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{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nThe Role of Multi-Modality Therapy for the Treatment of High-Grade Soft Tissue Sarcomas of the Extremities\n\n**Clinical Trial Summary:**\n\nPatients with Grade II and III soft tissue sarcomas of the extremity will be randomized to either receive or not receive radiation therapy following surgery for the removal of the local tumor. All patients in this protocol will receive adjuvant chemotherapy.\n\n**Clinical Trial Detailed Description:**\n\nPatients with Grade II and III soft tissue sarcomas of the extremity will be randomized to either receive or not receive radiation therapy following surgery for the removal of the local tumor. All patients in this protocol will receive adjuvant chemotherapy.\n\n**Clinical Trial Eligibility Criteria:**\n\nPatients must have biopsy-proven soft tissue sarcoma with one of the following diagnoses:\n Liposarcoma (round cell or pleomorphic).\n Fibrosarcoma.\n Malignant fibrous histiocytoma.\n Inflammatory malignant fibrous histiocytoma.\n Myxoid malignant fibrous histiocytoma.\n Malignant giant cell tumor.\n Angiomatoid malignant fibrous histiocytoma.\n Leiomyosarcoma.\n Malignant hemangiopericytoma.\n Rhabdomyosarcoma (embryonal, alveolar, pleomorphic or combined).\n Soft tissue sarcoma resembling Ewing's sarcoma.\n Synovial cell sarcoma.\n Epithelioid sarcoma.\n Clear cell sarcoma.\n Neurofibrosarcoma.\n Epithelioid schwannoma.\n Malignant triton tumor.\n Angiosarcoma.\n Mixed malignant mesenchymoma.\n Alvelar soft part sarcoma.\n Malignant granular cell tumor.\n All lesions must be Grade II or III. No patients with Grade I lesions will be acceptable.\n Patients must have undergone a limb-sparing procedure in which all gross tumor has been removed.\n Clinical evaluation must reveal no evidence of metastatic disease either in regional lymph nodes or more distant sites.\n The soft tissue sarcoma must be on the extremity either at or distal to the shoulder joint or at or distal to the hip joint.\n The definitive surgical procedure for a primary lesion or for a recurrence must have been performed no longer than four months from the date of randomization.\n Patients must not have received any prior chemotherapy or radiotherapy for their sarcoma.\n Patients without a history of any other malignant disease except basal cell carcinoma.\n Patients who have not had a serious infection, active bleeding disorders, or concomitant severe disease such as cirrhosis, ischemic heart disease, or evidence of severe impairment of renal function.\n Patients must be above the age of 30 and do not have a diagnosis of embryonal rhabdomyosarcoma.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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1
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nThe Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors\n\n**Clinical Trial Summary:**\n\nPatients with Grade I soft tissue sarcomas or benign, non-metastasizing invasive soft tissue tumors will receive wide local excision and be prospectively randomized as to either receive or not receive radiation therapy.\n\n**Clinical Trial Detailed Description:**\n\nThis is a randomized study. Patients undergo surgical excision of all gross disease and then are randomized to Arm I or Arm II.\n Arm I: Radiotherapy. Involved-field irradiation.\n Arm II: No further treatment.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n Biopsy-proven grade I soft tissue sarcoma or one of the following benign but highly invasive soft tissue tumors:\n Abdominal and extra-abdominal fibromatosis (desmoid,\n aggressive fibromatosis),\n Dermatofibrosarcoma protuberans,\n Intramuscular lipoma (infiltrating lipoma),\n Diffuse lipomatosis,\n Leiomyoma of deep soft tissue,\n Diffuse giant cell tumor of tendon sheath (proliferative synovitis).\n No clinical evidence of metastases in regional nodes or more distant sites.\n No primary intraperitoneal or retroperitoneal tumors.\n Resection of all gross tumor at the time of surgical excision required (margins may be pathologically positive or negative).\n No von Recklinghausen's disease.\n PRIOR/CONCURRENT THERAPY:\n Biologic Therapy: Not specified.\n Chemotherapy: No prior chemotherapy for sarcoma.\n Endocrine Therapy: Not specified.\n Radiotherapy: No prior radiotherapy for sarcoma.\n Surgery: No more than 4 months since definitive surgery for\n primary lesion or recurrence.\n No prior amputation.\n PATIENT CHARACTERISTICS:\n Age: 18 and over.\n Performance status: Not specified.\n Hematopoietic: Not specified.\n Hepatic: No cirrhosis.\n Renal: No evidence of severe renal impairment.\n Cardiovascular: No ischemic heart disease.\n OTHER:\n No prior malignancy except basal cell carcinoma.\n No serious infection.\n No active bleeding disorder.\n No severe concomitant disease.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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2
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients With CD4 <= 500 Cells/mm3\n\n**Clinical Trial Summary:**\n\nTo determine the effect of Viracept in combination with modified antiretroviral therapy on the outcome of cutaneous and mucosal Kaposi's Sarcoma (KS).\n\n**Clinical Trial Detailed Description:**\n\nThis is an open-label, randomized, pilot, Phase II study of the safety and efficacy of Viracept in combination with modified antiretroviral therapy as treatment in patients with cutaneous and mucosal KS. Patients will be randomized to modify (add or switch or initiate) their current antiretroviral therapy and will add Viracept or remain on their current background antiretroviral therapy for a 2 month period. Initially 20 patients will be randomized in a 2:1 ratio (i.e., 14 Viracept, 6 control) for a 2 month period. Response to therapy will be evaluated at the end of the 2 month control phase. At this point, patients who were initially assigned to the control arm will continue on open label Viracept for an additional 10 month period.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria\n Patients must have:\n - HIV-positivity.\n - Diagnosed KS proven by biopsy.\n - NOTE:\n - Patients must not opt for immediate topical, systemic or radiation treatment.\n - At least 4 cutaneous lesions not treated within the previous 4 weeks.\n - Life expectancy > 6 months.\n - Signed, informed consent from parent or legal guardian for those patients < 18 years of age.\n Exclusion Criteria\n Co-existing Condition:\n Patients with the following conditions and symptoms are excluded:\n - Neoplastic disease (excluding KS) requiring systemic cytotoxic or radiation therapy or who have had these therapies within 1 month of baseline and have not completely recovered from the effects of these therapies.\n - Unstable or severe intercurrent medical conditions, including but not limited to, significant symptomatic visceral KS.\n - Clinically significant malabsorption syndrome.\n - Renal insufficiency.\n Patients with any of the following prior conditions are excluded:\n Significant Fever (> 101 degrees F (38 degrees C) for >= 7 days) and/or diarrhea (> 6 loose stools/day for >= 7 days) within one month of baseline.\n 1. Immediate topical or systemic treatment for KS lesions.\n - Use of Retinoid class drugs, either topically or systemically, or beta-carotene compounds or Vitamin A doses of more than 15,000 IU (5,000 mcg) per day concurrently.\n Immediate radiation treatment.\n 1. Treatment of KS lesions with intra-lesional chemotherapy within 4 weeks of entry.\n - History of > 2 weeks of prior therapy with Indinavir or Ritonavir.\n - Use of Retinoid class drugs, either topically or systemically, or beta-carotene compounds or Vitamin A doses of more than 15,000 IU (5,000 mcg) per day within 4 weeks of entry.\n Treatment of KS lesions with radiation within 4 weeks of entry. Active substance abusers; urine drug tests may be performed if drug abuse is suspected.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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3
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nCombination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells.\n PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients with peripheral neuroectodermal tumors, Ewing's sarcoma, Wilms' tumor, or bone cancer.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the response rate and event-free survival of patients with peripheral primitive neuroectodermal tumors or Ewing's sarcoma treated with cyclophosphamide, doxorubicin, vincristine, etoposide, and ifosfamide, followed by surgery (if feasible) and radiotherapy. II. Determine the response to a uniform treatment regimen in order to clarify whether these disease categories each have a different prognosis.\n OUTLINE: Patients are stratified according to disease category (primitive neuroectodermal tumor vs Ewing's sarcoma). Patients receive treatment on regimen A as outlined below during courses 1-3 and 6 and regimen B as outlined below during courses 4, 5, and 7 in the absence of disease progression or unacceptable toxicity. Each course lasts 3-4 weeks. Patients without metastatic disease after completion of course 3 undergo complete tumor resection, if feasible. Patients achieving complete response with or without microscopic residual disease after completion of course 7 undergo radiotherapy twice daily, 5 days a week, for 3 weeks. Patients with gross residual disease after completion of course 7 undergo radiotherapy twice daily, 5 days a week, for 3.6 weeks. Regimens A and B are defined below: Regimen A: Patients receive cyclophosphamide IV over 6 hours on days 1 and 2, doxorubicin IV continuously and vincristine IV continuously on days 1-3, and vincristine IV on day 9. Regimen B: Patients receive etoposide IV over 1 hour, followed immediately by ifosfamide IV over 1 hour on days 1-5. Patients are followed monthly for 18 months and then every 6 months for 18 months.\n PROJECTED ACCRUAL: A maximum of 50 patients (25 per stratum) will be accrued for this study within 5 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Diagnosis of peripheral primitive neuroectodermal tumor, including peripheral neuroepithelioma or Askin tumor OR Diagnosis of localized or metastatic Ewing's sarcoma, including the following: Unresectable or metastatic small cell osteosarcoma Unresectable or metastatic other nonrhabdomyosarcomatous soft-tissue sarcomas Unresectable or metastatic other non-osteosarcomatous bone sarcomas Desmoplastic small round-cell tumor Metastatic or non-metastatic Wilms' tumor Immunocytochemistry, electron microscopy, and/or chromosomal analysis may be required to rule out other small round cell neoplasms\n PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified\n PRIOR CONCURRENT THERAPY: Not specified\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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4
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nSurgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether giving chemotherapy after surgery is more effective than surgery alone in treating soft tissue sarcoma.\n PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients who have soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Compare the local disease control, overall survival, and relapse-free survival in patients with high-grade soft tissue sarcoma treated with adjuvant high-dose doxorubicin and ifosfamide plus filgrastim (G-CSF) vs no adjuvant chemotherapy and G-CSF after definitive surgery.\n - Compare the toxicity and morbidity of these regimens in these patients.\n OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, site of primary tumor (extremity vs trunk, including shoulder, pelvic girdle, head, or neck vs central, including intrathoracic, visceral, uterine, or retroperitoneal), size of primary tumor (less than 5 cm vs 5 cm or greater in largest diameter), postoperative radiotherapy (yes vs no), and isolated limb perfusion therapy (yes vs no).\n Some patients undergo isolated limb perfusion therapy with cytotoxics and/or cytokines.\n No more than 8 weeks after biopsy or inadequate surgery, patients undergo definitive surgery. Patients with complete resection undergo radiotherapy assessment and then randomization. Patients with incomplete or marginal resection (except for central lesions) undergo re-excision and, in the absence of macroscopic disease, assessment for postoperative radiotherapy followed by randomization.\n - Randomization: Patients are randomized to 1 of 2 treatment arms.\n - Arm I: Patients receive no adjuvant chemotherapy or filgrastim (G-CSF). Beginning within 6 weeks after surgery, eligible patients undergo radiotherapy as outlined below.\n - Arm II: Beginning within 4 weeks after surgery, patients receive high-dose doxorubicin IV over 20 minutes followed by ifosfamide IV over 24 hours and G-CSF subcutaneously daily beginning 24 hours after completion of ifosfamide infusion and continuing for 10 days. Treatment continues every 3 weeks for 5 courses. Beginning within 6 weeks after completion of chemotherapy, eligible patients undergo radiotherapy as outlined below.\n - Radiotherapy: Patients with incomplete or marginal resection undergo radiotherapy 5 days a week for 6-6.6 weeks. Patients with complete microscopic resection undergo radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 1 week.\n Patients are followed every 2 months for 1 year, every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter.\n PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study within 3.5 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically proven soft tissue sarcoma that is amenable to definitive surgery no more than 8 weeks after biopsy or inadequate surgery\n - Eligible subtypes:\n - Alveolar soft part sarcoma\n - Angiosarcoma\n - Fibrosarcoma\n - Leiomyosarcoma\n - Malignant fibrous histiocytoma\n - Liposarcoma (round cell and pleomorphic)\n - Miscellaneous sarcoma (including pelvic mixed mesodermal tumors)\n - Malignant paraganglioma\n - Neurogenic sarcoma\n - Rhabdomyosarcoma\n - Synovial sarcoma\n - Unclassifiable sarcoma\n - Ineligible subtypes:\n - Chondrosarcoma\n - Dermatofibrosarcoma\n - Embryonal rhabdomyosarcoma\n - Ewing's sarcoma\n - Kaposi's sarcoma\n - Liposarcoma (myxoid and well differentiated)\n - Malignant mesothelioma\n - Neuroblastoma\n - Osteosarcoma\n - Confirmed high-grade tumor (i.e., Trojani Grade II or III)\n - No metastases on staging with chest x-ray and thoracic CT scan\n - No regional lymph node involvement\n - Locally recurrent disease allowed\n - Interval of 3 months or more between definitive surgery and recurrence\n PATIENT CHARACTERISTICS:\n Age:\n - 16 to 69\n Performance status:\n - WHO 0-1\n Life expectancy:\n - Not specified\n Hematopoietic:\n - WBC greater than 4,000/mm^3\n - Platelet count greater than 120,000/mm^3\n - No bleeding disorders\n Hepatic:\n - Bilirubin no greater than 1.25 times normal\n - No severe hepatic dysfunction\n Renal:\n - Creatinine less than 1.6 mg/dL OR\n - Creatinine clearance greater than 60 mL/min\n Cardiovascular:\n - No clear history of angina\n - No documented myocardial infarction\n - No existing cardiac failure\n Other:\n - No serious infection\n - No other malignancy except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - Not specified\n Chemotherapy:\n - No prior systemic chemotherapy\n Endocrine therapy:\n - Not specified\n Radiotherapy:\n - No prior radiotherapy to affected area\n Surgery:\n - See Disease Characteristics\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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5
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nSurgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether surgery plus combination chemotherapy is more effective than surgery alone in treating patients with lung metastases from soft tissue sarcoma.\n PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus combination chemotherapy with that of surgery alone in treating patients who have soft tissue sarcoma that has spread to the lung.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Compare disease control, overall survival, and relapse-free survival in patients with lung metastases secondary to soft tissue sarcoma treated with high-dose doxorubicin and ifosfamide with or without filgrastim (G-CSF) before and after metastasectomy vs metastasectomy alone. II. Determine the safety and morbidity of this regimen in these patients.\n OUTLINE: This is a randomized, multicenter study. Patients are stratified according to location of metastases (unilateral vs bilateral). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients are assigned to regimen A or B. Regimen A: Patients receive high-dose doxorubicin IV and ifosfamide IV continuously on day 1 and filgrastim (G-CSF) subcutaneously on days 3-13. Regimen B: Patients receive chemotherapy as above without G-CSF. Treatment on both regimens continues every 3 weeks for 3 courses. Patients then undergo radical pulmonary metastasectomy via thoracotomy or sternotomy with wedge resection or lobectomy. Patients with responding disease after metastasectomy receive 2 additional courses on the regimen to which they were originally assigned. Arm II: Patients undergo radical pulmonary metastasectomy as in arm I. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.\n PROJECTED ACCRUAL: A total of 340 patients (170 per treatment arm) will be accrued for this study within approximately 4.5 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically proven soft tissue sarcoma with pulmonary metastases for which radical metastasectomy is feasible Eligible subtypes: Malignant fibrous histiocytoma Liposarcoma Synovial sarcoma Malignant paraganglioma Fibrosarcoma Leiomyosarcoma Neurogenic sarcoma Unclassified sarcoma Angiosarcoma (including hemangiopericytoma) Miscellaneous sarcoma (including mixed mesodermal tumors of the uterus) Ineligible subtypes: Alveolar rhabdomyosarcoma Kaposi's sarcoma Rhabdomyosarcoma of any type Malignant mesothelioma Chondrosarcoma Neuroblastoma Dermatofibrosarcoma Osteosarcoma Epithelioid sarcoma Primitive neuroectodermal tumor Ewing's sarcoma No extrapulmonary disease Previously treated local recurrence allowed Patients with primarily metastatic disease must have undergone radical treatment of primary tumor according to local protocols Reevaluation of metastases required before randomization\n PATIENT CHARACTERISTICS: Age: 16 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 120,000/mm3 Hepatic: Bilirubin no greater than 1.25 times normal Renal: Creatinine no greater than 1.6 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of cardiovascular disease Other: No other severe medical illness (including psychosis) No prior or concurrent other primary malignancy except adequately treated carcinoma in situ of the cervix or basal cell carcinoma\n PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease Prior neoadjuvant or adjuvant chemotherapy for primary soft tissue sarcoma allowed if cumulative dose of doxorubicin no greater than 200 mg/m2 At least 1 year since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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6
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nCombination Chemotherapy, Surgery, and Radiation Therapy in Treating Children With Advanced Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.\n PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, surgery, and radiation therapy in treating children who have advanced soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Assess the response to vincristine/ifosfamide/doxorubicin (VID) with granulocyte colony-stimulating factor support in children with newly diagnosed, inoperable or metastatic non-rhabdomyosarcoma soft tissue sarcomas. II. Estimate the 2-year and event-free survival rates in children treated with VID plus radiotherapy and/or surgery. III. Establish a bank of frozen tumor and peripheral blood tissue for use in further molecular studies.\n OUTLINE: The following acronyms are used: DOX Doxorubicin, NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor (Amgen), NSC-614629 IFF Ifosfamide, NSC-109724 Mesna Mercaptoethane sulfonate, NSC-113891 VCR Vincristine, NSC-67574 VID VCR/IFF/DOX Induction: 3-Drug Combination Chemotherapy. VID. Local Control: Surgery and/or Radiotherapy plus 3-Drug Combination Chemotherapy. Excision of the primary tumor and pulmonary metastases; and/or irradiation of the primary tumor and pulmonary metastases using x-rays or Co60 beam energies of at least 4 MV (electrons or iridium-192 implant allowed for boost); plus VID. Continuation: 3-Drug Combination Chemotherapy. VID.\n PROJECTED ACCRUAL: A total of 40 patients will be entered over 2.7 years if there are at least 7 responses in the first 20 patients.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Biopsy proven non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) Evaluable residual tumor after initial biopsy or excision required Registration required within 42 days of definitive diagnosis Grade II/III, unresectable or metastatic disease The following histologies exclude: Angiofibroma of the nasopharynx Mesothelioma Desmoid tumor Peripheral neuroepithelioma Desmoplastic small cell tumor Rhabdomyosarcoma Extraosseous Ewing's sarcoma Undifferentiated sarcoma Kaposi's sarcoma Grade 1 NRSTS, including: Angiomatoid malignant fibrous histiocytoma Dermatofibrosarcoma protuberans Myxoid and well-differentiated liposarcoma Well-differentiated and infantile hemangiopericytoma Well-differentiated malignant peripheral nerve sheath tumor\n PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine normal for age No hydronephrosis Cardiovascular: Shortening fraction greater than 28% Other: No HIV infection Not pregnant or nursing Effective contraception required of fertile women\n PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy No prior nephrectomy (surgical correction of hydronephrosis allowed)\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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7
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nCombination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug is a way to kill more tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.\n PURPOSE: Randomized phase III trial to compare the effect of two combination chemotherapy regimens followed by radiation therapy in treating patients with small cell lung cancer.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Compare the survival rate in patients with newly diagnosed small cell lung cancer and good performance status treated with an intensive regimen of ifosfamide/carboplatin/etoposide with mid-cycle vincristine (VICE) vs. standard chemotherapy followed, as feasible, by thoracic radiotherapy.\n - Compare the adverse effects of treatment and quality of life (including psychological distress, physical status, and functional status and global quality of life) in these patients.\n - Compare the Rotterdam Symptom Checklist vs. the EORTC QLQ-C30 and LC13 quality-of-life questionnaires in relation to compliance and ability to detect differences between treatments.\n OUTLINE: This is a randomized study.\n The first group receives standard combination chemotherapy with doxorubicin/cyclophosphamide/etoposide (ACE) or cisplatin/etoposide (PE) every 3 weeks for 6 courses.\n The second group receives intensive combination chemotherapy with carboplatin/ifosfamide/etoposide on days 1-3 with vincristine on day 14 (VICE). Courses repeat every 4 weeks for 6 courses.\n Patients in both groups are considered for thoracic radiotherapy beginning 4-5 weeks after the first day of the last course of chemotherapy.\n Concurrent prophylactic antibiotics should be given. Patients who relapse may receive further treatment at the clinician's option.\n Patients are followed monthly for 6 months, every 2 months for up to 1 year, every 3 months for up to 2 years, every 6 months for 5 years, and annually thereafter.\n PROJECTED ACCRUAL: A total of 400 patients will be entered over 3 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Microscopically proven small cell lung cancer\n - Diagnosis based on bronchial, mediastinal, pleural, lung, or lymph node biopsy, sputum cytology, or bronchial brushing or fine needle aspirate cytology\n - No pleural fluid cytology\n - No prior therapy\n PATIENT CHARACTERISTICS:\n Age:\n - Any age\n Performance status:\n - WHO 0-2\n Hematopoietic:\n - WBC more than 3,000\n - ANC more than 1,500\n - Platelets more than 100,000\n Hepatic/Renal:\n - Alkaline phosphatase, aminotransferase, sodium, and LDH normal or no more than 1 of them abnormal\n - Creatinine or urea normal\n - Creatinine clearance or GFR more than 65 mL/min\n Other:\n - No clinical evidence of infection\n - No prior or concurrent malignancy that interferes with protocol treatments or comparisons\n - No other condition that contraindicates treatment\n - Willing and able to complete quality-of-life questionnaires\n - Hospital Anxiety and Depression Scale, Rotterdam Symptom Checklist, and EORTC questionnaires completed prior to randomization\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - See Disease Characteristics\n Chemotherapy:\n - See Disease Characteristics\n Endocrine therapy:\n - See Disease Characteristics\n Radiotherapy:\n - See Disease Characteristics\n Surgery:\n - See Disease Characteristics\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nCryosurgery in Treating Patients With Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Cryosurgery kills cancer cells by freezing them. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining cryosurgery with chemotherapy may kill more tumor cells.\n PURPOSE: Phase I trial to study the effectiveness of cryosurgery with or without chemotherapy in treating patients who have soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Assess the safety and morbidity associated with cryosurgical ablation in patients with soft tissue sarcomas of the extremity.\n OUTLINE: All patients undergo 1 session of cryoablation. Patients with high-grade sarcoma receive systemic chemotherapy 10-14 days after cryoablation at the discretion of the consulting medical oncologist, and undergo surgery 2-3 weeks following chemotherapy. Patients with low-grade sarcoma and those with high-grade sarcoma who do not receive chemotherapy undergo surgery 4-6 weeks after cryoablation. Surgery for all patients consists of en bloc resection or amputation, with limb salvage attempted when feasible. Patients are followed weekly for 3 weeks.\n PROJECTED ACCRUAL: A total of 12 patients (approximately 6 patients with low-grade, high-risk sarcoma and 6 with high-grade sarcoma) will be entered over approximately 6 months. The study will be suspended for the following: vascular complication that requires surgical intervention for correction in 2 patients; any neuropraxia that shows no evidence of resolution after 3 months in 2 patients; any wound complication that requires surgical correction in 4 patients; or any deep wound infection that requires surgical drainage in 4 patients.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Biopsy-proven soft tissue sarcoma (STS) of the extremity Review by Pathology Department of the University of Southern California CT or MRI required prior to biopsy Disease in one of the following categories: High-grade tumor Low-grade tumor at high risk for local recurrence, i.e.: Adjacent to bone or vital neurovascular structures and able to be removed with a minimal surgical margin (i.e., plane of dissection goes through reactive zone of tumor) Lesion more than 5 cm in diameter The following tumors exclude: Primary sarcoma of the bone Metastatic carcinoma STS of the head and neck Visceral STS, e.g., breast, uterus, spermatic cord, mediastinum chest wall STS of the pelvis or retroperitoneum\n PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Hematopoietic: WBC at least 3,000 Platelets at least 75,000 Hemoglobin at least 9 g/Dl Hepatic: Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 2.5 times normal Renal: Not specified Other: No concurrent disease that renders patient medically or psychologically unable to tolerate treatment\n PRIOR CONCURRENT THERAPY: At least 30 days since therapy for sarcoma\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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9
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nSurgery Followed by Chemotherapy in Treating Young Patients With Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with surgery and/or radiation therapy may kill more tumor cells.\n PURPOSE: This randomized phase III trial is studying surgery followed by different regimens of combination chemotherapy given together with radiation therapy and/or additional surgery to compare how well they work in treating patients with soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Assess whether good survival rates can be maintained for patients with stage I (pathologic T1) soft tissue sarcomas (STS) treated with limited chemotherapy after complete surgical resection, and whether disease-free survival can be improved by improving the precision of pretreatment staging and the assessment of the completeness of the resection.\n - Compare the survival of patients with high-risk nonmetastatic STS treated with alternating regimens of carboplatin, epirubicin, and vincristine (CEV) and ifosfamide, vincristine, and etoposide (IVE) vs continuation of ifosfamide, vincristine, and dactinomycin (IVA) after initial therapy with IVA.\n - Assess whether the improved outcome seen for patients with stage III (node positive) STS in an earlier protocol (SIOP-MMT-89) can be maintained with 3 courses of alternating CEV/IVE without altering local therapy.\n - Compare outcome of patients with nonmetastatic STS to those with stage IV STS who are registered on this protocol but referred to treatment on the European Intergroup Stage IV Study.\n - Assess survival and the risk of late sequelae in patients with non-rhabdomyosarcoma malignant mesenchymal tumors treated on this protocol.\n - Evaluate the role of neoadjuvant chemotherapy, new prognostic factors (e.g., ploidy, histologic grading), and recommendations for the management of fibrosarcoma in infants and of fibromatoses.\n - Assess ifosfamide nephrotoxicity based on total dose administered and the long-term toxicity based on the potential predictive value of early evidence of nephrotoxicity.\n OUTLINE: This is a randomized study for patients with high-risk, nonmetastatic sarcoma, except those with the following characteristics: age less than 6 months, stage I/II non-alveolar orbital tumor, stage III disease, or age less than 3 years with parameningeal disease. Patients are stratified according to disease type (rhabdomyosarcoma (RMS) vs non-RMS disease), parameningeal site of disease, and participating center. Patients with RMS are further randomized by alveolar histology. Randomization occurs after the first course of chemotherapy.\n All patients, regardless of disease stage, are registered to this study and outcome is followed, although patients with metastatic RMS or non-RMS malignant mesenchymal tumors are referred for treatment on the SIOP-MMT-98 study. Patients diagnosed more than 8 weeks prior to entry or who are unavailable for follow-up are not treated on study. Doses are modified for patients under 1 year of age or under 10 kg of body weight. All other patients are assigned therapy based on risk group.\n After surgery, patients with complete resection and with proven or possible chemosensitive histologies proceed to chemotherapy on the low-risk regimen. Patients with questionable completeness of resection proceed to chemotherapy for standard-risk or high-risk tumors, as appropriate. Regardless of resection results, patients who underwent scrotal surgery for paratesticular tumors proceed to chemotherapy for standard-risk tumors. Alveolar RMS is considered high risk.\n LOW-RISK TUMORS (T1 N0 M0): Strategy 951\n - Tumors must be resectable without extensive, mutilating surgery, and resection margins must be microscopically negative at all sites. Patients with positive margins may undergo re-excision.\n - Vincristine is administered weekly for 4 weeks with dactinomycin given on the same day as the first and fourth doses of vincristine. The course is repeated once after a 3-week rest.\n STANDARD-RISK TUMORS (T1-2 N0 M0): Strategy 952\n - After resection as above, patients with incompletely resected T1 tumors, completely resected T1 tumors that extended beyond the tissue or organ of origin, or completely or incompletely resected T2 tumors at favorable sites (vagina, uterus, or paratesticular region) receive chemotherapy on this regimen.\n - Ifosfamide, vincristine, and dactinomycin (IVA) is started within 8 weeks of surgery and administered every 3 weeks for 3 courses; during this course only, vincristine is administered weekly throughout the 6 weeks. Response is assessed at week 8.\n - Patients with at least a 50% response at week 8 receive 3 more courses of IVA and are reassessed at week 17; those with a complete response (CR) discontinue treatment, while those with less than a CR begin local therapy (described below) on week 18 concurrently with 3 more courses of IVA (unless no further response was seen after week 8).\n - Patients with less than a 50% response at week 8 receive carboplatin, epirubicin, and vincristine (CEV) on weeks 9, 15, and 21 and ifosfamide, vincristine, and etoposide (IVE) on weeks 12, 18, and 24. Patients with less than a CR at week 17 receive concurrent local therapy beginning at week 18.\n HIGH-RISK TUMORS: Strategy 953\n - Patients with high-risk tumors after surgery are randomized to IVA as in strategy 952 (Arm I) or to 3 weeks of IVA (1 course) as in Strategy 952 followed by CEV and IVE as in Strategy 952 (Arm II). Response is assessed at week 8. Patients with parameningeal disease who are at least 3 years of age proceed to radiotherapy at week 9, regardless of response.\n - Patients on Arm I with at least a 50% response at week 8 receive 3 more courses of IVA and are reassessed at week 17; those who continue to respond between weeks 8 and 17 receive 3 additional courses of IVA. Patients with no further response receive 4 alternating courses of CEV and IVE. All patients with less than a CR at week 17 begin local therapy on week 18 concurrently with the additional chemotherapy. Patients on Arm I with less than a 50% response at week 8 receive alternating CEV and IVE as in Strategy 952. Patients with less than a CR at week 17 begin concurrent local therapy at week 18.\n - Patients on Arm II who have at least a 50% response at week 8 continue treatment with 2 courses of sequential IVA, CEV, and IVE. Local therapy is concurrently administered, beginning on week 18, to patients who have not achieved a CR by week 17. Patients on Arm II who have less than a 50% response at week 8 proceed immediately to local therapy with additional chemotherapy at the investigator's discretion. Patients with less than a CR after local therapy are considered for treatment on a phase II protocol.\n LOCAL THERAPY\n - Local therapy consists of conservative resection of residual disease (unless more debilitating surgery is appropriate). Patients with residual disease after surgery undergo external-beam radiotherapy 5 days per week for 6-7 weeks or brachytherapy; hyperfractionation is specifically excluded. For patients receiving radiotherapy, the dactinomycin dose in the IVA regimen is omitted from the middle course of chemotherapy and possibly the last course of chemotherapy during concurrent administration. Patients receiving alternating CEV and IVE have the courses reversed during concurrent radiotherapy, with possible omission of epirubicin for the third course.\n - Radical surgery is considered for any patient who has residual disease at week 27.\n TREATMENT FOR RELAPSE\n - Patients treated with Strategy 951 proceed to therapy with at least 6 alternating courses of IVE and CEV, with local therapy initiated after the second course. Other patients receive at least 6 alternating courses of CEV and vincristine, carboplatin, and etoposide (modified Vincaepi), with local therapy initiated after the second course. Patients who have already received either regimen may be re-treated with carboplatin and etoposide and vincristine and cyclophosphamide if relapse occurs more than 6 months after treatment, while those who relapse in less than 6 months are considered for phase II chemotherapy trials. Patients with metastatic relapse are evaluated for bone marrow or peripheral blood stem cell transplantation.\n Patients are followed every 2 months until 2 years after diagnosis, every 3 months for 1 year, every 6 months for 2 years, and then annually until 10 years after diagnosis.\n PROJECTED ACCRUAL: A total of 400 patients with high-risk nonmetastatic disease will be accrued for this study within approximately 4 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically confirmed primary soft tissue sarcoma:\n - Rhabdomyosarcoma\n - Non-rhabdomyosarcoma\n - Soft tissue primitive neuroectodermal tumor (PNET)\n - Extraosseous Ewing's sarcoma\n PATIENT CHARACTERISTICS:\n Age:\n - Under 18\n Performance status:\n - Not specified\n Life expectancy:\n - Not specified\n Hematopoietic:\n - Not specified\n Hepatic:\n - Not specified\n Renal:\n - Not specified\n PRIOR CONCURRENT THERAPY:\n Biologic:\n - Not specified\n Chemotherapy:\n - Not specified\n Endocrine:\n - Not specified\n Radiotherapy:\n - Not specified\n Surgery:\n - Prior primary surgery allowed\n Other:\n - No other prior therapy\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nMonoclonal Antibody A1G4 Plus BCG in Treating Patients With Cancer\n\n**Clinical Trial Summary:**\n\nRATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody A1G4 with BCG may kill more tumor cells.\n PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody A1G4 plus BCG in treating patients with cancer.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Assess the toxicity and feasibility of immunizing patients with anti-idiotypic rat monoclonal antibody A1G4 combined with Bacillus Calmette Guerin (BCG) adjuvant.\n - Determine whether immunization with A1G4 combined with BCG results in an immune response directed against GD2 ganglioside in patients.\n OUTLINE: All patients are treated with A1G4 diluted in sterile physiologic saline mixed with Bacillus Calmette Guerin (BCG) organisms. The vaccine is injected intradermally in multiple sites. Booster immunizations are administered during weeks 2, 4, 8, 12, 20, 28, 36, 44, 52. Immunizations are not administered in limbs where draining lymph nodes have been surgically removed or previously irradiated. Isoniazid is administered for 5 days after each BCG injection. If severe skin reactions are present at the injection site, the BCG dose is decreased. If skin reactions persist, the BCG dose is stopped but A1G4 injections continue.\n At least 6 patients are accrued at each dose level of A1G4. Dose escalation is not carried out until patients have been followed for at least 8 weeks after the first immunization without encountering grade 3 or worse non-skin toxicity.\n If 0-1 patient experiences dose limiting toxicity (DLT) at a given dose level, then patients are accrued to the next higher dose level. If 2 or more patients experience DLT, the MTD is defined as the previous dose level.\n Patients are followed for at least 1 year.\n PROJECTED ACCRUAL: A total of 24 patients are expected to complete this study. If patients are removed early from the study prior to evaluation for serological response, additional patients will be accrued until 6 patients are evaluable for serological response.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically confirmed GD2 positive tumors which include:\n - High risk neuroblastoma (stage IV, or N-myc amplified, or localized neuroblastoma multiply recurrent)\n - Recurrent or metastatic osteosarcoma\n - Recurrent or metastatic GD2 positive sarcomas\n - If free of disease, patient must be fully recovered from toxic effects or complications of prior treatments (chemotherapy or surgery)\n - No greater than 6 months since last chemotherapy or surgery before first injection of A1G4\n PATIENT CHARACTERISTICS:\n Age:\n - Any age\n Performance status:\n - Not specified\n Life expectancy:\n - At least 6 months\n Hematopoietic:\n - Absolute neutrophil count greater than 500/mm^3\n - Absolute leukocyte count greater than 500/mm^3\n - Peripheral T-cell phytohemagglutinin activation (PHA) at least 50% of normal\n Hepatic:\n - Not specified\n Renal:\n - Not specified\n Cardiovascular:\n - No significant heart disease (NYHA class III or IV)\n Other:\n - No other serious intercurrent illnesses\n - No active infections requiring antibiotics\n - No active bleeding\n - No primary immunodeficiency\n - Not pregnant or nursing\n - Adequate contraception required of all fertile patients\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - No concurrent antibiotics\n - No prior mouse antibodies and detectable human antimouse antibody (HAMA) titer\n Chemotherapy:\n - See Disease Characteristics\n - At least 6 weeks since nitrosoureas\n - At least 4 weeks since other systemic chemotherapy\n Endocrine therapy:\n - No concurrent nonsteroidal anti-inflammatory agents\n - No concurrent corticosteroid\n Radiotherapy:\n - At least 4 weeks since radiotherapy\n - No prior radiation therapy to the spleen\n Surgery:\n - See Disease Characteristics\n - No splenectomy\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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11
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nCombination Chemotherapy With or Without Hyperthermia Therapy in Treating Patients With Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. It is not known whether receiving chemotherapy plus hyperthermia is more effective than receiving chemotherapy alone in treating patients with soft tissue sarcoma.\n PURPOSE: This randomized phase III trial is studying combination chemotherapy alone to see how well it works compared to combination chemotherapy and hyperthermia therapy in treating patients with soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine local progression-free survival of patients with high-risk soft tissue sarcoma treated with neoadjuvant etoposide, ifosfamide, and doxorubicin with or without regional hyperthermia.\n - Determine the tumor response rate, local disease control rate, and overall survival in patients treated with this regimen.\n OUTLINE: This is a randomized study. Patients are stratified according to high-risk category (S1 vs S2 vs S3) and disease site (extremity vs nonextremity). Patients are randomized to one of two treatment arms.\n - Arm I: Patients receive etoposide IV over 30 minutes on days 1 and 4, ifosfamide IV over 60 minutes on days 1-4, and doxorubicin IV over 30 minutes on day 1. Treatment continues every 21 days for a total of 4 courses. Patients also undergo regional hyperthermia.\n - Arm II: Patients receive chemotherapy alone as in arm I. Patients in both arms undergo definitive surgery 4-6 weeks after chemotherapy. Patients also undergo radiotherapy beginning 4-6 weeks after surgery. After completion of surgery and radiotherapy, patients with non-resectable tumors showing no disease progression receive an additional 4 courses of chemotherapy with or without regional hyperthermia according to above treatment schedule.\n Patients are followed every 3 months for 1 year, every 4 months for 2 years, and then every 6 months thereafter.\n PROJECTED ACCRUAL: A total of 340 patients (170 patients per arm) will be accrued for this study within 3.5 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically proven grade II or III soft tissue sarcoma of one of following high-risk groups:\n - Grade II/III primary tumor with lesion size of at least 5 cm, deep, and extracompartmental (S1)\n - Local recurrence of primary tumor (S2)\n - Inadequate surgical excision of S1 or S2 (S3)\n - Disease recurrence after prior surgery allowed\n - The following histological types are eligible:\n - Malignant fibrous histiocytoma\n - Liposarcoma (round cell and pleomorphic)\n - Leiomyosarcoma\n - Fibrosarcoma\n - Rhabdomyosarcoma\n - Synovial sarcoma\n - Malignant paraganglioma\n - Neurofibrosarcoma (malignant schwannoma)\n - Extraskeletal Ewing's sarcoma\n - Extraskeletal osteosarcoma\n - Malignant peripheral neuroectodermal tumors\n - Mesenchymal chondrosarcoma\n - Angiosarcoma\n - Miscellaneous sarcoma\n - Unclassified sarcoma\n - No distant metastases\n PATIENT CHARACTERISTICS:\n Age:\n - 18 to 70\n Performance status:\n - WHO 0-2 OR\n - Karnofsky 60-100%\n Life expectancy:\n - Not specified\n Hematopoietic:\n - WBC at least 3,500/mm^3\n - Platelet count at least 100,000/mm^3\n - No bleeding disorder\n Hepatic:\n - Bilirubin less than 1.25 times upper limit of normal\n - No severe hepatic dysfunction\n Renal:\n - Creatinine clearance greater than 60 mL/min\n - No chronic renal failure\n Cardiovascular:\n - No documented existing cardiac failure\n - No manifest heart failure (New York Heart Association class III or IV)\n - Left ventricular ejection fraction no more than 10% below institutional normal\n Other:\n - No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix\n - No other severe disease\n - No severe cerebrovascular disease\n - No extremely obese patients\n - No prior metallic implants relevant to the regional hyperthermia field\n - Not pregnant or nursing\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - Not specified\n Chemotherapy:\n - No prior chemotherapy\n Endocrine therapy:\n - Not specified\n Radiotherapy:\n - No prior radiotherapy (except to disease recurrence outside study irradiation field)\n Surgery:\n - See Disease Characteristics\n - No prior mutilative surgery\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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12
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{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nTroglitazone in Treating Patients With Liposarcoma\n\n**Clinical Trial Summary:**\n\nTroglitazone may help liposarcoma cells develop into normal cells. This was a single arm, open-label study with a two-stage design to evaluate troglitazone in patients with liposarcoma stratified by histologic subtype.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n I. To evaluate the clinical activity of troglitazone in patients with malignant liposarcoma stratified by histologic subtype.\n II. To perform correlative imaging, biological, and biochemical testing of patients in order to define the degree to which in vivo terminal differentiation may be promoted by this therapeutic intervention.\n III. To evaluate the tolerance and safety of troglitazone in this patient population.\n PROJECTED ACCRUAL:\n Initially, 14 patients of each of the 5 histologic subtypes of liposarcoma will be accrued. If 1 or more patients show evidence of biological response, an additional 16 patients of each subtype will be accrued for a total of 30 patients per subtype. If 4 or more of 30 patients achieve biological response then troglitazone will be deemed promising in that histologic subtype.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically proven liposarcoma that is incurable by standard surgery Measurable or evaluable disease required No active CNS involvement or leptomeningeal disease\n PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT less than 5 times upper normal limit Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No poorly controlled atrial arrhythmias, angina pectoris, or myocardial infarction within past 6 months No symptomatic congestive heart failure, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within past 3 months Other: Not pregnant or nursing Fertile patients must use effective contraception No known active retroviral disease\n PRIOR CONCURRENT THERAPY: Recovered from toxic effects of all prior therapy No concurrent cytotoxic therapy Biologic therapy: Not specified Chemotherapy: Prior chemotherapy allowed Endocrine therapy: No concurrent hormonal therapy Radiotherapy: Prior radiation therapy for metastatic disease allowed No radiotherapy to sole site of measurable disease within past 6 months Surgery: Not specified\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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13
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nIfosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether ifosfamide or doxorubicin is more effective for advanced or metastatic soft tissue sarcoma.\n PURPOSE: Randomized phase III trial to compare the effectiveness of ifosfamide with that of doxorubicin in treating patients who have advanced or metastatic soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the progression free survival rate in patients with advanced or metastatic soft tissue sarcoma treated with either of two different regimens of ifosfamide or doxorubicin. II. Assess the toxic effects of these therapies and response rate in these patients.\n OUTLINE: This is a randomized, multicenter study. Patients are randomized into one of 3 arms (continuous ifosfamide, ifosfamide daily for 3 days, or doxorubicin). Patients are stratified by performance status (0 vs 1), liver involvement (no vs yes), histological type (leiomyosarcoma vs synovial sarcoma vs other), and histological grade (1 vs 2 vs 3). Arm I: Patients receive doxorubicin by bolus infusion for 5-20 minutes once every 3 weeks. Arm II: Patients receive ifosfamide by intravenous infusion for 4 hours on days 1, 2, and 3 every three weeks. Arm III: Patients receive ifosfamide by intravenous infusion for 72 hours every 3 weeks. Patients are assessed after every 2 courses of therapy. Each course of therapy consists of 3 weeks of treatment. Patients may receive a maximum of 6 courses of therapy in the absence of toxicity and disease progression. Patients are followed every 12 weeks for survival.\n PROJECTED ACCRUAL: A total of 780 patients (260 per treatment arm) will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically proven advanced or metastatic soft tissue sarcoma including the following: Malignant fibrous histiocytoma Liposarcoma Rhabdomyosarcoma Synovial sarcoma Malignant paraganglioma Fibrosarcoma Leiomyosarcoma Angiosarcoma including haemangiopericytoma Neurogenic sarcoma Unclassified sarcoma Mixed mesodermal tumor of the uterus Measurable disease with evidence of progression in prior 6 weeks No symptomatic or known CNS metastases\n PATIENT CHARACTERISTICS: Age: 15 to 65 Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3000/mm3 Neutrophil count greater than 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater 1.75 mg/dL Albumin at least 25 g/L Renal: Creatinine clearance greater than 70 mL/min Cardiovascular: No history of uncontrolled cardiovascular disease Other: Fertile women must use effective contraception No other severe medical illness including psychosis No prior primary malignant tumor except: Adequately treated carcinoma in situ of the cervix Basal cell carcinoma\n PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No radiotherapy to the sole index lesion Surgery: Not specified\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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14
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nAntineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.\n PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating patients who have soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with incurable soft tissue sarcoma.\n - Describe response, tolerance to, and side effects of this regimen in these patients.\n OUTLINE: This is an open-label study.\n Patients receive gradually escalating doses of antineoplastons A10 and AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached.\n Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.\n Tumors are measured every 2 months for 1 year and then every 3 months for 1 year.\n PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically confirmed soft tissue sarcoma that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy\n - Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan\n PATIENT CHARACTERISTICS:\n Age:\n - 6 months and over\n Performance status:\n - Karnofsky 60-100%\n Life expectancy:\n - At least 2 months\n Hematopoietic:\n - WBC at least 2,000/mm^3\n - Platelet count at least 50,000/mm^3\n Hepatic:\n - No hepatic insufficiency\n - Bilirubin no greater than 2.5 mg/dL\n - SGOT and SGPT no greater than 5 times upper limit of normal\n Renal:\n - No renal insufficiency\n - Creatinine no greater than 2.5 mg/dL\n - No history of renal conditions that contraindicate high dosages of sodium\n Cardiovascular:\n - No uncontrolled hypertension\n - No history of congestive heart failure\n - No history of other cardiovascular conditions that contraindicate high dosages of sodium\n Pulmonary:\n - No serious lung disease, such as chronic obstructive pulmonary disease\n Other:\n - Not pregnant or nursing\n - Fertile patients must use effective contraception during and for 4 weeks after study participation\n - No active infection\n - No nonmalignant systemic disease\n - Not high medical or psychiatric risk\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - At least 4 weeks since immunotherapy\n - No concurrent immunomodulating agents\n Chemotherapy:\n - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)\n Endocrine therapy:\n - Concurrent corticosteroids allowed\n Radiotherapy:\n - At least 8 weeks since prior radiotherapy\n Surgery:\n - Recovered from prior surgery\n Other:\n - Prior cytodifferentiating agents allowed\n - No prior antineoplastons\n - No other concurrent antineoplastic agents\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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15
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nTemozolomide in Treating Patients With Advanced Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.\n PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have advanced soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the efficacy, as measured by the response rate, of temozolomide in patients with unresectable, stage IV, or recurrent soft tissue sarcoma who have failed no more than 2 prior treatment regimens. II. Determine the clinical and laboratory toxicities, as well as patient tolerance, of this regimen in this patient population.\n OUTLINE: Patients are stratified according to ECOG performance status (0-1 vs 2), prior surgery (yes vs no), prior radiotherapy (yes vs no), and prior chemotherapy regimens (0 vs 1 vs 2). Patients receive oral temozolomide every 12 hours for 5 days. Courses repeat every 4 weeks for at least 18 months in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for the first 18 months, every 6 months for the next 18 months, and then annually thereafter until death.\n PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically, cytologically, or clinically confirmed unresectable, stage IV, or recurrent soft tissue sarcoma No Ewing's sarcoma, Kaposi's sarcoma, bone sarcomas, mesotheliomas, or primitive neuroectodermal tumors Bidimensionally measurable disease by x-ray, CT scan or MRI, or physical examination No CNS metastases No more than 2 prior chemotherapy regimens for advanced, recurrent, or metastatic disease\n PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin greater than 10.0 g/dL WBC at least 3,500/mm3 OR Absolute neutrophil count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 1.5 times ULN Alkaline phosphatase less than 2 times ULN Renal: Calcium less than ULN Creatinine or BUN less than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or fully excised and/or treated stage I cancer currently in complete remission No nonmalignant systemic disease rendering patient a poor medical risk No acute infection requiring IV antibiotics HIV negative No AIDS-related illness No frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction)\n PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic response modifier treatment allowed At least 4 weeks since prior immunotherapy At least 4 weeks since prior biologic therapy No concurrent epoetin alfa Chemotherapy: See Disease Characteristics Prior dacarbazine allowed At least 4 weeks since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy for malignancy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to areas of measurable disease unless there is clear progression or there is measurable disease outside the area of prior radiation No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery and recovered Other: No other concurrent investigational drugs\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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16
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nAdjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumors cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy is more effective for early-stage breast cancer.\n PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of adjuvant chemotherapy plus radiation therapy in treating women who have early-stage breast cancer.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Compare the effects of synchronous vs sequential adjuvant chemotherapy and radiotherapy on local recurrence, disease-free and overall survival, and treatment delay in women with early-stage breast cancer.\n - Compare the safety of these regimens, in terms of dose intensity and toxicity, in this patient population.\n - Compare the quality of life and cosmetic outcome in patients treated with these regimens.\n OUTLINE: This is a randomized, multicenter study. Patients are stratified according to clinical oncologist, axillary clearance (yes vs no), radiotherapy boost intent (boost vs no boost), and chemotherapy intent (cyclophosphamide, methotrexate, and fluorouracil [5-FU] vs anthracycline-containing regimen). Patients are randomized to one of two treatment arms.\n Patients receive any chemotherapy regimen that includes cyclophosphamide, methotrexate, and 5-FU. Some regimens may also include epirubicin, doxorubicin, mitoxantrone, and/or mitomycin. Chemotherapy repeats every 3 weeks for 4-8 courses.\n - Arm I (synchronous chemoradiotherapy): Patients receiving synchronous therapy receive any of the above chemotherapy regimens plus daily radiotherapy between courses 2 and 3 OR courses 5 and 6 of chemotherapy. Radiotherapy is administered for 3-5 weeks.\n - Arm II (sequential chemoradiotherapy): Patients receiving sequential therapy receive any of the above chemotherapy regimens followed by daily radiotherapy beginning after completion of all chemotherapy (after course 6 or 8). Radiotherapy is administered for 3-5 weeks.\n Treatment in both arms continues in the absence of disease progression or unacceptable toxicity.\n Quality of life is assessed before chemotherapy, 2-3 weeks after the completion of all treatment, and then at 1, 2, and 5 years.\n Patients are followed annually for 10 years.\n Peer Reviewed and Funded or Endorsed by Cancer Research UK\n PROJECTED ACCRUAL: A total of 2,250 patients (1,125 per treatment arm) will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically confirmed invasive breast cancer\n - Early-stage disease\n - No metastatic disease\n - Complete surgical excision of tumor\n - Planned use of adjuvant chemotherapy and radiotherapy\n - If participating in the cosmetic outcome evaluation portion of the study, must have unilateral disease\n - Hormone receptor status\n - Not specified\n PATIENT CHARACTERISTICS:\n Age:\n - Not specified\n Sex:\n - Female\n Menopausal status:\n - Not specified\n Performance status:\n - Not specified\n Life expectancy:\n - Not specified\n Hematopoietic:\n - Bone marrow function adequate\n Hepatic:\n - Hepatic function adequate\n Renal:\n - Renal function adequate\n Cardiovascular:\n - Cardiac function adequate\n Other:\n - No other prior malignancy except basal cell or squamous cell skin cancer or carcinoma in situ\n - No other medical or social condition that would preclude study compliance\n - Fit to receive both adjuvant chemotherapy and radiotherapy (administered either synchronously or sequentially)\n - Not pregnant or nursing\n - Fertile patients must use effective contraception\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - Not specified\n Chemotherapy:\n - See Disease Characteristics\n - No prior chemotherapy\n - No concurrent epirubicin and doxorubicin as a study combination chemotherapy regimen\n Endocrine therapy:\n - Prior or concurrent hormonal therapy allowed\n - No concurrent tamoxifen if treated with methotrexate, mitomycin, and mitoxantrone as a study combination chemotherapy regimen\n Radiotherapy:\n - See Disease Characteristics\n - No concurrent internal mammary chain irradiation\n - No concurrent orthovoltage irradiation to the whole breast\n Surgery:\n - See Disease Characteristics\n - Recovered from prior surgery\n Other:\n - Concurrent participation in another clinical trial allowed\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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17
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nEcteinascidin 743 in Treating Patients With Advanced Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.\n PURPOSE: Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients who have advanced soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the therapeutic activity of ecteinascidin 743 in patients with advanced soft tissue sarcomas. II. Determine the duration of response in these patients. III. Determine the acute side effects in these patients.\n OUTLINE: This is a multicenter study. Patients receive ecteinascidin 743 (ET-743) IV over 24 hours every 3 weeks. Treatment continues for at least 2-6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression and every 12 weeks after disease progression.\n PROJECTED ACCRUAL: Approximately 28-44 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically proven soft tissue sarcoma, including the following cell types: Malignant fibrous histiocytoma Liposarcoma Rhabdomyosarcoma Synovial sarcoma Malignant paraganglioma Fibrosarcoma Leiomyosarcoma Angiosarcoma including hemangiopericytoma Neurogenic sarcoma Unclassified sarcoma Miscellaneous sarcoma including mixed mesodermal tumors of the uterus Cell types NOT allowed: Malignant mesothelioma Chondrosarcoma Neuroblastoma Osteosarcoma Ewing's sarcoma Embryonal rhabdomyosarcoma Measurable lesion with evidence of progression within 6 weeks prior to study (osseous lesions, hepatomegaly, lymphedema, ascites, and pleural lesions are not considered measurable) No symptomatic or known CNS metastases\n PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.75 mg/dL Albumin at least 2.5 g/dL AST and ALT less than 1.5 times upper limit of normal (ULN) (2.5 times ULN if liver metastasis present) Alkaline phosphatase less than 2.5 times ULN No other significant hepatic disease (e.g., active hepatitis, cirrhosis, etc.) Renal: Creatinine no greater than 1.36 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No prior cardiovascular disease Other: No other severe medical illness No psychosis No prior or concurrent second primary malignant tumors, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma Fertile patients must use effective contraception\n PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy No more than 1 prior regimen of combination chemotherapy OR No more than 2 prior single agent regimens No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to sole index lesion No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational drugs\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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18
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nMonoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.\n PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy plus etoposide in treating patients who have neuroblastoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine the antitumor effects of monoclonal antibody 3F8, etoposide, and isotretinoin using standard imaging methods and tumor marker studies in patients with high-risk neuroblastoma.\n - Assess progression-free survival in these patients after this treatment.\n - Assess the effects of oral etoposide on human anti-mouse antibody and anti-idiotype response in these patients.\n OUTLINE: Patients are stratified according to disease status (evaluable but not measurable vs second or subsequent remission with no measurable or evaluable disease).\n Patients receive monoclonal antibody 3F8 (MOAB 3F8) IV over 1.5 hours once daily on days 1-10 and oral etoposide once daily on days 29-49. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression, human anti-mouse antibody (HAMA) response, or unacceptable toxicity.\n If HAMA fails to develop after completion of 4 courses of MOAB 3F8, patients continue treatment with MOAB 3F8 on days 1-5 every 8 weeks until HAMA reaches greater than 1,000 U/mL or until month 24, whichever occurs first.\n Beginning after completion of 4 courses of etoposide and MOAB 3F8 or if HAMA develops, patients receive oral isotretinoin twice daily for 14 days followed by at least a 14-day rest. Treatment repeats for a total of 6 courses.\n PROJECTED ACCRUAL: A total of 50 patients (25 per stratum) will be accrued for this study within 5 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - High-risk neuroblastoma by:\n - Histopathology OR\n - Bone marrow involvement plus elevated urinary catecholamines\n - Prior tumor progression on standard chemotherapy and poor long-term prognosis as indicated by 1 or more of the following:\n - N-myc amplification in tumor cells\n - Diploid chromosomal content plus lp loss of heterozygosity in tumor cells\n - Distant skeletal metastases\n - Unresectable primary tumor infiltrating across the midline\n - More than 10% tumor cells in bone marrow\n - Less than 30% chance of long-term progression-free survival\n - Evaluable (microscopic marrow metastasis, elevated tumor markers, abnormal bone scan or MIBG or PET scan) but not measurable (CT scan, MRI) disease documented at least 4 weeks after completion of prior systemic therapy\n - No rapidly progressive disease as defined by 1 or more of the following:\n - Serum lactic dehydrogenase greater than 1.5 times upper limit of normal due to tumor\n - An opiate requirement for pain from tumor\n - Greater than 25% increase in tumor by successive imaging studies\n - Life expectancy less than 8 weeks\n - Second or subsequent remission after chemotherapy and/or radiotherapy allowed provided there is less than 30% chance of survival\n - No prior myelodysplastic syndromes or leukemia\n PATIENT CHARACTERISTICS:\n Age:\n - Not specified\n Performance status:\n - Not specified\n Life expectancy:\n - See Disease Characteristics\n - At least 8 weeks\n Hematopoietic:\n - Not specified\n Hepatic:\n - No grade 3 or worse liver toxicity\n Renal:\n - No grade 3 or worse renal toxicity\n - Creatinine clearance at least 60 mL/min\n Cardiovascular:\n - No grade 3 or worse cardiac toxicity\n Pulmonary:\n - No grade 3 or worse pulmonary toxicity\n Other:\n - Not pregnant\n - No grade 3 or worse gastrointestinal toxicity\n - No grade 3 or worse neurologic system toxicity\n - No grade 4 hearing deficit\n - No active life-threatening infection\n - No prior exposure to mouse antibodies and human anti-mouse antibody greater than 1,000 ELISA units/mL\n - No allergy to mouse proteins\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - Not specified\n Chemotherapy:\n - See Disease Characteristics\n Endocrine therapy:\n - Not specified\n Radiotherapy:\n - See Disease Characteristics\n Surgery:\n - See Disease Characteristics\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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19
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{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nRadiation Therapy Plus Doxorubicin in Treating Patients With Resectable Primary or Recurrent Retroperitoneal Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.\n PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus doxorubicin in treating patients who have resectable primary or recurrent peritoneal soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the toxicity and maximum tolerated dose of preoperative external beam radiotherapy when combined with doxorubicin and followed by intraoperative radiotherapy in patients with resectable primary or recurrent soft tissue sarcoma of the retroperitoneum. II. Assess radiologic and pathologic response in patients treated with this preoperative regimen.\n OUTLINE: This is a dose-escalation study of external beam radiotherapy. Patients receive doxorubicin IV bolus followed immediately by doxorubicin IV over 4 days every week for 5 weeks concurrently with external beam radiotherapy 5 days a week for 4 weeks. Patients with stable or responding disease undergo surgical resection of primary tumor and all adjacent gross disease approximately 6 weeks after completion of chemoradiotherapy. Patients receive intraoperative radiotherapy (IORT) to the tumor bed if all gross disease has been resected and if the area of maximal tumor adherence to the retroperitoneum can be encompassed within a single IORT field (maximum 15 cm). Cohorts of 3-6 patients receive escalating doses of external beam radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 30% of patients experience grade 3 or worse dose-limiting toxicity.\n PROJECTED ACCRUAL: A total of 15-45 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically or cytologically proven resectable primary or recurrent soft tissue sarcoma of the retroperitoneum Greatest dimension of the 3-dimensional assessment of tumor size must be 5-35 cm Grade 2 or 3, including dedifferentiated liposarcoma and retroperitoneal recurrences of gastrointestinal leiomyosarcoma\n PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Zubrod 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Renal function normal Creatinine less than 1.6 mg/dL Gastrointestinal: Must maintain adequate oral nutrition (90-100% of estimated need for calories and protein) and be free of nausea and vomiting prior to radiotherapy (feeding tube allowed) Other: Prior malignancy allowed at the discretion of the protocol investigator No other serious uncontrolled medical condition Not pregnant or nursing Fertile patients must use effective contraception\n PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior abdominal radiotherapy Surgery: See Disease Characteristics\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nRosiglitazone in Treating Patients With Liposarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Rosiglitazone may help liposarcoma cells develop into normal fat cells.\n PURPOSE: Phase II trial to study the effectiveness of rosiglitazone in treating patients who have liposarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine the clinical activity of rosiglitazone in patients with liposarcoma.\n - Assess the impact of this regimen on markers of tumor proliferation and differentiation status in these patients using biologic and biochemical testing and correlative imaging.\n - Determine the tolerance and safety of this regimen in these patients.\n OUTLINE: Patients are stratified by histologic subtype (well differentiated vs dedifferentiated vs myxoid/round cell vs pleomorphic).\n Patients receive oral rosiglitazone twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.\n Patients are followed at 1-3 weeks and then every 3 months thereafter.\n PROJECTED ACCRUAL: A total of 56-120 patients (14-30 per stratum) will be accrued for this study within 15 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically proven liposarcoma that is incurable with standard multimodality approaches (e.g., surgery and/or radiotherapy and/or chemotherapy)\n - Well differentiated OR\n - Dedifferentiated OR\n - Myxoid/round cell OR\n - Pleomorphic\n - Measurable disease\n - No clinically unstable brain metastases\n - No progression on prior troglitazone therapy for liposarcoma\n PATIENT CHARACTERISTICS:\n Age:\n - 18 and over\n Performance status:\n - ECOG 0-2\n Life expectancy:\n - At least 3 months\n Hematopoietic:\n - Absolute neutrophil count at least 1,000/mm3\n - Platelet count at least 90,000/mm3\n Hepatic:\n - Bilirubin no greater than 2.0 mg/dL\n - SGOT less than 5 times upper limit of normal\n Renal:\n - Creatinine no greater than 2.4 mg/dL\n Cardiovascular:\n - No poorly controlled atrial arrhythmias, symptomatic angina pectoris, or myocardial infarction within the past 4 months\n - No symptomatic congestive heart failure, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within the past 3 months\n Other:\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective barrier contraception\n - Oral contraceptives are not considered effective contraception\n - No active retroviral disease\n - No condition that would preclude informed consent\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - Not specified\n Chemotherapy:\n - See Disease Characteristics\n - Prior chemotherapy allowed and recovered\n - No concurrent cytotoxic therapy\n Endocrine therapy:\n - No concurrent hormonal therapy\n Radiotherapy:\n - See Disease Characteristics\n - Prior radiotherapy allowed and recovered\n - At least 6 months since prior radiotherapy to the sole site of measurable disease\n - Concurrent localized radiotherapy to a single site of disease allowed if there are other sites of measurable disease\n Surgery:\n - Not specified\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nCombination Chemotherapy in Treating Patients With Metastatic Breast Cancer\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Drugs such as mesna may be effective in preventing some of the side effects of chemotherapy.\n PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of etoposide and ifosfamide given with mesna, and cisplatin in treating patients who have metastatic breast cancer.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine the objective response rate in patients with metastatic breast cancer treated with etoposide, ifosfamide with mesna, and cisplatin.\n - Determine the tolerability and toxicity of this regimen in these patients.\n OUTLINE: Patients are stratified according to number of prior chemotherapy courses for metastatic disease (0 vs 1).\n Patients receive etoposide IV over 60-90 minutes, cisplatin IV over 30 minutes, and ifosfamide IV over 30 minutes on days 1-3. Mesna is administered IV over 15 minutes 30 minutes prior to and 4 hours after ifosfamide, then orally at 8 hours post infusion. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.\n Patients are followed every 3 months.\n PROJECTED ACCRUAL: At least 36 patients (16 per stratum) will be accrued over 36 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically proven progressive metastatic breast cancer\n - Measurable disease\n - Any lesion measurable in 2 dimensions\n - Hepatic metastases if the sum of the measurements below the costal margin in the midclavicular line and the tip to the xiphoid process is greater than 5 cm during quiet respiration\n - Hepatic defects that are clearly measurable by radionuclide, CAT, or MRI scans\n - Bone metastases are not considered measurable disease\n - Evaluable disease allowed if measurable disease also present\n - No brain metastases, carcinomatous meningitis, or spinal cord compression\n - Hormone receptor status:\n - Not specified\n PATIENT CHARACTERISTICS:\n Age:\n - Not specified\n Menopausal status:\n - Not specified\n Performance status:\n - ECOG 0-2\n Life expectancy:\n - At least 3 months\n Hematopoietic:\n - Hemoglobin at least 10 g/dL\n - WBC at least 4,000/mm3\n - Platelet count at least 100,000/mm3\n Hepatic:\n - Bilirubin no greater than 2.0 mg/dL\n Renal:\n - Creatinine no greater than 1.5 mg/dL\n - No bladder outlet obstruction\n Cardiovascular:\n - No symptomatic cardiovascular disease (e.g., congestive heart disease) or inability to tolerate a fluid load\n Other:\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective contraception\n - No active infection\n - No prior malignancies except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - No greater than 1 prior biologic response modifier treatment for metastatic disease\n Chemotherapy:\n - No greater than 1 prior chemotherapy regimen for metastatic disease allowed\n - Patients who relapsed during or within 6 months after adjuvant chemotherapy are considered to have failed 1 regimen\n - Patients who relapsed more than 6 months after adjuvant chemotherapy are considered to not have had a prior regimen\n - Greater than 4 weeks since prior chemotherapy (greater than 6 weeks for mitomycin or nitrosoureas) and recovered\n - No prior cisplatin, etoposide, or ifosfamide\n Endocrine therapy:\n - Prior medical or surgical hormonal therapy allowed\n Radiotherapy:\n - Prior radiation therapy to areas of measurable disease allowed if indicator lesion increased in size by greater than 25% after treatment\n - Recovered from effects of prior radiotherapy\n Surgery:\n - Recovered from effects of major surgery\n Other:\n - At least 7 days since prior nephrotoxic drugs (e.g., aminoglycosides, diuretics, lithium, intravenous contrast, or nonsteroidal antiinflammatory drugs)\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nSTI571 in Treating Patients With Recurrent or Refractory Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: STI571 may interfere with the growth of cancer cells and may be an effective treatment for soft tissue sarcoma.\n PURPOSE: Phase I/II trial to study the effectiveness of STI571 in treating patients who have recurrent or refractory soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the maximum tolerated dose and associated toxicity of STI571 in patients with refractory or recurrent soft tissue sarcoma. II. Determine the pharmacokinetic profile of this treatment regimen in these patients. III. Determine the objective response and duration of response in these patients with this treatment regimen.\n OUTLINE: This is a dose escalation and dose efficacy, multicenter study. In the dose efficacy portion, patients are stratified according to disease type (gastrointestinal stromal tumor vs all other soft tissue sarcomas). Phase I: Patients receive oral STI571 daily for a maximum of 24 months in the absence of disease progression or unacceptable toxicity. Cohorts of 3-8 patients receive escalating doses of STI571 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6-8 patients experience dose limiting toxicities. The recommended phase II dose is defined as the dose preceding the MTD. Phase II: Patients receive the recommended phase II dose of STI571 as in phase I. Patients are followed every 8 weeks until disease progression, and then every 16 weeks thereafter.\n PROJECTED ACCRUAL: Approximately 47-72 patients (7-32 in phase I and 40 in phase II) will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically confirmed soft tissue sarcoma Malignant fibrous histiocytoma Liposarcoma Rhabdomyosarcoma Synovial sarcoma Malignant paraganglioma Fibrosarcoma Leiomyosarcoma Angiosarcoma Hemangiopericytoma Neurogenic sarcoma Unclassified sarcoma Miscellaneous sarcoma (including mixed mesodermal tumors of the uterus) Gastrointestinal stromal tumor (GIST) (must be c-kit positive) No malignant mesothelioma, chondrosarcoma, neuroblastoma, osteosarcoma, Ewing's sarcoma, or embryonal rhabdomyosarcoma Phase I study and nonGIST phase II study patients: Must have received one prior first line combination chemotherapy regimen or two first line single agent regimens Adjuvant chemotherapy not considered first line, unless disease progression within 6 months of treatment Phase II GIST patients: No more than one prior first line combination chemotherapy regimen or two first line single agent regimens Adjuvant chemotherapy not considered first line, unless disease progression within 6 months of treatment Measurable disease with evidence of progression in past 6 weeks Osseous lesions and pleural effusions not considered measurable No symptomatic or known CNS metastases\n PATIENT CHARACTERISTICS: Age: 15 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.8 mg/dL Albumin at least 25 g/L Renal: Creatinine no greater than 1.4 mg/dL OR Creatinine clearance greater than 65 mL/min Cardiovascular: No history of cardiovascular disease Other: No prior or concurrent second primary malignant tumors except adequately treated carcinoma in situ of the cervix or basal cell carcinoma No other severe illness (including psychosis) Not pregnant Fertile patients must use effective contraception during and for 6 months following study\n PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No other concurrent local or systemic chemotherapy Endocrine therapy: No concurrent systemic corticosteroid therapy Radiotherapy: No prior radiotherapy to sole index lesion Concurrent radiotherapy to any lesion allowed if not the sole target lesion Surgery: Not specified Other: No prior embolization to sole index lesion No other concurrent investigational drug No concurrent warfarin\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nMeasurement and Prediction of Outcomes of Amplification\n\n**Clinical Trial Summary:**\n\nThe long-term goal of this research program is to develop methods to predict both the benefit and the satisfaction that hearing-impaired patients will derive from auditory amplification in daily life. This proposal has three primary objectives: (1) To determine the influence of extra-audiological variables, such as personality attributes and expectations, on the subjective outcomes of hearing aid fittings, (2) To establish a scientific basis for selection, administration, and interpretation of self-report measures of hearing aid fitting outcome, (3) To resolve the long-standing debate about the efficacy of using clinically measured loudness perception data in hearing aid prescriptions.\n\n**Clinical Trial Detailed Description:**\n\nThe long-term goal of this research program is to develop methods where by clinicians can predict both the benefit and the satisfaction that individual hearing-impaired patients will derive from amplification in daily life. The present proposal continues the research directions pursued in several cycles of previous RR&D funding from 1986 to 1996. This proposal has three primary objectives: (1) To determine the influence of extra-audiological variables, such as personality attributes and expectations, on the subjective outcomes of hearing aid fittings, (2) To establish a scientific basis for selection, administration, and interpretation of self-report measures of hearing aid fitting outcome, (3) To resolve the long-standing debate about the efficacy of using clinically measured loudness perception data in hearing aid prescriptions.\n HYPOTHESES:\n 1. Inter-subject differences in personality traits, coping style, and/or expectations account for a significant and substantial amount of the variance in hearing aid fitting outcomes, independent of hearing impairment and fitting strategy.\n 2. Prediction of hearing aid fitting outcomes will be substantially improved if the prediction model includes extra-audiological data as well as data on impairment and hearing aid.\n 3. The post-fitting time course of hearing aid fitting outcome data is different for different outcome variables.\n 4. Self-report hearing aid fitting outcomes are stable after 3 months of hearing aid use.\n 5. Fitting outcomes are optimized for individuals with unpredictable loudness perception when clinically measured loudness data are used in the hearing aid fitting protocol.\n PROCEDURES: Investigations will explore:(1)the determinants and characteristics of subjective outcome variables, and (2) the value of individual loudness data in hearing aid fitting. Subjects will be elderly men and women with bilateral sensorineural hearing loss. The work will be performed at the Memphis VAMC Hearing Aid Research Laboratory.\n Determinants and characteristics of subjective outcome variables. When self-reports are used to evaluate hearing aid fitting outcome, it is assumed that the data primarily reflect the efficacy of the hearing aid and the fitting strategy. There is a lack of information about the extent to which other variables might impact self-report data. We will explore this topic with 120 potential hearing aid wearers, followed from their initial expression of interest in amplification through the entire fitting process and for six months after the fitting. Data describing a range of pre-fitting variables as well as hearing impairment, and hearing aid fitting will be collected in a consortium of six clinical sites (including 5 VA sites) coordinated from the Memphis laboratory. The Memphis research team will complete data collection with each subject by collecting outcome data at three post-fitting intervals.\n\n**Clinical Trial Eligibility Criteria:**\n\nHearing-impaired patients\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nAnalysis of Molecular Markers of Drug Resistance in Tumor Biopsies From Previously Untreated Aggressive Non-Hodgkin's Lymphoma\n\n**Clinical Trial Summary:**\n\nAlthough the cause(s) of clinical drug resistance in non-Hodgkin's lymphomas (NHL) are unknown, in vitro studies suggest that abnormalities of the cell cycle and mechanisms of apoptosis may play an important role. Clinical studies have now shown that p53, bcl-2 and tumor proliferation all have significant effects on clinical drug resistance. To further investigate the role of genes that control the cell cycle and apoptosis, we wish to correlate the expression of multiple molecular targets [including but not restricted to bcl-2, BAX, bcl-6, MIB-1, p53, p21, p27, p16, cyclin D(1), cyclin A, cyclin E, mdm-2, cpp 32, mcl-1, EBER-1, ALK, and a panel of B, T and other cell lineage markers], involving these pathways, with clinical outcome following treatment with combination chemotherapy. All clinical data and tissue samples for this study will come from patients who have been previously enrolled on two protocols for the initial treatment of aggressive lymphomas. No new patients will be enrolled for this study.\n\n**Clinical Trial Detailed Description:**\n\nAlthough the cause(s) of clinical drug resistance in non-Hodgkin's lymphomas (NHL) are unknown, in vitro studies suggest that abnormalities of the cell cycle and mechanisms of apoptosis may play an important role. Clinical studies have now shown that p53, bcl-2 and tumor proliferation all have significant effects on clinical drug resistance. To further investigate the role of genes that control the cell cycle and apoptosis, we wish to correlate the expression of multiple molecular targets using immunohistochemistry and cDNA microarray expression profiling (including but not restricted to bcl-2, BAX, bcl-6, MIB-1, p53, p21, p27, p16, cyclin D1, cyclin A, cyclin E, mdm-2, cpp 32, mcl-1, EBER-1, ALK, and a panel of B, T and other cell lineage markers), involving these pathways, with clinical outcome following treatment with combination chemotherapy. All clinical data and tissue samples for this study will come from patients who have been previously enrolled on two protocols for the initial treatment of aggressive lymphomas. No new patients will be enrolled for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nPrior enrollment on the clinical trial of ProMACE-CytaBOM versus ProMACE-MOPP (81-C-0166) or Short Course ProMACE-CytaBOM (87-C-0180) for the treatment of previously untreated aggressive lymphomas.\n Informed consent for participation in the above clinical trials.\n Adequate biopsy material from initial biopsy and/or biopsies at relapse of disease.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nLiposomal Doxorubicin Plus Ifosfamide in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.\n PURPOSE: Phase I trial to study the effectiveness of combining liposomal doxorubicin with ifosfamide in treating patients who have advanced or metastatic soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine the maximum tolerated dose of ifosfamide in combination with doxorubicin HCl liposome in patients with previously untreated advanced or metastatic soft tissue sarcoma.\n - Determine the objective response in patients treated with this regimen.\n - Determine the dose-limiting toxicity in patients treated with this regimen.\n OUTLINE: This is a multicenter, dose-escalation study of ifosfamide.\n Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 and ifosfamide IV over 4 hours on days 1-3 OR on days 1-4 (for patients enrolled on dose level 6). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n Cohorts of 3-6 patients receive escalating doses of ifosfamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.\n Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter.\n PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically confirmed soft tissue sarcoma\n - Advanced and/or metastatic disease\n - Must be of any of the following types:\n - Malignant fibrous histiocytoma\n - Liposarcoma (excluding lipomas and well-differentiated liposarcomas)\n - Rhabdomyosarcoma\n - Synovial sarcoma\n - Malignant paraganglioma\n - Fibrosarcoma\n - Leiomyosarcoma\n - Angiosarcoma\n - Neurogenic sarcoma\n - Sarcoma not otherwise specified\n - Paraffin blocks and slides must be available\n - Measurable disease\n - Osseous lesions and pleural effusions are not considered measurable disease\n - Evidence of progressive disease within the past 6 weeks\n - The following conditions are excluded:\n - Gastrointestinal stromal tumors\n - Malignant mesothelioma\n - Chondrosarcoma\n - Neuroblastoma\n - Osteosarcoma\n - Ewing's sarcoma\n - Embryonal rhabdomyosarcoma\n - No symptomatic or known CNS metastases\n PATIENT CHARACTERISTICS:\n Age:\n - 18 to 70\n Performance status:\n - WHO 0-1\n Life expectancy:\n - Not specified\n Hematopoietic:\n - WBC at least 4,000/mm^3\n - Platelet count at least 100,000/mm^3\n Hepatic:\n - Bilirubin no greater than 1.75 mg/dL\n - Albumin at least 2.5 g/dL\n Renal:\n - Creatinine no greater than 1.4 mg/dL\n - Creatinine clearance at least 65 mL/min\n Cardiovascular:\n - Ejection fraction at least 50% by echocardiogram or isotopic methods\n - No history of cardiovascular disease\n Other:\n - No other prior or concurrent primary malignancies except adequately treated carcinoma in situ of the cervix or basal cell carcinoma\n - No other severe medical illness\n - No psychosis\n - No psychological, familial, sociological, or geographical condition that would preclude study participation\n - Not pregnant\n - Fertile patients must use effective contraception (barrier method for men) during and for 6 months after study participation\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - Not specified\n Chemotherapy:\n - No prior chemotherapy for advanced disease\n - No other concurrent systemic chemotherapy for malignancy\n Endocrine therapy:\n - Not specified\n Radiotherapy:\n - No prior radiotherapy to sole indicator lesion\n - Concurrent radiotherapy allowed except to sole indicator lesion\n Surgery:\n - Not specified\n Other:\n - No other concurrent investigational drugs\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nErlotinib in Treating Patients With Malignant Mesothelioma of the Lung\n\n**Clinical Trial Summary:**\n\nErlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. This phase II trial is studying how well erlotinib works in treating patients with malignant mesothelioma of the lung\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\n I. Determine the 1-year survival rate in patients with unresectable malignant pleural mesothelioma treated with erlotinib.\n II. Determine the response rate in patients with measurable disease treated with this drug.\n III. Determine the frequency and severity of toxic effects of this drug in these patients.\n IV. Measure epidermal growth factor receptor (EGFR) expression, EGFR gene amplification, and other activation products in the EGFR signaling pathway in tumor samples and correlate with clinical outcomes in patients treated with this drug.\n OUTLINE: This is a multicenter study.\n Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n Patients are followed every 6 months for 2 years and then annually for 1 year.\n PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 14-18 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Histologically confirmed malignant pleural mesothelioma\n - Epithelial\n - Sarcomatous\n - Biphasic\n - Measurable or nonmeasurable disease\n - Not amenable to extrapleural pneumonectomy\n - No known CNS metastases\n - Performance status - Zubrod 0-1\n - WBC at least 3,000/mm^3\n - Absolute neutrophil count at least 1,500/mm^3\n - Platelet count at least 100,000/mm^3\n - Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n - SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver involvement of tumor)\n - Creatinine no greater than 2 times ULN\n - No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation\n - No active peptic ulcer disease\n - No intractable nausea or vomiting\n - Must be able to swallow and/or receive enteral medications via gastrostomy feeding tube\n - No known history of the following:\n - Dry eye syndrome\n - Sjogren's syndrome\n - Keratoconjunctivitis sicca\n - Exposure keratopathy\n - Fuch's dystrophy\n - Other active disorders of the cornea\n - Not pregnant or nursing\n - Fertile patients must use effective contraception\n - No HIV-positive patients receiving combination antiretroviral therapy\n - No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer that is in complete remission\n - No prior biologic therapy for this tumor\n - No prior chemotherapy for this tumor\n - See Disease Characteristics\n - At least 3 weeks since prior radiotherapy and recovered\n - See Disease Characteristics\n - At least 4 weeks since prior major surgery (e.g., thoracotomy or laparotomy), excluding minor surgeries (e.g., mediastinoscopy, thoracoscopy, or minor biopsies)\n - Recovered from prior surgery\n - No prior surgical procedures affecting absorption\n - No prior investigational anticancer agents for this tumor\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nErlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme\n\n**Clinical Trial Summary:**\n\nRATIONALE: Erlotinib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.\n PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have recurrent or progressive glioblastoma multiforme.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine the response rate of patients with recurrent or progressive glioblastoma multiforme treated with erlotinib.\n - Determine the progression-free and overall survival of patients treated with this drug.\n OUTLINE: Patients receive oral erlotinib daily. Treatment continues in the absence of disease progression or unacceptable toxicity.\n Patients are followed for survival.\n PROJECTED ACCRUAL: A total of 73 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically confirmed glioblastoma multiforme\n - Radiographic evidence of recurrence or progression\n - Biopsies to confirm tumor recurrence allowed if a sufficent percentage of cases are confirmed to be recurrent tumor\n - Previously treated with optimal radiotherapy and at least 1 cytotoxic chemotherapy regimen\n PATIENT CHARACTERISTICS:\n Age\n - 18 and over\n Performance status\n - Not specified\n Life expectancy\n - Not specified\n Hematopoietic\n - Absolute neutrophil count at least 1,500/mm^3\n - Platelet count at least 100,000/mm^3\n Hepatic\n - Bilirubin no greater than 2 times normal\n - Alkaline phosphatase no greater than 2 times normal\n - ALT no greater than 3 times normal\n Renal\n - BUN no greater than 1.5 times normal OR\n - Creatinine no greater than 1.5 times normal\n Other\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective contraception\n - No medical condition that would interfere with oral administration of erlotinib\n - No other medical or psychiatric illness that would preclude study therapy\n - No active infection\n - No other malignancy within the past 3 years except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer\n PRIOR CONCURRENT THERAPY:\n Biologic therapy\n - No concurrent immunotherapy for brain cancer\n - No concurrent biologic therapy for brain cancer\n Chemotherapy\n - See Disease Characteristics\n - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered\n - No concurrent chemotherapy for brain cancer\n Endocrine therapy\n - Concurrent glucocorticosteroids allowed\n - No concurrent hormonal therapy for brain cancer\n Radiotherapy\n - See Disease Characteristics\n Surgery\n - Not specified\n Other\n - No prior epidermal growth factor receptor (EGFR) inhibitor\n - No concurrent EGFR inhibitor\n - No other concurrent antineoplastic therapy\n - No concurrent anti-epileptic agents other than modest- or non-enzyme-inducing drugs such as the following:\n - Gabapentin\n - Lamotrigine\n - Divalproex\n - Felbamate\n - Levetiracetam\n - Tiagabine\n - Topiramate\n - Zonisamide\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma.\n\n**Clinical Trial Detailed Description:**\n\nThis is an open-label (patients will know the names of the study drugs they receive), randomized (patients will be assigned by chance to receive 1 of 2 treatment schedules with trabectidin) study designed to examine the the survival, safety, and pharmacokinetics (blood levels) trabectedin when administered to patients with 2 types of cancer (Liposarcoma or Leiomyosarcoma) who have received treatment with other anti-cancer therapy (Anthracycline and/or Ifosfamide). Trabectedin (also referred to as Yondelis) is a drug being developed to treat patients with cancer. Yondelis will be administered intravenously (i.v.) via a central catheter (tube) into a central vein once a week (0.58 mg/m2 as a 3-hour infusion on Days 1, 8, and 15 of each 28-day treatment cycle) or once every 3 weeks (1.5 mg/m2 administered as a 24-hour infusion on Day 1 of every 21-day treatment cycle) until disease progression. Patients in each arm will be pretreated with 20 mg of dexamethasone i.v. 30 minutes prior to each infusion.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Have advanced liposarcoma or leiomyosarcoma that has metastasized (spread)\n - Have a pathology specimen available for centralized review\n - Have progressive or relapsed (reappearance of) disease, received treatment with anthracycline and/or ifosfamide before enrollment in study, and have at least one measurable tumor lesion\n - Have adequate bone marrow, liver and kidney function\n - Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n Exclusion Criteria:\n - Previous exposure to Yondelis i.v. formulation, ET-743 (ecteinascidin)\n - Cancer that has metastasized (spread) to the central nervous system\n - Active viral hepatitis or chronic liver disease\n - Unstable cardiac (heart) condition including congestive heart failure or angina pectoris (heart pain), myocardial infarction (heart attack) within 1 year before enrollment\n - History of another neoplastic (malignant or nonmalignant tumor) disease (except basal cell carcinoma or cervical carcinoma adequately treated), unless in remission for 5 years or more before enrollment\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nDoxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy such as doxorubicin and ifosfamide use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors, such as pegfilgrastim, cause the body to make blood cells. It is not yet known whether doxorubicin alone is more effective with or without ifosfamide and pegfilgrastim in treating soft tissue sarcoma.\n PURPOSE: This randomized phase III trial is studying giving doxorubicin alone to see how well it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in treating patients with locally advanced or metastatic soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Compare the progression-free and overall survival of patients with locally advanced or metastatic soft tissue sarcoma treated with doxorubicin with vs without ifosfamide and pegfilgrastim as first-line therapy.\n - Compare the response in patients treated with these regimens.\n - Compare the treatment-related mortality of patients treated with these regimens.\n - Compare the toxicity of these regimens in these patients.\n OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to WHO performance status (0 vs 1), age group (less than 50 years of age vs 50 years of age and over), presence of liver metastases (yes vs no), histological grade (2 vs 3), and participating center. Patients are randomized to 1 of 2 treatment arms.\n - Arm I: Patients receive doxorubicin IV on day 1 (or IV continuously on days 1-3).\n - Arm II: Patients receive doxorubicin IV on days 1-3 and ifosfamide IV over 4 hours on days 1-4. Patients also receive pegfilgrastim subcutaneously on day 5.\n In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter.\n PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically confirmed soft tissue sarcoma\n - Locally advanced unresectable* OR metastatic disease\n - High-grade (grade 2-3) disease according to the FNLCC grading system NOTE: *Disease that could prove resectable (including pulmonary metastasectomy) after a response to chemotherapy is allowed\n - The following tumor types are eligible:\n - Malignant fibrous histiocytoma\n - Myxoid and round cell liposarcoma, pleomorphic liposarcoma, or dedifferentiated liposarcoma\n - Pleomorphic rhabdomyosarcoma\n - Synovial sarcoma\n - Myxofibrosarcoma, intermediate and high-grade\n - Fibrosarcoma\n - Leiomyosarcoma\n - Angiosarcoma\n - Malignant peripheral nerve sheath tumor\n - Epithelioid sarcoma\n - Alveolar rhabdomyosarcoma\n - Unclassifiable sarcoma, not otherwise specified\n - The following tumor types are not eligible:\n - Gastrointestinal stromal tumor\n - Mixed mesodermal tumor\n - Chondrosarcoma\n - Malignant mesothelioma\n - Neuroblastoma\n - Osteosarcoma\n - Ewing's sarcoma/primitive neuroectodermal tumor\n - Desmoplastic small round cell tumor\n - Embryonal rhabdomyosarcoma\n - Alveolar soft part sarcoma\n - Must have a measurable lesion with clinical evidence of progression within the past 6 weeks\n - Osseous lesions and pleural effusions are not considered measurable\n - No known or symptomatic CNS metastases\n PATIENT CHARACTERISTICS:\n Age\n - 18 to 60\n Performance status\n - WHO 0-1\n Life expectancy\n - Not specified\n Hematopoietic\n - Absolute neutrophil count at least 2,000/mm^3\n - Platelet count at least 100,000/mm^3\n Hepatic\n - Bilirubin no greater than 1.8 mg/dL\n - Albumin at least 2.5 g/dL\n Renal\n - Creatinine no greater than 1.4 mg/dL OR\n - Creatinine clearance greater than 65 mL/min\n Cardiovascular\n - No history of cardiovascular disease\n Other\n - Not pregnant\n - Negative pregnancy test\n - Fertile patients must use effective contraception\n - No other severe medical illness\n - No psychosis\n - No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or basal cell skin cancer\n - No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up schedule\n PRIOR CONCURRENT THERAPY:\n Biologic therapy\n - Not specified\n Chemotherapy\n - No prior chemotherapy for advanced or metastatic disease\n - Prior adjuvant chemotherapy allowed provided there was no disease progression within 6 months after completion of treatment\n Endocrine therapy\n - Not specified\n Radiotherapy\n - No prior radiotherapy to the sole index lesion\n Surgery\n - Not specified\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nVaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor\n\n**Clinical Trial Summary:**\n\nRATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may cause a stronger immune response and kill more tumor cells.\n PURPOSE: This phase I trial is studying the side effects of vaccine therapy when given together with sargramostim in treating patients with advanced sarcoma or brain tumor.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine the feasibility of treatment with telomerase: 540-548 peptide vaccine and sargramostim (GM-CSF) in patients with sarcoma or brain tumor.\n - Determine the safety and tolerability of this regimen in these patients.\n - Determine the frequency of T-cell specific vaccine antigens during and after administration of this regimen in these patients.\n - Determine, preliminarily, the clinical response, if any, of patients treated with this regimen.\n OUTLINE: Patients receive telomerase: 540-548 peptide vaccine subcutaneously (SC) on day 3 and sargramostim (GM-CSF) SC on days 1-4 of weeks 1, 3, 5, 7, 9, 11, 15, 19, and 23.\n PROJECTED ACCRUAL: A total of 35 patients (20 adult and 15 pediatric) will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically or cytologically confirmed diagnosis of 1 of the following malignancies:\n - Stage III or IV sarcoma, including:\n - Leiomyosarcoma\n - Synovial cell sarcoma\n - Liposarcoma\n - Gastrointestinal stromal tumor\n - Brain tumor, including:\n - Diffuse pontine glioma*\n - Glioblastoma multiforme\n - Glialsarcoma NOTE: *For patients with diffuse pontine glioma, the requirement for histologic verification may be waived\n - No known curative therapy\n - HLA A*0201 positive by genotyping\n PATIENT CHARACTERISTICS:\n Age\n - Over 2\n Performance status\n - Karnofsky 60-100% (patients over age 16)\n - Lansky 60-100% (patients under age 16)\n Life expectancy\n - Not specified\n Hematopoietic\n - WBC greater than 3,000/mm^3\n - Absolute neutrophil count greater than 1,500/mm^3\n - Platelet count greater than 100,000/mm^3\n Hepatic\n - AST and ALT less than 2.5 times upper limit of normal (ULN)\n - Bilirubin less than 1.5 times ULN\n Renal\n - Creatinine less than 1.5 times ULN\n Cardiovascular\n - No clinically significant cardiovascular disease\n Pulmonary\n - No clinically significant pulmonary disease\n PRIOR CONCURRENT THERAPY:\n Biologic therapy\n - No prior hematopoietic stem cell transplantation\n - No other concurrent vaccine therapy\n - No other concurrent immunotherapy\n Chemotherapy\n - No prior chemotherapy\n - No concurrent chemotherapy\n Endocrine therapy\n - Concurrent dexamethasone allowed provided patient has been on a decreasing dose for the past 2 weeks and the current dose is the lowest clinically acceptable dose (ideally, less than 9-12 mg/day)\n Radiotherapy\n - No prior extensive-field radiotherapy that would compromise bone marrow function\n - At least 2 weeks since prior local radiotherapy\n Surgery\n - At least 2 weeks since prior surgery\n Other\n - At least 2 weeks since prior imatinib mesylate\n - No concurrent local anesthetic to administration site of vaccine\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nMonoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Monoclonal antibodies, such as monoclonal antibody 3F8, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Combining monoclonal antibody 3F8 with sargramostim may cause a stronger immune response and kill more tumor cells.\n PURPOSE: Phase II trial to study the effectiveness of combining monoclonal antibody 3F8 with sargramostim in treating patients who have neuroblastoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine the efficacy of sargramostim (GM-CSF) in enhancing monoclonal antibody 3F8-mediated ablation in patients with high-risk neuroblastoma.\n - Determine the prognostic impact of minimal residual bone marrow disease on relapse-free survival of patients treated with this regimen.\n - Compare the effects of short-term (2-hour intravenous) vs prolonged (subcutaneous release) daily GM-CSF on granulocyte activation, in order to establish the optimal route for tumor-cell kill in these patients.\n OUTLINE: This is an open-label study. Patients are stratified according to evaluable disease (yes [primary refractory bone marrow disease] vs no [no evidence of disease]).\n Patients receive sargramostim (GM-CSF) subcutaneously on days -5 to 4 and monoclonal antibody 3F8 IV over 0.5-1.5 hours on days 0-4. Treatment repeats every 3 weeks for 4 courses and then every 8 weeks for up to a total of 24 months in the absence of disease progression or unacceptable toxicity.\n Beginning after 2 courses of GM-CSF and monoclonal antibody 3F8, patients also receive oral isotretinoin twice daily on days 1-14 (when no monoclonal antibody 3F8 is administered). Treatment with isotretinoin repeats approximately every 28 days for 6 courses.\n PROJECTED ACCRUAL: A total of 340 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Diagnosis of neuroblastoma by histopathology OR bone marrow metastases and high urine catecholamine levels\n - Disease must meet risk-related treatment guidelines and any of the following International Neuroblastoma Staging System stages:\n - Stage 4 with (any age) OR without (> 18 months of age of age) MYCN amplification\n - MYCN-amplified other than stage 1\n - No evidence of disease (i.e., in complete response/remission or very good partial response/remission) OR disease resistant to standard therapy (i.e., incomplete response in bone marrow)\n - No progressive disease or MIBG-avid soft tissue tumor\n PATIENT CHARACTERISTICS:\n - No existing renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity ≥ grade 3\n - No human anti-mouse antibody (HAMA) titer greater than 1,000 Elisa units/mL\n - No history of allergy to mouse proteins\n - No active life-threatening infection\n - Not pregnant\n - Negative pregnancy test\n PRIOR CONCURRENT THERAPY:\n - Not specified\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nGefitinib in Treating Patients With Progressive Metastatic Neuroendocrine Tumors\n\n**Clinical Trial Summary:**\n\nThis phase II trial is studying how well gefitinib works in treating patients with progressive metastatic neuroendocrine tumors. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\n I. To determine the 6 month progression free survival rate in patients with progressive, advanced neuroendocrine tumors treated with ZD1839.\n SECONDARY OBJECTIVES:\n I. Objective tumor response rate. II. Progression free survival and time to progression. III. Improvement in circulating hormone levels. IV. Overall survival V. We will explore the molecular characterization of these tumors in attempt to understand the role of EGFR expression and its inhibition with ZD1839 in neuroendocrine tumors. The measurements will be performed on pretreatment and post-treatment tumor biopsies when possible: EGFR expression and gene amplification (IHC for EGFR and phosphorylated EGFR, ISH for gene amplification); Activation of the Ras/Raf/MAPK pathway (IHC for phosphorylated MAPK); Cell proliferation (Ki-67 staining); Apoptosis (TUNEL assay).\n OUTLINE: This is a multicenter study. Patients are stratified according to disease type (carcinoid vs islet cell and other neuroendocrine tumors).\n Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n Patients are followed every 3 months until disease progression and then every 6 months for up to 2 years from study entry.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Histologically confirmed metastatic neuroendocrine neoplasms or histologic confirmation of primary neuroendocrine tumor with clear clinical evidence of metastases\n - Measurable disease\n - Radiographic evidence of disease progression, following any prior systemic therapy, chemoembolization, embolization, or observation; for eligibility purposes, disease progression will be defined as follows:\n - Either of the following documented by comparison of the on-study radiographic assessment with a prior assessment of the same type performed within the previous 60 calendar weeks:\n - Appearance of a new lesion\n - At least 20% increase in the longest diameter (LD) of any previously documented lesion or an increase in the sum of the LDs of multiple lesions in aggregate of 20%\n - ≥4 weeks from the completion of major surgery, chemotherapy or other systemic therapy and hepatic artery embolization/chemoembolization to study registration\n - ≥3 weeks from the completion of radiation therapy to study registration\n - Recovered sufficiently from side effects of prior therapy\n - Absolute neutrophil count (ANC) ≥ 1000/mm3\n - PLT ≥ 75,000/ mm3\n - Hgb ≥ 8.0 g/dL\n - Total bilirubin ≤ 2 x upper normal limit (UNL)\n - Alkaline phosphatase ≤ 3 x UNL (5 x UNL if liver metastases present)\n - AST ≤ 3 x UNL (≤ 5 x UNL if liver metastases present)\n - Creatinine ≤ 1.5 x UNL\n - ECOG performance score (ps) ≤ 2\n - Life expectancy ≥ 24 weeks\n - Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent\n Exclusion Criteria:\n - Thyroid carcinoma of any histology or pheochromocytoma/paraganglioma\n - Any of the following as this regimen may be harmful to a developing fetus or nursing child:\n - Pregnant women\n - Breastfeeding women\n - Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)\n - NOTE: The effects of the agent(s) on the developing human fetus at the recommended therapeutic dose are unknown\n - Anaplastic or high-grade histology\n - Any of the following prior therapies:\n - > 1 prior systemic chemotherapy regimen (chemoembolization not counted as systemic chemotherapy)\n - Prior EGFR targeted regimen (e.g. OSI-774, EKB-569, ZD1839)\n - < 4 weeks from last Interferon injection\n - < 2 weeks from last octreatide short acting injection or < 6 weeks long acting injection; Note: concurrent octreatide allowed if stable dose has been administered for ≥1 month, there is documented tumor progression on the current dose, and there is no current plan for increasing dose • Other concurrent treatment considered investigational\n - Concurrent chemotherapy or radiation therapy\n - Any of the following:\n - Gastrointestinal tract disease resulting in an inability to take oral medication (e.g. dysphagia or inability to swallow capsules intact).\n - Requirement for IV alimentation\n - Prior procedures clearly adversely affecting intestinal absorption\n - Active peptic ulcer disease\n - Failure to fully recover from adverse effects of prior therapies regardless of interval since last treatment\n - Known abnormality of cornea, such as:\n - History of dry eye syndrome or Sjogren syndrome\n - Congenital abnormality\n - Abnormal slit-lamp examination using a vital dye (e.g.: fluorescein or Bengal-rose)\n - Abnormal corneal sensitivity test (Schirmer test)\n - Uncontrolled intercurrent illness including, but not limited to:\n - Ongoing or active infection\n - Symptoms of congestive heart failure\n - Unstable angina pectoris, cardiac arrhythmia\n - Psychiatric illness/social situation that would limit compliance with study requirement\n - Known brain metastases; Note: These patients are 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 - Known HIV-positive patients receiving combination anti-retroviral therapy; Note: These patients are excluded from the study because of possible pharmacokinetic interactions with ZD1839 and because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination and anti-retroviral therapy when indicated\n - Concurrent or recent use (≤ 7 days prior to ZD1839 administration) of phenytoin, carbamazepine, barbiturates, rifampicin, oxcarbazepine, rifapentine, modafinil, or St. John's Wort; Note: Because these drugs induce CYP3A4 enzymes and can cause reductions in ZD1839 plasma concentrations below levels thought to be biologically active, patients with concurrent or recent use of these drugs are excluded from the study\n - History of other invasive malignancy ≤ the previous 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nRadiolabeled Monoclonal Antibody Therapy in Treating Patients With Refractory, Recurrent, or Advanced CNS or Leptomeningeal Cancer\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to find a safe dose of a new medicine called antibody 8H9. Antibodies are made by the body to fight infections and in some cases, to fight tumors. The antibody 8H9 is made by mice and can attack many kinds of tumors. 8H9 antibody can have a dose of radiation attached to it called 131-I. 131I-8H9 has been given in the vein to patients to find cancer cells. This is the first study using 131I-8H9 in the fluid in the spine to kill cancer cells. 131-I is a beta emitting isotope used extensively for radiation targeted therapies.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nSubject Inclusion Criteria:\n - Patients must have a histologically confirmed diagnosis of a malignancy known to be 8H9 reactive. 8H9 expression must be confirmed by immunohistochemical staining of tumor and assessed by the Department of Pathology or by immunofluorescence of bone marrow except for patients confirmed to have neuroblastoma.\n - Patients must have CNS/ leptomeningeal disease which is refractory to conventional therapies or for which no conventional therapy exists OR a recurrent brain tumors with a predilection for leptomeningeal dissemination (medulloblastoma, PNET, rhabdoid tumor).\n - Patients must have no rapidly progressing or deteriorating neurologic examination.\n - Patients must have an absolute neutrophil count (ANC) > 1000/ul and a platelet count > 50,000/ul.\n - Patients may have active malignancy outside the central nervous system.\n - Both pediatric and adult patients of any age are eligible.\n - Patients or a legal guardian will sign an informed consent form approved by the IRB and obtained by the Principal or a Co- Investigator before patient entry. Minors will provide assent.\n - Patients with stored stem cells will be treated at the escalating dose while patients with no stem cells will be treated at the 50 mCi dose. Neuroblastoma patients can be treated at the 50 mCi dose with or without stored stem cells.\n Subject Exclusion Criteria:\n - Patients with obstructive or symptomatic communicating hydrocephalus.\n - Patients with an uncontrolled life-threatening infection.\n - Patients who are pregnant: Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is required during the study period.\n - Patients who have received cranial or spinal irradiation less than 3 weeks prior to the start of this protocol.\n - Patients who have received systemic chemotherapy (corticosteroids not included) less than 3 weeks prior to the start of this protocol.\n - Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity should all be less than grade 2. Patients with stable neurological deficits (because of their brain tumor) are not excluded. Patients with <= 3 hearing loss are not excluded.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nBiological Therapy in Treating Patients With Neuroblastoma That Has Not Responded to Previous Treatment\n\n**Clinical Trial Summary:**\n\nRATIONALE: Monoclonal antibodies, such as monoclonal antibody 3F8, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Beta-glucan, isotretinoin, and sargramostim may increase the effectiveness of monoclonal antibody 3F8 by making tumor cells more sensitive to the monoclonal antibody. Combining different types of biological therapy may kill more tumor cells.\n PURPOSE: This phase II trial is studying how well giving beta-glucan, isotretinoin, and sargramostim together with monoclonal antibody 3F8 works in treating patients with neuroblastoma that has not responded to previous treatment.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine the efficacy of beta-glucan, isotretinoin, and sargramostim (GM-CSF) in enhancing monoclonal antibody 3F8-mediated ablation in patients with high-risk refractory neuroblastoma.\n - Determine the antitumor activity of this regimen, in terms of assessing disease status in the bone marrow by real-time quantitative reverse transcription polymerase chain reaction, in these patients.\n - Determine the toxicity of this regimen in these patients.\n OUTLINE: This is an open-label study. Patients are stratified according to refractory disease (primary refractory [never had disease progression or disease recurrence] vs secondary refractory [recurrent disease that did not respond completely to reinduction therapy]).\n - Courses 1 and 2: Patients receive sargramostim (GM-CSF) subcutaneously once daily on days -5 to 11. Patients also receive oral beta-glucan once daily on days -2 to 11 and monoclonal antibody (MOAB) 3F8 IV over 30-90 minutes on days 0-4 and 7-11.\n - Courses 3 and 4: Patients receive GM-CSF, beta-glucan, and MOAB 3F8 as above. Patients also receive oral isotretinoin twice daily on days -2 to 11.\n Treatment repeats every 2-4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.\n Patients are followed every 3 months for 2 years.\n PROJECTED ACCRUAL: A total of 27-74 patients (10-33 for stratum 1 and 17-41 for stratum 2) will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Diagnosis of neuroblastoma, as defined by 1 of the following:\n - Histologically confirmed disease\n - Bone marrow metastases plus high urine catecholamines\n - High-risk disease meeting 1 of the following stage criteria:\n - Stage IV, with 1 of the following:\n - Any age with MYCN amplification\n - > 18 months of age without MYCN amplification\n - Stage III, with both of the following:\n - Any age with MYCN amplification\n - Unresectable disease\n - Stage 4S with MYCN amplification\n - Measurable or evaluable soft tissue disease\n - Relapsed disease resistant to standard induction chemotherapy and salvage therapy\n PATIENT CHARACTERISTICS:\n Age\n - Any age\n Performance status\n - Not specified\n Life expectancy\n - Not specified\n Hematopoietic\n - Not specified\n Hepatic\n - No severe hepatic toxicity ≥ grade 3\n Renal\n - No severe renal toxicity ≥ grade 3\n Cardiovascular\n - No severe cardiac toxicity ≥ grade 3\n Pulmonary\n - No severe pulmonary toxicity ≥ grade 3\n Other\n - Not pregnant\n - Negative pregnancy test\n - No severe neurologic toxicity ≥ grade 3\n - No severe gastrointestinal toxicity ≥ grade 3\n - No other severe major organ dysfunction except ototoxicity\n - No history of allergy to mouse proteins\n - No active life-threatening infection\n - No human anti-mouse antibody titer > 1,000 ELISA units/mL\n PRIOR CONCURRENT THERAPY:\n Biologic therapy\n - Not specified\n Chemotherapy\n - See Disease Characteristics\n Endocrine therapy\n - Not specified\n Radiotherapy\n - Not specified\n Surgery\n - Not specified\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nStudy of AP23573/MK-8669 (Ridaforolimus), A Mammalian Target of Rapamycin (mTOR) Inhibitor, in Participants With Advanced Sarcoma (MK-8669-018 AM1)(COMPLETED)\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to assess the efficacy of ridaforolimus when administered once daily for 5 consecutive days (QDx5) every two weeks in participants with advanced sarcoma.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patients ≥15 years of age with metastatic and/or unresectable sarcomas of the following histological subgroups: Bone sarcomas, such as osteosarcoma and Ewings sarcoma; Leiomyosarcoma; Liposarcomas; Any other soft tissue sarcoma except gastrointestinal stromal tumors (GIST). Patients with well-differentiated liposarcoma or desmoid tumors must have demonstrated progressive disease within the previous 6 months\n - Presence of at least one measurable lesion that: Can be accurately measured in at least one dimension with longest diameter ≥20 mm using conventional techniques or ≥10 mm with spiral computerized tomography (CT) scan (or otherwise at least twice the reconstruction interval for CT or magnetic resonance imaging [MRI] scans)\n - Eastern Cooperative Oncology Group (ECOG) performance status ≤1\n - Minimum life expectancy of 3 months\n - Adequate renal and hepatic function, as specified in the protocol\n - Adequate bone marrow function, as specified in the protocol\n - Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL\n - Male and female patients who are not surgically sterile or postmenopausal must agree to use reliable methods of birth control for the duration of the study until 30 days after the last dose of study drug\n - Able to understand and give written informed consent\n Exclusion Criteria:\n - Women who are pregnant or lactating\n - Presence of brain metastases\n - Prior therapy with rapamycin, rapamycin analogues or tacrolimus\n - Prior anticancer treatment (chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifiers, signal transduction inhibitors, etc) within 4 weeks prior to the first dose of ridaforolimus\n - Ongoing toxicity associated with prior anticancer therapy (except peripheral neuropathy of ≤ grade 1 by National Cancer Institute (NCI) toxicity criteria)\n - Another primary malignancy within the past three years (except for non-melanoma skin cancer and cervical carcinoma in situ)\n - Known or suspected hypersensitivity to drugs formulated with polysorbate 80 (Tween) or any other excipient contained in the study drug\n - Known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin)\n - Significant uncontrolled cardiovascular disease\n - Active infection requiring systemic therapy\n - Known human immunodeficiency virus (HIV) infection\n - Treatment with any investigational agent within 4 weeks prior to the first dose of ridaforolimus\n - Concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for 2 weeks prior to first planned dose of study drug\n - Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of ridaforolimus\n - Presence of any other life-threatening illness or organ system dysfunction which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluating the safety of the study drug\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nThe purpose of the study is to determine the dose of the combination of trabectedin (Yondelis) and Doxorubicin for which neutropenia (low white blood cell counts) could be managed with filgrastim (a Granulocyte-Colony Stimulation Factor that is used to help control neutropenia) in patients with a type of cancer called soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nThis is a multicenter, open-label (identity of the assigned study treatments will be known to patients and study staff) study to determine the dose of the combination of trabectedin (Yondelis) and Doxorubicin for which the neutropenia (low white blood cell counts) is manageable with the use of filgrastim (an agent used to manage neutropenia) and associated with clinically acceptable number of side effects severe enough to continuation of treatment in patients with recurrent or persistent soft tissue sarcoma (STS, a malignant tumor that attacks the body's infrastructure of fat, muscles, nerves, joints, blood vessels, or deep skin tissues). Patients will be enrolled in the study after all study-specific entry criteria are met and informed consent is obtained. Patients will be required to attend regular clinic visits to receive study medication and have their status monitored. A detailed explanation can be provided by the study physician (Investigator) conducting this study. Doxorubicin (50 to 75 mg/m2) will be given as a 10-15 minute intravenous (i.v.) infusion on Day 1 via a central venous catheter which is a tube placed into a large vein. Trabectedin (0.9 to 1.3 mg/m2) will be given as a 3 hour i.v. infusion, immediately following the administration of doxorubicin. Dexamethasone 20 mg will be given within 1 hour before the start of each doxorubicin i.v. infusion and filgrastim will be administered according to manufacturer's instructions.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Have a diagnosis of soft tissue sarcoma, recurrent or persistent\n - Signed informed consent obtained for all patients before performing any study-related procedures\n Exclusion Criteria:\n - Patients treated with more than 1 prior chemotherapy regimen (including adjuvant (or other additional) therapy)\n - Previous exposure to anthracyclines (a class of drugs used in cancer chemotherapy, example is Doxorubicin) or trabectedin\n - Less than 4 weeks since radiation therapy\n - Known metastases (spread) of cancer to the central nervous system\n - Other ongoing serious illness present at the time of enrollment as determined by the Investigator\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nTreatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients With Rabeprazole\n\n**Clinical Trial Summary:**\n\nThe primary objective of this study is to collect safety information on rabeprazole 10 mg and 20 mg in the treatment of gastroesophageal reflux disease (GERD) in children aged 12 to 16 years. The secondary objectives are to assess the efficacy of rabeprazole on the improvement of the symptoms of GERD and to explore the relationship of symptom relief to dose received, based on symptom frequency and severity, antacid use, and quality of life (QOL) measures.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Males and females aged 12 to 16 years with a clinical diagnosis of symptomatic GERD or suspected or endoscopically proven GERD.\n 2. Patients who have ever been treated with, or are currently receiving proton pump inhibitors (PPIs),histamine receptor (H2) blockers, or antacids are eligible (as long as they can go off PPIs and H2 blockers for three days prior to dosing, except for cimetidine, which must be discontinued for at least seven days prior to dosing; exclusion criteria 5 and 6). Also, patients should be able to go off PPI therapy for two weeks at the end active drug treatment.\n 3. Children with stable asthma/reactive airways disease on stable treatment regimens are eligible.\n 4. Children on stable doses of allergy, antiepileptic, antidepressant, and attention deficit disorder medicines are eligible.\n 5. Patients must be able and willing to swallow the test drug tablet intact. The ability of the child to swallow an intact tablet must be confirmed by the site at Screening.\n 6. The patient is willing and able to give assent to participate.\n 7. The patient's parent or guardian gives written informed consent.\n 8. Post-pubertal females will be required to be abstinent during the course of the study.\n 9. Clinically insignificant laboratory findings.\n Exclusion Criteria:\n 1. Evidence of significant hepatic, renal, respiratory, endocrine, immune, infectious, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities that would interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study.\n 2. History of primary esophageal motility disorders or systemic condition affecting the esophagus (eg, scleroderma, esophageal infections).\n 3. History of eosinophilic esophagitis, persistent milk protein allergy, or allergic gastroenteropathy. History or current presence of peptic ulcers; current presence of Helicobacter pylori.\n 4. History of definitive acid-lowering surgery, previous esophageal surgery, or esophageal stricture is disallowed. History of fundoplication or feeding tube insertion is allowed.\n 5. Treatment with full therapeutic doses of H2-receptor antagonists or sucralfate within three days prior to dosing (or a shorter washout if agreed to by Investigator and Sponsor), except for cimetidine, which must be discontinued for at least seven days prior to dosing.\n 6. Treatment with a proton pump inhibitor within three days prior to dosing (or a shorter washout if agreed to by Investigator and Sponsor).\n 7. Inability to have 2-week PPI therapy-free period at end of active drug treatment.\n 8. Pregnancy or lactation.\n 9. Known or suspected drug addiction or alcohol abuse and/or a positive urine drug screen not explained by medication list; occasional alcohol or tobacco use is not an exclusion criterion.\n 10. Unwilling or unable to abide by the requirements of the study or violating the prohibitions and restrictions of the study defined in Section 9.4.\n 11. Any condition which would make the patient, in the opinion of the Investigator or Sponsor, unsuitable for the study.\n 12. Participation in another investigational drug study within one month prior to dosing.\n 13. A history of allergy/sensitivity to proton pump inhibitors or to their inactive ingredients.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nAn Analysis of the Response of Human Tumor Microvascular Endothelium to Ionizing Radiation\n\n**Clinical Trial Summary:**\n\nDoctors will take some tissue from the tissue removed during surgery in order to study how the blood vessels of the tumor respond to radiation therapy. The tissue obtained will be used to determine how these tumor blood vessels respond to radiation therapy delivered to the tumor, after it has been removed. This radiation is delivered in the research lab. This research is being conducted in order to develop new methods to treat tumors by radiation therapy. No additional surgery will be performed to obtain these samples, and only materials that remain after all diagnostic testing has been completed will be used.\n\n**Clinical Trial Detailed Description:**\n\nThe goal of this study is to determine if concepts established in mouse models of the tumor microvascular response to ionizing radiation (IR) therapy are applicable to human tumors in order to begin to establish that the engagement of the endothelial response is a valid target for IR in human tumors. A portion of tumor will be isolated from individuals who have signed informed consent for this protocol and are undergoing surgery on the Neurosurgery, Colorectal, and Gynecology, Head and Neck, Urology, and Hepatobiliary Services at Memorial Sloan-Kettering Cancer Center. Tumor tissue will be obtained from the surgical sample in pathology after adequate specimens have been obtained for diagnostic purposes. Tumor tissue will be irradiated ex vivo and the microvascular endothelial response will be determined. From specimens of adequate size, a pure tumor endothelial cell population will be isolated and the response to IR will be determined.\n Primary Outcomes:\n - To determine if human tumor microvascular endothelium displays similar dose parameters as mouse tumor endothelium.\n Secondary Outcomes:\n - To determine if tumor endothelium isolated to near homogeneity demonstrates dose parameters similar to those used in single dose radiotherapy of brain tumors.\n - To determine if the microvascular endothelium of tumors of different types behaves in a similar fashion in its response to IR.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patients who are felt to have adequate tumor volume for these studies, at least a 2 x 2 x 2 cm3 tumor by physical exam, imaging studies or colonoscopy reports\n - Primary or recurrent tumors are eligible\n - Patients must be suitable candidates for surgery\n - Patients who have signed the informed consent\n Exclusion Criteria:\n - Patients who are not considered suitable candidates for surgery\n - Patients who have received prior radiation therapy to the tumor being removed\n - Patients who have received chemotherapy within 6 months of tumor removal\n - Patients who are pregnant\n - Patients may choose to be excluded at any time\n - Minors are excluded from this study because there are expected to be very few minors with the tumor types which the investigators are evaluating in this study\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Study Of Oral Palbociclib (PD-0332991), A Cyclin-Dependent Kinase Inhibitor, In Patients With Advanced Cancer\n\n**Clinical Trial Summary:**\n\nPD-0332991 may work in cancer by stopping cancer cells from multiplying. PD-0332991 is in a new class of drugs called cyclin-dependent kinase (CDK inhibitors). This research study is the first time that PD-0332991 will be given to people. PD-0332991 is taken by mouth daily.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Advanced solid tumors (excluding SCLC and retinoblastoma) or follicular of diffuse large cell non-Hodgkin's lymphoma, histologically or cytologically proven at diagnosis which is refractory to or intolerant of established therapy know to provide clinical benefit for their condition; tumors must express Rb\n - Adequate blood cell counts, kidney function and liver function and and ECOG score of 0, 1, or 2.\n - Patients may have to have tumor biopsy before and after treatment.\n Exclusion Criteria:\n - Prior stem cell or bone marrow transplant\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\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nImmunologic Factors in Reflux Esophagitis and Barrett’s Esophagus\n\n**Clinical Trial Summary:**\n\nBy using combination of the expression of COX-2 and NOS and immunologic reaction in the esophagus with manometry of LES and cruel diaphragm and 24 hr esophageal pH monitoring to investigate the mechanisms and to make a new and more clinically applicable clarification of these reflux diseases will be valuable in the clinical management and prevention. We will perform the following works and complete the objectives: 1) comparing the difference of immuno-inflammatory reactions among NERD, reflux esophagitis and Barrett’s esophagus; 2) the different expression of PGs & COX-2 in functional heartburn, hiatus hernia, NERD, reflux disease and Barrett’s esophagus; determining the subtype of EP receptor (EP1~4); 3) determining and comparing the expression of NOS in the esophagus; 4) investigating the role of ROS in the esophagus; 5) in correlating cytokine, COX-2 and NOS with LESP, TLESR, diaphragm EMG and 24-hour esophageal pH ; 6) the difference of expression of cytokine, atrophic gastritis and Hp in gastric mucosa, in correlating with intragastric acid status, among functional heartburn, hiatus hernia, NERD, erosive esophagitis and Barrett’s esophagus; to determine whether should eradicate Hp in reflux esophageal disease; 7) the effects of lipid peroxidation related immunologic reaction, with relation to COX-2 and NOS, in the inflammatory activity and esophageal carcinogenesis of esophagus; 8) the effects of cytokines, COX-2 and NOS on the apoptosis in these reflux esophageal diseases; 9) integrating immuno-inflamatory reaction, COX-2, NOS with manometry of LES and diaphragm, and 24-hour pH monitoring and intragastric pH to newly clarify GERD into evidence based categories.\n\n**Clinical Trial Detailed Description:**\n\nIt has been commonly accepted that there is considerable geographic variation in the prevalence of gastroesophageal reflux disease (GERD) and much less prevalent in Asia. However, a tendency of increasing the prevalence of GERD has been observed in Taiwan with four folds of growth (attached 1 & 2), Japan and Singapore. GERD is a chronic, relapsing disease, causing a poor quality of life lower than that of CAD and a greater burden with exhausting socioeconomic and medical resource much higher than peptic ulcer disease. Thus, thoroughly elucidating the mechanisms of GERD, in combination of basic science and clinical characteristics, to well and correctly clarify these diseases will be greatly helpful in clinical application.\n Reflux of duodenal contents is believed to contribute to esophageal injury, Barrett’s esophagus and esophageal cancer. HCL and bile acid, particularly conjugated form at low pH, has now been considered playing a more important pathogenetic role in the reflux esophagitis; on the contrary, low gastric acid status may increase the risk of dysplasia and carcinogenesis on Barrett’s esophagus due to increased pulse of bile acid. While, only limited reports focusing immune mechanism in the complex populations of GERD. In few preliminary literatures showed that cytokine and tumor necrosis factors are associated with GERD and Barrett’s esophagus; it is worthwhile to further investigate. The effect of benefit or harm of presence of Hp infection in GERD is debated; most are epidemiologic study, lacking evidence- based data; whether need to eradicate Hp in the patients with reflux disease or not is difficult to conclude. The current theory of transient relaxation of LES (TLESRs) as the major pathophysiologic mechanism of GERD has been challenged after pooling mass clinical experiences. Particularly after recent development of endoscopic therapy of GERD, we found that current understanding of integration of anatomy and physiology of motility of LES and related components in GERD is still insufficient. It will be important to integrate evidence- based basic and clinical data of esophagus, in order to enter new era of the treatment of GERD.\n Recently, Fass R et al., proposed a new conceptual framework of GERD; they suggest that it should be divided into three categories, instead of a linear relation in the same spectrum, including NERD, reflux esophagitis and Barrett’s esophagus. In our clinical observation, we also have got the same concept; TLESR alone cannot fit all of the clinical characteristics and fails to explain all mechanisms of GERD. Based on currently advanced concepts from the top of world and our observations, we propose the following hypotheses: (1). LES and cruel diaphragm are the equally important barriers of lower esophagus in prevention of reflux. TLESR alone is insufficient to causing these reflux diseases; on the contrary, hiatus hernia is believed playing an important role in the beginning and late stage of GERD than previously known; so called small hiatus hernia (< 2 cm) and dynamic abnormality of crual diaphragm with ‘physiologic’ hernia with transient sac should not be neglected, particularly in the patients of ‘minimal esophagitis’ and NERD and maybe also in those of Barrett’s esophagus. (2). Once dysfunction of LES and cruel diaphragm with loss of both intrinsic and extrinsic sphincters, there should be an indirect or intermediate defense or mediator before resulting in NERD, reflux esophagitis or Barrett’s esophagus; immuno-inflammatory reaction and COX-2 expression are the firstly candidates. (3) The mechanism of NERD is dysfunction of both sphincters with a physiologic hernial sac, but without immunological abnormality. (4). NOS is the major modulator of the LES and cruel diaphragm. (5). Benefit or harm of Hp infected stomach to esophagus probably depends on the resulting intragastric acid status rather than the simplified concept of the presence of Hp itself. (6). Via different patterns of expression of NOS, COX-2 and immuno-inflammatory reaction, the refluxed HCL and bile acid in the lower esophagus can make lower esophagus expressed as three categories: (a). Symptom –NERD, (b). Inflammatory necrosis- reflux esophagitis, (3). Cell cycle abnormality with metaplasia- Barrett’s esophagus; no linear relationship between these three.\n The above hypotheses are mainly based on the following evidences or speculations: prostaglandins (PGs) possess dual effects of pain sensation and motility in the gastrointestinal tract. It is believed that PGE2 release during inflammation initiated by acid injury is a key component of LES dysfunction and reflux damage. Gastric and duodenal juice can induce production of ROS, thereby damaging esophageal mucosa, which is strongly associated with reflux esophagitis. ROS may induce DNA modifications and act as carcinogens. ROS can induce apoptosis in cultured gastric cells. Apoptosis is believed to occur in these conditions; and suppression or inhibition of apoptosis contributes to carcinogenesis and its progression. However, this is still lacking sufficient related data in bile acid related esophagitis and esophageal carcinogenesis with ROS and apoptosis. Therefore, it will be valuable to elucidate the role of ROS in the HCL and bile acid related esophagitis and carcinogenesis with relation to apoptosis. Recently, COX-2 is believed to highly contribute to esophageal carcinogenesis. And ROS can up-regulate COX-2 in bovine luteal cells. Therefore, we believe to elucidate the role and mechanism of PGs and COX-2 in the reflux esophagitis. Additionally, NO produced from nNOS can relax lower esophageal sphincter and play a role in the NANC modulation in the LES. However, pervious hypothesis “cNOS is beneficial and iNOS is harmful to gastrointestinal tract” has been highly questioned recently. While, the interaction of COX-2 and NOS has been known to effect on the modulation of the function and inflammatory activity in the cardiopulmonary system and kidneys. So, we can believe that in order to elucidate the mechanisms of esophageal function and esophagitis, simultaneous investigation of the effects and roles of COX-2 and NOS is necessary and very import. NO modulating agents and COX-2 inhibitor is believed to of the most promising in the treatment of reflux esophagitis and its related metaplasic or neoplastic complications in the future. Unfortunately, there is still lacking sufficient integrated clinical and molecular biologic data in this task.\n It has been preliminarily known that IL-8 and IL-1β (TH-1cytokines) play a role in the early inflammatory stage in reflux esophagitis; IL-4 and L-10 (TH-2cytokines) may play an important role in the development of Barrett’s esophagus; and TNF-αand p53 mutant are closely related with dysplasia and carcinogenesis of Barrett’s esophagus, but its clinical application remains to be further testified, particularly in correlating with COX-2 and NOS expressions. It has been known that IL-1β is an extremely potent acid suppressant. Hp- infected stomach with mucosal inflammation can up-regulate the IL-β expression and result in gastric atrophy with hypoacidic status and increase in the risk of gastric cancer; we speculate this low acid status may decrease the acid injury to esophagus with lower risk of NERD and reflux disease; on the contrary, the risk of Barrett’s esophagus, dysplasia and carcinogenesis may increase by increasing bile acid pulse. This hypothesis is worthwhile to be testified to elucidate these dates.\n By using combination of the expression of COX-2 and NOS and immunologic reaction in the esophagus with manometry of LES and cruel diaphragm and 24 hr esophageal pH monitoring to investigate the mechanisms and to make a new and more clinically applicable clarification of these reflux diseases will be valuable in the clinical management and prevention. We will perform the following works and complete the objectives: 1) comparing the difference of immuno-inflammatory reactions among NERD, reflux esophagitis and Barrett’s esophagus; 2) the different expression of PGs & COX-2 in functional heartburn, hiatus hernia, NERD, reflux disease and Barrett’s esophagus; determining the subtype of EP receptor (EP1~4); 3) determining and comparing the expression of NOS in the esophagus; 4) investigating the role of ROS in the esophagus; 5) in correlating cytokine, COX-2 and NOS with LESP, TLESR, diaphragm EMG and 24-hour esophageal pH ; 6) the difference of expression of cytokine, atrophic gastritis and Hp in gastric mucosa, in correlating with intragastric acid status, among functional heartburn, hiatus hernia, NERD, erosive esophagitis and Barrett’s esophagus; to determine whether should eradicate Hp in reflux esophageal disease; 7) the effects of lipid peroxidation related immunologic reaction, with relation to COX-2 and NOS, in the inflammatory activity and esophageal carcinogenesis of esophagus; 8) the effects of cytokines, COX-2 and NOS on the apoptosis in these reflux esophageal diseases; 9) integrating immuno-inflamatory reaction, COX-2, NOS with manometry of LES and diaphragm, and 24-hour pH monitoring and intragastric pH to newly clarify GERD into evidence based categories.\n I. Patient selection by GERD symptom questionnaire with score of severity and frequency, and quality of life (QoL).\n II. Panendoscopic examination: the patients were clarified into NERD, reflux esophagitis or Barrett’s esophagus (each n=20), with additional group of hiatus hernia (n=20 for each those > 2 cm and < 2 cm, respectively; the patients are free of symptom and endoscopically erosive esophagitis); another group of functional heartburn (%time of pH < 4 less than 4 and DeMeester score < 14.72; n =50).\n III. Endoscopic biopsy: specimens of esophagus, cardia and antrum will be obtained for histology (H&E stain for inflammatory activity, atrophic gastritis and Hp, and special stain for Barrett’s esophagus).\n IV. Immunological and molecular study of esophageal and cardia specimens: EIA, immunohistochemistry, Western blotting, RT-PCR of COX-2, NOS and cytokine. EIA for PGs.\n V. Immunological and molecular study of antral specimens of stomach: EIA, immunohistochemistry and Western blotting of IL-1β.\n VI. Blood sampling for plasma: EIA for cytokines, PGI, PGII, PGI/II, gastrin and Hp titers.\n VII. Esophageal manometry: LESP will be divided into hypertensive, normotensive and hypotensive; calculate TLESRs at the same time. VIII. Diaphragm EMG: DEMG will be divided into hypertensive, normotensive and hypotensive. IX. 24-hour esophageal pH monitoring: recording total numbers of reflux episodes, total duration of pH < 4 and DeMester score; record intragastric pH.\n X. In vitro esophageal tissue culture: endoscopic biopsy specimens of esophagus from the patients. 1) adding HCL or bile acid into tissue culture to measure the expression of cytokine, COX-2 and NOS; 2) adding cytokine into tissue culture to measure COX-2 expression; 3) adding PGs, arachidonic acid, L-arginine and ROS, respectively or in combination, into incubated esophageal specimens to measure cytokine and COX-2 expression ; 4) instill PGs antagonists, COX inhibitors, NOS inhibitors or ROS scavengers, each alone or in combination, into incubated esophageal specimens to measure cytokine COX-2 expression.\n This is a study of an integrated clinical anatomy-physiology, immunology and molecular biology in gastroesophageal reflux disease. Starting from clinic to bench and back from bench to bedside, detailed mechanisms of GERD will be obtained and a new clarification will be provided to further clinical application in the treatment and prevention of GERD. The role of Hp will be elucidated and to determine whether should eradicate Hp in the reflux esophageal diseases.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - age between 18-80\n - endoscopy diagnosed esophagitis\n - GERD questionnaire screened nonerosive reflux disease\n Exclusion Criteria:\n - A history of esophageal, gastric or abdominal surgery.\n - Gastric or esophageal cancer.\n - Esophageal varices.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nTopoisomerase II Alpha Gene Amplification and Protein Overexpression Predicting Efficacy of Epirubicin\n\n**Clinical Trial Summary:**\n\nprospective evaluation of topoisomerase II alpha gene amplification and protein overexpression as markers predicting the efficacy of epirubicin in the primary treatment of breast cancer patients.\n\n**Clinical Trial Detailed Description:**\n\nClinical evaluation of topo II a as a predictive marker: Preliminary results from a clinical study suggest that complete remission after treatment with anthracyclines for advanced breast cancer is observed only in case of topo II a gene amplification (7 complete remissions, all in patients with topo II a gene amplified tumors, no complete remissions in patients with a normal or deleted topo II a gene).\n Moreover, our group has analyzed the predictive value of topo II a in a population of node-positive breast cancer patients randomly treated either with anthracyclines or with CMF (Belgian cooperative trial). In a first study, topo II a was evaluated by immunohistochemistry, which allows the detection of topo II a protein expression. The results of this study suggested that patients deriving the highest benefit from anthracyclines were those in which topo II a protein is immunostained in more than 10% of tumor cells. The main findings of this study should be seen as hypothesis-generating because of the limited number of patients evaluated (about fifty in each study arm) and because topo II a protein levels depend on gene amplification as well as on tumor proliferation rate. Therefore, topo II a protein expression does not necessarily reflect topo II a gene status.\n The second study run by our group was based on the same series of patients evaluated in the first study, but, this time, both HER-2 and topo II a genes were evaluated by fluorescence in-situ hybridization (FISH), which allows the detection of gene aberrations. The main findings of the second study were quite consistent with the pre-clinical data suggesting that only HER-2 amplified/topo II a amplified tumours show great sensitivity to anthracyclines while the efficacy of these same agents in HER-2 amplified/topo II a non-amplified tumors is comparable to the efficacy of other drugs or regimens like CMF.\n Nevertheless, although the results reported in this study bring some additional support to the hypothesis of topo II a as a marker predicting the efficacy of anthracyclines, no definitive conclusions can be drawn because of the fairly limited number of patients evaluated, and the retrospective nature of the analyses.\n The present study protocol: Supported by \"in-vitro\" and preliminary \"in-vivo\" data, briefly summarized above, this study is designed to test prospectively the value of topo II alpha gene amplification and protein overexpression in predicting the efficacy of anthracyclines. To our knowledge this is the only prospective trial worldwide which is attempting to prospectively clarify the predictive value of this interesting biological marker. This study could have important practical implications in the daily clinical management of early breast cancer patients because, if the trial confirms that topo II a gene amplification and/or protein overexpression are associated with high efficacy of anthracyclines, while topo II a normal/deleted gene and low protein content are associated with modest efficacy, an important step forward in the direction of anthracycline \"tailoring\" would be accomplished.\n The practical advantage of this approach would be to use anthracyclines primarily in patients who are supposed to derive the largest benefit, thus sparing the long-term anthracycline-related toxicity (i.e. secondary acute myeloid leukemia, cardiac dysfunction, and amenorrhea/sterility in case of fertile women) to those patients for whom no significant gain in antitumor activity is anticipated.\n To reach this ambitious aim, early breast cancer patients with tumors of at least 2 cm (defined by breast ultrasound) will be evaluated for topo II a gene and protein expression. For this purpose, a pre-treatment biopsy (tru-cut) will be performed and topo II a gene will be evaluated on fixed samples by FISH. The use of a triple probe will allow the concomitant evaluation of the HER-2 gene status. Topo II a protein will be evaluated by immunohistochemistry (IHC). Afterwards, all patients, independently of the topo II a gene and protein status, will be treated with single-agent epirubicin Eligibility criteria will allow the participation of patients for whom the use of an anthracycline-based adjuvant therapy would have been most probably proposed after breast cancer surgery, mainly because of estrogen receptor (ER) negativity. Therefore, no overtreatment with anthracyclines will occur in this group of patients. Pathological complete response (pCR) to epirubicin will be correlated with the topo II a gene and protein status. The study has two biological hypotheses, one for the subgroup of patients with ER negative/HER-2 amplified tumors, the other one for the subgroup of patients with ER negative/HER-2 non amplified tumors.\n 1. st hypothesis: Patients with ER negative/HER-2 amplified tumors: In this subgroup of patients, topo II a gene will be amplified in about 40% of cases. We hypothesize that in topo II a amplified tumors a three-fold increase in pCR rate will be observed, as opposed to the pCR rate in tumors with topo II a normal or deleted gene.\n 2. nd hypothesis : Patients with ER negative/HER-2 non amplified tumors: In this subset of patients, almost no topo II a gene aberrations will be found based on previous data discussed above. However, recent data reported by C. Sotiriou et al using cDNA microarrays, suggest that in this subset of ER-negative HER-2 negative tumors, also defined as the basal-like subset, two distinct subgroups can be identified (i.e. basal-like 1 and 2). While basal-like 1 tumors show a high proliferation rate and high levels of topo II a RNA, basal-like 2 tumors have a moderate-low proliferation rate and normal levels of topo II a RNA. We hypothesize that the topo II a RNA overexpression in basal-like 1 tumors is not related to topo II a gene amplification because no concomitant HER-2 gene amplification is reported in this subset of tumors. The second study hypothesis is that in ER negative/HER-2 non amplified tumors with topo II a protein overexpression, a 2.5 fold increase in pCR rate will be observed, as opposed to the pCR rate in tumors with low topo II a protein content.\n A tumor sample drawn at the time of pre-treatment biopsy will be frozen and used to perform oligonucleotide based microarrays (Affymetrix). This technique allows the evaluation of thousands of genes and ultimately provides us with the tumor genetic profile. Homogeneous genetic profiles (genetic clusters) that might be identified, will be correlated with the efficacy of single-agent epirubicin. This correlation will allow us to address the secondary end-point of this study, which is the identification of other genes or eventually a genetic profile playing a role in the determination of sensitivity to anthracyclines. Among the genes that could interfere with sensitivity to anthracyclines, p-53 seems to deserve special attention. Indeed, \"in-vitro\" data suggest that at least some p-53 mutated tumors are poorly sensitive to anthracyclines, primarily because anthracycline-induced apoptosis is prevented. Interestingly, p-53 mutated tumors display frequently HER-2 gene amplification and therefore topo II a gene amplification (23). Accordingly, p-53 mutations could hamper response to anthracyclines even in tumors carrying topo II a gene amplification. This hypothesis will also be explored in the present study, because p-53 mutations will be evaluated by DNA sequencing, and the efficacy of epirubicin in topo II a amplified and non-amplified tumors will be correlated with p-53 status.\n Additionally, patients with inflammatory breast cancer will be treated with dense administration of epirubicin (100 mg/m2/2 weeks). We keep the same drug as for early breast cancer but we use a slightly more aggressive regimen with a higher dose-density. The feasibility of the administration of epirubicin 100 mg/m2 every two weeks with granulocyte-growth factor support has been shown in the neoadjuvant, metastatic and adjuvant settings with acceptable toxicity. This neoadjuvant epirubicin regimen may be completed by adjuvant chemotherapy, such as taxane-based regimens, since the sequential approach (anthracyclines and taxanes) has been suggested superior to anthracyclines regimen in LABC.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Histologically-confirmed breast cancer (operable, locally advanced or inflammatory)\n 2. Age less than 70 years\n 3. Female patient\n 4. Tumor size 2 cm at ultrasound examination.\n 5. ER-negative tumors defined according to immunohistochemistry (i.e. < 10% of positive cells after immunostaining).\n 6. Multifocal and multicentric breast tumors are allowed if all foci are ER-negative.\n 7. Fixed and frozen samples from the primary tumor, obtained before treatment with epirubicin, must be available for evaluation of biological markers (topo II alpha gene and protein, HER-2 gene, p-53 gene, oligonucleotides microarrays).\n 8. Written informed consent before study registration.\n 9. Performance status 0 or 1 (ECOG scale)\n 10. Normal CBC, hepatic and renal functions\n 11. Normal left ventricular ejection fraction by echocardiography or muga scan\n 12. Negative pregnancy test for all women of childbearing potential. Patients of childbearing potential must implement adequate non-hormonal measures to avoid pregnancy during treatment.\n Exclusion Criteria:\n 1. Metastatic breast cancer\n 2. Serious medical conditions like:\n 1. congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled arrhythmias.\n 2. history of significant neurologic or psychiatric disorders\n 3. active uncontrolled infection\n 4. active peptic ulcer, unstable diabetes mellitus\n 3. Concomitant contralateral invasive breast cancer\n 4. Concurrent treatment with hormonal replacement therapy\n 5. Concurrent treatment with any other anti-cancer therapy\n 6. Previous treatment with anthracyclines for breast cancer\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nThe Prevalence and Significance of Gastro-oesophageal Reflux in Cystic Fibrosis Before and After Lung Transplantation\n\n**Clinical Trial Summary:**\n\nGastro-oesophageal reflux (GOR) has been found to be prevalent in children with cystic fibrosis (CF)and may further worsen lung damage via reflex bronchospasm or pulmonary aspiration. Chest physiotherapy may result in increased episodes of GOR as demonstrated in children. Lung transplantation may worsen pre-existing GOR. This study will determine the prevalence, severity and significance of symptomatic and silent GOR in adults with CF before and after lung transplant using 24hr oesophageal pH monitoring, a valid symptom questionnaire, quality of life questionnaires and gastric emptying studies. This study will identify the extent of GOR in a large adult CF population and the impact on lung function and quality of life together with the effects of medical and physiotherapy treatment on gastro-oesophageal function.\n\n**Clinical Trial Detailed Description:**\n\nA factorial longitudinal study will be undertaken in adults with cystic fibrosis. Results will be compared with age matched healthy controls. It is not deemed appropriate to randomise patients with gastro-oesophageal reflux(GOR) to a treatment versus no treatment group as immediate treatment for GOR once diagnosed is regarded as obligatory.\n Subjects: 180 adults with CF will be recruited from the Adult Cystic Fibrosis Unit at the Alfred Hospital to participate in the study. The ambulatory studies will be undertaken during baseline state in the outpatient setting. Fifteen age matched control subjects will be recruited from the general population.\n Subjects who give their consent for participation in the study will undertake the following outcome measures:\n 1. Demographic data including age, gender, BMI, prescribed medication at the time of the study, lung function tests including FEV1, FVC, FEV1/FVC ratio and MMEF, genotype, pH of saliva and sputum.\n 2. Structured symptom questionnaire using a reliable valid measure developed by Carlsson et al 1998 will be used to assess patient's symptom scores.\n 3. Dual-channel 24hour oesophageal pH monitoring will be undertaken using a digitrapper (Medtronic, Sweden)and dual antimony tipped probe (Synectics, Sweden). Following calibration of the probes the distal antimony tip is positioned 5cm above the upper border of the lower oesophageal sphincter and the proximal probe 15 cm above the distal probe in the upper oesophagus.The patient will be instructed in using the three event buttons on the digitrapper recording start and finish time of meals, upright versus supine positioning and reflux episodes. The subject will be provided with a detailed 24hr 'Activity Diary' to record all meals (including percutaneous gastrostomy feeds), positions and activities including usual chest physiotherapy and physical exercise.The recorded pH information is downloaded into a computer program for analysis. The following indices will be measured in the distal and proximal oesophagus:\n - Number of reflux episodes\n - Fraction of reflux time\n - Number of reflux episodes with duration longer than 5 minutes\n - Duration of longest episodes in minutes\n - DeMeester score (an overall weighted score of gastro-oesophageal function).\n 4. Quality of life questionnaires: SF36, Quittner CF Questionnaire (CFQ), Dietary and Bowel Symptom Questionnaires.\n 5. Chest radiographs\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - * Diagnosis of cystic fibrosis\n - Medically stable\n Exclusion Criteria:\n - * Known oesophageal varices\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nApplication of Genetic Polymorphisms of DNA Repair in The Prediction of Prostate Cancer Susceptibility and Its Clinical Outcome\n\n**Clinical Trial Summary:**\n\nPrimary: to investigate the effects of DNA repair gene polymorphisms on prostate cancer susceptibility, pathological grade, disease stage and clinical outcome Secondary: to understand the association between DNA repair gene polymorphism and prostate cancer and provided important information for screening, prevention and treatment of prostate cancer\n\n**Clinical Trial Detailed Description:**\n\nDNA repair plays a key role in carcinogenesis through the removal and repair of DNA damage induced by endogenous and environmental sources. The DNA repair system included four pathways: 1) Base Excision Repair (BER), 2) Nucleotide Excision Repair (NER), 3) Mismatch Repair (MMR) and 4) Double-Strand Break Repair, including homologous recombination pathway and nonhomologous end-joining repair pathway. Decreased and impaired DNA repair capacity has been reported in various cancers, however, its effect on prostate cancer still under investigated.\n Common polymorphisms in DNA repair gene may alter protein function and individual’s capacity to repair damaged DNA, hence, influence the cancer susceptibility. Polymorphic variants of DNA repair gene have been found to be associated with cancer susceptibility, but rare studies have investigated their effect on prostate cancer. Since variation in the function of these DNA repair genes also impact a cancer cell’s viability or resistance to treatment, genetic variants in DNA repair might serve as a valuable biomarker in forcasting the result of cancer treatment. In fact, some reports have demonstrated the association between polymorphisms of DNA repair genes and results of treatment of various cancers.\n For the present study proposal, we focused on several DNA repair genes: X-ray repair cross- complementing group 1 (XRCC1), human oxoguanine glycosylase I (hOGG1), xeroderma pigmentosum complementation group D (XPD), hMSH2, hMLH1 and X-ray repair cross-complementing group 3 (XRCC3), which might have relevance in prostate carcinogenesis based on their known functions. XRCC1 is involved in DNA repair in the base excision pathway, the hOGG1 gene encodes a DNA glycosylase /apurinic-apyrimidinic lyase that catalyzes the excision and removal the 8-OH-dG (8-hydroxy- 2-deoxyguanine) - which is a major form of oxidative DNA damage. The XPD gene codes for a DNA helicase involved in transcription and nucleotide excision repair. The hMSH2 and hMLH1 are genes involved with mismatch repair. The XRCC3 gene encoded a protein in the double-strand break homologous recombinational repair pathways.\n In this proposed study, we will also use PCR-based methods to investigate the effects of DNA repair gene polymorphisms on prostate cancer susceptibility, pathological grade, disease stage and clinical outcome. With these efforts, we will further understand the association between DNA repair gene polymorphism and prostate cancer and provided important information for screening, prevention and treatment of prostate cancer.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - prostate cancer approved by pathology\n Exclusion Criteria:\n - combined with other malignancy\n - accepting blood transfusion within 6 months\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nEstablishment of Comprehensive Genetic Analysis From a Single Cell\n\n**Clinical Trial Summary:**\n\nPreimplantation genetic diagnosis (PGD) is the integration of both assisted reproductive technologies and molecular genetic technologies and was shown to improve implantation rate and reduce spontaneous abortions after implantation. The principal problems in single cell PCR include amplification failure, ADO and contamination. Multiple displacement amplification (MDA) is a technique used in the amplification of very low amounts of DNA and reported to yield large quantities of high-quality DNA. By this approach, the diagnosis of gene disorders form single cell will be more accurate and reliable.\n\n**Clinical Trial Detailed Description:**\n\nPreimplantation genetic diagnosis (PGD) for couples at risk of conceptions with serious genetic disorders is firmly established as a valid reproductive option for couples to consider following appropriate genetic counseling. The procedure entails a balance of risks between establishing a successful pregnancy and minimizing the risk of misdiagnosis. PGD of single gene disorders relies on PCR-based tests performed on single cells (polar bodies or blastomeres). Despite the use of increasingly robust protocols, allele drop-out (ADO; the failure to amplify one of the two alleles in a heterozygous cell) remains a significant problem for diagnosis using single cell PCR. In extreme cases ADO can affect >40% of amplifications and has already caused several PGD misdiagnoses.\n Fundamental to most genetic analysis is availability of genomic DNA of adequate quality and quantity. Because DNA yield from human samples is frequently limiting, much effort has been invested in developing methods for whole genome amplification (WGA) by random or degenerate oligonucleotide-primed PCR. However, existing WGA methods like degenerate oligonucleotideprimed PCR suffer from incomplete coverage and inadequate average DNA size. Multiple displacement amplification (MDA) provides a highly uniform representation across the genome. Amplification bias among eight chromosomal loci was less than 3-fold in contrast to 4–6 orders of magnitude for PCR-based WGA methods. Average product length was >10 kb. MDA is an isothermal, strand-displacing amplification yielding about 20–30 μg product from as few as 1–10 copies of human genomic DNA. Amplification can be carried out directly from biological samples including crude whole blood and tissue culture cells. MDA-amplified human DNA is useful for several common methods of genetic analysis, including genotyping of single nucleotide polymorphisms, chromosome painting, Southern blotting and restriction fragment length polymorphism analysis, subcloning, and DNA sequencing. MDA-based WGA is a simple and reliable method that could have significant implications for genetic studies, forensics, diagnostics, and long-term sample storage.\n In this study we will carefully vary reaction conditions in single cell amplifications from isolated peripheral lymphocytes to minimize the rate of ADO. Consideration of the causal factors identified during this study should permit the design of PGD protocols that experience little ADO, thus improving the accuracy of PGD for single gene disorders.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Preimplantation genetic diagnosis\n Exclusion Criteria:\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nRandomized Controlled Study of Postoperative Adjuvant Therapy for Gastric Cancer Using TS-1 or TS-1+PSK\n\n**Clinical Trial Summary:**\n\nA randomized controlled study is conducted on patients with resected gastric cancer assigned to postoperative adjuvant therapy of TS-1 alone or PSK combined with TS-1, with the objective to examine or validate the outcome, QOL and prognostic factors (host and tumor factors), and explore the factors enhancing the antitumor effect of TS-1.\n\n**Clinical Trial Detailed Description:**\n\nThe 5-year survival after gastric cancer surgery remains poor as the cancer advances to stages II, IIIA, IIIB and IV. Tegafur-gimeracil-oteracil potassium (TS-1) is used as the first line treatment for advanced and recurrent gastric cancer. But TS-1 is accompanied by an adverse drug reaction of bone marrow suppression that is not readily seen in conventional oral fluoropyrimidines. Among randomized controlled trials on postoperative adjuvant chemotherapy for gastric cancer, the beneficial results of survival rates using Krestin (PSK) in combination with chemotherapy have been reported. With the objective to enhance the antitumor effect of TS-1 and to improve the QOL of patients, we have planned to validate the clinical significance of combined PSK and TS-1 therapy as postoperative adjuvant therapy for gastric cancer, using in principle the TS-1 regimen of 2-week dosing 1-week off for 6 months followed by 2-week dosing 2-week off for 6 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patients with microscopic stage II or IIIA resectable gastric cancer\n - Patients who have not received preoperative cancer therapy (radiotherapy, chemotherapy or immunotherapy)\n - Patients with serum immunosuppressive acidic protein (IAP) measured within 2 weeks before surgery\n - Patients with no metachronous or synchronous multiple cancer\n - Patients without severe impairment of renal, hepatic and bone marrow functions\n - Patients who are judged to be capable of tolerating surgery\n - Patients with preoperative performance status 0 to 2\n - Patients with no serious concurrent complications (such as bone marrow suppression, diarrhea and infection)\n - Patients who are judged to be capable of tolerating this treatment, and who have given written informed consent to participate in this study\n Exclusion Criteria:\n - Patients with fresh hemorrhage from the gastrointestinal tract\n - Patients with retention of body fluid necessitating treatment\n - Patients with infection, intestinal palsy or intestinal occlusion\n - Patients who are pregnant or hope to become pregnant during the study period\n - Patients with diabetes treated by continuous use of insulin or showing poor glycemic control\n - Patients with a history of ischemic heart disease\n - Patients with concurrent psychiatric disease or psychotic symptoms, and judged to have difficulties participating in the study\n - Patients receiving continuous administration of steroids\n - Patients who have experienced serious drug allergy in the past\n - Others, patients judged by the investigator or subinvestigator to be inappropriate as subject\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nGatekeeper European 005\n\n**Clinical Trial Summary:**\n\nEvaluation of the Gatekeeper System in the treatment of patients with Gastroesophageal Reflux Disease (GERD) who already have been treated under study protocols Endo 2000-03 and Endo 2000-04\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Subjects must have been part of the Endo 2000-03 or Endo 2000-04 clinical study\n - Subjects who have been informed of the nature of the long-term follow-up study and have agreed to its participation and provided Informed Consent\n Exclusion Criteria:\n - Underwent another endoscopic or surgical treatment for GERD (except re-intervention with Gatekeeper)\n - Developed other medical illness that may cause the subject to be non-compliant\n - Extensive Barrett's Esophagus (>2 cm)\n - Unable or unwilling to cooperate with the study procedures\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nNelfinavir Mesylate in Treating Patients With Recurrent, Metastatic, or Unresectable Liposarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Antiviral drugs, such as nelfinavir mesylate, may help prevent cancer cells from spreading.\n PURPOSE: This phase I/II trial is studying the side effects and best dose of nelfinavir mesylate and to see how well it works in treating patients with recurrent, metastatic, or unresectable liposarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n I. To assess the toxicity and tolerance of nelfinavir in patients with liposarcoma.\n II. To define the maximum tolerated dose (MTD) of nelfinavir when given daily as a single agent and to describe the toxicities at each does studied.\n III. To evaluate the pharmacokinetics of nelfinavir. IV. To assess the response rate and progression free survival in patients with liposarcoma treated with nelfinavir.\n V. To evaluate the expression and activity of certain proteins in the tumors of patients entered on this study, which may be important to the cytotoxicity of nelfinavir (SREBP-1, p21, NFkB (NFkappaB), caspase 3).\n OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.\n Patients receive oral nelfinavir mesylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion\n - Patients must have histologically confirmed liposarcoma, which is recurrent, metastatic or unresectable\n - There is no limit to prior chemotherapy regimens; in addition, patients may have prior radiation\n - All patients must have measurable disease, defined as lesions that can be accurately measured in at least one dimension (>= 20 mm with conventional techniques or >= 10mm with spiral CT scan); pleural effusions and ascites will not be considered measurable, but may be present in addition to the measurable lesion(s)\n - ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2; patients should have an expected survival of at least 3 months\n - Absolute neutrophil count >= 1,000/ul\n - Platelets >= 75000/ul\n - Total bilirubin =< 2.0 g/dl\n - AST(SGOT)/ALT(SGPT) =< 2.0X institutional upper limit of normal\n - Brain metastasis is not an exclusion; however, patients are only eligible if they have had successful control of the brain tumor(s) by surgery or radiation therapy\n - All prior therapy must have been completed at least 3 weeks prior to the patient's entry on this trial\n - No concurrent chemotherapy, radiotherapy, immunotherapy or other investigational agents\n - Women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation; should a women become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n - Ability to understand and willingness to sign a written informed consent document\n Exclusion\n - Patient has had prior treatment with or is currently taking a protease inhibitor\n - Patients enrolled cannot be on the following medications: cisapride, triazolam, midazolam, ergot derivatives, amiodarone, quinidine, dihydropyridine calcium antagonists (amlodipine, felodipine, isradipine, nicardipine, nifedipine, nimodipine, and nisoldipine), sildenafil, dilantin, rifampin or oral contraceptives\n - Uncontrolled intercurrent illness\n - Patients must have recovered from any expected toxicities of previous chemotherapy or radiation therapy\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nTreatment Of Gastroesophageal Reflux Disease By Endoscopic Fundoplication, A Placebo-Controlled Study\n\n**Clinical Trial Summary:**\n\nAim:\n To evaluate the therapeutic efficacy of a therapeutic procedure, involving endoscopic suturing, for gastroesophageal reflux disease (GERD) compared to a sham procedure.\n The hypotheses tested in this study were that active treatment would: 1) decrease the use of antisecretory medication, 2) decrease GERD symptoms, 3) improve quality of life, and 4) reduce esophageal acid exposure.\n\n**Clinical Trial Detailed Description:**\n\nGastroesophageal reflux disease (GERD) and the chronic, often lifelong, use of antisecretory medication have great clinical and economical implications for the patient, practicing physician and society in general. The currently available medication in GERD is very effective against heartburn, but less against the symptom of regurgitation. Surgical antireflux treatment offers a good alternative. The current surgical approach, a laparoscopic fundoplication, is safe and effective (a 90% reduction in use of antireflux medication), but in a significant subgroup of patients new symptoms arise (dysphagia, bloating) and perioperative morbidity, as well as financial costs are relatively high.\n An endoscopic suturing system has been developed, offering a minimally invasive antireflux treatment, which can be performed in an outpatient setting. The procedure aims to create an endoscopic fundoplication, and could possibly serve as an alternative to antireflux medication and surgery. Recent, uncontrolled studies, have shown that the results of the endoscopic suturing system are satisfactory and that the procedure is safe.\n This single-center, double-blinded, randomized, sham-controlled trial was conducted to evaluate the efficacy of endoscopic gastroplication by the Endocinch suturing system. Sixty patients with daily symptoms of GERD and abnormal esophageal 24-hr pH monitoring were randomly assigned to three endoscopic gastroplications (n = 20), to a sham procedure (n = 20) or to observation (n = 20). Primary endpoints were proton pump inhibitor use and GERD symptoms. Secondary endpoints were quality of life, 24-hr esophageal acid exposure, esophageal manometry and the occurrence of adverse events. Follow-up assessments were performed at 3 months. The research nurse and patients in the active and sham groups were blinded to the procedure assignment.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - typical symptoms of GERD (i.e., heartburn, regurgitation) for > 6 months,\n - pathological esophageal acid exposure after discontinuation of medical therapy, proven by ambulatory 24-hour pH-monitoring with > 5% of time a pH < 4 and a symptom-association probability > 95% (19)\n - patients considered for non-medical therapy, i.e. unwillingness to take life-long medication in medically-responding disease, suffering from medication side-effects or medically-intractable disease and unwillingness to undergo surgery\n - willingness to accept a pre-treatment observation period of three months duration\n - written informed consent\n Exclusion Criteria:\n - severe preexisting esophageal motility disorder (i.e., more than >40% non-transmitted or simultaneous contractions during a short esophageal manometry study)\n - hiatal hernia (> 3 cm in length)\n - history of antireflux or esophageal/gastric surgery\n - severe psychiatric disease\n - reflux esophagitis grade D (LA classification)\n - Barrett’s esophagus with dysplasia\n - esophageal stenosis/malignancy\n - pregnancy or lactation\n - history of low therapeutic compliance\n - other severe comorbidity (including cardiopulmonary disease, portal hypertension, collagen diseases, morbid obesity, coagulation disorder)\n - use of anticoagulant or immunosuppressive drugs\n - history of alcohol or drug abuse\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nAn Open-Label Study of Once-Daily Oral Administration of Esomeprazole 40 mg in Patients With Symptoms of Gastroesophageal Reflux Disease (GERD)\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to evaluate whether there is a difference in proportion of patients with resolution of heartburn and other symptoms related to gastroesophageal reflux disease (GERD) after four weeks of treatment with esomeprazole (NEXIUM®) in those subjects with Erosive Esophagitis (EE) and those without EE.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Symptoms of GERD as defined in this protocol: Heartburn (severity of mild, moderate or severe) 2 or more times in the 7 days prior to the Screening visit (Visit 1) and, on average, at least 2 times per week over the past 3 months.\n - Male or female, 18 to 70 years old, inclusive.\n - Non-pregnant, non-lactating female patients. Female patients must be postmenopausal, surgically sterile, or using a medically acceptable form of birth control, as determined by the investigator. Females of childbearing potential must agree to continue using an acceptable form of birth control throughout the conduct of the study.\n - Negative urine pregnancy test for females of childbearing potential.\n - Willingness to adhere to all protocol requirements.\n Exclusion Criteria:\n - Previous enrollment in the present study.\n - Significant clinical illness within 2 weeks prior to the first dose of study medication or a significant illness during the study.\n - Use of a PPI, including PRILOSEC OTC®, within 21 days of Screening (Visit 1) or at anytime during the study (Visit 1 through Visit 4).\n - Daily therapy with an H2 RA within 14 days of Screening (Visit 1): eg, ranitidine (ZANTAC®), cimetidine (TAGAMET®), nizatidine (AXID®), famotidine (PEPCID®) (occasional use; ie, less than daily, is permitted).\n - Use of H2 RAs at any frequency are prohibited throughout the entire study (Visit 1 through Visit 4).\n - A history of gastric or esophageal surgery (including, but not limited to, Nissen fundoplication and bariatric surgery), except for simple closure of a perforated ulcer or procedures that would not affect the study as determined by the Clinical Study Team physician at AstraZeneca.\n - Clinically significant gastrointestinal (GI) bleeding (eg, melena, frank hematochezia) within 3 days of Screening (Visit 1) or noted at the time of baseline EGD.\n - Non-acid related etiologies of esophagitis (eg, pill-induced, caustic ingestion or eosinophilic esophagitis).\n Generalized bleeding disorders resulting from hemorrhagic diathesis (such as abnormalities in clotting factors or platelets).\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nNucleic Acid Amplification Tests (NAATs) for the Diagnosis of Pharyngeal and Rectal Chlamydia and Gonorrhea Infections\n\n**Clinical Trial Summary:**\n\nInvestigators at the University of Alabama in Birmingham in collaboration with investigators from the Centers for Disease Control in Atlanta are evaluating the performance of three commercial nucleic acid amplification tests for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in pharyngeal and rectal swab specimens. Cultures for C. trachomatis and N. gonorrhoeae are performed as additional reference tests. Study subjects are men and women attending sexually transmitted disease (STD) and HIV care clinics in Birmingham, Alabama, who report sexual behaviors that place them at risk for pharyngeal or rectal sexually transmitted infections.\n\n**Clinical Trial Detailed Description:**\n\nIn the latter part of the 1990's, testing for Chlamydia trachomatis and Neisseria gonorrhoeae infections was revolutionized by the introduction of nucleic acid amplification tests (NAATs) which achieve greater sensitivity than traditional culture methods by exponentially replicating the nucleic acid of these organisms. The specimens collected for NAATs are easier to transport and NAATs permit collection of less invasive specimens for testing (i.e. voided urine or patient-collected vaginal swabs for women rather than urethral or endocervical swabs). Despite their somewhat higher costs, these tests have been found to be preferred by patients (because specimens can be collected less invasively), by clinicians (because of both their ease of collection and increased sensitivity), and to permit expanded screening both in traditional clinical settings and at outreach sites where testing has not typically been done in the past.\n NAATs have been cleared by FDA for testing of genital specimens (cervical and male urethral swabs and urine), but the performance of NAATs has not been adequately evaluated for diagnosis of C. trachomatis and N. gonorrhoeae infections occurring at rectal or pharyngeal sites of sexual exposure. Increasing numbers of heterosexual individuals might be engaging in orogenital or rectal sexual activity, especially adolescents and young adults who might view such exposures as less risky with respect to pregnancy and sexually transmitted diseases (STD) than penile-vaginal intercourse. Pharyngeal and rectal exposures, often without use of condoms, are relatively common among MSM. Recent demonstration of resurgent sexually transmitted diseases and unsafe sexual practices among men-who-have-sex-with-men (MSM), including those who are infected with the human immunodeficiency virus (HIV), provides an especially strong public health imperative to the need for careful evaluation of NAATs with pharyngeal and rectal specimens.\n The primary aim of this study is to compare the performance of the three NAATs that are available commercially to test pharyngeal and rectal specimens for C. trachomatis and N. gonorrhoeae infections with culture, the current method of choice, and with each other. In order to enroll adequate numbers of individuals with such infections, the study will be conducted during a 3-year period in a STD clinic and two HIV care clinics located in Birmingham, AL. Enrollment will be confined to individuals who are at high risk for genital C. trachomatis or N. gonorrhoeae infection, or who give a history of orogenital or rectal sexual exposures. An effort will be made to balance enrollment of heterosexual individuals and MSM, but resource limitations require that sample sizes be based on combining these subgroups.\n No adequate criterion-standard for pharyngeal or rectal infections exists due to the probable, but poorly defined, low sensitivity of the current standard, culture. Fortunately, the 3 NAATs employ different C. trachomatis and N. gonorrhoeae molecular targets and methods of nucleic acid amplification. By including all 3 NAATs plus culture in the study, combinations of the results of culture and a NAAT or of two NAATs can be utilized to take advantage of the likely independence of testing errors among truly uninfected subjects to construct more satisfactory criterion standards for infection for the purpose of estimating and comparing their sensitivities and specificities. A secondary aim of the study will be to compare this methodological approach, utilizing a traditional statistical and clinical epidemiological approach, with alternative methods that have been more widely used but strongly criticized by statisticians and clinical epidemiologists and with newer methods designed to meet these criticisms and to be more efficient than the traditional statistical approaches.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Age greater than 15 years.\n - If male, history of fellatio, cunnilingus, or receptive anal sex within the last two months.\n - If female, presenting for treatment of N. gonorrhoeae and/or C. trachomatis or contact to N. gonorrhoeae, C. trachomatis, or nongonococcal urethritis.\n - If female, history of fellatio or history of anal sex within the last two months.\n Exclusion Criteria:\n - Declines to participate.\n - History of receipt of antimicrobial agents active against N. gonorrhoeae or C. trachomatis in the preceding 30 days.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nStudy Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Greater than 44 weeks beyond neonatal period but less than 12 months\n - Presumptive diagnosis of GERD\n - Weight greater than 2.5 kg but less than 15 kg\n Exclusion Criteria:\n - History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption\n - Clinically significant medical or surgical abnormalities\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nCombination Chemotherapy in Treating Patients With Stage III or Stage IV Malignant Peripheral Nerve Sheath Tumors\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy, such as doxorubicin, ifosfamide, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy with or without radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.\n PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with stage III or stage IV malignant peripheral nerve sheath tumors.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n Primary\n - Determine the clinical response rate (complete and partial) in patients with sporadic or neurofibromatosis type 1 (NF1)-associated high-grade stage III or IV malignant peripheral nerve sheath tumors (MPNSTs) after treatment with 4 courses of chemotherapy comprising doxorubicin hydrochloride and ifosfamide (IA) followed by etoposide and ifosfamide (IE).\n Secondary\n - Evaluate the utility of fludeoxyglucose F18 positron emission tomography (^18FDG-PET) and automated MRI volumetric tumor analysis as tools to assess response to treatment.\n - Correlate response evaluation by 2-dimensional WHO criteria, 1-dimensional RECIST criteria, ^18FDG-PET, and volumetric MRI with percent necrosis in tumor specimens from patients who undergo surgery for local control after chemotherapy.\n - Evaluate the response of plexiform neurofibroma(s) (if present) to chemotherapy using WHO criteria and automated volumetric MRI analysis.\n - Evaluate the molecular biology of sporadic and NF1-associated MPNSTs by performing a detailed pathologic analysis of tumor samples with the goal to analyze if markers can be identified that predict for response to chemotherapy or outcome.\n - Construct a tissue microarray from submitted tumor samples, that will be used in the future to identify novel targets for treatment of MPNSTs.\n - Assess if a serum biomarker can be identified, that predicts for the presence of a MPNST versus benign plexiform neurofibroma.\n - Increase the knowledge of the epidemiology and clinical presentation of NF1-associated MPNSTs.\n OUTLINE: This is a multicenter study. Patients are stratified according to type of malignant peripheral nerve sheath tumor (MPNST) (sporadic MPNST vs neurofibromatosis type 1 [NF1]-associated MPNST). Patients receive 1 of 2 treatment regimens depending on the location of the MPNST and tumor response to chemotherapy.\n - Chemotherapy and local control by radiotherapy and surgery: Patients receive doxorubicin hydrochloride and ifosfamide (IA) chemotherapy comprising doxorubicin hydrochloride IV over 15 minutes on days 1 and 2 and ifosfamide IV over 1 hour on days 1-5. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity. Patients then receive etoposide and ifosfamide (IE) chemotherapy comprising etoposide IV over 1 hour and ifosfamide IV over 1 hour on days 1-5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients also receive filgrastim (G-CSF) subcutaneously (SC) after each chemotherapy course beginning on day 6 or 7 and continuing until blood counts recover or pegfilgrastim SC once on day 6 or 7.\n After recovery from chemotherapy, patients undergo radiotherapy and receive 2 more courses of IE during radiotherapy followed by 2 more courses of IA after completion of radiotherapy. Some patients may then undergo surgery.\n - Chemotherapy and local control by surgery: Patients receive 2 courses of IA followed by 2 courses of IE as above. After recovery from chemotherapy, patients undergo surgery. After recovery from surgery, patients receive 2 more courses of IA followed by 2 more courses of IE in the absence of disease progression or unacceptable toxicity.\n After completion of study treatment, patients are followed periodically for up to 5 years.\n PROJECTED ACCRUAL: A total of 74 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Newly diagnosed sporadic or neurofibromatosis type 1 (NF1)-associated high-grade malignant peripheral nerve sheath tumors (MPNSTs)\n - Stage III or stage IV (metastatic) disease\n - Measurable disease, defined as at least 1 tumor that is measurable in 2 dimensions on CT scan or MRI\n PATIENT CHARACTERISTICS:\n - Ejection fraction normal by echocardiogram or MUGA\n - Serum creatinine normal for age OR creatinine clearance > 60 mL/min\n - SGPT < 5 times upper limit of normal (ULN)\n - Bilirubin < 2.5 times ULN\n - Absolute neutrophil count ≥ 1,500/mm^3*\n - Hemoglobin ≥ 9.0 g/dL*\n - Platelet count ≥ 100,000/mm^3*\n - ECOG performance status 0-2\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective contraception during and for 6 months after completion of study treatment NOTE: * Unsupported\n PRIOR CONCURRENT THERAPY:\n - No prior chemotherapy for MPNST\n - Prior surgical resection of MPNST allowed provided residual or recurrent measurable disease is present\n - Recovered from toxic effects of all prior therapy\n - At least 3 weeks since prior chemotherapy or biologic therapy for treatment of a plexiform neurofibroma, optical pathway tumor, or other NF1-associated tumor (in patients with NF1)\n - At least 6 weeks since prior radiotherapy for treatment of a plexiform neurofibroma, optical pathway tumor, or other NF1-associated tumor (in patients with NF1)\n - At least 4 weeks since prior radiotherapy to the area involved by MPNST\n - No other concurrent growth factors (e.g., sargramostim [GM-CSF] or interleukin-11)\n - Concurrent epoetin alfa allowed\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nSymptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)\n\n**Clinical Trial Summary:**\n\nThe aim of this study is to compare investigator and patient-assessed gastroesophageal reflux disease symptoms in patients with erosive GERD or endoscopic-negative GERD (enGERD). An endoscopy will be performed at study start and study end. During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™ questionnaire). The study duration consists of a baseline period (8 days) and treatment period (28 days). Pantoprazole (tablet) will be administered once daily at one dose level. The study will provide further data on safety and tolerability of pantoprazole.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nMain Inclusion Criteria:\n - Written informed consent\n - Outpatients\n - History of GERD-related symptoms for at least 6 months prior to study inclusion\n - Endoscopically confirmed erosive GERD or non-erosive GERD\n Main Exclusion Criteria:\n - Acute peptic ulcer and/or ulcer complications\n - PPIs during last 7 days prior to study start\n - Systemic glucocorticoids or non-steroidal anti-inflammatory drugs including COX-2 inhibitors during the last 28 days prior to study start; except regular intake of acetylsalicylic acid up to a daily dose of 163 mg/day\n - Intake of PPIs in combination with antibiotics for eradication of H. pylori\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nGenetic Analysis of Familial Melanoma\n\n**Clinical Trial Summary:**\n\nIn collaboration with members of The International Melanoma Consortium, we propose to study melanoma in families lacking mutations in the cyclin-dependent kinase inhibitor 2 (CDKN2 or p16) gene, or the cyclin-dependant kinase 4 (CDK4). CDKN2 and CDK4 are both genes that encode presumed tumor suppressor genes, mutant forms of which are known to cause increased susceptibility to melanoma. The purpose of the present study then is to confirm the existence of and to identify additional gene(s) involved in heritable melanoma (cutaneous and ocular) and their precursor lesions (atypical nevi) by linkage analysis and gene mapping strategies. It is clear that the risk to develop atypical nevi and/or melanoma is strongly influenced by genetic and environmental factors (e.g. sun exposure). Characterization of such genes could provide important insights into the inheritance, pathogenesis, and treatment of this increasingly important disease.\n\n**Clinical Trial Detailed Description:**\n\nIn collaboration with members of The International Melanoma Genetics Consortium, we propose to study melanoma in families lacking mutations in the cyclin-dependent kinase inhibitor 2 (CDKN2A), or the cyclin-dependant kinase 4 (CDK4) genes. CDKN2 and CDK4 are both genes that encode presumed tumor suppressor genes, mutant forms of which are known to cause increased susceptibility to melanoma. The purpose of the present study then is to confirm the existence of and to identify additional gene(s) involved in heritable melanoma (cutaneous and ocular) and their precursor lesions (atypical nevi) by linkage analysis and gene mapping strategies. It is clear that the risk to develop atypical nevi and/or melanoma is strongly influenced by genetic and environmental factors (e.g. sun exposure). Characterization of such genes could provide important insights into the inheritance, pathogenesis, and treatment of this increasingly important disease.\n\n**Clinical Trial Eligibility Criteria:**\n\n- INCLUSION CRITERIA:\n Inclusion into this study was restricted to families containing at least three CMM cases with DNA available for genotyping, and CDKN2A and CDK4 involvement and had been excluded.\n All families must be mutation negative for both CDKN2A and CDK4.\n This study will also include families with at least one case of ocular and two cases of other cutaneous melanomas, or at least 2 ocular melanomas (except where they occur in parent and child).\n EXCLUSION CRITERIA:\n Any family showing evidence of haplotype sharing in the 9p21-p22 region, where CDKN2A is located, was also excluded.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nStudying Genes to Identify Melanoma in Patients in Iceland and Their Family Members\n\n**Clinical Trial Summary:**\n\nRATIONALE: Studying the genes expressed in samples of blood from patients with cancer and their family members may help doctors identify biomarkers related to cancer.\n PURPOSE: This clinical trial is studying genes to identify melanoma in patients in Iceland and their family members.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Assess the feasibility of Iceland Genomics Corporation (UVS) to identify melanoma in multiple-case families, individuals with multiple tumors, and selected additional family members in Iceland.\n - Assess the feasibility of mutation detection using sequencing and HPLC.\n - Determine UVS' ability to create datasets with demographic, epidemiologic and molecular data.\n OUTLINE: Participants and patients undergo blood collection and complete lifestyle questionnaires. All patients and population-based controls have DNA samples sequenced for MC1R. Demographic and epidemiologic data on all study participants is collected. Sequencing of the major melanoma susceptibility genes CFDKN2A, CDK4, and MC1R is also performed.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Patients diagnosed with melanoma and selected family members are eligible to participate\n - Must live in Iceland\n PATIENT CHARACTERISTICS:\n - Not specified\n PRIOR CONCURRENT THERAPY:\n - Not specified\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nObservation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nThis phase III trial is studying observation to see how well a risk based treatment strategy works in patients with soft tissue sarcoma. In the study, patients are assigned to receive surgery +/- radiotherapy +/- chemotherapy depending on their risk of recurrence. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\n I. Define a risk-based treatment strategy comprising observation only, adjuvant radiotherapy, or adjuvant chemoradiotherapy or neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy in young patients with non-rhabdomyosarcoma soft tissue sarcoma (NRSTS).\n II. Assess event-free and overall survival of patients treated with these regimens.\n III. Assess the pattern of treatment failure in these patients.\n SECONDARY OBJECTIVES:\n I. Assess the feasibility of a neoadjuvant chemoradiotherapy approach in patients with intermediate- or high-risk NRSTS.\n II. Assess the imaging and pathologic responses to neoadjuvant chemoradiotherapy in patients with intermediate- or high-risk NRSTS.\n III. Correlate imaging and pathologic response with clinical outcomes in patients with intermediate- or high-risk disease who undergo neoadjuvant chemoradiotherapy.\n IV. Prospectively define clinical prognostic factors associated with event-free survival, overall survival, local recurrence, and distant recurrence in these patients.\n V. Correlate patient outcomes with findings of biologic studies performed on tissue specimens collected on protocol COG-D9902 from these patients.\n VI. Determine whether the diagnosis and histologic grade of NRSTS assigned by the enrolling institution correlates with the diagnosis and histologic grade established by central expert pathology reviewers.\n VII. Compare the Pediatric Oncology Group (POG) and Fédération Nationale des Centres de Lutte Contre le Cancer (French Federation of Cancer Centers [FNCLCC]) pathologic grading systems to determine which better correlates with clinical outcomes.\n OUTLINE: This is a multicenter study. Patients are divided into 3 risk groups according to presence of metastatic disease (yes vs no), status of prior surgery (resected vs unresected), grade of tumor (low vs high), and size of primary tumor (≤ 5 cm vs > 5 cm). Patients are assigned to different treatment regimens based on disease extent (nonmetastatic vs metastatic), tumor size (≤ 5 cm vs > 5 cm), extent of resection of primary tumor (resected vs unresected), extent of resection of metastases (complete or microscopic residual vs gross residual), microscopic tumor margins (negative vs positive), and tumor grade (low vs high).\n GROUP 1 (low risk [nonmetastatic, grossly resected disease, except high-grade tumor > 5 cm]): Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to regimen A. Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to regimen B.\n REGIMEN A (observation only): Patients undergo observation only.\n REGIMEN B (adjuvant radiotherapy): Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.\n GROUP 2 (intermediate risk [nonmetastatic, resected or unresected disease]): Patients with grossly resected, high-grade tumor > 5 cm (in maximum diameter) are assigned to regimen C. Patients with unresected tumor are assigned to regimen D.\n REGIMEN C (adjuvant chemoradiotherapy): Patients receive ifosfamide IV over 3 hours on days 1-3 in weeks 1, 4, 7, 10, 13, and 16 and doxorubicin hydrochloride IV over 24 hours on days 1 and 2 in weeks 1, 4, 13, 16, and 19. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.\n *NOTE: *Patients who receive brachytherapy will initiate radiotherapy in Week 1. If brachytherapy is administered, chemotherapy should begin within 2 weeks of completion of brachytherapy and the Weeks 1 and 19 doxorubicin should be given instead at Weeks 7 and 10.\n REGIMEN D (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Neoadjuvant chemoradiotherapy and surgery: Patients receive ifosfamide IV over 3 hours on days 1-3 in weeks 1, 4, 7, and 10 and doxorubicin hydrochloride IV over 24 hours on days 1 and 2 in weeks 1 and 4. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy**. Patients undergo surgical resection in week 13.\n NOTE: **Patients with primary hepatic tumors do not receive radiotherapy in week 4.\n Adjuvant chemotherapy with or without radiotherapy: Patients receive ifosfamide IV over 3 hours on days 1-3 in weeks 16 and 19 and doxorubicin hydrochloride IV over 24 hours on days 1 and 2 in weeks 16, 19***, and 22. Beginning in week 16, patients achieving gross total resection with positive microscopic margins undergo a total of 6 fractions of adjuvant radiotherapy. Patients achieving less than total gross resection undergo a total of 11 fractions of adjuvant radiotherapy. Patients achieving total gross resection with negative microscopic margins do not receive adjuvant radiotherapy.\n NOTE: ***Patients who receive adjuvant radiotherapy in week 16 receive doxorubicin hydrochloride in week 25 instead of week 19.\n GROUP 3 (high risk [metastatic, resected, incompletely resected, or unresected disease]): Patients with low-grade, all-sites resected tumor with either negative or positive microscopic margins are assigned to receive treatment as in group 1 regimen A. Patients with high-grade, grossly resected primary tumor, and metastatic disease are assigned to receive treatment as in group 2 regimen C. Patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in group 2 regimen D.\n In all groups, treatment continues in the absence of disease progression. After completing study treatment, patients are followed periodically for at least 5 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Newly diagnosed non-rhabdomyosarcoma soft tissue sarcoma (STS), confirmed by central pathology review via concurrent enrollment on protocol COG-D9902\n - Metastatic or non metastatic disease\n - Meets 1 of the following criteria:\n - Intermediate (i.e., rarely metastasizing) or malignant STS, including any of the following:\n - Adipocytic tumor, including liposarcoma of any of the following histology subtypes:\n - Dedifferentiated\n - Myxoid\n - Round cell\n - Pleomorphic type\n - Mixed-type\n - Not otherwise specified (NOS)\n - Fibroblastic/myofibroblastic tumors, including any of the following:\n - Solitary fibrous tumor\n - Hemangiopericytoma\n - Low-grade myofibroblastic sarcoma\n - Myxoinflammatory fibroblastic sarcoma\n - Adult fibrosarcoma*\n - Myxofibrosarcoma\n - Low-grade fibromyxoid sarcoma or hyalinizing spindle-cell tumor\n - Sclerosing epithelioid fibrosarcoma\n - So-called fibrohistiocytic tumors, including any of the following:\n - Plexiform fibrohistiocytic tumor\n - Giant cell tumor of soft tissues\n - Pleomorphic malignant fibrous histiocytoma (MFH)/undifferentiated pleomorphic sarcoma\n - Giant cell MFH/undifferentiated pleomorphic sarcoma with giant cells\n - Inflammatory MFH/undifferentiated pleomorphic sarcoma with prominent inflammation\n - Smooth muscle tumor (leiomyosarcoma)\n - Pericytic [perivascular] tumor (malignant glomus tumor or glomangiosarcoma)\n - Vascular tumor, including angiosarcoma\n - Chondro-osseous tumors of any of the following types:\n - Mesenchymal chondrosarcoma\n - Extraskeletal osteosarcoma\n - Tumors of uncertain differentiation, including any of the following:\n - Angiomatoid fibrous histiocytoma\n - Ossifying fibromyxoid tumor\n - Myoepithelioma/parachordoma\n - Synovial sarcoma\n - Epithelioid sarcoma\n - Alveolar soft-part sarcoma\n - Clear cell sarcoma of soft tissue\n - Extraskeletal myxoid chondrosarcoma (\"chordoid type\")\n - Malignant mesenchymoma\n - Neoplasms with perivascular epithelioid cell differentiation (PEComa)\n - Clear cell myomelanocytic tumor\n - Intimal sarcoma\n - Malignant peripheral nerve sheath tumor\n - Dermatofibrosarcoma protuberans meeting both of the following criteria:\n - Non metastatic disease\n - Tumor must be grossly resected prior to study enrollment\n - Embryonal sarcoma of the liver\n - Unclassified STS that is too undifferentiated to be placed in a specific pathologic category (undifferentiated STS or STS NOS)\n - Gross resection of the primary tumor ≤ 42 days prior to enrollment required except if any of the following circumstances apply:\n - Non metastatic high-grade tumor > 5 cm in maximal diameter and gross or microscopic residual tumor is anticipated after resection\n - Tumor of either high- or- low-grade that cannot be grossly excised without unacceptable morbidity\n - High-grade tumor with metastases\n - Patients with metastatic low-grade tumor whose disease is amenable to gross resection at all sites must undergo gross resection of all sites prior to study entry\n - Patients with a tumor recurrence after a gross total resection are not eligible\n - Tumors arising in bone are not eligible\n - Patients with epithelioid sarcoma, clear cell sarcoma, or clinical or radiologic evidence of regional lymph node enlargement must undergo sentinel lymph node biopsies or lymph node sampling to confirm the status of regional lymph nodes* NOTE: *Except in cases where the study radiologist reviews the imaging and indicates that a biopsy is not needed to confirm that the patient has lymph node involvement.\n - If lymph node biopsies are positive for tumor (or the lymph nodes are classified as positive by the study radiologist), formal lymph node dissection must be done at the time of definitive surgery(prior to study entry for patients assigned to study regimen C)\n - Patients with metastatic disease must undergo a biopsy to confirm the presence of metastatic tumor if all metastases are < 1 cm in maximal diameter (except in cases where the study radiologist reviews the imaging and indicated that a biopsy is not needed to confirm that the patient has metastatic disease)\n - Lansky performance status (PS) 50-100% (for patients ≤ 16 years of age) OR Karnofsky PS 50-100% (for patients > 16 years of age)\n - Life expectancy ≥ 3 months\n - Absolute neutrophil count ≥ 1,000/mm³*\n - Platelet count ≥ 100,000/mm³*\n - Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min (≥ 40 mL/min for infants < 1 year of age)* or serum creatinine based on age and/or gender as follows:\n - 0.4 mg/dL (1 month to < 6 months of age)\n - 0.5 mg/dL (6 months to < 1 year of age)\n - 0.6 mg/dL (1 year to < 2 years of age)\n - 0.8 mg/dL (2 years to < 6 years of age)\n - 1.0 mg/dL (6 years to < 10 years of age)\n - 1.2 mg/dL (10 years to < 13 years of age)\n - 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 years to < 16 years of age)\n - 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)\n - Patients with urinary tract obstruction by tumor must meet the renal function criteria listed above AND must have unimpeded urinary flow established via decompression of the obstructed portion of the urinary tract\n - Bilirubin ≤ 1.5 times upper limit of normal (ULN)*\n - Shortening fraction ≥ 27% by echocardiogram* OR ejection fraction ≥ 50% by radionuclide angiogram*\n - Not pregnant or nursing (patients undergoing radiotherapy and/or chemotherapy)\n - No nursing for ≥ 1 month after completion of study treatment in study regimens C or D\n - Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment\n - Negative pregnancy test\n - No evidence of dyspnea at rest*\n - No exercise intolerance*\n - Resting pulse oximetry reading > 94% on room air (for patients with respiratory symptoms)*\n - Prior treatment for cancer allowed provided the patient meet the prior therapy requirements\n - No prior anthracycline (e.g., doxorubicin or daunorubicin) or ifosfamide chemotherapy for patients enrolled on arm C or arm D\n - No prior radiotherapy to tumor-involved sites\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nStudy Evaluating Pantoprazole in Neonates and Preterm Infants With GERD\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Hospitalized patients\n - Presumed diagnosis of GERD\n - Term or post-term infants within the neonatal period less than 28 days or preterm infants with a corrected gestational age of less than 44 weeks\n Exclusion Criteria:\n - cardiovascular instability\n - clinically significant laboratory abnormalities\n - use of warfarin, carbamazepine, phenytoin, or rifampin\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nStudy Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)\n\n**Clinical Trial Summary:**\n\nTo assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - term or post term infants beyond the neonatal period of an age greater than 28 days but less than or equal to 11 months\n - clinical diagnosis of GERD\n - weight greater than 2.5 kg and less than or equal to 15 kg\n Exclusion Criteria:\n - known history of upper GI anatomic disorders\n - history of acute life-threatening medical conditions\n - clinically significant medical conditions or laboratory abnormalities\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nStudy Evaluating Pantoprazole in Adolescents With GERD\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is characterize the PK profile of single and multiple doses of pantoprazole in adolescents aged 12 to 16 years with Gastroesophageal Reflux Disease (GERD).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - 12-16 years old\n - clinical diagnosis of GERD\n - ability to swallow tablets\n Exclusion Criteria:\n - GI or malabsorption disorders\n - chronic use of warfarin\n - positive pregnancy test\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nPhase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nThis is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity.\n All patients with unresectable or metastatic soft tissue sarcoma (STS): leiomyosarcoma, liposarcoma, fibrosarcoma, and malignant fibrous histiocytoma (MFH) seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study.\n\n**Clinical Trial Detailed Description:**\n\nThis is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate, an oral multi-kinase inhibitor. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity which in the opinion of the treating physician or the trial Principal Investigator (PI) compromises the ability of the patient to receive treatment or the patient desires to stop treatment.\n All patients with unresectable or metastatic STS: leiomyosarcoma, liposarcoma, fibrosarcoma, and MFH seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study.\n An office visit will be required before the beginning of every cycle every 6 weeks to assess toxicity and for physical examination. Complete blood count (CBC) and differential, comprehensive metabolic panel, and electrocardiogram (ECG) will be obtained at every scheduled visit.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 grade less than or equal to 1.\n - Adequate organ function as defined by the following criteria:\n - Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) less than or equal to 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy\n - Total serum bilirubin less than or equal to 1.5 x ULN\n - Absolute neutrophil count (ANC) greater than or equal to1500/microL\n - Platelets greater than or equal to 100,000/microL\n - Hemoglobin greater than or equal to 9.0 g/dL\n - Serum calcium less than or equal to 12.0 mg/dL\n - Serum creatinine less than or equal to 1.5 x ULN\n - Histologically-proven liposarcoma, leiomyosarcoma, fibrosarcoma, or MFH\n - Measurable disease radiographically\n - Disease that is deemed surgically unresectable and/or metastatic\n - Age greater than or equal to 18 years\n - Life expectancy greater than 16 weeks\n - Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2\n - Patients may have had up to 3 prior chemotherapies within 4 weeks of starting the study treatment.\n Exclusion Criteria:\n - Major surgery or radiation therapy or chemotherapy within 4 weeks of starting the study treatment.\n - NCI CTCAE version 3 grade 3 hemorrhage within 4 weeks of starting the study treatment.\n - History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease.\n - Any of the following within the 6 months prior to study drug administration:\n - myocardial infarction,\n - severe/unstable angina,\n - coronary/peripheral artery bypass graft,\n - symptomatic congestive heart failure,\n - cerebrovascular accident or transient ischemic attack, or pulmonary embolism\n - Ongoing cardiac dysrhythmias of NCI CTCAE greater than or equal to grade 2\n - Prolonged QTc interval on baseline electrocardiogram (ECG) > 500 msec.\n - Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal medical therapy)\n - Prior tyrosine kinase inhibitor therapy\n - Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication\n - Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection\n - Concurrent treatment on another clinical trial, except supportive care or non-treatment trials\n - Concomitant use of agents known to induce or inhibit CYP3A4\n - Concomitant use of agents metabolized by the cytochrome P450 system\n - Ongoing treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg by mouth [PO] daily for thrombo-prophylaxis is allowed)\n - Pregnancy or breastfeeding patients\n - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nPhase I Study of P276-00 in Patients With Advanced Refractory Neoplasms\n\n**Clinical Trial Summary:**\n\nP276-00 is a molecule derived from Rohitukine, which through pre clinical assays was identified as a selective Cdk4-D1 and Cdk1-B inhibitor.The inhibition of these Cdks causes cell cycle arrest between the G1-S transition thus blocking the cell cycle events at an early stage of development. It therefore has the potential for being efficacious with lesser side effects.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Patients must have histologically and/ or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.\n 2. Patients of either sex, of all races and ethnic groups, and > 18 years of age.\n 3. ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2 .\n 4. Patients with life expectancy of at least 4 months.\n 5. Patients must have normal organ and marrow function as defined below:\n - Hemoglobin ≥10 gm/dL\n - absolute neutrophil count ≥ 1,500/mL\n - platelets ≥ 100,000/mL\n - total bilirubin within normal institutional limits\n - AST/ALT ≤ 2.5 X institutional upper limit of normal (ULN)\n - creatinine within 1.5 times the upper normal institutional limits\n 6. The effects of P276-00 on the developing human foetus are unknown. For this reason women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of the study during the duration of study participation and for at least 4 weeks after withdrawal from the study.\n 7. Women who are nursing should not be included into the study\n 8. Concomitant medications for diabetes, hypertension, pain relief and any other co-existing conditions, except cancer, are permitted when the patient is on study medication. There should be no change in the dosage of these medications in the 2 weeks prior to day 1 of cycle 1, with the exception of dosages for pain relief medication. Changes in the dose of anti-emetics and diuretics may be made provided they will not interfere with probable adverse effects of investigational product.\n 9. Ability to understand and the willingness to sign a written informed consent document.\n Exclusion Criteria:\n 1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study (date of consent); or patients who have not recovered from adverse events (except grade 1 toxicities) due to agents administered more than 4 weeks earlier.\n 2. Patients having received any other investigational agents within 4 weeks prior to the date of consent and patients who have not recovered completely from the side effects of the earlier investigational agent.\n 3. Patients with known brain metastases should be excluded from this clinical trial.\n 4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to P276-00.\n 5. Patients having history of myocardial infarction or uncontrolled cardiac dysfunction during the previous 6 months.\n 6. Patients having diarrhea requiring anti-diarrheal therapy.\n 7. Patients having coagulopathy requiring anticoagulation.\n 8. Patients with uncontrolled but stable 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 9. Women who are pregnant or nursing. P276-00 may have the potential for teratogenic or abortifacient effects. Since there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with P276-00, breastfeeding should be discontinued if the mother is to be treated with P276-00.\n 10. Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients are excluded from the study.\n 11. Patients requiring the use of concomitant medications that prolong the QT/QTc interval and/or are known to cause Torsades de Pointes (TdP)\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nEvaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD\n\n**Clinical Trial Summary:**\n\nThis study will be conducted in order to determine safety and efficacy esomeprazole, lansoprazole and pantoprazole control stomach acid by measuring the stomach acid in men and women of Hispanic origin who have GERD.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Signed informed consent\n - Males and females ages 18-69 who are of Hispanic origin\n - Symptoms of GERD, defined as heartburn at least 2 times a week on average over the last 3 months\n Exclusion Criteria:\n - Female patients who are pregnant or breastfeeding\n - Known intolerance or lack of response to Proton Pump Inhibitors (PPIs) such as Nexium, Prevacid, or Protonix\n - Current or relevant history of non-healed ulcers, stomach surgery, or esophageal surgery\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nE7389 Administered as an IV Bolus Infusion Day 1 and Day 8 Every 3 Weeks in Pre-Treated Patients With Advanced and/or Metastatic Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to evaluate the therapeutic activity and safety of E7389 in patients with advanced/metastatic soft tissue sarcoma who have failed standard chemotherapy.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Histologically proven advanced and/or metastatic malignant soft tissue sarcoma of high or intermediate grade, and of one of the following histologies (World Health Organization (WHO) classification 2002):\n - Leiomyosarcoma\n - Adipocytic (liposarcoma dedifferentiated, myxoid/round cell, pleomorphic, mixed-type not otherwise specified)\n - Synovial sarcoma\n - Other types of sarcoma, including:\n - Fibroblastic (adult fibrosarcoma, myxofibrosarcoma, sclerosing epithelioid fibrosarcoma).\n - So-called fibrohistiocytic (pleomorphic Malignant Fibrous Histiocytoma (MFH), giant cell \"MFH\", inflammatory \"MFH\")\n - Malignant glomus tumors.\n - Skeletal muscles (rhabdomyosarcoma, alveolar or pleomorphic) excluding embryonal rhabdomyosarcoma.\n - Vascular (epithelioid haemangioendothelioma, angiosarcoma).\n - Uncertain differentiation (synovial, epithelioid, alveolar soft part, clear cell, desmoplastic small round cell, extra-renal rhabdoid, malignant mesenchymoma, perivascular epithelioid cell tumor (PEComa), intimal sarcoma) excluding chondrosarcoma, Ewing tumors / Primitive neuroectodermal tumor (PNET)\n - Malignant peripheral nerve sheath tumors.\n - Malignant solitary fibrous tumors.\n - Undifferentiated soft tissue sarcomas not otherwise specified.\n - Other types of sarcoma (not listed as not eligible), if approved by the Study Coordinator (written or e-mail approval needed prior to registration).\n - The following tumor types are not eligible:\n - Embryonal rhabdomyosarcoma\n - Chondrosarcoma\n - Osteosarcoma\n - Ewing tumors / PNET\n - Gastro-intestinal stromal tumors (GIST)\n - Dermatofibrosarcoma protuberans\n - Inflammatory myofibroblastic sarcoma\n - Neuroblastoma\n - Malignant mesothelioma\n - Mixed mesodermal tumors of the uterus\n 2. Formalin fixed paraffin embedded tumor blocks and representative H/E (hematoxylin/eosin) slides must be available for histological central review. Histological central review is not required before treatment start but is mandatory within 10 days of registration. Local histopathological diagnosis will be accepted for entry into the study.\n 3. Relapsed, refractory and/or metastatic disease incurable by surgery or radiotherapy.\n 4. Evidence of objective progression within the last 6 months (RECIST) documented by measurements of disease, i.e. appearance of new lesions, increase of 20% in the sum of the diameters of measurable lesions, or progression of non measurable lesions to be confirmed by an external review, without other specific treatment since objective documentation of progression.\n 5. Presence of measurable disease, as defined by RECIST.\n 6. Patients must have received no more than one combination or two single agent chemotherapy regimens for advanced disease; (neo)adjuvant therapy is not counted towards this requirement.\n 7. No major surgery, hormonal therapy (other than replacement), chemotherapy or radiotherapy, immunotherapy or other investigational agent within the last 28 days and/or not recovered from prior therapy within the last 28 days. Use of erythropoietin is considered supportive care and is permitted.\n 8. Absence of brain or subdural metastases, unless patient has completed local therapy and has discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment with E7389. Any signs (e.g., radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks.\n 9. Absence of pre-existing neuropathy > Grade 2\n 10. At least 18 years of age.\n 11. WHO performance status 0 or 1.\n 12. Adequate bone marrow function (absolute neutrophil count >1.5 x 109/L, platelets >100 x 109/L)\n 13. Adequate hepatic function (bilirubin < 1.5 mg/mL or 25 µmol/L, SGOT/AST and SGPT/ALT <= 3 x UNL or < 5 x UNL in patients with liver metastases).\n 14. Adequate renal function: serum creatinine < 2.0 mg/dl or 177 µmol/l or calculated (Cockcroft and Gault formula) creatinine clearance > 40 ml/min.\n 15. Women should either not be of childbearing potential (having had a hysterectomy, a bilateral oophorectomy or bilateral tubal ligation, or be post-menopausal with a total cessation of menses of >1 year), or not be pregnant (negative serum pregnancy test at entry), should not be lactating, should agree to use contraceptive methods (with a documented failure rate < 1%, vasectomized partner sterile prior to trial entry and sole sexual partner or double-barrier contraception) while on treatment and during a period of 3 months after the end of treatment. Sexually active male participants must use barrier methods of contraception.\n 16. Before patient registration/randomization, written informed consent must be given according to International Conference on Harmonization/Good Clinical Practice (ICH/GCP), and national/local regulations.\n Exclusion Criteria:\n 1. Prior history of malignancies other than sarcoma (except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or the patient has been free of any other malignancies for > 3 years).\n 2. Significant cardiovascular impairment (history of congestive heart failure > New York Heart Association (NYHA) grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia).\n 3. Patients who are receiving anti-coagulant therapy with warfarin or related compounds, other than for line patency, and cannot be changed to heparin-based therapy, are not eligible. If a patient is to continue on mini-dose warfarin, then the prothrombin time (PT) / international normalized ratio (INR) must be closely monitored.\n 4. Severe/uncontrolled intercurrent illness/infection.\n 5. Patients with a known hypersensitivity to halichondrin B and/or halichondrin B chemical derivative.\n 6. Patients who participated in a prior E7389 clinical trial.\n 7. Patients without freedom (by the law or administrative decision), hospitalized without their consent (mental disability, upon legal request), admitted in medical or social establishment for other reasons than clinical research, with any psychological, familial, sociological, geographical condition potentially hampering compliance with the study protocol and follow-up schedule ; those conditions should be assessed with the patient before registration in the trial.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nEffects of AFQ056 and Baclofen on Meal-Induced Gastroesophageal Reflux\n\n**Clinical Trial Summary:**\n\nThis study will assess the safety and tolerability of oral single dose applications of AFQ056 in GERD patients.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Male and female patients with GERD (18-60 years) with a history of moderate to severe reflux symptoms (heartburn or acid regurgitation more than 2 days/week, and/or night-time reflux, and/or after meal reflux) for ≥ 3 months with:\n - uncomplicated reflux-esophagitis of any degree as evidenced by esophagogastroduodenoscopy (EGD) within the last 12 months, OR (and) a pathological ambulatory 24-hours pH measurement within the last 12 months with pH < 4 for ≥ 9% of the time.\n - Females must be of no child bearing potential (postmenopausal women with no regular menstrual bleeding for at least 1 year or women who have been surgically sterilized at least 6 months prior). Menopause will be confirmed by a plasma FSH level of 37.0 – 185.0 mIU/mL. Surgical sterilization procedures must be supported with clinical documentation.\n - Patients must be able to completely finish the high-fat breakfast within 15 minutes.\n - Body mass index must be below 30. Patients must weigh at least 60 kg to participate in this study.\n - Patients must be able to communicate well with the investigator, to understand and comply with the requirements of the study and to understand and sign the written informed consent.\n Exclusion Criteria:\n History of:\n - Upper gastrointestinal (GI) surgery or radiation\n - GI disorders other than GERD that may significantly affect the incidence and/or assessment of reflux episodes (GI motility disorders, connective tissue disease like scleroderma, Barrett’s esophagus, hiatal hernia > 3-4 cm, previous esophageal bleeding, esophageal varices, active gastric or duodenal ulcer disease, active esophagitis\n - Delayed gastric emptying, or endoscopic indications for a delay in gastric emptying or gastric outlet obstruction.\n - Neurologic/psychiatric disorders including a family history of epilepsy clinically significant cardiac disease\n - Diabetes mellitus or other metabolic disorders including hyperlipidemia requiring treatment\n - Any significant acute or chronic conditions except for following treated by the quoted drugs with a stable therapy for at least 4 weeks:\n - Hypertension well-controlled with the following:\n 1. ACE inhibitors: benazepril, captopril, cilazapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril tert-butylamine, quinapril, ramipril, spirapril, trandolapril, zofenopril, and/or\n 2. angiotensin II receptor antagonists: candesartan cilexetil, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan, and/or\n 3. diuretics: amiloride, bendroflumethiazide, bumetanide, canrenoate de potassium, chlortalidone, cicletanine, clopamide, cyclothiazide, furosemide, hydrochlorothiazide, indapamide, methyclothiazide, piretanide, spironolactone, torasemide, triamterene, xipamide, and/or\n 4. calcium antagonists: bepridil, felodipine, isradipine, lercanidipine, manidipine, nimodipine, nitrendipine, amlodipine, nicardipine BUT NOT diltiazem, nifedipine, verapamil\n - Well-compensated asthma with topical use of corticosteroids and/or β2-mimetics\n - Patients on thyroid hormone therapy with a normal TSH value.\n - Nonsteroidal anti-inflammatory drugs including aspirin use in the week prior to treatment/impedance monitoring.\n - Patients with body mass index ≥ 30.\n Other protocol-defined inclusion/exclusion criteria may apply\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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65
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nDeoxycholic Acid Injection for the Treatment of Superficial Lipomas\n\n**Clinical Trial Summary:**\n\nThe purpose of this research is to compare the safety and effectiveness of 4 different concentrations of deoxycholic acid injection against a placebo in the treatment of superficial lipomas.\n\n**Clinical Trial Detailed Description:**\n\nA lipoma is a fatty lump typically located on the trunk, shoulder, arms or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - One or more lipomas, based on clinical diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics:\n - History of slow growth followed by dormancy, and stable for at least 6 months.\n - Greatest length by greatest perpendicular width between 1 and 16 square centimeters, inclusive\n - Discrete, oval to rounded in shape, not hard or attached to underlying tissue\n - Located on the trunk, arms, legs, or neck\n - Stable body weight with a body mass index of less than 30 kg/m²\n - Signed informed consent\n Exclusion Criteria:\n - Absence of significant medical conditions that could affect safety\n - History of surgical treatment for lipomas\n - Treatment with an investigational agent within 30 days before ATX-101 treatment\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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66
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nEfficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Full-term or gestational age >/= 28 to 44 weeks\n - In-patient in Neonatal Intensive Care Unit, special care nursery, or equivalent\n - Patient must be on a stable mode of feeding or with minimal variations for at least 2 days prior to randomization\n Exclusion Criteria:\n - Patients with a need for resectional or reconstructive surgery of the gastrointestinal tract\n - Patients with any condition that may require surgery during the course of the study\n - Patients with acute respiratory distress within 72 hours prior to enrollment\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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67
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nNexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients\n\n**Clinical Trial Summary:**\n\nTo compare the efficacy of three different long-term treatment strategies of reflux disease in primary care setting.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Subjects who seek medical advice in primary care for symptoms thought to be GERD related (GERD is a condition which develops when the reflux of stomach content causes troublesome symptoms and / or complications).\n Exclusion Criteria:\n - Subjects with any clinical GERD treatment (PPI, H2-receptor antagonists) within the last 3 months prior to Visit 1.\n - A history of severe esophagitis or known other complications, with alarm symptoms\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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68
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nStudy of Families With Melanoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: A study that evaluates patients' lifestyle, skin, and blood and tissue samples may help doctors understand the risk factors for melanoma relapse.\n PURPOSE: This clinical trial is studying the risk factors for melanoma in families with melanoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n Primary\n - Determine what lifestyle factors and which genes govern relapse from melanoma.\n Secondary\n - Compare sun exposure and genes that cause melanoma in patients with melanoma vs healthy participants.\n - Assess how unusual moles relate to sun exposure and genes that cause melanoma.\n OUTLINE: This is a multicenter, cohort study.\n Patients and healthy participants complete lifestyle questionnaires by mail and telephone. Some patients* and healthy participants undergo a skin examination to count moles and classify skin type (e.g., degree of freckling and wrinkling indicative of sun damage).\n NOTE: *Patients diagnosed with primary invasive melanoma after September 2005 do not need to consent to a skin examination.\n Patients and healthy participants also undergo blood collection for lymphocyte analysis, DNA extraction, and the measurement of minerals, vitamins, and beta carotene. Tissue samples from original diagnosis are examined by immunohistochemistry for gene expression and mutations, including CDKN2A and CDK4.\n Patients and healthy participants are followed annually.\n Peer reviewed and funded or endorsed by Cancer Research UK\n PROJECTED ACCRUAL: A total of 3,700 patients and healthy participants will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Meets 1 of the following criteria:\n - Newly diagnosed primary invasive melanoma (patient group)\n - Lentigo maligna malignant melanoma allowed\n - Rare variants of melanoma allowed, including any of the following:\n - Acral lentiginous\n - Subungual\n - Ear, nose, and throat\n - Oropharyngeal\n - Perineal\n - Vaginal\n - Vulval\n - Rectal\n - Nodal with no known primary\n - Patients undergoing sentinel node biopsy are eligible\n - No in situ melanoma, melanocytic intraepidermal neoplasia, or ocular melanoma\n - Healthy participant meeting either of the following criteria (control group):\n - Relative of a patient who was diagnosed with melanoma after September 2005\n - Healthy volunteer who is age- and sex-matched for patients who were diagnosed with melanoma before October 2005\n PATIENT CHARACTERISTICS:\n - Not specified\n PRIOR CONCURRENT THERAPY:\n - Not specified\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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69
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nIodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer\n\n**Clinical Trial Summary:**\n\nRATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody 3F8, can find tumor cells and carry tumor-killing substances to them without harming normal cells. This may be an effective treatment for central nervous system cancer or leptomeningeal metastases.\n PURPOSE: This phase II trial is studying the side effects and how well iodine I 131 monoclonal antibody 3F8 works in treating patients with central nervous system cancer or leptomeningeal cancer.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine if intrathecal iodine I 131 monoclonal antibody 3F8 activity in patients with GD2-expressing central nervous system or leptomeningeal neoplasms is sufficiently promising (i.e., 6-month overall survival rate ≥ 25%) to warrant further study.\n - Determine the response rate in patients treated with this drug.\n - Determine the cumulative toxicities of this drug in these patients.\n - Describe the effects of human-antimouse antibody on cerebrospinal fluid and serum pharmacokinetics in patients treated with this drug.\n OUTLINE: This is an open-label study.\n Patients receive intrathecal iodine I 131 monoclonal antibody 3F8 for dosimetry. Beginning approximately 1 week later, patients receive intrathecal iodine I 131 monoclonal antibody 3F8 on day 1. Treatment intrathecal iodine I 131 monoclonal antibody 3F8 repeats weekly for up to 4 courses in the absence of disease progression or unacceptable toxicity.\n Blood and cerebrospinal fluid samples are collected prior to and after administration of each course of study drug. Samples are analyzed to assess the intrathecal and blood pharmacokinetics of iodine I 131 monoclonal antibody 3F8 and serum human antimouse antibodies. Samples are also analyzed in tumor genetic studies.\n After completion of study treatment, patients are followed periodically for 3 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patients must have a histologically confirmed diagnosis of a malignancy known to expressGD2. Such tumors include medulloblastoma/primitive neuroectodermal tumor of the CNS, high grade astrocytomas, malignant glioma, neuroblastoma, retinoblastoma, ependymoma, rhabdoid tumors, sarcomas, melanoma or small cell lung carcinoma. For patients with other tumor types, GD2 expression must be confirmed by immunohistochemical staining and assessed by the Department of Pathology using prior frozen tissue, bone marrow or CSF cytology (send to Research Lab).\n - Patients must have CNS/ leptomeningeal disease including high risk medulloblastoma, or a CNS/leptomeningeal malignancy which is refractory to conventional therapies, or for which no conventional therapy exists, OR a recurrent brain tumors with a predilection for leptomeningeal dissemination (medulloblastoma, PNET, rhabdoid tumor).\n - Patients must have an absolute neutrophil count (ANC) > 1000/ul and a platelet count > 50,000/ul.\n - Patients may have active malignancy outside the central nervous system.\n - Patients who have a programmable shunt will not be excluded.\n - Both pediatric and adult patients of any age are eligible.\n - Patients or a legal guardian will sign an informed consent form approved by the IRB and obtained by the Principal or a Co- Investigator before patient entry. Minors will provide assent.\n Exclusion Criteria:\n - Patients with obstructive or symptomatic communicating hydrocephalus.\n - Patients with an uncontrolled life-threatening infection.\n - Patients who are pregnant: Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is required during the study period.\n - Patients who have received cranial or spinal irradiation less than 3 weeks prior to the start of this protocol.\n - Patients who have received systemic chemotherapy (corticosteroids not included) less than 3 weeks prior to the start of this protocol.\n - Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity should all be less than or equal to grade 2. Patients with stable neurological deficits (because of their brain tumor) are not excluded. Patients with <= 3 hearing loss are not excluded.\n - Patients must have no rapidly progressing or deteriorating neurologic examination.\n - Patients who have already received >45 Gy to the craniospinal radiation or >72 Gy focal brain radiation.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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70
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nIdentifying Gene Mutations in Patients With Melanoma and in Families With a History of Hereditary Melanoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Identifying gene mutations and other risk factors in patients with melanoma and in families with a history of hereditary melanoma may help doctors identify persons at risk for melanoma and other types of cancer. It may also help the study of cancer in the future.\n PURPOSE: This clinical trial is studying gene mutations in patients with melanoma and in families with a history of hereditary melanoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine the incidence and etiologic significance of variants of known melanoma susceptibility genes (MSGs) in families with multiple cases of melanoma.\n - Determine the proportion of multiple-case families that are explained by high-penetrance mutations in known MSGs.\n - Determine the proportion of multiple-case families that are explained by these mutations and whether it varies with latitude, as a surrogate for ultraviolet exposure, with number of affected relatives, with average age at onset of melanoma in relatives, with presence of multiple primary melanoma, or with other family-specific variables.\n - Determine the penetrance of MSG mutations in these families.\n - Determine if the penetrance varies with age, sex, or birth cohort.\n - Determine if the penetrance varies with the gene involved or nature of the mutation.\n - Assess the penetrance in mutations that also have a deleterious effect on the alternative splice product, p14ARF.\n - Determine whether carriers of MSGs have an increased susceptibility to other types of cancer.\n - Determine the risk of other types of cancers for mutation carriers.\n - Determine environmental exposures, in particular sun exposure, that modify risk of melanoma in MSG mutation carriers.\n - Determine the cutaneous phenotypes that correlate with melanoma risk in these families.\n - Correlate cutaneous phenotypes with the presence of MSG variants.\n - Determine the effect of other covariates, such as sun exposure or the presence of alleles of putative modifying genes (e.g., MC1R or CDKN2A), on phenotype.\n - Determine if modifier genes, such as those controlling pigmentation of the skin, and therefore sun susceptibility, modify risk in MSG mutation carriers.\n - Identify any histopathological correlates of MSG status in primary tumors arising in melanoma-susceptible individuals in these families.\n - Identify any histopathological correlates of primary melanomas in carriers of MSG mutations with other covariates.\n OUTLINE: This is a case-control, multicenter study.\n Participants complete 2 questionnaires and assist in the creation and expansion of a family pedigree. Blood samples are examined for melanoma susceptibility gene mutations, including CDK4 and CDKN2A.\n Participants are also examined for moles and photographed. Physical variables (e.g., skin, eye, and hair pigmentation) and sun damage (solar lentigines and freckling) are also noted.\n If available, tissue samples are examined for Clark level, Breslow thickness, and frequency of mitoses. Peri-lesional skin from tumors is examined by p53 staining.\n Participants are followed periodically to monitor cancer development.\n Peer reviewed and funded or endorsed by Cancer Research UK\n PROJECTED ACCRUAL: A total of 5,000 participants will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Meets one of the following criteria:\n - Prior multiple primary melanomas\n - Histological samples available\n - Family history of melanoma, with melanoma in two first-degree relatives (e.g., cases of melanoma in both a mother and son or in two brothers but not in two cousins)\n - Family history of melanoma, where three or more individuals (of any relationship) have had melanoma\n PATIENT CHARACTERISTICS:\n - Not specified\n PRIOR CONCURRENT THERAPY:\n - Not specified\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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71
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nPhase 3/Safety & Efficacy of Esomeprazole in Infants\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD). This research study consists of a screening, open-label, and double-blind treatment withdrawal phase. The screening phase ensures the patient eligibility. No study medication is dispensed during the screening phase. During the open-label phase, patients are administered esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase, the patients are administered either his/her open-label dose or placebo. Double-blind means neither the physician, parent, or patient will know if patient is taking esomeprazole or placebo. The patient will have an equal chance of receiving esomeprazole or placebo.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - patients' parents must sign the informed consent prior to the beginning of any study-related procedures (according to local regulations)\n - patients must have symptoms at study entry and have a clinical diagnosis of suspected GERD, symptomatic GERD, or GERD proven by a test called an endoscopy, a test using a long tube inserted in the body for diagnostic exams\n Exclusion Criteria:\n - patients who have used a PPI (proton pump inhibitors; used to reduce the amount of acid in the stomach) within 7 days before enrollment in the open label treatment phase (Day 0)\n - patients with a history of acute life-threatening event\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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72
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nAssessment of Gastro-esophageal Reflux Using Endo-Flip vs Bravo\n\n**Clinical Trial Summary:**\n\nMonitoring oesophageal pH provides a definitive diagnosis of patients with gastro-oesophageal reflux disease (GORD), especially those in whom the association between reflux and symptoms is uncertain and those under consideration for anti-reflux surgery. Standard ambulatory investigation is normally performed by naso-oesophageal catheter however this is associated with considerable discomfort and in turn altered behaviour which reduces reflux provoking activities. Furthermore results of catheter based ambulatory pH studies are compromised by the high variability of acid exposure in patients with suspected GORD.\n Prolonging pH measurements by the catheter-free Bravo™ system from 24 to 48 and 96hrs significantly improves the consistency (reliability) and reproducibility of diagnoses based on oesophageal acid exposure, as well as the ability to associate acid reflux to symptom episodes. This improves diagnosis especially in those with intermittent symptoms.\n However pH monitoring does not provide a direct assessment of the underlying pathophysiology. Incompetence of the oesophago-gastric junction (OGJ) related to disruption of its structure and function is considered to be the most important cause of GORD. A more relevant assessment of the reflux barrier may be its distensibility (i.e. the ease with which the OGJ is opened to allow retrograde passage of gastric contents); however this is not assessed by current clinical investigations.\n Endo-FLIP (Crospon Medical Devices) is a new tool which assesses OGJ structure and function, and appears to provide relevant information regarding its distensibility and competence.\n This study applies to using Endo-Flip to record OGJ distensibility and Bravo to record acid exposure and symptom association in patients with reflux symptoms. The variability of pH measurements and symptoms and diagnostic accuracy will be assessed over 96hrs. Endo-FLIP results will then be compared against Bravo. The outcome of post investigation therapy will then be compared with Endo-Flip and Bravo results to assess if baseline testing can predict the outcome of acid suppression therapy.\n Study Hypothesis\n 1. There is a positive, continuous association between OGJ distensibility measured by Endo-FLIP on % acid exposure assessed by prolonged Bravo pH monitoring\n 2. The results of Endo-FLIP and prolonged Bravo predict treatment outcome of a trial of proton pump inhibitor therapy\n\n**Clinical Trial Detailed Description:**\n\nThis is a single centre study of patients (n=60) referred for investigation of reflux symptoms. Each patient is investigated by Endo-FLIP™, endoscopy, and 96 hour Bravo™ pH monitoring off acid suppressant medication.\n After calibration the Endo-FLIP catheter will be inserted orally or nasally until the liquid-filled compliant bag at the distal segment of the catheter (which houses 16 impedance sensors) straddles the OGJ. Stepwise bag distensions of 10, 20 and 30 ml will then be conducted and the associated intra-bag pressure measured. The Endo-FLIP display will allow real-time imaging of OGJ intra-luminal geometry during distension. Intra-bag pressure and CSA at the impedance planimetry segment best localized within the OGJ will be reported as mean ± SEM.\n An endoscopy will then be performed to confirm the position of the squamo-columnar junction (SCJ). Images will be taken of the SCJ using standard white light and narrow band imaging. Then 2 x 2 biopsies from the SCJ and 2 cm proximally will be taken. In conclusion, the Bravo® delivery system will be passed orally with the patient lying in the left lateral decubitus position and the capsule will be deployed 6 cm proximal to the SCJ after 1 minute of suction to stabilize the position.\n After 2 measurements for 48 hours (separated by a battery change) the patient will return the receiver for the final download and analysis. In addition to pH measurement and symptom documentation during the 96hr period, pepsin lateral flow tests (Technostics, Hull, UK) will be performed by collecting expectorated saliva on returning to the lab on day 2 and day 4. Patients will also be provided with two further kits to be used if and when they experience symptoms during the 4 day study.\n The primary outcome assessment of oesophageal acid exposure will be percent time pH<4 over the measurement period (e.g. 24, 48 or 96h). Other parameters that will be analysed are the number of reflux events and the association of these events with symptoms recorded on the Bravo™ receiver. The presence or absence of pepsin in expectorated saliva will also be assessed.\n All subjects will complete a quality of life assessment (SF-36). Symptom severity will be assessed at baseline and at follow-up and will be documented by validated questionnaires (Eraflux) before and after resumption of routine acid reducing therapy. Those that undergo anti-reflux surgery will also be followed up at 3 and 6 months.\n LOS distensibility measurements using Endo-FLIP will also be collected in those diagnosed with achalasia on manometry in order to be used as reference values for the Bravo study.\n Patient symptoms will be reviewed at baseline off treatment and again after six weeks of returning back onto their standard acid reducing medication. Patients referred for anti-reflux surgery will be reviewed 3 and 6 months after the procedure.\n This is a prospective study of 60 consecutive patients referred for the investigations typical reflux symptoms (power calculations to allow comparison of 24hr vs. 48hr pH testing).\n Analysis\n Bravo:\n 1. Retrospective analysis: Formal statistical analysis of the pH and symptom database that was collected prospectively over the last 4 years (contains >200 Bravo pH studies). This will establish the correlation between pH results from 24, 48 and 96hr monitoring with clinical variables (e.g. severity of reflux symptoms, symptom association) and outcome (e.g. response to PPI, response to fundoplication).\n 2. Prospective analysis: The day-to-day variability of pH measurements will be calculated. Patients will be classified by acid exposure (abnormal: >4.2% time pH<4) and symptom index (positive SI: >50% association of reflux events and any symptom) during each 24hr and 48hr test period. The reproducibility and accuracy of 24hr vs. 48hr pH testing will be assessed with 96hr results as the reference standard.\n Endo-Flip: Stepwise bag distensions of 10, 20 and 30 ml will be conducted and the associated intra-bag pressure measured. The Endo-FLIP display will allow real-time imaging of OGJ intraluminal geometry during distension. The primary outcome assessment of OGJ distensibility will be the intra-bag pressure and cross-sectional area at the impedance planimetry segment best localized within the LOS as mean ± SEM for each consecutive volume distension. The correlation of OGJ distensibility with oesophageal acid exposure will then be assessed.\n The correlation and interaction between OGJ distensibility, acid exposure, reflux-symptom association and symptom characteristics (e.g. severity and predominant symptom) at baseline and on treatment will be assessed by co-variant regression analysis.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Provision of written, fully informed consent to undergo mechanistic procedures: Endo-FLIP, endoscopy and biopsy, 4 day wireless pH monitoring by the Bravo system\n - All subjects should be off acid suppression medication (e.g. PPI, H2RA) for at least 5 days prior to endoscopy\n Exclusion Criteria:\n - Significant gastrointestinal symptoms or disease other than reflux\n - Previous upper GI surgery or interventions such as oesophageal dilatations\n - Predominant symptoms of motility disorders, e.g. dysphagia\n - Presence of major oesophageal dysmotility on manometry, e.g. achalasia\n - Significant co-morbidity requiring ongoing treatment or investigation\n - Physical, neurological or psychiatric conditions preventing repeated visits to hospital or compliance with study procedures (e.g. physical impairment/reduced mobility)\n - Pregnant at the time of enrolment\n - No haematological abnormalities (no anticoagulants)\n - No medications influencing gastrointestinal function within 3 days of the study.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nGrowth Hormone in the Treatment of HIV-Associated Wasting\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to compare physical function and lean body mass in patients getting different doses of somatropin compared to patients not getting the drug.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Have clearly documented HIV infection, determined by the presence of HIV confirmed by one of the following: Western blot, immunofluorescence assay, HIV culture, polymerase chain reaction (PCR) amplification, branched DNA (bDNA) signal amplification or the presence of p24 antigen. These tests may have been performed at any time in the past, but the results must be available for review by Serono prior to entry into the study.\n 2. Have evidence of AIDS wasting, with at least one of the following:\n - Documented unintentional weight loss of at least 10%, or\n - In the absence of unintentional weight loss of 10%, weight less than 90% of ideal body weight (Metropolitan Height and Weight Tables), or\n - In the absence of unintentional weight loss of 10%, body mass index < 20 kg/m².\n 3. Be at least 18 years of age.\n 4. Be receiving at least 90% of estimated caloric requirement on current nutritional regimen, according to a formal nutritional analysis.\n 5. Meet the following laboratory testing criteria at the week -4 visit (pre study screening):\n - AST, ALT, and amylase < 3 times the upper limit of normal.\n - Fasting triglyceride level < 500 mg/dl (or <5.64 mmol/l).\n - Fasting glucose < 110 mg/dl (or < 6.1mmol/l).\n 6. Be taking an antiretroviral medication that is approved or available under a Treatment IND (in the US) or a temporary approval (outside the US).\n - The subject must have been on the antiretroviral therapy for at least 8 weeks prior to study Day 1.\n - The subject must agree not to change the antiviral regimen during the 12 weeks of study drug administration (unless medically mandated).\n 7. Be capable of completing all required study activities and assessments (including all required exercise performance tests).\n 8. Understand and sign an informed consent document.\n Exclusion Criteria:\n 1. Any medical history of the following:\n - Pancreatitis.\n - Carpal tunnel syndrome (unless resolved by surgical release).\n - Glucose intolerance [for the purpose of this protocol defined as fasting blood glucose ≥ 110 mg/dl (6.1 mmol/l), or 2 hour/random blood glucose ≥ 140 mg/dl (7.8 mg/dl)].\n - Angina pectoris.\n - Coronary artery disease.\n - Any disorder associated with moderate to severe edema (e.g., cirrhosis, nephrosis, congestive heart failure, lymphedema).\n - Allergy or hypersensitivity to growth hormone.\n 2. Any of the following medical conditions:\n - Active AIDS-defining opportunistic infection.\n - Any active malignancy, except for localized cutaneous Kaposi's sarcoma (fewer than 10 lesions, none of which exceeds 2 cm in size, not on active therapy).\n - A central nervous system (CNS) mass, or CNS process associated with active neurological findings.\n - Chronic diarrhea (defined as 6 or more liquid stools per day).\n - Unstable or untreated hypertension.\n 3. Patients with acute critical illnesses in intensive care units due to complications following open heart or abdominal surgery, multiple accidental trauma, or with acute respiratory failure.\n 4. Either of the following aspects of the medical regimen in the 30 days prior to study entry (60 days prior to receiving study drug):\n - New systemic therapy for opportunistic infection.\n - New therapy for wasting, including parenteral or oral hyperalimentation, tube feeding, anabolic or progestational agents, or appetite stimulants.\n 5. Prior radiation therapy or systemic chemotherapy.\n 6. Use of glucocorticoids within the past six months or growth hormone within the past year.\n 7. An untreated or suspected serious systemic infection, or persistent fever > 101°F (or 38.5°C) during the 30 days prior to study entry.\n 8. Evidence of gastrointestinal (GI) bleeding, obstruction, or malabsorption as determined by the Investigator.\n 9. Active substance abuse which would prevent informed consent or compliance with study activities.\n 10. Dementia which would preclude the patient from giving informed consent or complying with the requirements of this protocol.\n 11. If female, be neither pregnant or breast feeding.\n 12. Use of an investigational agent under another protocol unless discussed and approved in advance by Serono's Therapeutic Director.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nInterleukin 11, Thrombocytopenia, Imatinib in Chronic Myelogenous Leukemia (CML) Patients\n\n**Clinical Trial Summary:**\n\nThe goal of this clinical research study is to find out if IL-11 (NeumegaTM) may increase the platelet count in patients with Chronic myeloid leukemia (CML) who develop low platelet counts while receiving therapy with imatinib mesylate (Gleevec, STI571), or other tyrosine kinase inhibitors such as AMN107, dasatinib, or SK1606.\n Primary Objective:\n 1. To determine efficacy of low-dose interleukin-11, (IL-11, oprelvekin, NeumegaTM) in improving the thrombocytopenia associate with imatinib or other tyrosine kinase inhibitor therapy in patients with CML.\n Secondary Objective:\n 1. To determine the safety of low-dose IL-11 in patients with CML and thrombocytopenia associated with imatinib or other tyrosine kinase inhibitors\n\n**Clinical Trial Detailed Description:**\n\nIL-11 is a hormone normally produced in your body that plays a role in stimulating the production of platelets.\n Before you can start treatment on this study, you will have what are called \"screening tests\". These tests will help the doctor decide if you are eligible to take part in the study. You will have a blood sample (1 teaspoon) collected to check your platelet count. Women who are able to have children must have a negative blood pregnancy test.\n If you are found to be eligible to take part in this study, you will receive one injection of IL-11 under the skin (usually of the arms, legs or abdomen) 3 times a week. If your platelet count increases, treatment will continue on this schedule as long as a platelet increase is observed. If the treatment is well tolerated but there is not enough of a platelet improvement, the dose and frequency of IL-11 injections may be increased. If the platelet count becomes high enough, treatment may be stopped but may also be restarted if necessary.\n During therapy with IL-11, additional blood samples (1 teaspoon each) will be collected to measure the platelet count every week until the platelets are stable and then every 2 to 6 weeks while you are receiving treatment on study. No other tests are required for this study.\n While you are on this study, you will continue your treatment with imatinib mesylate or other tyrosine kinase inhibitor as decided by your doctor for standard care.You will be taken off if there is no response to treatment or if there are unacceptable side effects. There will be no follow-up after you go off study.\n This is an investigational study. The Food and Drug Administration (FDA) has approved IL-11 for use in chemotherapy-caused low platelet counts. A maximum of 30 patients will take part in this study. All will be enrolled at M. D. Anderson.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - CML patients in chronic or accelerated phase receiving treatment with imatinib mesylate (Gleevec), or other tyrosine kinase inhibitors such as AMN107, dasatinib, or SK1606.\n - Grade >/= 3 thrombocytopenia (platelets <50 * 10(9)/L) after the first 4 weeks of therapy with the tyrosine kinase inhibitor. Thrombocytopenia must be either recurrent (i.e., second or greater episode of grade >/= 3 thrombocytopenia) or having required dose reductions of the tyrosine kinase inhibitor.\n - Signed informed consent.\n - Expected to have therapy with imatinib continued for > 3 months.\n Exclusion Criteria:\n - Known allergies to E. coli.\n - New York Heart Association (NYHA) class III or IV.\n - Patient has known hypersensitivity to Neumega or any component of Neumega.\n - Thrombocytopenia that is considered to be unrelated to treatment with imatinib.\n - Stem cell transplantation within 60 days.\n - History of atrial arrhythmias\n - Pregnancy\n - Papilledema\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nUracil and Tegafur/Leucovorin (UFT/LV) Versus UFT/LV+ Polysaccharide-K (PSK) for Stage IIIa/IIIb Colorectal Cancer\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to conduct a randomised controlled trial (RCT) comparing UFT/LV and UFT/LV + PSK in patients with histological stage IIIa/IIIb colorectal cancer who have undergone curative surgery without residual cancer using 3-year disease free survival (DFS) as the primary endpoint, and also to analyze the 3-year overall survival (OS), compliance, adverse events, quality of life (QOL) and relationship with tumor factors.\n\n**Clinical Trial Detailed Description:**\n\nTo conduct a randomized controlled trial comparing chemotherapy using UFT/LV and immunochemotherapy using UFT/LV combined with PSK in patients with histological stage IIIa and IIIb colorectal cancer (adenocarcinoma) who have undergone curative surgery without residual cancer (R0) using 3-year disease-free survival rate as primary endpoint, and also to analyze the 3-year overall survival, compliance, adverse events, QOL and relationship with tumor factors.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patient with a histological diagnosis of primary colon or rectal cancer (adenocarcinoma)\n - Patient with histological stage IIIa or IIIb cancer (according to the Japanese Classification of Colorectal Cancer, 7th edition)\n - Patient who has undergone curative surgery with no residual cancer\n - Pretreatment criterion: patient who has not undergone preoperative cancer treatment (radiotherapy, chemotherapy or immunotherapy)\n - Patient who is at least 20 years and below 80 years of age\n - Patient with performance status (PS) of 0-1 (according to Eastern Cooperative Oncology Group, ECOG)\n - Restrictions of concomitant medications and therapies: except in the case of metastasis or recurrence, concomitant use of other chemotherapeutic and immunotherapeutic agents that may affect the results of this trial, and concomitant use of radiotherapy are prohibited in principle.\n - Organ function (laboratory data): patient who satisfies the following conditions or data of laboratory tests conducted within 2 weeks prior to start of trial\n - Gastrointestinal function: no diarrhea (watery stool)\n - White blood cell count: > 4,000/mm3\n - Platelet count: > 100,000/mm3\n - Serum GOT and GPT: < 100 IU/L\n - Serum total bilirubin: < 2.0 mg/dL\n - Serum creatinine: below the upper limit of facility normal range\n Exclusion Criteria:\n - Patient with residual cancer (R1 or R2)\n - Patient with anal canal lesion (P) or perianal skin lesion (E)\n - Patient with stricture and not capable of oral intake\n - Patient passing fresh blood from the gastrointestinal tract\n - Patient with retention of body cavity fluid necessitating treatment\n - Patient with infection, intestinal palsy or intestinal occlusion\n - Patient with active multiple cancers or patient who has less than 5 years of remission from a metachronous cancer (except carcinoma in situ and skin cancer)\n - Patient who is pregnant or wishes to become pregnant during this trial\n - Patient on continuous insulin treatment for diabetes or has poorly controlled diabetes\n - Patient with a history of ischemic heart disease and judged to have difficulties to participate in this trial\n - Patient with concurrent psychiatric disease or neurological symptoms and judged to have difficulties to participate in this trial\n - Patient on continuous steroid therapy\n - Patient with a history of serious drug allergy\n - Patient who is judged for other reasons by the investigator or doctor in charge to be inappropriate as a subject\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nEvaluation of Intraprostatic Fiducial Markers For External Beam Radiation Therapy\n\n**Clinical Trial Summary:**\n\nThe goal of this clinical research study is to evaluate a system for localizing (targeting for treatment) the prostate for external beam radiation therapy. The system will be used to locate the prostate before treatment and to measure movement of the prostate during treatment. The data collected with the system will be compared to CT images taken during the course of your radiation therapy treatment. Researchers will try to use this information to verify the performance of the system, which could lead to improved positioning and tracking of the prostate during treatment.\n\n**Clinical Trial Detailed Description:**\n\nThe prostate may change position on a day-to-day basis due to differences in positioning, muscle tone, rectal filling, and bladder filling. Soft tissue like the prostate is not usually visible with normal x-rays, but certain metals like gold are visible. Many institutions are using an FDA-approved system (fiducial system), the one being used in this study, which involves implanting small gold markers to locate the prostate on a daily basis. This system allows the prostate to be located before treatment, which may improve radiation delivery to the prostate and decrease radiation exposure to normal tissue such as the rectum and bladder. The ability of this system to provide information on the location of the prostate before treatment should allow for more precise and accurate radiation treatment of prostate cancer.\n The small implanted gold markers are 3 mm long and 1 mm wide (about the size of a grain of rice). If you agree to take part in this study, 3 markers will be permanently implanted into your prostate using a needle similar to the biopsy needle used to diagnose your cancer.\n Treatment for prostate cancer during this research study will not be different from the MD Anderson standard of care. You will have intensity-modulated radiation therapy (IMRT) treatment for the prostate cancer performed using the CT-Linac treatment machine (ExaCT, Varian Medical Systems, Palo Alto, CA). This machine will have the same IMRT capabilities as other treatment machines in the Radiation Oncology Department.\n During the study, the position of the gold markers seen on x-ray will be used to make adjustments to the position of your prostate for your radiation therapy treatment. The positions reported by the fiducial system will be recorded and used for daily treatment.\n Three (3) times per week, you will have a CT scan of your prostate. The CT scans will be performed just before the delivery of radiation. Radiotherapists will assist you onto the treatment table and position it for your treatment. The treatment table will then be rotated 180 degrees from the treatment machine and the CT scan of your prostate will be performed. After the CT scan, which will take about 5-8 minutes, the couch will be rotated back to the original position.\n A trans-abdominal ultrasound of your prostate will also be performed twice per week for the first two weeks and then once a week from then on while you are on study. The MD Anderson staff and researchers will analyze the changes in prostate movement during radiation therapy using the scanned CT images and ultrasound images and compare them with positional changes displayed by the fiducial-based system.\n Targeting of your prostate on a daily basis will be performed using the fiducial-based system. This will involve performing a pair of x-rays before your treatment. A shift will be made if needed using the implanted prostate markers. The position of the seeds after the shift will be routinely verified with another pair of x-rays. After alignment has occurred, a radiation treatment will then be delivered.\n This is an investigational study. The fiducial-based system is FDA-approved. A total of 20 patients will take part in this study. All will be enrolled at MD Anderson.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Patients with pathologic diagnosis of prostate cancer.\n 2. Patients must plan to have external beam radiation as the definitive treatment for their prostate cancer with daily localization.\n 3. Patients must be able to tolerate transrectal or transperineal implantation of three fiducial markers into the prostate.\n 4. Patients must be able to tolerate frequent (e.g. three CT scans per week) CT scanning.\n 5. Patients must be able to lie flat and still for the duration of the fiducial-based localization and CT scanning sessions.\n 6. Patients must have anatomy that will allow an adequate pelvic image on portal imaging and CT scanning.\n 7. If patients received hormone therapy, then it must have started more than 8 weeks prior to implantation of fiducials.\n 8. Patients on hormonal therapy at the time of simulation must remain on hormone therapy until their radiation course is complete.\n 9. Patients must understand and sign informed consent.\n Exclusion Criteria:\n 1. Patients who are not candidates for trans-rectal prostate biopsy or cannot tolerate placement of three fiducial prostate markers.\n 2. Patients with an estimated prostate volume of less than 20 cc.\n 3. Patients who have had prior prostate surgery or are planned to have prostate surgery for prostate cancer.\n 4. Patients who have had previous radiation therapy to the pelvis.\n 5. Patients who have had prior prostate brachytherapy implant or who have a planned course of therapy using prostate brachytherapy (permanent seeds or high dose rate).\n 6. Patients with a body habitus that the CT bore of the CT/Linac treatment machine cannot accommodate (i.e. height greater than 6' 3\" or body weight greater than 300 pounds).\n 7. Patients on anticoagulant medication (e.g., coumadin, clopidogrel, low-molecular weight heparin) other than aspirin will not be eligible. Patients on aspirin should discontinue aspirin 7 days prior to fiducial placement and for 5 days afterward.\n 8. Patients with hip prostheses will not be eligible.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nPost-Operative Chemoradiation for Extremity & Trunk Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nThe goal of this clinical research study is to learn if the combination of radiation therapy plus low dose doxorubicin chemotherapy given after surgery is effective in the treatment of sarcoma. The safety of this treatment will also be studied.\n\n**Clinical Trial Detailed Description:**\n\nDoxorubicin is a drug that is commonly used to treat certain kinds of cancer.\n The radiation treatment and chemotherapy will start around 4-6 weeks after surgery. During the study, you will receive radiation treatments 5 days a week for 6 - 61/2 weeks. On Day 1 of each week of radiation therapy, you will be given doxorubicin through a continuous injection into a vein for 4 days in a row. A special tube is placed into a large vein in the neck or chest region or through a large vein in the arm. This is called a central venous line. A small pump is then used to give the drug. This pump is about the size of a pack of cigarettes. You will receive appropriate instructions for the maintenance of the pump. The doxorubicin and radiotherapy will be given on an outpatient basis at M. D. Anderson.\n If the disease gets worse or you experience any intolerable side effects, chemotherapy and/or radiation therapy may be stopped and you may be taken off the study. At that time, your doctor will discuss other treatment options with you.\n Before the start of each week of treatment, you will have a physical exam and blood tests (around 2 tablespoons). You will also have a MRI to check on the status of the disease.\n After the study, you will have follow-up visits at M. D. Anderson every 3-4 months for the first 2 years after the study then every 6 months for the next 3 years. After that you will have follow-up visits once a year for the rest of your life to check on the status of the disease. At every follow-up visit you will have ultrasound scans. You will have a MRI at the first follow-up visit then only when the doctor feels it is necessary.\n This is an investigational study. Doxorubicin is FDA approved and is commercially available. Up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. All patients with cytological or histological proof of large (> 5 cm), completely resected soft tissue sarcoma of the extremity or trunk (AJCC Stage IB, IIA, IIC, and III) will be eligible. Patients with stage IV sarcoma who are considered for primary tumor treatment with surgery and postoperative radiation are also eligible.\n 2. Patients who have undergone pre-referral surgical resection or excisional biopsy with no measurable residual disease on appropriate radiological imaging will be eligible. The adequacy of the surgical resection will be evaluated at MDACC and re-excision will be performed as necessary. Negative surgical resection margins are desirable; positive margins, however, are allowable if re-excision would result in functional deficit.\n 3. Patients may have received prior doxorubicin-based systemic chemotherapy up to a total doxorubicin dose of 450 mg/m2. Inclusion of patients with a prior history of malignancy will be at the discretion of the Study Chairman.\n 4. Patients must have a Karnofsky P.S. of > 70 or a Zubrod P.S. of 0 or 1.\n 5. Absolute neutrophil count must be > 1,500 cells/mm; platelet count > 100,000 platelets/ml; serum creatinine < 1.8 mg/dl, serum glutamate oxaloacetate transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) < 3 x normal, total bilirubin < 1.5 mg/dl. For patients with cumulative doxorubicin 400 - 450 mg/m2, EF > 50%.\n 6. EKG (within 6 weeks of the planned start of treatment).\n 7. Echocardiogram or multiple gated acquisition scan (MUGA) (if prior doxorubicin treatment or history of either myocardial infarction or congestive heart failure).\n 8. Patients must have no uncontrolled co-existing medical conditions.\n 9. Women of childbearing potential must not be pregnant or breast feeding and must practice adequate contraception.\n 10. All patients must sign an informed consent.\n Exclusion Criteria:\n 1) Patients with a history of prior radiotherapy in the area of the primary tumor or those in whom the anticipated radiation field would include the perineum, scrotum, or vaginal introitus will not be eligible.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nPhase II Study of TS-1 Therapy and TS-1+PSK Therapy Against Advanced Gastric Carcinoma\n\n**Clinical Trial Summary:**\n\nA randomized controlled study is conducted on unresectable advanced gastric carcinoma and recurrent gastric carcinoma to compare TS-1 therapy with TS-1 + PSK therapy. The primary endpoint of this study is progression-free survival (PFS), with secondary endpoints of anticancer effect, time to treatment failure (TTF), QOL (FACT-BRM), compliance, adverse drug reactions and immunological factors.\n\n**Clinical Trial Detailed Description:**\n\nTegafur / gimeracil / oteracil potassium (TS-1) is widely used as a first-line drug for unresectable advanced gastric carcinoma and recurrent gastric carcinoma in Japan and the response rate of TS-1 against gastric carcinoma was reported to be excellent at 46.5% in a phase II study. However, since adverse drug reactions tend to occur in patients treated with standard regimen of TS-1, drug reduction or discontinuation is often required, which is one drawback of this drug. On the other hand, although Krestin (PSK) has been reported to show survival effects in postoperative immunochemotherapy against gastric carcinoma, the efficacy of PSK has not been established in patients with unresectable advanced gastric carcinoma and recurrent gastric carcinoma. Since the main effect of PSK was to recover physiological functions, including immune function of the host, it was expected that PSK would improve the compliance of TS-1 by alleviating adverse drug reactions of TS-1 therapy and the concomitant use of TS-1 with PSK would result in the improvement of treatment results. Therefore, we decided to conduct a randomized phase II study on patients with unresectable advanced gastric carcinoma and recurrent gastric carcinoma to compare TS-1 therapy with TS-1+PSK therapy.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patients with unresectable advanced gastric carcinoma and recurrent gastric carcinoma.\n - Patients who are 20 years old or older at the time of obtaining consent.\n - Patients who have not received prior treatment, including radiotherapy, chemotherapy and immunotherapy, before the start of treatment (however, patients are excluded when six months or more have passed since they received postoperative adjuvant chemotherapy.)\n - Patients who do not develop metachronous or simultaneous multi cancer.\n - Patients who do not show severe impairments in renal function, liver function and bone marrow function and who maintain the major organ functions which meet all requirements as described below (laboratory values are values measured before the start of protocol treatment and should be updated ones which are measured within two weeks before protocol treatment is started.) WBC counts: >= 3,000 /mm3 and < 12,000 /mm3 Neutrophil counts (ANC): >= 1,500 /mm3 Platelet counts: >= 100,000 /mm3 Amount of hemoglobin: >= 8.0 g/dL Serum GOT and GPT: Less than 100 IU/L Serum total bilirubin: Less than 1.5 mg/dL Serum creatinine: Less than 1.5 mg/dL\n - Patients whose performance status scores are 0 to 2.\n - Patients who are judged that they can endure this treatment in a comprehensive manner and who have provided written informed consent to participate in this research.\n - Presence or absence of measurable lesion does not matter, but if there are measurable lesions in patients, the lesions should be confirmed within 28 days before the enrollment.\n Exclusion Criteria:\n - Patients with fresh blood in the digestive tract.\n - Patients with body fluids which require treatment.\n - Patients with infectious disease, intestinal paresis and ileus.\n - Patients with diarrhea (watery stool).\n - Female patients who are pregnant or want to become pregnant during this study or male patients who intend to make someone pregnant during this study.\n - Diabetic patients who are being treated with insulin or are poorly controlled.\n - Patients with ischemic heart disease which require treatment\n - Patients who are complicated with psychosis and judged that it is difficult for them to participate in this study.\n - Patients who continue to receive steroids.\n - Patients who have experienced serious drug allergy in the past.\n - Patients who are taking health foods including agaricus which are considered to have immunostimulating effects.\n - Patients judged to be inappropriate for this study by investigators and sub-investigators.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nForeshortened Esophagus and Its Surgical Therapy\n\n**Clinical Trial Summary:**\n\nBackground The existence, diagnosis and treatment of short esophagus is one of the controversies of the past which has recently re-emerged The missed diagnosis of short esophagus and the consequent inadequacy of treatment is one of the major causes of failure of antireflux surgery.\n The daily clinical practice of surgeons dedicated to therapy of esophageal diseases could take advantage of the definition of frequency, preoperative predictors, intraoperative management and post operative outcomes of cases of foreshortened esophagus, in order to offer the patient affected by GERD the elements necessary for a conscious choice of therapy and to plan the best performance of the surgical procedure.\n Aims of the Study To define the percentage of cases among the total of antireflux procedures performed, in which, after standard isolation of the ge junction and eventual dissection of the mediastinal esophagus at least two centimetres of esophagus can not be replaced without any applied tension below the apex of the diaphragmatic hiatus.\n To define the percentage of surgical procedures aimed to treat electively a condition of non reducible G-E junction and foreshortened esophagus, among a multicentric formed case series of patients submitted to antireflux surgery.\n To define the preoperative clinical and instrumental predictors for a surgical procedure aimed to treat foreshortened esophagus.\n To record the intra-operative, postoperative, 6 month and 12 month outcome of procedures adopted for the surgical treatment of GERD.\n Materials and Methods The study will comprise patients in which surgical therapy for GERD is indicated according to the international guidelines and the Centres policy .\n Patients will be submitted to the antireflux procedure chosen by the surgeon according to the internationally recognized scientific surgical principles and the personal judgement.\n The preoperative study and the postoperative follow up adopted in the present study are accepted by the Centres as they correspond to the international guidelines and the Centres' current practice criteria for the surgical treatment of GERD.\n\n**Clinical Trial Detailed Description:**\n\nINTRODUCTION The existence, diagnosis and treatment of short esophagus is one of the controversies of the past within esophageal surgery which has recently re-emerged. This entity was described in detail by radiologists in the 60's. Many surgeons confirmed its existence in the operating room, describing the clinical, anatomical and surgical patterns along with the modalities of surgical treatment of shortened esophagus following progressive fibrosis and retraction of the esophageal wall consequent to severe long standing gastro-esophageal reflux disease (GERD). Contrarily other surgeons denied its existence claiming that the gastro-oesophageal junction can be reduced into the abdomen without tension in virtually all patients and that the esophagus is, in fact, not shortened. In the case series of open antireflux surgery, the percentage of dedicated procedures aimed to treat the condition of non-reducibility of the gastro-esophageal junction (GEJ) below the diaphragm is highly variable.\n In the present era of minimally invasive antireflux surgery, short esophagus again seems to originate controversy and open debate. Many thousands of laparoscopic standard antireflux operations have been performed in the world and numerous articles report satisfactory short and medium-term functional results in over 90% of cases, although in these experiences the need for a tailored approach has not emerged. However, in the last two or three years, many reports on the diagnosis and laparoscopic management of shortened esophagus in GERD surgery have been published.\n The controversy is based on four facts.\n 1. If the indications for surgical therapy of GERD are restricted to severe, long standing cardial incontinence and to the complications associated with a hiatus hernia, then the number of patients with panmural esophagitis and esophageal shortening will be higher in percentage than if the indications are open also to refluxers otherwise treatable with intermittent low dosage medical therapy\n 2. The clinical-instrumental predictors of esophageal elastic or fibrotic shortening are not defined and current studies adopt different evaluation criteria\n 3. The perception of \"excessive tension\" of the fundoplication at the operating table is highly subjective.\n 4. During the process of progressive shortening of the esophagus, the portion of the fundus attracted above the diaphragm may take the appearance of a funnel hardly distinguishable from a thickened oesophagus. Therefore the gastric fundus may be erroneously wrapped around the herniated stomach.\n Preoperative assessment of the length of the esophagus in order to decide which surgical technique to adopt is controversial. Yau et all. demonstrated that there is an association between esophageal shortening measured by standard manometry and postoperative para-esophageal herniation, but this increased risk is small. Predictors of the need for esophageal lengthening procedure are para-esophageal hernia, Barrett's esophagus and failed antireflux surgery. However no preoperative assessment can give information on the degree of elasticity or fibrosis of the esophagus.\n Through laparoscopic surgery, by cranially distending the diaphragmatic hiatus the pneumoperitoneum may by artefact increase the length of the intra-abdominal esophagus, and the impossibility to manually palpate and feel the tension applied to the esophagus to bring the GEJ below the diaphragm may make it difficult to recognize a condition of shortened esophagus, more so if the experience of the surgeon is not adequate.\n On the basis of a radiological classification used since the sixties, later validated with a radiological-manometric study it was demonstrated that the progressive orad migration of the GEJ is associated with an increasing severity of cardial incontinence and gastro-esophageal reflux.\n Recent studies have shown that the permanent orad displacement of the GEJ across or above the diaphragm is not infrequent in patients affected by various grades of GERD and that it is present in 50% of patients undergoing antireflux surgery for severe, not otherwise manageable GERD. Up to 25% of patients may require a procedure of lengthening of the esophagus in order to place the fundoplication below the diaphragm without tension.\n The missed diagnosis of short esophagus and the consequent inadequacy of treatment is one of the major causes of failure of antireflux surgery.\n As the number of antireflux operations, mainly laparoscopic, performed per year has remarkably increased, the issue of the so-called short esophagus is today one of the major points in the management of antireflux surgery, which deserves reappraisal and definitive clarification.\n The daily clinical practice of surgeons dedicated to therapy of esophageal diseases could take advantage of the definition of frequency, preoperative predictors, intraoperative management and post operative outcomes of cases of foreshortened esophagus in order to offer the patient affected by GERD, the elements necessary for a conscious choice of therapy, whether medical or surgical and to plan the best performance of the surgical procedure.\n AIMS OF THE STUDY Principal aim\n 1. To define the percentage of cases among the total of antireflux procedures performed, in which, after standard isolation of the ge junction and eventual dissection of the mediastinal esophagus at least two centimetres of esophagus can not be replaced without any applied tension below the apex of the diaphragmatic hiatus.\n Secondary aims\n 2. To define the percentage of surgical procedures aimed to treat electively a condition of non reducible, foreshortened esophagus, among a multicentric formed case series of patients submitted to antireflux surgery;\n 3. To define the preoperative clinical and instrumental predictors for a surgical procedure aimed to treat foreshortened esophagus;\n 4. To record the intra-operative, postoperative, 6 month and 12 month outcome of procedures adopted for the surgical treatment of GERD;\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - patients aged > 18 years, undergoing surgery for the treatment of GERD, of massive incarcerated hiatus hernia ± GERD, in which a laparotomic, laparoscopic or thoracotomic approach is preoperatively indicated.\n Exclusion Criteria:\n - association of GERD with epiphrenic esophageal diverticulum, collagen diseases, undetermined esophageal motility disorders;\n - redo antireflux surgery, previous surgery on the thoracic and abdominal esophagus and stomach, on the diaphragm.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nAssessing Outcomes After Surgery for Gastroesophageal Reflux Disorder\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to review pre-operative studies and patient evaluation reports and compare those with the results of the post-operative studies, patient evaluation reports and subjective patients' outcomes following laparoscopic surgery for gastroesophageal reflux disorder. This will allow us to evaluate how patients have benefited from the procedure.\n\n**Clinical Trial Detailed Description:**\n\nThis study will include all patients who have laparoscopic surgery for gastroesophageal reflux disorder. Patients who participate will be asked to answer questionnaires regarding symptoms of reflux before and after surgery. In addition medical charts will be reviewed for relevant data.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - patients must have GERD and must plan to have laparoscopic surgery for GERD.\n - patients must be at least 18 years of age\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nImpact of GERD on Daily Life (NIS)\n\n**Clinical Trial Summary:**\n\nThe aim of this study is to gather epidemiological data in a population of GERD patients in primary care with a history of erosive esophagitis (less than or equal to 3 years).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patients with erosive esophagitis (endoscopical findings according to the Los Angeles Classification; grade A-D) currently not treated with a proton pump inhibitor, for whom the general practitioner (GP) has decided to initiate or change the treatment for GERD\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nAn Efficacy and Safety Study of XP19986 in Subjects With Symptomatic GERD\n\n**Clinical Trial Summary:**\n\nTo evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with symptomatic GERD\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - History and documentation of GERD diagnosed by a gastroenterologist, with symptoms (heartburn and/or regurgitation) on ≥ 3 days during the week prior to screening and prior to randomization\n Exclusion Criteria:\n - Current or historical endoscopic evidence of erosive esophagitis LA Classification Grade B, C, or D\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nSThe Effects of Melatonin on GERD Symptoms\n\n**Clinical Trial Summary:**\n\nWe hypothesize that melatonin as compared to PPI and to placebo, improves GERD symptoms by decreasing esophageal acid exposure and esophageal acid sensitivity in GERD. We hypothesize that melatonin as compared to PPI and to placebo reduce the frequency and duration of transient lower esophageal sphincter relaxations (TLESRs). In addition we hypothesize that melatonin as compared to PPI and to placebo improves quality of life and quality of sleep of GERD patients.\n\n**Clinical Trial Detailed Description:**\n\nBackground: Gastroesophageal reflux disease (GERD) is a chronic, persistent and common medical problem. The standard of care for GERD includes chronic administration of acid-suppressive drugs. However, clinical failure in GERD is increasingly reported.\n Aim: To determine the efficacy of treatment with melatonin as compared to standard dose proton pump inhibitor (PPI) as compared to placebo in patients with GERD.\n Study objectives: [1] To compare the degree of GERD symptoms improvement and esophageal acid sensitivity before and after treatment. [2] To determine the effect of treatment on the % total, upright and supine time pH <4 using 24-hour esophageal pH monitoring. [3] To determine the effect of treatment on frequency and duration of lower esophageal sphincter relaxation. [4] To compare the quality of life and quality of sleep in GERD patients before and after treatment.\n Methods: This is a randomized, double blind, parallel groups study of 150 patients with GERD. Patients with classic heartburn symptoms (heartburn and/or regurgitation) and normal upper endoscopy from the gastroenterology department at Rabin Medical Center will be enrolled into the study. At baseline, all enrolled patients will have 24-hour esophageal pH monitoring and a modified acid perfusion test to assess the extent of distal esophageal acid exposure and esophageal acid sensitivity, respectively. Patients will be evaluated by a demographics questionnaire, the GERD Symptom Questionnaire, the Quality of Sleep questionnaire and the SF-36. Baseline urinary excretion of the main melatonin metabolite, 6-sulfatoxymelatonin (6SMT) will be assessed in all subjects at baseline. Patients will be randomized to either melatonin or standard dose PPI or placebo over a period of 4 weeks. In addition patients will fill a diary on a daily basis that documents severity and frequency of GERD-related symptoms. Symptom score (frequency x severity) will be calculated for previous 7 days at baseline and at the end of treatment in all groups. After 4 weeks of treatment, patients will undergo a second 24-hour esophageal pH monitoring, a modified acid perfusion test and will complete the GERD Symptom Questionnaire, the Quality of Sleep Questionnaire and the SF-36.\n Implications: This study will determine if melatonin decreases GERD symptoms, acid esophageal exposure and improves quality of life and sleep in patients with GERD. Furthermore, if there will be a significant clinical response to melatonin it will be possible to add this compound to the treatment armamentum of GERD.\n\n**Clinical Trial Eligibility Criteria:**\n\nINCLUSION CRITERIA:\n - Ages 18-75.\n - Male or female.\n - GERD symptoms at least twice a week for the last three months.\n - Able to read, understand and complete study questionnaires and diary\n - Understand the study procedures and sign written informed consent.\n - Able to comply with all study requirements.\n EXCLUSION CRITERIA:\n - Subjects with erosive esophagitis (EE), Barrett's esophagus (BE) and esophageal stricture or adenocarcinoma on upper endoscopy.\n - Subjects with previous upper gastrointestinal surgery.\n - Subjects with clinically significant medical conditions (cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic and psychiatric); examples as follows: liver cirrhosis, severe COPD, severe renal failure, severe heart failure, active malignancy.\n - Subjects requiring narcotics (morphine, methadone, etc.).\n - Subjects requiring melatonin\n - Subjects with diabetes, scleroderma and neuromuscular disorders.\n - Lactating or pregnant women.\n - Subjects with an unrecognized lifestyle such as shift workers.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nLIFE NIS, GERD-Patients - Evaluation of Burden of Disease Determined by GERD Impact Scale (GIS)\n\n**Clinical Trial Summary:**\n\nEvaluate burden of disease in Patients with newly occurred upper GI symptoms related to GERD (symptom frequency & severity, QoL, lifestyle modifications, self-medication) - baseline data according to GERD impact scale presenting to specialists, especially internists\n - Evaluate effect of treatment with a acid suppressive therapy on these parameters: looking for improvement of symptom burden and quality of life according to the GERD impact sca\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patients with newly occured upper GI symptoms related to GERD\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nGemcitabine Hydrochloride and Tanespimycin in Treating Patients With Stage IV Pancreatic Cancer\n\n**Clinical Trial Summary:**\n\nThis randomized phase II trial is studying three different schedules of gemcitabine hydrochloride and tanespimycin to see how well they work in treating patients with stage IV pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and tanespimycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\n I. To assess the effect of gemcitabine hydrochloride and tanespimycin (17-AAG) on 6-month survival rate in patients with stage IV pancreatic adenocarcinoma.\n SECONDARY OBJECTIVES:\n I. To determine the overall survival of these patients. II. To determine the time to disease progression (TTP) in these patients. III. To determine the confirmed response rate and duration of response in these patients.\n IV. To determine the time to treatment failure in these patients. V. To determine the adverse events in these patients.\n TERTIARY OBJECTIVES:\n I. To determine the effects of treatment on molecular targets, such as CDK4, akt, phospho-akt, Hsp90, Hsp70, and CHK1, and correlate these with clinical endpoints, including survival at 6 months, TTP, response rate, and overall survival.\n II. To determine the effect of gemcitabine hydrochloride metabolizing enzyme genotype on toxicity, and clinical outcome.\n OUTLINE: This is a multicenter study. Patients are stratified according to Eastern Cooperative Oncology Group (ECOG) performance status (0, 1, or 2). Patients are randomized to 1 of 3 treatment arms.\n ARM I: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on day 9 of course one.\n ARM II: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9 of course one.\n ARM III: Patients receive gemcitabine hydrochloride IV over 30 minutes on day 8 and tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.\n Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and periodically during treatment for pharmacogenetic studies. Tumor tissue samples that are available are also collected for laboratory studies. Samples are analyzed for number of circulating tumor cells, levels of intracellular targets (e.g., CDK4, akt, phospho-akt, Hsp90, Hsp70, and CHK1), single nucleotide DNA polymorphisms, and Vav1 expression. Samples are analyzed by reverse transcriptase-polymerase chain reaction, immunofluorescence, and immunohistochemistry.\n After completion of study treatment, patients are followed periodically for up to 2 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Histologically or cytologically confirmed pancreatic adenocarcinoma\n - Clinical stage IV disease\n - No known brain metastases\n - ECOG performance status 0-2\n - Life expectancy ≥ 12 weeks\n - Absolute Neutrophil Count (ANC) ≥ 1,500/mm³\n - Platelet count ≥ 100,000/mm³\n - Total bilirubin normal\n - Aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN)\n - Alkaline phosphatase ≤ 2 times ULN (5 times ULN if liver metastases are present)\n - Creatinine normal\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective contraception\n - Ejection fraction > 40% by echocardiogram\n - Patients who received prior anthracyclines must have a normal ejection fraction by echocardiogram\n - Corrected QT interval (QTc) < 500 msec\n - Pulse oximetry > 88% on room air at rest and after gentle exercise (according to Group Medicare Guidelines)\n - No history of allergic reactions attributed to compounds of similar chemical or biologic composition to tanespimycin (17-AAG) or gemcitabine hydrochloride\n - No known allergy to eggs\n - No concurrent uncontrolled illness including, but not limited to, any of the following:\n - Ongoing or active infection\n - Symptomatic congestive heart failure\n - Unstable angina pectoris\n - Cardiac arrhythmia\n - Psychiatric illness/social situations that would limit compliance with study requirements\n - No active ischemic heart disease within the past 12 months\n - No history of uncontrolled dysrhythmias\n - No congenital long QT syndrome\n - No left bundle branch block\n - No other significant cardiac disease, including any of the following:\n - New York Heart Association class III or IV heart failure\n - Myocardial infarction within the past year\n - Poorly controlled angina\n - Uncontrolled dysrhythmias\n - History of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)\n - No clinically significant interstitial lung disease\n - No symptomatic pulmonary disease requiring medication, including any of the following:\n - Dyspnea\n - Dyspnea on exertion\n - Paroxysmal nocturnal dyspnea\n - Significant pulmonary disease requiring oxygen*, including chronic obstructive/restrictive pulmonary disease\n - No pulmonary or cardiac symptoms ≥ grade 2\n - No history of cardiac or pulmonary toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or vincristine)\n - No prior chemotherapy for metastatic disease\n - No prior radiotherapy to the chest\n - No prior radiotherapy that potentially included the heart in the field (e.g.,mantle radiotherapy)\n - More than 3 months since prior adjuvant chemotherapy or chemotherapy for locally advanced disease\n - More than 3 weeks since prior radiotherapy\n - No concurrent medications that prolong or may prolong QTc\n - No concurrent antiarrhythmic drugs\n - No concurrent prophylactic colony-stimulating factors\n - No other concurrent investigational agents\n - No other concurrent anticancer therapy\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nProtracted Etoposide During Induction Therapy for High Risk Neuroblastoma\n\n**Clinical Trial Summary:**\n\nHigh-risk neuroblastoma is an aggressive childhood cancer that shows up as a lump or mass in the belly or around the spinal cord in the chest, neck, or pelvis. Often the tumor has spread around the body to the bones or to the soft center of the bone, called the bone marrow. High-risk neuroblastoma often responds to treatment at first, but it frequently comes back and may be even more difficult to treat.\n Chemotherapy (drug treatments for cancer) is usually given at high doses in short bursts (3 to 5 days) followed by a few weeks of rest and recovery. This burst and recovery is called a \"cycle\" and usually takes about 21 days. Some scientists and physicians have tried to give chemotherapy at lower doses for more days, called \"metronomic\" chemotherapy. This method of giving chemotherapy has been used to treat neuroblastoma that has failed more standard types of treatment (relapsed neuroblastoma) and has shown some promise for those patients. One of the reasons it may work is by killing the blood vessels that feed the tumor as well as killing tumor cells themselves (the way that burst chemotherapy works). We think that giving a burst of chemotherapy together with metronomic therapy may kill the tumor while decreasing the side effects that we have seen in the past.\n Treatment for high risk neuroblastoma usually occurs in 3 stages: induction, consolidation, and maintenance. During the induction phase, patients will receive chemotherapy and possibly more surgery to get rid of most of the tumor cells. Most of the chemotherapy drugs during induction will be given in the standard burst method. One of the chemotherapy drugs, etoposide, will be given in lower, metronomic doses. The doctors will study how the tumors respond and the side effects patients have. After induction most childrens' tumors will have disappeared, also called remission. These children will receive the second stage of treatment called consolidation. During this stage, subjects will receive radiation treatments to the tumor and then higher doses of chemotherapy. Because of the side effects of the high doses of chemotherapy, we will collect and store some special blood cells (called hematopoietic stem cells) early in treatment and keep them frozen. After the high doses of chemotherapy, these cells will be thawed and given to the subject. . This is called hematopoietic stem cell transplant (HSCT). The final stage of treatment, called maintenance, consists of a drug taken by mouth for 6 months.\n Surgery to remove large, or bulky, tumors is a standard part of treatment for high risk neuroblastoma. A few children can have their main tumor removed before chemotherapy, but most require the tumor to shrink first. Surgery has usually been scheduled for after 3 to 5 cycles of therapy, but no one really knows how quickly the tumors are ready to come out. Because chemotherapy has significant side effects that can change the risks of surgery, we will study how early surgeries to remove tumors can happen.\n This study is being done to evaluate the outcomes of disease response and survival in children with high risk neuroblastoma treated on this regimen.\n\n**Clinical Trial Detailed Description:**\n\nInduction Phase Overview The induction phase is approximately 15 weeks long. Chemotherapy is generally given every 3 weeks, each 3 week block is called a \"cycle\". During these 15 weeks we will treat subjects with chemotherapy 5 times using combinations of 4 different chemotherapy drugs. All IV chemotherapy drugs will be given in the hospital. During this 15 weeks doctors will try to collect special blood cells called hematopoietic stem cells. If the subject's tumor has not been removed completely you will have a surgery to take the rest of the tumor out as soon as possible once it has shrunk with the first two cycles of chemotherapy.\n Induction Phase Chemotherapy During the first 2 cycles of chemotherapy all children will receive two drugs: cisplatin and etoposide. Cisplatin is given through an IV for everyone. If participating in the research treatment plan, etoposide by mouth mouth for 14 days. After the first two cycles we will repeat studies to see if the tumor has shrunk. Then all children will receive two other chemotherapy drugs called cyclophosphamide and adriamycin during the 3rd cycle. If the subject responded to the first two cycles, the 4th cycle will be IV cisplatin and oral etoposide again; if the subject did not respond to the first two cycles, the 4th cycle will be IV cisplatin with standard IV etoposide. The 5th cycle will again be adriamycin and cyclophosphamide.\n If subjects choose not to participate in the research treatment plan, or are not eligible for the research treatment plan, cycle 1, 2, and 4 will be IV Cisplatin and IV Etoposide.\n Here is the induction treatment:\n Treatment #1, 2, and 4:\n Cisplatin and etoposide: Cisplatin will be given once a day for 5 days through an IV. Etoposide will be given either by mouth once a day for 14 days (research treatment plan) or through an IV for 3 days (standard treatment plan).\n Treatment #3 and 5: Cyclophosphamide and adriamycin: Cyclophosphamide and adriamycin are given daily for 2 days, both drugs are given through an IV. Cyclophosphamide may cause irritation of the bladder so another drug called mesna will be given several times after each dose to help prevent this.\n After treatment #3 and #5 patients will receive a drug called G-CSF. It stimulates the body to make white blood cells (infection fighting cells) to help prevent infections that can happen because of chemotherapy. G-CSF is an injection that must be given daily.\n Surgery: If the primary tumor was not removed before chemotherapy,subjects will undergo a second surgery after receiving chemotherapy. Tumor reevaluation is after cycle #2 and if it is resectable subjects will have surgery at that time. If this is not possible images of the tumor will be taken after cycle #3 and again after cycle #5. Surgery will occur as soon as the tumor is resectable\n Stem Cell Harvest Stem cells are special cells that can make all the different types of blood cells. Usually they are found in the bone marrow, but after chemotherapy many more of them are in your blood stream. Between the third and fifth cycles of induction, stem cells will be collected from the blood using a procedure called apheresis. The central line or catheter is connected to a machine that draws some of the subjects blood out of one side of the catheter, filters out the stem cells, and returns the rest of the blood through the other side of the catheter. Each apheresis procedure takes about 4-6 hours. The procedure may need to be done several times to collect enough stem cells.\n The consolidation phase takes approximately 15 weeks to complete and consists of radiation to the tumor followed by high doses of chemotherapy and hematopoietic stem cell transplant.\n HERE IS THE TREATMENT PLAN:\n Local Tumor Radiation:\n Local radiation therapy is given daily for about 2 weeks. Radiation beams will be aimed at the sites of the tumor. Each child's treatment will be designed just for them. The doctor who gives radiation will discuss the therapy in detail. Some children require sedation for radiation therapy. Radiation therapy does not usually require admission to the hospital.\n High Dose Chemotherapy and Hematopoietic Stem Cell Transplant Carboplatin, etoposide and melphalan: Carboplatin and etoposide are given daily for 4 days followed by melphalan for 3 days. Stem cells will be infused after chemotherapy.\n After high dose therapy subjects will receive G-CSF to help stimulate the growth of white blood cells. Other drugs will be used during and after the chemotherapy to prevent or decrease side effects from this treatment. Until the stem cells restore safe levels of blood cells, subjects will need to be hospitalized. This treatment may require hospitalization for 3 to 4 weeks or longer.\n Maintenance Phase Starting approximately 3 months following stem cell transplant subjects will receive six monthly treatments with 13-cis-retinoic acid. 13-cis retinoic acid is a drug closely related to vitamin A and has been shown to help stop the multiplication of any remaining neuroblastoma cells in the body. This drug will be taken 2 times a day by mouth for 14 days and then not take it for the following 14 days. This 28-day cycle will be repeated 6 times.\n AFTER COMPLETING STUDY TREATMENT The consolidation phase of treatment for high risk neuroblastoma lasts about 4 months. The entire treatment will last about 12-14 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n Pts can be enrolled but receive standard etoposide bolus dosing based on clinical conditions at diagnosis (need for emergency intervention because of renal, neurologic, or airway compromise). Pts who meet all other eligibility criteria may also choose to participate in the clinical trial w/o receiving the upfront window protracted dosing of etoposide; these children will receive standard etoposide bolus dosing.\n Less than 18 yo at diagnosis\n DIAGNOSIS Neuroblastoma or ganglioneuroblastoma verified by histology and/or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites.\n Pts with newly diagnosed neuroblastoma and age 365 or more days with the following: * INSS Stage 2a/2b with MYCN amplification , AND unfavorable pathology * INSS Stage 3 with MYCN amplification AND/OR unfavorable pathology\n Pts with newly diagnosed neuroblastoma with INSS Stage 4 are eligible with the following: * Age more than 18 months (greater than 547 days) regardless of biologic features * Age 12 to 18 months (365-547 days) with any unfavorable biologic feature (MYCN amplification, unfavorable pathology and/or DNA index equal to 1) or any biologic feature that is indeterminant/unsatisfactory/unknown.\n Pts with newly diagnosed neuroblastoma and age less than 365 days with INSS Stage 3, 4, 4S neuroblastoma with MYCN amplification (more than 10).\n Pts 365 days or more initially diagnosed with INSS stage 1, 2, 4S who develop distant metastatic disease (meet criteria for INSS stage 4).\n Pts may have had no prior systemic therapy except:\n - Localized emergency radiation to sites of life threatening or function-threatening disease\n - No more than one cycle of chemotherapy according to the intergroup low or intermediate risk neuroblastoma studies prior to determination of MYCN amplification and histology.\n TIME FROM DIAGNOSIS Pts must be entered on this study - Within 3 weeks of diagnosis - After recovery from only 1 cycle of chemo on low/intermediate risk NB therapy, - Within 3 weeks of progression with widely metastatic tumor for INSS stage 1, 2, 4S if they received no prior chemotherapy.\n HEMATOPOIETIC FUNCTION\n - ANC 750/µL or more\n - Plt 75,000/µL or more\n - or bone marrow involvement with tumor.\n LIVER FUNCTION Pts must have adequate liver function defined as\n - Direct Bilirubin 1.5 mg/dL or less\n - AST and ALT 5 x ULN or less\n Pts of childbearing potential must practice an effective method of birth control while on study.\n Exclusion Criteria:\n Patients who do not meet inclusion criteria.\n Patients who are pregnant or lactating are not eligible.\n EXCLUSION CRITERIA UPFRONT WINDOW Patients can be enrolled onto Stratum 1 but receive standard etoposide bolus dosing based on clinical conditions at diagnosis. Patients who meet all other eligibility criteria may also choose to participate in the clinical trial without receiving the upfront window protracted dosing of etoposide; these children will receive standard etoposide bolus dosing.\n Patients whose tumor requires emergency intervention because of spinal cord compression, CNS compromise, or airway compromise.\n Patients requiring dialysis.\n If the patient and/or the patient's legally authorized guardian chose to participate in the clinical trial but chose to not participate in the phase II upfront window.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nComparison of Acid Reflux at Two Levels in the Esophagus Using the BRAVO Capsule\n\n**Clinical Trial Summary:**\n\nThe purpose of this research is to study the level of acid exposure above the gastroesophageal junction and the distal esophagus in patients with reflux symptoms using a capsule type acid measurement system. Patients with reflux symptoms are likely to have more acid reflux just above the junction of the stomach and the esophagus that may help to improve the diagnosis of gastroesophageal reflux disease (GERD). This may help better treat the reflux symptoms.\n\n**Clinical Trial Detailed Description:**\n\nUpper gastrointestinal symptoms and diseases, specifically dyspepsia and acid reflux are common problems faced by the adult U.S. population. These symptoms frequently necessitate an upper gastrointestinal endoscopy, which is performed to rule out anatomic diseases. Moreover, these symptoms can be associated with complications such as erosive esophagitis, Barrett's esophagus, peptic ulcer disease and gastric cancer. The role and the level of acid (pH levels) in patients presenting with these symptoms has been poorly defined in previous studies since they have used catheter based pH systems which provided recordings only for 24 hours, at only a single location in the esophagus or stomach, and has been associated with patient discomfort leading to inconsistent results. This pilot project will attempt to study the level of acid exposure in the distal esophagus and proximal stomach of patients and correlate it with their symptoms.\n Many individuals in the Western world are troubled by heartburn, acid regurgitation, abdominal pain (dyspepsia), or bowel habit disturbances; up to one in two subjects in cross sectional population based studies report such symptoms. Gastro-esophageal reflux (GERD) is probably the commonest chronic disease of the population of the Western world. The reported prevalence of symptomatic GERD has ranged, on average, from 15% to 25%. Similarly, dyspepsia is a common condition in the general population; the reported prevalence range in populations is 15-40%. The majority of patients have functional (or non-ulcer) dyspepsia in that they do not have any underlying structural explanation for their symptoms, such as peptic ulcer disease or reflux esophagitis. However, given the significant morbidity and absence from work associated with the condition, the pathogenesis and treatment of patients with dyspepsia still requires further research. Studies are thus needed to determine the long term effects of these symptoms on healthcare costs but in the short run to determine the correlation of symptoms to acid levels and acid exposure.\n Upper Gastrointestinal Diseases & pH Recording: Continuous esophageal pH recordings are widely used to study GERD and its treatment (5). Gastric pH recordings are less used clinically, but monitoring of gastric pH has been used for the pharmacological comparison of various anti-secretory agents. Continuous pH recordings in the esophagus and stomach are usually displayed as graphs of pH versus time or as percentage of time with pH above or below a particular value (often 4.0).\n Although there is no doubt that gastric acidity is directly involved in GERD pathogenesis, relationships between gastric and esophageal acidity are not clear. Lack of focus on gastric acid may relate to the general belief that gastric acid secretion is usually normal in GERD. Distinct patterns of esophageal acidity in GERD have been previously reported. There is a clear relationship between these descriptors and the present findings of integrated esophageal acidity. Previous pH-based analyses have nicely correlated esophagitis grade with acid exposure, but gastric acidity has been somewhat neglected as the major determinant of esophageal acid exposure in GERD aside from observations that acid inhibition could diminish esophageal acid exposure. Hirschowitz reported basal and pentagastrin-stimulated gastric acid secretion in esophagitis comparable to unspecified medical conditions without esophagitis. Others, however, have reported increased basal, peak, or maximal gastric acid secretion in GERD compared to healthy subjects. In studies of gastro-esophageal reflux, the esophageal pH electrode is traditionally positioned above the proximal limit of the lower esophageal sphincter (LES). This convention was adopted early on to avoid the electrode slipping into the stomach during swallowing when the esophagus shortens by 2-3 cm. As consequence, a conventionally placed electrode will only detect acid refluxing into the distal esophagus if it reaches this point 5 cm above the LES. If acid exposure of the most distal esophagus and proximal stomach is greater than that of the conventional measuring point proximal to the LES, it could have significance clinically. This reflux in the distal esophagus and proximal stomach may explain the high incidence of metaplasia and neoplasia of the most distal esophagus that occurs in the general population.\n Previous studies in patients with dyspepsia have revealed either normal levels of pH or mildly elevated levels in the stomach. The correlation between the symptoms and the acid levels has been tested only in a few previous studies. The most distal esophagus and the gastroesophageal junction is exposed to significant amounts of gastric acid, even in subjects without reflux or dyspeptic symptoms. This is of importance for not only understanding the pathophysiology of these diseases but also for treatment with acid suppressive medication. Data are lacking on the benefits of effective acid inhibition with proton pump inhibitors in dyspepsia. In two large, double blind multicenter clinical trials, BOND and OPERA , patients (n=1262) with functional dyspepsia were randomized to four weeks of treatment with omeprazole 20 mg or 10 mg once daily, or placebo. The primary efficacy variable was complete absence of symptoms. The BOND but not the OPERA trial showed a significant benefit of omeprazole over placebo. Pooling the BOND and OPERA trials, complete relief of symptoms was achieved in 38.2% of the 20 mg omeprazole group (p=0.002) and in 36.0% of the 10 mg omeprazole group (p=0.02) compared with 28.2% in the placebo group suggesting that acid suppression may play a role in the treatment of these symptoms. However, before future treatment studies are conducted, correlation of patient symptoms with levels of esophageal and gastric pH levels will be important.\n Current practice for measuring esophageal and gastric pH: The current catheter based 24-hr pH system involves placement of a catheter into the esophagus and stomach via the nostril. The tip of the catheter has sensors to measure esophageal and gastric pH. The patient is then sent home (after the catheter is placed, tip coming out of one nostril) and is given a box that measures pH exposure. This is uncomfortable to the patient, leading to change in their daily activities, diet, etc. with resulting data probably not reflective of their \"daily habits\". Moreover, since the catheter is passed blindly into the esophagus and stomach, the exact location of pH measurement is probably not accurate.\n The Bravo pH System: The Bravo pH system (FDA approved) is a novel capsule based and wireless testing system, which allows a capsule, size of a kidney bean, to be attached in the esophagus or the stomach once the endoscopy has been performed. This attachment is helped with the use of a small clip, which then detaches and is passed through the patient in the stool. Preliminary studies using this Bravo pH capsule have shown good tolerability of using this, presence of 48-hour results as well as good correlation with acid suppressive therapy in these patients. To study the level of acid exposure in the stomach and the distal esophagus in patients with upper gastrointestinal diseases and symptoms, specifically in those with dyspepsia and acid reflux using a novel pH system.\n Study Design: Patients presenting to the gastroenterology endoscopy unit for upper gastrointestinal symptoms will be invited to participate in the study. The patient's symptoms will be accurately noted using standardized and validated questionnaires. All patients will undergo standard upper endoscopy. The patient demographics including age, gender, ethnicity will be noted. The findings at the time of upper endoscopy such as presence of hiatal hernia, erosive esophagitis, ulcer disease, H. pylori infection, and cancer will be recorded. After the endoscopic procedure is over, two Bravo pH capsules will be placed in the distal esophagus and the proximal stomach after the landmarks have been determined endoscopically. The patients will be provided with a single pH recorder and will be asked to return to the Gastroenterology unit lab, 24-48 hours after placement. Patients will be encouraged to continue with their routine activity including meals. They will fill out a second questionnaire at the end of the study regarding any discomfort that they may have experienced with the Bravo capsule. Data will then be recorded regarding the levels of acid exposure at the sites in the esophagus and stomach, patient demographics and comfort.\n Safety Evaluation: Patients who have undergone Bravo in previous studies have reported chest discomfort, chest pain, abdominal pain, and nausea. No major complications have been reported. Thus, there is not a significant risk to the patient undergoing the procedure, except that of the standard endoscopy, for which they have already been scheduled.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Patients referred for upper endoscopy for any reason including those with acid reflux, dyspepsia, weight loss, Barrett's esophagus,suspected Helicobacter pylori infection.\n 2. Patients able to provide written informed consent.\n Exclusion Criteria:\n 1. Lack of severe comorbid conditions precluding an upper endoscopy.\n 2. Patients with history of esophageal or gastric cancer.\n 3. Patients status post esophageal or gastric resection.\n 4. Patients with esophageal varices.\n 5. Patients with severe esophageal strictures.\n 6. Patients with acute upper gastrointestinal bleeding.\n 7. Inability to provide informed written consent.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nSafety and Efficacy Study of Trabectedin for the Treatment of Localized Myxoid / Round Cell Liposarcoma\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to evaluate the safety and efficacy of trabectedin for the treatment of localized (non-metastatic) myxoid / round cell liposarcoma (malignant tumor derived from primitive or embryonal lipoblastic cells).\n\n**Clinical Trial Detailed Description:**\n\nThis is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), multicenter (when more than one hospital or medical school team work on a medical research study) study of trabectedin for the treatment of localized myxoid / round cell liposarcoma (MRCL). Trabectedin will be given at 1.5 milligram per meter square (mg/m^2) over a 24-hour intravenous (iv) infusion every 3 weeks for a minimum of 3 and a maximum of 6 cycles along with dexamethasone 20 mg iv which will be given within 30 minutes before start of each trabectedin iv infusion. Participants whose myxoid/round cell liposarcoma (MRCL) do not progress at the end of the neoadjuvant treatment will be followed every 6 weeks for disease progression or until 6 months post definitive surgery, in the absence of unacceptable toxicity and/or disease progression. Efficacy will be assessed by determining the pathologic Complete Response (pCR) rate assessed in the tumor surgical specimen by a central pathology review. Participants' safety will be monitored throughout the trial.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Pathological diagnosis of myxoid / round cell liposarcoma (MRCL) and availability of pathology specimens for central review and pharmacogenomic studies\n - Clinical evidence of locally advanced (Stage III), non-metastatic tumor, including locally recurring disease after initial surgery\n - Measurable disease (by Response Evaluation Criteria In Solid Tumors [RECIST])\n - No prior chemotherapy or radiation (except for adjuvant post-operative radiotherapy)\n - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2\n Exclusion Criteria:\n - Known hypersensitivity to any of the components of the trabectedin intravenous (iv) formulation or dexamethasone\n - Pregnant or lactating women and women of reproductive potential who are not using effective contraceptive methods\n - History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 5 years or longer\n - Known distant metastases\n - Other serious illnesses such as congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nRegistry for Patients With Acquired Resistance to Small Molecule Kinase Inhibitors in Non-Small-Cell Lung Cancer\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to try to learn more about how small molecule kinase inhibitors work in treating lung cancer. Some early studies have shown that gefitinib, erlotinib and similar drugs are more likely to work if a particular DNA change (also known as a mutation) is found in a protein that is important in lung cancer. This protein is called the epidermal growth factor receptor (EGFR). Since small molecule kinase inhibitors sometimes stop working, we would like to examine your tumor to learn why these medicines are not working as well. Your tumor will be examined for a variety of things including changes in the DNA of the EGFR. We will also sequence parts of the genes for HER2, HER3, HER4, and KRAS, other proteins thought to be important in lung cancer.\n\n**Clinical Trial Detailed Description:**\n\nThe goal of this protocol is to determine mechanisms of resistance to epidermal growth factor (EGFR) tyrosine kinase inhibitors (EGFR-TKI) in non-small cell lung cancer (NSCLC). A number of trials have shown small molecule kinase inhibitors to be active agents in the treatment of NSCLC [1]. Clinically these drugs have been noted to produce dramatic but infrequent responses. Mutations in the epidermal growth factor receptor have been shown to correlate with sensitivity to gefitinib and erlotinib[2,3]. However, we know that most patients who have initial responses to EGFR-TKI eventually progress. The mechanism of acquired clinical resistance to these inhibitors in patients incompletely understood.\n This is a protocol to study clinical characteristics and biopsy tissue of patients with non-small cell lung cancer who have had previous clinical response to small molecule kinase inhibitors and subsequently experience progression of disease. The tissues and other specimens will be used to carry out laboratory studies to explore the molecular basis of sensitivity and resistance to small molecule kinase inhibitors.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n Patients diagnosed with unresectable or metastatic non-small cell lung cancer (NSCLC) and who fulfill the following eligibility criteria will be considered eligible for this study.\n - Patient must have previously received treatment with small molecule kinase inhibitors targeting at least, in part, EGFR patients may have received other treatments since treatment with small molecule kinase inhibitors including radiation or chemotherapy)\n - Development of disease progression while actively receiving tyrosine kinase inhibitor\n - Signed informed consent\n Exclusion Criteria:\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nEffect of Imatinib on Bone Metabolism in Patients With Chronic Myelogenous Leukemia or Gastrointestinal Stromal Tumors\n\n**Clinical Trial Summary:**\n\nThe drug that you are taking for your cancer, imatinib (GleevecTM), has recently been shown to have some new types of side effects. In some people, imatinib can affect how bones are made.\n The purpose of this study is to find out if imatinib is causing these side effects in you. We can check how your bones form by testing your blood and urine. We can also check your bone strength by doing a special X-ray of your bone called bone density (or DEXA scan).\n\n**Clinical Trial Detailed Description:**\n\nPreliminary data from this institution suggest that imatinib, likely by inhibiting platelet derived growth factor receptor (PDGFR), inhibits bone formation and resorption in a high percentage of patients with either chronic myelogenous leukemia (CML) or gastrointestinal stromal tumors(GIST).1 Some, but not all, patients taking imatinib developed hypophosphatemia but the effect on bone, as measured by markers of bone synthesis and metabolism, was seen in some patients with normal phosphate levels as well. Marked urinary phosphate wasting with elevated levels of parathyroid hormone was seen in nearly all patients. The effect of imatinib on bone may be dose-related. Patients with hypophosphatemia were routinely started on oral phosphate replacement, but follow up determinations of urinary phosphate wasting were not performed.\n The clinical consequences of these abnormalities on bone are not yet known. This trial will study 60 patients with CML in chronic phase, early accelerated phase (as detected by cytogenetics only) or GIST who are already taking imatinib. Parameters relating to bone metabolism will be checked every 3 months for 2 years. We will determine the incidence of bone abnormalities in this treated population, determine whether fasting serum phosphate can predict for changes in bone metabolism, determine whether there is change in bone density by measuring serial bone densitometry, determine whether oral phosphate replacement can restore phosphate balance, and determine whether there is a dose effect of imatinib on parameters of bone metabolism.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patients with CML in chronic phase, accelerated phase based on cytogenetic abnormalities in addition to Philadelphia chromosome but with less than 5 % blasts, or GIST taking imatinib\n - Patients with life expectancy of at least 12 months; patients must be on imatinib at time of study entry.\n - Ability to sign informed consent and/or assent\n Exclusion Criteria:\n - Patients with a known parathyroid disorder; active thyroid disorder except stable, replaced hypothyroidism; Cushing's syndrome; uncontrolled diabetes mellitus (could have unexpected fluid, electrolyte and mineral shifts); sarcoidosis (elevated calcitriol levels from granulomata); hypercalcemia of malignancy (i.e., PTHrP-mediated or extensive bone mets);known tumor-induced osteomalacia; Paget's disease of bone; known X-linged or autosomal dominant hypophosphatemic rickets/osteomalacia; known renal tubular disease (e.g., Fanconi's syndrome); chronic GI malabsorption sydrome.\n - Patients taking oral calcium in excess of calcium 750 mg and Vitamin D 400 mg daily (ie, that contained in a single multivitamin). Patients taking more than these amounts may be eligible for this study if vitamin and mineral supplementation in excess of this is stopped for a minimum of 2 weeks prior to study entry.\n - Patients taking oral or intravenous steroids, calcitonin, any selective estrogen modulating agent such as tamoxifen or raloxifene, gallium nitrate, and other bone seeking radionuceotides, any calcimimetic agent such as cinacalet.\n - Patients who have had prior treatment with cisplatin, carboplatin, oxaliplatin, ifosfamide, or cyclophosphamide.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Model for Genetic Susceptibility: Melanoma\n\n**Clinical Trial Summary:**\n\nThe goal of this study is to find out if some people are more likely to get melanoma, a form of skin cancer, than others are. To do this we will compare people who have had more than one melanoma to people who have had only one melanoma and to people who are similar but who have not developed melanoma.\n People respond to the environment in different ways. Some may be born with genes that make them more likely to get this type of skin cancer. Each person has many ways to repair normal damage to their genes. Specific genes may affect the repair of sun damage. Other genes affect the way the skin itself reacts to the sun. We want to find out which genes have normal changes in them and lead to different responses to exposures, such as the sun. We also want to find out if sun habits are related to the way these genes work.\n\n**Clinical Trial Detailed Description:**\n\nThe purpose of this study is to better understand genetic susceptibility to melanoma and the interactions of specific polymorphisms with each other and with environmental factors.\n To accomplish this, buccal swabs or blood specimens from patients with melanoma (either single primary or multiple primary) have been collected. Specimens will be prepared in the Epidemiology Laboratory at MSKCC. They will be analyzed at MSKCC for INK4A (and functional assays for DNA repair capacity when blood is available) and the melanocortin gene (MC1R), at the University of North Carolina for polymorphisms in DNA repair genes and immune function genes, at the University of Pennsylvania for polymorphisms in the melanocortin receptor gene (MC1R) and immune function genes, and at the University of California (Irvine) for polymorphisms in metabolizing genes (P450's and GST's). Samples will be banked at MSKCC and the University of New Mexico. In order to perform this study, subjects from population-based registries in the United States (New Jersey, North Carolina, Michigan, San Diego/Imperial Counties), Canada (Cancer Care Ontario, British Columbia), Italy (Turin), Australia (New South Wales, Tasmania), were interviewed, asked to provide blood or buccal swab samples and asked to provide permission to obtain and review slides of their primary melanoma. This study is now closed to accrual.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - The subject must have a histologically confirmed invasive first primary melanoma newly diagnosed between January 1, 2000 and December 31, 2000.\n OR the subject must have a histologically confirmed invasive or in situ second primary melanoma newly diagnosed between January 1, 1998 and December 31, 2003. One of the earlier primaries must be invasive melanoma OR the subject must be a randomly ascertained control from the general.\n - The patient must be a resident of a one of the specific geographic areas participating in this study.\n Exclusion Criteria:\n - Subjects who do not speak English or Italian\n - Subject is unable to sign informed consent\n - Subject is unable to participate in telephone interview\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Study to Evaluate the Role of Alternative Medicine in Difficult to Treat GERD Patients\n\n**Clinical Trial Summary:**\n\nPatients with refractory GERD on BID PPI's assigned to the acupuncture group will have significant improvement in their symptoms after receiving acupuncture for 6 weeks as compared to sham acupuncture given for the same duration.\n Primary Aim 1:To determine the efficacy of acupuncture in the treatment of refractory GERD.\n Participants with refractory GERD on BID PPIs randomized to yoga will have a significant relief in the symptoms of reflux.\n Primary Aim 2:To determine the efficacy of yoga in the treatment of refractory GERD.\n\n**Clinical Trial Detailed Description:**\n\nBACKGROUND\n Prevalence and burden of disease:\n Gastroesophageal reflux disease (GERD) defined as presence of symptoms of heartburn and/or acid regurgitation is a common chronic disorder. It is a significant health problem especially in the Western population associated with a huge economic burden and impaired quality of life (1, 2). The prevalence of GERD in the adult population of the United States is 40% (symptoms at least once a month). Approximately 20% report GERD related symptoms weekly while 14% report them on a daily basis.\n The leading gastrointestinal symptoms evaluated in a primary care office setting are those related to a diagnosis of GERD. The mainstay of treatment for GERD symptoms at present time are proton pump inhibitors (PPI) in combination with life style changes. In fact, PPI have become one of the most commonly written prescriptions, trends suggesting that per year scripts have doubled since 1999. It is estimated that Americans spend in excess of 10 billion US dollars/year on PPIs and two of the top five selling drugs in the United States are PPIs (5). For patients who prefer to refrain from long-term medication use, may benefit from acid-reflux surgeries such as Nissen fundoplication. However, acid-reflux reducing procedures are associated with operative morbidity and mortality including several complications including gas bloat syndrome. A large number of patients who undergo surgery for reflux symptoms may eventually relapse and require PPIs. Thus, treatment of reflux, either pharmacological or surgical, is costly (6-9) and presents a significant economic burden on the health-care delivery system.\n Social Impact of the disease:\n GERD symptoms are associated with bodily pain, impaired social, emotional and physical functioning which has a profound impact on daily living. Much research has been done to evaluate the true burden of GERD on our society. For instance, 40% of patients with nighttime symptoms of GERD reported that such symptoms affected their ability to function the next day. Furthermore, 27% of these patients reported that their own night-time symptoms affected their spouses ability to sleep (10). Clearly, this data indicates a huge number of Americans who report the effects of heartburn on personal and spousal quality of life. GERD symptoms need to be addressed effectively as successful treatment for GERD results in improvements in health related quality of life (11, 12). In the treatment of GERD, the goal should be complete symptom resolution as this has been shown to be associated with a clinically significant improvement in health related quality of life (HRQL) (13).\n Refractory GERD:\n Despite life style changes and compliant therapy with PPI, a large number of patients may have persistent symptoms and classified to have refractory GERD, a distinctive group that is difficult to manage (14). The putative reasons remain poorly defined but likely include contributions from factors such as non-acid reflux, visceral hypersensitivity, and abnormal esophageal motor events (14). A study by Tack et al investigated mechanisms for poor response to PPI therapy and showed persistence of acid reflux in 11%, bile reflux alone in 38% and a combination of acid and bile reflux in 26%. However, persistence of acid or bile reflux does not prove a causal relationship with symptoms (15). Also, in this group of individuals with acid or bile reflux on BID PPI's, a possible treatment option is Nissen's fundoplication, the utility of which is yet to be proven in this cohort. There is no consensus definition of refractory GERD and generally, it is defined as non-response of symptoms to optimum PPI trial. The goal of providing symptomatic relief to these refractory patients is extremely challenging in view of limited options. It is to these patients that the investigators would like to evaluate in a feasibility study the use of complementary medicine modalities including acupuncture and yoga that may be relatively safe, cost-effective therapies to help with the distressing symptoms of GERD.\n Complementary and alternative medicine:\n Complementary and alternative medicine (CAM) is a group of diverse medical and health care systems, therapies and products that are not presently considered to be part of conventional medicine. These methods have been used for centuries in the eastern culture for a myriad group of diseases. CAM became popular in the US in the 1990's where majority of people used it as a complement to conventional medicine and not as an alternative (16-18). Recently, there has been much interest in applying these modalities not as secondary therapies to conventional treatment but as the primary method. Amongst them acupuncture and yoga have gained a great deal of popularity.\n Acupuncture (AC):\n Acupuncture is part of the traditional Chinese medicine a complete system of healing that dates back to 200 BC. The general theory of acupuncture is based on the premise that there are patterns of energy flow (Qi) through the body that are essential for health and disruptions of this flow are believed to be responsible for disease. Studies have shown that AC modulates the endorphin system via the central pain processing pathways (19, 20). Acupuncture has been widely used for various gastrointestinal disorders. It is conceivable that acupuncture may be effective in patients with GERD because it has been shown to alter acid secretion, GI motility and visceral pain (21, 22).\n The pathogenesis of GERD is multifactorial. The predominant mechanism postulated to cause GERD is transient relaxation of the lower esophageal sphincter (TLESR). Pathological reflux may also occur due to low LES pressures (23). Studies have shown that acupoint stimulation can decrease the rate of TLESR's and hence prevents reflux (24). The investigators propose to use 3 acupoints ST-36, PC-6, CV-12 for treatment of symptoms of GERD. These points are described in the subsequent sections. Acupuncture will be performed by Dr. Santosh Sharma who has the expertise in this treatment modality and is currently offering his therapy for several years at the Veterans Affairs Medical Center, Kansas City.\n Yoga:\n Yoga refers to a combination of breathing exercises and postures designed to involve specific muscle groups with systemic effects on the various organ systems. Yoga originated in India at least 3000 years ago. The practice of yoga came to US in 1890 and gained popularity in 1960s because of a rising interest in and cultural acceptance of alternative modalities and mind body therapies. Yoga is offered in local YWCA, health clubs and yoga centers and in hospitals as part of disease prevention and management programs (25).The most popular form is Hatha yoga. As discussed below, the usefulness of yoga has been studied in certain chronic illnesses such as back pain with promising results. The investigators propose to use yoga exercises specifically designed for reflux symptoms. Dr. Vijay Kumar will be offering yoga classes to patients with refractory GERD. Dr. Vijay Kumar is a Professor of Computer Science at University of Missouri - Kansas City and has been offering classes for several years at various levels.\n Evidence for use of acupuncture and yoga:\n Several randomized controlled trials have been conducted demonstrating the beneficial effects of acupuncture. A randomized controlled study in 29 patients with mild to moderate ulcerative colitis with a 4 month follow up after completion of acupuncture sessions showed a statistically significant improvement in colitis activity index (CAI) as compared to the control group. The study concluded that acupuncture provided an additional therapeutic benefit to patients with mild to moderate ulcerative colitis (26).\n Another randomized 3-arm study was conducted to assess the efficacy and safety of traditional Chinese acupuncture compared with sham acupuncture (needling at defined non-acupuncture points) and conservative therapy in patients with chronic pain due to osteoarthritis of the knee. Addition of acupuncture led to significant improvement in the symptoms (27). Recently, Dickman et al evaluated the efficacy of adding acupuncture (twice a week over 4 weeks) as compared to doubling the PPI dose in 30 refractory GERD patients(28). The acupuncture group demonstrated a significant decrease in mean daytime heartburn scores compared to high-dose PPI group. Mean nighttime heartburn and regurgitation scores improved only in the acupuncture group. Thus this study showed that adding acupuncture as compared to doubling the PPI dose was more effective in controlling symptoms of GERD in patients on standard dose of PPI.\n Similar benefits have been demonstrated with the use of yoga. A randomized controlled trial compared yoga, exercise and self care book for chronic low back pain showed that yoga was more effective than a self-care book for improving function and reducing chronic low back pain and the benefits persisted for at least several months (29). Yoga was also found to be useful in improving symptoms related to irritable bowel in a randomized trial conducted in Canada (30).\n CLINICAL RELEVANCE OF THIS STUDY GERD is a well known, widely prevalent, clinical entity. The symptoms of GERD if not relieved can affect the daily functioning/productivity of individuals. This can be especially frustrating for some patients, who may spend hundreds of dollars every year on prescription medications, and are still not able to obtain relief of their symptoms. In the United States alone, it is estimated that PPI costs alone make up over $10billion/year (5). However, despite these staggering costs, it is clear that even PPI therapy is not the definitive answer for all patients. Indeed, it has been reported that 37% of patients receiving PPIs also note concomitant antacid use. This finding underscores the fact that even with PPI therapy, a large percentage of patients do not achieve full symptom relief. When left untreated--or when treated inadequately--severe GERD can progress to esophagitis, esophageal ulcers, esophageal strictures, laryngeal disease, chronic cough, Barrett's esophagus, and esophageal adenocarcinoma. Clearly, such patients with refractory symptoms are the ones in the direst need for additional modalities of therapy. Yoga and acupuncture may be a promising option for these patients, as they represent cost-effective, yet underused, options which may be usefully employed to control the symptoms of GERD.\n Data Collection:\n Patient demographics, order of randomization, responses to questionnaires, and antacid use will be collected by the study coordinator and recorded in a database.\n RISK AND BENEFIT TO THE STUDY PARTICIPANT:\n This pilot prospective study has the potential to identify new treatments for GERD symptoms. The participants in this study may experience relief from their GERD symptoms persistent on high dose acid suppressive therapy. This may improve their quality of life and level of functioning. The risks to the study group are minimal. There is minor risk of bruising, needle breakage and infection with the acupuncture needles and musculoskeletal symptoms in patients undergoing yoga. If the study shows significant improvement in reflux symptoms with acupuncture or yoga, then these methods may have a wider application to the entire spectrum of GERD symptoms with the prospect of avoiding pharmacologic and surgical therapies.\n STATISTICAL METHODS AND DATA ANALYSIS:\n Data Analysis:\n Data will be analyzed with the help of a statistical software program. Categorical and continuous variables will be compared using the Student's t-test and chi-square test. A p value of < 0.05 will be considered significant.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - All patients must be a Kansas City VA Hospital patient.\n - 18 yrs or older.\n - agreeable to randomization.\n - patients with refractory GERD on bid PPI.\n - negative endoscopy in the last 5 yrs.\n - able to follow simple instructions and perform simple exercises.\n - capable of giving informed consent.\n Exclusion Criteria:\n - GERD with known complications e.g. peptic stricture.\n - Hepatitis C.\n - HIV.\n - Peripheral neuropathy.\n - Irritable bowel syndrome\n - Previous acupuncture.\n - any other major co morbidity e.g. scleroderma etc.\n - chronic anticoagulation.\n - pregnancy/lactation.\n - prior h/o esophageal surgery.\n - H/o of Barrett's esophagus.\n - Esophageal cancer.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nPhase 2 Study for the Treatment of Superficial Lipomas\n\n**Clinical Trial Summary:**\n\nThe purpose of this research is to compare the safety and effectiveness of 3 different concentrations of deoxycholic acid for injection against a placebo in the treatment of superficial lipomas.\n\n**Clinical Trial Detailed Description:**\n\nA lipoma is a fatty lump typically located on the trunk, shoulder, arms, or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - One or more lipomas, based on clinical and histological diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics:\n - History of slow growth followed by dormancy, and stable for at least 6 months\n - Greatest length multiplied by greatest perpendicular width between 1 and 16 cm², inclusive\n - Discrete, oval to rounded in shape, not hard or attached to underlying tissue\n - Without changes in overlying skin (ie, inflammation, pain or tenderness, hyperpigmentation)\n - Located on the trunk, arms, legs, or neck\n - Signed informed consent.\n Exclusion Criteria:\n - Absence of significant medical conditions that could affect safety\n - History of surgical or deoxycholate treatment for lipomas\n - Treatment with an investigational agent within 30 days before ATX-101 treatment\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nEnvironmental Pollutants and the Risk of Soft Tissue Sarcoma: A Pilot Study\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to assess the feasibility of conducting a large hospital based case control study of the role of dioxins and dioxinlike polychlorinated dibenzofurans (PCDFs) and polychlorinated biphenyls (PCBs).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patients with Soft tissue sarcoma at MSKCC are eligible for this study if they meet the following criteria:\n - Between 18 and 79 years of age\n - were diagnosed within the previous 6 months with primary soft tissue sarcoma of one of the following histologic subtypes: liposarcoma, leiomyoscaroma, MFH, or synovial sarcoma\n - are enrolled in protocol 02-060 (\"Novel Biochemical and Molecularr Determinants for Soft Tissue Sarcoma\"; PI, Dr. Samuel Singer)\n - controls will be eligibile for this study if they meet the following criteria\n - are b/w 18-79 years of age\n - have no prior history of cancer (other than non melanoma skin cancer)\n Exclusion Criteria:\n - Individuals will be excluded if they\n - are unable to sign informed consent for medical or other reasons\n - do not speak english\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nAssociation of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to test whether injected medications will increase the amount of fat released by a fat cell. We will compare prednisolone (a synthetic cortisone) combined with isoproterenol (a drug given for asthma) versus using isoproterenol alone. We will also test if injections of isoproterenol and prednisolone will shrink the size of lipomas, which are benign fatty tumors.\n\n**Clinical Trial Detailed Description:**\n\nLipomas are benign, non-cancerous fatty tumors that occur under the skin and make a bump that can be easily felt and often seen. The current treatment for lipomas is surgery. Isoproterenol, a medication used for the treatment of asthma and approved for injection under the skin, is known to cause fat cells to give up their fat. The fat cells become resistant to isoproterenol with repeated use. Prednisolone, a synthetic cortisone medication used to treat immune problems like allergy and approved for injection under the skin, keeps the fat cells from becoming resistant to isoproterenol. It is not known, if the fat cells in lipomas act like other fat cells or if the combination of isoproterenol and prednisolone injections would shrink lipomas without surgery. This study is designed to test this possibility.\n Subjects will have a screening visit, 2 microdialysis visits a week apart, 20 treatment visits 5 days per week for 4 weeks, and up to 12 follow-up visits a year after treatment visits. During screening, subjects will have a history, physical exam, blood testing, electrocardiogram and a pregnancy testing if female with reproductive capacity. The first microdialysis visit will consist of placing two microdialysis catheters under the skin after the area is numbed. One microdialysis catheter will be in the lipoma and the other under the skin 2 inches away. The microdialysis catheter will connect to a pump, isoproterenol will be infused and the amount of fat breakdown measured. One week later prednisolone will be injected into the lipoma and under the skin 2 inches away. The microdialysis visit will be repeated 24 hours later.\n Treatment will consist of injecting the lipoma 5 days a week with a mixture of isoproterenol and prednisolone in the Pennington clinic as a diabetic would inject insulin. Each week the blood pressure, pulse and lipoma will be measured and subjects will be asked how they feel. At the end of the treatment period the physical examination, blood test and electrocardiogram will be repeated.\n The insertion of the microdialysis probes under the skin into the fat tissue could be uncomfortable, but numbing medication will be injected first to prevent this problem. At higher doses, isoproterenol could lower blood pressure and increase pulse rate. This should not happen at the doses used, but blood pressure and pulse will be monitored throughout the study. Prednisolone, at higher doses, could decrease the body's production of cortisone. This should not happen at the doses being used, but cortisone in the body will be measured during the trial. Blood tests involve the discomfort of a needle going through the skin of the arm, possible bruising and rarely fainting or infection. Trained technicians and sterile needles will minimize these risks.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - You are a man or a woman between the ages of 18-60, inclusive.\n - You have a body mass index (BMI) between 20 and less than 40 kg/m2. BMI is a number calculated from your height and weight.\n - You have a lipoma (a benign fatty tumor) that is 1 inch or more in diameter under the skin of your abdomen or on another area of your body that is easily accessible to study (such as the thigh).\n - You have not gained or lost more than 11 pounds in the last 3 months.\n - Your exercise routine has been stable for the last 3 months or you are sedentary. Sedentary means you do less than 60 minutes of exercise per week.\n Exclusion Criteria:\n - You have a history of heart or blood vessel disease.\n - Your blood pressure is above 140/90 mmHg.\n - You have type 1 diabetes.\n - You have a history of kidney or liver disease.\n - You have thyroid disease that has not been treated.\n - You are a smoker.\n - You use a Beta-2 (B2) adrenergic stimulator (a type of drug used to treat asthma), a beta adrenergic blocker (a type of drug used to treat blood pressure) or glucocorticoid medications (a type of drug used to treat immune system disease).\n - You have a problem with alcoholism or other substance abuse.\n - You are pregnant or breast feeding.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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96
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)\n\n**Clinical Trial Summary:**\n\nThis study includes patients with sleep disturbances associated with gastroesophageal reflux disease (GERD) and has 3 treatment arms. Patients will receive only one of the following treatment arms: esomeprazole 20 mg once daily, esomeprazole 40 mg once daily, matching placebo once daily. The relief to the sleep disturbances will be assessed.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - A history of heartburn or acid regurgitation for 3 months or longer or any history of erosive esophagitis.\n - Nightime heartburn averaging at least 2 or 3 times per week and a history of sleep disturbances associated with GERD for 1 month or more.\n - Nightime heartburn graded as moderate or severe on 3 of the last 7 days of the run-in period and sleep disturbances associated with GERD as documented in the run-in diary card on at least 3 of the last 7 days of the run-in period..\n Exclusion Criteria:\n - Any condition other than GERD that is either the primary cause of, or a significant contributor to the patients sleep disturbance.\n - Shift workers who work between 12am (midnight) and 6am.\n - Sleep medication, antihistamine, benzodiazepine, or anti-anxiety medication use that has not been stable for at least 3 months or is not expected to remain stable during the patients participation in the study.\n - Other diseases / conditions as listed in the protocol.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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97
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nBrostallicin Clinical Trial for Myxoid Liposarcoma\n\n**Clinical Trial Summary:**\n\nThis is a Phase II, multicenter, open-label clinical trial designed to determine the efficacy and safety of Brostallicin when administered once every 3 weeks in patients with myxoid liposarcoma with (12;16) translocation. The primary objective of this study is to determine the response rate following Brostallicin administration.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n 1. Patient has provided informed consent.\n 2. Histologically confirmed myxoid liposarcoma.\n 3. Patients with metastatic and/or unresectable myxoid liposarcoma that is progressive and standard curative measures do not exist or are no longer effective.\n 4. Patient has measurable tumor on CT, spiral CT, or MRI scan that meet RECIST criteria.\n 5. Age ≥18 years\n 6. Karnofsky performance status (KPS) ≥ 70% (see Appendix III).\n 7. Life expectancy of at least 3 months.\n 8. Acceptable liver function:\n - Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n - AST (SGOT), ALT (SGPT) and alkaline phosphatase ≤ 2.5 times ULN (if liver metastases are present, then ≤ 5 × ULN is allowed).\n 9. Acceptable renal function: For all patients serum creatinine within normal limits, OR calculated creatinine clearance ≥ 60 mL/min/1.73 m(2) for patients with creatinine levels above institutional normal.\n 10. Acceptable hematologic status:\n - Absolute neutrophil count (ANC) ≥ 1500 cells/mm(3) (1.5 ×10(9)/L)\n - Platelet count ≥ 100,000 platelet/mm(3) (100 ×10(9)/L)\n - Hemoglobin ≥ 9 g/dL.\n Exclusion Criteria:\n 1. Patient received any of the following within the specified time period prior to initiation of treatment in this study:\n - Chemotherapy, major surgery, significant traumatic injury, or irradiation, whether conventional or investigational within 28 days\n - Mitomycin-C or nitrosurea within 42 days.\n - ET-743 at any time (Stage 1 only).\n 2. Patients heavily pretreated with chemotherapy and radiation, defined as follows:\n - ≥ 12 cycles of an alkylating agent-containing regimen, or\n - > 2 cycles carboplatin, or\n - > 2 cycles mitomycin C, or\n - irradiation to 25% of bone marrow-containing areas, or\n - high-dose chemotherapy requiring hematopoietic stem-cell reinfusion.\n 3. Known hypersensitivity to any study drug component.\n 4. Uncontrolled brain metastases in the judgement of the Investigator.\n 5. Abnormal cardiac or cardiovascular function, or serious cardiac illness or medical condition in the previous 6 months including, but not confined to:\n - New York Heart Association (NYHA) grade 2 or higher congestive heart failure (CHF) or who has had angioplasty or placement of coronary stents within the previous 6 months\n - Myocardial infarction within the past 6 months\n - High-risk uncontrolled arrhythmias\n - Angina pectoris that requires antianginal medication\n - Has clinically significant valvular heart disease\n - Evidence of transmural infarction on ECG\n - Poorly controlled hypertension (e.g., blood pressure: systolic >180 mm Hg or diastolic >100 mm Hg).\n 6. Pregnant or lactating females. All patients (males and females) who are fertile must agree to use an effective barrier method of birth control (i.e., latex condom, diaphragm, cervical cap, etc) to avoid pregnancy.\n 7. Not recovered from acute toxicity of all previous therapy prior to enrollment.\n 8. History of prior malignancies within 3 years, except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast.\n 9. Any evidence of serious and/or unstable pre-existing medical, psychiatric, or other condition (including laboratory abnormalities) that could interfere with patient safety or obtaining informed consent.\n 10. Any active uncontrolled infection including AIDS, hepatitis B or C.\n 11. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow up schedule.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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98
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Study of R1507 in Participants With Recurrent or Refractory Sarcoma\n\n**Clinical Trial Summary:**\n\nThis study will evaluate the efficacy and safety of R1507 in participants with recurrent or refractory sarcoma. Eight cohorts of sarcoma participants will be studied in parallel. Cohort 1: Ewing's sarcoma primary cohort defined as participants who have relapsed less than or equal to (<=) 24 months from diagnosis, received at least two prior chemotherapy programs and are unresectable. Cohort 2: Ewing's sarcoma non-primary (secondary) cohort defined as participants who have relapsed greater than or equal to (>=) 24 months from diagnosis or have only received one prior chemotherapy program. Cohort 3: Expanded Ewing's sarcoma defined as participants with recurrent or relapse regardless of prior number of salvage regimens and regardless of time of relapse. Cohort 4: participants with osteosarcoma. Cohort 5: Participants with synovial sarcoma. Cohort 6: Participants with rhabdomyosarcoma Cohort 7: Participants with alveolar soft part sarcoma (7a), desmoplastic small round cell tumors (7b), extraskeletal myxoid chondrosarcoma (7c), clear cell sarcoma (7d), myxoid liposarcoma (7e). Cohort 8: Participants with unspecified sarcoma diagnosis. Participants in the expanded Ewing's sarcoma Cohort 3 will receive 27 milligrams (mg)/kilogram (kg) every 3 weeks intravenously (IV). All other participants will receive R1507 9 mg/kg IV weekly. The anticipated time on study treatment is until disease progression or unacceptable adverse events, withdrawal or death.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - progressive, recurrent or refractory Ewing's sarcoma, or recurrent or refractory osteosarcoma, synovial sarcoma, rhabdomyosarcoma, or other sarcomas of the following sub-types: alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma and myxoid liposarcoma;\n - Cohort 3 only: age must be >= 2 and <= 21 years\n Exclusion Criteria:\n - clinically significant unrelated systemic illness which would compromise the participant's ability to tolerate the investigational agent, or interfere with the study procedures or results;\n - known hypersensitivity to any of the components of R1507 or prior hypersensitivity reactions to monoclonal antibodies;\n - treatment (within the past 2 weeks) with pharmacologic doses of corticosteroids or other immunosuppressive agents;\n - current or prior therapy with insulin-like growth factor (IGF) inhibitor (monoclonal or specific kinase inhibitor);\n - history of solid organ transplant;\n - other malignant disease diagnosed within the previous 5 years, excluding intra-epithelial cervical neoplasia or non-melanoma skin cancer;\n - active central nervous system disease\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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99
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nCombination Chemotherapy in Treating Patients Undergoing Surgery for Newly Diagnosed High-Grade Osteosarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy, such as ifosfamide, methotrexate, cisplatin, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.\n PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating patients undergoing surgery for newly diagnosed high-grade osteosarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - To evaluate the efficacy of a new induction regimen comprising ifosfamide in combination with high-dose methotrexate, cisplatin, and doxorubicin hydrochloride, in terms of clinical response and pathological response of the tumor, in patients with newly diagnosed high-grade osteosarcoma.\n - To determine the overall survival and disease-free survival of these patients.\n - To evaluate the toxicity of this regimen.\n - To correlate MRI imaging of the primary tumor with histopathologic grading after treatment with this regimen.\n OUTLINE: This is a multicenter study.\n - Neoadjuvant chemotherapy (weeks 1-15): Patients receive ifosfamide IV over 1 hour on days 1-5 and 36-40; doxorubicin hydrochloride IV over 18 hours on days 1-3 and 36-38 and IV over 72 hours on days 71-73; high-dose methotrexate IV over 4 hours on days 22, 29, 57, 64, 92, and 99; and cisplatin IV over 4 hours on day 71.\n - Surgery (week 16): Patients undergo resection of the tumor on day 106. Patients found to have unresectable disease are treated on an alternative protocol unless they have clear clinical and pathologic response to treatment.\n - Adjuvant chemotherapy (weeks 18-43): Beginning 2 weeks after surgery, patients receive ifosfamide IV over 1 hour on days 120-124, 155-159, 225-229, and 260-264; doxorubicin hydrochloride IV over 18 hours on days 120-122 and 155-157 and IV over 72 hours on days 190-192; high-dose methotrexate IV over 4 hours on days 141, 148, 176, 183, 211, 218, 246, 253, 281, and 288; and cisplatin IV over 4 hours on days 190 and 289.\n After completion of study therapy, patients are followed every 2 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically confirmed osteosarcoma of the extremity\n - High-grade (grade III or IV) disease\n - No low-grade disease (e.g., parosteal or periosteal osteosarcoma)\n - No secondary osteosarcoma (i.e., tumor occurring in a radiotherapy field designed for a prior tumor)\n - No Paget's disease\n - No known metastases\n PATIENT CHARACTERISTICS:\n - Total bilirubin < 2 times normal\n - AST < 2 times normal\n - Alkaline phosphatase < 2 times normal\n - Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 60 mL/min\n - LVEF ≥ 45%\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective contraception\n - No other prior malignancy except retinoblastoma\n - Patients with familial retinoblastoma syndrome who develop osteosarcoma unrelated to radiotherapy (e.g., in a primary site in the extremities) are eligible\n PRIOR CONCURRENT THERAPY:\n - No prior chemotherapy or radiotherapy\n - Patients with retinoblastoma may have received radiotherapy to the orbits\n - At least 28 days since prior initial amputation\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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