-GERD controls per a GI physician with normal esophageal mucosa undergoing upper endoscopy for other indications at UNC.\n Procedures (methods): Esophageal biopsies will be obtained specifically for research purposes before ablation therapy or, in subjects not receiving ablative therapy, after completion of the clinically indicated procedure and before withdrawal of the endoscope. Information from the medical record or from patient interview will be obtained regarding diagnosis (Barrett's esophagus, GERD, etc), and a questionnaire administered regarding the duration and frequency of reflux symptoms and complications of reflux disease. Subjects who are enrolled in the pre-ablation group will have additional biopsies and questionnaires administered during scheduled follow-up visits. On the last follow-up visit, this group will also undergo impedance-pH testing using standard methods, to assess for degree of control of esophageal acid exposure, and for number, duration and symptom correlation of non-acid reflux events.\n\nClinical Trial Eligibility Criteria:\n\nInclusion:\n Eligible subjects will be mentally competent women and men between the ages of 18-80, able to speak and read English and who meet one of the following criteria:\n - Two or greater cm of dysplastic Barrett's Esophagus (BE), who will undergo or have undergone radiofrequency ablation (RFA) for BE at the University of North Carolina, Chapel Hill (UNC), or\n - Diagnosed with gastroesophageal reflux disease (GERD) per a GI physician undergoing upper endoscopy (EGD) for other indications at UNC, or\n - Non-GERD controls per a GI physician with normal esophageal mucosa undergoing upper endoscopy for other indications at UNC.\n Exclusion:\n - Subjects with a bleeding diathesis or other contraindication of endoscopic biopsy.\n - Current use of warfarin, heparin, and/or low molecular weight heparin (requires discontinuation of medication 5 days prior to and 7 days after EGD).\n - Pregnant women\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
161	[ { "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\nClinical Trial Title:\n\nRacial Disparity in Barrett's Esophagus\n\nClinical Trial Summary:\n\nThe goal of the proposed research is to investigate the molecular mechanisms of racial disparity in Barrett's esophagus (BE), the premalignant lesion of esophageal adenocarcinoma. Specifically, the investigators hypothesize that environmental factors, genetic factors, and potentially gene environment interactions play crucial roles in the observed racial disparity in developing Barrett's esophagus.\n Patients are recruited through UNC hospitals prior to scheduled esophagogastroduodenoscopy (EGD). Participants complete a questionnaire, have body measurements obtained, and have blood, biopsies, and gastric aspirate collected. Participants also complete a 24 hour pH impedance test.\n\nClinical Trial Detailed Description:\n\nThe goal of the proposed research is to investigate the molecular mechanisms of racial disparity in Barrett's esophagus, the premalignant lesion of esophageal adenocarcinoma. Specifically, the investigators hypothesize that environmental factors, genetic factors, and potentially gene environment interactions play crucial roles in the observed racial disparity in developing Barrett's esophagus.\n Participants: Patients aged 18-80 presenting at the Gastrointestinal (Gl) Endoscopy Clinic at UNC-Chapel Hill for elective upper endoscopy with a primary or secondary indication of reflux symptoms.\n Procedures (methods): Endoscopic biopsy, pH impedance and sampling of gastric secretions will be performed according to our standard protocol. A series of questionnaires assessing demographics, environmental exposure (e.g., smoking, drinking), markers of socioeconomic status (SES), body measurement, previous health history, and gastroesophageal reflux disease (GERD) symptomatology will be administered to our subjects.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Aged 18 to 80\n - Self-identify is \"not Hispanic or Latino\" and either \"African American\" or \"White.\"\n - Cases will be eligible for inclusion if they have endoscopically evident Barrett's Esophagus (BE) of any length. BE will be defined as: 1) Any upward displacement of the squamocolumnar junction noted on endoscopy such that the interface of squamous and columnar mucosa is no longer at the interface of the most distal tubular esophagus and the proximal gastric folds. The characteristic pale pink coloration of the squamous epithelium in these areas will be replaced by the darker salmon color commonly seen in BE. 2) Histologic interpretation of biopsies consistent with intestinal columnar metaplasia containing goblet cells, which are positively stained by Alcian blue staining as barrel-shaped cells.\n - Controls will be eligible for inclusion if they have classic symptoms of gastroesophageal reflux disease (GERD), but no endoscopic or histological evidence of BE. Both erosive and non-erosive GERD will be eligible. Because we expect GERD to outnumber BE and patients with GERD may be slightly less willing to participate in the study than patients with BE (based on recruitment for the studies noted above), we plan to randomly sample one fourth of eligible controls. If approximately 20% fewer GERD than BE participate, a final study population with an approximately 1:2 BE to GERD ratio will be achieved. Oversampling of patients with GERD will improve study power.\n Exclusion Criteria:\n - Patients who are unable to read or comprehend the informed consent or written questionnaires;\n - Patients who are status post partial or complete esophageal resection;\n - Patients with prevalent BE who have undergone endoscopic ablation;\n - Patients found to have high-grade dysplasia or esophageal cancer on the index endoscopy;\n - Patients with surgical anti-reflux procedures;\n - Patients of races other than Caucasian and African Americans;\n - Pregnant women.\n - Patients with a bleeding diathesis or other contraindication of endoscopic biopsy.\n - Current use of warfarin, heparin, and/or low molecular weight heparin (requires discontinuation of medication 5 days prior to and 7 days after EGD).\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
162	[ { "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\nClinical Trial Title:\n\nCombination Therapy of Gemcitabine and Trabectedin in L-sarcomas\n\nClinical Trial Summary:\n\nL-sarcomas represent about one third of all adult soft tissue sarcomas (24 % liposarcomas and 12 % leiomyosarcomas). Approval for the induction of trabectedin into the treatment armamentarium of advanced and/or metastatic soft tissue sarcomas after treatment failure with anthracyclines and/or ifosfamide depended mainly on its activity in the L-sarcomas (Garcia-Carbonero 2004, Le Cesne 2005, and Demetri 2009). Significant activity has been described for the use of gemcitabine and especially the combination of gemcitabine and docetaxel mainly in leiomyosarcomas and liposarcomas (Maki 2007). However, the combination of gemcitabine and docetaxel is associated with significant toxicity. Pulmonary toxicity and refractory peripheral oedema are the most common severe adverse events. The aim of the present phase I study will be to examine safety data of this promising treatment combination of gemcitabine and trabectedin in L-sarcomas.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Patients with histologically confirmed L-sarcomas (leiomyosarcoma and liposarcoma)\n - Measurable disease according to RECIST 1.1\n - Any treatment line except adjuvant setting: evidence of primary metastatic situation or disease progression within the last 6 months (based on RECIST 1.1) in computed tomography or magnetic resonance imaging\n - Any prior treatment possible\n - Age >= 18 years\n - WHO PS =< 1\n - Effective contraception during study medication and up to 3 months from treatment discontinuation\n - Signed informed consent form\n Exclusion Criteria:\n - Surgical intervention < 4 weeks\n - Pregnancy or lactation\n - Known allergic reaction to trabectedin or gemcitabine or one of their components\n - The following laboratory values:\n Absolute neutrophil count < 1.5 x 103/mm3 Platelets < 100.000/mm3 Hb < 9 g/dL Serum creatinine >= 2.5 mg/dl SGOT and/or SGPT and/or alkaline phosphatase and/or CPK > 2.5 x ULN Total bilirubin > 1 x ULN except in the case of Gilbert's syndrome\n - Participation in another study (four weeks before and during the study)\n - Prior malignancy apart from completely resected basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
163	[ { "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\nClinical Trial Title:\n\nYONDELIS (Trabectedin) Single Patient Compassionate Use / Expanded Access\n\nClinical Trial Summary:\n\nThe YONDELIS (trabectedin) Single Patient Compassionate Use /Expanded Access program provides patients with advanced soft tissue sarcoma, who do not qualify for ongoing clinical trials with YONDELIS (trabectedin), access to this investigational treatment.\n\nClinical Trial Detailed Description:\n\nThe single patient treatment instructions for use are intended for a single patient with advanced soft tissue sarcoma. The patient will be treated with YONDELIS® (trabectedin) i.v. formulation at a dose of 1.5 mg/m2 i.v. over 24 hours on Day 1 every 21 days, provided that he/she fulfills all eligibility criteria.\n The patient may continue to receive therapy until there is evidence of disease progression or unacceptable toxicity. Safety will be evaluated and serious adverse events will be reported. Disease assessments will occur according to institutional practice.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n 1. Signed informed consent.\n 2. 18 years-of-age or older.\n 3. Unresectable, advanced or metastatic, histologically proven soft tissue sarcoma.\n 4. Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or better.\n 5. Hematologic variables:\n - Hemoglobin ≥9 g/dL\n - ANC ≥1,500/μL\n - Platelet count ≥100,000/μL\n 6. Serum creatinine ≤ upper limit of normal (ULN)\n 7. Hepatic function variables:\n - Total bilirubin ≤ ULN\n - Total alkaline phosphatase ≤ ULN, or if > ULN, then alkaline phosphatase liver fraction or 5'-nucleotidase must be ≤ ULN.\n - AST (serum aspartate transaminase [SGOT]) and ALT (serum alanine transaminase [SGPT]) must be ≤ 2.5xULN\n - Albumin ≥2.5 g/dL\n Exclusion Criteria:\n 1. Pregnant or breast-feeding women, or patients (male or female) not employing adequate contraception. Acceptable means of birth control include IUD, oral contraceptive, subdermal implant, and a condom with a contraceptive sponge or suppository.\n 2. Less than 4 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or therapy with any investigational agent\n 3. Active viral hepatitis or chronic liver disease\n 4. Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias\n 5. Active infection\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
164	[ { "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\nClinical Trial Title:\n\nSymptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease\n\nClinical Trial Summary:\n\nThe purpose of this study is to evaluate the impact of gastroesophageal reflux disease (GERD) treatment in primary care setting on symptom control and daily life in symptomatic GERD patients, using both GERD questionnaire and clinical symptoms assessment\n\nClinical Trial Detailed Description:\n\nA prospective, observational study to describe symptom control and impact on daily life in patients with gastroesophageal reflux disease (GERD)\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Patients known or newly diagnosed with GERD\n - Patients with typical GERD symptoms as heartburn and regurgitation for ≥2 days in the previous week\n - Patients, currently not treated with a proton pump inhibitor\n Exclusion Criteria:\n - Patients who have been receiving treatment with non-steroidal antiinflammatory drugs within two weeks prior the inclusion in the study\n - Patients with medical history of surgery of the esophagus, stomach or duodenum\n - Pregnant or nursing females\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
165	[ { "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\nClinical Trial Title:\n\nEfficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer\n\nClinical Trial Summary:\n\nThe purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have FGFR2 polysomy or gene amplification.\n\nClinical Trial Detailed Description:\n\nA Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 monotherapy versus paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE study). Patients were to be assigned to strata by FGFR2 status of: polysomy, low or high gene amplification.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Female or male aged 25 or over\n - Histological diagnosis of locally advanced or metastatic gastro adenocarcinoma (including adenocarcinoma of the lower third of the oesophagus or the gastro oesophageal junction )\n - Radiographically confirmed progression after 1 prior chemotherapy or chemoradiotherapy for gastric cancer. Suitable for and expected to benefit from paclitaxel monotherapy.\n - At least one lesion, not previously irradiated, that has baseline at least 10mm in the longest diameter for non nodal lesions and is assessed by Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI)\n - Provision of either an archival tumour sample or a fresh tumour sample for confirmation of FGFR2 polysomy/gene amplification\n Exclusion Criteria:\n - Prior exposure to AZD4547 or history of hypersensitivity other drugs similar in structure or class to AZD4547. Hypersensitivity to paclitaxel or formulated in cremophor EL (polyoxyethylated castor oil)\n - Prior taxane treatment for gastric cancer with the exception of adjuvant/neo-adjuvant therapy given > 6 months; Major surgery, radiotherapy with wide field of radiation or any cancer treatment within 4 weeks before the first dose of the study treatment\n - With the exception of alopecia, any unresolved toxicities from prior therapy with a Common Terminology Criteria for AE (CTCAE) grade >1 at the time of starting study treatment.\n - Blood and Echocardiogram (ECG) readings that are deemed to be abnormal by falling outside of the reference ranges in the protocol inclusion/exclusion section.\n - Taking other regular medication that are predicted to interact with AZD4547 due to their route of metabolism.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
166	[ { "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\nClinical Trial Title:\n\nStudy of ABT-700 in Subjects With Advanced Solid Tumors\n\nClinical Trial Summary:\n\nThis is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-700 in subjects with advanced solid tumors that may have MET amplification or c-Met overexpression. ABT-700, previously known as h224G11 in publications, is an anti-c-Met antibody. The early clinical development plan for ABT-700 is based on the activity demonstrated in preclinical models. Up to 124 subjects will be enrolled.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Subject with advanced solid tumors; Dose-expansion: evidence for MET gene amplification.\n - Subject must have disease: a) that is not amenable to surgical resection, or b) that has progressed or recurred despite standard therapy, or c) that has failed to respond to standard therapy, or d) for which no effective therapy exists.\n - Subject cannot tolerate or must not be eligible for other approved therapeutic options with known survival advantage.\n - Subjects enrolled on the combination therapy phase must satisfy the above inclusion criteria and also the following: Subjects must have inoperable, locally advanced or metastatic cancer and be eligible to receive docetaxel or FOLFIRI/cetuximab or erlotinib in combination with ABT-700.\n Exclusion Criteria:\n - Subject has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days, or herbal therapy within 7 days prior to the first dose of ABT-700.\n - Subjects with uncontrolled metastases of the central nervous system. Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease after definitive therapy and have not used steroids for at least 1 month prior to first dose of ABT-700.\n - Subject has unresolved adverse events > Grade 1 from prior anticancer therapy except for alopecia or anemia.\n - Subject has had major surgery within 21 days prior to the first dose of ABT-700.\n - Subjects enrolled on the combination therapy phase must not meet the above exclusion criteria and must be eligible to receive docetaxel or FOLFIRI/cetuximab or erlotinib per most current prescribing information, or at the discretion of the Investigator. Subjects with K-Ras mutation-positive colorectal cancer will be excluded from receiving FOLFIRI/cetuximab.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
167	[ { "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\nClinical Trial Title:\n\nAutologous T Cells and Cyclophosphamide in Treating Patients With Soft Tissue Sarcoma That is Metastatic or Cannot Be Removed By Surgery\n\nClinical Trial Summary:\n\nThis phase I trial studies the side effects and how well giving autologous T cells with cyclophosphamide works in treating patients with soft tissue sarcoma that is metastatic or cannot be removed by surgery. Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving autologous T cells together with cyclophosphamide may kill more tumor cells.\n\nClinical Trial Detailed Description:\n\nPRIMARY OBJECTIVES:\n I. Assess the feasibility, safety and toxicity of treating patients with NY-ESO-1 specific cellular adoptive immunotherapy in myxoid/round cell liposarcoma (MRCL) and synovial sarcoma patients receiving autologous cluster of differentiation (CD)8+ NY-ESO-1 specific T cells following cyclophosphamide conditioning.\n SECONDARY OBJECTIVES:\n I. Evaluate the antitumor effect and persistence of adoptively transferred CD8+ antigen-specific cytotoxic T lymphocyte (CTL) lines following cyclophosphamide conditioning.\n OUTLINE:\n Patients receive cyclophosphamide intravenously (IV) on days -3 and -2. Patients receive NY-ESO-1-specific T cells IV on day 0.\n After completion of study treatment, patients are followed up for 8 weeks.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Histopathological documentation of the diagnosis of synovial sarcoma or myxoid liposarcoma with metastatic or unresectable disease who have received an alkylating agent containing regimen (such as doxorubicin plus ifosphamide); this includes patients who received an alkylating agent as part of adjuvant therapy and then relapsed; patients who were treated on the PICCASSO trial who have progressed will be allowed on the study; \"unresectable disease\" shall include patients with locally advanced disease where a surgery could be attempted but where this surgery would be mutilating, debilitating and would likely fail to result in long-term disease free survival; in this setting a patient might reasonably choose to undergo salvage/second line systemic therapy but could also pursue aggressive surgical options as standard of care\n - Able to tolerate high-dose cyclophosphamide\n - NY-ESO-1 expression in > 25% of tumor by immunohistochemistry (IHC) (at least 2+)\n - Expression of human leukocyte antigen (HLA)-A0201; high resolution HLA typing performed at any experienced HLA lab will be accepted\n - Zubrod performance status of '0-1'\n - Patients with metastatic disease must have bi-dimensionally measurable disease by palpation on clinical exam, or radiographic imaging (computed tomography [CT] scan)\n - All patients must have an electrocardiogram (ECG); all patients must have a normal stress test within 182 days prior to treatment\n - Patients must have already been leukapheresed on either protocol 1246 or 2365 prior to entry into this study; patients who are unable to have a leukapheresis product collected, for whatever reason, will be unable to participate in this study\n - If there is a patient with an NY-ESO-1 expressing sarcoma who would be otherwise eligible for the trial, where there has been disagreement between pathologists regarding the histopathologic diagnosis, eligibility will be decided on by the principal investigator (PI)\n - Patients must have had NY-ESO-1 specific cells already in production; patients must have NY-ESO-1 specific cells that have been generated and sorted; these cells may be either in the process of expansion or expanded and frozen at the time of enrollment\n - Patients with definitively treated brain metastasis and patients with 4 or fewer untreated lesions less than 1 cm each will be included at the discretion of the principal investigator (PI)\n - Patients must be off metformin at least 2 weeks before receiving T cell therapy\n - Patients must have hemoglobin A1C < 8.5%\n Exclusion Criteria:\n - Patients for whom we are unable to generate NY-ESO-1 specific cells\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 - Significant hepatic dysfunction (serum glutamic oxaloacetic transaminase [SGOT] > 150 IU or > 3x upper limit of normal [ULN])\n - Bilirubin > 1.6 mg/dL\n - Prothrombin time (PT) > 1.5 x control\n - Most patients with metastatic sarcoma will have pulmonary metastasis and it is expected that the majority will have some mild to moderate baseline shortness of breath; these patients will be allowed on study so long as their Eastern Cooperative Oncology Group (ECOG) performance status is 1; patients with severe pulmonary dysfunction (>= grade 3 respiratory disorders as defined by Common Terminology Criteria for Adverse Events [CTCAE] version [v]4) will not allowed on study until their condition improves; however, patients who have recently experienced a decrease in their pulmonary function will be required to undergo pulmonary function testing; patients with a forced expiratory volume in one second (FEV1) < 1.5L or diffusing capacity of carbon monoxide (DLco) (corrected [corr] for hemoglobin [Hgb]) < 50% will be excluded; patients with a reversible cause of pulmonary dysfunction may undergo repeat testing and enroll if their pulmonary function tests (PFT's) meet criterion\n - All patients must have an echocardiogram (echo) showing ejection fraction (EF) > 50% and normal troponin and creatine kinase (CK) MB (echo may be done at the time of stress test as a stress echo); furthermore the following significant cardiovascular abnormalities will be excluded:\n - Active, symptomatic congestive heart failure\n - Clinically significant hypotension\n - Symptoms of coronary artery disease\n - Presence of cardiac arrhythmias on EKG requiring drug therapy which has not been stable for at least 6 months\n - Patients with symptomatic untreated brain metastasis or asymptomatic untreated brain metastasis > 1 cm will not be allowed to participate; additionally, patients with five or more untreated brain metastasis under 1 cm will not be allowed to participate; treatment may include surgery or stereotactic radiation at the discretion of the patient's treatment team; patients must be off steroids when starting therapy\n - Patients with active infections or oral temperature > 38.2 C within 72 hours of study entry or systemic infection requiring chronic maintenance or suppressive therapy\n - Chemotherapeutic agents (standard or experimental or other immunosuppressive therapies) less than 3 weeks prior to T cell therapy; (patients with bulky disease may undergo cytoreductive chemotherapy but treatment will be discontinued at least 3 weeks prior to T cell infusion); patients may receive palliative radiation therapy two weeks prior to T cell infusion\n - Clinically significant autoimmune disorders or conditions of immunosuppression; patients with acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV)-1 associated complex or known to be HIV antibody seropositive or known to be recently pathologic complete response (PCR)+ for hepatitis are not eligible for this study; virology testing will be done within 6 months of T cell infusion; the severely depressed immune system found in these infected patients and the possibility of premature death would compromise study objectives\n - Current treatment with steroids\n - Patients must not be receiving any other experimental drugs within 3 weeks of the initiation of treatment and must have recovered from all side effects of such therapy\n - Patients who were not negative for hepatitis B virus (HBV), hepatitis C virus (HCV) at the time of their leukapheresis on 1246 or 2365 must be retested to be sure they are PCR negative\n - Patients with a history of myocarditis, pericarditis, endocarditis\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
168	[ { "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\nClinical Trial Title:\n\nBiomarkers in Tissue Samples From Patients With Ewing Sarcoma\n\nClinical Trial Summary:\n\nRATIONALE: Studying samples of tissue in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how well patients respond to treatment.\n PURPOSE: This research study is studying biomarkers in tissue samples from patients with Ewing sarcoma.\n\nClinical Trial Detailed Description:\n\nOBJECTIVES:\n - To describe the spectrum of GGAA-microsatellite polymorphisms at specific loci in genomic DNA prepared from Ewing sarcoma tumor specimens.\n - To determine if there are differences in GGAA-microsatellite polymorphisms in genomic DNA prepared from Ewing sarcoma tumor specimens as compared to non-afflicted European and African normal genomic DNA.\n - To determine if GGAA-microsatellite polymorphisms at specific loci in genomic DNA prepared from Ewing's sarcoma tumor specimens correlates with disease outcome in patients treated on COG protocol AEWS0031.\n - To determine whether whole-genome amplification introduces alterations in GGAA-microsatellites as compared to non-amplified genomic DNA.\n OUTLINE: Genomic PCR is used to amplify the microsatellites in the NR0B1 and GSTM4 promoters. In addition to determining microsatellite size, each microsatellite is sequenced following cloning into the pCR4 vector (Invitrogen) using standard topoisomerase cloning protocols.\n\nClinical Trial Eligibility Criteria:\n\nDISEASE CHARACTERISTICS:\n - Specimens from patients with Ewing sarcoma used for protocol COG-AEWS08B1\n - Obtained from patient samples taken from patients enrolled on COG-AEWS0031\n - Whole genome-amplified DNA will be used\n PATIENT CHARACTERISTICS:\n - Not specified\n PRIOR CONCURRENT THERAPY:\n - Not specified\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
169	[ { "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\nClinical Trial Title:\n\nPredictive Study of Radiation Induced Sarcoma\n\nClinical Trial Summary:\n\nDevelopment of sarcoma within or adjacent to radiation field is a well known event of poor prognosis and unknown risk factors. Advanced techniques of radiation therapy including intensity modulated radiation therapy, tomotherapy or Arc therapy are providing new modalities of radiation delivery that could be responsible for developing these induced tumors. There is little data on molecular biology of radiation induced sarcoma even if some tools are still available to characterize these types of tumors aiming to compare their profile to a sarcoma observed in non irradiated area. An update of the GETO-GCSF registry, currently called CONTICANET data base in the framework of EORTC, represents the backbone of the project. The next step should follow two axes, a clinical one based on the dosimetric analysis of the characteristics of delivered radiation therapy and the second one based on a molecular characterization of the sarcomas developed in irradiated field.The data base will be updated and organized through the CONTICANET network and the radiation oncologists involved in the treatment of soft tissue sarcoma. A retrospective analysis of the clinical data and the parameters describing the initial treatment will be registered using the methodology proposed by I. Diallo for radiation induced tumors developed in childhood. The most recent data will be extracted in DICOM format for intercomparison in a dedicated software.A centralized review of pathological specimens is planned to validate the correct classification of the tumors inside the current staging system developed for soft tissue sarcoma.\n\nClinical Trial Detailed Description:\n\nThe biological study will include the two following steps:1. On frozen specimen: genic profile of the tumor will be studied with two different techniques: CGH-array from extracted DNA in order to evaluate the number of gene copies, amplifications and deletions. The RNAm expression profile will be studied to evaluate the level of the gene expression. More than 200 data collected in Institut Bergonié, coming from de novo sarcoma would be used as a comparative specimen since the pathological diagnosis is the same as the one observed for radiation induced sarcoma. A comparison between the two populations will be able to define profiles, gene modifications and signalisation pathways of radiation induced sarcoma. 2. On blood sample: 2 groups of patients will be compared: those with radiation induced sarcoma and patients receiving radiation therapy for more than 5 years ago without developing sarcoma. The study will be performed with the inform consent of the patients and of the controlled cases.This second step requires 2 blood samples (2 x 5 ml). They will be collected and sent to the molecular biology laboratory located in Centre Alexis VAUTRIN (Nancy).- One sample of 5 mm will be dedicated to study radiation induced apoptosis assessed by flow cytometry. A correlation has been described between radiation-induced apoptosis of CT8+ lymphocytes after an 8 Gy irradiation and the occurrence of severe late toxicity after radiation therapy for patients treated for several types of tumors.- The second sample will be used to study the polymorphism of the genes involved in reparation of DNA by using chip screening of single nucleotide polymorphisms (SNP). This sample will be used after DNA extraction from mononuclear blood cells. DNA will be extracted and controlled by flow cytometrical separation. It will be sent to Bordeaux molecular biology laboratory in Institut Bergonié (Prof. JM COINDRE) to perform an evaluation of the single nucleotide polymorphism. The aim of this part of the protocol is to study variances in gene, the product of which plays a role in radiation response and in the development of adverse effects after radiation therapy. For patients with radiation-induced sarcoma, the results of this analysis will be compared with the data obtained from DNA analysis extracted from the tumors. The clinical, pathological and biological characterisation of radiation-induced sarcoma obtained will allow to identify constitutional variances linked with an increased sensitivity to radiation therapy leading to discuss indication of irradiation in a population at risk. Pediatric radiation therapy and adjuvant treatment after surgery for breast carcinoma will be the main targets of this selection of patients. This project will be able to select radiation modality in patients at risk (intensity modulated radiation therapy or 3D conformal approach, stereotactic approaches, partial irradiation of the breast).\n\nClinical Trial Eligibility Criteria:\n\nradiation-induced sarcoma group\n Inclusion Criteria:\n 1. Age > 18 ans when radiation was performed\n 2. suffering from a radiation induced sarcoma\n Exclusion Criteria:\n 1. private individuals of freedom or under tutelage (including legal guardianship)\n 2. initial tumor treated by radiotherapy was a sarcoma\n 3. patient bearer of an osteosarcoma\n Free from irradiation induced sarcoma group\n Inclusion Criteria:\n 1. Age > 18 ans when radiation was performed\n 2. surviving irradiated patients for cancer for more than 5 years and free of from radiation-induced sarcoma.\n Exclusion Criteria:\n 1. private individuals of freedom or under tutelage (including legal guardianship)\n 2. History of cancer (except baso-cellular cutaneous epithelioma or in situ epithelioma of the cervix) that has relapsed in the 5 years preceding recruitment for the trial\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
170	[ { "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\nClinical Trial Title:\n\nStudy of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Liposarcoma\n\nClinical Trial Summary:\n\nThe purpose of this study is to evaluate the effectiveness and safety of single agent pazopanib in subjects with unresectable or metastatic liposarcoma.\n\nClinical Trial Detailed Description:\n\nThis is a Phase II, multicenter, prospective, open label, single arm study. The primary endpoint of the study is progression-free rate as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 at week 12 after start of treatment. The secondary endpoints include overall progression-free survival (PFS), response rate (RR), duration of response, overall survival (OS), and toxicity assessment through the reporting of adverse events.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Written informed consent.\n - Age > or = to 18 years.\n - Histologically or cytologically confirmed high- or intermediate-grade liposarcoma (allowed subtypes include liposarcoma dedifferentiated, myxoid/round cell, pleomorphic, mixed-type, or not otherwise specified).\n - Surgically unresectable or metastatic disease.\n - Any number of prior treatment treatment regimens, including treatment naive subjects.\n - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n - Measurable or evaluable (non-measurable) disease per RECIST guidelines version 1.1. Subjects must have documented disease progression within the past 6 months.\n - Adequate organ system function determined within 14 days prior to first dose of study treatment.\n - Left ventricular ejection fraction (LVEF) > 50% of the institutional LLN within 28 days prior to the first dose of study treatment.\n - Females must be of either non-child bearing potential or have a negative pregnancy test within 7 days prior to the first dose of study treatment.\n Exclusion Criteria:\n - Well differentiated liposarcoma.\n - Prior treatment with tyrosine kinase inhibitors (TKIs) or vascular endothelial growth factor (VEGF) inhibitors.\n - Prior malignancy (Note: subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible).\n - History or clinical evidence of central nervous system metastases or leptomeningeal carcinomatosis, unless previously treated, asymptomatic, and off steroids and anti-seizure medication for 6 months prior to first dose of study drug\n - Clinically significant gastrointestinal (GI) abnormalities that may increase the risk for GI bleeding.\n - Clinically significant GI abnormalities that may affect absorption of investigational product.\n - Presence of uncontrolled infection.\n - Corrected QT interval > 480 msecs using Bazett's formula.\n - History of certain cardiovascular conditions within the past 6 months.\n - Poorly controlled hypertension [defined as systolic blood pressure of > or = 140 mmHg or diastolic blood pressure > or = 90 mmHg].\n - History of cerebrovascular accident including transient ischemic attack, pulmonary embolism, or untreated deep vein thrombosis within the past 6 months.\n - Prior major surgery or trauma within 28 days prior to the first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.\n - Evidence of active bleeding or bleeding diathesis.\n - Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage.\n - Hemoptysis in excess of 2.5 mL within 8 weeks of first dose of study drug.\n - Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.\n - Unable or unwilling to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug, whichever is longer, prior to the first dose of study drug and for the duration of study treatment.\n - Radiation therapy, minor surgery, tumor embolization, chemotherapy, immunotherapy, biologic therapy, investigational therapy, or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug.\n - Administration of any non-oncologic investigational drug within 30 days or five half-lives (whichever is longer) prior to receiving the first dose of study drug.\n - Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity, except alopecia.\n - Known immediate or delayed hypersensitivity reaction to idiosyncrasy to drugs chemically realted to pazopanib or excipients that contraindicates participation.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
171	[ { "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\nClinical Trial Title:\n\nPD-0332991, 5-FU, and Oxaliplatin for Advanced Solid Tumor Malignancies\n\nClinical Trial Summary:\n\nThis study is for patients with advanced solid tumor malignancies (cancer that has spread to other parts of the body).\n The purpose of this study is to test the safety and effectiveness of a new combination of drugs, PD-0332991 and 5-Fluorouracil and Oxaliplatin for patients with advanced solid tumor malignancies . PD-0332991 stops cells from dividing by blocking an enzyme called cyclin-dependent kinase (CDK), which cancer cells need to grow and divide. By inhibiting this enzyme, PD-0332991 prevent cancer cells from growing and dividing, while the 5-Fluorouracil and Oxaliplatin damage the cells, hopefully increasing the killing of cancer cells, thus decreasing the tumors in the body.\n PD-0332991 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration for use in colorectal cancer. It is given as a pill which is taken once a day for one week followed by one week off. 5-Fluorouracil and Oxaliplatin are administered as an infusion into a vein once every 2 weeks and are approved for and used as chemotherapy for several cancers.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Retinoblastoma-positive, histologically proven advanced solid tumor malignancies for which no curative therapy exists\n - Biopsy accessible tumor deposits\n - Corrected QT interval less than 500 milliseconds by EKG\n - ECOG preformance status 0-2\n - Subjects with no brain metastases or a history of previously treated brain metastases who have been treated by surgery or stereotactic radiosurgery at least 4 weeks prior to enrollment and have a baseline MRI that shows no evidence of active intracranial disease and have not had treatment with steroids within 1 week of study enrollment.\n - Adequate hepatic, bone marrow, and renal function\n - Partial thromboplastin time must be </= 1.5 x upper limit normal range and INR < 1.5. Subjects on anticoagulant will be permitted to enroll as long as the INR is in acceptable therapeutic range.\n - Life expectancy > 12 weeks\n - Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and/or postmenopausal women must be amenorrheic for at least 12 months.\n - Subject is capable of understanding and complying with parameters of the protocol and able to sign and date the informed consent.\n Exclusion Criteria:\n - Intolerant of, or ineligible for 5-FU, oxaliplatin and/or the combination of both\n - CNS metastases that do not meet the criteria outlined in the inclusion criteria\n - Peripheral neuropathy >/= Grade 2 at baseline or peripheral neuropathy >/= Grade 1 with neuropathic pain\n - Active severe infection or known chronic infection with HIV or hepatitis B virus\n - Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia or myocardial infarction, stroke, or congestive heart failure within the last 6 months.\n - Life-threatening visceral disease or other severe concurrent disease\n - Women who are pregnant or breastfeeding\n - Anticipated patient survival under 3 months\n - Concurrent use of known CYP 3A4 inhibiting or activating medications\n - Clinically significant and uncontrolled major medical condition(s)\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: possibly relevant" } ]	possibly relevant
172	[ { "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\nClinical Trial Title:\n\nA Prospective Observational Study Evaluating c-MET Expression and EGFR Gene Mutation Correlation With Erlotinib Response\n\nClinical Trial Summary:\n\n1. Trial design: Prospective observational study\n 2. Target population: 200 NSCLC patients with histologically or cytologically confirmed stage IV or recurrent NSCLC who have progressive disease after 1st line chemotherapy who consent for study participation and meet the study selection criteria\n 3. Primary objective: To investigate C-met expression/amplification and EGFR gene mutations in NSCLC patients treated with Erlotinib\n - C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR\n 4. We will also assess the correlation of EGFR mutations and c-MET with clinical outcome (Overall Response Rate, Progression Free survival )\n 5. Duration of Trial Recruitment: 2 years\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Informed consent\n - 19~80 year old male or female\n - Histologically proven advanced or metastatic NSCLC\n - Failed to 1st line chemotherapy\n - Tumor tissue for genetic analysis\n - Evaluable target lesion by RECIST v1.1\n - ECOG performance from 0 to 3\n - Expected survival more than 12 weeks\n Exclusion Criteria:\n - Previous treatment of EGFR-tyrosine kinase inhibitors\n - Severe hypersensitivity to erlotinib\n - Residual toxicities (above grade 2) after previous chemotherapy\n - Total bilirubin more than 1.5x of upper normal limit Liver function tests more than 2.5x of upper normal limits\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
173	[ { "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\nClinical Trial Title:\n\nAnalysis of GERD Symptoms Using Gastroesophageal Reflux Impact Score Questionnaire for Quality of Life\n\nClinical Trial Summary:\n\nEven the patients complain GERD symptoms such as heartburn and acid regurgitation the final diagnosis could be reflux esophagitis (RE), non-erosive reflux disease (NERD) and even functional heartburn (FH). In addition, the GERD symptoms are consisted of esophageal symptoms and extraesophageal symptoms. Thus it is necessary to use effective tool for the measurement of GERD symptoms and response of proton pump inhibitor in short time. Several questionnaires have been made for the assessment of GERD symptoms in recent years However, their screening tools do not include the impact of symptoms on everyday life and take a long time to complete the questionnaires. The GERD impact scale (GIS) questionnaire has been developed to compensate for this. It is a simple, one-page, questionnaire to communicate to the doctor the frequency of reflux symptoms and their effect on quality of life, recognizing that it might also prompt clinicians to make appropriate treatment for patients' symptoms. However, there was no report regarding comparison of the characteristics and response to PPI in RE, NERD and FH groups using GIS questionnaire so far.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Adult Subjects (From 16 to 85 years old)\n - The subjects with GERD symptom who received 8 week PPI therapy\n Exclusion Criteria:\n - Patients with a history of gastrointestinal surgery, Barrett's esophagus, esophageal motility disorder, duodenal ulcer, benign gastric ulcer or gastroduodenal cancer and systemic disease requiring chronic medication (except for hypertension and diabetes mellitus)\n - Patients who took H2 blocker or a PPI to relieve these symptoms within 4 weeks\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
174	[ { "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\nClinical Trial Title:\n\nA Trial of Oral 5-azacitidine in Combination With Romidepsin in Advanced Solid Tumors, With an Expansion Cohort in Virally Mediated Cancers and Liposarcoma\n\nClinical Trial Summary:\n\nThe purpose of this study is to determine whether 5-azacitidine in combination with romidepsin cancer are effective in the treatment of advanced solid tumors.\n\nClinical Trial Detailed Description:\n\nThis is a two part, single-institution, open-label, Phase I dose-escalation study of oral 5-azacitidine in combination with intravenous (IV) romidepsin. Part 1 of the study is a traditional 3 + 3 dose escalation study designed to evaluate the maximum tolerated dose (MTD), dose limiting toxicities (DLTs), safety, pharmacokinetic (PK) profiles, and pharmacodynamic profiles of increasing doses of orally administered 5-azacitidine in combination with a constant dose of IV romidepsin. Part 2 is an expansion cohort study for the preliminary evaluation of efficacy in the treatment of virally mediated cancers and liposarcoma once the MTD has been determined. PK and PD data will also be collected for these subjects.\n - Plasma samples will be obtained, prior and during treatment, to assess the methylation status of free tumor DNA circulating in the blood\n - Archival tissue will be obtained on all participants for future correlative studies, such as baseline gene expression, methylation patterns.\n - Participants with accessible, biopsiable tumors will also undergo pre-treatment and post-treatment (~cycle 2D1) biopsies for correlative studies in the expansion cohort.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Understand and voluntarily sign informed consent form (ICF).\n - Age ≥ 18 years at time of signing ICF.\n - Adhere to study visit schedule and other protocol requirements.\n - Histologically or cytologically confirmed metastatic or unresectable solid tumor (phase I dose escalation), OR HPV+ nasopharyngeal cancer, HPV+ cervical cancer or liposarcoma (for expansion cohort).\n - Failed at least one previous chemotherapy regimen for metastatic disease if standard therapies exist.\n - Measurable disease per RECIST 1.1\n - Life expectancy ≥ 12 weeks\n - No previous cancer therapy ≥ 4 weeks.\n - ECOG performance status ≤ 1\n - Laboratory test results:\n - Absolute neutrophil count ≥ 1500/mm³\n - Platelet ≥ 100,000/mm³\n - Serum creatinine levels < 1.5 X ULN OR creatinine clearance >60 mL/min/1.73 m2 for subjects with creatinine levels > institutional normal\n - Serum bilirubin ≤ 1.5 times the upper limit of the normal range for the laboratory (ULN).\n - AST (SGOT) and ALT (SGPT) ≤ to 2.5 x ULN\n - Disease free of prior malignancies ≥ 5 years (except currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast).\n - Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with 5-azacitidine. All men/women of childbearing potential must use acceptable methods of birth control throughout the study.\n Exclusion Criteria:\n - Serious medical conditions, laboratory abnormality, or psychiatric illness that would prevent the subject from signing ICF.\n - Pregnant or breastfeeding women. (Lactating women must agree not to breast feed while taking 5-azacitidine).\n - Conditions, including laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret study data.\n - Chemotherapy, radiotherapy, or experimental drug or therapy ≤ 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to enrollment or adverse events < grade 1 due to agents administered >4 weeks earlier except for stable grade 2 neuropathy.\n - No other concomitant investigational agents.\n - Known or suspected hypersensitivity to 5-azacitidine, romidepsin, mannitol or other agents used in this study.\n - Uncontrolled brain metastases.\n - Known positive for HIV, infectious hepatitis, type B or C.\n - Uncontrolled intercurrent illness\n - Known GI disorders precluding oral administration of 5-azacitidine.\n - Known cardiac abnormalities such as:\n - Congenital long QT syndrome\n - QTc interval ≥ 500 milliseconds;\n - Myocardial infarction ≤6 months of C1D1. Subjects with a history of myocardial infarction between 6-12 months prior to C1D1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate;\n - Other significant ECG abnormalities including 2nd degree atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min);\n - Symptomatic coronary artery disease (CAD), e.g., angina. In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;\n - Screening ECG showing evidence of cardiac ischemia (ST depression, depression of ≥2 mm, measured from isoelectric line to the ST segment). If in any doubt, patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;\n - Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions and/or ejection fraction <40% by MUGA scan or <50% by echocardiogram and/or MRI;\n - Known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD);\n - Hypertrophic cardiomegaly or restrictive cardiomyopathy;\n - Uncontrolled hypertension, i.e., blood pressure (BP) of ≥160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria; or\n - Cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)\n - Patients taking drugs leading to significant QT prolongation\n - Concomitant use of CYP3A4 inhibitors\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
175	[ { "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\nClinical Trial Title:\n\nPazopanib or Pemetrexed and Crizotinib in Advanced Cancer\n\nClinical Trial Summary:\n\nThe goal of this clinical research study is to find the highest tolerable dose of the combination of Xalkori (crizotinib) either with Votrient (pazopanib) or Alimta (pemetrexed) or of the combination of 3 study drugs that can be given to patients with advanced cancer. The safety of these drug combinations will also be studied.\n Crizotinib is designed to block a protein called ALK, which is involved in cancer cell growth and survival.\n Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for tumor growth. This may prevent or slow the growth of cancer cells.\n Pemetrexed is designed to block proteins that may cause tumors to grow.\n\nClinical Trial Detailed Description:\n\nStudy groups:\n Dose escalation:\n If you are found to be eligible to take part in this study, your doctor will decide if you will receive one of the following drug combinations:\n - If you are in Group A, you will receive crizotinib and pazopanib.\n - If you are in Group B, you will receive crizotinib and pemetrexed.\n - If you are in Group C, you will receive pazopanib and pemetrexed.\n - If you are in Group D, you will receive crizotinib, pazopanib, and pemetrexed.\n Once it is decided which combination you will receive, you will be assigned to a dose level based on when you join the study.\n Up to 8 dose levels of crizotinib with pazopanib will be tested. Up to 6 dose levels of crizotinib with pemetrexed will be tested. Up to 6 dose levels of pazopanib with pemetrexed will be tested. Up to 8 dose levels of pazopanib with pemetrexed and crizotinib will be tested. Up to 6 participants will be enrolled at each dose level.\n The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose combination is found.\n Dose expansion:\n Once the highest tolerable dose of each study drug combination is found, up to 14 more participants may be enrolled to further study the safety of each combination of drugs at that dose.\n Study Drug Administration:\n Each study cycle is 21 days. Drugs should be taken and/or administered simultaneously. On days of pharmacokinetic testing (if you agree) you should take the drugs at least 1 hour before or 2 hours after a meal.\n If you are taking crizotinib, you will take it by mouth at the same time every day consistently either with or without food. It should be swallowed whole with a glass of water. You will take the drug every other day, 1 or 2 times a day. You will be told how often to take this drug.\n If you are taking pazopanib, you will take it by mouth at the same time every day with a glass of water. You should take it at least 1 hour before or 2 hours after a meal.\n If you receive pemetrexed:\n - You will receive it by vein on Day 1 of each cycle over about 10 minutes.\n - The day before your first dose of pemetrexed, you will start taking folic acid to help lower the risk of side effects. Although the study drug is designed to prevent the body from making folic acid that could help cancer grow and spread, some folic acid is needed to prevent side effects in non-cancerous tissue. You will take folic acid by mouth 1 time every day until at least 30 days after you received the last dose of pemetrexed.\n - The day before your first dose of pemetrexed, you will receive a vitamin B12 injection. You will receive an injection of Vitamin B12 about every 9 weeks after that. Vitamin B12 is given to help reduce the risks of side effects.\n - You will take dexamethasone by mouth 2 times a day on the day before, the day of, and the day after you receive pemetrexed.\n Study Visits:\n At every study visit, you will be asked about any other drugs or herbal supplements you are taking and about any side effects you may have.\n During Cycles 1 and 2, you will have weekly blood (about 1 tablespoon) collected for routine tests.\n During Week 1 of Cycles 2 and beyond:\n - Your medical history will be recorded, including any cancer symptoms.\n - You will have a physical exam, including measurement of your weight and vital signs.\n - Your performance status will be recorded.\n - Blood (about 1 tablespoon) and urine will be collected for routine tests.\n - If your doctor thinks it is needed, you will have an ECG to check your heart function.\n Every 6 weeks, or earlier if needed, blood (about 1 tablespoon) will be drawn for tumor marker testing.\n After about 6 weeks and then every 2-3 cycles after that, you will have a CT scan, x-ray, MRI scan, and/or PET scan to check the status of the disease. It may be done more often if your study doctor thinks it is needed.\n If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test every 2 cycles or at any time the study doctor thinks it is needed.\n Length of Study Participation:\n You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.\n Your participation on the study will be over once you have completed the end-of-dosing and/or follow-up visits.\n End-of-Dosing Visit:\n Within 30 days after your last dose of study drugs, you will have an end-of-study visit. If you are having side effects at the time of this visit, you may have follow-up for a longer period of time. At this visit, the following tests or procedures may be performed:\n - Your medical history will be recorded, including any cancer symptoms.\n - You will be asked if you have had any side effects.\n - You will have a physical exam, including measurement of your weight and vital signs.\n - Your performance status will be recorded.\n - Blood (about 1 tablespoon) and urine will be collected for routine tests.\n - Blood (about 1 tablespoon) will be drawn for tumor marker testing.\n - If the doctor thinks it is needed, you will have an x-ray, CT scan, MRI scan, and/or PET/CT scan to check the status of the disease.\n - If your doctor thinks it is needed, you will have an ECG to check your heart function.\n This is an investigational study. Crizotinib is FDA approved and commercially available for the treatment of locally advanced or metastatic non-small cell lung cancer. Pazopanib is FDA approved and commercially available for treatment of advanced renal cell carcinoma. Pemetrexed is FDA approved and commercially available for the treatment of non-small cell lung cancer.\n The combination of crizotinib with pazopanib, crizotinib with pemetrexed, pazopanib with pemetrexed, and giving all 3 drugs together to patients with advanced cancer is investigational.\n Up to 364 patients will take part in this study. All will be enrolled at MD Anderson.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n 1. Patients with advanced cancer, either refractory to standard therapy or for which no effective standard therapy that increases survival for at least 3 months is available.\n 2. Patients must have measurable or evaluable disease, as defined by RECIST 1.1.\n 3. Women of child-bearing potential and men must agree to use adequate contraception.\n 4. ECOG performance status of 0 to 2.\n 5. Adequate organ functions: (Crizotinib plus Pazopanib arm A): Neutrophils > 1000/uL; Platelets ≥ 75,000/uL; Total bilirubin < or= 2 x ULN (upper limit of normal); ALT < or = 2.5 x ULN or < o r= 5 x ULN if liver metastases persist; Serum creatinine < 2 x ULN (Crizotinib plus Pemetrexed arm B, Pazopanib plus Pemetrexed arm C, Crizotinib plus Pazopanib plus Pemetrexed arm D) Neutrophils > 1500/uL; Platelets > or = 100,000/uL; Total bilirubin < or = 2 x ULN (upper limit of normal); ALT < or = 2.5 x ULN or < or = 5 x ULN if liver metastases persist; Calculated GFR > 45 mL/min.\n 6. Creatinine Clearance: The standard Cockcroft and Gault formula must be used to calculate CrCl for enrollment or dosing. Also include in the pre-treatment or baseline text portion of the protocol, the 'On Study Evaluations or During Treatment' for every Pemetrexed treatment day, and also capture in the study Schedule of Events. No dosage adjustment is needed in patients with creatinine clearance > 45 mL/min. Insufficient numbers of patients have been studied with creatinine clearance <45 mL/min to give a dose recommendation. Therefore, Pemetrexed should not be administered to patients whose creatinine clearance is <45 mL/min.\n 7. For pemetrexed arms: The ability to interrupt NSAIDs 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Pemetrexed.\n 8. The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol for all pemetrexed arms.\n 9. Expansion cohort only for arms containing crizotinib: arm A (Crizotinib plus Pazopanib) and arm B (Crizotinib plus Pemetrexed) and arm D (Crizotinib plus Pazopanib Plus Pemetrexed) but not arm C (Pazopanib plus Pemetrexed). Patients must have ALK abnormality including: translocation, ALK amplification, mutation and overexpression as determined by FISH, IHC, qPCR, qRT-PCR, array Comparative Genomic Hybridization or direct sequencing (aCGH). Or patients must have a c-Met abnormality; either c-Met amplification or c-Met mutation or patients must have the ROS1 translocation as determined by FISH.\n Exclusion Criteria:\n 1. Patient receiving any concurrent chemotherapy.\n 2. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring intravenous antibiotics.\n 3. Symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris or congenital long QT syndrome.\n 4. Medical and/or psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk.\n 5. Known anaphylactic or severe hypersensitivity to study drugs or their analogs.\n 6. Patient has failed to recover from any prior surgery within 4 weeks of study entry.\n 7. Patient is pregnant or lactating.\n 8. Patient has had any treatment specific for tumor control within 3 weeks of dosing with investigational drugs and cytotoxic agents, or within 2 weeks of cytotoxic agent given weekly, or within 6 weeks of nitrosoureas or mitomycin C, or within 5 half-lives of biological targeted agents with half-lives and pharmacodynamic effects lasting less than 5 days (that includes, but is not limited to, erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents).\n 9. Patient has any signs of intestinal obstruction.\n 10. Patient is not able to swallow oral medication.\n 11. Patients receiving whole brain radiation within 14 days prior to the first dose of study drugs will be excluded. NOTE: Patients receiving palliative radiation (other than whole brain) before or during treatment may still be eligible as long as there are evaluable lesions that are not being irradiated.\n 12. Pemetrexed arms only: Presence of third space fluid which cannot be controlled by drainage.\n 13. Additional Exclusions for the 3 pazopanib containing arms (Crizotinib plus Pazopanib) and (Pazopanib plus Pemetrexed) and (Crizotinib plus Pazopanib plus Pemetrexed). 1. History of stroke or transient ischemic attack within 6 months prior to study enrollment. 2. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment. 3. Urine for proteinuria > or = 2+ (patients discovered to have > or = 2+ proteinuria on urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate < or = 1g of protein in 24 hours to be eligible).\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
176	[ { "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\nClinical Trial Title:\n\nA Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)\n\nClinical Trial Summary:\n\nA study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Parent or legal guardian agrees to have infant participate by giving written informed consent\n Exclusion Criteria:\n - History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery\n - History of intussusception\n - Known or suspected impairment of immunological function, including Severe\n Combined Immunodeficiency (SCID)\n - Prior administration of any rotavirus vaccine\n - Clinical evidence of active gastrointestinal illness, with the exception of well-controlled gastroesophageal reflux disease (GERD)\n - Receipt of 1) systemic corticosteroids (≥ 2mg/kg total daily dose of prednisone or equivalent) for 14 consecutive days or more since birth, or 2) systemic corticosteroids ≥ 2mg/kg/dose within 7 days prior to the administration of the first dose of study vaccine. Participant using non-systemic corticosteroids will be eligible for vaccination.\n - Residing in a household with an immunocompromised person\n - Prior receipt of a blood transfusion or blood products, including immunoglobulins\n - Participation in another interventional study within 14 days prior to the first study vaccination or expected anytime during the study\n - Receipt of investigational inactivated vaccines within 14 days or investigational live vaccines within 28 days prior to the first study vaccination or expected anytime during the study\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
177	[ { "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\nClinical Trial Title:\n\nA Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma\n\nClinical Trial Summary:\n\nThe purpose of this research is to evaluate the safest and most effective dose of a Food and Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors of varying sizes that occur commonly in the adult population). 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.\n\nClinical Trial Detailed Description:\n\nLipomas are common mesenchymal, benign, fatty tumors of varying sizes that occur in the general adult population. They usually present as painful or annoying lumps that are palpable and often visible in the subcutaneous tissue. Many subcutaneous lipomas are asymptomatic and are removed for non-medical reasons. However, they may cause the subject pain or discomfort or interfere with normal activity.\n Spontaneous remission of lipomas has not been reported. A lipoma, once it presents itself, remains there for the lifetime of a person who carries it and may stay small or become larger. Alternative treatments of the lipoma are surgery or liposuction. If a large excision is performed there is the problem of having a very large scar and the accompanying issues of healing a large scar, or possible formation of a hematoma followed by consolidation of the hematoma and the remnants of a mass of scar tissue. This is often painful and more problematic than the original lipoma. liposuction also has the potential for hematoma formation followed by scar mass residual.\n To avoid the complications listed above, a non-invasive method of treatment, such as enzyme mediated disassociation of adipose tissue, would be desirable. The primary aim of this study is to perform a step-wise approach in dosing to evaluate the safety and efficacy of clostridium histolyticum as a non-operative treatment for lipoma.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Clinical history lipoma at least one year and no treatment within last 90 days\n - Lipoma diagnosed as benign\n - Lipoma is a single mass with easily definable edges\n - Lipoma has an area of 2.0 to 17 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 - Subjects who have participated in any investigational drug trial within 45 days of enrollment in this study\n - Subjects with known allergy to collagenase or any of the inactive ingredients in XIAFLEX\n - Subjects with diabetes or any medical condition that would make the subject unsuitable for enrollment.\n - Subjects having a history of trauma in the area of the lipoma\n - Subjects with a history of connective tissue diseases or rheumatological diseases.\n - Subjects with uncontrolled hypertension\n - Subjects currently receiving or planning to receive anticoagulant medication except for less than 150 mg aspirin daily and over-the-counter nonsteroidal anti-inflammatory drugs) within 7 days before injection of study drug\n - Subjects having the following laboratory abnormalities:\n - ALT/AST greater than 3 times the upper limit of normal\n - Creatinine greater than 2\n - Hemoglobin/hematocrit and WBC outside the normal range\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
178	[ { "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\nClinical Trial Title:\n\nPI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer\n\nClinical Trial Summary:\n\nThe study is intended to investigate the safety of BYL719 and AUY922 in patients with advanced gastric cancer, and to determine the MTD and/or RDE of both drugs in combination. In addition, the preliminary efficacy of BYL719 in combination with AUY922, and the pharmacokinetics of both drugs will be assessed. Patients will be eligible for this study, if their tumors carry either a molecular alteration of PIK3CA, or an amplification of HER2.\n The study includes a dose escalation part followed by a safety expansion phase.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Patients with advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction;\n - Patients must not have a complete gastrectomy;\n - gastric tumors carrying PIK3CA mutation or amplification, or HER2-overexpression, or both;\n - at least one but no more than three previous lines of treatment for advanced or metastatic disease;\n - Patients with PIK3CA mutated or amplified tumors must have failed at least one line but no more than three lines of standard chemotherapy and/or targeted agents;Patients with HER2 amplified tumor must have failed at least one line, but no more than three lines, with or without anti-HER2 therapy. All HER2 positive patients are expected to have received trastuzumab unless contraindications were present or trastuzumab was unavailable;\n - Performance Status (PS) ≤ 1 ;\n - Adequate bone marrow, liver and other organ functions and laboratory parameters;\n - Recovery from all AEs of previous anti-cancer therapies, including surgery and radiotherapy, to baseline or to CTCAE Grade ≤ 1, except for alopecia;Negative serum pregnancy (β hCG) test within 72 hrs before starting study treatment in all pre-menopausal women and women < 12 months after the onset of menopause.\n * Exclusion Criteria:\n - Progressive disease during or after prior combination treatment with PI3K-inhibitors and HSP90- inhibitors;\n - history of prior significant toxicity from another PI3K- or HSP90- inhibitor requiring discontinuation of treatment;\n - primary CNS tumor or uncontrolled CNS metastasest;\n - Patients who are currently receiving medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug treatment;\n - Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting glucose ≥ 140 mg/dL / 7.8 mmol/L, history of clinically significant gestational diabetes mellitus or documented steroid-induced diabetes mellitus;Patients with diarrhea CTCAE Grade ≥ 2 ;\n - Patients with acute or chronic pancreatitis; History or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or ophthalmopathy as assessed by ophthalmologic examination at baseline that would be considered a risk factor for CSR/RVO;\n - Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral BYL719;\n - Patients receiving chronic slow-release formulation of Proton Pump Inhibitors (PPI), H2-antagonists or other gastric pH elevating agents;\n - Treatment with therapeutic doses of coumarin-based anticoagulants (e.g., warfarin sodium, Coumadin®). Low doses of courmarin-based anticoagulants;\n - Patients receiving chronic or high dose corticosteroids therapy; other protocol-defined inclusion/exclusion criteria may apply.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
179	[ { "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\nClinical Trial Title:\n\nAlisertib in Treating Patients With Advanced or Metastatic Sarcoma\n\nClinical Trial Summary:\n\nThis phase II trial studies how well alisertib works in treating patients with sarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or has spread to other places in the body (metastatic). Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.\n\nClinical Trial Detailed Description:\n\nPRIMARY OBJECTIVES:\n I. To determine the response rate (complete response [CR] + partial response [PR]) assessed for patients within each cohort: liposarcoma (cohort 1); leiomyosarcoma (non-uterine) (cohort 2); undifferentiated sarcoma (including pleomorphic undifferentiated sarcoma, formerly known as malignant fibrous histiocytoma, and myxofibrosarcoma) (cohort 3); malignant peripheral nerve sheath tumor (cohort 4); and other sarcomas (cohort 5).\n SECONDARY OBJECTIVES:\n I. To estimate the progression-free survival (PFS) for patients treated with MLN8237 (alisertib) in each cohort.\n II. To estimate the overall survival (OS) for patients treated with MLN8237 (alisertib) in each cohort.\n III. To assess the adverse events associated with patients treated with MLN8237 in each cohort\n OUTLINE:\n Patients receive alisertib orally (PO) twice daily (BID) on days 1-7. 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 6 months for 18 months.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Patients must have histologically or cytologically confirmed sarcoma that is metastatic and/or locally advanced or locally recurrent and unresectable; confirmation of pathologic diagnosis will be performed at the registering site; patients will been rolled on one of five cohorts of the study:\n - Cohort 1: liposarcoma\n - Cohort 2: leiomyosarcoma (non-uterine)\n - Cohort 3: undifferentiated sarcoma (including malignant fibrous histiocytoma and myxofibrosarcoma)\n - Cohort 4: malignant peripheral nerve sheath tumor\n - Cohort 5: other sarcomas\n - Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST) 1.1; note: defined 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 >= 2 cm with conventional techniques or as >= 1 cm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam\n - Any number of prior therapies is permitted; note: the last dose of systemic therapy (including tyrosine kinase inhibitors) must have been given >= 4 weeks prior to initiation of study therapy; patients receiving BCNU or mitomycin C must have received their last dose of such therapy at least 6 weeks prior to initiation of therapy\n - Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2\n - Leukocytes >= 3,000/mcL\n - Absolute neutrophil count >= 1,500/mcL\n - Platelet count >= 100,000/mcL\n - Total bilirubin =< 1.5 x institutional upper limit of normal\n - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (alanine aminotransferase [AST]) < 3 x institutional upper limit of normal if no liver metastases or < 5 x institutional upper limit of normal if liver metastases present\n - Creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance >= 60 mL/min/1.73m^2 for patients with creatinine levels above institutional normal\n - Women of childbearing 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 4 months after completion of MLN8237 administration\n - Ability to understand and the willingness to sign a written informed consent document\n - According to current guidelines, patients must be able to take oral medication and to maintain a fast as required for approximately one hour before and two hours after MLN8237 administration\n Exclusion Criteria:\n - 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; patients who have had radiation therapy to more than 25% of the bone marrow; whole pelvic radiation is considered to be over 25%\n - Patients who are receiving any other investigational agents\n - Patients with known brain metastases\n - History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN8237 including, but not limited to, established allergic reaction to benzodiazepines\n - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, New York Heart Association (NYHA) class II-IV heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n - Pregnant women; note: women of child-bearing potential must have a negative serum or urine pregnancy test within 7 days prior to registration; breastfeeding should be discontinued if the mother is treated with MLN8237\n - Leiomyosarcoma of the uterus\n - Patients known to be human immunodeficiency virus (HIV)-positive on antiretroviral therapy\n - Prior allogeneic bone marrow or organ transplantation\n - Known history of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness such as severe chronic obstructive pulmonary disease, requirement for supplemental oxygen, or any conditions that could result in excessive toxicity associated with the benzodiazepine-like effects of MLN8237\n - Requirement for constant administration of proton pump inhibitor, histamine-2 (H2) antagonist, or pancreatic enzymes; note: intermittent uses of antacids or H2 antagonists are allowed\n - Inability to swallow oral medication or to maintain a required fast for approximately one hour before and two hours after MLN8237 administration or any condition that would modify small bowel absorption of oral medications, including malabsorption or resection of pancreas or upper bowel\n - Treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine, oxcarbazepine, primidone or phenobarbital, or rifampin, rifabutin, rifapentine, or St. John's wort within 14 days prior to the first dose of MLN8237 and during the study\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
180	[ { "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\nClinical Trial Title:\n\nA Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer\n\nClinical Trial Summary:\n\nThis study is comprised of two portions: a Phase 1 portion and a Phase 2 portion. The Phase 1 portion is a single-country, non-randomized, open label, clinical trial which will evaluate the safety, tolerability, preliminary efficacy, and PK profile of PD-0332991 as a single agent in Japanese patients with advanced solid tumors, and PD-0332991 in combination with letrozole in the first-line treatment of Japanese patients with ER(+) HER2(-) ABC. The Phase 2 portion is a single-country, non-randomized, open-label, single-cohort, multi-center clinical trial to evaluate the efficacy and safety of PD-0332991 in combination with letrozole for the first-line treatment of postmenopausal Japanese patients with ER(+) HER2(-) ABC.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n Phase 1\n - In Part 1, advanced solid tumor (except SCLC or retinoblastoma) proven histologically or cytologically at original diagnosis, that is refractory to standard therapy or for whom no standard of care therapy is available.\n - In Part 2 and Phase 2, post menopausal women with proven diagnosis of ER-positive, HER2-negative adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease (including bone only disease) not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.\n - Adequate blood cell counts, kidney function and liver function and and Eastern Cooperative Oncology Group [ECOG] score of 0 or 1.\n - Resolved acute effects of any prior therapy to baseline severity or Grade ≤1\n Phase 2\n - Adult women (≥ 20 years of age) with proven diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.\n - Documentation of histologically or cytologically confirmed diagnosis of ER(+) breast cancer based on local laboratory results.\n - Adequate blood cell counts, kidney function and liver function and and Eastern Cooperative Oncology Group [ECOG] score of 0 to 2.\n Exclusion Criteria:\n Phase 1\n - Active uncontrolled or symptomatic CNS metastases.\n - Uncontrolled infection, unstable or sever intercurrent medical condition, or current drug or alcohol abuse\n - Active or unstable cardiac disease or history of heart attack within 6 months\n Phase 2\n - HER2 positive tumor based on local laboratory results utilizing one of the sponsor approved assays.\n - Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.\n - Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
181	[ { "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\nClinical Trial Title:\n\nActivity and Tolerability of Pazopanib in Advanced and/or Metastatic Liposarcoma. A Phase II Clinical Trial\n\nClinical Trial Summary:\n\nSoft tissue and bone sarcomas are rare malignant tumors, which encompasses a large family of more than 50 histologically distinct tumor subtypes, all of which share a putative mesenchymal origin. In the case of soft tissue sarcomas (STS) surgical excision is the mainstay of treatment, but despite curative surgery, around half of patients develop distant metastases and die from disease. Few therapeutic approaches are currently available to patients with unresectable, locally advanced, or metastatic STS and only anthracyclines, ifosfamide and trabectedin have shown activity, with response rates of 20-40% in previously untreated patients. Recent and ongoing trials have investigated a variety of combination chemotherapeutic regimens (variously employing ifosfamide, doxorubicin, gemcitabine, temozolomide, vincristine, cisplatin, and dacarbazine, among others) as well as targeted therapies, which in some cases have yielded improvements in response rate but which have had little impact on survival. No other medical option is currently available, and the median survival of patients with soft-tissue sarcoma with non-resectable metastases is around 12-15 months, and approximately 8 months after second line chemotherapy.\n Liposarcomas are STS which account for at least 20% of all STS in adults. They can be further classified into 3 histologically and biologically different subtypes: well-differentiated liposarcoma/dedifferentiated liposarcoma (ALT-WD), myxoid or round cell liposarcoma and pleomorphic liposarcoma.\n ALT-WD liposarcomas are locally aggressive rarely metastasizing tumors characterized by ring or giant marker chromosomes on the cytogenetic analysis and by amplification of the 12q13-21 region on FISH (MDM2, CDK4 and HMGIC). They account for about 40% iv of liposarcomas with a 5 year OS around 80%. In a series of WD/DD treated with several regimens response rate was 12.5% OS 15 months and median PFS 3.6 months(95 CI: 3.3-5.9) Mixoid /round cell liposarcoma accounts for 45-50% of all liposarcomas. They tend to metastasize to unusual soft tissue and bone locations. High histologic grade with more than 5% of round cell component is associated with a 5-year OS of 50% approximately. They are characterized by t(23;16)(q13-14;p11) which leads to the fusion of CHOP and TLS genes Pleomorphic liposarcoma accounts for approximately 5-10% of all liposarcomas, characterized by high grade features with frequent and early lung metastasis and cytogenetically by high chromosome counts and complex structural rearrangements.\n VEGF is expressed in many STS in which increased expression is associated with higher grade and worse prognosis.\n Pazopanib is an oral angiogenesis inhibitor that targets mainly VEGFR, PDGFR and c-kit. Recently the results of a phase II trial of pazopanib in STS have been published. It was a four-cohort 2-stages study. The liposarcoma stratum was closed after the first stage because of a PFS at 12 weeks of 17% (3 out of 17 patients did not progressed after 12 weeks). After central pathologic review, 2 other patients initially classified as other STS were found to have liposarcoma with stable disease at 12 weeks (5/19: 26% PFS12w), thus fulfilling criteria for cohort expansion. Phase II study had been completed and in phase III study patients with liposarcomas were excluded so therefore data on the liposarcoma cohort are inconclusive.\n Furthermore the positive results of the phase III study PALETTE have been recently communicated, encouraging this treatment in other sarcomas: progression-free survival (PFS) per independent review was significantly prolonged with pazopanib (median: 4.6 vs 1.5 months; HR=0.31, 95% CI 0.24-0.40; P<0.0001). The interim analysis for overall survival shows a statistically non-significant improvement of pazopanib vs placebo (median: 11.9 vs 10.4 months, HR=0.83, 95% CI 0.62-1.09).\n Soluble factors associated with efficacy and toxicity of pazopanib in these patients had been also reported. Decreases in VEGFR2 and increase in PlGF were both associated with toxicity (HTA and TSH elevation) and poorer prognosis.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n 1. Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.\n Informed consent must be obtained prior to start of the specified screening window.\n Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study such as bone scan) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.\n 2. Age ≥ 18 years or legal age of consent if greater than 18 years\n 3. Histological confirmed diagnosis of high or intermediate grade malignant liposarcoma with metastatic or locally advanced disease. Formalin fixed paraffin embedded tumour block and/or representative H/E (haematoxylin/eosin) slides must be available for central pathologic review to classify tumors in the 2 eligible subtypes:\n Well-differentiated liposarcoma/de-differentiated liposarcoma (ALT-WD) Myxoid/round cell liposarcoma\n 4. Patient 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. If the only measurable lesion is in a previously irradiated area, RECIST progression should be documented after radiotherapy, in the previous 6 months before study entry.\n 7. The patient should not be considered eligible for surgery or radical radiotherapy. e.g. Patients to whom surgery/radiotherapy can not be performed with a curative intent due to the extension of the disease. In the case of radiotherapy, it may also be limited due to a previous treatment with radiotherapy in the same area.\n 8. The patient must have either been considered ineligible for systemic chemotherapy or received at least one previous regimen for relapsed, refractory or metastatic disease. A maximum of three previous lines for advanced/metastatic disease are allowed.\n Patients not eligible for systemic chemotherapy:\n Because of age, a biological condition or patient-refusal Generally, patients that received anthracyclines in the adjuvant setting are not eligible for first line therapy with this agent for advanced disease.\n Patients with a solitary kidney or >60 years old are usually not the best candidates for treatment with regular doses of ifosfamide.\n 9. Tumor tissue must be provided for all subjects for biomarker analysis before/during treatment with investigational product.\n 10. The patient should be able to swallow and retain study drug\n 11. Adequate organ system function as defined:\n Absolute neutrophil count (ANC)≥ 1.5 X 109/L Hemoglobin ≥ 9 g/dL (5.6 mmol/L) Platelets ≥ 100 X 109/L Prothrombin time (PT) or international normalized ratio (INR)≤ 1.2 X ULN Activated partial thromboplastin time (aPTT)≤ 1.2 X ULN Total bilirubin≤ 1.5 X ULN Alanine amino transferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 X ULN Serum creatinine ≤ 1.5 mg/dL (133 µmol/L)Or, if >1.5 mg/dL: Calculated creatinine clearance (ClCR)≥ 30 mL/min to ≥ 50 mL/min Urine Protein to Creatinine Ratio (UPC) <1 Or, 24-hour urine protein <1g\n 1. Subjects may not have had a transfusion within 7 days of screening assessment.\n 2. Subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range for the desired level of anticoagulation.\n 3. Concomitant elevations in bilirubin and AST/ALT above 1.0 x ULN (upper limit of normal) are not permitted.\n 4. If UPC ≥ 1, then a 24-hour urine protein must be assessed. Subjects must have a 24-hour urine protein value <1 g to be eligible. Use of urine dipstick for baseline renal function assessment is not acceptable.\n 12. A female is eligible to enter and participate in this study if she is of:\n Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:\n A hysterectomy A bilateral oophorectomy (ovariectomy) A bilateral tubal ligation Is post-menopausal Female subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for ≥ 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >40 mIU/mL and an estradiol value < 40pg/mL (<140 pmol/L).\n Female subjects using HRT must have experienced total cessation of menses for ≥ 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT\n Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception. The acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:\n Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product Oral contraceptive, either combined or progestogen alone Injectable progestogen Implants of levonorgestrel Estrogenic vaginal ring Percutaneous contraceptive patches Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository) Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug\n 13. LVEF above the lower limit of normal for the institution, based on ECHO or MUGA.\n Exclusion Criteria:\n 1. Prior history of malignancies other than liposarcoma. Subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.\n 2. Clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug. Screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated or if the subject has a history of CNS metastases.\n 3. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:\n Active peptic ulcer disease Known intraluminal metastatic lesion/s with risk of bleeding Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation History of abdominal fistula, gastrointestinal perforation, or intra‑abdominal abscess within 28 days prior to beginning study treatment.\n 4. Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:\n Malabsorption syndrome Major resection of the stomach or small bowel.\n 5. Corrected QT interval (QTc) > 480 msecs\n 6. History of any one or more of the following cardiovascular conditions within the past 6 months:\n Cardiac angioplasty or stenting Myocardial infarction Unstable angina Coronary artery bypass graft surgery Symptomatic peripheral vascular disease Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)\n 7. Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg].\n Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Following antihypertensive medication initiation or adjustment, blood pressure (BP) must be re-assessed three times at approximately 2-minute intervals. At least 24 hours must have elapsed between anti-hypertensive medication initiation or adjustment and BP measurement. These three values should be averaged to obtain the mean diastolic blood pressure and the mean systolic blood pressure. The mean SBP / DBP ratio must be <140/90 mmHg (OR 150/90 mm Hg, if this criterion is approved by Safety Review Team) in order for a subject to be eligible for the study.\n 8. History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.\n Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible\n 9. Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery).\n 10. Evidence of active bleeding or bleeding diathesis.\n 11. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage.\n Lesions infiltrating major pulmonary vessels (contiguous tumour and vessels) are excluded; however, the presence of a tumor that is touching, but not infiltrating (abutting) the vessels is acceptable (CT with contrast is strongly recommended to evaluate such lesions).\n 12. Recent hemoptysis (≥ ½ teaspoon of red blood within 8 weeks before first dose of study drug).\n 13. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.\n 14. Unable or unwilling to discontinue use of prohibited medications listed in section 7.4 of this protocol or at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study.\n 15. Treatment with any of the following anti-cancer therapies:\n radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of Pazopanib chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of Pazopanib\n 16. Administration of any non-oncologic investigational drug within 30 days or 5 half lives whichever is longer prior to receiving the first dose of study treatment\n 17. Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: definitely relevant" } ]	definitely relevant
182	[ { "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\nClinical Trial Title:\n\nA Study of Trabectedin (YONDELIS) in Patients With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma\n\nClinical Trial Summary:\n\nThe purpose of this study is to find the optimal dose of trabectedin for Chinese patients with locally advanced or metastatic L-sarcoma (liposarcoma or leiomyosarcoma) who were previously treated (in any order) with at least an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen (Part 1) and to evaluate whether the overall survival (OS) of the trabectedin group is superior to dacarbazine group (Part 2).\n\nClinical Trial Detailed Description:\n\nThe study is divided into 2 separate parts (ie, Part 1 and Part 2). Part 1 is a dose finding part (to find the optimal dose) of trabectedin for Chinese patients, and Part 2 is a multicenter, randomized (the study medication is assigned by chance), active-controlled (an active substance that is compared with the study medication to test whether the study medication has a real effect in clinical study), parallel-group (a study comparing the response in two or more groups of patients receiving different interventions), open-label (all people know the identity of the intervention) bridging part comparing the efficacy and safety of the optimal dose of trabectedin with dacarbazine in the same population as in Part 1. The study (in both Part 1 and Part 2) will consist of a screening phase, a treatment phase and a follow-up phase. Part 1: Optimal dose (ie, maximum tolerated dose [MTD]) is determined from the following 3 dose levels: Dose level 1 (1.5 mg/m2), Dose level 2 (1.2 mg/m2), and Dose level 3 (1.0 mg/m2)of trabectedin. Cohorts of 6 patients will be treated at each dose level. To determine MTD, dose limiting toxicity (DLT; any pre-defined adverse event that occurs during the first cycle ie, Cycle 1) will be determined. In the first cohort of 6 patients, (a) if DLT is less than or equal to 1 at a dose level, it is considered as MTD (b) if DLT is greater than 2, patients will be de-escalated to next dose level (c) if DLT is equal to 2, 3 more patients will be included at that dose level and if there will be no DLT in those 3 patients, that dose level is considered as MTD. Part 2: If the optimal dose found in Part 1 is 1.5 mg/m2, approximately 48 patients will be randomly assigned to either the trabectedin (approximately 32 patients) or dacarbazine (approximately 16 patients) treatment group in Part 2. If the optimal dose found in Part 1 is below 1.5 mg/m2, 123 patients will be randomly assigned to either the trabectedin (approximately 82 patients) or dacarbazine (approximately 41 patients) treatment group. Safety will be evaluated by assessing adverse events, clinical laboratory test, multiple gated acquisition scans, electrocardiograms, vital signs, and physical examination throughout the study up to 30 days after the end of treatment.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Histologically proven, unresectable, locally advanced or metastatic liposarcoma or leiomyosarcoma\n - Treated in any order with at least: an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen\n - Measurable disease at baseline in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) criteria\n - Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n - Adequate recovery from prior therapy; all side effects (except alopecia) have resolved to Grade 1 or less according to the National Cancer Institute\n - Adequate organ function and hepatic function\n Exclusion Criteria:\n - Prior exposure to trabectedin (both Part 1 and Part 2) or dacarbazine (Only Part 2)\n - Less than 3 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or therapy with any investigational agent\n - Other malignancy within past 3 years (exceptions: basal or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, or Federation Internationale de Gynecologie et d'Obstetrique (FIGO) Stage 1 carcinoma of the cervix)\n - Known central nervous system metastasis\n - Active or symptomatic viral hepatitis or chronic liver disease\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
183	[ { "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\nClinical Trial Title:\n\nA Phase 1 Study Evaluating AMG 232 in Advanced Solid Tumors or Multiple Myeloma\n\nClinical Trial Summary:\n\nFirst in human, open-label, sequential dose escalation and expansion study of AMG 232 in subjects with advanced solid tumors or multiple myeloma\n\nClinical Trial Detailed Description:\n\nStudy Design: This is an open-label, dose exploration study evaluating AMG 232 in subjects with advanced p53WT solid tumors or multiple myeloma. The study will be conducted in 2 parts: Part 1 - Dose Exploration (parts 1a, 1b and 1c) and Part 2 - Dose Expansion. Part 1a is aimed at evaluating the safety, tolerability, PK and PD of AMG 232 and determining the MTD of a 7-day once daily (QD) dosing schedule in subjects with advanced solid tumors using a practical continuous reassessment method (CRM). Part 1b will evaluate the safety and tolerability of 3-day QD dosing schedule (or alternate dosing schedule based upon emerging data) with a particular emphasis on evaluating the tolerability of daily doses equal to or higher than the part 1a MTD in subjects with solid tumors or multiple myeloma. Part 1c will evaluate the safety and tolerability of 7-day twice daily (BID) dosing schedule with daily cumulative doses equal to or higher than the part 1a MTD in subjects with solid tumors. The dose expansion part of the study (Part 2) can open once the MTD has been determined in Part 1a. Part 2, part 1b and part 1c can be explored in parallel. The dose expansion part will consist of up to 85 additional subjects with specific tumors harboring MDM2 amplification (liposarcoma [LPS], gliobastoma [ GBM ] and all other solid tumors) or potentially harboring MDM2 overexpression (ER+ metastatic breast cancer) and a group of subjects with multiple myeloma.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Men or women > 18 years old\n - Pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, or which no standard therapy is available, or the subject refuses standard therapy or multiple myeloma\n - Willing to undergo pre-dose core needle tumor biopsies or bone marrow aspirate for subjects with multiple myeloma.\n - Ability to take oral medications and willing to record daily adherance to investigational product\n - Adequate hematological, renal, hepatic, and coagulation laboratory assessments\n Exclusion Criteria:\n - Active brain metastases\n - For solid tumor-History or presence of hematological malignancies unless curatively treated with no evidence of disease for greater than or equal to 5 years\n - Active infection requiring intravenous (IV) antibiotics\n - Anti-tumor therapy\n - Therapeutic or palliative radiation therapy within 30 days of starting treatment\n - Currently enrolled in another investigational device or drug study\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
184	[ { "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\nClinical Trial Title:\n\nPD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer\n\nClinical Trial Summary:\n\nA Phase II study to investigate the potential utility of PD 0332991 in the treatment of early stage ER+ Human epidermal growth factor receptor 2 (HER2)- breast cancer, to investigate whether the combination of PD 0332991 and anastrozole is able to: 1) improve the pathologic complete response rate when compared to the historical control of single agent aromatase inhibitors, 2) result in fewer patients with on therapy Ki67>10% compared to historical control.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nPre-registration PIK3CA Mutant Inclusion\n - Clinical T2-T4c, any N, M0 invasive ER+ (Allred Score of 6-8) and HER2 negative (0 or 1+ by IHC or FISH negative for amplification) breast cancer, by AJCC 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node. Note: Patients with invasive ER+ (Allred Score of 6-8) HER2- breast cancer or DCIS in the contralateral breast the patient are eligible\n - Female ≥18 years of age\n - ECOG performance status of 0, 1 or 2\n - Life expectancy > 4 months\n - Premenopausal, patient must be willing to comply with pregnancy requirements\n - Adequate organ and marrow function\n - leukocytes ≥ 3,000/mcL\n - absolute neutrophil count ≥ 1,500/mcL\n - platelets ≥ 100,000/mcL\n - total bilirubin ≤ ULN\n - AST(SGOT)/ and ALT(SGPT) < 2.5 X ULN\n - Creatinine ≤ ULN\n - Able to understand and willing to sign an IRB-approved written informed consent document\n Exclusion\n - Prior treatment of this cancer including: surgery, radiation, chemotherapy, biotherapy, hormonal therapy, investigational agent prior to study entry\n - Receiving any investigational agents\n - Prior therapy with any Cdk4 inhibitor\n - Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism\n - Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled symptomatic cardiac arrhythmia, psychiatric illness/social situations that would limit compliance with study requirements\n - Pregnant/nursing\n - Unwilling to employ adequate contraception\n - Known HIV-positive on combination antiretroviral therapy\n - Evidence of inflammatory cancer\n - Known metastatic disease\n - Current use of anticoagulation therapy\n - Previous excisional biopsy of the breast cancer or sentinel lymph node biopsy\n - Any condition that impairs patient's ability to swallow PD 0332991 tablets (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption)\n - History of allergic reactions attributed to compounds of similar chemical or biologic composition to PD 0332991 or other agents used in the study\n - Corrected QT interval >470 msec\n Registration PIK3CA Mutant Inclusion The criteria below must be met in addition to the pre-registration criteria, except treatment with endocrine therapy for this cancer is allowed prior to registration\n - PIK3CA mutant cohort: tumor PIK3CA mutation present\n - Premenopausal women, serum estradiol level in postmenopausal range ≤ 7 days prior to registration\n Exclusion Criteria below must be met in addition to the pre-registration criteria -Current use or anticipated need for food or drugs that are known strong CYP3A4 inhibitors (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone, diltiazem, and delavirdine) or inducers (i.e. dexamethasone, glucocorticoids, progesterone, rifampin, phenobarbital, St. John's wort)\n PIK3CA Wild Type Inclusion\n - Clinical T2-T4c, any N, M0 invasive ER+ (Allred Score of 6-8) and HER2 negative (0 or 1+ by IHC or FISH negative for amplification) breast cancer, by AJCC 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node. Note: Patients with invasive ER+ (Allred Score of 6-8) HER2- breast cancer or DCIS in the contralateral breast the patient are eligible\n - For the PIK3CA wild type cohort: tumor PIK3CA mutation absent. Note that if a patient did not have sufficient research tissue for PIK3CA sequencing at pre-registration or if PIK3CA sequencing result is delayed, she could be registered and enrolled on the PD991 trial without assigning to a particular cohort at the time of enrollment. PIK3CA sequencing will be performed in the future on tumors collected at subsequent time points to assign the treatment cohort or when the PIK3CA sequencing data is available\n - For the endocrine resistant cohort: Ki67 > 10% by central testing at Washington University AMP laboratory from a tumor biopsy performed after at least 2 weeks on neoadjuvant endocrine therapy. Note that prior neoadjuvant endocrine therapy could include any endocrine therapy (including aromatase inhibitor, tamoxifen, fulvestrant) alone or in combination, or endocrine therapy in combination with any investigational agent that is not a Cdk 4/6 inhibitor\n Patients who had a Day 17 Ki67 > 10% from the NCI9170 trial are eligible for the endocrine resistant cohort\n - Female >18 years of age\n - ECOG performance status of 0, 1 or 2\n - Life expectancy > 4 months\n - If premenopausal, patient must be willing to comply with pregnancy requirements\n - Adequate organ and marrow function:\n - leukocytes ≥ 3,000/mcL\n - absolute neutrophil count ≥ 1,500/mcL\n - platelets ≥ 100,000/mcL\n - total bilirubin ≤ ULN\n - AST(SGOT)/ and ALT(SGPT) < 2.5 X ULN\n - Creatinine ≤ ULN\n - In premenopausal women, serum estradiol level in postmenopausal range ≤ 7 days prior to registration.\n - Able to understand and willing to sign an IRB-approved written informed consent document\n Exclusion\n - Prior treatment of this cancer including: Surgery, Radiation therapy, Chemotherapy, Biotherapy, Hormonal therapy, Investigational agent prior to study entry\n - Receiving any other investigational agents\n - Prior therapy with any Cdk4 inhibitor\n - Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism\n - Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled symptomatic cardiac arrhythmia, psychiatric illness/social situations that would limit compliance with study requirements\n - Pregnant/nursing\n - Unwilling to employ adequate contraception\n - Known HIV-positive on combination antiretroviral therapy\n - Evidence of inflammatory cancer\n - Known metastatic disease\n - Current use of anticoagulation therapy\n - Previous excisional biopsy of the breast cancer or sentinel lymph node biopsy\n - Any condition that impairs patient's ability to swallow PD 0332991 tablets (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption)\n - History of allergic reactions attributed to compounds of similar chemical or biologic composition to PD 0332991 or other agents used in the study\n - Corrected QT interval >470 msec\n - Current use or anticipated need for food or drugs that are known strong CYP3A4 inhibitors (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone, diltiazem, and delavirdine) or inducers (i.e. dexamethasone, glucocorticoids, progesterone, rifampin, phenobarbital, St. John's wort)\n Endocrine Resistant Inclusion\n - Clinical T2-T4c at diagnosis or screening, any N, M0 invasive ER+ (Allred Score at least 3 or > 1% ER positivity) and HER2 negative (0 or 1+ by IHC or FISH negative or equivocal) breast cancer, by AJCC 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node. Note: Patients with invasive breast cancer that is ER pos, HER2 neg or equivocal or DCIS in the contralateral breast are eligible; multi-focal diseases are not excluded. The dominant lesion will be followed per protocol\n - Ki67 > 10% by central testing at Washington University AMP laboratory from a tumor biopsy performed after at least 2 weeks on neoadjuvant endocrine therapy. If Ki67 is > 10% by local testing, the Ki67 slide and H&E slide need to be reviewed by the study pathologist to confirm eligibility (discuss with Study Chair). For patients external to Washington University, please contact the Washington University coordinator by email so that a screening ID# can be assigned prior to shipment of the slides\n - Female ≥ 18 years of age\n - ECOG performance status of 0, 1 or 2\n - Pre- or post-menopausal women are eligible. If premenopausal, patient must be willing to comply with pregnancy requirements and agrees with GnRH agonist therapy for ovarian suppression during the study\n - Adequate organ and marrow function:\n - Leukocytes ≥ 3,000/mcL\n - Absolute neutrophil count ≥ 1,500/mcL\n - Platelets ≥ 100,000/mcL\n - Total bilirubin ≤ ULN\n - AST(SGOT)/ and ALT(SGPT) < 2.5 X ULN\n - Creatinine ≤ ULN\n - Able to understand and willing to sign an IRB-approved written informed consent document\n Exclusion\n - Prior treatment of this cancer including: Surgery, Radiation, Chemotherapy\n - Receiving any other investigational agents\n - Prior therapy with Cdk4 inhibitor\n - Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism\n - Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled symptomatic cardiac arrhythmia, psychiatric illness/social situations that would limit compliance with study requirements\n - Pregnant/nursing\n - Unwilling to employ adequate contraception\n - Known HIV-positive on combination antiretroviral therapy\n - Known metastatic disease\n - Current use of anticoagulation therapy\n - Previous excisional biopsy of the breast cancer or sentinel lymph node biopsy\n - Any condition that impairs patient's ability to swallow PD 0332991 tablets (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption)\n - History of allergic reactions attributed to compounds of similar chemical or biologic composition to PD 0332991 or other agents used in the study\n - Corrected QT interval >470 msec\n - Current use or anticipated need for food or drugs that are known strong CYP3A4 inhibitors (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone, diltiazem, and delavirdine) or inducers (i.e. dexamethasone, glucocorticoids, progesterone, rifampin, phenobarbital, St. John's wort)\n Adjuvant Inclusion\n - Derived benefit from PD 0332991 in the neoadjuvant setting in this trial. This includes the 26 patients who achieved complete cell cycle arrest only after the addition of PD 0332991 (C1D1 Ki67 >2.7% and C1D15 Ki67 ≤ 2.7%) from the main study (PIK3CA WT, mutant, or unknown cohorts) as well as any patients who have a Ki67 ≤ 10% on C1D15 biopsy in the endocrine resistant cohort\n - ECOG performance status of 0, 1 or 2\n - Premenopausal, patient must be willing to comply with pregnancy requirements laid out\n - Adequate organ and marrow function\n - leukocytes ≥ 3,000/mcL\n - absolute neutrophil count ≥ 1,500/mcL\n - platelets ≥ 100,000/mcL\n - total bilirubin ≤ ULN\n - AST(SGOT)/ and ALT(SGPT) ≤ 2.5 X ULN\n - Creatinine ≤ ULN\n - Underwent surgery of the breast and axilla for curative intent\n - At least 4 weeks post completion of adjuvant chemotherapy and radiation therapy if indicated\n - Patients who already started on adjuvant hormonal therapy are eligible under the following conditions:\n - For the 26 patients who enrolled in the initial cohorts and derived benefit from neoadjuvant PD 0332991 (C1D1 Ki67 >2.7% and C1D15 Ki67 ≤ 2.7%), adjuvant PD 0332991 should be initiated as soon as possible if adjuvant hormonal therapy has been initiated and the patient has completed radiation if indicated\n - For patients who enrolled in the endocrine resistant cohort and derived benefit from neoadjuvant PD 0332991 (C1D15 Ki67 ≤ 10%), adjuvant PD 0332991 should be initiated within 6 months or sooner after initation of adjuvant hormonal therapy\n - Able to understand and willing to sign an IRB-approved written informed consent document\n Exclusion\n - Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism\n - Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled symptomatic cardiac arrhythmia, ssychiatric illness/social situations that would limit compliance with study requirements\n - Pregnant/nursing\n - Unwilling to employ adequate contraception\n - Known HIV-positive on combination antiretroviral therapy. -Known metastatic disease\n - Any condition that impairs patient's ability to swallow PD 0332991 tablets (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption)\n - History of allergic reactions attributed to compounds of similar chemical or biologic composition to PD 0332991 or other agents used in the study\n - Corrected QT interval >470 msec\n - Current use or anticipated need for food or drugs that are known strong CYP3A4 inhibitors (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone, diltiazem, and delavirdine) or inducers (i.e. dexamethasone, glucocorticoids, progesterone, rifampin, phenobarbital, St. John's wort)\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
185	[ { "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\nClinical Trial Title:\n\nA Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)\n\nClinical Trial Summary:\n\nThe study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy.\n - Confirmed diagnosis of ER positive breast cancer\n - No prior systemic anti-cancer therapy for advanced ER+ disease.\n - Postmenopausal women\n - Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or bone-only disease\n - Eastern Cooperative Oncology Group [ECOG] 0-2\n - Adequate organ and marrow function\n - Patient must agree to provide tumor tissue\n Exclusion Criteria:\n - Confirmed diagnosis of HER2 positive disease\n - Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term\n - Known uncontrolled or symptomatic CNS metastases\n - Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ≤ 12-months from completion of treatment.\n - Prior treatment with any CDK 4/6 inhibitor.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
186	[ { "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\nClinical Trial Title:\n\nEfficacy of EGFR TKIs in Patients With Rare EGFR-mutated NSCLC\n\nClinical Trial Summary:\n\nLung cancer is the leading cause of cancer-related death worldwide and is well known to remain a major health problem. Non-small-cell lung cancer (NSCLC) constitutes more than 80% of all the cases of lung cancer.\n Today, NSCLC can be defined by various molecular criteria. Especially, somatic mutations within the epidermal growth factor receptor (EGFR) gene itself were discovered in a subset of NSCLC patients.\n Two activating EGFR mutations are in-frame deletion in exon 19 and the substitutions for L858R in exon 21, which account for 85% of all clinically important mutations related to EGFR TKI sensitivity.\n Besides two activating EGFR mutations, other EGFR mutations in NSCLC have been discovered. G719 and L861 are reported to have intermediate sensitivity to EGFR TKI. And in-frame insertions within exon 20 and T790, which are known to be resistant to EGFR TKIs.\n However, there are still other EGFR mutations such as E709 and S768 as well as doublet EGFR mutations are also observed. These rare mutations have not been fully described and data on their correlation with response to EGFR-TKIs are still unclear.\n Research hypothesis Rare EGFR mutations of unknown clinical significance in NSCLC patients, which are distinguish from mutations such as deletion in exon 19, L858 and insertion in exon 20, have some possibility of EGFR TKI sensitivity.\n Rationale for conducting this study It has an opportunity to be shown the efficacy of EGFR TKIs in patients with rare EGFR mutation in large number of patients in Korea (Asia) during the short period.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n 1. Histological confirmed non-small cell lung cancer (NSCLC), Stage IIIB or stage IV, between January 1, 2008 to December 31, 2011\n 2. Confirmed EGFR rare mutations (EGFR mutation except both exon 19 deletion and exon 21 L858R) using direct DNA sequencing\n 3. Experiences of treatment with EGFR TKIs.\n 4. at least one measurable and/or evaluable lesion according to RECIST criteria (version 1.1)\n Exclusion Criteria:Subjects should not enter the study if any of the following exclusion criteria are fulfilled: EGFR wild type, EGFR exon 19 deletion alone, EGFR L858R alone\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
187	[ { "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\nClinical Trial Title:\n\n1st-line Activity of Dovitinib and Correlation With Genetic Changes in RCC\n\nClinical Trial Summary:\n\nThe main purpose of this study is to find out how useful dovitinib is when given as the initial treatment to participants with advanced kidney cancer, that has spread to other parts of the body. The usefulness of dovitinib will be assessed by: how long the disease is controlled while participants are receiving the drug, the proportion of participants who get a reduction in the size of their tumours and how long participants live (both while on dovitinib and on any subsequent therapy they may receive).\n If participants have secondary disease in the bones, the study will evaluate how useful dovitinib is in controlling this site of disease. In addition, this study will look for changes in the genetic makeup of tumour cells and see if some of these changes are associated with a benefit from dovitinib. The study will also compare and contrast the genetic changes in the primary tumour cells with cells from secondary tumour specimens, and with cells from tumour specimens taken if a participant's disease has worsened. The purpose of the latter is to identify possible ways in which the tumour becomes resistant to the study drug.\n\nClinical Trial Detailed Description:\n\nThe purpose of this prospective, single centre, non-randomised, open-label, phase II study will evaluate the activity of dovitinib in the treatment naïve population of patients with advanced RCC.\n Background: Prior to the middle of last decade, the only systemic therapy for patients with advanced RCC was immunotherapy (interleukin-2 and interferon-alpha) with limited effectiveness and a multitude of side-effects. Since 2006, there have been 6 targeted therapies that have been FDA-registered for the treatment of advanced RCC; the anti-VEGFR tyrosine kinase inhibitors (sunitinib, sorafenib and pazopanib), the anti-VEGF antibody bevacizumab (with interferon-alpha) and the mTOR inhibitors (everolimus and temsirolimus). These treatments have significantly advanced outcomes for patients with this disease but unfortunately they do not represent cures. The median overall survival for patients treated with a standard first-line therapy (sunitinib) is just over 2 years and the median PFS for subjects receiving this agent is only 11 months. This means that the typical time it takes for subjects to develop resistance to standard first-line tyrosine kinase inhibitor (TKI) treatment, as evidenced by significant tumour growth on imaging, is under 1 year.\n Despite the recent rapid advancements in the treatment options for subjects with advanced RCC, there is still an unmet need for more effective therapeutic options for patients with this disease so as to improve survival and make steps towards the ultimate treatment aim for patients with metastatic disease - cure. Available data suggests that dovitinib is a very active agent in metastatic RCC. If it has efficacy in the heavily pre-treated RCC population, one would expect it to be considerably more active when it is moved forward into the first-line setting.\n Dovitinib is a broad-targeted receptor Tyrosine Kinase Inhibitor (TKI) primarily active against three receptors that mediate tumour growth and survival: vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR) and fibroblast growth factor receptor (FGFR). A distinguishing feature of dovitinib (compared to other anti-VEGFR TKI's) is its FGFR inhibition. Up-regulation of the fibroblast growth factor receptor 1 (FGFR1) pathway has been demonstrated in metastatic RCC and is a postulated mechanism of resistance to anti-VEGFR therapies. This is thought to be one of the reasons why dovitinib has activity in subjects treated with prior anti-VEGFR therapies. If we move the FGFR inhibition forward into the first-line setting (by using dovitinib) we hope to be able prevent or delay the development of resistance acquired through FGFR up-regulation. We hope this may allow subjects to remain on first-line therapy for much longer and in doing so improve survival and outcomes for this group of patients.\n Dovitinib has been studied in heavily pre-treated subjects with metastatic RCC, and in these phase I/II studies it looks very active. If it has efficacy in the heavily pre-treated RCC population, it is possible it would be more active when it is moved forward in to the first-line setting.\n While we have good prognostic markers to risk-stratify subjects with RCC, there is a lack of predictive markers to guide us as to which patients are best served with each of the different agents available for use. It is therefore imperative that drug development studies in this disease have companion biomarker analysis to identify potentially useful predictive biomarkers for future research. This study also aims to explore (using FISH) the amplification/deletion status of range of genes-of-interest, selected for their relevance to the biology of RCC and the mechanism-of-action of dovitinib. Amplification/deletion of these genes will be further validated using DNA sequencing. The status of these genes-of-interest will be correlated with outcomes of these subjects treated with dovitinib.\n The hypothesis of this study is that dovitinib will demonstrate anti-tumour activity when administered to subjects with advanced RCC in the first-line setting and that this activity will correlate with FGFR gene amplification status.\n The primary objective is to evaluate the activity of dovitinib in the treatment naïve population of patients with advanced RCC.\n Secondary Objectives:\n - To determine the gene amplification status for FGFR-1,-2,-3 in this patient population\n - To measure the strength of the correlation between measures of clinical efficacy and FGFR gene amplification status\n - To further evaluate safety\n Exploratory Objectives:\n - To assess for amplifications/deletions for genes related to RCC biology in this group of subjects treated with dovitinib.\n - To correlate gene amplification status with DNA gene sequence.\n - To evaluate differences in tumour gene status between primary and metastatic samples from same subject and again on post-treatment biopsy to elucidate mechanisms of resistance to dovitinib.\n - To evaluate effects of dovitinib on bone metastases and pain.\n Investigational treatment: Thirty patients from the greater Auckland region will be treated with dovitinib (500 mg p.o. o.d., 5 days on/2 days off) until disease progression, unacceptable toxicity, patient withdrawal or death.\n The primary analysis will be performed when 20 progression and/or death events have occurred. No interim efficacy analysis is planned for this study. However, an independent Data Monitoring Committee (DMC) will review data collection (including analysing the adverse event information) and will meet at specified time points during the study.\n Visit schedule: Patients will attend clinic visits every 3 weeks while on treatment. Tumour response assessments will occur every 9 weeks until week 54, then every 12 weeks thereafter until disease progression (estimated median time to disease progression = 16 months). Once all patients have completed study treatment, patients will continue to be followed up 3-monthly until approximately 2 months after 20 death events have occurred.\n For each patient there will be three separate phases in the study: pre-treatment (screening & baseline), treatment and follow-up.\n Pre-treatment phase (Screening/Baseline): The patient must provide a signed informed consent form (ICF) prior to any study related procedure. A screening period of 28 days is allowed to assess eligibility. Radiologic evaluation (CT of the head, chest, abdomen and pelvis) and baseline tumour measurement using RECIST v1.1 will be performed. Other screening and baseline assessments include ECG & echocardiogram to assess cardiac function, performance status assessment (ECOG & WHO), physical examination (including the buccal cavity), height, weight & vital signs. Laboratory investigations include haematology, chemistry, amylase, lipase, serum lipid profile, coagulation, urinalysis, thyroid function, cardiac enzymes and pregnancy test (if applicable). Disease specific information, general medical information including medical history, concomitant medications, prognostic group according to Heng criteria and demographic data will also be collected.\n Treatment phase: This study does not have a fixed treatment duration, as patients will continue therapy until disease progression, intolerable toxicity or withdrawal. Following study inclusion and initiation of study treatment, the patient should visit the site on day 1, 8 and 15 during cycle 1, then day 1 of every subsequent cycle. Patients will have their first dose of study treatment on Day 1, Cycle 1. A study cycle is defined as a period of 21 days.\n Tumour response will be evaluated every 3 cycles after registration until week 54, then every 4 cycles until documented disease progression. ECOG performance status will be assessed on day 1 of every cycle. Safety assessments are routinely performed including collection of adverse events (AEs), Serious Adverse Events (SAEs), concomitant medications, vital signs, physical examination, weight, haematological and biochemistry assessments, urinalysis, thyroid function and cardiac enzymes. ECG, amylase, lipase, serum lipids and coagulation will be measured if clinically indicated. An echocardiogram will be performed at weeks 12 and 24, and as clinically indicated. Plasma for storage will be collected on Day 1 of Cycles 1 and 3. Participants with bone metastases will have plasma collected for C-telopeptide testing on day 1 of weeks 1, 2 and 13, and will complete a Quality of Life questionnaire (FACT-BP) at 4 time points: on day 1 of weeks1, 2, 4 and 13.\n The End of Treatment (EOT) visit will take place approximately 7 days after the last dose of dovitinib. At this visit the following assessments will be performed and the following data collected: physical examination, ECOG performance status, weight, vital signs, adverse events, concomitant medications, antineoplastic therapies, haematology, biochemistry, amylase and lipase measurements.\n Safety follow-up: All patients who discontinue study treatment will have a safety follow-up visit within 30 days of the last dose of dovitinib. Safety assessments will include collection of AEs, SAEs, vital signs, concomitant medications and any new antineoplastic therapies. Patients who progress will be invited to provide an (optional) additional biopsy sample of their tumour, at least 10 days after the last dose of dovitinib, but before any new anticancer therapies are initiated.\n Efficacy follow-up: Patients who discontinue the study treatment for reasons other than progression will continue to have radiologic assessments, using the same schedule as for patients who remain on treatment, until documented disease progression.\n Survival follow-up: Patients who have discontinued study treatment will be followed-up for survival every 3 months by clinical visits or telephone call until death occurs, the patient is lost to follow-up, or withdraws consent for follow-up for survival. Further treatment will be at the discretion of the investigator.\n Statistical Methods: All data will be presented descriptively as means, medians or proportions. Progression free and overall survival from the first dose of dovitinib until disease progression or death will be determined using the method of Kaplan-Meier. The correlation between PFS, OS and baseline biomarker status as well as FGFR gene amplification status will be measured using Spearman's rho. Generalized estimating equations (GEE) for repeated measures will also be used to test the significance of changes in biomarker amplification status relative to baseline. Ordinal logistic regression analysis using a repeated measures structure will be applied to compare bone pain control over the treatment period relative to baseline.\n Sample Size Calculation and Expected Duration: The response rate (RR) reported for sunitinib, when studied in a phase III trial versus interferon in the first-line setting was approximately 31%, with a 95%CI ranging from 26 to 36% (Motzer, NEJM 356: 115, 2007). The target sample size in this phase II study is 30, which was based on the assumption that the RR for dovitinib would fall within the range of sunitinib. With such a sample size, the prevalence of dovitinib RR using RECIST 1.1 will be measured with a precision that extends to 15 percentage points, with a 95% probability.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Advanced renal cell (clear cell) carcinoma confirmed histologically, including either distant metastases or locally advanced disease that is not resectable or potentially resectable following response. Sarcomatoid change is allowed if clear cell predominant. Histological variants, papillary, chromophobe and collecting duct carcinoma are not allowed.\n - Availability of FFPE tissue for gene status analysis. If unavailable, an image-guided biopsy of a metastatic disease site is required.\n - Evaluable disease by RECIST 1.1 criteria\n - ECOG (WHO) performance status 0 or 1\n - Age ≥ 18 years\n - Absolute neutrophil count ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; haemoglobin > 9 g/dL; serum total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 3.0 x ULN; serum creatinine ≤ 1.5 x ULN or creatinine clearance >35 ml/min by Cockcroft and Gault.\n Exclusion Criteria:\n - Uncontrolled brain metastases. For know brain metastases, definitive treatment with either surgery, stereotactic radiotherapy or whole brain radiotherapy is required. Patients must be neurologically stable for > 4 weeks after CNS treatment ends, and either be off corticosteroids or receiving a low daily dose.\n - Another primary malignancy within 3 years prior to starting study treatment, except for adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix. If another primary tumour was noted within this period, a metastatic disease site biopsy is required to confirm renal origin.\n - Prior systemic anticancer treatment for renal carcinoma. Prior bisphosphonates are allowed.\n - Radiotherapy ≤ 4 weeks prior to starting the study drug or non-recovery from related toxicities. Palliative radiotherapy for bone lesions ≤ 2 weeks prior to starting study drug is allowed.\n - Major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic) ≤ 4 weeks prior to starting study treatment or non-recovery from surgical side effects.\n - History of pulmonary embolism or untreated deep venous thrombosis within the past 6 months. If a history of PE or DVT within the past 6 months is present, patients must be clinically stable on appropriate doses of anticoagulation as per thrombosis specialist advice.\n - Impaired cardiac function or clinically significant cardiac diseases, including history of serious uncontrolled ventricular arrhythmias; clinically significant resting bradycardia; LVEF assessed by 2-D echocardiogram < 50% or lower limit of normal (whichever is higher) or multiple gated acquisition scan < 45% or lower limit of normal (whichever is higher). Within 6 months prior to starting study drug: myocardial infarction, severe/unstable angina, coronary artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack; uncontrolled hypertension defined by a SBP ≥ 160 mm Hg and/or DBP ≥ 90 mm Hg, with or without anti-hypertensive medication. Initiation or adjustment of antihypertensive medication is allowed before study entry.\n - Impaired gastrointestinal function or GI disease that may significantly alter dovitinib absorption, e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection.\n - Cirrhosis, chronic active hepatitis or chronic persistent hepatitis\n - Known diagnosis of human immunodeficiency virus infection (testing is not mandatory)\n - Current full dose anticoagulation treatment with therapeutic doses of warfarin, dabigatran or anti-platelet therapy. Treatment with ≤ 100mg acetylsalicyclic acid daily is allowed as are therapeutic or prophylactic doses of low molecular weight heparin, provided there is no recent evidence of bleeding.\n - Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. infection, diabetes) that could cause unacceptable safety risks or compromise protocol compliance.\n - Pregnant or breast-feeding women\n - Women of child-bearing potential or fertile males not using effective contraception.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
188	[ { "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\nClinical Trial Title:\n\nDovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib\n\nClinical Trial Summary:\n\nThe purpose of this signal seeking study was to determine whether treatment with dovitinib (TKI258) demonstrated sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.\n\nClinical Trial Detailed Description:\n\nThis was a phase II, open label study to determine the efficacy and safety of treatment with dovitinib (TKI258) in patients with a diagnosis of select solid tumors or hematological malignancies that have been pre-identified (prior to study consent) to have mutations, translocations or amplifications and whose disease has progressed on or after standard treatment.\n Genomic profiling is becoming more accessible to patients and their physicians. As such, more patients have been identified with potentially-actionable mutations, translocations or amplifications but do not have access to targeted drug treatment. This is a signal-seeking study to match patients with tumor pathway activations inhibited by dovitinib to the RTK inhibitor dovitinib. Pre-identification of mutations, translocations, or amplifications will be performed locally at a CLIA certified laboratory prior to participation on the trial.\n For the purpose of this study, genomic profiling is not considered part of screening. Informed consent must be signed before any screening activities take place. Once eligibility (screening criteria met) has been confirmed by Novartis, the patient will initiate therapy with dovitinib single-agent. The patient may not receive any additional anti-cancer therapy during treatment with dovitinib.\n Patients received study treatment until disease progression (assessed by investigator per RECIST 1.1 or appropriate hematologic response criteria), unacceptable toxicity, death or discontinuation from study treatment for any other reason (e.g., withdrawal of consent, start of a new anti-neoplastic therapy or at the discretion of the investigator), otherwise known as End of Treatment. All patients who discontinue from study treatment due to disease progression must have their progression clearly documented.\n Disease assessment (by RECIST 1.1 or appropriate hematological response criteria) will be performed every 8 weeks (±4 days) after first dose of study drug (Day 1 of every odd cycle), until disease progression or end of treatment, whichever occurs first. The frequency of disease assessment may be reduced to every 12 weeks for patients who have at least 4 post-baseline disease assessments and are clinically stable (except AML patients). Scans was assessed locally by the investigator. After discontinuation of treatment, patients, regardless of reason for treatment discontinuation, will be followed for safety for 30 days after the last dose.\n All patients will be followed for survival status every 3 months for 2 years after the last patient has enrolled in the study,regardless of treatment discontinuation reason (except if consent is withdrawn or patient is lost to follow-up)\n\nClinical Trial Eligibility Criteria:\n\nKey Inclusion Criteria:\n Patients eligible for inclusion in this study had to meet all of the following criteria:\n 1. Patient's age was ≥ 18 years of age at the time of signing informed consent.\n 2. Patient had a confirmed diagnosis of a selected solid tumor (except for primary diagnosis of urothelial tumors, hepatocellular carcinoma (HCC), endometrial carcinoma, metastatic breast cancer (mBC), squamous NSCLC, and renal cell carcinoma (RCC)) or hematologic malignancies (except for primary diagnosis of FLT3 AML and multiple myeloma). Additional tumor types could be excluded during the course of the study in the case of early futility or success based upon an interim analysis or at the discretion of Novartis.\n 3. Patient was in need of treatment because of progression or relapse defined as:\n - radiological progression for solid tumor and lymphoma\n - for hematologic malignancies, measureable progression or relapse by appropriate criteria\n 4. Patients had pre-identified tumor with a mutation and/or translocation of one of the known kinase targets of dovitinib. The qualifying alteration were assessed and reported by a CLIA-certified laboratory. The mutations included:\n 1. FGFR 1-3 (amplifications were also allowed)\n 2. PDGFRα or PDGFRβ\n 3. VEGFR1-2 (KDR)\n 4. FLT3, cKIT (amplifications are also allowed),\n 5. RET, TrkA (NTRK1), or CSF-1R\n 5. Patient had archival tissue available for submission to allow for molecular testing related to pathway activation. If the tissue was not available or not of sufficient quantity the patient was willing to undergo a fresh tumor biopsy to allow for this analysis. The sample was submitted prior to first study dose unless agreed upon between Novartis and the investigator.\n 6. Patient received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options were anticipated to result in a durable remission.\n 7. Diffuse large B cell lymphoma only: Patient received or was ineligible for autologous or allogeneic stem cell transplant. This did not apply to patients with Mantle cell lymphoma or follicular lymphoma\n 8. Patients with measurable disease as per appropriate guidelines:\n a. Solid Tumors: by RECIST 1.1\n 9. Lymphoma: Patient had at least one measurable nodal lesion (≥2 cm) according to Cheson criteria (Cheson 2007). In case where the patient had no measurable nodal lesions ≥ 2 cm in the long axis at screening, then the patient had at least one measurable extra-nodal lesion.\n 10. Leukemia only: Relapsed/refractory leukemia for which no standard therapy options were anticipated to result in a durable remission:\n 1. Acute myelogenous leukemia (AML) by World Health Organization (WHO) classification (except FLT3) or acute lymphoblastic leukemia (ALL) relapsed or refractory to standard chemotherapy; unsuitable for standard chemotherapy or unwilling to undergo standard chemotherapy. Philadelphia chromosome (Ph) positive ALL eligible if failed prior tyrosine-kinase inhibitor therapy.\n 2. Age > 60 years with AML (except FLT3) not candidates for or have refused standard chemotherapy, excluding patients with acute promyelocytic leukemia (APL) or with favorable cytogenetic abnormalities.\n 3. For patients with Chronic Myeloid Leukemia (CML) only accelerated and blast phase CML were allowed.\n 11. Patient with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1\n 12. Patient with a life expectancy of at least 16 weeks\n 13. All Patients were having adequate bone marrow as described below:\n 1. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L (not applicable for leukemia patients).\n 2. Platelets (PLT) ≥ 75 x 109/L (no platelet transfusion within past 14 days) (not applicable for leukemia patients).\n 3. Hemoglobin (Hgb) ≥ 9 g/dl (not applicable for leukemia patients).\n 4. International Normalized Ratio (INR) ≤ 1.5.\n 5. Serum amylase and lipase ≤ upper limit of normal (ULN).\n 14. All patients had adequate organ function defined as described below:\n 1. Potassium, calcium (corrected for serum albumin) and magnesium within normal limits (WNL). Supplementation was allowed to meet eligibility requirements. Bisphosphonates to treat malignant hypercalcemia WERE NOT allowed.\n 2. Serum creatinine ≤ 1.5 x ULN or Serum creatinine >1.5 - 3 x ULN if\n - creatinine clearance by 24-hr urine was ≥ 30 mL/min/1.73m2 (≥50 mL/min/1.73m2 in the presence of proteinuria as defined by inclusion criterion #16 or\n - calculated creatinine clearance (CrCl) was ≥ 30 mL/min using the Cockroft- Gault equation CrCl = (140 - age in years) x (weight in kg) / (72 x serum creatinine in mg/dL) (if female, multiply the number by 0.85)\n 3. Alanine aminotransferase (AST) and/or aspartate aminotransferase (ALT) ≤ 3.0 x upper limit of normal range (ULN)\n 4. Total serum bilirubin within normal range (or ≤ 1.5 x ULN)\n 15. Urine dipstick reading: Negative for proteinuria or, if documentation of +1 results for protein on dipstick reading, then total urinary protein ≤ 500 mg and measured creatinine clearance ≥ 50 mL/min/1.73m2 from a 24 hour urine collection.\n 16. For Leukemia patients, peripheral blast counts < 50,000 blasts/mm3\n Key Exclusion Criteria:\n Patients eligible for this study did not meet any of the following criteria:\n 1. Patients who received prior treatment with dovitinib (TKI258).\n 2. Patients with a known hypersensitivity to dovitinib (TKI258) or to its excipients.\n 3. Patients with brain metastasis or history of brain metastasis or leptomeningeal carcinomatosis.\n 4. Patients with diarrhea ≥ CTCAE grade 2.\n 5. Patients with neuropathy ≥ CTCAE grade 2.\n 6. Patients with acute or chronic pancreatitis.\n 7. Patients with external biliary drains.\n 8. Patients with a history of pulmonary embolism (PE), or untreated deep venous thrombosis (DVT) ≤ 6 months prior to starting study drug. Note: Patients with recent DVT who were treated with therapeutic anti-coagulant agents for at least 6 weeks are eligible.\n 9. Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:\n 1. History or presence of serious uncontrolled ventricular arrhythmias.\n 2. Clinically significant resting bradycardia.\n 3. LVEF assessed by either 2-D echocardiogram (ECHO) < 50% or lower limit of normal (whichever was the higher), or 2-D multiple gated acquisition scan (MUGA) < 45% or lower limit of normal (whichever was the higher).\n 4. Any of the following within 6 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, coronary artery bypass graft (CABG), congestive heart failure (CHF), cerebrovascular accident (CVA), transient ischemic Attack (TIA).\n 5. Uncontrolled hypertension defined by a SBP ≥ 160 mm Hg and/or DBP ≥ 100 mm Hg, with or without anti-hypertensive medication(s). Initiation or adjustment of antihypertensive medication(s) was allowed prior to study entry.\n 10. Patients with uncontrolled diabetes mellitus.\n 11. Patients with clinical evidence of active CNS leukemia.\n 12. Patient who received Allogeneic stem cell transplant and/or had active has graft-versus host disease (GVHD).\n 13. Patient received Autologous stem cell transplant within last 4 weeks.\n 14. Impairment of GI function or GI disease that could significantly alter the absorption of dovitinib (e.g. severe ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n 15. Any other condition that was, in the Investigator's judgment, contraindicate patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g. infection/inflammation, intestinal obstruction, unable to swallow oral medication, social/psychological complications.\n 16. Patients who were treated with any hematopoietic colony-stimulating growth factors (e.g.,G-CSF, GM-CSF) ≤ 2 weeks prior to starting study drug. Erythropoietin or darbepoetin therapy, if initiated at least 2 weeks prior to enrollment, could be continued. Restriction was not applicable for patients with Leukemia.\n 17. Patient who received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, monoclonal antibodies or mitomycin-C) prior to starting study drug or who had not recovered to a grade 1 from side effects of such therapy (except for alopecia and neuropathy). Patients with leukemia could receive therapy with hydroxyurea and/or steroids for the purpose of cytoreduction but must discontinue use prior to first dose of study drug.\n 18. Patients who received the last administration of an anticancer small molecule therapy (e.g. sunitinib, sorafenib, pazopanib, axitinib, everolimus, temsirolimus, ridaforolimus) ≤ 2 weeks prior to starting study drug, or who had not recovered from the side effects of such therapy.\n 19. Patients not able to discontinue their current anti-cancer therapy prior to first dose of study drug.\n 20. Patients who received radiotherapy ≤ 4 weeks prior to starting the study drug or who had not recovered from radiotherapy-related toxicities (note: palliative radiotherapy for bone lesions ≤ 2 weeks prior to starting study drug is allowed).\n 21. Patients who had undergone major surgery (e.g., intra-thoracic, intra-abdominal, intrapelvic) ≤ 4 weeks prior to starting study treatment or who had not recovered from side effects of such surgery.\n 22. Patient was currently receiving antiplatelet therapy of prasugrel or clopidogrel, or full dose anticoagulation treatment with therapeutic doses of warfarin. However, treatment with low doses of warfarin (e.g., ≤ 2 mg/day) or locally accepted low doses of acetylsalicylic acid (up to 100 mg daily) to prevent cardiovascular events or strokes was allowed.\n 23. Patients with another primary malignancy within 3 years prior to starting study treatment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix.\n 24. Cirrhosis of the liver or known hepatitis B or C infection that was either acute or was considered chronic because the virus did not become undetectable:\n 1. Hepatitis C Virus (HCV) infection: acute or chronic infection as depicted by a positive HCV RNA testing (note: in a patient with known anti-HCV but with a negative test for HCV RNA, re-testing for HCV RNA 4-6 months later was requested to confirm the resolution of HCV infection).\n 2. Hepatitis B Virus (HBV) infection: acute infection (HBsAg+ with or without HBeAg+ or detectable serum HBV DNA), HBV carriers as evidence by ongoing presence of HBsAg and detectable serum HBV DNA levels.\n 25. Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing was not mandatory).\n 26. Patients who received investigational agents within ≤ 5t1/2 of the agent (or ≤ 4 weeks when half-life was unknown) prior to starting study drug.\n 27. Patient with history of non-compliance to medical regimen.\n 28. 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 29. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they were using highly effective methods of contraception (defined below). Highly effective contraception had to be used by both sexes (female patients and their male partners) during study treatment and for 30 days after the last doseof study medication.\n Highly effective contraception methods included:\n - Total abstinence (when this was in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post- ovulation methods) and withdrawal were 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.\n In case of oophorectomy alone, only when the reproductive status of the woman was 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 was the sole partner for that subject.\n - Combination of the following (a+b):\n 1. Placement of an intrauterine device (IUD) or intrauterine system (IUS)\n 2. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\n 30. Oral, implantable, or injectable hormone contraceptives might be affected by cytochrome P450 interactions, and were therefore not considered effective for this study Women of child-bearing potential (sexually mature women) who had not undergone a hysterectomy or who were not naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months), were required to have a negative serum pregnancy test ≤ 14 days prior to starting study drug.\n 31. Post-menopausal women were allowed to participate in this study. Women were 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 six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks prior to entry in the study. In the case of oophorectomy alone, only when the reproductive status of the woman was confirmed by follow up hormone level assessment, then she was considered not of child bearing potential.\n 32. Fertile males not willing to use contraception. Fertile males must use condom with spermicide. Highly effective contraception, as defined above, was to be used by both sexes (male patients and their female partners) during study treatment and for 90 days after the last dose of study medication and was not to father a child in this period. A condom was required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
189	[ { "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\nClinical Trial Title:\n\nAssessment of Helical Tomotherapy Radiotherapy (54 Gy) Followed by Surgery in Retro-peritoneal Liposarcoma\n\nClinical Trial Summary:\n\nRetro peritoneal liposarcomas are rare (less than 15% of sarcomas) whose prognosis is locoregional.\n In the treatment of retroperitoneal liposarcomas main prognostic factor is the quality of the surgical resection. The effect of radiotherapy combined with surgery is uncertain and until now limited perhaps because of limited prescribed doses (of the order of 45Gy to 50Gy) due to high risk of organ toxicity nearby.\n The helical tomotherapy is an innovative equipment radiotherapy to make conformational radiotherapy modulation intensity and is particularly suitable for irradiations precision (imaging mode associated with daily scanner) in large complex volumes. Increasing doses (increase of the prescribed dose to 54 Gy, thus potentially curative), the helical tomotherapy should allow to improve the efficacy of radiotherapy.\n\nClinical Trial Detailed Description:\n\nRetro peritoneal liposarcomas are rare (less than 15% of sarcomas) whose prognosis is locoregional. In the treatment of retroperitoneal liposarcomas main prognostic factor is the quality of the surgical resection. The effect of radiotherapy combined with surgery is uncertain and until now limited perhaps because of limited prescribed doses (of the order of 45Gy to 50Gy) due to high risk of organ toxicity nearby.\n Two elements can overcome these difficulties:\n - Preoperative radiotherapy made rather than Postoperatively, the tumor in place back the gastrointestinal tract and reducing toxicity,\n - The contribution of conformal radiotherapy techniques with intensity modulation (IMRT). The helical tomotherapy is an innovative equipment radiotherapy to make conformational radiotherapy modulation intensity and is particularly suitable for irradiations precision (imaging mode associated with daily scanner) in large complex volumes. Increasing doses (increase of the prescribed dose to 54 Gy, thus potentially curative), the helical tomotherapy should allow to improve the efficacy of radiotherapy.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n 1. Liposarcoma histologically proven, in case of non-biopsy contributive: diagnosis radiologically validated meeting multidisciplinary consultation (RCP)\n 2. Protocol TOMOREP technically feasible,\n 3. Patients over 18 years\n 4. Considered a priori tumor operable even with excision multi-visceral\n 5. Absence of morbidity against-indicating surgery necessary. The evaluation will be performed by the surgeon or the radiotherapist according to the definitions by the ASA classification.\n 6. Original form (as well as tumors made after first incomplete excision) and form in first relapse.\n 7. Life expectancy greater than 6 months\n 8. Patient signed informed consent,\n 9. Patient affiliated to a social security scheme.\n Exclusion Criteria:\n 1. Metastasis associated\n 2. Extension intraperitoneal associated mesenteric extension\n 3. bilaterally\n 4. Against disease-indicating the need for surgery (ASA 3 and 4).\n 5. Cons-indication for radiotherapy (such as prior radiotherapy the volume to be treated).\n 6. Patient included in another clinical study\n 7. Unable to undergo medical monitoring test for geographical, social or psychological,\n 8. Private patient freedom and major subject of a measure of legal protection or unable to consent.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
190	[ { "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\nClinical Trial Title:\n\nBreast Cancer Molecular Analysis Protocol\n\nClinical Trial Summary:\n\nThis is a molecular testing study for patients with metastatic breast cancer. The purpose of this study is to find defects in the DNA of the cancer that could potentially be treated with US Food and Drug Administration (FDA)approved or investigational drugs. For example, if your cancer has a mutation in the Epidermal Growth Factor Receptor (EGFR) gene (a mutation is a change int he DNA sequence of a gene) that makes this receptor \"superactive\" a drug that inhibits this receptor may also inhibit the growth of the cancer. If this genetic defect is not present in the cancer the same drug may not work. This EGFR gene mutation based patient selection for treatment has worked in lung cancer and we are testing its value in breast cancer. What drugs may be available against particular genetic abnormalities in the context of this clinical study will change over time.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n 1. All patients with metastatic breast cancer who are considered for further systemic therapy are eligible regardless of number of prior therapies.\n 2. Patient must have a metastatic lesion that could be safely biopsied with or without image-guidance. The final arbiter to decide what lesion can be biopsied is the physician who will perform the biopsy.\n 3. There is no age limit for this study. However, this study will not include children because metastatic breast cancer does not occur in children.\n 4. Patients may participate in the biopsy study multiple times to repeat molecular assessment of the cancer after progression.\n 5. Patients who undergo routine clinical biopsy of metastatic breast cancer are also eligible to participate in this study. When the routine biopsies are obtained for diagnostic or other purposes, additional biopsies will be taken during the same biopsy session for molecular analysis.\n Exclusion Criteria:\n 1. Known medical contraindication for needle biopsy procedure such as bleeding disorder, low platelet count, inability to provide informed consent\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
191	[ { "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\nClinical Trial Title:\n\nTivantinib in Treating Patients With Previously Treated Malignant Mesothelioma\n\nClinical Trial Summary:\n\nThis phase II trial studies how well tivantinib works in treating patients with previously treated malignant mesothelioma. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.\n\nClinical Trial Detailed Description:\n\nPRIMARY OBJECTIVES:\n I. To determine the objective response rate of patients with malignant mesothelioma who are treated with ARQ 197 (tivantinib).\n SECONDARY OBJECTIVES:\n I. To determine the progression-free survival of patients with malignant mesothelioma who are treated with ARQ 197.\n II. To determine the toxicity experienced by patients with malignant mesothelioma who are treated with ARQ 197.\n III. To determine median and overall survival of patients with malignant mesothelioma who are treated with ARQ 197.\n TERTIARY OBJECTIVES:\n I. To determine the frequency of mesenchymal-epithelial transition (MET) gene amplification in malignant mesothelioma patient tumor samples, and to correlate the results with MET immunohistochemistry (IHC).\n II. To determine whether MET gene amplification results in increased sensitivity to ARQ 197 as observed by improved clinical outcomes (response rate [RR] and progression free survival [PFS]) compared to those without MET gene over-expression/amplification.\n III. To determine whether high baseline serum hepatocyte growth factor (HGF), as well as changes in serum HGF during treatment at pre-defined early time points, correlate with treatment efficacy and clinical outcome, as measured by response rate and progression-free survival.\n IV. To identify mutations by sequencing of specific areas of the MET gene in tumor samples (semaphorin [SEMA], jumonji [JM] and tyrosine kinase domains).\n V. To perform immunohistochemistry (IHC) of mesothelioma tumors for HGF, MET and phosphorylated (p)-MET (pY1003 and pY1230/34/35).\n VI. To assess serum HGF and serum soluble MET levels by enzyme linked immunosorbent assay (ELISA) (R&D systems) pre-treatment, after 2 cycles and at disease progression.\n OUTLINE:\n Patients receive tivantinib orally (PO) twice daily (BID). Treatment continues in the absence of disease progression or unacceptable toxicity.\n After completion of study treatment, patients are followed up for 1 year.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Patients must have histologically or cytologically confirmed malignant pleural or peritoneal mesothelioma, epithelial, sarcomatoid, or mixed subtype; the patient's disease must be metastatic, recurrent, or unresectable\n - Patients must have measurable disease, defined 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 calipers by clinical exam; pleural effusions and ascites are not considered measurable lesions\n - No more than two prior cytotoxic chemotherapy regimens; prior chemotherapy with pemetrexed is required; prior intrapleural cytotoxic agents (including bleomycin) are allowed, and are not counted as a cytotoxic chemotherapy; chemotherapy must have been completed at least 4 weeks prior; patients who have previously received radiation therapy are eligible provided that the only site of measurable disease is not located within the radiation therapy port; at least 4 weeks must have elapsed from completion of the radiation therapy and all signs of toxicity must have resolved\n - Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)\n - Life expectancy of greater than 3 months\n - Hemoglobin >= 9.0 g/dL\n - White blood cells (WBC) >= 3,000/mcL\n - Absolute neutrophil count >= 1,500/mcL\n - Platelets >= 100,000/mcL\n - Total bilirubin =< 1.5 X institutional upper limit of normal\n - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal\n - Serum creatinine =< 1.5 X institutional upper limit of normal OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal\n - The effects of ARQ 197 on the developing human fetus are unknown; for this reason and because tyrosine kinase inhibitors as well as other therapeutic agents used in this trial 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 4 months after completion of ARQ 197 administration\n - Ability to understand and the willingness to sign a written informed consent document\n Exclusion Criteria:\n - 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 (to grade =< 1) due to agents administered more than 4 weeks earlier\n - Patients who are receiving any other investigational agents\n - Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events\n - History of allergic reactions attributed to compounds of similar chemical or biologic composition to ARQ 197\n - ARQ 197 is metabolized by cytochrome P450 (CYP)2C19, and to a lesser extent CYP3A4; the metabolism and consequently overall pharmacokinetics of ARQ 197 could be altered by inhibitors and/or inducers or other substrates of CYP2C19 and CYP3A4; while inhibitors/inducers of these cytochrome P450 isoenzymes are not specifically excluded, investigators should be aware that ARQ 197 exposure may be altered by the concomitant administration of these drugs; because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n - History of congestive heart failure defined as Class II to IV per New York Heart Association (NYHA) classification; active coronary artery disease (CAD); clinically significant bradycardia or other uncontrolled, cardiac arrhythmia defined as >= grade 3 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, or uncontrolled hypertension; myocardial infarction occurring within 6 months prior to study entry (myocardial infarction occurring > 6 months prior to study entry is 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 ARQ 197 is a tyrosine kinase inhibitor with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ARQ 197, breastfeeding should be discontinued if the mother is treated with ARQ 197\n - Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ARQ197; 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 - No prior treatment with a c-MET inhibitor\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
192	[ { "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\nClinical Trial Title:\n\nA Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery\n\nClinical Trial Summary:\n\nThe PENELOPEB study is designed to demonstrate that in the background of standard anti-hormonal therapy palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early breast cancer at high risk of relapse after showing less than pathological complete response to neoadjuvant taxane- containing chemotherapy. Considering the high risk of recurrence in patients after neoadjuvant chemotherapy and a high CPS-EG score, palbociclib appears to be an attractive option with a favourable safety profile for these patients.\n\nClinical Trial Detailed Description:\n\nAbout one third of patients with hormone-receptor (HR)-positive, HER2- normal breast cancer and residual disease after neoadjuvant chemotherapy have a substantial risk of relapse. The clinical-pathologic stage - estrogen/grade (CPS-EG)1 combining clinical stage before neoadjuvant treatment, pathological stage after neoadjuvant treatment, grading and estrogen-receptor status can be used to identify these high-risk patients. The CPS-EG score was additionally validated in 2454 patients with HRpositive/ HER2-normal tumors from the German neoadjuvant studies' metadatabase. Patients who had a score of 3 or higher or Score 2 and ypN+ disease show a 3-years iDFS of 77% despite adequate local therapy and adjuvant endocrine treatment. Cyclin dependent kinases (CDK), a group of serine/threonine kinases, play a key role in regulating cell cycle progression by interacting with specific cyclin proteins in luminal-type tumors.2,3 PD-0332991 (palbociclib) is an oral, highly selective inhibitor of CDK4/6 kinase activity that prevents cellular DNA synthesis by prohibiting progression of the cell cycle from G1 to S phase through blocking retinoblastoma (Rb) phosphorylation.4 Preclinical studies identified luminal ER subtype, elevated expression of cyclin D1 and Rb protein, and reduced p16 expression as being associated with sensitivity to palbociclib.\n\nClinical Trial Eligibility Criteria:\n\nBased on protocol E version 10 dated 12 April 2016\n Inclusion Criteria\n 1. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.\n 2. Willingness and ability to provide archived formalin fixed paraffin embedded tissue block or a partial block from surgery after neoadjuvant chemotherapy and from core-biopsy before start of neoadjuvant chemotherapy, which will be used for centralized retrospective confirmation of hormone- and HER2-status and to evaluate correlation between genes, proteins, and mRNAs relevant to the endocrine and cell cycle pathways and sensitivity/resistance to the investigational agents. In case of bilateral breast cancer, tumor tissue of both sides needs to be assessable.\n 3. Histologically confirmed unilateral or bilateral primary invasive carcinoma of the breast.\n 4. Residual invasive disease post-neoadjuvant either in the breast or as residual nodal invasion.\n 5. Centrally confirmed hormone-receptor-positive (≥1% ER and/or PR positive stained cells) and HER2-normal (IHC score 0-1 or FISH negative (in-situ hybridization (ISH) ratio) <2.0 status) assessed preferably on tissue from post-neoadjuvant residual invasive disease or core biopsy of the breast, or if no other tissue is available the residual tumor of the lymphnode can be assessed.\n In case of bilateral breast cancer hormonreceptor positivity and HER2-normal status has to be centrally confirmed for both sides.\n 6. Centrally assessed Ki-67, pRB, and Cyclin D1 status assessed preferably on post-neoadjuvant residual invasive disease of the breast, or if not possible, of residual nodal invasion or core biopsy. In case of bilateral breast cancer, tumor tissue of both sides needs to be assessable.\n 7. Patients must have received neoadjuvant chemotherapy of at least 16 weeks. This period must include 6 weeks of a taxane -containing neoadjuvant therapy (Exception: For patients with progressive disease that occurred after at least 6 weeks of taxane-containing neoadjuvant treatment, a total treatment period of less than 16 weeks is also eligible).\n 8. Adequate surgical treatment including resection of all clinically evident disease and ipsilateral axillary lymph node dissection. Histologically complete resection (R0) of the invasive and ductal in situ tumor is required in case of breast conserving surgery as the final treatment. No evidence of gross residual disease (R2) is required after total mastectomy (R1 resection is acceptable). Axillary dissection is not required in patients with a negative sentinel-node biopsy before (pN0, pN+(mic)) or after (ypN0, ypN+(mic) neoadjuvant chemotherapy.\n 9. Less than 16 weeks interval since the date of final surgery or less than 10 weeks from completing radiotherapy (whichever occurs last) and date of randomization.\n 10. Completion of adjuvant radiotherapy according to standard guidelines (e.g. AGO Mamma, NCCN) is strongly recommended. If radiotherapy is not performed the reason for this needs to be documented in the eCRF.\n 11. No clinical evidence for locoregional or distant relapse during or after preoperative chemotherapy. Local progression during chemotherapy is not an exclusion criterion.\n 12. A clinical-pathologic stage - estrogen/grade (CPS-EG) score of ≥3, or score 2 if nodal status at surgery is ypN+, calculated using local estrogen receptor status and grade assessed on either core biopsies taken before start of neoadjuvant treatment or surgical specimen (see chapter 21.1).\n 13. Age at diagnosis at least 18 years.\n 14. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 (see Appendix 21.2).\n 15. Resolution of all acute toxic effects of prior anti cancer therapy or surgical procedures to NCI CTCAE version 4.0 Grade ≤1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).\n 16. Estimated life expectancy of at least 5 years irrespective of the diagnosis of breast cancer.\n 17. The patient must be accessible for scheduled visits, treatment and follow-up. Patients registered on this trial must be treated at the participating center which could be the Principal or a Co- investigator's site.\n Exclusion Criteria\n 1. Known severe hypersensitivity reactions to compounds similar to palbociclib or palbociclib/placebo excipients or to endocrine treatments.\n 2. Inadequate organ function immediate prior to randomization including: Hemoglobin <10g/dL (100g/L); ANC < 2000/mm³ (< 2.0 x 109/L); Platelets <100,000/mm³ (< 100 x 109/L); AST or ALT >1.5 x upper limit of normal (ULN); alkaline phosphatase > 2.5 x ULN, total serum bilirubin > 1.25 x ULN; serum creatinine >1.25 x ULN or estimated creatinine clearance < 60 mL/min as calculated using the method standard for the institution; severe and relevant co-morbidity that would interact with the participation in the study\n 3. Evidence for infection including wound infections, Human Immunodeficiency Virus (HIV) or any type of Hepatitis\n 4. QTc >480 msec\n 5. Uncontrolled electrolyte disorders (eg, hypocalcemia, hypokalemia, hypo¬magnesemia).\n 6. Any of the following within 6 months of randomization: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 4.0 Grade ≥2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.\n 7. Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection.\n 8. Prior malignancy (including invasive or ductal in-situ breast cancer) within 5 years prior to randomization, except curatively treated basal cell carcinoma of the skin and carcinoma in situ of the cervix.\n 9. Current severe acute or uncontrolled chronic systemic disease (e.g. diabetes mellitus) 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 patient inappropriate for entry into this study.\n 10. Recent (within the past year) or active suicidal behavior.\n 11. Pregnancy or lactation period. Women of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment and for 90 days after discontinuation. A serum pregnancy test must be negative in premenopausal women or women with amenorrhea of less than 12 months.\n 12. Major surgery within 2 weeks prior to randomization.\n 13. 10 weeks or more have passed since completion of radiotherapy at day of randomization.\n 14. Prior treatment with any CDK4/6 inhibitor.\n 15. Patients treated within the last 7 days prior to randomization and/or concurrent use of drugs known to be strong CYP3A4 inhibitors or inducers (see appendix 21.3)\n 16. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to randomization.\n 17. Male patients.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
193	[ { "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\nClinical Trial Title:\n\nAn Observational Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer\n\nClinical Trial Summary:\n\nClinical trials are, due to the inclusion and exclusion criteria, accomplished with defined patient groups, which are not representative for the whole patient population.\n Especially elderly patients and patients with co-morbidities are underrepresented in clinical trials.\n This non-interventional study will examine the efficiency and toxicity of the Yondelis® + PLD combination therapy in a general patient population to evaluate if the data collected in the clinical trials can be assigned to a general patient population.\n\nClinical Trial Detailed Description:\n\nYondelis® (trabectedin) was approved (in combination with PLD) in the European community in December 2009 for the treatment of platinum-sensitive ovarian cancer relapse. Based on the outcomes of study OVA-301, this non-interventional study will investigate the role of a platinum-free treatment regimen in patients with progressive ovarian cancer relapsing > 6 months after completing previous platinum-based chemotherapy. In particular, this study aims at collecting the \"real-life\" data with regard to the response and the influence of the mentioned therapy on the \"tumor related events\", to objectify the value of palliative care.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Women age >18, no upper limit\n - Patients with relapsed platinum-sensitive ovarian cancer\n - Before inclusion in the NIS written informed consent must be given\n Exclusion Criteria:\n - According to summary of product characteristics\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
194	[ { "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\nClinical Trial Title:\n\nCompound Sodium Alginate Double Action Chewable Tablets 4-hour Esophageal pH Study in GERD Patients\n\nClinical Trial Summary:\n\nThis study is being conducted to assess the effectiveness of the Compound Sodium Alginate Double Action Chewable Tablets compared to placebo on acidic reflux events into the esophagus in patients diagnosed with Gastroesophageal Reflux Disease (GERD).\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - meets the diagnostic criteria for GERD with a GERD history of frequent episodes of GERD-related symptoms during the last 2 months prior to study screening. The patient must also meet the following criteria:\n 1. The only or main symptom is heartburn (burning feeling back of breast bone) and/or acid reflux. Symptoms persists or have occurred repeatedly for more than 2 months;\n 2. As assessed by the Investigator at screening by questioning of the patient, the frequency of occurrence of heartburn is ≥ 3 days/week and the score of severity of heartburn in general is ≥ moderate within 3 weeks before screening\n Exclusion Criteria:\n - Patients who have a history of drug, solvent or alcohol abuse (weekly alcohol intake ≥ 140g).\n - Patients who have suffered cardiac chest pain within the last year.\n - Patients who have suffered a recent, significant unexplained weight loss of more than 6 Kg in the last 6 months.\n - Female patients of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions or are unwilling to be sexually abstinent.\n - Pregnancy or lactating mother.\n - Patients with a history and/or symptom profile suggestive of the following: any other gastrointestinal (GI) disease, erosive GERD (Los Angeles [LA] classification grades C-D), Barrett's esophagus, acute peptic ulcer and/or ulcer complications, Zollinger-Ellison syndrome, gastric carcinoma, pyloric stenosis, oesophageal or gastric surgery, intestinal obstruction, current pernicious anaemia, indication for H-pylori eradication therapy, known gastro-intestinal bleeding (hematochezia or hematemesis) within the last 3 months, and severe diseases of other major body systems.\n - Patients who are observed at screening to have a hiatus hernia with a diameter which exceeds 3cm.\n - Patients who have taken anti-cholinesterase drugs, traditional Chinese medicines for treating gastrointestinal disease, ulcerlmin or misoprostol preparations within 7 days prior to screening or throughout the study.\n - Patients who have taken PPIs during the 10 days prior to screening, prokinetics or H2 antagonists during the 5 days prior to screening or systemic glucocorticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs, except for low dose aspirin which can be given for cardioprotection) on more than 3 consecutive days or PPI-based triple or quadruple therapy for eradication of H-pylori during the last 28 days.\n - Patients taking or requiring to take macrolide antibiotics, such as erythromycin, azithromycin, from the day before screening.\n - Patients with difficulty in swallowing.\n - Patients with known hypophosphataemia, phenylketonuria or hypercalcaemia.\n - Patients with severe constipation, or history of intestinal obstruction.\n - In the opinion of the Investigator, patients with damaged heart or kidney function and patients who require a low sodium diet.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
195	[ { "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\nClinical Trial Title:\n\nEfficacy and Safety of Plitidepsin in Patients With Advanced Unresectable or Metastatic, Relapsed/Refractory, Dedifferentiated Liposarcoma (DLPS): an Exploratory Phase II Multicenter Trial\n\nClinical Trial Summary:\n\nLiposarcomas are soft tissue sarcomas most frequent. We distinguish three subtypes on the basis of their histological and cytogenetic characteristics: well-differentiated liposarcoma / dedifferentiated, myxoid liposarcoma and / or round cell liposarcoma and pleomorphic. Dedifferentiated liposarcomas (LDD) represent 20% of liposarcomas and are characterized by well-differentiated component associated with a contingent sarcomatous differentiation and fat-usually high grade. The LDD are most often rétropértionéal seat. Thus, their development is very long asymptomatic. At diagnosis, tumor volume is often very important making surgical removal impossible in a high proportion of cases. Operable tumors have also a risk of local recurrence by about 50% and about 20% metastatic. Chemotherapy is the only treatment of these advanced forms. However, the currently available drugs (adriamycin, ifosfamide) have only very limited effectiveness. Progression-free survival of patients does not exceed 2 months. The LDD is characterized cytogenetically by the constant presence of two amplicons (1p32 and 6q23) respectively targeting genes MAP3K5 and JUN. These two genes encode proteins involved in the signaling pathway Jun N-terminal kinase (JNK). Activation of JNK is involved in the loss of adipose differentiation and tumor aggressiveness of LDD. The plitidepsin is a drug capable of inducing apoptosis of tumor cells carrying a functional activation of the JNK pathway. This drug has such a pro-apoptotic and anti-proliferative in vitro models of LDD. plitidepsin could represent the treatment of choice for patients with advanced LDD. The objective of this study is to evaluate the anti-tumor activity of plitidepsin patients with locally advanced dedifferentiated liposarcomas and / or metastatic.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n 1. Voluntarily signed and dated written informed consent prior to any study specific procedure.\n 2. Histologically confirmed DLPS by central review.\n 3. Metastatic or unresectable locally advanced disease\n 4. Progressive disease according to RECIST v1.1 criteria diagnosed on the basis of two CT scan obtained at an interval less than 3 months and confirmed by central review\n 5. At least one prior anthracycline-containing chemotherapy regimen\n 6. Age ≥ 18 years.\n 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.\n 8. Measurable disease according to RECIST v1.1 outside any previously irradiated field.\n 9. Adequate hematological, renal, metabolic and hepatic function.\n 1. Hemoglobin ≥ 9 g/dl (patients may have received prior red blood cell [RBC] transfusion, if clinically indicated); absolute neutrophil count (ANC) ≥ 1.2 x 109/l, and platelet count ≥ 100 x 109/l.\n 2. Alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) 2.5 x upper limit of normality (ULN) (5 in case of extensive skeletal involvement for AP exclusively).\n 3. Total bilirubin 1.5 x ULN.\n 4. Albumin > 25 g/l.\n 5. Calculated creatinine clearance (CrCl) ≥ 40 ml/min (according to cockroft and Gault formula).\n 6. Creatine phosphokinase (CPK) ≤ 2.5 x ULN.\n 10. Troponin I ≤ ULN\n 11. No prior or concurrent malignant disease in the last 5 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma.\n 12. At least three weeks since last chemotherapy (six weeks in case of nitrosoureas and mitomycin C), immunotherapy or any other pharmacological treatment and/or radiotherapy.\n 13. Recovery to grade ≤ 1 from any adverse event (AE) derived from previous treatment (excluding alopecia of any grade and non-painful peripheral neuropathy grade ≤ 2) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 4.0).\n 14. Left ventricular ejection fraction (LVEF) by echocardiogram (ECHO) or multiple gated acquisition (MUGA) within normal limits.\n 15. Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for six months after discontinuation of treatment. Acceptable methods of contraception include intrauterine device (IUD), oral contraceptive, subdermal implant and double barrier.\n 16. Patients with a french social security in compliance with the French law relating to biomedical research\n Exclusion Criteria:\n 1. Previous treatment with plitidepsin.\n 2. More than three prior lines of therapy for advanced disease.\n 3. Concomitant diseases/conditions:\n 1. History or presence of unstable angina, myocardial infarction, congestive heart failure or clinically significant valvular heart disease. Symptomatic arrhythmia or any arrhythmia requiring ongoing treatment, and/or prolonged QT-QTc grade > 1.\n 2. Previous mediastinal radiotherapy.\n 3. Previous treatment with anthracyclines at cumulative doses in excess of 450 mg/m2 doxorubicin equivalent.\n 4. Symptomatic arrhythmia or any arrhythmia requiring ongoing treatment, and/or prolonged QT-QTc grade > 1.\n 5. Active uncontrolled infection.\n 6. Myopathy or persistent CPK elevations > 2.5 x ULN in two different determinations performed with one week apart.\n 7. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.\n 4. Evidence of progressive or symptomatic central nervous system (CNS) or leptomeningeal metastases.\n 5. Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding.\n 6. Tumor tissue sample not available for pathological review and/or JNK immunochemistry testing.\n 7. Participation in a clinical study and / or receipt of an investigational drug during the last 30 days.\n 8. Previous enrolment in the present study.\n 9. Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons.\n 10. Known hypersensitivity to any involved study drug or any of its formulation components\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
196	[ { "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\nClinical Trial Title:\n\nStudy of SelfFit Mobile Medical App for Hearing Loss Diagnostics and Hearing Device Fitting / Fine Tuning\n\nClinical Trial Summary:\n\nThe purpose of this clinical study is to validate the comparability of prescription formula fitting of hearing aids based on full diagnostic audiometry and SelfFit interactive fitting of hearing aids based on hearing loss screening (mild to moderate hearing losses) using in-situ audiometry, provided and executed through the mobile medical app.\n\nClinical Trial Detailed Description:\n\nThe technology utilized within the mobile medical App is partially described in the US patent application US2011/0002490A1. The app is to be used in combination with a hearing aid to deliver the output and targets accurate individual acoustical amplification for effective compensation of a users hearing loss.\n The electronic circuitry incorporating the digital signal processing algorithms - dynamic range compression, noise reduction - is providing the acoustical amplification according to parameters (acoustical gain, compression ratio, time constants) calculated through the App on base of in-situ hearing loss diagnostics (pure tone audiometry, loudness scaling). Within the study, amplification parameters will be transmitted to the prototyped device through a prototyped audio streaming box.\n Individual audiogram represents hearing thresholds (softest audible sounds) at different frequencies. At least two test frequencies are used involving one in the lower region of device's bandwidth (such as 750 Hz) and one in the higher region of the device's bandwidth (such as 2 kHz). Hearing thresholds are assessed by presenting pure tones of different known levels (SPL) to the user and the thresholds for each of the test frequencies are determined according to the user response to a verbally formulated question (how many tones did you hear?) and multiple choice answer buttons (0, 1, or 2).\n Second hearing loss characteristic obtained by the app. is the personal loudness scaling. By presenting a band-limited noise stimuli and collecting the user response about perceived loudness level Medical Mobile App calculates dynamic range of users hearing at given frequency.\n The calculation of optimal amplification parameters is performed by App using a proprietary \"fitting formula\" derived from scientific data.\n Final adjustment of amplification parameters called fine tuning is performed while presenting the user with realistic acoustical environment during operation of the hearing device. Fine tuning relates to slight changes of the parameters initially obtained by the \"fitting formula\". The acoustical signals are presented using audio streaming through the hearing aid. In particular the presented signals include \"speech in quiet\" and \"speech in background noise\". Presented speech signal is composed from two or more sources that are processed with different signal processing parameters. During the presentation of the speech signal App presents the speech source visually as two or more speakers. The user is asked to provide his listening preference by choosing the preferred speaker. The signal processing parameters relating to the preferred sound are used for final adjustment of hearing device.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - Hearing loss at the better ear between 35dB and 50dB (PTA1/2/4)\n - Active lifestyle\n - No language problems\n - No medical contra-indications\n - Age: between 18 and 75 years\n - About 50% experienced users and 50% new users\n - Willing to participate in the trial with one three hour visit to the AMC.\n Exclusion Criteria:\n - Conductive hearing loss in the middle ear\n - Severe hearing loss\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
197	[ { "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\nClinical Trial Title:\n\nA Phase II Study of Anlotinib in STS Patients\n\nClinical Trial Summary:\n\nAnlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd.\n ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and VEGFR3. It has the obvious resistance to new angiogenesis. The protocol is to explore ALTN for the effectiveness of advanced soft tissue sarcoma and security.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n - 1.Faild in introditional treatmeat, Mainly includes:MFH/liposarcoma/leiomyosarcoma/SS and others(MPNST/Fibrosarcoma/CCS/ASPS/AS/ES; 2.Receiveed at least one chemotherapy regimens treatment; 3.18-70years, ECOG:0-2,Expected survival period >3 months; 4.HB≥100g/L,ANC(Absolute Neutrophil Count) ≥1.5×109/L；PLT\n - 80×109/L ,BIL/Cr in normal range,ALT/AST(aspartate aminotransferase )≤1.5ULN(for hepatic metastases,ALT/AST(aspartate aminotransferase )≤5ULN) ;TG≤ 3.0mmol/L，cholesterol≤7.75mmol/L; LVEF\n - LLN. 5.Used contraceptive during the study and after 6 months; 6.Volunteer.\n Exclusion Criteria:\n - 1. Received vascular endothelial growth inhibitor type of targeted therapy; 2.With the second cancer; 3.Participated in other clinical trials in four weeks; 4.Received in other radiotherapy or chemotherapy treatment in four weeks; 5.AE>1 6.Has influence of oral drugs; 7.Brain metastases, spinal cord compression, cancerous meningitis; 8.Any serious or failed to control the disease 9.Artery/venous thrombotic; 10.Coagulant function abnormality; 11.Arteriovenous thrombosis event; 12.Hitory of psychiatric drugs abuse or a mental disorder; 13.Immunodeficiency history; 14.Concomitant diseases.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
198	[ { "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\nClinical Trial Title:\n\nSafety and Tolerability of Multiple Doses of ITI-214 in Healthy Adults and in Adults With Stable Schizophrenia\n\nClinical Trial Summary:\n\nThe purpose of this study is to characterize the safety and tolerability profile of ITI-214 when administered as multiple doses of oral solution at escalating dose levels.\n\nClinical Trial Detailed Description:\n\nThe drug being tested in this study is called ITI-214. This study will look at how well different doses of ITI-214 are tolerated in healthy people and in people with stable schizophrenia. In addition, exploratory neuroimaging will be conducted in participants with schizophrenia.\n This multi-center trial will be conducted in the United States. The study will be comprised of 2 parts: Multiple-Rising Dose (MRD) and Neuroimaging (NI). Approximately 40 healthy participants are planned to be enrolled in the MRD part of the study and approximately 36 patients with stable schizophrenia are planned to be enrolled in the Neuroimaging part of the study.\n Participants in the MRD (parallel design) part will be enrolled in cohorts for different dose levels. In each dose cohort, participants will be randomly assigned to active dose or placebo—which will remain undisclosed to participants and study doctor during the study (unless there is an urgent medical need). The following dose cohorts will be enrolled: Doses A, B, C, and D.\n Participants will be asked to take the study drug in oral solution once daily for a total of 14 days while confined at the study site. Participants will be contacted by telephone 22 and 44 days after last dose of study drug for a follow-up assessment.\n Participants in the Neuroimaging (NI) part of the study will be randomly assigned to one of six treatment sequences. Each sequence consists of 3 cross-over treatment periods. The following doses will be tested: Doses E, F, G, and H.\n Each participant will undergo 3 treatment periods of placebo or ITI-214 once daily dosing for 7 days in each of the periods. There will be a washout period of a minimum of 7 days between treatment periods. Participants will be confined at the study site for 5 days of each treatment period and will report to the site on other dosing days for study drug administration. There will be follow-up assessments on Days 14 and 37 of Period 3.\n Study was terminated due to business decision. The study compound is being transferred to Intra-Cellular Therapies, Inc.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n Healthy Participants\n 1. Is capable of understanding and complying with protocol requirements.\n 2. The participant or; when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.\n 3. Is a healthy man or woman, aged 18 to 55 years, inclusive (non-elderly) or aged ≥65 years (elderly), at the time of informed consent and first study medication dose.\n 4. Weighs at least 50 kg and has a body mass index (BMI) between 18.0 and 35.0 kg/m^2, inclusive at Screening.\n 5. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.\n 6. A female participant with no childbearing potential. The participant has been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who are postmenopausal (defined as continuous amenorrhea of at least 2 years and follicle-stimulating hormone (FSH) >40 IU/L.\n Participants with schizophrenia:\n 1. Is capable of understanding and complying with protocol requirements.\n 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.\n 3. Is capable of consenting. A standard evaluation by a psychiatrist will be implemented to assess the participant's capacity to consent.\n 4. Is a man or woman, aged 18 to 60 years (non-elderly), inclusive, or aged ≥65 years (elderly, if decided to enroll), at the time of informed consent and first study medication dose.\n 5. Weighs at least 50 kg and has a body mass index (BMI) between 18.0 and 35.0 kg/m^2, inclusive at Screening.\n 6. Is diagnosed with schizophrenia criteria as defined by the Diagnostic & Statistical Manual of Mental Disorders 4th Edition - Text Revision (DSM-IV-TR) and determined by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I), schizoaffective disorder, or schizophreniform disorder; on a stable dose of one and only one of the second generation antipsychotics (except olanzapine, clozapine, or quetiapine) for at least 2 months by medical history and assessed by site staff; Positive and Negative Syndrome Scale (PANSS) Conceptual Disorganization item score ≤ 4 and PANSS Hallucinatory Behavior or Unusual Thought Content item scores ≤ 4. For the MRD part, the subject is diagnosed with schizophrenia criteria as defined by the DSM-IV-TR and determined by the SCID-I, schizoaffective disorder, or schizophreniform disorder; on a stable dose of one and only one of the second generation antipsychotics (except clozapine) for at least 2 months by medical history and assessed by site staff; PANSS Conceptual Disorganization item score ≤ 4 and PANSS Hallucinatory Behavior or Unusual Thought Content item scores ≤ 4.\n 7. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.\n 8. A female subject of childbearing potential* who is sexually active with a nonsterilized* male partner agrees to use an acceptable method of contraception* from signing of informed consent and for 12 weeks postdose.\n Exclusion Criteria:\n Healthy Participants\n 1. Has received any investigational compound within 30 days prior to the first dose of study medication.\n 2. Has received ITI-214 in a previous clinical study or as a therapeutic agent.\n 3. Is an immediate family member, study site employee, or in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.\n 4. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.\n 5. Has a known hypersensitivity to any component of the formulation of ITI-214 or Listerine.\n 6. Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1).\n 7. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.\n 8. Has taken any excluded medication, supplements, or food products.\n 9. Is pregnant or lactating or intending to become pregnant before, during, or within 12 weeks after participating in this study; or intending to donate ova during such time period.\n 10. If male, the participant intends to donate sperm during the course of this study or for 12 weeks after last dose.\n 11. Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking ITI-214, or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias. Elderly participants may have been eligible for enrollment if approved by the investigator and Takeda medical monitor.\n 12. Has mental retardation or medical condition that can cause cognitive impairment.\n 13. Has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, any surgical intervention known to impact absorption [eg, bariatric surgery or bowel resection], esophageal reflux, peptic ulcer disease, erosive esophagitis, or frequent [more than once per week] occurrence of heartburn).\n 14. Has a history of cancer, except basal cell carcinoma which has not been in remission for at least 5 years prior to Check-in (Day -1)\n 15. Has a positive test result for hepatitis B surface antigen (HBsAg), antibody to hepatitis C (anti-HCV) or a known history of human immunodeficiency virus infection at Screening.\n 16. Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in (Day -1). Cotinine test is positive at Screening or Check-in (Day -1). The participant has poor peripheral venous access.\n 17. Has donated or lost 450 mL or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days prior the first dose of study medication.\n 18. Has a Screening or Check-in (Day -1) abnormal (clinically significant) electrocardiogram (ECG). Entry of any participant with an abnormal (not clinically significant) ECG must be approved and documented by signature by the principal investigator.\n 19. Has a supine blood pressure outside the ranges of 90 to 140 mm Hg for systolic and 60 to 90 mm Hg for diastolic, confirmed on repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in (Day -1).\n 20. Has a resting heart rate outside the range 50 to 100 bpm, confirmed on repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in (Day -1).\n 21. Has a QTcF >440 ms (males) or >460 ms (females) or PR outside the range 120 to 220 ms, confirmed on repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in (Day -1).\n 22. Has abnormal Screening or Check-in (Day -1) laboratory values that suggest a clinically significant underlying disease or participant with the following lab abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5 the upper limits of normal.\n 23. Has a risk of suicide according to the Investigator's clinical judgment (eg, per Columbia-Suicide Severity Rating Scale [C-SSRS] or has made a suicide attempt in the previous 6 months).\n Participants with schizophrenia:\n 1. Has received any investigational compound within 30 days prior to the first dose of study medication.\n 2. Is an immediate family member, study site employee, or in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.\n 3. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.\n 4. Has a known hypersensitivity to any component of the formulation of ITI-214 or Listerine.\n 5. Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -2 of Periods 1).\n 6. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.\n 7. Has taken any excluded medication, supplements, or food products.\n 8. Iis pregnant or lactating or intending to become pregnant before, during, or within 12 weeks after participating in this study; or intending to donate ova during such time period.\n 9. If male, the participant intends to donate sperm during the course of this study or for 12 weeks after last dose.\n 10. Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking ITI-214, or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias.\n 11. Has mental retardation.\n 12. Has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, any surgical intervention known to impact absorption [eg, bariatric surgery or bowel resection], esophageal reflux, peptic ulcer disease, erosive esophagitis, or frequent [more than once per week] occurrence of heartburn).\n 13. Subject has a history of cancer, except basal cell carcinoma which has not been in remission for at least 5 years prior to Check-in Day -1 for MRD part) and Day -2 of Period 1 for Neuroimaging part ).\n 14. Has a positive test result for hepatitis B surface antigen (HBsAg), antibody to hepatitis C (anti-HCV) or a known history of human immunodeficiency virus infection at Screening.\n 15. Participants who currently use nicotine-containing products but will not maintain their nicotine use habit throughout the study.\n 16. Has poor peripheral venous access.\n 17. Has donated or lost 450 mL or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days prior the first dose of study medication.\n 18. The subject has a Screening or Check-in (Day -1 for MRD part) and Check-in (Day -2 of Period 1 for Neuroimaging part) abnormal (clinically significant) ECG. Entry of any subject with an abnormal (not clinically significant) ECG must be approved and documented by signature by the principal investigator or medically qualified sub-investigator.\n 19. The subject has a supine blood pressure outside the ranges of 90 to 140 mm Hg for systolic and 60 to 90 mm Hg for diastolic, confirmed on repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in (Day -1 for MRD part) and Check-in (Day -2 of Period 1 for Neuroimaging part).\n 20. The subject has a resting heart rate outside the range 50 to 100 bpm, confirmed on repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in (Day -1 for MRD part) and Check-in (Day -2 of Period 1 for Neuroimaging part).\n 21. The subject has a QTcF >440 ms (males) or >460 ms (females) or PR outside the range 120 to 220 ms, confirmed on repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in (Day -1 for MRD part) and Check-in (Day -2 of Period 1 for Neuroimaging part).\n 22. The subject has abnormal Screening or Check-in (Day -1 for MRD part) and Check-in (Day -2 of Period 1 for Neuroimaging part) laboratory values that suggest a clinically significant underlying disease or has the following lab abnormalities: ALT and/or AST >1.5 the upper limits of normal.\n 23. Has a risk of suicide according to the Investigator's clinical judgment (eg, per C-SSRS) or has made a suicide attempt in the previous 6 months.\n 24. Has a current diagnosis of significant psychiatric illness other than schizophrenia, per DSM-IV.\n 25. For subjects enrolled in the neuroimaging part at the site performing fMRI, the subject has a personal history of claustrophobia or inability to tolerate mock scanner environment during habituation/screening session; surgery involving metal implants, non-removable body metal objects (metal body piercing, dentures, dental plates or bridges, any implanted device that is electrically, magnetically, and mechanically activated); a personal history of seizures, other neurologic disease, or increased intracranial pressure; history of open head injury or significant closed head injury; or hearing loss.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant
199	[ { "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\nClinical Trial Title:\n\nEfficacy and Safety of PD-0332991 in Patients With Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib\n\nClinical Trial Summary:\n\nThe treatment of advanced GIST patients is based on imatinib followed with sunitinib in case of resistance/intolerance. However, the median progression-free survival (PFS) on sunitinib is frequently short, and after failure with both imatinib and sunitinib, treatment remains controversial.\n Previous studies on GISTs have linked 9p21 alterations to tumor progression (El-Rifai et al. 2000; Kim et al., 2000; Schneider-Stock et al., 2003; Schneider-Stock et al., 2005; Romeo et al. 2009; Haller et al., 2008) but the driver gene was not positively identified (CDKN2A, CDKN2B, or MTAP) (Astolfi et al., 2010; Belinsky et al., 2009; Perrone et al., 2005; Assamaki et al. 2007; Huang et al., 2009). A recent study has shown that homozygous 9p21 deletions target CDKN2A and more specifically p16INK4a 4. Most of the CINSARC genes are known to be under the transcriptional control of E2F. RB1 sequesters E2F, which is released from the complex upon RB1 phosphorylation by CDK4. CDK4 is, in turn, inhibited by p16INK4a. Hence, we hypothesize that alteration of the restriction point via deletion of p16INK4a (and more rarely of RB1: 20% of cases) gene in GISTs is likely to be a causative event that leads to the overexpression of CINSARC genes, which in turn induce chromosome instability and ultimately metastasis. Low p16INK4a expression was associated with response to PD-0332991 in several in vitro tumor model(Konecny et al. 2011; Katsumi et al. 2011; Finn et al. 2009). Considering our molecular data, we believed that PD-0332991 warrants clinical investigation in advanced gastrointestinal stromal tumors with alteration of p16INK4a. This alteration is detectable by comparative genomic hybridization which is a technique highly manageable in the context of routine clinical care and clinical trial.\n Exploratory, one-arm, multicenter, phase II clinical trial based on twostage Simon's design\n To assess the antitumor activity of PD-0332991 in terms of non-progression at 16 weeks (after centralized review) in patients with documented disease progression while on therapy with imatinib and sunitinib for unresectable and/or metastatic GIST.\n This is a multicentre single-arm Phase II study evaluating the efficacy and safety of orally PD-0332991, 125 mg/day, 21 days on/7 days off, in patients with documented disease progression while on therapy with 2nd line sunitinib for unresectable and/or metastatic GIST. Indeed, the usual treatment for advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib is best supportive care for which outcome data are already available (Demetri et al., 2012; Italiano et al., 2012). Sixty three patients will be included in 10 centres of the French Sarcoma Group over a period of 18 months of enrolment.\n Patients will be evaluated at scheduled visits in up to three study periods:\n - Pre-treatment (PRE TT): from signature of informed consent to the first treatment by PD-0332991.\n - Treatment (TT): from the first treatment by PD-0332991 to the first 28 days following the last PD-0332991 administration.\n - Follow-up (FUP): after treatment discontinuation, all patients must be followed up for 28 days after the last dose of the study drug for safety assessment (AEs and/or SAEs).\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\n 1. Male or female patients ≥ 18 years of age\n 2. Histologically confirmed GIST of any anatomical location and confirmed by the RRePS Network ; positive immunohistochemical staining for c-KIT (CD117); or negative staining for KIT, but with either positive staining for DOG1 or an identified mutation of KIT or PDGFRA gene\n 3. CDKN2A gene deletion assessed by array-comparative genomic hybridization (array-CGH)\n 4. Unresectable and/or metastatic disease with documented progression according to modified RECIST criteria (see section 7.2.1.5 of protocol) after 1st line imatinib and 2nd line sunitinib. Progression on the last line of treatment should be confirmed by central review with two radiological assessments identical (CT scans or MRI) obtained at less from 4 months interval within the 24 months before inclusion.\n 5. At least one measurable GIST lesion according to RECIST (v1.1 Appendix 3). A previously irradiated lesion is eligible to be considered as a measurable lesion provided that there is objective evidence of progression of the lesion prior to starting PD-0332991.\n 6. A performance status of 0, 1 or 2 according to the Eastern Cooperative Oncology Group (ECOG) scale(Appendix 1)\n 7. Recovery from Grade 2 to 4 toxicity related to prior line of treatment assessed according to NCICTCAE v.4.0 (Appendix 2)\n 8. Adequate bone marrow function as shown by:\n Blood absolute neutrophil count (ANC) ≥ 1.5 x 109/L\n 1. Blood platelets ≥ 100 x 109/L\n 2. Blood hemoglobin (Hgb) > 9 g/dL\n 9. Adequate liver function as shown by:\n c. Serum or plasma ALT and AST ≤ 3.0 x ULN (regardless of the presence or absence of metastases) d. Serum or plasma total bilirubin: ≤ 1.5 x ULN (excepted for patients with Gilbert's syndrome)\n 10. Adequate renal function as shown by serum creatinine ≤ 2 x ULN\n 11. Patients who give a written informed consent obtained according to French and European regulations.\n 12. Patients affiliated to the French Social Security\n Exclusion Criteria:\n 1. RB1 gene deletion assessed by array-comparative genomic hybridization (array-CGH)\n 2. Patients who received anti-cancer drugs ≤ 5 days prior to starting PD-0332991\n 3. Patients who are treated or planned to be treated concomitantly with other cytotoxic or antineoplastic treatments, such as chemotherapy, immunotherapy, biological response modifiers, or radiotherapy\n 4. Patients with another primary malignancy within 2 years prior to starting the study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or completely excised (R0 resection) basal or squamous cell carcinoma of the skin\n 5. Patients with a corrected QT interval using Bazett's formula (QTcB) > 470 msec.\n 6. Current use or anticipated need for food or drugs that are known strong cytochrome P450 (CYP)3A4 inhibitors (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, tilithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone, diltiazem, and delaviridine)\n 7. Patients with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PD-0332991 (e.g. severe ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or extensive (>1m) small bowel resection, inability to swallow oral medications). Prior partial gastrectomy is not an exclusion criterion.\n 8. Patients with prior complete gastrectomy\n 9. Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism.\n 10. Patients with any clinically significant medical or surgical condition which, according to investigators' discretion, should preclude participation\n 1. i.e. active or uncontrolled infection, uncontrolled diabetes, active or chronic liver disease (cirrhosis, chronic active hepatitis or chronic persistent hepatitis)\n 2. hepatitis B or C virus carriers with normal liver function tests, can be included\n 11. Known diagnosis of human immunodeficiency virus (HIV) infection. HIV testing is not mandatory\n 12. Patients who are currently receiving anticoagulation treatment with therapeutic doses :\n 1. of warfarin or equivalent anticoagulant (e.g. high dose aspirin or clopidogrel or other)\n 2. or have an INR >1.5. Treatment with acetylsalicyclic acid 100 mg daily or low molecular weight heparin (LMWH) is allowed\n 13. Pregnant or breast-feeding women\n 14. Women of child-bearing potential not employing two effective methods of birth control. Effective contraception must be used throughout the trial and 24 weeks after the end of PD-0332991 (e.g. condom with spermicidal jelly, foam suppository or film; diaphragm with spermicide; male condom and diaphragm with spermicide, oral, implantable, or injectable contraceptives). Women of child-bearing potential defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e. who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test ≤ 21 days prior to starting study drug.\n 15. Fertile males not willing to use contraception as stated above\n 16. Patients unwilling or unable to comply with the protocol.\n\nPatient 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\"." } ]	[ { "role": "assistant", "content": "Answer: not relevant" } ]	not relevant

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