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NCT01097681	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: type 2 diabetes mellitus\n\nICD Codes: \"E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44\"\n\nDrugs: asp1941\n\nSMILES: OCC@H1OC@H(C@H(O)C@@H(O)C@@H1O)C1=CC=C(F)C(CC2=CC3=CC=CC=C3S2)=C1\n\nCT Criteria: Inclusion Criteria:\n - Type 2 diabetic patients for at least 12 weeks\n - Fasting plasma glucose level of < 240 mg/dL\n - Body Mass Index ( BMI )20.0 - 35.0kg/m2\n - GFR value based on the Japanese GFR estimation equation at screening, of ≥ 30 ml/min/1.73m2\n Exclusion Criteria:\n - Type 1 diabetes mellitus patients\n - Receiving insulin within 12 weeks before screening\n - Diabetic ketoacidosis\n - Dysuria and/or urinary tract infection, genital infection\n - Significant renal, hepatic or cardiovascular diseases\n - Severe gastrointestinal diseases \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00697476	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: small cell lung cancer\n\nICD Codes: \"C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2\"\n\nDrugs: topotecan, vorinostat\n\nSMILES: CCC@@1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=C(C=CC(O)=C4CN(C)C)N=C13)C2=O\n\nCT Criteria: Inclusion Criteria:\n - Histologically or cytologically proven diagnosis of SCLC;\n - Limited or extensive-stage disease in patients who have received a single chemotherapy regimen or combined modality (chemotherapy + chest radiotherapy) regimen and relapsed after completion of first-line chemotherapy (sensitive relapse);\n - Age >/= 18 years;\n - ECOG Performance Status 0-2;\n - Life expectancy of at least 12 weeks;\n - Measurable lesions according to RECIST criteria;\n - Adequate cardiac, hepatic, renal, and bone marrow function;\n - Written informed consent.\n Exclusion Criteria:\n - Prior treatment with an HDAC inhibitor;\n - Symptomatic and/or unstable pre-existing brain metastases;\n - Superior Vena Cava Syndrome;\n - Spinal cord compression;\n - Severe or uncontrolled medical diseases (Hypertension, diabetes, congestive heart failure, myocardial infarction within 6 months of study, chronic renal disease, or active uncontrolled infections);\n - Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ;\n - Pregnant or breastfeeding women. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01092325	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: heart failure\n\nICD Codes: \"I50.814, I09.81, I50.82, I50.89, I50.9, T86.22, I11.0\"\n\nDrugs: cxl-1020, cxl-1020, placebo for cxl-1020 cohort 1, placebo for cxl-1020 cohort 2, cxl-1020 dose for echo cohort a, cxl-1020 doses for echo cohort b\n\nSMILES: CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\nCT Criteria: Inclusion Criteria:\n In order to be eligible for randomization, a patient MUST:\n - Be a male or post menopausal or surgically sterile female outpatient between 18 and 85 years of age\n - Have chronic Systolic HF due to primary/idiopathic dilated cardiomyopathy, coronary artery disease or hypertension, and stable for at least 30 days prior to screening\n - Have a core echo lab confirmed left ventricular ejection fraction ≤ 40% in a baseline 2D-Echocardiogram prior to and within 60 days of the first dose of study medication with evidence of at least minimal LV dilation on the basis of an observed LV-EDV index that is above normal\n - Have a baseline NT-Pro-BNP of greater than or equal to the top of the normal reference range (124pg/ml) prior to and within 60 days of the first dose of study medication\n - Be on unchanging doses of HF medications (with exception of diuretic dosage) for 2 weeks prior to randomization without planned initiation of new hemodynamically active therapy during the conduct of the study\n - Be capable of understanding the nature of the trial and be willing to participate as documented by written informed consent\n - Be willing and able to comply with the study protocol requirements for the duration of the study, including pharmacokinetic sampling\n - If a post-menopausal or surgically sterile female, confirmation of sterility status (Post menopausal or surgically sterile for at least 6 months) - (Post-menopausal subjects will require a urine pregnancy test for confirmation prior to enrollment and urine pregnancy tests prior to each dosing)\n - If a fertile male, must be using 2 approved contraceptive methods (a condom and a spermicidal agent, even if the partner is using birth control) for the duration of the study and for 3 months following participation in the study and further agree to not donate sperm for 3 months after participation in the study. Must have a negative urine test for drugs of abuse and a negative ethanol breath test at screening and before each dosing period\n - Have required local lab data within non-exclusionary ranges before each dosing\n Exclusion Criteria:\n In order to be eligible for randomization, a patient MUST NOT:\n - Have participated in any investigational drug study within 30 days preceding randomization or have previously received therapy with CXL-1020\n - Have a heart rate <50 or ≥ 90 BPM at baseline prior to randomization.\n - Have a blood pressure >150 Systolic and/or >90 diastolic mmHg at baseline prior to randomization\n - Have a systolic blood pressure of less than 100 mmHg at baseline prior to randomization\n - Have QT/QTc prolongation > 460 msec or > 500msec in patients with preexisting bundle branch block (only applies to non-paced patients in sinus rhythm)\n - Have experienced a documented symptomatic or electrocardiographically recorded episode of atrial fibrillation/flutter within 60 days before screening and be in normal sinus rhythm at each baseline before study drug is administered\n - Have a history of sustained or hemodynamically significant VT or VF requiring cardioversion, or self-terminating VT associated with hypotension\n - Have non-sustained VT (HR > 120 bpm) of 10 beats or more during monitoring in the baseline monitoring period prior to each dose of study medication, or in any Holter or EKG recording within 1 year of first dose of study medication.\n - Have a weight or height that exceeds the specifications for the ICG Device of (greater than 341 pounds or taller than 7 feet 2 inches.)\n - Be post-successful cardiac resuscitation\n - Have a history of worsening HF within 30 days prior to screening as defined by:\n - Unscheduled ER or clinic visits relating to HF or hospital admission for management of HF\n - Treatment with intravenous inotropic or vasodilator drugs\n - Be diagnosed with acute coronary syndrome or acute myocardial infarction within three months prior to screening\n - Have a history of stroke (CVA) or transient ischemic attack (TIA) within six months prior to screening\n - Have a history of CCS Class III or IV angina\n - Be a patient whose HF etiology is attributable to either restrictive/obstructive cardiomyopathy, idiopathic hypertrophic cardiomyopathy (as defined by any wall thickness > 1.8 cm) or uncorrected severe valvular disease\n - Be receiving concomitant therapy with any antiarrhythmic drugs other than amiodarone\n - Have experienced the firing of an implantable ICD for documented ventricular ectopy within three months prior to screening\n - Have a known allergy to the ICG Device sensor gel or adhesive\n - Have unsuitable Echocardiographic Windows for the comprehensive Echo assessments required in the Echo cohorts (exclusion for echo cohorts only)\n - Have a skin lesion at the site of the ICG Device sensor placement.\n - Have a screening or baseline serum Na < 130 mEq/l or > 145 mEq/l; a serum K < 3.5 mEq/l or > 5.0 mEq/l; a serum Ca < 7.5 mg/dl or > 10 mg/dl; or a serum Mg < 1.6 mEq/l or > 3.0 mEq/l., or a digoxin level above 1ng/ml\n - Have a screening TSH < 0.1 mcU/ml or > 5.0 mcU/ml\n - Have a screening or baseline serum creatinine > 2.5 mg/dl; an ALT or AST >3 times the upper normal limit; or a hemoglobin < 10 g/dl\n - Have taken ethanol within 24 hours or a PDE5 inhibitor within 96 hours of study admission\n - Have other clinically significant laboratory or medical conditions that, in the opinion of the Investigator, make the patient unsuitable for evaluation in the study\n - Have a generalized atopic state or a history of a mild to moderate documented drug allergy\n - Be receiving a drug which is expected to possess the potential for a clinically significant pharmacokinetic interaction with CXL-1020, as defined in the IDB.\n Note: Patients receiving cardiac resynchronization therapy for HF are eligible provided that the device has been placed for greater than 30 days and pacemaker settings can be left unchanged for the study period. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00376519	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: graft versus host disease, leukemia, lymphoma, multiple myeloma and plasma cell neoplasm, myelodysplastic syndromes, secondary myelofibrosis\n\nICD Codes: \"D89.810, D89.811, D89.813, D89.812\", \"C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01\", \"S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S\", \"C96.20, C96.29, D47.09\", \"D46.9, D46.C, D46.Z\", \"D75.81, C94.41, C94.42, C94.40\"\n\nDrugs: cyclophosphamide, cyclosporine, fludarabine phosphate, mycophenolate mofetil\n\nSMILES: ClCCN(CCCl)P1(=O)NCCCO1, CCC@@H1NC(=O)C@H(C@H(O)C@H(C)C\\\\C=C\\\\C)N(C)C(=O)C@H(C(C)C)N(C)C(=O)C@H(CC(C)C)N(C)C(=O)C@H(CC(C)C)N(C)C(=O)C@@H(C)NC(=O)C@H(C)NC(=O)C@H(CC(C)C)N(C)C(=O)C@@H(NC(=O)C@H(CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C, NC1=NC(F)=NC2=C1N=CN2C@@H1OC@H(CO)C@@H(O)C@@H1O, NC@@H(CCCNC(N)=N)C(O)=O\n\nCT Criteria: Inclusion Criteria:\n Patient and Donor Demographic Criteria\n - Patient must be 18-45 years of age.\n - Patients must have three partially HLA matched UCB units. Units identified as the HSC source must be HLA matched at 4-6 HLA- A and B (at low to intermediate resolution) and DRB1 (at high resolution), and the units must be HLA matched at 4-6 HLA- A, B, DRB1 antigens with each other. Total cryopreserved HSC graft cell dose must be >2.5 x 107 nucleated cells per kilogram recipient body weight. Also, the two umbilical cord blood (UCB) units must be ABO-matched.\n - The UCB unit identified as the Treg source must be HLA matched at 4-6 HLA antigens with the patient (without an HLA or ABO matching criterion with the UCB HSC source).\n Disease Criteria\n - Patients must have a hematological malignancy as listed below:\n - Acute myelogenous leukemia: high risk CR1 (as evidenced by preceding myelodysplastic syndrome (MDS), high risk cytogenetics such as those associated with MDS or complex karyotype, or >2 cycles to obtain complete remission (CR); second or greater CR. Must be in remission by morphology (<5% blasts within normocellular marrow).\n - Acute lymphocytic leukemia: high risk CR1 as evidenced by high risk cytogenetics t(9;22), t (1:19), t(4;11) or other MLL rearrangements or > 1 cycle to obtain CR; second or greater CR.\n - Chronic myelogenous leukemia resistant to imatinib therapy\n - Myelodysplasia (MDS) IPSS Int-2 or High risk (i.e. RAEB, RAEBt) or refractory anemia with severe pancytopenia or high risk cytogenetics. Blasts must be < 10% by a representative bone marrow aspirate morphology (otherwise induction chemotherapy to achieve < 10% blasts is required pre-transplant).\n - Advanced myelofibrosis\n - Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma or follicular lymphoma that have progressed after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant.\n - Lymphoplasmacytic lymphoma, mantle-cell lymphoma, prolymphocytic leukemia are eligible after initial therapy in CR1+ or PR1+.\n - Large cell non-Hodgkins lymphoma (NHL) > CR2/> PR2. Patients in CR2/PR2 with initial short remission(<6 months) are eligible.\n - Lymphoblastic lymphoma, Burkitts lymphoma, and other high-grade NHL after initial therapy if stage III/IV in CR1/PR1 or after progression if stage I/II <1 year.\n - Multiple myeloma beyond PR2. Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin > 3 mg/L, may be considered for this protocol after initial therapy.\n - Recipients will have a Karnofsky score > 80% and have acceptable organ function ie creatinine < 2.0, bilirubin, AST/ALT, ALP < 2 x normal, pulmonary function > 50% normal, left ventricular ejection fraction > 45%. Note: All patients with a creatinine > 1.2 or a history of renal dysfunction must have creatinine clearance (must be > 40 ml/min to be eligible).\n - Recipients will sign informed consent approved by the Committee on the Use of Human Subjects at the University of Minnesota.\n Exclusion Criteria:\n - Pregnant or breastfeeding\n - Evidence of HIV infection or known HIV positive serology\n - Current active infection\n - Available HLA matched sibling donor.\n - CML in active blast crisis \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01466985	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: hiv-1 infection\n\nICD Codes: \"B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4\"\n\nDrugs: doravirine, placebo\n\nSMILES: CN1C(O)=NN=C1CN1C=CC(=C(OC2=CC(=CC(Cl)=C2)C#N)C1=O)C(F)(F)F, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\nCT Criteria: Inclusion Criteria:\n - Diagnosis of HIV-1-infection ≥3 months prior to screening\n - Participants with female partner(s) of child-bearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug\n - Body Mass Index (BMI) ≤35 kg/m^2\n - Other than HIV infection, participants baseline health is judged to be stable\n - No clinically significant abnormality on electrocardiogram (ECG)\n - Participant is ART-naïve (defined as having never received any antiretroviral agent or ≤30 consecutive days of an investigational antiretroviral agent (excluding an Non-Nucleoside Reverse Transcriptase Inhibitor NNRTI) or ≤60 consecutive days of combination ART not including an NNRTI)\n - Participant is willing to receive no other ART for the duration of the treatment phase of this study.\n Exclusion Criteria:\n - History of stroke, chronic seizures, or major neurological disorder\n - History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological (outside of HIV-1 infection), renal, respiratory, or genitourinary abnormalities or diseases\n - History of clinically significant neoplastic disease\n - Participant has used any immune therapy agents or immunosuppressive therapy within 1 month prior to treatment in this study\n - Participant has one or more pre-existing risk factors for Torsades de Pointes (New York Heart Association Functional Classification II through IV heart failure, familial long-QT-syndrome, uncorrected hypokalemia, QTcF >470 msec)\n - Participant requires or is anticipated to require chronic daily prescription medications\n - Current (active) diagnosis of acute hepatitis due to any cause\n - History of chronic Hepatitis C virus (HCV) unless there has been documented cure and/or patient with a positive serologic test for HCV has a negative HCV viral load.\n - Positive Hepatitis B surface antigen\n - Participant is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies (such as St. Johns Wort Hypericum perforatum) beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug, throughout the study, until the post-study visit\n - Participant consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer 284 mL/10 ounces, wine 125 mL/4 ounces, or distilled spirits 25 mL/1 ounce) per day\n - Participant consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day\n - Participant is an excessive smoker (i.e., more than 10 cigarettes/day) and is unwilling to restrict smoking to ≤10 cigarettes per day\n - Major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit\n - Participation in another investigational study within 4 weeks prior to the prestudy (screening) visit\n - History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food\n - Current regular user (including use of any illicit drugs) or has a history of drug (including alcohol) abuse within approximately 1 year \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00445458	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: advanced breast cancer, advanced malignant solid tumors, breast neoplasms\n\nICD Codes: \"C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60\", \"C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60\"\n\nDrugs: hki-272, paclitaxel\n\nSMILES: CCOC1=C(NC(=O)\\\\C=C\\\\CN(C)C)C=C2C(NC3=CC=C(OCC4=CC=CC=N4)C(Cl)=C3)=C(C=NC2=C1)C#N, HC@@1(CC@@H(C)C@2(H)CC(=O)C@H(C)\\\\C=C(C)\\\\C@@H(O)C@@H(OC)C(=O)C@H(C)CC@H(C)\\\\C=C\\\\C=C\\\\C=C(C)\\\\C@H(CC@3(H)CCC@@H(C)C@@(O)(O3)C(=O)C(=O)N3CCCCC@@3(H)C(=O)O2)OC)CCC@@H(OCCO)C@@H(C1)OC\n\nCT Criteria: Inclusion Criteria:\n Inclusion criteria for both parts of clinical trial:\n - Good performance status\n - Normal ejection fraction\n - Adequate cardiac, kidney, and liver function\n - Adequate blood counts\n - At least one measurable target lesion\n - Negative pregnancy test for female subjects\n Inclusion Criteria for Part 1 Only:\n - Pathologically confirmed solid tumor not curable with available standard therapy\n Inclusion Criteria for Part 2 Only:\n - Pathologically confirmed breast cancer\n - HER2 positive tumor\n - Prior treatment with Herceptin\n Exclusion Criteria:\n Exclusion criteria for both parts of clinical trial:\n - Major surgery, radiotherapy, chemotherapy or investigational agents within two weeks of treatment day 1\n - Subjects with bone or skin as the only site of disease\n - Active central nervous system metastases\n - Significant cardiac disease or dysfunction\n - Significant gastrointestinal disorder\n - Inability or unwillingness to swallow HKI-272 capsules\n - Prior exposure to HKI-272 or other HER2 targeted agents, except trastuzumab (Part 2 only). Prior lapatinib is permitted in arm B of part 2.\n - Treatment with a taxane within 3 months of treatment day 1\n - Grade 2 or greater motor or sensory neuropathy\n - Pregnant or breast feeding women\n - Known hypersensitivity to paclitaxel or Cremophor EL\n - Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2\n - Any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin\n Exclusion Criteria for Part 2 Only:\n - More than 1 (arm A) or 3 (arm B) prior cytotoxic chemotherapy regimen for metastatic disease \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00316953	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, childhood chronic myelogenous leukemia, chronic myelogenous leukemia, bcr-abl1 positive, meningeal chronic myelogenous leukemia, recurrent childhood acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, unspecified childhood solid tumor, protocol specific\n\nICD Codes: \"C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01\", \"C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01\", \"C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01\", \"C83.57, C83.50, C91.01, C91.02, C83.52, C83.56, C83.53\", \"M94.1, A68.9, A68.0, A68.1, M35.6\", \"H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509\"\n\nDrugs: dasatinib\n\nSMILES: CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1\n\nCT Criteria: Inclusion Criteria:\n - Histologically confirmed diagnosis of 1 of the following:\n - Malignant extracranial solid tumor\n - Recurrent or refractory disease\n - Known bone marrow metastases* allowed\n - Imatinib mesylate-resistant Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL), defined as M3 bone marrow in a patient who previously received imatinib mesylate-containing treatment regimen\n - Imatinib mesylate-resistant Ph+ chronic myelogenous leukemia (CML), as defined by any of the following:\n - Increasing WBC or platelet count while on imatinib mesylate therapy\n - Lack of any cytogenetic response after an adequate duration of imatinib mesylate therapy, as defined by 1 of the following:\n - Failed to achieve a complete hematologic response after completion of 3 months of imatinib mesylate treatment\n - Failed to achieve a partial or complete cytogenetic response (i.e., ≤ 35% Ph+ cells) after 6 months of imatinib mesylate treatment\n - Appearance of accelerated or blastic feature while on imatinib mesylate therapy\n - Reappearance of Ph+ clones after an initial complete cytogenetic response to imatinib mesylate\n - More than 30% increase in Ph+ cells in peripheral blood or bone marrow cytogenetics while on imatinib mesylate therapy\n - Imatinib mesylate intolerance, as defined by development of adverse effects requiring discontinuation of imatinib mesylate therapy\n - Measurable disease (for patients with CML or ALL)\n - Determined by hematologic, cytogenetic, and molecular studies for CML\n - Determined by bone marrow blast percentage for ALL\n - Measurable or evaluable disease (for patients with solid tumors)\n - No known curative therapy or survival-prolonging therapy with an acceptable quality of life\n - No CNS solid tumors\n - CNS-positive leukemia allowed\n - Karnofsky performance status (PS) ≥ 50% (for patients > 10 years of age)\n - Lansky PS ≥ 50% (for patients ≤ 10 years of age)\n - No evidence of graft-vs-host disease\n - Solid tumors:\n - Absolute neutrophil count ≥ 1,000/mm^3 (750/mm^3 if bone marrow infiltration)\n - Platelet count ≥ 100,000/mm^3 (transfusion independent) (50,000/mm^3 if bone marrow infiltration)\n - Hemoglobin ≥ 8.0 g/dL (red blood cell RBC transfusions allowed)\n - ALL/CML:\n - Platelet count ≥ 20,000/mm^3 (platelet transfusions allowed)\n - Hemoglobin ≥ 8.0 g/dL (RBC transfusions allowed)\n - Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine based on age, as follows:\n - No greater than 0.6 mg/dL (1-23 months of age)\n - No greater than 0.8 mg/dL (2- 5 years of age)\n - No greater than 1.0 mg/dL (6-9 years of age)\n - No greater than 1.2 mg/dL (10-12 years of age)\n - No greater than 1.4 mg/dL (13 years of age and over female)\n - No greater than 1.5 mg/dL (13-15 years of age male)\n - No greater than 1.7 mg/dL (16 years of age and over male)\n - Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n - ALT ≤ 110 U/L\n - Albumin ≥ 2 g/dL\n - Normal 12-lead EKG with corrected QTc < 450 msec AND meets 1 of the following criteria:\n - Shortening fraction normal\n - Ejection fraction normal\n - No evidence of dyspnea at rest\n - No exercise intolerance\n - Pulse oximetry > 94% if there is a clinical indication for determination\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective contraception\n - No uncontrolled infection\n - No swallowing dysfunction that would prevent taking an oral or liquid medication\n - See Disease Characteristics\n - Recovered from prior chemotherapy, immunotherapy, or radiotherapy\n - No myelosuppressive chemotherapy within the past 3 weeks (6 weeks for nitrosoureas)\n - At least 7 days since prior growth factors\n - At least 14 days since prior pegfilgrastim\n - At least 7 days since prior biologic agents\n - At least 2 weeks since prior local small-port palliative radiotherapy\n - At least 3 months since prior total-body irradiation, craniospinal radiation, or radiation to ≥ 50% of the pelvis\n - At least 6 weeks since other prior substantial bone marrow radiation\n - At least 3 months since prior stem cell transplantation\n - Hydroxyurea cytoreduction for Ph+ leukemia allowed provided it is discontinued 24 hours before first dose of dasatinib\n - Prior intrathecal (IT) therapy allowed (for patients with CNS-positive leukemia)\n - Concurrent IT therapy comprising hydrocortisone, cytarabine, methotrexate, or cytarabine (liposomal) allowed (for patients with CNS-positive leukemia)\n - No other concurrent investigational drugs\n - No other concurrent anticancer agents, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy\n - No concurrent enzyme-inducing anticonvulsants, including any of the following:\n - Phenytoin\n - Phenobarbital\n - Carbamazepine\n - Felbamate\n - Primdone\n - Oxcarbazepine\n - No concurrent antithrombotic or antiplatelet agents, including any of the following:\n - Warfarin\n - Heparin\n - Low-molecular weight heparin\n - Aspirin\n - Ibuprofen\n - Other nonsteroidal anti-inflammatory drugs\n - No concurrent CYP3A4 inhibitors, including itraconazole, ketoconazole, and voriconazole\n - No concurrent highly active antiretroviral treatment for HIV-positive patients \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00078559	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: kidney transplantation, kidney disease\n\nICD Codes: \"N26.2, Q63.0, Q63.2, Z52.4, I75.81, N19, N20.0\", \"I12.9, N18.9, Q61.9, I12.0, D63.1, N18.1, N18.5\"\n\nDrugs: alemtuzumab, sirolimus, tacrolimus, methylprednisolone (or equivalent), acetaminophen, diphenhydramine, trimethoprim (tmp)/sulfa (bactrim, septra), valgancyclovir, acyclovir, pentamidine, clotrimazole, nystatin\n\nSMILES: NC@@H(CCCNC(N)=N)C(O)=O, CC(=O)CC(C1=CC=CC=C1)C1=C(O)C2=C(OC1=O)C=CC=C2, COC1=CC2=C(C(OC)=C1OC)C1=CC=C(OC)C(=O)C=C1C(CC2)NC(C)=O, HC@@12CCC@(O)(C(=O)CO)C@@1(C)CC@H(O)C@@1(H)C@@2(H)CC@H(C)C2=CC(=O)C=CC@12C, CC1=CC(O)=CC(C)=C1Cl, CN(C)CCOC(C1=CC=CC=C1)C1=CC=CC=C1, COC1=CC(CC2=CN=C(N)N=C2N)=CC(OC)=C1OC, NC1=NC(=O)C2=C(N1)N(COCCO)C=N2, CC(C)C@@H1CCC@@H(C)CC@H1O, ClC1=CC=CC=C1C(N1C=CN=C1)(C1=CC=CC=C1)C1=CC=CC=C1, CC@H1OC(OC2CC(O)C(C(O)CC(=O)CC(O)C(O)CCC(O)CC(O)CC(O)CC(=O)OC(C)C(C)C(O)C(C)\\\\C=C\\\\C=C\\\\CC\\\\C=C\\\\C=C\\\\C=C\\\\C=C\\\\2)C(O)=O)C@@H(O)C@@H(N)C@@H1O\n\nCT Criteria: Inclusion Criteria\n - Kidney transplant with primary cadaveric or non-Human Leukocyte Antigen (HLA)-identical living donor kidney (0-3 HLA-antigen mismatch)\n - Receiving only a kidney and no other organs\n - Able to take medications by mouth\n - Willing to use acceptable methods of contraception\n Exclusion Criteria\n - Received HLA-identical living-donor kidney transplant\n - HLA-antigen mismatch greater than 3\n - Panel reactive antibody (PRA) value greater than 10% at any time prior to enrollment\n - Received a non-heart-beating donor allograft\n - Received a kidney from a donor who is greater than 60 years of age\n - End-stage Renal Disease (ESRD) due to Focal Segmental Glomulerosclerosis (FSGS)\n - Previous kidney transplant\n - Received multiorgan transplant\n - Concomitant systemic corticosteroid therapy for other medical diseases\n - Known hypersensitivity to alemtuzumab, tacrolimus, methylprednisolone, or sirolimus\n - Human Immunodeficiency Virus (HIV) infected\n - Hepatitis C virus infected\n - Positive for hepatitis B surface antigen\n - Received dual or en-bloc pediatric kidneys\n - Anti-human Globulin (AHG) or T cell crossmatch positive\n - Investigational drug within 6 weeks of study entry\n - Known clinically significant cardiovascular or cerebrovascular disease\n - Previous or current history of cancer or lymphoma. Patients with adequately treated basal or squamous cell skin carcinoma are not excluded.\n - Clinically significant coagulopathy or a requirement for chronic anti-coagulation therapy precluding biopsy\n - Cytomegalovirus (CMV)-negative recipient, if received kidney is from a CMV-positive donor\n - History of a psychological illness or condition that, in the opinion of the investigator, may interfere with the study\n - Graves disease. Patients who have been previously adequately treated with radioiodine ablative therapy are not excluded.\n - Active systemic infections\n - Platelets less than 100,000 cells/mm^3 at study entry\n - Pregnant or breastfeeding \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00595686	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: hematologic neoplasms\n\nICD Codes: \"E70.338, E70.339, P09.3, O28.0, P61.8, P61.9, T45.8X1A\"\n\nDrugs: snx-5422\n\nSMILES: CC1(C)CC2=C(C(=NN2C2=CC(NC@H3CCC@@H(CC3)OC(=O)CN)=C(C=C2)C(N)=O)C(F)(F)F)C(=O)C1\n\nCT Criteria: Inclusion Criteria:\n - >18 years old\n - Karnofsky performance status > 60\n - confirmed hematological malignancy\n - refractory to available therapy or for which no therapy is available\n - adequate hepatic, renal and hematological function\n Exclusion Criteria:\n - CNS malignancy\n - at risk for prolonged QT interval\n - significant GI/liver disease\n - other serious concurrent illness or medical condition \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01391117	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: hepatitis c virus\n\nICD Codes: \"B00.81, B25.1, B26.81, B58.1, K75.4, A51.45, B17.2\"\n\nDrugs: placebo., placebo., tmc649128., placebo., placebo, tmc649128, tmc649128., tmc649128, tmc649128., placebo.\n\nSMILES: CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\nCT Criteria: Inclusion Criteria:\n - Documented chronic (> 6 months) genotype 1a or 1b Hepatitis C virus (HCV) infection\n - Treatment-naive volunteer, meaning never received (Peg)IFN, RBV or any other approved or investigational treatment for chronic HCV infection (Panels 1, 2, 3 or 4) OR volunteer is a documented prior non-responder or relapser subject to previous treatment regimens (IFN/RBV or pegylated IFN/RBV) but has stopped this treatment at least 6 months before screening\n - volunteer has never received a HCV polymerase inhibitor and HCV protease inhibitor treatment was stopped since at least one year (Panels 1, 2 or 3)\n - Volunteer with HCV plasma RNA levels of > 100,000 IU/mL at screening\n - Body Mass Index of 18.0 to 35.0 kg/m2\n - Healthy based on a medical evaluation including medical history, physical examination, blood tests, vital signs, and electrocardiogram.\n Exclusion Criteria:\n - Evidence of liver cirrhosis\n - Historical liver biopsy graded as liver cirrhosis or evidence for the presence of oesophageal varices or a transient elastography (Fibroscan) result of more than 14.6 kPa within 2 years prior to screening\n - Evidence of decompensated liver disease defined as prior history or current evidence of ascites, hepatic encephalopathy, bleeding oesophageal or gastric varices\n - Evidence of renal dysfunction, documented by an estimated creatinine clearance below 70 mL/min\n - Evidence of any other cause of significant liver disease in addition to hepatitis C, this may include but is not limited to hepatitis B, drug- or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilsons disease, non-alcoholic steatohepatitis, or primary biliary cirrhosis\n - Volunteer with diagnosed or suspected hepatocellular carcinoma\n - Volunteer receiving or having received any treatment for HCV during the 6 months before screening\n - Volunteer coinfected with Human Immunodeficiency Virus-1 (HIV-1) or HIV-2, or hepatitis A or B virus infection, or clinically active tuberculosis at study screening. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01193478	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: hcv infection\n\nICD Codes: \"K94.02, K94.12, K94.22, K94.32, N99.511, A02.9, A31.0\"\n\nDrugs: gs-5885, placebo, gs-5885, placebo, gs-5885, placebo, gs-5885, placebo, gs-5885, placebo, gs-5885, placebo\n\nSMILES: HC@(N=C(O)OC)(C(C)C)C(=O)N1CC2(CC2)CC@@1(H)C1=NC=C(N1)C1=CC2=C(C=C1)C1=C(C=C(C=C1)C1=CC3=C(C=C1)N=C(N3)C@@1(H)N(C(=O)C@@(H)(N=C(O)OC)C(C)C)C@3(H)CCC@@1(H)C3)C2(F)F, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, HC@(N=C(O)OC)(C(C)C)C(=O)N1CC2(CC2)CC@@1(H)C1=NC=C(N1)C1=CC2=C(C=C1)C1=C(C=C(C=C1)C1=CC3=C(C=C1)N=C(N3)C@@1(H)N(C(=O)C@@(H)(N=C(O)OC)C(C)C)C@3(H)CCC@@1(H)C3)C2(F)F, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, HC@(N=C(O)OC)(C(C)C)C(=O)N1CC2(CC2)CC@@1(H)C1=NC=C(N1)C1=CC2=C(C=C1)C1=C(C=C(C=C1)C1=CC3=C(C=C1)N=C(N3)C@@1(H)N(C(=O)C@@(H)(N=C(O)OC)C(C)C)C@3(H)CCC@@1(H)C3)C2(F)F, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, HC@(N=C(O)OC)(C(C)C)C(=O)N1CC2(CC2)CC@@1(H)C1=NC=C(N1)C1=CC2=C(C=C1)C1=C(C=C(C=C1)C1=CC3=C(C=C1)N=C(N3)C@@1(H)N(C(=O)C@@(H)(N=C(O)OC)C(C)C)C@3(H)CCC@@1(H)C3)C2(F)F, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, HC@(N=C(O)OC)(C(C)C)C(=O)N1CC2(CC2)CC@@1(H)C1=NC=C(N1)C1=CC2=C(C=C1)C1=C(C=C(C=C1)C1=CC3=C(C=C1)N=C(N3)C@@1(H)N(C(=O)C@@(H)(N=C(O)OC)C(C)C)C@3(H)CCC@@1(H)C3)C2(F)F, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, HC@(N=C(O)OC)(C(C)C)C(=O)N1CC2(CC2)CC@@1(H)C1=NC=C(N1)C1=CC2=C(C=C1)C1=C(C=C(C=C1)C1=CC3=C(C=C1)N=C(N3)C@@1(H)N(C(=O)C@@(H)(N=C(O)OC)C(C)C)C@3(H)CCC@@1(H)C3)C2(F)F, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\nCT Criteria: Inclusion Criteria:\n - Chronically infected with HCV genotype 1\n - HCV treatment-naïve\n - Not co-infected with HIV or HBV\n - HCV RNA viral load of at least 100,000 IU/mL\n - BMI 19 to 35 kg/m2\n - Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.\n Exclusion Criteria:\n - History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol\n - Decompensated liver disease or cirrhosis or evidence of hepatocellular carcinoma\n - Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype\n - Subjects with known, current use of amphetamines and/or cocaine; subjects taking methadone or buprenorphine (opioid replacement therapy) or ongoing alcohol abuse \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00258349	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: breast cancer, male breast cancer, recurrent breast cancer, stage iiib breast cancer, stage iiic breast cancer, stage iv breast cancer\n\nICD Codes: \"C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60\", \"C50.021, C50.022, C50.029, C50.121, C50.122, C50.129, C50.621\", \"C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60\", \"C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60\", \"C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60\", \"C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60\"\n\nDrugs: vorinostat, trastuzumab\n\nSMILES: ONC(=O)CCCCCCC(=O)NC1=CC=CC=C1, HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1\n\nCT Criteria: Inclusion Criteria:\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective contraception\n - No active or ongoing infection\n - No history of allergic reaction to compounds of similar chemical or biologic composition to vorinostat or other agents used in study\n - No psychiatric illness or social situation that would preclude study compliance\n - No other uncontrolled illness\n - More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin; 1 week for capecitabine) and recovered\n - More than 3 weeks since prior radiotherapy and recovered\n - Recovered from prior therapy\n - At least 2 weeks since prior valproic acid\n - More than 4 weeks since prior investigational agents\n - More than 4 weeks since prior lapatinib ditosylate\n - No concurrent combination antiretroviral therapy for HIV-positive patients\n - Measurable disease, defined as >= 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan\n - No other concurrent investigational agents\n - Concurrent bisphosphonates allowed provided therapy was initiated prior to study treatment\n - No other concurrent anticancer therapy\n - Recurrent or progressive disease while receiving prior trastuzumab (Herceptin) (with or without chemotherapy) OR relapsed within 3 months of last dose of prior adjuvant trastuzumab for metastatic disease\n - Histologically confirmed breast cancer\n - Must overexpress HER-2 gene\n - Metastatic or chest wall recurrent disease\n - Site of measurable disease must not have been irradiated (except chest wall recurrence treated with adjuvant radiation therapy)\n - No untreated brain metastases\n - Previously treated brain metastasis responsive to radiotherapy and/or surgery allowed provided the brain is not the sole site of measurable disease\n - ECOG 0-2\n - Absolute neutrophil count >= 1,500/mm^3\n - Platelet count >= 100,000/mm^3\n - Hemoglobin >= 9 g/dL\n - AST and ALT =< 2 times upper limit of normal\n - Bilirubin =< 1.5 mg/dL (3 mg/dL in the presence of Gilberts disease provided direct bilirubin is normal)\n - Creatinine =< 1.5 mg/dL\n - LVEF normal by nuclear scan or echocardiogram\n - No evidence of PR prolongation or AV block by EKG\n - No symptomatic congestive heart failure\n - No unstable angina pectoris\n - No cardiac arrhythmia \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01384799	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: head and neck cancer\n\nICD Codes: \"C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11\"\n\nDrugs: cudc-101, cisplatin\n\nSMILES: COC1=C(OCCCCCCC(=O)NO)C=C2C(NC3=CC=CC(=C3)C#C)=NC=NC2=C1, HC@@12N(C)C3=CC(OC)=C(C=C3C@@11CCN3CC=CC@(CC)(C@@13H)C@@(H)(OC(C)=O)C@2(O)C(=O)OC)C@1(CC@@2(H)CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC\n\nCT Criteria: Inclusion Criteria:\n - Subjects with locally advanced, pathologically confirmed diagnosis of squamous cell carcinoma of the head and neck at the following sites: oral cavity, oropharynx, hypopharynx and larynx with either:\n - Stage IV p16 positive tumors and >10 pack-years smoking history.\n - Stage III/IV p16 negative tumors, regardless of smoking history.\n - At least evaluable disease; one measurable site of disease according to RECIST (Version 1.1) criteria (at least 10 mm for conventional CT/MRI or spiral CT scan) is desirable.\n - Subjects enrolled in the MTD expansion cohort must have at least 1 tumor lesion that is suitable for repeat biopsy (pre- and post-CUDC-101 infusion).\n - Age ≥ 18 years\n - ECOG performance < 2\n - Life expectancy ≥ 3 months\n - If female, neither pregnant nor lactating\n - If of child bearing potential, must use adequate birth control throughout the participation in the treatment phase and for 60 days following the last study treatment.\n - Absolute neutrophil count ≥ 1,800/µL; platelets ≥ 100,000/µL; hemoglobin ≥ 8.0 g/dL, creatinine ≤ 1.5x upper limit of normal (ULN); total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2 x ULN.\n - Serum magnesium and potassium within normal limits (may be supplemented to achieve normal values)\n - Able to render informed consent and to follow protocol requirements.\n Exclusion Criteria:\n - Prior radiotherapy to the region of the study cancer or adjacent anatomical sites, or > 25% of marrow-bearing area.\n - Prior chemotherapy for the current indication.\n - Prior therapy that specifically and directly targets EGFR, HER2 or HDAC.\n - Use of investigational agent(s) within 30 days prior to study treatment.\n - Primary tumor site of nasopharynx, sinuses, or salivary gland.\n - History of cardiac disease with a New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF), myocardial infarction (MI) or unstable angina in the past 6 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment.\n - Patients with prolonged QTc Interval >450 msec.\n - Acquired Immune Deficiency Syndrome (AIDS) or known infection with human immunodeficiency virus (HIV). Testing is not required.\n - Known history of gastrointestinal bleeding, ulceration, or perforation within 6 months prior to study treatment.\n - Known history of stroke or cerebrovascular accident within 6 months prior to study treatment.\n - Symptomatic cardiac conduction abnormality within 12 months prior to study treatment.\n - Prior history of hearing impairment.\n - Known history of renal disease or ongoing renal impairment.\n - Any uncontrolled condition (such as active systemic infection, diabetes, hypertension), which in the opinion of the investigator, could affect the subjects participation in the study.\n - Prior allergic reaction to cisplatin, carboplatin or other platinum-containing compounds.\n - Central nervous system metastases. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01634789	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: healthy\n\nICD Codes: \"Z76.3, Z76.2\"\n\nDrugs: bazedoxifene, bazedoxifene, bazedoxifene, bazedoxifene/conjugated estrogens\n\nSMILES: CC1=C(N(CC2=CC=C(OCCN3CCCCCC3)C=C2)C2=C1C=C(O)C=C2)C1=CC=C(O)C=C1, CC1=C(N(CC2=CC=C(OCCN3CCCCCC3)C=C2)C2=C1C=C(O)C=C2)C1=CC=C(O)C=C1, CC1=C(N(CC2=CC=C(OCCN3CCCCCC3)C=C2)C2=C1C=C(O)C=C2)C1=CC=C(O)C=C1, CC1=C(N(CC2=CC=C(OCCN3CCCCCC3)C=C2)C2=C1C=C(O)C=C2)C1=CC=C(O)C=C1\n\nCT Criteria: Inclusion Criteria:\n - Generally healthy postmenopausal women\n - Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 and body weight >= 50 kg\n Exclusion Criteria:\n - Pregnant or nursing females; females of childbearing potential \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT00646139	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: lymphoma, lymphoproliferative disorder, small intestine cancer, unspecified adult solid tumor, protocol specific\n\nICD Codes: \"S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S\", \"D47.Z1\", \"C17.9, C78.4, D37.2, C17.8, D13.30, D13.39, Z12.13\", \"H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509\"\n\nDrugs: src kinase inhibitor kx2-391\n\nSMILES: O=C(CC1=CC=C(C=N1)C1=CC=C(OCCN2CCOCC2)C=C1)NCC1=CC=CC=C1\n\nCT Criteria: DISEASE CHARACTERISTICS:\n - Confirmed diagnosis of advanced solid tumor or lymphoma\n - Metastatic or unresectable disease\n - Standard curative or palliative measures do not exist or are no longer effective\n - Patients with treated brain or ocular metastases are eligible\n PATIENT CHARACTERISTICS:\n - ECOG performance status 0-2\n - Life expectancy ≥ 14 weeks\n - ANC ≥ 1,500/mm³\n - Platelet count ≥ 100,000/mm³\n - Hemoglobin ≥ 10 g/dL\n - Serum bilirubin ≤ 2.5 times upper limit of normal (ULN)\n - ALT and AST ≤ 2.5 times ULN\n - Alkaline phosphatase ≤ 2.5 times ULN\n - Serum creatinine ≤ 1.5 times ULN or creatinine clearance > 60 mL/min\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective barrier contraception for 1 month prior to, during, and for 6 months after completion of study treatment\n - No inflammatory bowel disease, malabsorption syndrome, or other medical condition that may interfere with oral drug absorption\n - No signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions including, but not limited to, active infections that, in the opinion of the investigator, precludes protocol participation or compliance\n - No history of any of the following within the past 6 months:\n - Angina pectoris\n - Coronary artery disease\n - Hypertension\n - Cerebral vascular accident\n - Transient ischemic attack uncontrolled by medical therapy\n - No history of confirmed cardiac conduction abnormalities or arrhythmias\n - No known history of hepatitis B or C, or HIV infection\n - No known history of coagulation disorders or hemolytic conditions (e.g., sickle cell anemia)\n PRIOR CONCURRENT THERAPY:\n - Recovered from all prior therapy\n - No prior major surgery to the upper gastrointestinal tract\n - More than 2 weeks since prior investigational agents or systemic anticancer agents (28 days for agents with unknown elimination half-lives or known elimination half-lives > 50 hours)\n - More than 4 weeks since prior radiotherapy to the sternum, pelvis, scapulae, vertebrae, or skull and recovered\n - More than 4 weeks since prior major surgery\n - More than 1 week since prior palliative low-dose radiotherapy to the limbs and recovered\n - More than 2 weeks since prior and no concurrent hormones (e.g., estrogen contraceptives, hormone replacement, anti-estrogen, or progesterone) or antiplatelet agents\n - More than 2 weeks since prior and no concurrent anticoagulants (e.g., coumadin) except prophylactic doses of anticoagulants for indwelling venous catheters\n - More than 2 weeks or 5 half-lives since prior and no concurrent cytochrome P450 modulators (e.g., strong inducers or inhibitors) \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00633087	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: prostate cancer\n\nICD Codes: \"C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5\"\n\nDrugs: 2-deoxyglucose\n\nSMILES: HC(H)(C=O)C@@(H)(O)C@(H)(O)C@(H)(O)CO\n\nCT Criteria: Inclusion Criteria:\n - Patients with any histologically proven metastatic solid tumor malignancy, without a standard option of therapy will be eligible for the Phase I portion of this trial. Patients with prostate cancer with metastatic disease, and progression after initial hormonal therapy will be eligible for both the Phase I and II portion of this trial. Phase II patients must have either measurable disease or a PSA value > 5 ng/ml.\n - Patients with prostate cancer in whom bicalutamide or flutamide has been recently withdrawn, must demonstrate progression of disease and be at least 6 weeks and 4 weeks respectively beyond the discontinuation of such agents. LHRH agonists will be continued.\n - Age >18 years and an estimated life expectancy of at least 6 months.\n - ECOG performance status < 2. (see Appendix B)\n - Patients must be ³ 4 weeks since last prior therapy (including surgery, chemotherapy, radiation therapy). All previous clinically significant treatment-related toxicities have resolved to less than or equal to Grade 1.\n - An ANC >1500/µl, hemoglobin > 10 g/dl, and platelet count >100,000/µl are required.\n - Adequate renal function (serum creatinine < 1.5 mg/dL or creatinine clearance > 50 ml/min)\n - Total bilirubin must be within normal limits. Transaminases (SGOT and/or SGPT) must be less than 2.5X the institutional upper limit of normal.\n - Serum potassium within institutional limit of normal.\n - Fasting blood glucose < institutional ULN.\n - In the Phase I portion of this study patients may have had prior chemotherapy.\n - In the Phase II portion of this study patients may not have had prior chemotherapy.\n - Women of childbearing potential must have a negative pregnancy test (Phase I trial).\n - Men and women of childbearing potential must consent to using effective contraception while on treatment and for 3 months thereafter.\n Exclusion Criteria:\n - Known infection with HIV. Patients without prior HIV testing will not be required to be tested.\n - History of glucose intolerance.\n - Patients with ongoing coagulopathies and/or receiving oral anticoagulants.\n - Second primary malignancy except most situ carcinoma (e.g. in situ carcinoma of the of the cervix, adequately treated non-melanomatous carcinoma of the skin) or other malignancy treated at least 5 years previously with no evidence of recurrence.\n - Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events\n - Patients with diabetes mellitus, hypoglycemia, history of seizure disorder, known autonomic dysfunction, clinically significant uncontrolled gastrointestinal disorder, known G6PD deficiency, and allergy to methylparaben or propylparaben will be excluded, based on known potential toxicities.\n - The effects of 2-deoxyglucose on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because Agent Class as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 3 months thereafter. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n - Active clinically significant infection requiring antibiotics.\n - History of clinically significant unexplained episodes of hypotension, fainting, dizziness, or lightheadedness.5.2.10 History or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4; see Appendix D, New York Heart Association Criteria) within the last 6 months, particularly coronary artery disease, arrhythmias, or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure.\n - History of transient ischemic attack, stroke, or seizure disorder or any other CNS disease considered to be significant by the investigator.\n - Major surgery within 4 weeks of the start of study treatment, without complete recovery.\n - Antitumor therapy within 28 days of the start of study treatment (within 6 or 4 weeks for bicalutamide or flutamide, respectively).\n - Phase I only: Inability to discontinue prohibited medications for 24 hours before and after dosing on Cycle 1, Day 1 of Weeks 1 and 2.\n - Patients who are unable (as per Investigator discretion) or unwilling to give written informed consent. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01870245	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: healthy volunteer\n\nICD Codes: \"Y99.2\"\n\nDrugs: achn-975, placebo\n\nSMILES: CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\nCT Criteria: Key Inclusion Criteria:\n - Body weight between 40 and 100 kilograms (between ~88 pounds and ~220 pounds)\n - Use of contraception\n - Stable health\n - Negative tests for alcohol, tobacco, and drugs of abuse\n Key Exclusion Criteria:\n - History of clinically significant disease\n - Pregnancy \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT00038194	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: prostate cancer\n\nICD Codes: \"C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5\"\n\nDrugs: imatinib mesylate, docetaxel\n\nSMILES: CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1, HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1\n\nCT Criteria: Inclusion:\n - Patients with histologic proof of adenocarcinoma of the prostate and must have progressed on conventional hormonal therapy.\n - Patients must have bone metastases which can be demonstrated by bone scans. Lytic bone lesions should be considered for biopsy if there is a clinical suspicion of histologic conversion to small cell carcinoma.\n - Patients must have evidence of progression of disease. PSA- progression is defined as 2 consecutive increments in PSA (an absolute change of at least 1ng/mL) over 4 weeks. An increase by 25% of the product of bidimensional disease qualifies as progression. An increase in the number of metastatic lesions on bone scan qualifies as progression.\n - All patients must have a minimum PSA of 1ng/ml.\n - Patients on antiandrogens should be discontinued from flutamide or nilutamide for at least 4 weeks and bicalutamide for 8 weeks. If progression is documented as below prior to this time interval, patients are eligible.\n - Patients must have a performance status of < 2 (ECOG).\n - Patients must have an expected survival from cancer or co-morbidity of at least three months.\n - Patients may receive no concurrent chemotherapy, immunotherapy or ketoconazole.\n - Patients should not have received prior chemotherapy or radiation within the last 30 days and no Strontium or Samarium within the last 90 days.\n - Patients must have castrate serum testosterone levels (< 30ng/dl). For patients who are medically castrated, luteinizing hormone releasing hormone analog must continue to maintain testicular suppression.\n - Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of > 1,500/mm3 and platelet count of > 100,000/mm3.\n - Patients should have adequate hepatic function defined with a bilirubin of < 1.5 mg/dl and AST/ALT < 2X the upper limits of normal.\n - Patients should have adequate renal function defined as serum creatinine clearance > 40 cc/min (measured or calculated by Cockcroft and Gault formula) or serum creatinine < 1.5 X upper limit of normal.\n - Fully recovered from any previous surgery (at least 4 weeks since major surgery.\n - Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution. The only approved consent is attached to this protocol.\n Exclusion:\n - Patients with severe intercurrent infection.\n - Patients whose tumors contain small cell or sarcomatoid elements.\n - Patients with NYHA Class III/IV CHF, unstable angina or MI in the last 6 months or evidence of active myocardial ischemia on ECG.\n - CNS metastases that are uncontrolled.\n - Prior hypersensitivity or dose-limiting toxicity with docetaxel.\n - Oxygen-dependent lung disease\n - Contraindications to corticosteroids.\n - Uncontrolled severe hypertension or uncontrolled diabetes mellitus.\n - Second malignancies (except non-melanoma skin cancer) unless disease-free for 3 years.\n - Overt psychosis or mental disability or otherwise incompetent to give informed consent.\n - Patients with a history of non-compliance with medical regimens or who are considered potentially unreliable. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT00003382	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: fallopian tube cancer, ovarian cancer, primary peritoneal cavity cancer\n\nICD Codes: \"C57.00, C57.01, C57.02\", \"C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2\", \"C30.0, Z12.81, D14.0, C14.8, D37.09, Z86.003, Z85.818\"\n\nDrugs: gemcitabine hydrochloride, topotecan hydrochloride\n\nSMILES: NC1=NC(=O)N(C=C1)C@@H1OC@H(CO)C@@H(O)C1(F)F, CCC@@1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=C(C=CC(O)=C4CN(C)C)N=C13)C2=O\n\nCT Criteria: DISEASE CHARACTERISTICS:\n - Histologically documented refractory or recurrent ovarian epithelial or fallopian tube cancer\n - No borderline ovarian cancer\n - Extra-ovarian papillary serous tumors eligible\n - Must not be eligible for any higher priority phase II or III GOG protocol\n PATIENT CHARACTERISTICS:\n Age:\n - 18 and over\n Performance status:\n - GOG 0-2\n Life expectancy:\n - Not specified\n Hematopoietic:\n - Granulocyte count at least 1,500/mm^3\n - Platelet count at least 100,000/mm^3\n Hepatic:\n - SGOT no greater than 3 times upper limit of normal (ULN)\n - Bilirubin no greater than 1.5 mg/dL\n - Elevated levels of alkaline phosphatase allowed\n Renal:\n - Creatinine no greater than 1.5 mg/dL\n Cardiovascular:\n - No angina pectoris or clinically significant multifocal uncontrolled cardiac dysrhythmias\n - No uncontrolled hypertension\n Other:\n - No other active malignancy\n - No prior malignancy within the past 5 years except nonmelanomatous skin cancer\n - No active infection\n - No underlying medical problem that would prevent compliance\n - No known hypersensitivity to E. coli-derived drug preparations\n - Fertile patients must use effective contraception\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - Not specified\n Chemotherapy:\n - Must have received at least 1 prior platinum- and paclitaxel-based regimen\n - At least 4 weeks since prior chemotherapy\n - No prior topotecan and/or gemcitabine\n - No prior chemotherapy for a different prior malignancy\n Endocrine therapy:\n - Not specified\n Radiotherapy:\n - No prior radiotherapy to more than 10% of bone marrow\n - At least 2 weeks since limited field radiation therapy\n Surgery:\n - Not specified \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01232439	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: alcohol dependence\n\nICD Codes: \"F10.20, F10.24, F10.27, F10.280, F10.281, F10.282, F10.288\"\n\nDrugs: opioid receptor kappa antagonist\n\nSMILES: CC1=CC(=CC(C)=C1)C@@H1CCCN1CC1=CC=C(OC2=CC=C(C=C2F)C(N)=O)C=C1\n\nCT Criteria: Inclusion Criteria:\n - Healthy male or female\n - Have clinical laboratory tests within normal reference ranges\n - Have arterial and venous access sufficient to allow blood sampling\n Exclusion Criteria:\n - Currently enrolled in, or discontinued within the last 30 days from a clinical trial\n - History of severe allergies or multiple adverse drug reactions\n - Have an abnormal ECG at screening visit\n - Have abnormal sitting blood pressure\n - Have an increased risk of seizures\n - Current suicidal ideation\n - Positive test for HIV, hepatitis C, or hepatitis B\n - Women who are breast feeding\n - Smoke more than 10 cigarettes per day, or equivalent\n - Drink more than 5 cups of coffee per day, or equivalent\n - Have a history of head injury\n - Unable to undergo a MRI\n - Suffer from claustrophobia \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00581789	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: non small cell lung cancer\n\nICD Codes: \"C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2\"\n\nDrugs: erlotinib, sunitinib\n\nSMILES: CCN(CC)CCNC(=O)C1=C(C)NC(\\\\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C\n\nCT Criteria: Inclusion Criteria:\n - Histologically or cytologically proven stage IIIB (with pleural effusion or pericardial effusion) or IV (either primary or recurrent) NSCLC (except squamous cell histology).\n - Measurable disease per RECIST\n - Life expectancy of at least 12 weeks.\n - Adequate bone marrow, hepatic and renal function\n - ECOG performance status 0, 1 or 2.\n - One and only one prior treatment with a chemotherapy regimen, including a platinum based regimen for advanced disease (Stage IIIB with malignant effusion or Stage IV).\n - Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.\n - Female patients must be surgically sterile, postmenopausal or agree to use effective contraception during the period of therapy. Male patients must be surgically sterile or agree to use effective contraception during the period of therapy.\n Exclusion Criteria:\n - Squamous cell histology.\n - History of untreated brain metastases\n - Prior treatment with >1 systemic chemotherapy-based regimens for advanced disease (Stage IIIB with malignant effusion or Stage IV).\n - Prior treatment with any receptor tyrosine kinase inhibitors, VEGF inhibitors, or other angiogenic inhibitors (including but not limited to bevacizumab, sunitinib, erlotinib, gefitinib, or thalidomide).\n - Prior chemotherapy, radiation therapy, surgery, or investigational agent within 4 weeks prior to study entry, except palliative radiation therapy to a non-target lesions (must have been completed 2 weeks prior to study enrollment).\n - Eligibility of patients receiving any medications or substances known to induce or inhibit CYP3A4 and /or with the potential to affect the activity or pharmacokinetics of sunitinib or erlotinib will be determined following review of their case by the Principal Investigator.\n - NCI CTCAE grade 3 hemorrhage within 4 weeks of starting therapy.\n - Ongoing treatment with warfarin\n - Prior treatment with high-dose chemotherapy requiring stem cell rescue.\n - Prior irradiation to >25% of the bone marrow (whole pelvis = 25%).\n - Diagnosis within prior 3 years of second malignancy, except basal cell carcinoma, squamous cell skin carcinoma or in situ carcinoma that has been completely treated without evidence of recurrent disease for 12 months.\n - Current treatment on another therapeutic clinical trial or receipt of another investigative agent within 4 weeks of study entry.\n - Any of the following within 12 months prior to starting study treatment: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus.\n - Hypertension (>150/100mmHg) that cannot be controlled with standard antihypertensive agents.\n - Ongoing cardiac dysrhythmias of grade >2, ≥ grade 3 atrial fibrillation, or QTc interval of >450 msec for males and >470 msec for females.\n - Evidence of hemoptysis <4 weeks of starting study treatment.\n - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.\n - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality\n - HIV-positive patients\n - Women who are pregnant or breast feeding \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT00320073	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: unspecified adult solid tumor, protocol specific\n\nICD Codes: \"H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509\"\n\nDrugs: erlotinib hydrochloride, pemetrexed disodium, vinflunine\n\nSMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2, HC@@(CCC(O)=O)(NC(=O)C1=CC=C(CCC2=CNC3=C2C(O)=NC(=N)N3)C=C1)C(O)=O, CCC@@12C=CCN3CCC@@4(C@H13)C@@H(N(C)C1=CC(OC)=C(C=C41)C@1(CC@@H3CC@H(CN@@(C3)CC3=C1NC1=CC=CC=C31)C(C)(F)F)C(=O)OC)C@(O)(C@@H2OC(C)=O)C(=O)OC\n\nCT Criteria: DISEASE CHARACTERISTICS:\n - Histologically confirmed solid tumors\n - Advanced/unresectable or metastatic disease\n - Refractory to standard therapy OR no standard therapy exists\n - No lymphoma\n - Measurable or evaluable disease\n - Measurable disease is defined as at least one target lesion measuring ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan\n - Evaluable disease includes ascites, pleural effusion, bone metastases, pulmonary lymphangitic spread, and lesions not meeting above criteria as measurable\n - Patients with clinically significant ascites or pleural effusions that cannot be controlled by drainage are not eligible\n - Brain metastases allowed if CNS-directed treatment has been given, patient has been off CNS-directed therapy for > 3 months, and CNS disease has been clinically and radiographically stable for at least 8 weeks\n PATIENT CHARACTERISTICS:\n - Life expectancy > 3 months\n - ECOG performance status 0-2\n - Absolute neutrophil count ≥ 1,500/μL\n - Platelet count ≥ 100,000/μL\n - Creatinine clearance ≥ 60 mL/min\n - Patients assigned to group 1 with creatinine clearance 45-80 mL/min must be able to withhold NSAIDS during pemetrexed disodium administration\n - Total bilirubin ≤ 1.5 mg/dL\n - AST and ALT ≤ 3 times upper limit of normal (ULN) OR ≤ 5 times ULN if due to known liver metastases\n - No New York Heart Association class III or IV heart failure\n - No unstable angina\n - No myocardial infarction within the past 6 months\n - No poorly controlled hypertension\n - No prior allergic reaction to any vinca alkaloid\n - No uncontrolled active infection or severe illness\n - Able to receive vitamin B12 and folate supplementation and dexamethasone during chemotherapy\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective contraception during and for 3 months after last dose of chemotherapy\n PRIOR CONCURRENT THERAPY:\n - At least 4 weeks since prior chemotherapy, investigational agents, or surgery\n - Concurrent cytochrome P450/CYP3A4 inducers or inhibitors are allowed provided patient has been on a stable dose for ≥ 2 weeks prior to study entry\n - No concurrent ketoconazole, itraconazole, ritonavir, amprenavir, or indinavir\n - No concurrent enzyme-inducing antiepileptic drugs (EIAEDs) (e.g., phenytoin, carbamazepine, phenobarbital, primidone, or oxcarbazepine) for patients assigned to group 2 \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01027234	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: healthy\n\nICD Codes: \"Z76.3, Z76.2\"\n\nDrugs: azd8418, placebo\n\nSMILES: CC@@H(C1CC1)N1CC2=CC(=CC(Cl)=C2C1=O)C1=CC(=NO1)C(=O)N(C)C, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\nCT Criteria: Inclusion Criteria:\n - Healthy male volunteers\n - Healthy female volunteers of non-childbearing potential\n Exclusion Criteria:\n - History of any clinically significant medical, neurologic, or psychiatric disease (including repeated episodes of major depression) or a disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation\n - History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD8418 \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT00633997	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: diabetes mellitus, type 2\n\nICD Codes: \"E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44\"\n\nDrugs: vildagliptin, vildagliptin\n\nSMILES: CN(C)C(=N)NC(N)=N, CN(C)C(=N)NC(N)=N\n\nCT Criteria: Inclusion Criteria:\n - Healthy volunteers and patients with type 2 diabetes\n - Non-smoking, Caucasian and African American, male and female (postmenopausal, surgically sterile or using double-barrier method of contraception) subjects between 30 and 65 years of age (inclusive)\n - Type 2 diabetics on metformin and/or sufonylurea\n Exclusion Criteria:\n - History of type 1 diabetes or insulin use\n - History of coagulation abnormalities\n - History of abnormal heart conditions\n - Pregnancy or breastfeeding\n Other protocol-defined inclusion/exclusion criteria may apply \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00288054	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: lung cancer\n\nICD Codes: \"C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2\"\n\nDrugs: docetaxel\n\nSMILES: HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1\n\nCT Criteria: DISEASE CHARACTERISTICS:\n - Histologically or cytologically proven newly diagnosed single, primary, bronchogenic stage IIIA or selected stage IIIB (excluding malignant pleural effusion) non-small cell lung cancer (NSCLC) of one of the following cellular types:\n - Adenocarcinoma\n - Large cell carcinoma\n - Squamous cell carcinoma\n - Unspecified\n - Histology or cytology from involved mediastinal or supraclavicular nodes will be sufficient for diagnosis if a separate primary lesion of the lung parenchyma is clearly evident on radiographs (i.e., a second biopsy will not be required)\n - Underwent positron emission tomography (PET) scan within the past 42 days\n - N2 or N3 mediastinal disease by PET scan OR enlarged nodes on CT scan determined to be N2 or N3 by biopsy\n - Measurable disease, defined as lesions that can be accurately measured in at least one dimension as ≥ 2 cm by conventional techniques or ≥ 1 cm by spiral CT scan\n - Pleural effusion, ascites, bone lesions, and laboratory parameters are not considered measurable disease\n - No brain metastases\n - Malignant pleural effusion allowed provided 1 of the following is true:\n - Present before mediastinoscopy or exploratory thoracotomy AND the pleural fluid is transudate with negative cytology\n - Present only after but not before exploratory or staging thoracotomy AND the pleural fluid is either transudate or exudate with negative cytology\n - Present only on CT scan but not on decubitus chest x-ray AND deemed too small to tap under either CT scan or ultrasound guidance\n PATIENT CHARACTERISTICS:\n - Zubrod performance status 0-1, meeting ≥ 1 of the following criteria OR Zubrod performance status 2 with no co-morbidities or meeting 1 of the following criteria:\n - No co-morbidities\n - FEV_1 < 2 L OR < 1 L with estimated contralateral FEV_1 ≥ 0.6 L\n - DLCO > 10 mL/mm Hg/min\n - Albumin < 0.85 times lower limit of normal\n - Unintentional weight loss > 10% within the past 6 months\n - Controlled congestive heart failure which, in the opinion of the investigator, may become decompensated due to radiotherapy\n - FEV_1 < 2 L OR < 1 L with estimated contralateral FEV_1 ≥ 0.6 L\n - Absolute neutrophil count ≥ 1,500/mm^3\n - Platelet count ≥ 100,000/mm^3\n - Serum creatinine ≤ 1.5 times upper limit of normal (ULN)\n - Must provide prior smoking history\n - Serum bilirubin normal\n - Meets one of the following criteria:\n - Alkaline phosphatase (AP) ≤ 4 times ULN AND SGOT or SGPT normal\n - AP normal AND SGOT or SGPT ≤ 2.5 times ULN\n - No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or adequately treated stage I or II cancer from which the patient is currently in complete remission\n - No pregnant or nursing patients\n - Fertile patients must use effective contraception\n PRIOR CONCURRENT THERAPY:\n - No prior chemotherapy or curative surgery for this cancer\n - No prior radiotherapy to the neck and/or thorax for any reason\n - No prior therapy which specifically targets the EGFR pathway\n - No concurrent growth factors (e.g., filgrastim G-CSF, epoetin alfa, or pegfilgrastim) or amifostine\n - No concurrent intensity-modulated radiotherapy\n - No concurrent prophylactic mediastinal, contralateral hilar, or supraclavicular lymph node radiotherapy \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01115712	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: healthy, overweight, obesity\n\nICD Codes: \"Z76.3, Z76.2\", \"E66.3\", \"E66.8, E66.9, E66.1, O99.214, O99.215, O99.210, O99.211\"\n\nDrugs: placebo, comparator: pioglitazone, comparator: hyperinsulinemic euglycemic clamp\n\nSMILES: CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CCC1=CN=C(CCOC2=CC=C(CC3SC(=O)NC3=O)C=C2)C=C1\n\nCT Criteria: Inclusion Criteria:\n - Subject has a BMI of greater than 28 kg/m^2 and less than or equal to 38 kg/m^2\n - Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months\n - Subject is willing to avoid major dietary changes for the duration of the study\n Exclusion Criteria:\n - Subject has history of diabetes (Type 1, Type 2 or steroid-induced)\n - Subject has a history of hypersensitivity to pioglitazone or other thiazolidinediones\n - Subject has a history of liver disease, other than non-alcoholic fatty liver disease or non-alcoholic steatohepatitis\n - Subject has a history of congestive heart failure\n - Subject has a active or past history of atherosclerotic heart disease, heart failure, osteoporosis, osteopenia, recurrent bone fractures, or anemia\n - Subject has a history of stroke, chronic seizures, or major neurological disorder\n - Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological or renal abnormalities or diseases\n - Subject has a history of neoplastic disease within the past 5 years \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00551096	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: malignant solid tumour, biliary cancer, pancreatic cancer\n\nICD Codes: \"C24.9, C24.8\", \"C25.3\"\n\nDrugs: gemcitabine, capecitabine, zd6474\n\nSMILES: HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1, HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1, COC1=C(OCC2CCN(C)CC2)C=C2N=CN=C(NC3=C(F)C=C(Br)C=C3)C2=C1\n\nCT Criteria: Inclusion Criteria:\n - Age 18 years or older\n - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (measure of your ability to perform everyday tasks)\n - Life expectancy of at least three months\n Blood samples and other testing may apply for further testing of eligibility.\n Exclusion Criteria:\n - Uncontrolled illness (for example, current infections or heart conditions)\n - Abnormal laboratory tests (such as blood or urine testing)\n - Pregnant or breastfeeding women\n Further exclusion criteria may apply. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01199367	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: breast cancer\n\nICD Codes: \"C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60\"\n\nDrugs: kw-2450 in combination with lapatinib and letrozole\n\nSMILES: N#CC1=CC=C(C=C1)C(N1C=NC=N1)C1=CC=C(C=C1)C#N\n\nCT Criteria: Inclusion Criteria\n 1. Histopathologically or cytologically confirmed, advanced or metastatic breast cancer (stage IIIb, IIIc or IV disease) including inflammatory breast cancer or inoperable locally advanced disease.\n 2. Documented ErbB2 overexpression\n 3. Estrogen receptor positive (ER+) and/or progesterone positive (PgR+) tumors\n 4. Measurable or non-measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria\n 5. A life expectancy of > 3 months for Phase 1 and > 6 months for Phase 2\n 6. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2 at study entry in Phase 1 and ≤ 1 in Phase 2;\n 7. Normal cardiac ejection fraction\n 8. Adequate hematologic, hepatic and renal function\n 9. Post-menopausal female (defined as the absence of a menstrual cycle for at least 12 consecutive months) or male subjects ≥ 18 years of age.\n 10. Sign an IRB or EC approved informed consent\n Exclusion Criteria\n 1. Type 1 diabetes or uncontrolled Type 2 diabetes\n 2. Subjects showing clinical evidence or with a history of cataract(s), proliferate retinopathy or significant macular edema\n 3. Subjects with abnormal free T4 values and a history or evidence of thyroid disease\n 4. Subjects who are unable or unwilling to take metformin\n 5. Uncontrolled intercurrent illness\n 6. Known or suspected human immunodeficiency virus (HIV) infection or hepatitis B or C\n 7. Subjects with inflammatory diseases of the gastrointestinal tract\n 8. History of other malignancy. Subjects who have been disease free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible;\n 9. Subjects with extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor\n 10. A history of prior treatment with other agents specifically targeting IGFRs\n 11. Subjects who require pharmacological doses of glucocorticoids beyond replacement doses. The use of topical, intra-ocular or inhalation glucocorticoids is permitted \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01582308	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: type 2 diabetes mellitus\n\nICD Codes: \"E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44\"\n\nDrugs: sitagliptin 100 mg, saxagliptin 5 mg, vildagliptin 50 mg, vildagliptin 50 mg bid, placebo\n\nSMILES: NC@@H(CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F, NC@H(C(=O)N1C@H2CC@H2CC@H1C#N)C12CC3CC(CC(O)(C3)C1)C2, OC12CC3CC(C1)CC(C3)(C2)NCC(=O)N1CCCC@H1C#N, OC12CC3CC(C1)CC(C3)(C2)NCC(=O)N1CCCC@H1C#N, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\nCT Criteria: Inclusion Criteria:\n - female participants of reproductive potential must not be pregnant and agree to use (and/or have their partner use) two acceptable methods of birth control beginning at least 2 weeks prior to administration of the first dose of study drug until at least 2 weeks after the last administration of study drug\n - has a body mass index between 18 and 43 kg/m^2 inclusive\n - has a clinically confirmed diagnosis of T2DM\n - is not currently receiving any oral antihyperglycemic medications and has a screening visit hemoglobin A1c (HbA1c) between 6.5% and 10% inclusive\n - must not have been previously treated with a DPP-4 inhibitor or glucagon-like peptide-1 analogs within 12 weeks of prestudy visit\n - has fasting plasma or serum glucose (FPG) ≤200 mg/dL (11.1 mmol/L) at screening and randomization\n - is a non-smoker or has not used nicotine or nicotine-containing products for at least approximately the last 6 months\n - is willing to follow the American Heart Association weight maintaining diet and exercise program or equivalent beginning 2 weeks prior to administration of first dose of study drug and throughout the study until the poststudy visit\n - agrees to refrain from the consumption of grapefruit and grapefruit juice for at least 2 weeks prior to the start of the study and throughout the study\n - agrees to refrain from the consumption of all fruit juices periodically throughout the study\n Exclusion Criteria:\n - is mentally or legally incapacitated, has significant emotional problems at the time of prestudy visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last 5 years\n - has an estimated creatinine clearance of ≤60 mL/min\n - has a history of stroke, chronic seizures, or major neurological disorder\n - has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases (with the exception of stable thyroid disease, T2DM and typical associated diseases such as hypertension and hyperlipidemia)\n - must not have been previously treated with any regimen that includes insulin (injected or inhaled) for at least 3 months\n - has a history of type 1 diabetes mellitus and/or history of ketoacidosis, or C peptide ≤0.8 ng/mL (≤0.26 nmol/L); or secondary forms of diabetes, acute metabolic diabetic complications or evidence of significant diabetic complications (i.e. retinopathy, neuropathy, nephropathy)\n - has a history of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease\n - is on a weight loss program and is not in the maintenance phase, or participant has been treated with a weight loss medication within 8 weeks of screening\n - anticipates the use of any new medication(s), including prescription and non-prescription drugs or herbal remedies beginning approximately 2 weeks prior to administration of the initial dose of study drug and throughout the study until the poststudy visit\n - anticipates any change in dose of current stable medications\n - has donated or lost 1 unit of blood within 4 weeks of the prestudy visit\n - has had major surgery within 30 days prior to screening or has planned major surgery\n - has a history of uncontrolled hypertension\n - is taking a medication which is not permitted in the study to treat a co-morbid condition, including but not limited to cytochrome P450 3A4/5 inhibitors and inducers, P-glycoprotein 1 inhibitors, and human organic anion transporter 3 inhibitors\n - consumes excessive amounts of alcohol, coffee, tea, cola, or other caffeinated beverage daily\n - has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food\n - is currently a regular user (including \"recreational use\") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately the past 6 months\n - is a nursing mother \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01570790	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: combretastatin a4 phosphate, age-related macular degeneration, amd, cnv, choroidal neovascularization\n\nICD Codes: \"H35.3130, H35.3230, H35.3110, H35.3120, H35.3131, H35.3132, H35.3190\", \"H44.2A1, H44.2A2, H44.2A3, H44.2A9, H35.3231, H35.3232, H35.3211\"\n\nDrugs: combretastatin a-4 phosphate, combretastatin a-4 phosphate, combretastatin a-4 phosphate\n\nSMILES: COC1=CC(=CC(OC)=C1OC)C@@H(O)CC1=CC(O)=C(OC)C=C1, COC1=CC(=CC(OC)=C1OC)C@@H(O)CC1=CC(O)=C(OC)C=C1, COC1=CC(=CC(OC)=C1OC)C@@H(O)CC1=CC(O)=C(OC)C=C1\n\nCT Criteria: Inclusion Criteria:\n 1. Age 50 years or older;\n 2. 12-lead electrocardiogram (ECG) performed at least 2 weeks but less than 4 weeks prior to entry into the study showing a QTc <440 with no evidence of current or prior myocardial ischemia, infarction or significant arrhythmia as determined by review and signature of the cardiologist.\n 3. Adequate bone marrow function:\n Absolute granulocyte count ≥1500 cells/mm3; Platelet count ≥100,000 cells/mm3; Hemoglobin ≥9.0gm/ dL;\n 4. PT/PTT within the institution upper limit of normal (ULN) or INR <1.1 ;\n 5. Adequate hepatic function:\n Total bilirubin within the institution ULN; Alanine and aspartate aminotransferase (ALT/AST) <3 times the institutional ULN;\n 6. Adequate renal function: serum creatinine ≤2.0 mg/dL;\n 7. Ophthalmic criteria:\n 1. Best corrected visual acuity in the study eye of ≤20/40 and ≥20/800 in the fellow eye.\n 2. Subfoveal choroidal neovascularization (as illustrated by fluorescein angiography) secondary to age-related macular degeneration, with a total lesion size of ≤12 total disc areas, of which at least 50% must be active CNV.\n 3. Subretinal hemorrhage ≤50% of total lesion size;\n 4. For patients with minimally classic and purely occult CNV, there must be documented evidence of ≥2 lines of vision loss (ETDRS) during the previous 12 weeks;\n 5. Clear ocular media and adequate papillary dilatation to permit good quality stereoscopic fundus photography;\n 8. Male fertile patients must abstain from sexual intercourse or use effective birth control;\n 9. Women must be post-menopausal for at least 12 months prior to study entry, or surgically sterile, or must be using two forms of effective contraception.\n 10. Able to return for all study visits within required visit windows;\n 11. Be able to give written informed consent.\n Exclusion Criteria:\n 1. Previous subfoveal thermal laser therapy;\n 2. Any subfoveal scarring or atrophy, or >25% of the total lesion size is made up of scarring or atrophy;\n 3. Significant media opacities, including cataract, which can interfere with visual acuity, assessment of toxicity, or fundus photography;\n 4. Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of ≥-8.0 diopters, or axial length of ≥25mm), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis and other uveitic entities;\n 5. Any condition that might interfere with assessment of the progression of CNV;\n 6. Any intraocular surgery in the study eye within 12 weeks of screening for the study;\n 7. Other treatment for AMD of the study eye within 12 weeks prior to screening;\n 8. Known allergy to fluorescein;\n 9. Any current or history of significant gastrointestinal, oral, or nasal bleeding;\n 10. Serious intercurrent infections or other nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy;\n 11. Grade 2 (CTC v.3.0) or greater pre-existing peripheral neuropathy;\n 12. Psychiatric disorders or other conditions rendering patients incapable of complying with the requirements of the protocol;\n 13. Pregnant or breast-feeding women;\n 14. History of angina, myocardial infarction, CHF, non-controlled atrial arrhythmias or clinically significant arrhythmias including conduction abnormality, nodal junctional arrhythmias and dysrhythmias, sinus bradycardia or tachycardia, supraventricular arrhythmias, atrial fibrillation or flutter, syncope or vasovagal episodes;\n 15. Abnormal cardiac stress test;\n 16. Uncontrolled hypertension (consistently >150/100mmHg irrespective of medication);\n 17. Uncontrolled hypokalemia and/or hypomagnesemia;\n 18. ECG with evidence of prior myocardial infarction, QTc > 450 msec or other clinically significant abnormalities;\n 19. Drug(s) known to prolong the QTc interval;\n 20. Patients with conditions associated with QTc prolongation;\n 21. Any investigational drug or device within 4 weeks prior to screening;\n 22. Decreased ejection fraction ≤50% or prior myocardial infarction. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01416038	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: ovarian cancer, fallopian tube cancer, peritoneal cancer\n\nICD Codes: \"C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2\", \"C57.00, C57.01, C57.02\", \"K65.1, K66.0, N99.4, N73.6, R88.0, Z49.32, Z49.02\"\n\nDrugs: low dose cyclophosphamide (oral)\n\nSMILES: ClCCN(CCCl)P1(=O)NCCCO1\n\nCT Criteria: Main Inclusion Criteria:\n - Subjects with stage IIc-IV epithelial ovarian, fallopian tube and peritoneal cancer who have completed adjuvant treatment consisting of up to 8 cycles of paclitaxel and carboplatin chemotherapy or other acceptable chemotherapy after initial debulking surgery with evidence of a complete or partial response by radiological imaging. These subjects may remain on hormonal therapy during the trial if such treatment has been prescribed by their treating physician. These subjects may have been in a clinical trial for an investigational carboplatin based adjuvant therapy.\n - Subjects with recurrent ovarian, fallopian tube or peritoneal cancer who have clinical or radiologic evidence of a complete or partial response or stable disease after completion of first-line chemotherapy for their recurrent disease and are not suitable for additional cytotoxic therapy are eligible. These subjects may have previously received a course of adjuvant chemotherapy earlier in their disease management as described in point one above. These subjects are eligible regardless of their CA-125 results. These subjects may have been in a clinical trial of an investigational therapy.\n - Subjects may have received previous courses of an investigational biologic therapy including active or passive immunotherapy greater than 60 days prior to receiving the first injection of DPX-Survivac\n - At least 30 days since localized surgery, radiotherapy or chemotherapy\n - Subjects may be on a biphosphonate provided it had not been initiated within 14 days prior to receiving the first injection of DPX-Survivac\n Main Exclusion Criteria:\n - Subjects undergoing concurrent chemotherapy, radiation therapy, immunotherapy are excluded\n - Subjects who participated in therapeutic adjuvant ovarian cancer studies are excluded except for platinum-based adjuvant studies\n - Subjects who have received more than one course of chemotherapy for recurrent disease\n - Subjects receiving bevacizumab for maintenance therapy are excluded (subjects who received bevacizumab as part of their adjuvant therapy will be permitted)\n - History of autoimmune disease\n - Subjects with recent history of thyroiditis\n - Presence of an acute infection requiring antibiotics within 4 weeks of study entry or a chronic infection including but not limited to: urinary tract infection, HIV, viral hepatitis\n - Subjects with brain metastases\n - Concurrent (within the last 5 years) second malignancy other than non melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer\n - Acute or chronic skin disorders that will interfere with subcutaneous injection of the vaccine or subsequent assessment of potential skin reactions\n - Serious intercurrent chronic or acute illness, such as cardiac disease, hepatic disease, or other illness considered by the investigator as an unwarranted high risk for an investigational product\n - Subjects on steroid therapy or other immunosuppressive, such as azathioprine or cyclosporin A\n - Allergies to any component of the vaccine\n - Pregnant or nursing mothers\n - Subjects with a medical or psychological impediment to probable compliance with the protocol \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00084591	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: colorectal cancer\n\nICD Codes: \"C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2\"\n\nDrugs: capecitabine\n\nSMILES: HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1\n\nCT Criteria: DISEASE CHARACTERISTICS:\n - Histologically confirmed primary adenocarcinoma of the rectum\n - Distal border of the tumor within 12 cm of the anal verge by proctoscopic exam\n - Clinical stage T3-4, N1-2 (stage II or III) disease by 2 of the following tests:\n - Physical exam\n - Transrectal ultrasound\n - Pelvic CT scan\n - Pelvic MRI\n - No clinical evidence of metastatic disease\n PATIENT CHARACTERISTICS:\n Age\n - 18 and over\n Performance status\n - ECOG 0-1\n Life expectancy\n - More than 3 months\n Hematopoietic\n - Absolute neutrophil count ≥ 1,500/mm^3\n - Platelet count ≥ 100,000/mm^3\n - No known, uncontrolled coagulopathy\n Hepatic\n - Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n - SGOT and SGPT ≤ 1.5 times ULN\n - Alkaline phosphatase ≤ 2.5 times ULN\n Renal\n - Creatinine ≤ 1.5 times normal\n - Creatinine clearance > 50 mL/min\n Cardiovascular\n - No clinically significant cardiac disease\n - No congestive heart failure\n - No symptomatic coronary artery disease\n - No poorly controlled cardiac arrhythmias\n - No myocardial infarction within the past year\n Gastrointestinal\n - No active inflammatory bowel disease\n - No lack of physical integrity of the upper gastrointestinal tract\n - No malabsorption syndrome\n Other\n - No other prior or concurrent malignancy except inactive, non-invasive carcinoma of the cervix or non-melanoma skin cancer\n - No concurrent serious, uncontrolled infection(s)\n - No prior unanticipated severe reaction to fluoropyrimidine therapy\n - No known sensitivity to fluorouracil\n - No prior uncontrolled seizures\n - No CNS disorders that would preclude study participation\n - No other medical or psychiatric condition that would preclude study participation\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective contraception during and for 3 months after study participation\n PRIOR CONCURRENT THERAPY:\n Biologic therapy\n - No prior immunotherapy for rectal cancer\n Chemotherapy\n - No prior chemotherapy for rectal cancer\n Endocrine therapy\n - Not specified\n Radiotherapy\n - No prior radiotherapy for rectal cancer\n - No prior pelvic radiotherapy\n Surgery\n - More than 4 weeks since prior major surgery and recovered\n - No prior surgery for rectal cancer\n Other\n - More than 4 weeks since prior participation in another investigational drug study\n - No concurrent celecoxib \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01166412	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: contraception\n\nICD Codes: \"Z92.0, Z30.012, Z30.09\"\n\nDrugs: levonorgestrel patch with bmi 32 kg/m2 to <40 kg/m2, levonorgestrel patch with bmi <32 kg/m2, levonorgestrel patch with bmi 32 kg/m2 to <40 kg/m2, levonorgestrel patch with bmi <32 kg/m2\n\nSMILES: HC@@12CCC@@(O)(C#C)C@@1(CC)CCC@1(H)C@@3(H)CCC(=O)C=C3CCC@@21H, HC@@12CCC@@(O)(C#C)C@@1(CC)CCC@1(H)C@@3(H)CCC(=O)C=C3CCC@@21H, HC@@12CCC@@(O)(C#C)C@@1(CC)CCC@1(H)C@@3(H)CCC(=O)C=C3CCC@@21H, HC@@12CCC@@(O)(C#C)C@@1(CC)CCC@1(H)C@@3(H)CCC(=O)C=C3CCC@@21H\n\nCT Criteria: Inclusion Criteria:\n - 1. Good general health.\n - 2. Aged 18-44 years, inclusive, at the enrollment visit.\n - 3. Intact uterus with at least one ovary.\n - 4. Pap test within the last 12 months or undergo a Pap test at screening prior to enrollment. If a potential subject states that she has had a Pap test within the last 12 months, then she will need to provide documentation of acceptable test results.\n - 5. Cervical mucus score of >7, which is based on the modified Insler scoring system during the screening cycle. The cervical mucus is collected by aspiration and the assessment is based on the modified Insler scoring system (the volume and pH of the mucus are not included in the total scoring) yielding a total possible score of 12 (3, 4).\n - 6. Regular menstrual cycles that occur every 28 ± 7 days.\n 1. If subject is postpartum or post-abortal (with abortion in second trimester), she will be required to have two normal menstrual cycles prior to screening.\n 2. If subject had an abortion in the first trimester, she will be required to have at least one menstrual cycle (two menses) prior to screening.\n - 7. Heterosexually abstinent or, if heterosexually active, must have undergone previous tubal sterilization, be in monogamous relationship with a vasectomized partner, or only use male or female condoms (use of condoms that are pre-lubricated with or without spermicide is acceptable) for the entire duration of the study. Use of a spermicide applied separately is not allowed. Cervical caps or diaphragms are not allowed during study participation.\n - 8. In the opinion of the investigator, able to comply with the protocol, willing to record requested information in the daily diary, and live within the study site catchment area or within a reasonable distance from the site.\n - 9. Understand and sign an IRB approved informed consent form prior to screening activities (including fasting blood draw).\n - 10. Willing to refrain from use of skin lotions/creams/gels on area of patch application and not use any vaginal creams, lubricants, gels, or spermicides for 3 days prior to study admission through to the end of the study.\n - 11. Agree not to participate in any other clinical trials during the course of this study.\n Exclusion Criteria:\n Contraindications for enrollment will be the same as those for use of combined hormonal contraceptives as referenced in the World Health Organization (WHO) Medical Eligibility Criteria(MEC category 1 or 2) (1), in addition to contra-indications specific to this clinical trial including:\n - 1. Known hypersensitivity or contraindication to progestins.\n - 2. Known or suspected pregnancy.\n - 3. Prior hysterectomy or bilateral oophorectomy.\n - 4. Prior cervical surgery (LEEP, Cone biopsy, Cryosurgery).\n - 5. A history (within prior 12 months) or drug or alcohol abuse.\n - 6. Undiagnosed abnormal genital bleeding.\n - 7. Undiagnosed vaginal discharge or vaginal lesions or abnormalities. Subjects diagnosed at screening with a Chlamydia or gonococcus infection may not be included in the trial unless they are treated and proof of cure is documented after treatment (i.e. repeat test with negative results). In accordance with PI/medical designee assessment and local standards of practice, women with a history of genital herpes can be included if outbreaks are infrequent. Antiviral prophylactic therapy is permitted.\n - 8. Uncontrolled thyroid disorder.\n - 9. History or presence of dermal hypersensitivity in response to topical application. Specifically any reaction to application of a plastic bandage (Band-Aid), surgical or bandage tape, other skin patches, or adhesives.\n - 10. Any Pap test finding that would require additional workup or treatment during the study interval. HPV testing will not be done at screening for these subjects.\n - 11. Use of an injectable hormonal contraceptive (Depo-Provera®) within the past 10 months.\n - 12. Use of oral contraceptives, contraceptive implants, or other sex steroid hormones within 30 days prior to screening visit.\n - 13. Women who are breastfeeding or within 30 days of discontinuing breast feeding.\n - 14. Women planning to undergo major surgery within four months of study enrollment.\n - 15. Women planning pregnancy within their months of study enrollment.\n - 16. Smoking in women who are ages 18-44 years old that smoke 15 cigarettes or more per day must be evaluated by the PI for inclusion based on risk factors that would increase their risk for CVD and thromboembolism.\n - 17. Current or past deep vein thrombophlebitis or thromboembolic disorders.\n - 18. History of known thrombophilia in a first-degree relative <45 years of age suggesting familial defect in blood coagulation system, which in the opinion of the principal investigator, suggests use of a hormonal contraceptive could pose a significant risk.\n - 19. Cerebrovascular or cardiovascular disease or increased risk for arterial thrombosis.\n - 20. History of retinal vascular lesions, unexplained partial or complete loss of vision.\n - 21. Known or suspected carcinoma of the breast, endometrium, or any other known or suspected progestin-dependent neoplasia.\n - 22. Past history of any other carcinoma (excluding basal cell carcinomas) unless in remission for more than 5 years.\n - 23. Current or past medically diagnosed severe depression, which, in the opinion of the investigator, could be exacerbated by use of a hormonal contraceptive, unless she is stable on antidepressant medication.\n - 24. Headaches with focal neurological symptoms only in women over 35 years old.\n - 25. History of cholestatic jaundice of pregnancy or jaundice with prior steroid use or other benign or malignant liver tumors; active liver disease.\n - 26. Systolic BP > 140 mm Hg and/or Diastolic blood pressure (BP) > 90 mm Hg after 5-10 minutes rest.\n - 27. Clinically significant abnormal serum chemistry values according to the Principal Investigators judgment.\n - 28. Participation in another clinical trial involving an investigational drug or device within last 30 days (prior to screening).\n - 29. Use of liver enzyme inducers within last 90 days (prior to screening) or intention to use liver enzyme inducers during the study (see Appendix 2 Exclusionary Medication List).\n - 30. Known HIV infection.\n - 31. Women at high risk of contracting HIV, e.g. women with multiple sex partners who need to use condoms consistently, injection drug users. Women enrolled in the study, who use condoms to protect against STIs or pregnancy, should be instructed that they can use condoms that are pre-lubricated with spermicide or lubricated, but they cannot use a spermicide applied separately and they should record all condom use in their diaries.\n - 32. Women who use any medications on the Exclusionary Medication List (see Appendix 2) OR used any within the past three months prior to the screening visit.\n - 33. Women with BMI ≥40 kg/m2 are excluded. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01023945	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: type 2 diabetes mellitus\n\nICD Codes: \"E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44\"\n\nDrugs: asp1941, placebo\n\nSMILES: OCC@H1OC@H(C@H(O)C@@H(O)C@@H1O)C1=CC=C(F)C(CC2=CC3=CC=CC=C3S2)=C1, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\nCT Criteria: Inclusion Criteria:\n - Type 2 diabetic patients for at least 12 weeks\n - HbA1c value between 7.0 and 10.0% at screening\n - Fasting plasma glucose ≥ 126mg/dL and < 240mg/dL at screening\n - Body Mass Index (BMI) 20.0 - 45.0 kg/m2.\n Exclusion Criteria:\n - Type 1 diabetes mellitus patients\n - Serum creatinine > upper limit of normal\n - Proteinuria（albumin/creatinine ratio > 300mg/g）\n - Dysuria and/or urinary tract infection\n - Significant renal, hepatic or cardiovascular diseases\n - Severe gastrointestinal diseases \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00078637	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: neoplasms, lymphoma, malignant\n\nICD Codes: \"C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2\", \"S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S\"\n\nDrugs: e7820\n\nSMILES: CC1=C2C(=CNC2=C(NS(=O)(=O)C2=CC=CC(=C2)C#N)C=C1)C#N\n\nCT Criteria: Inclusion Criteria:\n - Patients must have a histologically or cytologically confirmed malignant solid tumor or lymphoma. Malignancy must be advanced and require systemic therapy. Malignancy must be one for which no standard therapy is available or the patient must not be a candidate for standard therapy.\n - Patients must have a Karnofsky Performance Status of >= 70%,\n - Patients must have a life expectancy of >= 3 months,\n - Patients must be aged >= 18 years,\n - Patients must have adequate renal function as evidenced by serum creatinine <= 1.5 mg/dL or creatinine clearance >= 60 mL/minute/1.73m2,\n - Patients must have adequate bone marrow function as evidenced by ANC >= 1,500 mm3 and platelets >= 100,000 mm3, must have adequate liver function as evidenced by bilirubin <= 1.5 mg/dL and alanine transaminase (ALAT) and aspartate transaminase (ASAT) <= 2.5 times the upper limits of normal (ULN) (unless related to liver metastases in which case <= 5 x ULN),\n - Patients must be willing and able to comply with the study protocol for the duration of the study, and\n - Patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.\n Exclusion Criteria:\n - Patients who have a history of previous hypersensitivity to sulfonamide derivatives, Patients who have received chemotherapy within 4 weeks (6 weeks if nitrosoureas were received) of commencing study treatment,\n - Patients who have had radiation to >= 25% of their bone marrow (e.g., pelvic radiation) within 4 weeks of E7820 treatment,\n - Patients who have not recovered from any clinically significant chemotherapy or radiotherapy related toxicity at study entry.\n - Patients who have received investigational drugs or other antineoplastic therapy within 28 days of E7820 treatment,\n - Patients who have had major surgery within 4 weeks of study drug administration,\n - Women who are pregnant or breast-feeding. -- Women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential),\n - Fertile men and fertile women who are not willing to use contraception or fertile men or fertile women with a partner who is not willing to use contraception,\n - Patients with active central nervous system (CNS) metastases (i.e., evidence of progressive clinical symptoms, edema requiring corticosteroids, or tumors exhibiting growth on sequential MRI or CT scans),\n - Patients who are known to be positive for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus,\n - Patients with severe uncontrolled intercurrent illness/infection (excluding malignancies),\n - Patients with a history of unstable ischemic disease,\n - Patients with a history of clinically significant thrombosis,\n - Patients receiving antithrombotic (including aspirin) or therapeutic anticoagulant therapy (prior to study entry, patients receiving these types of drugs must have been off therapy for at least 7 days),\n - Patients with a history of documented vascular headache with neurological changes,\n - Patients < 30% of ideal weight for height and age according to the Metropolitan Life Insurance Company Statistical Bulletin, or\n - Patients with significant disease, or any condition, which in the Investigators opinion would exclude the patient from the study, or\n - Patients who have pulmonary disease that puts them at risk of hemoptysis. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01034592	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: anemia, leukemia, acute myeloid leukemia (aml), myelodysplastic syndromes (mds)\n\nICD Codes: \"D53.2, D64.9, D46.4, D53.0, D53.9, D61.3, D61.9\", \"C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01\", \"C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01\", \"D46.Z, D46.9, C94.6, D46.C\"\n\nDrugs: lenalidomide\n\nSMILES: NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O\n\nCT Criteria: INCLUSION CRITERIA\n - Understand and voluntarily sign an informed consent form\n - Diagnosis of DBA\n - Age ≥ 18 years at the time of signing the informed consent form.\n - Able to adhere to the study visit schedule and other protocol requirements.\n - Red blood cell transfusion-dependent with a requirement of at least one unit of RBCs per month for the 2 months prior to study enrollment (eg, 2 units/8 weeks)\n - If applicable, ongoing therapy with a stable or decreasing dose of prednisone ≤ 60 mg/d or corticosteroid equivalent, for which there has been no treatment-related improvement in RBC transfusion requirements for at least 2 months prior to study entry\n - Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 at study entry.\n - Laboratory test results within these ranges:\n - Absolute neutrophil count (ANC) ≥ 1500/uL\n - Platelet (Plt) count ≥ 100,000/uL\n - Serum creatinine ≤ 2.0 mg/dL\n - Direct bilirubin ≤ 1.5 mg/dL\n - Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN)\n - Alanine aminotransferase (ALT) ≤ 2.5 x ULN\n - Disease-free of prior malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma \"in-situ\" of the cervix or breast\n - Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of ≥ 50 milli-International Units (MIU)/mL within 10 to 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy\n - Able to take aspirin (81 to 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin)\n EXCLUSION CRITERIA\n - Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.\n - Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide)\n - Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study\n - Use of any other experimental drug or therapy (excluding steroids) specifically used for DBA within 28 days of baseline including metoclopramide, leucine, danazol, or other hormonal therapy\n - Clinically significant anemia due to factors such as iron, B12, folate deficiencies, autoimmune or hereditary hemolysis, or gastrointestinal bleeding.\n - Known hypersensitivity to thalidomide\n - The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs\n - Any prior use of lenalidomide\n - Concurrent use of other anti-cancer agents or treatments\n - Known positive for HIV or infectious hepatitis, type A, B or C \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT00113529	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: carcinoma, renal cell\n\nICD Codes: \"C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8\"\n\nDrugs: gefitinib + sunitinib\n\nSMILES: COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1\n\nCT Criteria: Inclusion Criteria:\n - Histologically confirmed renal cell carcinoma with metastases\n - Evidence of unidimensionally measurable disease\n - Failure of 1 prior immunotherapy or no prior systemic therapy for metastatic RCC\n Exclusion Criteria:\n - RCC without any clear (conventional) cell component\n - History of or known brain metastases\n - Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study entry \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01607125	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: depression\n\nICD Codes: \"F32.A, F53.0, P91.4, Z13.31, Z13.32\"\n\nDrugs: vortioxetine (lu aa21004), placebo\n\nSMILES: CC1=CC=C(SC2=CC=CC=C2N2CCNCC2)C(C)=C1, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\nCT Criteria: Inclusion Criteria:\n All subjects must have:\n - a Hamilton Depression Rating Scale (HAM-D17) total score ≤ 7\n Subjects remitted from depression must:\n - be in remission from recurrent depression having suffered from at least two previous Major Depressive Episodes (MDEs)\n - have received prescribed treatment with an antidepressant or a recognised psychotherapy for depression for a previous MDE\n - report present subjective cognitive dysfunction\n - not have been treated with antidepressants or received other psychotherapy for depression for at least six weeks prior to screening visit\n Control group subjects must:\n - have no history of MDEs\n - have no history of MDEs in a biological parent or other first degree relative as reported by the subject\n - not report present subjective cognitive dysfunction\n - never have been treated with antidepressants or psychotherapy\n Exclusion Criteria:\n - The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason\n Other inclusion and exclusion criteria may apply. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01469923	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: obesity\n\nICD Codes: \"E66.8, E66.9, E66.1, O99.214, O99.215, O99.210, O99.211\"\n\nDrugs: azd2820, placebo\n\nSMILES: CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\nCT Criteria: Inclusion Criteria:\n - Provision of signed and dated, written informed consent prior to any study specific procedures including the genetic sampling and analyses\n - Obese but otherwise healthy male subjects aged 18 - 45 years with suitable veins for cannulation or repeated venepuncture\n - Male subjects should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after the last dose of investigational product\n - Have a body mass index (BMI) between 27 and 40 kg/m2\n Exclusion Criteria:\n - History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subjects ability to participate in the stud\n - A history of erectile dysfunction or anatomic abnormality of the penis (eg, cavernosal fibrosis, Peyronies disease, or plaques) which interferes with normal erectile function\n - Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome\n - History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD2820\n - Any clinically significant abnormalities in clinical chemistry, haematology (including eosinophilia) or urinalysis results as judged by the investigator \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01411267	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: lymphoblastic leukemia, acute, childhood, myelogenous leukemia, acute, childhood\n\nICD Codes: \"C83.57, C83.50, C91.01, C91.02, C83.52, C83.56, C83.53\"\n\nDrugs: ac220, cytarabine, etoposide, methotrexate\n\nSMILES: CC(C)(C)C1=CC(NC(=O)NC2=CC=C(C=C2)C2=CN3C(SC4=C3C=CC(OCCN3CCOCC3)=C4)=N2)=NO1, ClCCN(CCCl)P1(=O)NCCCO1, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)NC@@H(CCC(O)=O)C(O)=O\n\nCT Criteria: Inclusion Criteria:\n - Patients must be greater than 1 month and ≤ 21 years of age at study entry.\n - Patients must have a diagnosis of relapsed/refractory AML, ALL or acute leukemia of ambiguous lineage and meet the following criteria:\n 1. Patients with AML or leukemia with ambiguous lineage must have greater than or equal to 5% blasts in the bone marrow.\n 2. Patients with ALL must have an M3 marrow (marrow blasts >25%).\n 3. Patients with ALL must have MLL gene rearrangement or hyperdiploid >50 chromosomes.\n 4. Patients with treatment related AML (t-AML) are eligible, provided they meet all other eligibility criteria.\n - Karnofsky > 50% for patients >16 years of age and Lansky >50% for patients ≤16 years of age.\n - Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.\n - Myelosuppressive chemotherapy:\n - Patients with ALL who relapse during standard maintenance therapy are eligible at time of relapse.\n - For patients with ALL and AML who relapse while they are receiving cytotoxic therapy, at least 14 days must have elapsed since the completion of cytotoxic therapy.\n - Cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of AC220.\n - Patients who have received other FLT3 inhibitors (ex. lestaurtinib, sorafenib) are eligible for this study.\n - Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor.\n - Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair.\n - XRT: 2 wks must have elapsed since local palliative XRT for CNS chloromas; No washout period is necessary for other chloromas; at least 3 months must have elapsed if prior TBI, craniospinal XRT.\n - Hematopoetic Stem Cell Transplant: At least 90 days must have elapsed since hematopoietic stem cell transplant (HSCT) and patients must not have active GVHD.\n - Patient must have adequate renal and hepatic functions as indicated by the following laboratory values:\n - Patients must have a calculated creatinine clearance or radioisotope GFR ≥70mL/min/1.73m2 or a normal serum creatinine based on age/gender.\n - Total bilirubin <1.5 x ULN for age or normal conjugated bilirubin.\n - Alanine transaminase (ALT) <5 × ULN (unless related to leukemic involvement).\n - Patient must have a shortening fraction of ≥ 27% by echocardiogram, OR an ejection fraction of ≥ 50% by radionuclide angiogram.\n - Reproductive Function\n - Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed within 2 weeks prior to enrollment.\n - Female patients with infants must agree not to breastfeed their infants while on this study.\n - Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study and for a minimum of 6 months after study treatment.\n Exclusion Criteria:\n - Patients will be excluded if they have CNS 3 disease.\n - Patients will be excluded if they have uncontrolled or significant cardiovascular disease, including:\n - A myocardial infarction within 12 months.\n - Uncontrolled angina within 6 months.\n - Diagnosed or suspected congenital long QT syndrome or any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes TdP); any history of arrhythmia will be discussed with the Sponsors Medical Monitor prior to patients entry into the study.\n - Prolonged QTcF interval on pre-entry ECG (≥450 ms).\n - Any history of second or third degree heart block (may be eligible if the patient currently has a pacemaker).\n - Heart rate < 50/minute on pre-entry ECG.\n - Uncontrolled hypertension.\n - Complete left bundle branch block.\n - Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or TdP.\n - Patients will be excluded if they have a systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. The patient needs to be off pressors and have negative blood cultures for 48 hours.\n - Patient is receiving or plans to receive concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.\n - Any significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.\n - Patients who are concurrently receiving CYP3A4 and 5 inhibitors and inducers \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT00384228	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: chronic myelogenous leukemia, acute lymphoblastic leukemia (philadelphia chromosome positive)\n\nICD Codes: \"C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01\"\n\nDrugs: nilotinib\n\nSMILES: CC1=CN(C=N1)C1=CC(NC(=O)C2=CC=C(C)C(NC3=NC=CC(=N3)C3=CN=CC=C3)=C2)=CC(=C1)C(F)(F)F\n\nCT Criteria: Inclusion Criteria:\n - Diagnosed as Ph+ ALL who are either relapsed after or refractory to standard therapy\n - Diagnosed as CML in blast crisis or accelerated phase or chronic phase who are resistant or intolerant to imatinib\n - Performance status is normal or ambulatory and capable of all self-care Exclusion Criteria\n - A history of significant or serious uncontrolled cardiovascular disease\n - Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of nilotinib\n - Patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control\n Exclusion Criteria:\n - Cytopathologically confirmed CNS infiltration NB: in absence of suspicion of CNS involvement, lumbar puncture is not required\n - Impaired cardiac function, including any one of the following\n - LVEF < 45% as determined by echocardiogram\n - Complete left bundle branch block\n - Use of a cardiac pacemaker\n - ST depression of > 1mm in 2 or more leads and/or T-wave inversions in 2 or more contiguous leads\n - Congenital long QT syndrome\n - History of or presence of significant ventricular or atrial tachyarrhythmias\n - Clinically significant resting bradycardia (< 50 beats per minute)\n - QTc > 480 msec on screening ECG (using the QTcF formula)\n - Right bundle branch block plus left anterior hemiblock, bifascicular block\n - Myocardial infarction within 3 months prior to starting AMN107\n - Uncontrolled angina pectoris\n - Other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)\n - Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of AMN107 (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)\n - Use of therapeutic warfarin\n - Acute or chronic liver or renal disease considered unrelated to tumor (e.g., hepatitis, cirrhosis, renal insufficiency, etc.)\n - Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol\n - Treatment with any hematopoietic colony-stimulating growth factors (e.g., G-CSF) ≤ 1 week prior to starting study drug.\n - Patients who are currently receiving treatment with any of the medications listed in (cf. Post-text suppl. 5) that cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in (cf. Post-text suppl. 5) have the potential to prolong the Q-T interval.\n - Patients who have received chemotherapy ≤ 1 week or who are within 5 half-lives of their last dose chemotherapy (6 weeks for nitrosurea or mitomycin-C) prior to starting study drug or who have not recovered from side effects of such therapy. Hydroxyurea is permitted at the investigators discretion prior to enrollment.\n - Patients who have received Glivec® ≤ 1 week or who have not recovered from side effects of such therapy.\n - Patients who have received immunotherapy ≤ 1 week prior to starting study drug or who have not recovered from side effects of such therapy.\n - Patients who have received any investigational drug (excluding STI571/Glivec) ≤ 4 weeks or investigational cytotoxic agent within 1 week (or who are within 5 half-lives of a previous investigational cytotoxic agent) prior to starting study drug or who have not recovered from side effects of such therapy.\n - Patients who have received wide field radiotherapy ≤ 4 week or limited field radiation for palliation ≤ 2 week prior to starting study drug or who have not recovered from side effects of such therapy.\n - Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.\n - Patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control. (Women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of AMN107). Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug\n - Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)\n - Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.\n - Patients unwilling or unable to comply with the protocol\n Other protocol-defined inclusion and exclusion criteria may apply. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00003005	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: leukemia\n\nICD Codes: \"C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01\"\n\nDrugs: cordycepin, deoxycoformycin\n\nSMILES: HC@@1(CO)CC@@(H)(O)C@@(H)(O1)N1C=NC2=C(N)N=CN=C12, OCC@H1OC@H(CC@@H1O)N1C=NC2=C1N=CNCC@H2O\n\nCT Criteria: DISEASE CHARACTERISTICS: TdT positive acute lymphocytic leukemia or blastic chronic myelogenous leukemia Failed at least one standard treatment\n PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky greater than 70% Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL Transaminases no greater than 2.5 times normal Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance greater than 60 mL/min Cardiovascular: Ejection fraction greater than 40% Other: Not pregnant or nursing No serious concurrent illness\n PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since radiation therapy Surgery: Not specified \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01494012	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: recurrent ovarian epithelial cancer, recurrent ovarian germ cell tumor, malignant tumor of peritoneum, stage iv ovarian epithelial cancer, stage iv ovarian germ cell tumor\n\nICD Codes: \"H18.523, H18.521, H18.522, H18.529\", \"G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2\", \"C48.2, C48.1, C78.6, C48.8\", \"H18.523, H18.521, H18.522, H18.529\"\n\nDrugs: fludeoxyglucose f 18\n\nSMILES: HC(=O)C@H(18F)C@@H(O)C@H(O)C@H(O)CO\n\nCT Criteria: Inclusion Criteria:\n - Patients must have persistent, metastatic, or recurrent platinum resistant or refractory ovarian or primary peritoneal cancer.\n - No restriction on previous treatment regimens, but patients must be at least 2 weeks out from last chemotherapy or investigational agent.\n - Patients must be >= 18.\n - Patients must have a life expectancy of at least 6 months.\n - Patients must have KPS >= 60.\n - Patients must have acceptable organ and marrow function as defined below (within 2 weeks prior to radiotherapy):\n - leukocytes >=3,000/uL\n - absolute neutrophil count >=1,500uL\n - platelets >=100,000/uL\n - total bilirubin within 1.5X normal institutional limits\n - AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal\n - creatinine within normal institutional limits OR\n - creatinine clearance >=60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal\n - Patients must be willing to undergo a pre- and post-treatment FDG-PET/CT.\n - Ability to understand and the willingness to sign a written informed consent document.\n Exclusion Criteria:\n - Patients should not have received radiation overlapping with the proposed treatment field.\n - Patients cannot be receiving chemotherapy or other investigation agents from two weeks prior to radiation through undergoing their post-therapy FDG-PET/CT\n - Patients cannot be pregnant or nursing.\n - Patients cannot have disease >= 8cm or greater than 3 regions of disease.\n - Patients cannot have concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01159847	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: type 1 diabetes\n\nICD Codes: \"E10.65, E10.9, E10.21, E10.36, E10.41, E10.42, E10.44\"\n\nDrugs: sitagliptin, insulin\n\nSMILES: NC@@H(CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F, Na+.Na+.O-P(O-)(F)=O\n\nCT Criteria: Inclusion Criteria:\n 1. Diabetes diagnosed according to the report of WHO in 1999.\n 2. Age at onset between 25~70 years.\n 3. Disease duration of less than 3 year.\n 4. No ketoacidosis within the first 6 months after diagnosis of diabetes.\n 5. GADA positive twice within one month.\n 6. Fasting C-peptide (FCP) level of 0.2 nmol/L or more.\n Exclusion Criteria:\n 1. Insulin requirements more than 0.8 units/kg/day.\n 2. Evidence of chronic infection or acute infection affected blood glucose control within 4 weeks prior to visit 1.\n 3. History of any malignancy.\n 4. Pregnancy, breastfeeding or planned pregnancy within two years.\n 5. Secondary diabetes.\n 6. Congestive heart failure requiring pharmacologic treatment.\n 7. Renal disease or renal dysfunction or diabetic nephropathy suggested by serum creatinine levels≥1.5 mg/dL (132μmol/L) for males and ≥1.4mg/dL (123μmol/L) for females or abnormal creatinine clearance at Visit 1.\n 8. Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT00704691	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: peripheral t-cell lymphomas, adult t-cell leukemia, adult t-cell lymphoma, peripheral t-cell lymphoma unspecified, angioimmunoblastic t-cell lymphoma, anaplastic large cell lymphoma, t/null cell systemic type, cutaneous t-cell lymphoma with nodal/visceral disease\n\nICD Codes: \"S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S\", \"S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S\"\n\nDrugs: lenalidomide\n\nSMILES: NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O\n\nCT Criteria: Inclusion Criteria:\n 1. Understand and voluntarily sign an informed consent form.\n 2. Age 19 and over at the time of signing the informed consent form.\n 3. Able to adhere to the study visit schedule and other protocol requirements.\n 4. Patients with a confirmed diagnosis of peripheral T-cell lymphomas according to the World Health Organization (WHO) classification in the relapsed and/or refractory setting following prior anthracycline therapy. Subtypes of peripheral T-cell lymphomas which meet this criteria will include the following: adult T-cell leukemia/lymphoma, peripheral T-cell lymphoma unspecified, angioimmunoblastic T-cell lymphoma, anaplastic large-cell lymphoma, T/null cell, primary systemic type, subcutaneous panniculitis-like T-cell lymphoma, hepatosplenic gamma-delta T-cell lymphoma, and enteropathy-type T-cell lymphoma 33.\n 5. Patients with a history of PTCL or cutaneous T-cell lymphoma (CTCL) with nodal/visceral disease in the relapsed and/or refractory setting following prior anthracycline therapy. This includes ≥ 3-6 cycles of CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) or an equivalent, CHOP-like regimen +/- radiation therapy. The definition for relapsed and refractory disease is provided in Appendix 5.\n 6. All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study.\n 7. At least one measurable lesion according to the International Working Group response criteria for non-Hodgkins lymphoma (see Appendix 5).\n 8. ECOG performance status of less than or equal to 2 at study entry (see Appendix 2).\n 9. Laboratory test results within these ranges:\n - Absolute neutrophil count greater than or equal to 1.5 x 109/L\n - Platelet count greater than or equal to 100 x 109/L (>70 x 10^9/L if bone marrow was involved)\n - Serum creatinine less than or equal to 2.0 mg/dL\n - Total bilirubin less than or equal to 1.5 mg/dL\n - AST (SGOT) and ALT (SGPT) less than or equal to 2 x upper limit of normal (ULN) or less than or equal to 5 x ULN if hepatic metastases are present.\n 10. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to therapy and again within 24 hours of prescribing lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex* condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix 1: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.\n * For patients who have latex allergies or whose partner(s) have latex allergies alternatives will be discussed.\n 11. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.\n 12. Disease free of prior malignancies for greater than or equal to 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma \"insitu\" of the cervix or breast\n 13. Able to take aspirin (81 mg) daily as prophylactic anticoagulation, if deemed necessary by investigator (patients intolerant to ASA may use warfarin or low molecular weight heparin).\n Exclusion Criteria:\n 1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.\n 2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).\n 3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.\n 4. Use of any other experimental drug or therapy within 28 days of baseline.\n 5. Known hypersensitivity to thalidomide.\n 6. The development of erythema nodorum if characterized by a desquamating rash while taking thalidomide or similar drugs.\n 7. Any prior use of lenalidomide.\n 8. Concurrent use of other anti-cancer agents or treatments within the past 28 days.\n 9. Known positive for HIV or infectious hepatitis, type A, B or C.\n 10. (Other) Precursor T-cell lymphomas (including immature T-cell lymphomas/leukemias) and cutaneous T-cell lymphomas (CTCL) with skin as the only organ of involvement\n 11. Patients with prolonged QT interval on baseline EKG (>430 ms)\n 12. Equal to greater than grade 3 peripheral neuropathy.\n 13. Natural Killer (NK) cell lymphomas \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01360827	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: squamous cell carcinoma of the head and neck\n\nICD Codes: \"C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8\"\n\nDrugs: emd 1201081 + 5-fu + cisplatin + cetuximab, emd 1201081 + 5-fu + cisplatin + cetuximab\n\nSMILES: HC@@12N(C)C3=CC(OC)=C(C=C3C@@11CCN3CC=CC@(CC)(C@@13H)C@@(H)(OC(C)=O)C@2(O)C(=O)OC)C@1(CC@@2(H)CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, HC@@12N(C)C3=CC(OC)=C(C=C3C@@11CCN3CC=CC@(CC)(C@@13H)C@@(H)(OC(C)=O)C@2(O)C(=O)OC)C@1(CC@@2(H)CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC\n\nCT Criteria: Inclusion Criteria:\n - Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN).\n - Recurrent and/or metastatic SCCHN, not suitable for local therapy.\n - At least 1 measurable lesion either by computerized tomography (CT) scan or magnetic resonance imaging (MRI) (according to RECIST 1.0).\n - Karnofsky performance status (KPS) of ≥ 70 / Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at trial entry.\n Exclusion Criteria:\n - Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 2 months prior to trial entry.\n - Nasopharyngeal carcinoma.\n - Medical history of diagnosed interstitial lung disease.\n - Known hypersensitivity against any of the components of the trial treatment.\n - Previous treatment with experimental or non-approved epidermal growth factor receptor (EGFR) targeting therapy or experimental or nonapproved EGFR signal transduction inhibitors (prior treatment with cetuximab is allowed).\n - Relevant cardiovascular co-morbidities.\n - Concomitant chronic systemic immune therapy, or hormonal therapy as cancer therapy, steroid use ≥ 10 mg prednisone equivalent.\n - Known human immunodeficiency virus (HIV) positivity, active hepatitis C, or active hepatitis B. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT00657280	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: heart failure, congestive\n\nICD Codes: \"I50.20, I50.21, I50.22, I50.30, I50.31, I50.32, I50.40\"\n\nDrugs: sitagliptin\n\nSMILES: NC@@H(CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F\n\nCT Criteria: Inclusion Criteria:\n 1. Diagnosis of nonischemic dilated cardiomyopathy, current NYHA class I-III congestive heart failure\n 2. Treatment with a stable comprehensive heart failure regimen for at least 3 months (including beta-blockers and ACE-inhibitors or angiotensin receptor blockers unless intolerant)\n 3. Age > 18 yrs\n Exclusion Criteria:\n 1. Cardiomyopathy primarily due to one of the following:\n 1. Ischemic heart disease\n 2. Primary valvular lesion\n 3. Hypertrophic cardiomyopathy\n 2. Cardiac resynchronization within the last 3 months\n 3. Calculated creatinine clearance <30 ml/min or end-stage renal disease on dialysis. Creatinine clearance will be determined by the Cockcroft-Gault formula.\n 4. Diagnosis of diabetes mellitus by:\n 1. Diabetes previously diagnosed per patient history\n 2. 2 or more fasting glucose values > 125 mg/dl\n 5. History of heart transplantation\n 6. Pregnancy or active breast feeding\n 7. Hospitalization for decompensated heart failure within 30 days prior to enrollment. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00176241	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: head and neck cancer\n\nICD Codes: \"C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11\"\n\nDrugs: gemcitabine, paclitaxel\n\nSMILES: HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1, HC@@1(CC@@H(C)C@2(H)CC(=O)C@H(C)\\\\C=C(C)\\\\C@@H(O)C@@H(OC)C(=O)C@H(C)CC@H(C)\\\\C=C\\\\C=C\\\\C=C(C)\\\\C@H(CC@3(H)CCC@@H(C)C@@(O)(O3)C(=O)C(=O)N3CCCCC@@3(H)C(=O)O2)OC)CCC@@H(OCCO)C@@H(C1)OC\n\nCT Criteria: Inclusion Criteria:\n 1. 18 yrs old or greater & have histologically or cytologically proven metastatic or recurrent head & neck cancer & have failed at least 1 prior, but not more than 3 chemotherapeutic regimen. Patients who have recurred after previous surgery and/or radiation may participate in this trial, & patients may have had prior neoadjuvant or adjuvant therapy. No restriction is placed on the # of cycles (beyond 1) of prior therapy, however, patients must not have received the combination of Gemcitabine & Paclitaxel previously.\n 2. Patients with known brain metastases are eligible for this trial if disease has been treated & the patient is clinically stable & documented by a stable or improved pretreatment CT or MRI of the brain to evaluate CNS disease within 28 days prior to registration.\n 3. Patients must have measurable OR non-measurable disease documented by CT, MRI, X-ray or nuclear exam (FDG-PET). Measurable disease must be assessed within 28 days prior to registration & non-measurable must be assessed within 42 days prior to registration. Pleural effusions, ascites & lab parameters are not acceptable as only evidence of disease.\n 4. Patients must have progressed after at least 1 prior chemotherapeutic regimen. Prior biologic therapy or radiation is permitted; however, at least 2 wks must have elapsed since completion of prior therapy & patients must have recovered from all associated toxicities at time of registration.\n 5. At least 3 wks must have elapsed since surgery (thoracic or other major surgeries) & patients must have recovered from all associated toxicities at time of registration. Measurable or non-measurable disease must be present outside the area of surgical resection.\n 6. Patients must have an ANC 1,500/µl & platelet count 100,000/µl obtained within 28 days prior to registration.\n 7. Patients must have adequate hepatic function documented by a serum bilirubin 1.5 x institutional ULN & LFTs (SGOT or SGPT) 2.5 x the institutional ULN obtained within 28 days prior to registration.\n 8. All patients with pulmonary metastasis must have an FEV1 of > 1000 ml/min obtained within 28 days prior to registration & must have PFTs with DLCO.\n 9. All patients must have a Zubrod Performance Status of 0,1 or 2.\n 10. Peripheral neuropathy, if present, must be Grade 1.\n 11. Patients must be informed of investigational nature of this study & must sign & give written informed consent in accordance with institutional & federal guidelines.\n Exclusion Criteria:\n 1. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 5 yrs.\n 2. Pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including fetal death from the chemotherapeutic agents. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method (hormonal or barrier method of birth control; abstinence) prior to study entry & for duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n 3. Patients taking drugs that are strong inducers of the enzyme CYP3A4 including anticonvulsants (i.e., phenytoin, phenobarbital, carbamazepine, or primidone) & rifampin OR strong inhibitors of CYP3A4 (clarithromycin, itraconazole, and ketoconazole) will be excluded from this study. Patients must be off these medications for 2 wks in order to participate in this trial. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01619332	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: type ii diabetes\n\nICD Codes: \"E23.2, N25.1, P70.2, O24.92, Z83.3, Z86.32, E10.65\"\n\nDrugs: placebo, sitagliptin, lez763\n\nSMILES: CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, NC@@H(CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F, NC@@H(CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F\n\nCT Criteria: Inclusion criteria:\n - All subjects: (suggest this will reduce duplication)\n - Male or female aged 18-65 yr,\n - Subjects must weigh at least 50 kg to participate in the study. Body mass index (BMI) must be within the range of 18-37 kg/m2 (inclusive\n - Only postmenopausal females or female subjects who report surgical sterilization (women without child bearing potential) will be allowed in this study.\n - Subjects with stable conventional sleep-wake cycle\n Normal Healthy Volunteers\n - Healthy male or female subjects,\n - must be in good health (as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at Screening).\n Type II Diabetic Patients\n - Type 2 diabetes diagnosed by American Diabetes Association criteria for at least 3 months prior to screening.\n - Patients either drug naïve or on stable dose of metformin (stable dose for at least 4 weeks prior to Screening). The metformin dose should remain constant during the course of the study.\n - HbA1c 6.5 to 9.5 % inclusive at screening\n Exclusion criteria:\n All subjects:\n - Smokers (use of tobacco products in the previous 3 months).\n - Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.\n - Significant illness within two weeks prior to dosing.\n - Have (or have history of) drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations\n Normal Healthy Volunteers\n • History of diabetes, or adrenal disorders.\n Type II Diabetic Patients\n - Type 1 diabetes mellitus; positive anti-GAD antibodies; acquired or secondary forms of diabetes such as those resulting from pancreatic surgery/injury, cystic fibrosis related diabetes\n - Evidence of clinically significant diabetic complications (such nephropathy, retinopathy, neuropathy) Other protocol defined inclusion/exclusion criteria may apply \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01132625	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: advanced solid tumors\n\nICD Codes: \"K74.02, G47.22, H35.3133, H35.3134, H35.3113, H35.3114, H35.3123\"\n\nDrugs: auy922\n\nSMILES: CCNC(=O)C1=NOC(=C1C1=CC=C(CN2CCOCC2)C=C1)C1=CC(=C(O)C=C1O)C(C)(C)C\n\nCT Criteria: Inclusion Criteria:\n - Patients with advanced malignant solid tumors\n - ECOG Performance Status of ≤ 2\n - Patients must have the following laboratory values:\n - Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Hemoglobin (Hgb) ≥ 8.5 g/dl, Platelets (plt) ≥ 100 x 109/L\n - Potassium, Calcium, Magnesium, Phosphorus within normal limits or correctable with supplements\n - AST/SGOT and ALT/SGPT ≤ 2.5 x Upper Limit of Normal (ULN)\n - Serum bilirubin ≤ 1.5 x ULN, Serum albumin > 2.5g/dl, Serum creatinine≤ 1.5 x ULN or 24-hour clearance ≥ 50 ml/min\n - Able to sign informed consent and to comply with the protocol\n Exclusion Criteria:\n - Patients with brain metastasis.\n - Prior treatment with any HSP90 or HDAC inhibitor compound.\n - Treatment with therapeutic doses of coumarin anticoagulants.\n - Pregnant and lactating women.\n - Severe and/or uncontrolled acute or chronic liver disease\n - Severe and/or uncontrolled acute or chronic renal disease\n - Chronically significant heart disease\n - History (or family history) of long QT syndrome. QTc ≥ 450 msec on screening ECG, ischemic heart disease, heart fail, ECG abnormalities, atrial fibrillation, atrial flutter or ventricular arrhythmias including ventricular tachycardia or Torsades de Pointes.\n - Patients who are currently receiving treatment with any medication which has a relative risk or prolonging the QTcF interval or inducing Torsades de Pointes\n - Patients with known disorders due to a deficiency in bilirubin glucuronidation (e.g Gilberts syndrome).\n Other protocol-defined inclusion/exclusion criteria may apply \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01188707	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: non small cell lung cancer\n\nICD Codes: \"C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2\"\n\nDrugs: belinostat and erlotinib\n\nSMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2\n\nCT Criteria: Inclusion Criteria:\n 1. Signed consent of an approved informed consent form\n 2. A. For the dose escalation phase: Patients with histological or cytological confirmed non-small cell lung cancer who are rated suitable for treatment with Erlotinib B. For MTD expansion phase: Patients diagnosed with non- small cell lung cancer rated suitable for treatment with Erlotinib and with measurable disease according to RECIST version 1.1\n 3. Performance status (ECOG) ≤ 2\n 4. Life expectancy at least 3 months\n 5. Age ≥ 18 years\n 6. Acceptable liver, kidney and bone marrow function, defined as:\n - Bilirubin ≤ 1.5 x upper limit of normal (ULN)\n - ASAT, ALAT and alkaline phosphatase ≤ 3 x ULN (if liver metastases is ≤ 5 x ULN allowed)\n - Serum creatinine ≤ 1.5 x upper limit of normal (ULN)\n - WBC> 2.5 x 109 / l, neutrophils> 1.0 x 109 / l, platelets> 100 x 109 / l\n - Hemoglobin> 9.0 g / dl or> 5.6 mmol / l\n 7. Acceptable coagulation: PT and APTT within ≤ 1.5 x ULN or in the therapeutic range if given anticoagulant\n 8. A negative pregnancy test for women of childbearing age. In fertile men and women the use of effective contraception methods are required during the trial\n 9. Serum potassium within normal range\n Exclusion Criteria:\n 1. Treatment with experimental drugs within the last 4 weeks\n 2. Former anti-cancer therapy within the last 3 weeks before the start of experimental treatment, including chemotherapy, radiotherapy, endocrine therapy or immunotherapy\n 3. Simultaneous presence of active infection or other concomitant present medical condition likely to affect the experimental procedures, including significant cardiovascular disease (New York Heart Association Class III or IV heart disease, myocardial infarction within the past 6 months, unstable angina, congestive heart failure requiring treatment, unstable arrhythmia or the need for antiarrhythmic drugs or signs of ischemia on ECG, marked baseline prolongation of QT / QTc interval, for example repeated demonstration of a QTc interval> 500 msec; long QT syndrome; required the use of concurrent medication on dosage belinostat days, which may cause torsades de pointes (see Appendix 1).\n 4. Altered mental status that prevents understanding of the informed consent process and / or execution of the necessary experiments\n 5. Secondary malignancy present (previous malignancy accepted if cured by treatment for > 3 years ago)\n 6. Intestinal obstruction or threatening bowel obstruction \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01020305	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: prostate cancer, prostatic neoplasms, castrate-resistant prostate cancer (crpc), androgen-insensitive prostate cancer, hormone-refractory prostate cancer, metastatic disease\n\nICD Codes: \"C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5\", \"B38.81, N42.31, Z87.430, N40.0, N40.1\", \"C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5\", \"C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5\", \"C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5\"\n\nDrugs: temsirolimus, casodex (bicalutamide)\n\nSMILES: CN1N=NC2=C(N=CN2C1=O)C(N)=O, CC(O)(CS(=O)(=O)C1=CC=C(F)C=C1)C(=O)NC1=CC(=C(C=C1)C#N)C(F)(F)F\n\nCT Criteria: INCLUSION CRITERIA\n - Histologically-confirmed adenocarcinoma of the prostate, characterized as symptomatic castration-resistant prostate cancer (CRPC)\n - Serum PSA ≥ 2 ng/mL\n - Rising PSA on 3 consecutive occasions at least 1 week apart (not limited to the 30-day screening period)\n - Failure of bilateral orchiectomy and/or therapy with an LHRH agonist and bicalutamide\n - Castrate level of testosterone (< 50 ng/dL)\n - Currently being treated with bicalutamide\n - No prior antiandrogen therapy except bicalutamide\n - Age ≥ 18 years\n - Life expectancy > 6 months\n - Performance status\n - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n - OR\n - Karnofsky performance status ≥ 80%\n - Ability to understand and the willingness to sign a written informed consent\n EXCLUSION CRITERIA\n - Radiotherapy for prostate cancer within 28 days prior to Day 1, except single-fraction radiotherapy for pain control\n - Prior treatment with mTOR inhibitors\n - Prior treatment with chemotherapy for prostate cancer\n - Symptomatic bone metastases (ie, asymptomatic bone metastases are eligible)\n - Visceral metastases\n - Absolute neutrophil count (ANC) < 1500/uL\n - Platelet count ≤ 100 x 10e9/L\n - Total bilirubin ≥ 1.5 x Upper Limit of Normal (ULN)\n - Alkaline phosphatase > 2.5 x ULN\n - AST > 2.5 x ULN\n - ALT > 2. 5x ULN\n - Serum creatinine > 2.0 mg/dL\n - Hemoglobin < 9 g/dL\n - Men with reproductive potential who do not agree to use an accepted and effective method of contraception during the study treatment period and for at least 3 months after completion of the study treatment\n - History of other malignancies within 5 years except for tumors with a negligible risk for metastasis or death, such as adequately-controlled basal cell carcinoma, squamous-cell carcinoma of the skin, or early-stage bladder cancer\n - Participation in another experimental drug study either planned or within 4 weeks of the first study treatment\n - Persistent Grade ≥ 1 AEs due to prior drug therapy, including investigational drugs, administered more than 14 days before study enrollment\n - Previously treated or other known brain metastases\n - Ongoing or active infection\n - Symptomatic congestive heart failure, New York Heart Association Grade II or greater\n - Unstable angina pectoris\n - Cardiac arrhythmia\n - Significant vascular disease (eg, aortic aneurysm, aortic dissection)\n - Symptomatic peripheral vascular disease\n - Psychiatric illness/social situations that would limit compliance with study requirements\n - Other uncontrolled intercurrent illness\n - Known to be positive for the human immunodeficiency virus (HIV) infection and receiving antiretroviral therapies (HIV positive not requiring antiretroviral therapy iseligible if all other entry criteria are meet)\n - Inability to comply with study and/or follow-up procedures \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01058655	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: gastrointestinal cancer\n\nICD Codes: \"C49.A0, C49.A1, C49.A2, C49.A5, C49.A3, C49.A4, C49.A9\"\n\nDrugs: everolimus, tivozanib\n\nSMILES: HC@@1(CC@@H(C)C@2(H)CC(=O)C@H(C)\\\\C=C(C)\\\\C@@H(O)C@@H(OC)C(=O)C@H(C)CC@H(C)\\\\C=C\\\\C=C\\\\C=C(C)\\\\C@H(CC@3(H)CCC@@H(C)C@@(O)(O3)C(=O)C(=O)N3CCCCC@@3(H)C(=O)O2)OC)CCC@@H(OCCO)C@@H(C1)OC, COC1=C(OC)C=C2C(OC3=CC(Cl)=C(C=C3)N=C(O)N=C3NOC(C)=C3)=CC=NC2=C1\n\nCT Criteria: For the Phase I component:\n Inclusion Criteria:\n - 18 years of age or older\n - Histologic confirmation of a gastrointestinal malignancy, limited to cancer of the esophagus, stomach, small bowel, liver, biliary tract, gallbladder, pancreas, large bowel, appendix, rectum and anus.\n - Locally advanced or metastatic disease\n - Disease that: a) has recurred or progressed following standard therapy, b) for which no standard therapy currently exists, or c) for which the subject is not a candidate for or unwilling to undergo standard therapy. There is no limit to the number of prior regimens received by the patient.\n - ECOG Performance Status of 0, 1 or 2\n - Life expectancy of at least 12 weeks\n - Adequate organ function as outlined in the protocol\n - At least 4 weeks is required from : a) previous regimen of chemotherapy, b) immunotherapy or biological therapy, c) other investigational agents, and d) radiotherapy.\n - At least 4 weeks is required from treatment of bevacizumab\n - At least 4 weeks is required from prior systemic hormonal therapy or treatment with strong CYP3A4 inducers or inhibitors\n - If female and of child bearing potential, documentation of negative pregnancy test prior to enrollment.\n Exclusion Criteria:\n - Prior therapy with inhibitors of mTOR or VEGFR (prior treatment with bevacizumab is allowed).\n - Clinically apparent CNS metastases or carcinomatous meningitis\n - Clinically significant cardiovascular disease\n - Major surgery within 4 weeks of the start of study treatment or patients who have not recovered from the side effects of any major surgery.\n - Active bleeding diathesis or history of Grade 2 or greater clinically significant bleeding within 3 months of enrollment\n - Active infection requiring antibiotics\n - Participants with a known positive history of chronic Hepatitis B viral infection or known positive HBV-DNA test are excluded.\n - History of interstitial pneumonitis or severely impaired lung function defined as 88% or less O2 saturation at rest in room air\n - Immunocompromise or chronic use of immunosuppressant medications\n - Uncontrolled serious medical or psychiatric illness\n - Subjects with non-healing wounds, active peptic ulcers, or unhealed bone fractures\n - Significant proteinuria, defined as urine dipstick protein of 3+ or greater\n - Concurrent malignancy (other than non-melanoma skin cancer) diagnosed within the past 3 years or any currently active malignancy\n - Elevated fasting levels of the following: serum cholesterol, serum triglycerides, and serum glucose\n - Patients who are pregnant or lactating\n - Malabsorption, uncontrolled vomiting or diarrhea, or any disease significantly affecting gastrointestinal function that could interfere with absorption of study drugs\n - Inability to swallow pills\n For the phase II component, only patients with metastatic colorectal cancer will be enrolled.\n For the Phase II component:\n Inclusion Criteria (Phase II):\n - 18 years of age or older\n - Histologic confirmation of colorectal cancer\n - Stage IV disease\n - At least one site of disease measurable by RECIST criteria\n - Receipt of or intolerance to a fluoropyrimidine (fluorouracil or capecitabine), irinotecan, oxaliplatin, bevacizumab, and a monoclonal antibody to epidermal growth factor receptor (cetuximab or panitumumab). If a patients tumor was K-RAS mutation positive, then previous treatment with cetuximab or panitumumab is not required.\n - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n - Life expectancy of at least 12 weeks\n - Adequate organ function as outlined in the protocol\n - At least 3 weeks is required from: (a) previous regimen of chemotherapy, (b)immunotherapy or biological therapy, (c) other investigational agents, and (d) radiotherapy. Of note, concomitant radiotherapy is NOT allowed, while a patient is on protocol.\n - At least 3 weeks is required from prior treatment with bevacizumab\n - At least 3 weeks is required since prior systemic hormonal therapy or treatment with strong CYP3A4 inducers or inhibitors.\n - Negative pregnancy test for women of child bearing potential\n Exclusion Criteria (Phase II):\n - Prior therapy with inhibitors of mTOR or VEGFR (prior treatment with bevacizumab is allowed)\n - Clinically apparent CNS metastases or carcinomatous meningitis, as determined by physical examination and imaging studies\n - Clinically significant cardiovascular disease, defined as follows:\n (A)Symptomatic congestive heart failure, (B)Symptomatic coronary artery disease or myocardial infarction within 3 months of enrollment, (C)Cardiac arrhythmias not controlled with medication, (D)Deep venous thrombosis or pulmonary embolus within the last 6 months, (E) Cerebrovascular accident within the last 12 months, (F)Poorly controlled hypertension, defined as systolic pressure > 150 mmHg or diastolic pressure > 100 mmHg documented on 2 consecutive measurements taken at least 24 hours apart, (G)Symptomatic peripheral vascular disease, defined as claudication on walking ≤\n 1 block\n - Major surgery within 4 weeks of the start of study treatment or patients who have not recovered from the side effects of any major surgery. Major surgery defined as those surgeries that require general anesthesia\n - Active bleeding diathesis or history of grade 2 or higher clinically significant bleeding (hemoptysis, hematemesis, hematochezia, or melena) within 3 months of enrollment\n - Active infection requiring antibiotics\n - Participants with a known positive history of chronic Hepatitis B viral infection or known positive HBV-DNA test are excluded.\n - History of interstitial pneumonitis or severely impaired lung function defined as less than or equal to 88% O2 saturation at rest in room air.\n - Immunocompromise or chronic use of immunosuppressant medications (prednisone ≤ 10 mg daily or the equivalent of a comparable steroid is allowed, if deemed necessary by a study investigator)\n - Uncontrolled serious medical or psychiatric illness\n - Subjects with non-healing wounds, active peptic ulcers, or unhealed bone fractures\n - Significant proteinuria, defined as urine dipstick protein 3+ or greater\n - Concurrent malignancy (other than non-melanoma skin cancer) diagnosed within the past 3 years or any currently active malignancy.\n - Elevated fasting levels of the following: serum cholesterol, serum triglycerides, and serum glucose.\n - Patients who are pregnant or lactating\n - Malabsorption, uncontrolled vomiting or diarrhea, or any disease significantly affecting gastrointestinal function that could interfere with absorption of study drugs\n - Inability to swallow pills \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00623064	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: bladder cancer, transitional cell cancer of the renal pelvis and ureter\n\nICD Codes: \"D30.3, C67.5, C67.9, C79.11, C67.0, C67.1, D41.4\"\n\nDrugs: cisplatin, gemcitabine hydrochloride, lapatinib ditosylate\n\nSMILES: HC@@12N(C)C3=CC(OC)=C(C=C3C@@11CCN3CC=CC@(CC)(C@@13H)C@@(H)(OC(C)=O)C@2(O)C(=O)OC)C@1(CC@@2(H)CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, NC1=NC(=O)N(C=C1)C@@H1OC@H(CO)C@@H(O)C1(F)F, CS(=O)(=O)CCNCC1=CC=C(O1)C1=CC2=C(C=C1)N=CN=C2NC1=CC(Cl)=C(OCC2=CC(F)=CC=C2)C=C1\n\nCT Criteria: DISEASE CHARACTERISTICS:\n - Histologically proven transitional cell carcinoma of the urothelial tract\n - Metastatic or locally advanced disease\n - Measurable disease according to RECIST\n - Involvement of at least one target not in previously irradiated fields\n - Overexpressing HER1 and/or HER2 receptors (HER2 3+ by IHC OR HER2 FISH or CISH positive)\n - No clinical signs of CNS involvement\n PATIENT CHARACTERISTICS:\n - WHO performance status 0-1\n - ANC ≥ 1,500/mm³\n - Thrombocytes > 100,000/mm³\n - Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n - AST/ALT ≤ 3 times ULN\n - Creatinine clearance ≥ 60 mL/min\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective double-barrier contraception during and for 3 months after completion of study treatment\n - Cardiac ejection fraction normal\n - Normal 12 lead ECG\n - No serious cardiac illness or medical condition within the past 6 months including, but not limited to, any of the following:\n - Documented congestive heart failure\n - High-risk uncontrolled arrhythmias\n - Angina pectoris requiring antianginal medication\n - Clinically significant valvular heart disease\n - Evidence of transmural infarction on ECG\n - Poorly controlled hypertension (e.g., systolic blood pressure BP > 180 mm Hg or diastolic BP > 100 mm Hg)\n - No peripheral neuropathy > grade 1\n - Able to swallow and retain oral medication\n - No other malignancy within the past 3 years except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\n - No active or uncontrolled infections, serious illnesses, malabsorption syndrome or medical conditions, hepatitis, HIV, and/or cirrhosis\n - No psychological, familial, sociological, or geographical condition potentially hampering study protocol compliance or follow-up schedule\n - No current active hepatic or biliary disease (with the exception of Gilberts syndrome, asymptomatic gallstones, liver metastases or stable chronic liver metastases or stable chronic liver disease)\n PRIOR CONCURRENT THERAPY:\n - Recovered from any effects of surgery\n - Intravesicle therapy for superficial disease allowed\n - Prior neoadjuvant or adjuvant chemotherapy allowed\n - Must have a minimum interval of six months between the completion of neoadjuvant or adjuvant chemotherapy and the diagnosis of metastatic disease\n - No prior chemotherapy for metastatic disease\n - No radiotherapy within the past 4 weeks\n - No drugs and herbal inducers or inhibitors of CYP3A4 (e.g., bergamottin or glabridin) within 10 days prior to study treatment and while receiving lapatinib ditosylate therapy\n - No other concurrent anticancer therapy or investigational agents\n - No other concurrent anticancer agents\n - No concurrent treatment with other investigational therapy for other diseases or conditions\n - No concurrent prophylactic antibiotics\n - No concurrent prophylactic filgrastim (G-CSF)\n - At least 14 days since prior and no concurrent herbal or dietary supplements\n - No concurrent consumption of grapefruit juice \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01857115	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: multiple myeloma\n\nICD Codes: \"C90.01, C90.02, C90.00\"\n\nDrugs: carfilzomib, cyclophosphamide, dexamethasone\n\nSMILES: CC(C)CC@H(NC(=O)C@H(CCC1=CC=CC=C1)NC(=O)CN1CCOCC1)C(=O)NC@@H(CC1=CC=CC=C1)C(=O)NC@@H(CC(C)C)C(=O)C@@1(C)CO1, ClCCN(CCCl)P1(=O)NCCCO1, CC@@H(OC@H1OCCN(CC2=NNC(=O)N2)C@H1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F\n\nCT Criteria: Inclusion Criteria:\n Disease-related\n 1. Patient is a newly diagnosed MM patient.\n 2. Patient is age ≥ 65 year of age or who are ineligible for autologous stem cell transplantation.\n 3. Patient has measurable disease, defined as follows: any quantifiable serum monoclonal protein value (generally, but not necessarily, ≥ 0.5 g/dL of M-protein) and, where applicable, urine light-chain excretion of > 200 mg/24 hours. For patients with oligo- or non-secretory MM, it is required that they have measurable plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or an abnormal free light chain ratio (n.v.: 0.26-1.65). We anticipate that less than 10% of patients admitted to this study will be oligo- or non-secretory MM with free light chains only in order to maximize interpretation of benefit results.\n Demographic:\n 4. Age ≥ 18 years.\n 5. Life expectancy ≥ 3 months.\n 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Appendix F).\n Laboratory:\n 7. Adequate hepatic function, with serum ALT ≤ 3.5 times the upper limit of normal and serum direct bilirubin ≤ 2 mg/dL (34 µmol/L) within 14 days prior to randomization.\n 8. Absolute neutrophil count (ANC) ≥ 1.0 × 109/L within 14 days prior to randomization.\n 9. Corrected serum calcium ≤ 14 mg/dL (3.5 mmol/L).\n 10. Alanine transaminase (ALT): ≤ 3 x the ULN.\n 11. Hemoglobin ≥ 8 g/dL (80 g/L) within 14 days prior to randomization (subjects may be receiving red blood cell RBC transfusions in accordance with institutional guidelines).\n 12. Platelet count ≥ 50 × 109/L (≥ 30 × 109/L if myeloma involvement in the bone marrow is > 50%) within 14 days prior to randomization.\n 13. Creatinine clearance (CrCl) ≥ 15 mL/minute within 7 days prior to randomization, either measured or calculated using a standard formula (eg, Cockcroft and Gault).\n Ethical/Other:\n 14. Written informed consent in accordance with federal, local, and institutional guidelines.\n 15. Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception.\n 16. Male subjects must agree to practice contraception.\n Exclusion Criteria:\n Disease-related:\n 1. Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid; ≤ to the equivalent of dexamethasone 40 mg/day for 4 days)\n 2. Patient with relapsed or refractory multiple myeloma.\n 3. Patients with non-secretory MM unless serum free light chains are present and the ratio is abnormal.\n Concurrent Conditions:\n 4. Pregnant or lactating females (Appendix I).\n 5. Major surgery within 21 days prior to randomization.\n 6. Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to randomization.\n 7. Known human immunodeficiency virus infection.\n 8. Active hepatitis B or C infection.\n 9. Unstable angina or myocardial infarction within 4 months prior to randomization, NYHA Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker.\n 10. Uncontrolled hypertension, uncontrolled congestive heart failure (CHF) or uncontrolled diabetes within 14 days prior to randomization.\n 11. Non-hematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas.\n 12. Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to randomization.\n 13. Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib).\n 14. Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment.\n 15. Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomization.\n 16. Any other clinically significant medical disease or condition that, in the Investigators opinion, may interfere with protocol adherence or a subjects ability to give informed consent. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT02245438	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: healthy\n\nICD Codes: \"Z76.3, Z76.2\"\n\nDrugs: tipranavir low dose, tipranavir high dose, ritonavir low dose, ritonavir high dose, norethindrone-ethinyl estradiol\n\nSMILES: HC@@(CC)(C1=CC(NS(=O)(=O)C2=NC=C(C=C2)C(F)(F)F)=CC=C1)C1=C(O)CC@@(CCC)(CCC2=CC=CC=C2)OC1=O, HC@@(CC)(C1=CC(NS(=O)(=O)C2=NC=C(C=C2)C(F)(F)F)=CC=C1)C1=C(O)CC@@(CCC)(CCC2=CC=CC=C2)OC1=O, CC(C)C@H(NC(=O)N(C)CC1=CSC(=N1)C(C)C)C(=O)NC@H(CC@H(O)C@H(CC1=CC=CC=C1)NC(=O)OCC1=CN=CS1)CC1=CC=CC=C1, CC(C)C@H(NC(=O)N(C)CC1=CSC(=N1)C(C)C)C(=O)NC@H(CC@H(O)C@H(CC1=CC=CC=C1)NC(=O)OCC1=CN=CS1)CC1=CC=CC=C1, HC@@12CCC@@(O)(C#C)C@@1(C)CCC@1(H)C3=C(CCC@@21H)C=C(O)C=C3\n\nCT Criteria: Inclusion Criteria:\n 1. Female subjects between 18 and 50 years of age inclusive\n 2. A Body Mass Index (BMI) between 18 and 29 kg/m2\n 3. Signed informed consent prior to trial participation\n 4. Ability to swallow numerous large capsules without difficulty\n 5. Acceptable laboratory values that indicate adequate baseline organ function are required at the time of screening. Laboratory values are considered to be acceptable if severity is less than or equal to Grade 1, based on the AIDS Clinical Trials Group Grading Scale. All abnormal laboratory values greater than Grade 1 are subject to approval by the trial clinical monitor.\n 6. Acceptable medical history, physical examination and ECG, and chest X-ray (if not conducted within the last 12 months) are required prior to entering the treatment phase of the study\n 7. Willingness to abstain from alcohol for 48 hours prior to Study Day 0 and abstain from alcohol for the duration of the study. In addition, red wine must not have been ingested within 5 days prior to Day 0 (Visit 2)\n 8. Willingness to abstain from ingesting grapefruit, grapefruit juice, or products containing grapefruit juice, within 10 days before Day 0, Visit 2 and for the duration of the study\n 9. Willingness to abstain from ingesting Seville oranges, garlic supplements, St. Johns Wort, Milk Thistle, or methylxanthine-containing drinks or food (coffee, tea, cola, energy drinks, chocolate, etc) within 5 days of Day 0, Visit 2 and for the duration of the study\n 10. Willingness to abstain from over the counter herbal medications for the duration of the study\n 11. Reasonable probability for completion of the study\n Exclusion Criteria:\n 1. Female subjects who are of reproductive potential who:\n - Have positive serum beta-human chorionic gonadotropin at Visit 1, or on Day 0 or Day 1\n - Have not been using a barrier contraceptive method for at least 3 months prior to Visit 3 (Day 1)\n - Are not willing to use a reliable method of double-barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during the trial and 30 days after completion/termination\n - Are breast-feeding\n 2. Participation in another trial with an investigational medicine within 30 days prior to Day 0 (Visit 2)\n 3. Use of any medication listed in the protocol within 30 days prior to Day 0 (Visit 2)\n 4. Use of any other pharmacological contraceptive (including oral, patch or injectable contraceptives) for 1 month prior to study initiation and for the duration of the study\n 5. Administration of antibiotics within 10 days prior to Day 0 (Visit 2) or during the trial\n 6. History of central nervous system (CNS), gastrointestinal, hepatic, or renal disorders within the past sixty (60) days. Subjects will be excluded for these disorders greater than sixty days if, in the opinion of the investigator, the subject does not qualify as a healthy volunteer\n 7. History of thrombotic disease\n 8. History of migraine headache\n 9. Have serological evidence of hepatitis B or C virus\n 10. Have serological evidence of exposure to HIV\n 11. Recent history of alcohol or substance abuse (within 6 months of study period)\n 12. Cigarette smoking (greater than 10 cigarettes per day)\n 13. Blood or plasma donations within 30 days prior to Day 0 (Visit 2) or during the trial.\n 14. Subjects with a seated systolic blood pressure either <100 mm Hg or >150 mm Hg; resting heart rate either <50 beats/min or >90 beats/min. For subjects with a resting heart rate below 50, due to a high fitness level, the investigator may discuss exclusion with the medical monitor on a case-by-case basis\n 15. Subjects with a history of any illness or allergy that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering Tipranavir, Ritonavir or NET/EE to the subject\n 16. Subjects who have had an acute illness within 2 weeks prior to Day 0 (Visit 2)\n 17. Subjects who are currently taking any over-the-counter drug within 7 days prior to Day 0,(Visit 2) or who are currently taking any prescription drug that, in the opinion of the investigator in consultation with the clinical monitor, might interfere with either the absorption, distribution or metabolism of the test substances\n 18. Known hypersensitivity to TPV, RTV, or NET/EE\n 19. Inability to comply with the protocol \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT00063583	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: diabetes mellitus, diabetic nephropathy\n\nICD Codes: \"P70.2, O24.92, Z83.3, E10.65, E10.9, E11.65, E11.9\", \"E10.21, E11.21, E13.21, E08.21, E09.21\"\n\nDrugs: pirfenidone\n\nSMILES: CC1=CN(C(=O)C=C1)C1=CC=CC=C1\n\nCT Criteria: Inclusion\n - Type 1 or type 2 diabetes\n - Males and females greater than or equal to 18 years.\n - Abnormal kidney function determined by glomerular filtration rate\n - History of proteinuria\n - Blood pressure controlled to <140/90 on anti-hypertensive medication\n Exclusion\n - Cancer, liver disease, hepatitis, HIV+\n - History of heart attack, unstable angina, stroke or peptic ulcer in the past 6 months\n - Pregnant or planning to become pregnant during the study period\n - Other known kidney disease besides diabetic nephropathy\n - Expect to begin dialysis or receive a kidney transplant within 1 year of study enrollment \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00102622	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: ovarian cancer\n\nICD Codes: \"C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2\"\n\nDrugs: paclitaxel\n\nSMILES: HC@@1(CC@@H(C)C@2(H)CC(=O)C@H(C)\\\\C=C(C)\\\\C@@H(O)C@@H(OC)C(=O)C@H(C)CC@H(C)\\\\C=C\\\\C=C\\\\C=C(C)\\\\C@H(CC@3(H)CCC@@H(C)C@@(O)(O3)C(=O)C(=O)N3CCCCC@@3(H)C(=O)O2)OC)CCC@@H(OCCO)C@@H(C1)OC\n\nCT Criteria: Inclusion Criteria:\n - Age greater than or equal to 18 years\n - Recurrent epithelial ovarian cancer or primary peritoneal cancer with histologic confirmation of the original tumor. Recurrent disease may be manifested as an elevated cancer antigen (CA)-125 using the following criteria: (a) increase in CA-125 to at least 2 times the upper limit of normal (assayed on 2 occasions at least 7 days apart) for subjects with a history of normal pre-treatment values or values that normalized with the most recent treatment - OR - (b) increase in CA-125 to 2 times the lowest observed value on the most recent treatment (assayed on two occasions at least 7 days apart) for subjects whose CA-125 did not normalize with the most recent treatment.\n - Platinum-resistant disease, defined as recurrence less than six months after discontinuation of treatment with platinum therapy or platinum-refractory disease defined as progression on a platinum-containing regimen.\n - A treatment-free interval of at least three weeks for cytotoxic therapies, radiation therapy, or other experimental drugs prior to first treatment on this protocol.\n - A Zubrod performance status of two or less.\n Exclusion Criteria:\n - Previous administration of tgDCC-E1A.\n - Progression on any taxane-containing regimen, or recurrent within 6 months of receiving a weekly taxane-containing regimen.\n Previous radiation to more than 25% of marrow-bearing areas.\n - Any of the following laboratory values: Hemoglobin <9.0 gm/dl, absolute neutrophil count (ANC) <1.5 K/ml, platelet <100 K/ml, creatinine >2 mg/dl, bilirubin >2 mg/dl, Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT)>2 times the upper limit of normal, or abnormal coagulation profiles (>2 seconds beyond upper range of normal Prothrombin Time (PT) or Partial thromboplastin time (PTT)).\n - Known human immunodeficiency virus (HIV)-positive status or active systemic infection.\n - History of other invasive malignancies, except for non-melanoma skin cancer, unless there is no evidence of other cancer within the past 5 years.\n - Patients with grade 2 or greater neurotoxicity.\n - Patients with unstable angina or those who have had a myocardial infarction within the past six months. Patients with evidence of abnormal cardiac conduction are eligible if their disease has been stable for the past six months. Patients with an ejection fraction under 40%. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT00456833	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: non small cell lung cancer\n\nICD Codes: \"C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2\"\n\nDrugs: rad001, erlotinib\n\nSMILES: HC@@1(CC@@H(C)C@2(H)CC(=O)C@H(C)\\\\C=C(C)\\\\C@@H(O)C@@H(OC)C(=O)C@H(C)CC@H(C)\\\\C=C\\\\C=C\\\\C=C(C)\\\\C@H(CC@3(H)CCC@@H(C)C@@(O)(O3)C(=O)C(=O)N3CCCCC@@3(H)C(=O)O2)OC)CCC@@H(O)C@@H(C1)OC, COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2\n\nCT Criteria: Inclusion criteria:\n - Age over 18 years\n - Advanced Non Small Cell Lung Cancer which is not responding to chemotherapy treatment including either cisplatin or carboplatin\n - Only 1-2 previous chemotherapy regimens for advanced disease\n - More than 2 weeks from previous surgery, radiation or chemotherapy\n - Ability to perform normal daily functions\n Exclusion criteria:\n - Chronic steroid treatment\n - Prior treatment with EGFR inhibitors\n - Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions or other severe medical conditions\n - Other cancers within the past 2 years\n - Pregnant or breastfeeding women Other protocol-defined inclusion/exclusion criteria may apply \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT00277758	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: hepatitis c\n\nICD Codes: \"B18.2, B17.10, B17.11, B19.20, B19.21, B15.0, B15.9\"\n\nDrugs: ribavirin, ribavirin + pegylated interferon-alpha\n\nSMILES: NC(=O)C1=NN(C=N1)C@@H1OC@H(CO)C@@H(O)C@H1O, NC(=O)C1=NN(C=N1)C@@H1OC@H(CO)C@@H(O)C@H1O\n\nCT Criteria: Inclusion Criteria:\n - Men and women, age >18 years to < 65 years.\n - Ability and willingness to sign an informed consent.\n - Hepatitis C antibody positive status confirmed by the NYPH laboratory.\n - Genotype 1 HCV confirmed by the NYPH laboratory using the DupliType assay as performed by Quest Diagnostics.\n - Liver biopsy demonstrating chronic hepatitis but without cirrhosis within 2 years of enrollment.\n - Prothrombin time < 3 seconds longer than control.\n - Platelet count ≥75,000 mm3\n - Neutrophil count ≥ 1000/mm3\n - Hemoglobin ≥12 g/dL for women and ≥13 g/dL for men\n - Subject must agree not to participate in a conception process (defined as active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization etc.) while on study drugs and for 6 months following permanent discontinuation of study therapy.\n Women of reproductive potential (defined for this study as sexually mature women who have not been post-menopausal for at least 24 consecutive months, or have not undergone hysterectomy or oophorectomy) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 MIU/mL performed within 30 days prior to enrollment and again within 24 hours before initiating study therapy.\n All subjects must not participate in a conception process, and if participating in sexual activity that could lead to pregnancy, male subjects must take every precaution to avoid risk of pregnancy for their female partners, women subjects/male partners must use two reliable methods of contraception simultaneously, while receiving study therapy and for 6 months following permanent discontinuation of study therapy.\n NOTE A: Reliable forms of contraception are a combination of two of the following methods: 1) condoms (male or female) with or without a spermicidal agent. 2) diaphragm or cervical cap with spermicide, 3) IUD, or 4) hormonal-based contraception.\n NOTE B: An IUD is an adequate method of contraception but increases the risk of pelvic inflammatory disease.\n Exclusion Criteria:\n - Previous IFN-alpha, RBV or IL2 therapy\n - Any active viral hepatitis other than hepatitis C virus infection, as defined by the presence of IgM antibody to Hepatitis A Virus (HAV) within 30 days of enrollment, or Hepatitis B Virus Surface Antigen (HBsAg) positivity, or positive plasma HBV DNA by PCR methodology when HB core antibody is the only serologic marker of HBV infection within 30 days of entry.\n - ALT and AST > 5x ULN, total bilirubin > 1.5 x ULN\n - Signs/symptoms of advanced liver disease.\n - Uncontrolled infection, except hepatitis C\n - HIV infection as determined by HIV ELISA & Western blot assay, and confirmed by plasma HIV assay (PCR or bDNA)\n - Cardiac condition that cannot be controlled by medication: Because of the risk of anemia associated with RBV use and the potential to induce cardiac ischemia, subjects with a positive cardiac stress test are ineligible. Therefore, subjects > 40 years of age with ≥ 1 risk factor for ASHD (i.e., hyperlipidemia, hypertension, smoking history, family history) should have an EKG preformed. If the EKG is abnormal and consistent with ischemic heart disease, the subject should have a cardiac stress test to R/O ASHD.\n - CNS or psychiatric illness uncontrolled by medication. In particular, psychiatric illness, especially depression. Subjects with a psychiatric illness, a previous suicide attempt or hospitalization for a psychiatric Dx Will be enrolled at the discretion of the investigator.\n - Concurrent therapy with any immune-modulating agents, e.g,. interleukins, interferons, therapeutic vaccines, corticosteroids, immunosuppressive agents (azathioprine, 6-mercaptopurine, Cyclosporine-A, FK506, Rapamycin, antilymphocyte antibodies).\n - Pregnant or nursing women (all women of child bearing age should be using effective contraception)\n - History of malignancy with receipt of cancer therapy within 24 weeks.\n - Any severe illness that would make the subject unsuitable for the study.\n - Active asthma, or asthma uncontrolled by medication.\n - Any immunologically mediated disease, including Crohns disease, ulcerative colitis, rheumatoid arthritis, lupus erythematosis, ITP, autoimmune hemolytic anemia, eczema, psoriasis.\n - Untreated thyroid disease.\n - Heroin or cocaine use within 9 months of enrollment.\n - Inadequate venous access.\n NOTE: If screening TSH is abnormal, obtain free thyroxin index. If the free thyroxine index is normal, the subject may enter the study. If the free thyroxin index is low, the subject may be treated with thyroid hormone replacement medication and enter the study once the free thyroxin index is corrected. If the free thyroxin index is elevated indicating hyperthyroidism, the subject should not enroll in the study.\n Patients with preexistent antibodies against thyroid peroxidase or thyroglobulin should not be enrolled.\n - Allergy to any of the medications to be used in the study (i.e., IL2, PEG-IFN/RBV), or other components of the study products. Peg Intron: benzyl alcohol, NaCl, Na-phosphate, EDTA, polysorbate 80, m-cresol, IL2; phosphate buffer, SDS, mannitol. RBV: cellulose, lactose, croscarmellose, magnesium stearate, Blue pharmaceutical ink: shellac, anhydrous ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, Blue # 2 aluminum lake.\n - Alcohol dependency, for example, current alcohol use of more than 1 drink/day any time during the previous 6 months. One drink is defined as 12 ounces of beer, 5 ounces of wine, or 1-¼ ounces of hard liquor.\n - Severe retinopathy due to diabetes, hypertension, CMV, or macular degeneration\n - Acute therapy for a serious infection or other serious medical illness that is potentially life threatening and requires systemic therapy and/or hospitalization within 14 days of study entry.\n - Serum creatinine > 2.0 mg/dL or creatinine clearance < 50 mL/min as estimated by the Cockcroft-Gault equation. This screening value must be obtained within 30 days of enrollment.\n - History of major organ transplantation with an existing graft.\n - Subject judged by the investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results.\n - Subjects with biopsy proven liver disease other than HCV infection.\n - Subjects with hemoglobinopathies or any other causes or tendencies toward hemolysis.\n - Subjects with chronic pulmonary disease with functional limitations. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT02043756	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: neoplasms\n\nICD Codes: \"C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2\"\n\nDrugs: mitoxantrone hydrochloride liposome, mitoxantrone\n\nSMILES: OCCNCCNC1=CC=C(NCCNCCO)C2=C1C(=O)C1=C(C(O)=CC=C1O)C2=O, OCCNCCNC1=CC=C(NCCNCCO)C2=C1C(=O)C1=C(C(O)=CC=C1O)C2=O\n\nCT Criteria: Inclusion criteria:\n - Patients must compliance with the requirements and restrictions listed in the consent form\n - Patients with Pathology and / or cytologically proven malignant solid tumor\n - Patients must be 18-70 years old ,both male and female\n - Failure of standard chemotherapy\n - Patients have no better choice and may be benefit from the use of anthracyclines\n - Patients must have Eastern Cooperative Oncology Group (ECOG)Performance Status of 0-2\n - Objective tumor from the last chemotherapy, biological therapy or other experimental interval treatment least 4 weeks\n - Expected survival time ≥ 3 months\n - Patients agreed to take effective contraceptive measures during the trial\n - Blood routine, liver and kidney function, cardiac function examination in accordance with the following requirements.\n Exclusion criteria:\n - Pregnancy and breast-feeding women\n - Multiple sclerosis\n - Patients that have histories of ischemic heart disease and heart congestive,arrhythmia that need to be a treatment and significant valvular disease\n - Patients with heart disease induced by anthracycline\n - Patients requiring other antineoplastic treatment\n - Patients with temperature above 38 degrees or active infection that may effects in clinical tests\n - Patients are allergic to anthracycline and liposomal drugs\n - Patients are allergic to eggs,egg products,soybean and soybean products\n - Patients with uncontrolled primary or metastatic brain tumors \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01187836	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: heart failure\n\nICD Codes: \"I50.814, I09.81, I50.82, I50.89, I50.9, T86.22, I11.0\"\n\nDrugs: trv120027, placebo\n\nSMILES: CCC@H(C)C@H(NC(=O)C@H(CC1=CC=C(O)C=C1)NC(=O)C@@H(NC(=O)C@H(CCCNC(N)=N)NC(=O)CNC)C(C)C)C(=O)NC@@H(CC1=CN=CN1)C(=O)N1CCCC@H1C(=O)NC@H(C)C(O)=O, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\nCT Criteria: Inclusion Criteria:\n - Diagnosis of congestive heart failure made at least 3 months prior to screening\n - NYHA Class III or IV heart failure, ejection fraction </= 35% and , and in the opinion of the investigator, right-heart catheterization is clinically indicated.\n - Baseline mean PCWP >/= 20 mmHg\n - Systolic blood pressure at screening must be >/= 100 mmHg. Heart rate at screening must be </= 90 bpm.\n Exclusion Criteria:\n - Any significant disease or condition that would interfere with the interpretation of safety or efficacy in this study as determined by the Investigator based on medical history, physical examination or laboratory tests.\n - Significant valve disease\n - Current signs or symptoms of acute myocardial ischemia or acute coronary syndrome (ACS) or coronary revascularization in the past 3 months.\n - Sustained or uncontrolled ventricular arrhythmia. Inclusion of patients with atrial fibrillation with a heart rate ≤ 90 bpm is permitted. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01062152	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: myelodysplastic syndrome\n\nICD Codes: \"D46.9, D46.C, D46.Z\"\n\nDrugs: ezatiostat hydrochloride, lenalidomide (revlimid®)\n\nSMILES: CCOC(=O)C@@H(N)CCC(=O)NC@@H(CSCC1=CC=CC=C1)C(=O)NC@@H(C(=O)OCC)C1=CC=CC=C1, NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O\n\nCT Criteria: Inclusion Criteria:\n - Histologic diagnosis of primary or de novo MDS using WHO classification\n - Non-del(5q) low or Intermediate-1risk MDS\n - ECOG performance status of 0-1\n - Documented significant cytopenia for at least 2 months\n - Must have discontinued growth factors (EPO, G-CSF, GM-CSF) for at least 21 days prior to study entry\n - All study participants must be registered into the mandatory RevAssist® program and be willing and able to comply with the requirements of RevAssist®\n - Females of childbearing potential should have two negative serum pregnancy tests with a sensitivity of at least 50 mIU/mL. The first test should be performed within 10-14 days, and the second test within 24 hours of prescribing lenalidomide (prescriptions must be filled within seven days)\n Exclusion Criteria:\n - Known hypersensitivity to Telintra™ (intravenous or oral)\n - Known prior therapy with or hypersensitivity to thalidomide or lenalidomide\n - Prior allogenic bone marrow transplant for MDS\n - History or prior malignancy\n - Except for treated carcinoma of uterine cervix, basal cell or squamous cell skin cancer, or other cancers (e.g. breast, prostate) for which patient has been disease-free for at least 3 years.\n - MDS evolving from:\n - A pre-existing myeloproliferative disorder\n - An autoimmune disease\n - Secondary to prior treatment with radiation or chemotherapy\n - History of MDS IPSS score>1.0\n - Pregnant or lactating women\n - Leptomeningeal or leukemic meningitis\n - Prior treatment with DNA methyltransferase inhibitors (DMTI) e.g., azacitadine, decitabine, etc. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00724984	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: lymphoma, hodgkin disease, lymphoma, non-hodgkin\n\nICD Codes: \"S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S\", \"C81.77, C81.97, C81.17, C81.27, C81.37, C81.47, C81.70\", \"S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S\"\n\nDrugs: pci-24781\n\nSMILES: CN(C)CC1=C(OC2=CC=CC=C12)C(=O)NCCOC1=CC=C(C=C1)C(=O)NO\n\nCT Criteria: Inclusion Criteria:\n - • age ≥ 18 years\n - Phase I: Any measurable, histologically confirmed, and previously treated lymphoma\n - Phase II: Measurable, histologically confirmed, and previously treated lymphoma in one of the following categories:\n 1. Follicular non-Hodgkins Lymphoma\n 2. Mantle cell lymphoma\n - Ability to swallow oral capsules without difficulty\n - Estimated life expectancy > 12 weeks\n - ECOG performance status ≤ 1\n - Willing and able to sign a written informed consent\n Exclusion Criteria:\n - • More than four prior systemic treatment regimens (not counting maintenance rituximab; salvage therapy/conditioning regimen preceding autologous bone marrow transplantation ABMT and ABMT count as one regimen)\n - Allogeneic bone marrow transplant\n - Immunotherapy, chemotherapy, radiotherapy or experimental therapy within 4 weeks before first day of study drug dosing\n - Major surgery within 4 weeks before first day of study drug dosing\n - CNS lymphoma or a history of meningeal carcinomatosis\n - Prior treatment with an HDAC inhibitor (unless for treatment of Mycosis fungoides or Sézary syndrome)\n - Creatinine > 1.5 x institutional upper limit of normal (ULN) or creatinine clearance ≤ 50 mL/min\n - Total bilirubin > 1.5 x institutional ULN (unless elevated from documented Gilberts syndrome)\n - AST and ALT > 2.5 x institutional ULN\n - Platelet count < 75,000/µL for Phase I and <100,000>µL for Phase II\n - Absolute neutrophil count (ANC) < 1500/µL\n - Malabsorption\n - Corticosteroids > 20 mg prednisone equivalent per day (topical, inhaled, or nasal corticosteroids are permitted)\n - Concurrent therapeutic anticoagulation (Phase I only)\n - Uncontrolled illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV heart failure), unstable angina pectoris, cardiac arrhythmia, and psychiatric illness that would limit compliance with study requirements\n - Risk factors for, or use of drugs known to prolong QTc interval or that may be associated\n - QTc prolongation (defined as a QTc ≥ 450 msecs) or other significant ECG abnormalities including 2nd degree AV block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min). If the screening ECG has a QTc ≥ 450 msecs, the ECG can be submitted for a centralized, cardiologic evaluation.\n - History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty and/or stenting within the past 6 months.\n - For patients with history of myocardial infarction, congestive heart failure, abnormal left ventricular ejection fraction (LVEF), and/or prior anthracycline exposure, LVEF < 50%, as assessed by ventriculography (nuclear or heart catheterization) or echocardiogram, when performed within 28 days of first dose of study drug.\n - For patients with history of coronary artery disease, a cardiac stress test (either exercise or pharmacologic) that demonstrates clinically significant abnormalities when performed within 28 days of first dose of study drug.\n - Known HIV infection.\n - Other medical or psychiatric illness or organ dysfunction which, in the opinion of the investigator, would either compromise the patients safety or interfere with the evaluation of the safety of the study agent.\n - Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound).\n - Women of child-bearing potential, or sexually active men, unwilling to use adequate contraceptive protection during the course of the study. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00650572	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: cancer\n\nICD Codes: \"C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2\"\n\nDrugs: arry-380, her2 inhibitor; oral\n\nSMILES: CC1=CC(NC2=NC=NC3=CC=C(NC4=NC(C)(C)CO4)C=C23)=CC=C1OC1=CC2=NC=NN2C=C1\n\nCT Criteria: Key Inclusion Criteria (Part 1 and Part 2):\n - Histological or cytological evidence of HER2+ cancer (Part 1) or HER2+ metastatic breast cancer (Part 2).\n - Patients should have received at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy (patients with HER2+ breast cancer and with clinical indication for trastuzumab or lapatinib should have received prior therapy with trastuzumab and lapatinib, if available).\n - Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0 and 2.\n - Additional criteria exist.\n Key Exclusion Criteria (Part 1 and Part 2):\n - Uncontrolled or symptomatic brain metastases (patients may be considered adequately controlled if on a stable steroid dose for at least 30 days).\n - Treatment with an investigational medicinal product or device within 30 days prior to first dose of study drug.\n - Radiotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites).\n - Chemotherapy within 21 days prior to first dose of study drug.\n - Major surgery within 30 days prior to first dose of study drug.\n - Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or active hepatitis C.\n - Additional criteria exist. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01775189	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: healthy\n\nICD Codes: \"Z76.3, Z76.2\"\n\nDrugs: alo-02 weight-matched placebo, crushed alo-02 30 mg/3.6 mg, oxycodone weight-matched placebo, crushed oxycodone ir 30 mg\n\nSMILES: CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CC(=O)OC1=CC=CC=C1C(O)=O, CC(=O)OC1=CC=CC=C1C(O)=O\n\nCT Criteria: Inclusion Criteria:\n - Healthy subjects\n - Non-dependent, recreational opioid users. (Must use opioid for non-therapeutic purposes on at least 10 occassions within the last year and at least once in the 8 weeks before Visit 1 (Screening Visit).\n - Must have experience with intranasal opioid administration (snorted opioid drugs on at least 3 occassions within the last year before Visit 1 (Screening Visit).\n Exclusion Criteria:\n - Diagnosis of substance and/or alcohol dependence\n - Subject has participated in, is currently participating in, or seeking treatment for substance and/or alcohol related disorder. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01211626	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: hcv infection\n\nICD Codes: \"K94.02, K94.12, K94.22, K94.32, N99.511, A02.9, A31.0\"\n\nDrugs: ana773, placebo\n\nSMILES: CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\nCT Criteria: Part A Inclusion:\n - Male or female, ages 18 to 65 years\n - No clinically significant abnormalities\n - No serious or severe chronic conditions\n - Non-smokers\n Part A Exclusion:\n - Female subjects who are pregnant or breast-feeding\n - History of significant medical condition that could interfere with study medication or associated study assessments\n - History of or current drug or alcohol abuse\n Part B Inclusion Criteria:\n - Male or female, ages 18 to 65 years\n - Diagnosed with chronic liver disease consistent with chronic hepatitis C infection for at least 6 months\n - Screening HCV RNA ≥ 375,000 copies/mL or ≥ 75,000 IU/mL\n - Naïve to or have relapsed from prior IFN-alpha based therapy\n Part B Exclusion Criteria:\n - Female subjects who are pregnant or breast-feeding\n - Received anti-viral therapy or immunomodulatory therapy within 90 days prior to administration of the first dose of study medication\n - Use of an investigational drug or participation in an investigational study with a licensed drug within 30 days\n - History of significant medical condition that could interfere with study medication or associated study assessments\n - History of or current drug or alcohol abuse \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01188304	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: healthy volunteer\n\nICD Codes: \"Y99.2\"\n\nDrugs: aleglitazar, aspirin, placebo\n\nSMILES: COC@@H(CC1=CC=C(OCCC2=C(C)OC(=N2)C2=CC=CC=C2)C2=C1SC=C2)C(O)=O, CC(=O)OC1=CC=CC=C1C(O)=O, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\nCT Criteria: Inclusion Criteria:\n - Healthy volunteers, aged 40 to 65 years inclusive\n - Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive\n - Females of child-bearing potential must be willing to use two acceptable methods of contraception during the study and at least 3 months before start of the study\n - Non-smoker or currently smoking less than 5 cigarettes (or equivalent amount of other tobacco products) per day and is willing and able to stop smoking during the period in study center\n - Volunteer drinks no more than 3 cups of coffee, tea or soft drinks per day and is willing and able to stop drinking coffee, tea and soft drinks during the period in study center\n Exclusion Criteria:\n - Any clinically relevant abnormal laboratory test results at screening\n - Volunteer has taken any prescribed, herbal or over-the-counter medication within 2 weeks prior to first dosing\n - A history of any clinical significant gastro-intestinal, cardiovascular, musculoskeletal, endocrine, hematological, psychiatric, renal, hepatic, bronchopulmonary or neurological conditions or lipid disorders\n - A positive test for human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B or hepatitis C\n - History of intolerance to non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin, history of gastric or duodenal ulceration, personal or family history of abnormal clotting or bleeding \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00424645	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: hematologic malignancy, solid tumor\n\nICD Codes: \"E70.338, E70.339, P09.3, O28.0, P61.8, P61.9, T45.8X1A\"\n\nDrugs: voraxaze (glucarpidase), placebo\n\nSMILES: CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\nCT Criteria: Inclusion Criteria:\n 1. Patients with solid tumors and hematologic malignancies, receiving high dose methotrexate (MTX) (> / = 1 g/m^2 up to 14 g/m^2), who have delayed MTX clearance. Delayed MTX clearance is defined as: a) Serum MTX level at 72 +/- 2 hrs from initiation of infusion > / = 0.1 µmol/L for MTX doses 1-3.5 g/m^2 OR b) Serum MTX level at 72 +/- 2 hrs from initiation of infusion > / = 0.3 µmol/L for MTX doses > 3.5 g/m^2\n 2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n 3. IRB-approved signed informed consent\n Exclusion Criteria:\n 1. Any medical or psychiatric illness that is deemed by the investigator to be likely to interfere with patients ability to sign informed consent, cooperate and participate in the study\n 2. Patients receiving medications which may interfere with MTX excretion or enhance MTX toxicity (e.g. Penicillins, Cephalosporins, Tetracyclines, Non-Steroidal Anti-inflammatory Agents, Salicylates, Thiazide Diuretics, Bactrim, and Probenecid)\n 3. Patients with uncontrolled cardiac disease such as uncontrolled angina, cardiac arrhythmia, or Congestive Heart Failure (CHF) (New York Heart Association (NYHA) 4)\n 4. Patients with known hypersensitivity to any of the components of the study drug \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01278056	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: non-alcoholic steatohepatitis, increased iron storage / disturbed distribution\n\nICD Codes: \"K75.81\"\n\nDrugs: exjade\n\nSMILES: CC(C)N1CCN(CC1)C1=CC=C(OCC@H2COC@@(CN3C=NC=N3)(O2)C2=C(Cl)C=C(Cl)C=C2)C=C1\n\nCT Criteria: Inclusion Criteria (shortened):\n - Patients with elevated liver enzymes\n - Elevated serum ferritin (females > 300 ng/ml, males > 450 ng/ml)\n - Liver Histology consistent with a diagnosis of NASH\n Exclusion Criteria (shortened):\n - Alcohol intake > 140 g/week\n - Established liver cirrhosis Child Pugh B or C\n - Copresence of other causes of chronic liver disease\n - Anemia < 10 g/dl\n - Any elevation of liver enzymes > 5 ULN (ALAT, ASAT, g-GT), > 2.5 ULN (other), > 1.5 (Bilirubin)\n - Serum creatinine > 1.4 mg/dl or Ccr < 60 ml/min\n - Hemochromatosis\n - Known allergy or contraindication to the administration of Deferasirox\n - Sexually active pre-menopausal female patients who are unable to use a highly effective method of birth control. An exception is made for those who have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation.\n - Patients with impaired coagulation\n - History of blood transfusion during the 6 months prior to study entry\n - Oral iron supplementation within the last 4 weeks of study entry\n - Treatment with phlebotomy within 2 weeks of screening visit\n - Desferal treatment within 1 month of the screening visit\n - Patients currently or previously treated with deferiprone or Deferasirox\n - Presence of a surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any study drug\n - Positive HIV serology\n - Patients with active inflammatory diseases that may interfere with the accurate measurement of serum ferritin\n - Patients with a diagnosis of a clinically relevant cataract or a previous history of clinically relevant ocular toxicity related to iron chelation\n - Pregnant or breast feeding patients\n - Patients treated with systemic investigational drug within 4 weeks prior or with topical investigational drug within 7 days prior to the screening visit\n - Medications with proven or suspected influence on NASH such as glitazones, statins, or metformin are no exclusion criteria for study entry (insulin is not regarded to interfere with NASH). \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01313390	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: head and neck cancer\n\nICD Codes: \"C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11\"\n\nDrugs: docetaxel, everolimus\n\nSMILES: HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1, HC@@1(CC@@H(C)C@2(H)CC(=O)C@H(C)\\\\C=C(C)\\\\C@@H(O)C@@H(OC)C(=O)C@H(C)CC@H(C)\\\\C=C\\\\C=C\\\\C=C(C)\\\\C@H(CC@3(H)CCC@@H(C)C@@(O)(O3)C(=O)C(=O)N3CCCCC@@3(H)C(=O)O2)OC)CCC@@H(OCCO)C@@H(C1)OC\n\nCT Criteria: DISEASE CHARACTERISTICS:\n - Histologically confirmed squamous cell carcinoma of the head and neck\n - Locally advanced or metastatic disease\n - No patients with locally advanced disease for whom radiotherapy is indicated\n - Recurrent disease\n - Incurable disease\n - Measurable disease by RECIST criteria\n - Recurrent disease within a prior radiation field can be considered to be measurable\n - Patients may have received 1 line of prior chemotherapy (but not a taxane) for locally advanced or metastatic disease\n - Patients may have received prior radiation therapy for locally advanced or metastatic disease (but must have completed the radiotherapy > 6 months before recruitment)\n - No disease relapsed within 6 months of radiotherapy\n - No evidence of central nervous system metastases\n PATIENT CHARACTERISTICS:\n - ECOG performance status 0-1\n - Life expectancy ≥ 12 weeks\n - Absolute neutrophil count ≥ 1,500/mm³\n - Platelet count ≥ 100,000/mm³\n - Hemoglobin ≥ 10 g/dL\n - Urea and creatinine normal\n - Serum bilirubin normal\n - AST or ALT ≤ 1.5 times upper limit of normal (ULN)\n - Alkaline phosphatase < 2.5 times ULN\n - Negative pregnancy test\n - Not pregnant or nursing\n - Fertile patients must use effective contraception during and for 3 months (female) or 2 months (male) after the last dose of the study treatment\n - No uncontrolled infection\n - No mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study\n - No prior malignancy likely to interfere with the patients ability to comply with treatment and/or follow up\n PRIOR CONCURRENT THERAPY:\n - See Disease Characteristics\n - No prior chemotherapy for any cancer, except for head and neck cancer\n - No prior taxane\n - No prior therapy with any erbB inhibitors (except cetuximab given with radiotherapy, as indicated in treatment algorithm)\n - More than 6 months since prior radiotherapy for locally advanced or metastatic disease\n - At least 4 weeks since prior investigational drug\n - No concurrent use of drugs known to inhibit CYP3A4 (except dexamethasone), or block P-glycoprotein, including grapefruit juice\n - No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy, radiotherapy, or experimental medications\n - No concurrent live vaccines during everolimus therapy \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT00547053	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: cystic fibrosis\n\nICD Codes: \"E84.9, Z14.1, E84.0, E84.11, E84.8, E84.19, P09.4\"\n\nDrugs: amiloride solution for inhalation\n\nSMILES: NC(N)=NC(=O)C1=C(N)N=C(N)C(Cl)=N1\n\nCT Criteria: Inclusion Criteria:\n - Diagnosis of Cystic Fibrosis\n - Two positive cultures for Burkholderia dolosa lung infection\n Exclusion Criteria:\n - Positive pregnancy test or currently breast feeding (if applicable)\n - Known sensitivity to Amiloride \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01120834	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: lymphoma\n\nICD Codes: \"S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S\"\n\nDrugs: azacytidine, vorinostat\n\nSMILES: NC1=NC(=O)N(C=N1)C@@H1OC@H(CO)C@@H(O)C@H1O, ONC(=O)CCCCCCC(=O)NC1=CC=CC=C1\n\nCT Criteria: Inclusion Criteria:\n - Patients must have histologically confirmed diffuse large B cell lymphoma, relapsed after or resistant to prior systemic therapy.\n - Subjects must have measurable disease on cross sectional imaging that is at least 1.5 cm in diameter.\n - Patients should have relapsed following or be deemed ineligible for autologous stem cell transplantation. There is no limit to number of prior therapies.\n - Age > = 18 years.\n - ECOG performance status < = 2.\n - Patients must have normal organ and marrow function as defined below:\n - ANC > = 1,000/uL\n - platelets > = 75,000//uL\n - total bilirubin < = 2 X upper limit of normal\n - AST(SGOT)/ALT(SGPT) < = 2.5 X upper limit of normal\n - Serum creatinine < = 1.5 X upper limit of normal (ULN)\n - Women of childbearing potential must have a negative serum pregnancy test prior to treatment\n - The effects of these investigational agents on the developing human fetus at the recommended therapeutic doses are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A woman who becomes pregnant while participating in the study must withdraw from the study immediately.\n - Ability to understand and the willingness to sign a written informed consent document.\n Exclusion Criteria:\n - Prior allogeneic transplant\n - Patients may not be receiving any other investigational agents.\n - Patients may not have previously received anti-lymphoma therapy with an HDAC inhibitor (.e.g. Depsipeptide, MS-275, LAQ-824, PXD-101, and valproic acid). Patients who have received an HDAC inhibitor for another indication such as epilepsy may enroll after a 30-day washout period\n - Patients with known active CNS lymphoma. Subjects with previous CNS lymphoma that have been treated with chemotherapy, radiotherapy or surgery who have remained asymptomatic for 90 days (3 months) and demonstrate, no CNS lymphoma, as shown by lumbar puncture, CT scan or MRI, are eligible..\n - Patients with known hypersensitivity to azacytidine, vorinostat or mannitol.\n - Patients with a currently active second malignancy.\n - Uncontrolled 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 - QTc interval > 0.470. Consider discontinuation of medications that prolong QTc interval to eliminate this exclusion if medically appropriate.\n - Pregnant and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT00316407	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: ovarian epithelial cancer stage iii, stage iv ovarian cancer, stage iv breast cancer\n\nICD Codes: \"C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2\", \"C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60\"\n\nDrugs: lapatinib (gw572016), carboplatin, paclitaxel\n\nSMILES: CS(=O)(=O)CCNCC1=CC=C(O1)C1=CC2=C(C=C1)N=CN=C2NC1=CC(Cl)=C(OCC2=CC(F)=CC=C2)C=C1, NC@@H(CCCNC(N)=N)C(O)=O, HC@@1(CC@@H(C)C@2(H)CC(=O)C@H(C)\\\\C=C(C)\\\\C@@H(O)C@@H(OC)C(=O)C@H(C)CC@H(C)\\\\C=C\\\\C=C\\\\C=C(C)\\\\C@H(CC@3(H)CCC@@H(C)C@@(O)(O3)C(=O)C(=O)N3CCCCC@@3(H)C(=O)O2)OC)CCC@@H(OCCO)C@@H(C1)OC\n\nCT Criteria: Inclusion Criteria:\n - Relapsed (Stage III or IV) ovarian, primary peritoneal, fallopian tube carcinoma patients.\n - Stage IV metastatic breast cancer patients who have failed no more than four previous chemotherapies for Stage IV disease.\n - Ability to swallow and retain oral medications.\n - Measurable disease\n Exclusion Criteria:\n - Treatment with previous weekly carboplatin and paclitaxel.\n - No prior treatment with erbB targeting therapies such as erlotinib, gefitinib and cetuximab.\n - No concomitant requirement for medication classification as CYP3A4 inducers or inhibitors. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01474083	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: type 2 diabetes mellitus\n\nICD Codes: \"E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44\"\n\nDrugs: gk1-399 (formerly ttp399), gk1-399 (formerly ttp399), gk1-399 (formerly ttp399), placebo\n\nSMILES: CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\nCT Criteria: Inclusion Criteria:\n - Be male or female, aged 18 through 75 years at screening.\n - Have a diagnosis of Type 2 Diabetes Mellitus (T2DM)\n - On a stable dose of background medication for the treatment of diabetes\n - Body Mass Index (BMI) between 20-40 kg/m2 (inclusive)\n Exclusion Criteria:\n - Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01522391	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: atopic dermatitis\n\nICD Codes: \"L20.89, L20.9\"\n\nDrugs: dpk-060 1% ointment, placebo for dpk-060 ointment\n\nSMILES: CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\nCT Criteria: Inclusion Criteria:\n - A clinical diagnosis of atopic dermatitis\n - Treatable eczematous lesions of a total area of at least 25 cm2 (100 cm2 for the initial five patients)\n - Female patients of childbearing potential had to be using an appropriate method of contraception.\n - Female patients of childbearing potential were not eligible before PK data from the first 10 patients had been evaluated and the Medical Products Agency (Swedish regulatory agency) had given approval to include women of childbearing potential.\n Exclusion Criteria:\n - Significant clinical illness, within the two weeks prior to first dose, which could affect the outcome of the study\n - Previous local or systemic antimicrobial therapy within the last four weeks prior to the first application of the investigational product (DPK-060 1% or placebo ointment)\n - Existence of any surgical or medical condition which, in the judgment of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug\n - Patients who had had systemic treatment for atopic dermatitis or other topical or transdermal treatments (such as nicotine, hormone replacement therapies)on the site of eczema within 14 days prior to first application of DPK-060 1% or placebo ointment and/or topical treatment with tar, any corticosteroid,topical immunomodulators or oral treatment with any corticosteroids within 14 days prior to first application and/or oral antihistamines within 14 days of the first dose.\n - A need for any other medication during the period 0 to 7 days before entry to the study, (excluding the oral contraceptive pill for females) except those deemed by the principal investigator / clinical investigator not to interfere with the outcome of the study\n - Diagnosis of other skin diseases, which in the opinion of the investigator, were likely to adversely affect the outcome of the study\n - History or evidence of significant cardiac, renal, hepatic or endocrine disease\n - Significant hypersensitivity or allergy, as judged by the investigator\n - Immunocompromised patients\n - Lice or scabies\n - Tinea corporis\n - Hypersensitivity to the ingredients of the vehicle\n - The presence of prominent tattoos at sites of application of DPK-060 1% or placebo ointment\n - Donation of blood, exceeding 450 mL, during the three months prior to first dose\n - Participation in a clinical study during the 12 weeks prior to first dose\n - Ongoing alcohol or drug abuse\n - Positive pregnancy test or lactation \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00467116	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: pancreatic cancer\n\nICD Codes: \"C25.3\"\n\nDrugs: gemcitabine hydrochloride\n\nSMILES: NC1=NC(=O)N(C=C1)C@@H1OC@H(CO)C@@H(O)C1(F)F\n\nCT Criteria: Inclusion Criteria:\n - Histologically confirmed adenocarcinoma of the pancreas (head, body, or tail) or periampullary region, meeting both of the following criteria:\n - Unresectable disease\n - Locally advanced disease\n - Measurable or evaluable disease by CT scan or MRI\n - No evidence of metastatic disease outside of the planned irradiation field\n - ECOG performance status 0-2\n - WBC ≥ 3,000/mm³\n - ANC ≥ 1,500/mm³\n - Platelet count ≥ 100,000/mm³\n - Hemoglobin ≥ 8.5 g/dL\n - AST and ALT ≤ 5 times upper limit of normal\n - Bilirubin ≤ 2.0 mg/dL\n - Creatinine ≤ 2.0 mg/dL\n - No clinical indication of compromised function of nonirradiated kidney\n - No secondary malignancies within the past 5 years except for resected nonmelanoma skin cancer or carcinoma in situ of the cervix\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective contraception\n Exclusion Criteria:\n - No acute hepatitis\n - No known HIV infection\n - No other active or uncontrolled infection\n - No significant history of uncontrolled cardiac disease, including any of the following:\n - Hypertension\n - Unstable angina\n - Myocardial infarction within the past 6 months\n - Congestive heart failure\n - Cardiomyopathy with decreased ejection fraction\n - No prior severe infusion reaction to a monoclonal antibody\n PRIOR CONCURRENT THERAPY:\n - No prior radiotherapy to planned field of treatment\n - No prior therapy that specifically and directly targets EGFR pathway\n - At least 14 days since prior surgery or biopsy\n - At least 28 days since prior bypass procedures\n - More than 5 years since prior and no other concurrent chemotherapy\n - No other concurrent investigational agent \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT00326586	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: prostate cancer\n\nICD Codes: \"C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5\"\n\nDrugs: ar antagonist (bms-641988)\n\nSMILES: CC(C)CC@H(NC(=O)C@@H(CCCNC(N)=O)NC(=O)C@H(CC1=CC=C(O)C=C1)NC(=O)C@H(CO)NC(=O)C@@H(CC1=CN=CC=C1)NC(=O)C@@H(CC1=CC=C(Cl)C=C1)NC(=O)C@@H(CC1=CC2=CC=CC=C2C=C1)NC(C)=O)C(=O)NC@@H(CCCNC(N)=N)C(=O)N1CCCC@H1C(=O)NC@H(C)C(N)=O\n\nCT Criteria: Inclusion Criteria:\n - Advanced castration-resistant prostate carcinoma with progressive disease\n - At least 4 weeks must have elapsed from major surgery\n - Patient must be available for follow-up\n - Adequate liver and kidney function\n - Adequate blood values\n Exclusion Criteria:\n - Uncontrolled or significant heart disease\n - History of seizures\n - History of head injury, loss of consciousness, or stroke\n - Patients undergoing alcohol withdrawal\n - Any concurrent cancer\n - A serious uncontrolled medical disorder or active infection\n - Inability to swallow tablets \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01590407	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: hepatitis c, chronic\n\nICD Codes: \"B18.2, B18.0, B18.1, B18.8, B18.9, K71.3, K71.4\"\n\nDrugs: als-002200, placebo\n\nSMILES: CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\nCT Criteria: Inclusion Criteria:\n - Subject has provided written consent.\n - In the investigators opinion, the subject is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned.\n - Subject is in good health as deemed by the investigator.\n - Creatinine clearance of greater than 50 mL/min (Cockcroft-Gault)\n - Male or female, 18-55 years of age for HV and 18-65 years of age for subjects with CHC.\n - Body mass index (BMI) 18-32 kg/m2 inclusive for HV and 18-36 kg/m2 for subjects with CHC, minimum weight 50 kg in both populations.\n - A female is eligible to participate in this study if she is of non childbearing potential.\n - If male, subject is surgically sterile or practicing specific forms of birth control.\n Additional inclusion criteria for subjects with CHC genotype 1 infection:\n - Positive HCV antibody and a positive HCV RNA at screening.\n - Documentation of CHC infection for greater than 6 months at screening\n - CHC genotype 1 infection at screening\n - HCV RNA viral load ≥ 105 and ≤108 IU/mL using a sensitive quantitative assay.\n - Liver biopsy within two years or Fibroscan evaluation within 6 months prior to screening that clearly excludes cirrhosis. Fibroscan liver stiffness score must be < 12 kPa.\n - Absence of hepatocellular carcinoma as indicated by an ultrasound scan conducted during screening\n - No prior treatment for CHC\n - Absence of history of clinical hepatic decompensation.\n - Laboratory values include:\n - Prothrombin time < 1.5x ULN\n - Platelets > 120,000/mm3\n - Albumin > 3.5 g/dL, bilirubin < 1.5 mg/dL at screening (subjects with documented Gilberts disease allowed).\n - Serum alanine aminotransferase (ALT) concentration < 5 x ULN\n - Alpha Fetoprotein (AFP) concentrations ≤ ULN. If AFP is ≥ ULN, absence of a hepatic mass must be demonstrated by ultrasound within the screening period.\n Exclusion Criteria:\n - Clinically significant cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder.\n - Positive test for HAV IgM, HBsAg, HCV Ab (HV only), or HIV Ab.\n - Abnormal screening laboratory results that are considered clinically significant by the investigator.\n - Drug allergy such as, but not limited to, sulfonamides and penicillins, including those experienced in previous trials with experimental drugs.\n - Participation in an investigational drug trial or having received an investigational vaccine within 30 days or 5 half lives (whichever is longer) prior to study medication.\n - Clinically significant blood loss or elective blood donation of significant volume.\n - For healthy subjects, history of regular use of tobacco.\n - The subject has a positive pre-study drug screen.\n - Laboratory abnormalities including:\n - Thyroid Stimulating Hormone (TSH) > ULN\n - Hematocrit < 34 %\n - White blood cell counts < 3,500/mm3 \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00122876	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: carcinoma, hepatocellular, liver neoplasms\n\nICD Codes: \"C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8\", \"D13.4, Z85.05, C22.8, C78.7, C22.9, D37.6\"\n\nDrugs: talaporfin sodium\n\nSMILES: CCC1=C(C)\\\\C2=C\\\\C3=C(C=C)C(C)=C(N3)\\\\C=C3/N=C(C@@H(CCC(O)=O)C@@H3C)/C(/CC(=O)NC@@H(CC(O)=O)C(O)=O)=C3\\\\N\\\\C(=C/C1=N2)C(C)=C3C(O)=O\n\nCT Criteria: Inclusion Criteria:\n - A diagnosis of primary Hepatocellular Carcinoma (HCC), established by any one of the following criteria in a clinical setting suggestive of HCC: (i) Two different imaging techniques that suggests HCC; (ii) Combination of one imaging technique that suggests HCC and serum alpha-fetoprotein (AFP) level >400 ng/mL; (iii) Histological evidence of HCC;\n - Subjects with at least 1 but no more than 3 lesions in the liver may be considered for enrollment in the study;\n - Eastern Cooperative Oncology Group (ECOG) performance status 0-2;\n - Life expectancy of at least 16 weeks;\n - Prior treatment failure with locally ablative techniques is allowed. Subjects who were not candidates for surgery, systemic chemotherapy, chemoembolization (TACE), intratumoral ethanol injection (PEI), radiofrequency ablation (RFA), cryoablation or other locally ablative technology may be eligible, but at least 4 weeks must have elapsed since the completion of any prior therapy and the subject must have recovered from acute side effects;\n - Understanding and ability to sign written informed consent;\n - 18 years of age or more;\n - Adequate hematologic, liver and renal functions as evidenced by the following: WBC > 2,400/mm; Platelet Count > 75,000/µl; Hemoglobin > 9.4 gm/dL; PT and PTT < 1.5 Control; AST, ALT < 5 x ULN; Bilirubin < 1.5 X ULN; Alk Phos < 3X ULN; Creatinine < 2.5 mg/dL (SI: 221 mmol/L)\n Exclusion Criteria:\n - Subjects who are candidates for surgery with curative intent;\n - Subjects with lesions larger than 8 cm in diameter and more than 40% of parenchymal disease involvement;\n - Known sensitivity to porphyrin type drugs;\n - Known history of porphyria;\n - Known presence of extrahepatic metastases;\n - Anticipated need for systemic chemotherapy during the first 8 weeks of the study;\n - Child-Pugh C cirrhosis;\n - Diffuse HCC;\n - Concurrent participation in another clinical trial involving experimental treatment;\n - Any concurrent disease or condition that in the opinion of the investigator impairs the subjects ability to complete the trial. Psychological, familial, sociological, geographical or medical conditions which in the Principal Investigators opinion could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trials data. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00635557	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: glioblastoma multiforme\n\nICD Codes: \"L51.0, L51.8, L51.9\"\n\nDrugs: mpc-6827 + carboplatin\n\nSMILES: COC1=CC=C(C=C1)N(C)C1=NC(C)=NC2=C1C=CC=C2\n\nCT Criteria: Inclusion Criteria:\n - Histologically proven WHO Grade IV glioblastoma multiforme at time of diagnosis or relapse\n - Prior treatment with radiotherapy and temozolomide\n - Evidence of measurable recurrent or residual primary tumor by contrast-enhanced MRI\n - Be a minimum of 4 weeks since prior surgical resection, major surgical procedure, radiation therapy or cytotoxic chemotherapy (6 weeks since prior BCNU or CCNU)\n - Have a Performance Scale of Karnofsky > 60%, ECOG < 2 or WHO < 2\n - If steroids are needed, be on a stable or decreasing dose of steroids for at least 1 week\n Exclusion Criteria:\n - Hypersensitivity to Cremophor EL\n - Have evidence of current/active intratumor hemorrhage by MRI\n - Have greater than second relapse\n - Have had prior treatment with platinum-based chemotherapy\n - Have cardiovascular disease\n - Have cerebrovascular disease\n - Have uncontrolled hypertension\n - Have a cardiac ejection fraction < 50%\n - Have Troponin-I elevated above the normal range \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01335074	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: hepatocellular carcinoma\n\nICD Codes: \"C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8\"\n\nDrugs: temsirolimus + sorafenib\n\nSMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1\n\nCT Criteria: Inclusion Criteria:\n - Male or female patients ≥ 18 years of age\n - Patients who have a live expectancy of at least 12 weeks\n - Patients with histologically or radiologically and serologically confirmed advanced HCC; documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable\n - At least one tumor lesion that can be accurately measured in at least one dimension according to RECIST and which has not been treated with local therapy (TACE, PEI, radiofrequency ablation); CT or MRI scans should be not more than 2 weeks old to be used as baseline scan\n - Patients who received sorafenib at 400 mg bid with consecutive dose reduction to 200 mg bid due to intolerance, toxicity or adverse events or patients who are not eligible for full-dose first-line therapy with sorafenib, e.g. due to myocardial ischemia.\n - At least a period of 4 weeks prior to baseline scan after completion of a local therapy such as surgery, radiation therapy, hepatic arterial embolization, TACE, PEI, radiofrequency ablation, cryoablation or others\n - Patients who have an ECOG PS of 0, 1 or 2 or a Karnofsky Performance Status > 70 %\n - Cirrhotic status of Child-Pugh class A or B; Child-Pugh status should be calculated based on clinical findings and laboratory results during the sorafenib pretreatment period\n - No signs of decompensated liver cirrhosis\n - White blood cells ≥ 3,000/mm³\n - Neutrophils ≥ 1,500/mm³\n - Platelets ≥ 100,000/mm³\n - Bilirubin ≤ 3x ULN\n - AST and ALT ≤ 3x ULN\n - Creatinine normal\n - PTT ≤ 1.5 ULN\n - INT 2.0 to 3.0\n - Fasting serum cholesterol ≤ 350 mg/dL\n - Triglycerides ≤ 300 mg/dL\n - Proteinuria ≤ 1 g in 24 h\n - No history of allergic reactions to compounds similar to temsirolimus or sorafenib\n - No prior thromboembolic disease\n - No history of hematemesis or hemoptysis\n - No other uncontrolled illness\n - Women of childbearing potential must have had a negative serum or urine pregnancy test 48 h prior to the administration of the first study treatment\n - Patients who give a written informed consent obtained according to local guidelines\n - No other concurrent investigational drugs or anticancer agents\n - No concurrent traditional Chinese or herbal medicine (e.g. sho-saiko-to, silymarine)\n Exclusion Criteria:\n - Patients currently receiving chemotherapy, immunotherapy or radiotherapy or who have received these with 4 weeks of study entry except for standard sorafenib therapy\n - Prior use of systemic investigational agents for HCC\n - Previous concurrent cancer that is distinct in primary site or histology from HCC, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors and any cancer curatively treated > 3 years prior to entry is permitted\n - Chronic treatment with steroids or another immunosuppressive agents\n - A known history of HIV seropositivity\n - Renal failure requiring hemo- or peritoneal dialysis\n - History of cardiac disease: congestive heart failure (NYHA > 2), active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than b-blockers or digoxin, uncontrolled hypertension; myocardial infarction more than 6 months prior to study entry is permitted\n - Comedication with known strong Cyp3A4 inhibitors or Cyp3A4/5 inducers\n - Active clinically serious infections (> grade 2 CTCAE v.3.0)\n - Known carcinomatous meningitis or uncontrolled brain disease\n - Patients with clinically significant gastrointestinal bleeding with 30 days prior to study entry or on oral anti-vitamin K medication (except low dose coumarin, i.e. INR outside the therapeutic range of 2.0 to 3.0)\n - History of organ allograft\n - Uncontrolled diabetes\n - Impairment of gastrointestinal function of gastrointestinal disease that may significantly alter the absorption of sorafenib (e.g. ulcerative colitis, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)\n - Patients who have not recovered from surgery\n - Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; if barrier contraceptives are being used, these must be continued throughout the trial by both sexes\n - Patients who are using other investigational agents or who had received investigational drugs < 4 weeks prior to study entry\n - Patients with contraindications to sorafenib or temsirolimus treatment.\n - History of noncompliance to medical regimens\n - Patients unwilling or unable to comply with the protocol\n - Substance abuse, medical, psychological or social conditions that may interfere with the patients participation in the study or evaluation of the study results \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01372761	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: obesity\n\nICD Codes: \"E66.8, E66.9, E66.1, O99.214, O99.215, O99.210, O99.211\"\n\nDrugs: zgn-433, normal saline\n\nSMILES: COC@@H1C@@H(CCC@2(CO2)C@H1C@@1(C)OC@@H1CC=C(C)C)OC(=O)\\\\C=C\\\\C1=CC=C(OCCN(C)C)C=C1, O\n\nCT Criteria: Inclusion Criteria:\n - Obese but otherwise healthy females\n - Non-childbearing potential (surgically sterile, post-menopausal, or receiving implanted or injectable contraceptive for at least 3 months)\n - BMI ≥ 30 and ≤ 50 kg/m2\n - Stable body weight during the past month\n Exclusion Criteria:\n - Use of weight loss agents in the past month\n - History of eating disorder\n - History of gastric bypass surgery\n - Current smokers \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00593008	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: pancreatic adenocarcinoma\n\nICD Codes: \"C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31\"\n\nDrugs: temsirolimus, gemcitabine\n\nSMILES: CN1N=NC2=C(N=CN2C1=O)C(N)=O, HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1\n\nCT Criteria: Inclusion Criteria:\n - Previously untreated metastatic pancreatic adenocarcinoma, histologically proven.\n - Measurable disease by RECIST criteria\n - ECOG Performance Status 0 or 1\n - Male or female, 18 years of age or older\n - Life expectancy of >/= 12 weeks\n - AST and ALT </= 2.5 x ULN\n - Total bilirubin </= 1.5 x ULN\n - Serum albumin >/= 2.5g/dL\n - Absolute neutrophil count >/= 1500/mm3; platelets >/= 100,000/mm3; hemoglobin >/= 9.0 g/dL\n - Serum creatinine </= 1.5 x ULN\n - Subjects with diabetes must have adequate glycemic control, with fasting serum glucose </= 1.5 x ULN\n - Female patients of childbearing age and male patients with partners of childbearing age must agree to use adequate birth control measures during the course of the study and for at least one month following withdrawal from the study\n Exclusion Criteria:\n - Previously treatment with gemcitabine or chemoradiation\n - Diagnosis of a second malignancy within the last 3 years, except for adequately treated basal cell carcinoma or squamous cell skin cancer\n - Ongoing cardiac dysrhythmias of NCI CTCAE grade >/= 2, atrial fibrillation, QTc prolongation to > 450 msec for males and >470 msec for females\n - Known immunodeficiency disorders or active infections requiring treatment\n - Pregnancy or breastfeeding\n - Known brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease\n - Prior radiation therapy or major surgery within 4 weeks of study entry\n - Prior radiation therapy to > 25% of the bone marrow\n - Subjects receiving other experimental or alternative therapies during the course of the trial will be excluded\n - History of prior hypersensitivity to polysorbate \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT00509899	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: myelofibrosis, polycythemia vera, thrombocytosis\n\nICD Codes: \"D75.81, C94.41, C94.42, C94.40\", \"D45\"\n\nDrugs: ruxolitinib\n\nSMILES: N#CCC@H(C1CCCC1)N1C=C(C=N1)C1=C2C=CNC2=NC=N1\n\nCT Criteria: Inclusion Criteria:\n - Diagnosed with PMF or Post-PV/ET MF\n - Patients with myelofibrosis requiring therapy\n - Adequate bone marrow reserve\n Exclusion Criteria:\n - Received anti-cancer medications or investigational therapy in the past 14 days \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01536704	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: smoking cessation\n\nICD Codes: \"Y36.881S, Y36.891S, Y36.880S, Y36.881A, Y36.881D, Y36.890S, Y36.891A\"\n\nDrugs: nicotine (2 mg), nicotine (4 mg)\n\nSMILES: CN1CCCC@H1C1=CN=CC=C1, CN1CCCC@H1C1=CN=CC=C1\n\nCT Criteria: Inclusion Criteria:\n - Participants must be healthy smokers who usually smoked their first cigarette within 30 minutes of waking.\n - Body Mass Index within the range 19-27 kilograms/meters^2\n Exclusion Criteria:\n - Participants who used chewing tobacco or tobacco products other than cigarettes within 21 days of screening visit \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00253318	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: breast cancer\n\nICD Codes: \"C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60\"\n\nDrugs: docetaxel, rad001, dexamethasone\n\nSMILES: HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1, HC@@1(CC@@H(C)C@2(H)CC(=O)C@H(C)\\\\C=C(C)\\\\C@@H(O)C@@H(OC)C(=O)C@H(C)CC@H(C)\\\\C=C\\\\C=C\\\\C=C(C)\\\\C@H(CC@3(H)CCC@@H(C)C@@(O)(O3)C(=O)C(=O)N3CCCCC@@3(H)C(=O)O2)OC)CCC@@H(O)C@@H(C1)OC, CC@@H(OC@H1OCCN(CC2=NNC(=O)N2)C@H1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F\n\nCT Criteria: Inclusion Criteria:\n 1. 18 years of age or older.\n 2. Diagnosis of metastatic breast cancer with at least one measurable or evaluable lesion. For the phase II portion of the study patients will be required to have measurable disease. Response will be determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.\n 3. No limit on the prior number of chemotherapies for the phase I portion of the study. No more than one prior chemotherapy regimen for the phase II portion of the study.\n 4. Signed informed consent to participate in the study must be obtained from patients after they have been fully informed on the nature and potential risks by the investigator with the aid of written information.\n 5. Adequate bone marrow function as shown by: Absolute neutrophil count (ANC) > or = 1.5 times 10(9)/L, Platelets > or = 100 times 10(9)/L, Hgb > or = 10g/dL.\n 6. Normal renal function as shown by serum creatinine < or = 1.5 times Upper Limit of Normal (ULN).\n 7. Hepatic Function Variables:\n - Bilirubin < or = ULN\n - Alkaline phosphatase < or = 5 times ULN. If alkaline phosphatase is < or = 2.5 times ULN, ALT/AST must be < or = 2.0 times ULN. If alkaline phosphatase is > 2.5 but < or = 5 times ULN, ALT/AST must be < or = 1.5 times ULN\n 8. Performance Status 0-2 on the World Health Organization (WHO) scale.\n Exclusion Criteria:\n 1. Patients enrolled in the Phase I portion of the trial may have received prior docetaxel in the adjuvant or metastatic setting. Patients enrolled in the Phase II portion of the trial will not be considered eligible if they have received prior docetaxel as treatment for metastatic breast cancer. For the purposes of this protocol, patients who develop systemic metastasis < 6 months from adjuvant docetaxel will be considered to have had treatment with docetaxel for metastatic breast cancer and will be ineligible for protocol participation.\n 2. Patients with a history of thromboembolism within the prior 6 months or active thrombophlebitis.\n 3. For the phase I portion of the study, patients with grade > 2 neuropathy, for the phase II portion of the trial, patients with > or = grade 2 neuropathy.\n 4. For the phase I portion of the trial, patients with treated brain metastasis that are stable for 3 months will be eligible for protocol participation. However, patients with brain metastasis will be excluded from the phase II portion of the trial.\n 5. Patients with an uncontrolled infection.\n 6. Patients with a known history of HIV seropositivity.\n 7. Patients with an active, bleeding diathesis, or on oral anti-vitamin K medication (except patients receiving 1 mg of warfarin to prevent central venous catheter thrombosis).\n 8. Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration).\n 9. Patients with impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).\n 10. Patients who received any other investigational drugs within the preceding 30 days.\n 11. Patients who have received mitomycin C or nitrosourea.\n 12. Patients receiving anti-neoplastic therapy less than 14 days prior to entry onto this study or who have not recovered from the toxic effects of such therapy.\n 13. Patients who received radiation therapy within 3 weeks prior to entry on this study or who have not recovered from the toxic effects of such therapy.\n 14. Patients who had surgery within 2 weeks prior to entry on this study or who have not recovered from the side effects of such therapy.\n 15. Patients with a history of noncompliance to medical regimens.\n 16. Patients unwilling to or unable to comply with the protocol.\n 17. Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A4 or patients taking lithium chloride. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01026428	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: \"idiopathic parkinsons disease\"\n\nICD Codes: \"G20\"\n\nDrugs: safinamide + levodopa\n\nSMILES: CC@H(NCC1=CC=C(OCC2=CC(F)=CC=C2)C=C1)C(N)=O\n\nCT Criteria: Inclusion Criteria:\n 1. Gender: male or female\n 2. Age: 30 years\n 3. Body Mass Index (BMI): 18 - 32 kg/m2\n 4. Diagnosed with idiopathic Parkinsons disease, with Hoehn and Yahr (H&Y) of I-III\n 5. Levodopa-responsive patients treated with a stable dose of levodopa/carbidopa\n 6. Electrocardiogram recording (12 leads) normal or with abnormalities which are not hazardous to the patient according to the opinion of the investigator.\n 7. Negative beta-HCG test and not lactating (females). Women who are of childbearing potential must be using acceptable methods of contraception and should be informed of the potential risks associated with becoming pregnant while enrolled within a clinical research study. Accepted forms of contraception are: i.e. intrauterine device and a barrier method, combined oral contraceptives and a barrier method, or double-barrier method throughout the study. Female volunteers who are post -menopausal or surgically sterile may be enrolled\n 8. Ability to maintain an accurate and complete dosing diary, with the help of a caregiver, recording doses of levodopa and study medication taken at home All parameters will be determined within three weeks prior to first dosing. Subjects must have given written informed consent before any study-related activities are carried out\n Exclusion Criteria:\n To be eligible for inclusion in this study the subjects must not meet any of the following criteria:\n 1. Co-administration of other drugs causing dopamine release (e.g. reserpine) or affecting levodopa metabolism (e.g COMT inhibitors except AADC inhibitors) or any other medication clinically contraindicated with MAO B inhibitors or with levodopa/carbidopa Note: Use of Selective serotonin reuptake inhibitors SSRI and selective noradrenalin reuptake inhibitors SNRI will be permitted, provided the dose is kept as low as possible and remains stable throughout the trial.\n 2. Co-administration of other MAO inhibitors (e.g. selegiline, rasagiline)\n 3. The patient is in a late stage of Parkinsons disease, and is experiencing severe, disabling peak-dose or biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms\n 4. Any indication of forms of Parkinsonism, other than idiopathic Parkinsons disease.\n 5. Treatment with any agent known to inhibit or induce drug-metabolizing enzymes (e.g., barbiturates, St Johns Wort etc.) within 4 weeks prior study treatment\n 6. Concomitant oral iron treatment\n 7. History of hypersensitivity or contraindications to MAO-B inhibitors or levodopa\n 8. Clinically relevant allergies (especially hypersensitivity toward any medicinal drugs)\n 9. Significant hepatic impairment\n 10. Significant renal impairment\n 11. Diseases or surgeries of the gastrointestinal tract which could influence the gastrointestinal absorption and/or motility\n 12. Diagnosis of Human Immunodeficiency Virus (HIV), or acute Hepatitis B or C\n 13. Clinically relevant disease which in the investigators opinion would exclude the subject from the study, such as significant cardiovascular and lung diseases, narrow-angle glaucoma or endocrinological diseases such as hyperthyroidism or pheochromocytoma\n 14. A neoplastic disorder, which is either currently active or has been in remission for less than one year.\n 15. Active psychiatric disease (e.g, schizophrenia, psychotic depression)\n 16. History of melanoma or current cancer disease and undiagnosed, but melanoma suspicious skin lesion\n 17. Signs for dementia which could interfere with the compliance to the study as judged by the investigator\n 18. Ophthalmologic history including any of the following conditions: albino subjects, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity (i.e., 20/70), retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation (uveitis), or diabetic retinopathy.\n 19. Consumption of important quantities of coffee or tea corresponding to more than 600 mg caffeine/day, or tobacco smoking (more than 10 cigarettes per day)\n 20. Diet considerably deviating from normal nutritional patterns (e.g. vegan; diets with very high protein content Atkins)\n 21. Participation in another clinical study within 30 days prior to the planned first drug administration\n 22. Alcohol and drug abuse (during the past three years)\n 23. Transfusion of blood or plasma derivatives within 3 month prior to the planned first drug administration\n 24. Blood donation within 90 days before the start of the clinical study\n 25. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01060904	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: disease, hodgkin\n\nICD Codes: \"C81.77, C81.97, C81.17, C81.27, C81.37, C81.47, C81.70\"\n\nDrugs: brentuximab vedotin, doxorubicin, vinblastine, dacarbazine, bleomycin, brentuximab vedotin\n\nSMILES: NC@@H(CCCNC(N)=N)C(O)=O, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(CC@(O)(CC@@H3OC@H3CC@H(N)C@H(O)C@H(C)O3)C(=O)CO)C(O)=C1C2=O, NC@@H(CCCNC(N)=N)C(O)=O, N1C=CN=C1, CC@@H(O)C@H(NC(=O)C@@H(C)C@H(O)C@@H(C)NC(=O)C@@H(NC(=O)C1=C(C)C(N)=NC(=N1)C@H(CC(N)=O)NCC@H(N)C(N)=O)C@@H(OC1OC(CO)C(O)C(O)C1OC1OC(CO)C(O)C(OC(N)=O)C1O)C1=CN=CN1)C(=O)NCCC1=NC(=CS1)C1=NC(=CS1)C(=O)NCCCS+(C)C, NC@@H(CCCNC(N)=N)C(O)=O\n\nCT Criteria: Inclusion Criteria:\n - Treatment-naive Hodgkin lymphoma, Stage IIa or IIb-IV\n - Measurable disease of at least 1.5 cm\n - Eastern Cooperative Oncology Group performance status <3\n Exclusion Criteria:\n - History of another primary malignancy that has not been in remission for at least 3 years\n - Known cerebral/meningeal disease \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00508365	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: hypertension\n\nICD Codes: \"I15.0, I97.3, K76.6, P29.2, G93.2, H40.053, I10\"\n\nDrugs: carvedilol cr capsules, placebo, lisinopril\n\nSMILES: COC1=CC=CC=C1OCCNCC(O)COC1=CC=CC2=C1C1=CC=CC=C1N2, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CC(C)NCC(O)COC1=CC=C(CC(N)=O)C=C1\n\nCT Criteria: Inclusion Criteria:\n - Males or females who are ≥ 65 years of age\n - Body mass index (BMI) between 24 and 37 kg/m2 where: BMI = (weight in kg)/ (height in meters)2\n - Subjects must have a documented history of essential hypertension and must be stable on treatment with an ACE inhibitor or angiotensin II receptor antagonist or renin antagonist and no more than one other antihypertensive medication at least 3 months before screening with a sitting SBP<180 mmHg and DBP<110 mmHg.\n - All subjects must be able to be safely (in the opinion of the Investigator) withdrawn or down-titrated from all antihypertensive treatment(s) and transitioned to lisinopril 10 mg OD for the two-week run-in phase.\n Exclusion Criteria:\n - Any clinically relevant abnormality identified on the screening history, physical or laboratory examination, or any other medical condition or circumstance making the volunteer unsuitable for participation in the study\n - Subject who metabolizes carvedilol poorly based on CYP2D6 genotype as determined at screening\n - Subject has persistent hyperkalemia or history of hyperkalemia resulting from either Type IV RTA (renal tubular acidosis) or previous treatment with an ACE inhibitor, ARB or renin inhibitor.\n - Subject has malignant (accelerated) hypertension, history of malignant hypertension, or history of secondary forms of hypertension\n - Subject has advanced hypertensive retinopathy (Keith Wagner Grade IV)\n - Subject has a history of hepatic impairment (characterized by prolonged prothrombin time/low concentrations of albumin) and/or renal insufficiency (subjects with an estimated CrCl ≤ 30 mL/min by Cockroft-Gault must be excluded). CrCL = 140-ageCrweight/70 x 0.85 (if female); Cr in mg/dL; Weight in kg\n - Subject is being treated for diabetes mellitus\n - Subject has a history of angioedema\n - Subject has been under treatment with 3 or more antihypertensive medications. (NOTE: A combination drug containing two antihypertensive agents represents two antihypertensive medications.)\n - Subject has been under treatment with HCTZ > 12.5 mg/day\n - Subject is receiving ongoing treatment or is anticipated to receive treatment with any of the following medications during the study:\n - monoamine oxidase inhibitors (MAO)\n - any Class I or III antiarrhythmic\n - alpha-adrenergic receptor blockers\n - beta-2-adrenergic agonists\n - all antidepressants including SSRIs\n - lithium\n - medications known to be inhibitors/inducers of cytochrome P-450 2D6 should be discontinued for at least 14 days or 5 half-lives which ever is longer prior to the first day of the run-in period\n - Treatment with any over-the-counter medications , herbal and dietary supplements, as well as grapefruit-containing products within 7 days or 5 half-lives (whichever is longer) prior to first day of run-in period through the end of the study unless approved by the PI and GSK medical monitor. Standard vitamins and/or daily multi-vitamins are permitted, however herbal vitamins should be excluded.\n - Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the run-in period\n - Subject has mean sitting SBP ≥ 180 mmHg at the screening assessment (one set of repeat measurement is permitted as per approval by the medical monitor).\n - Documented history of low blood pressure within six months of screening visit (average sitting SBP < 110 mm Hg and/or DBP /< 50 mm Hg) or blood pressure below these values at time of screening (one set of repeat measurement is permitted as per approval by the medical monitor).\n - Orthostatic hypotension diagnosed at screening (orthostatic hypotension is defined as a reduction in systolic blood pressure of 20 mmHg or more and/or a reduction in diastolic blood pressure of 10 mmHg or more for standing vs. supine measurements)\n - Subject has any of the following conditions:\n - uncontrollable or symptomatic arrhythmias; unstable angina\n - sick sinus syndrome or second or third degree heart block (unless treated with a permanent, functioning pacemaker)\n - bradycardia (seated heart rate <55 bpm) (one repeat measurement is permitted as per approval by the medical monitor) ; history of myocardial infarction, or history of stroke within 1 year of screening.\n - subject is in, or has a history of atrial fibrillation\n - Any of the following abnormalities on 12-lead ECG during screening:\n - complete RBBB or LBBB\n - evidence of second- or third-degree AV block\n - pathological Q-waves (Q-wave wider than 0.04 sec or depth greater than 0.4-0.5 mV)\n - any other abnormalities that investigator feels could be of concern when patient is taking a β-adrenergic blocking agent\n - Donation of blood in excess of 500 mL within a 56-day period including the estimated 150 mL of blood to be drawn during this study\n - History of asthma, COPD and/or hypersensitivity to β -adrenergic blocking agents\n - History of sensitivity to carvedilol, lisinopril, alpha-blockers, beta-blockers or ACE inhibitors\n - History of sensitivity to any of the study medications or components thereof\n - History of anaphylaxis or anaphylactoid reactions or severe allergic responses to drugs\n - History of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening\n - Unanticipated positive urine drug screen (UDS) at screening. Note: If the subject is taking a drug known to give a positive on the UDS, then this should be discussed with the medical monitor prior to sending the UDS. In this situation, with prior approval, a positive finding on the UDS will not be considered an exclusion\n - Positive for Hepatitis B surface antigen or HIV\n - Unwillingness or inability to follow the procedures outlined in the protocol or inability to provide written informed consent \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01217736	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: renal function\n\nICD Codes: \"N25.89, N25.9\"\n\nDrugs: aliskiren, placebo, vtp-27999\n\nSMILES: CCC@@H1NC(=O)C@H(C@H(O)C@H(C)C\\\\C=C\\\\C)N(C)C(=O)C@H(C(C)C)N(C)C(=O)C@H(CC(C)C)N(C)C(=O)C@H(CC(C)C)N(C)C(=O)C@@H(C)NC(=O)C@H(C)NC(=O)C@H(CC(C)C)N(C)C(=O)C@@H(NC(=O)C@H(CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, HC@@(CN=C(O)N1CCCC@(H)(C1)C@@(H)(OCCN=C(O)OC)C1=CC(Cl)=CC=C1)(CC@@1(H)CCCOC1)NC\n\nCT Criteria: Inclusion Criteria:\n - Healthy adult male or female, 18-75 years of age\n - Female subjects must be postmenopausal or surgically sterilized. Postmenopausal females must have had no regular menstrual bleeding for at least one (1) year prior to initial dosing. Menopause will be confirmed by plasma serum FSH level at screening between 23.0-116.3 mIU/ml. Female subjects who report surgical sterilization must have had the procedure at least six (6) months prior to initial dosing.\n - Male subjects, able to father a child, must be willing to use approved birth control methods for 2 weeks following completion of study.\n Exclusion Criteria:\n - Subjects under 18 and subjects over 75 years\n - Diabetes Mellitus and/or kidney disease\n - Myocardial infarction, stroke, or cardiovascular revascularization/angioplasty within the last 6 months\n - Unstable angina pectoris or CAD requiring treatment with an excluded concomitant medication\n - History of/or symptoms consistent with congestive heart failure\n - Hypertension\n - History of left ventricular ejection fraction < 45%\n - Current smokers or nicotine patch\n - Pregnant or lactating females\n - Cancer or any life threatening illness with expected death within 2 years or by completion of the study\n - Serum creatinine >1.4 mg/dl\n - Serum potassium <3.5 or >5.2 mmol/L without medication\n - Serum albumin < 2.0 g/dL\n - Hemoglobin < 11.5 g/dL or Hematocrit < 34%\n - Any serum AST >/= 60 or ALT >/= 75 IU/L\n - Use of any prescription drugs which may affect the renin-angiotensin-aldosterone system or with known effect on renal hemodynamics are not allowed within 10 days prior to dosing or during the study\n - Use of CYP3A4 inhibitors (e.g. Diltiazem, Ketoconazole, Nifedipine, or Verapamil)\n - Use of any prescription medication is prohibited within 14 days (or, if known, for at least 5 half-lives, if longer) prior to dosing, unless approved by both the Investigator and the Sponsor\n - Use of any over-the-counter (OTC) medication, including herbal products, is prohibited within the 14 days prior to dosing, unless approved by both the Investigator and the Sponsor\n - Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing\n - A known hypersensitivity or contraindication to the study drugs (Aliskiren) or drugs similar to the study drugs or PAH, and inulin\n - Any surgical or medical condition which alters absorption, distribution, metabolism or excretion of drugs or which may jeopardize the patient subject during this study, including gastric bypass\n - History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by past medical history\n - Acute infections and/or significant illness within 3 weeks of planned enrollment into this study\n - Any medical condition in the investigators opinion, which renders the subject unable to complete the study or which would produce significant risk to the subject\n - Administration of any other investigational drug within 30 days of planned dosing in the study\n - Poor intravenous (IV) access as determined by the study staff \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00473746	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: prostate neoplasms\n\nICD Codes: \"C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5\"\n\nDrugs: abiraterone acetate, abiraterone acetate, prednisone/prednisolone or dexamethasone\n\nSMILES: HC@@12CC=C(C3=CC=CN=C3)C@@1(C)CCC@@1(H)C@@2(H)CC=C2CC@@H(O)CCC@12C, HC@@12CC=C(C3=CC=CN=C3)C@@1(C)CCC@@1(H)C@@2(H)CC=C2CC@@H(O)CCC@12C, HC@@12CCC@(O)(C(=O)CO)C@@1(C)CC@H(O)C@@1(H)C@@2(H)CCC2=CC(=O)C=CC@12C\n\nCT Criteria: Inclusion Criteria:\n Phase 1\n - Histologically confirmed adenocarcinoma of the prostate\n - No prior therapy with chemotherapy for prostate cancer\n - Ongoing gonadal androgen deprivation therapy with luteinizing hormone-releasing hormone (LHRH) analogues or orchiectomy\n - Testosterone <50 ng/dL\n - Progressive disease after androgen deprivation\n - The presence of objective metastatic disease is NOT required for study eligibility\n - Demonstrate disease progression after antiandrogen withdrawal\n - Eastern Cooperative Oncology Group (ECOG) performance status score = 0-1\n - Laboratory values within protocol-defined parameters\n - Systolic blood pressure <160 mmHg and diastolic blood pressure <110mmHg documented on at least 3 different days\n - Baseline adrenocorticotropic hormone (ACTH) stimulation test demonstrating a peak cortisol >18 µg/dL\n - Agrees to protocol-defined use of effective contraception\n - Life expectancy of >=12 weeks\n Phase 2\n - Same as Phase 1 criteria with addition of following criteria\n - Neoadjuvant or adjuvant chemotherapy is only allowed if the last dose is >1 year from Cycle 1 Day 1\n - Target or non-target abnormalities must be present either on screening bone scan, computed tomography or magnetic resonance imaging\n - No prior treatment with ketoconazole for the management of androgen independent prostate cancer\n Exclusion Criteria:\n Phase 1\n - Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart) any herbal product known to decrease prostate specific antigen (PSA) levels (eg, saw palmetto and PC-SPES), or any systemic corticosteroid within 4 weeks prior to first dose of study drug\n - Initiation of bisphosphonate therapy within 4 weeks prior to first dose of study drug\n - Therapy with supplements or complementary medicines/botanicals within 4 weeks of first dose of study drug, except for any combination of the following: conventional multivitamin supplements, selenium, lycopene, soy supplements\n - Prior radiation therapy completed <4 weeks prior to enrollment\n - Prior chemotherapy for hormone refractory prostate cancer\n - Any currently active second malignancy, other than non-melanoma skin cancer\n - Systolic blood pressure >=160 mmHg or diastolic blood pressure >=110 mmHg measured on at least 2 occasions\n - NYHA Class III or IV congestive heart failure\n - Myocardial infarction within the 6 months prior to the first dose of study drug\n - Serious intercurrent infections or nonmalignant medical illnesses that are uncontrolled\n - Active psychiatric illnesses/social situations that would limit compliance with protocol requirements\n - Active or uncontrolled autoimmune disease that may require corticosteroid therapy during study\n Phase 2\n - Same as phase 1 with the following addition\n - Abnormal electrocardiogram, including any finding which would interfere with assessment of intervals (patients with long QT syndrome, bundle branch blocks or hemiblocks are prohibited) \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00579137	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: severe combined immunodeficiency disease, severe primary immunodeficiency disorder, undefined t cell deficiency disorder, wiskott-aldrick syndrome\n\nICD Codes: \"D81.0, D81.31, D81.1, D81.2\", \"D84.9, D81.9, D83.9, D84.821, B20, D82.2, D84.822\", \"D81.810, E53.0, E53.1, E61.0, E61.1, E61.2, E61.3\", \"D68.61, D69.41, D81.4, E24.1, E26.01, E26.81, E34.0\"\n\nDrugs: fludarabine\n\nSMILES: ClCCN(CCCl)P1(=O)NCCCO1\n\nCT Criteria: Inclusion Criteria:\n - Patients with a diagnosis of: Severe combined immunodeficiency disease\n This includes patients whose SCID is characterized by gene specific mutations as well as patients with clinically severe combined immunodeficiency without a defined genetic cause in which the diagnosis will be determined by a combination of clinical course with lymphocyte quantification and function assays.\n OR\n Severe primary immunodeficiency disorder, including undefined T cell deficiency disorder, Wiskott-Aldrich syndrome, and other severe immunodeficiencies for which satisfactory conventional therapy does not exist.\n - Availability of an HLA mismatched (up to one haplotype) family member or an HLA matched or mismatched (up to one antigen) unrelated donor.\n - Creatinine < 2.5 x normal for age.\n - Life expectancy greater than 6 weeks\n - Lansky/Karnofsky greater than or equal to 70%\n Exclusion Criteria:\n - Patients with an HLA matched related donor\n - Patients with symptomatic cardiac disease, or evidence of significant cardiac disease by echocardiogram (i.e., shortening fraction less than 25%)\n - Patients with known allergy to rat serum products\n - Patients with a severe infection that on evaluation by the Principal Investigator precludes ablative chemotherapy or successful transplantation\n - HIV positive\n - Pregnant \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01292135	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: b-cell chronic lymphocytic leukemia, small lymphocytic lymphoma\n\nICD Codes: \"C91.11, C91.12, C91.10\", \"S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S\"\n\nDrugs: pci-32765\n\nSMILES: NC1=NC=NC2=C1C(=NN2C@@H1CCCN(C1)C(=O)C=C)C1=CC=C(OC2=CC=CC=C2)C=C1\n\nCT Criteria: Inclusion Criteria:\n 1. Histologically confirmed CLL or SLL and satisfying at least 1 of the following criteria for requiring treatment:\n - Progressive splenomegaly and/or lymphadenopathy identified by physical examination or radiographic studies\n - Anemia (<11 g/dL) or thrombocytopenia (<100,000/μL) due to bone marrow involvement\n - Presence of unintentional weight loss > 10% over the preceding 6 months\n - NCI CTCAE Grade 2 or 3 fatigue\n - Fevers > 100.5° or night sweats for > 2 weeks without evidence of infection\n - Progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of < 6 months\n 2. 1 to 3 prior treatment regimens for CLL/SLL\n 3. ECOG performance status of ≤ 1\n 4. ≥ 18 years of age\n 5. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty\n 6. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations)\n Exclusion Criteria:\n 1. Any chemotherapy, therapeutic antineoplastic antibodies (not including radio- or toxin immunoconjugates), radiation therapy, or experimental antineoplastic therapy within 4 weeks of first dose of study drug\n 2. Radio- or toxin-conjugated antibody therapy within 10 weeks of first dose of study drug\n 3. Concomitant use of medicines known to cause QT prolongation or torsades de pointes\n 4. Transformed lymphoma or Richters transformation Any life-threatening illness, medical condition or organ system dysfunction which, in the investigators opinion, could compromise the subjects safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk\n 5. Any of the following laboratory abnormalities: oAbsolute neutrophil count (ANC) < 1000 cells/mm3 (1.0 x 109/L) oPlatelet count < 50,000/mm3 (50 x 109/L) oSerum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≥ 3.0 x upper limit of normal (ULN) oCreatinine > 2.0 x ULN or creatinine clearance < 40 mL/min \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01843972	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: healthy\n\nICD Codes: \"Z76.3, Z76.2\"\n\nDrugs: bi 691751, bi 691751, placebo, bi 691751, bi 691751, bi 691751, bi 691751, bi 691751, bi 691751, bi 691751\n\nSMILES: CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\nCT Criteria: Inclusion criteria:\n 1. Healthy male subjects\n 2. Subjects must be able to understand and comply with study requirements\n 3. Age from 18 to 55 years\n 4. BMI range: from 18.5 to 29.9 kg/m2\n 5. Known genotype as specified in the study protocol\n Exclusion criteria:\n 1. Any relevant deviation from healthy conditions \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01346163	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: schizophrenia\n\nICD Codes: \"F20.0, F20.1, F20.2, F20.3, F20.5, F20.89, F20.9\"\n\nDrugs: pf 03654746\n\nSMILES: CCNC(=O)C@H1CC@(F)(C1)C1=CC(F)=C(CN2CCCC2)C=C1\n\nCT Criteria: Inclusion Criteria:\n Initial Inclusion Criteria:\n 1. Subjects must be competent to provide informed consent to participate in a clinical trial before any trial-related procedures can take place;\n 2. Subjects must be willing and able to comply with scheduled visits, treatments, laboratory tests and other testing and study procedures;\n 3. Subjects who participate must be willing to remain in-patient for at least one week at the beginning of each treatment period and remain in the hospital until judged by the Investigator to be clinically stable and able to be discharged to outpatient status;\n 4. Subjects must be fluent in English and able to understand all study related materials;\n 5. Subjects must be between the ages of 18-40 (inclusive) and if Female be of non-childbearing potential;\n 6. Body Mass Index (BMI) 18 to 40 kg/m2 and a total body weight of at least 50 kg (110 lbs);\n Psychiatric Inclusion Criteria:\n 1. Subjects must have a current DSM-IV-TR diagnosis of schizophrenia of Paranoid (295.30), Disorganized (295.10), Undifferentiated (295.90) or Residual Type (295.60);\n 2. Subjects must be receiving ongoing maintenance antipsychotic monotherapy with risperidone, olanzapine, quetiapine, ziprasidone, paliperidone or aripiprazole;\n 3. Subjects must be on a stable medication treatment regimen 2 months, including concomitant psychotropic medications;\n 4. Evidence of stable control of symptoms for 3 months (eg, no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia);\n 5. No more than moderate severity rating (4) on any individual PANSS positive symptom item (P1, P3, P5, P6) or formal thought disorder (P2), with no more than two moderate items in total;\n 6. Calgary Depression Scale Score less than or equal to 10;\n 7. Subjects must have a minimal level of extrapyramidal symptoms as documented by a score on the ESRS-A Global Parkinsonism scale of 3;\n 8. Subjects must have an illness duration (from the time of diagnosis) of at least 1 year;\n 9. Subjects will meet the following cognitive performance criteria:\n 1. Performance less than the maximum cutoff (in parentheses) for at least ONE of the following MCCB tests: (i.) Letter-number span (20); (ii.) Hopkins Verbal Learning Test (HVLT) total (31); and (iii.) Continuous Performance T- test (CPT) d-prime (3.47);\n 2. Able to complete the Baseline MCCB validly as assessed by a certified MCCB test administrator;\n 3. Standard score greater than or equal to 75 on the National Adult Reading Test (NART) or other IQ measure.\n Exclusion Criteria:\n 1. Female subjects who still have child bearing potential and females who are breastfeeding;\n 2. History of febrile illness within 5 days prior to the first dose;\n 3. Any condition possibly affecting drug absorption (eg, gastrectomy);\n 4. Subjects who have a positive urine drug screen which cannot be explained by prescribed medications;\n 5. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening;\n 6. Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication;\n 7. 12-lead ECG demonstrating QTc less than or equal to 450 msec at screening;\n 8. Subjects who are using disallowed concomitant medications and who will not be able to discontinue these concomitant medications prior to randomization;\n 9. Subjects who have taken hormone replacement therapy within 28 days or have taken an herbal remedy 7 days prior to the first dose of trial medication;\n 10. Subjects with other conditions that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results, and in the judgment of the Investigator, would make the subject inappropriate for entry into this trial;\n 11. Subjects with serologic evidence of acute hepatitis or chronic hepatitis and subjects with known hepatitis C antibodies and elevated LFTs;\n 12. Subjects with AST and/or ALT 1.5xULN at the Screening Visit;\n 13. Subjects with a current DSM-IV axis I diagnosis other than schizophrenia;\n 14. Subjects with a concurrent psychiatric disorder other than schizophrenia coded on Axis I;\n 15. Subjects who have previously participated in a trial using PF-03654746;\n 16. Subjects who have DSM-IV defined psychoactive substance dependence (excluding nicotine dependence) within 12 months of screening or substance abuse within 3 months prior to Screening;\n 17. Subjects currently using illicit psychoactive substances as evidenced by positive urine toxicology screen (utox positive for cannabinoids will not be exclusionary due to the long elimination half life of these substances);\n 18. Subjects with evidence or history of mental retardation;\n 19. Subjects with significant risk of suicidal or violent behavior;\n 20. Subjects with a history of poor compliance;\n 21. Subjects who have received clozapine or monoamine oxidase inhibitors in the month prior to randomization;\n 22. Current treatment with haloperidol or other typical antipsychotic;\n 23. Current treatment (within 4 weeks) with psychotropic agents known to act at the GABA-A receptor, including benzodiazepines; sedative-hypnotics other than trazodone and chloral hydrate; carbamazepine, gabapentin, lamotrigine, and valproic acid;\n 24. Current treatment (within 4 weeks) with psychotropic agents known to effect cognition: amphetamine; barbiturates; lithium; MAOIs; methylphenidate;\n 25. Current treatment (within 4 weeks) with herbal preparations with possible psychotropic effects (eg, St. Johns wort, kava-kava, Valerian, S-Adenosyl Methionine SAMe);\n 26. Subjects with a history of seizures and or/seizure disorder, significant head injury/trauma, as defined by one or more of the following:\n 1. Loss of consciousness (LOC) for more than 1 hour;\n 2. Recurring seizures resulting from the head injury;\n 3. Clear cognitive sequelae of the injury;\n 4. Cognitive rehabilitation following the injury.\n 27. Subjects with a history of clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorders (eg, unstable angina, decompensated congestive heart failure, CNS infection or history of HIV seropositivity), which would pose a risk to the patient if they were to participate in the study or that might confound the results of the study. Active medical conditions that are minor or well controlled are not exclusionary if they do not affect risk to the patient or the study results. For example, the following are not exclusionary: a) stable and well controlled hypertension (BP normally 160/95 for at least 3 months); b) asthma (no serious attacks in the past year); c) hypothyroidism (T4 within normal limits for at least 1 year); and d) Type II diabetes (subjects with a reported HgbA1c outside of normal limits within the last 6 months should be reviewed with the study site Investigator);\n 28. Subject received ECT treatment within the last 6 months;\n 29. Prior participation in a clinical trial of any other psychotropic medication within 2 months;\n 30. Subjects with a history of treatment resistant schizophrenia;\n 31. Subjects with a history of Tardive dyskinesia (TD) or Neuroleptic Malignant Syndrome (NMS) as determined clinically by the Investigator;\n 32. Unwilling or unable to comply with the Lifestyle guidelines described in this Protocol;\n 33. Subjects with implanted metal;\n 34. Subjects with claustrophobia such that they are unable to tolerate MR scanning.\n 35. Subjects taking medication that inhibit CYP3A4 or CYP2D6 \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT00078390	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: non small cell lung cancer, lung cancer, stage iiia non small cell lung cancer, stage iiib non small cell lung cancer\n\nICD Codes: \"C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2\", \"C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2\"\n\nDrugs: s-3304\n\nSMILES: CC1=CC=C(C=C1)C#CC1=CC=C(S1)S(=O)(=O)NC@H(CC1=CNC2=CC=CC=C12)C(O)=O\n\nCT Criteria: INCLUSION CRITERIA\n - newly diagnosed non-small cell lung cancer of stage IIIA non-resectable or of stage IIIB without pleural effusion\n - ECOG performance status 0-1\n - adequate organ function\n - clinically indicated and able to receive conventional chemoradiation therapy\n EXCLUSION CRITERIA\n - patients with prior history of cancer, other than basal cell carcinoma after appropriate treatment, or prior systemic chemotherapy treatment\n - patients with other serious intercurrent illness including HIV/AIDS, or contraindicated for paclitaxel/carboplatin or thoracic irradiation treatment \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Failure\n" } ]	Failure
NCT01106859	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: insomnia\n\nICD Codes: \"F51.01, F51.02, F51.03, F51.04, G47.00, G47.09, A81.83\"\n\nDrugs: zopiclone, zolpidem tartrate sublingual tablet, placebo (sublingual tablet), placebo\n\nSMILES: CN1CCN(CC1)C(=O)OC1N(C(=O)C2=NC=CN=C12)C1=NC=C(Cl)C=C1, CN(C)C(=O)CC1=C(N=C2C=CC(C)=CN12)C1=CC=C(C)C=C1, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\nCT Criteria: Inclusion Criteria:\n - Male or female subjects between the ages of 21 and 64 inclusive. For female subjects only: Female subjects will be included if they are post-menopausal or sterilized, or if they are of childbearing potential, they are not breastfeeding, their pregnancy test is negative, they have no intention of becoming pregnant during the course of the study, and are using adequate contraceptive drugs or devices. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization or abstinence. Females using oral contraception must have started using the medication at least 4 weeks prior to screening. Surgical sterilization must have occurred at least 6 weeks prior to screening.\n - Good health on the basis of pre-study history and physical examination, vital signs and the results of blood chemistry, hematology, and urinalysis\n - Good binocular visual acuity, corrected or uncorrected\n - Possession of valid drivers license for 3 years or more\n - Driving experience at least 3000 km/year\n - Signed informed consent\n Exclusion Criteria:\n - A history of drug addiction or drug or substance abuse, including alcohol abuse, within the past 12 months\n - Has a history of restless legs syndrome, sleep apnea, narcolepsy or other primary sleep disorder\n - A known hypersensitivity to zolpidem or zopiclone\n - Has undergone oral surgery, tooth extraction or piercing of the lip/tongue within 60 days prior to screening\n - Has used any medication to promote sleep, including herbal medications, within 14 days (or 5 half-lives of the drug, whichever is longer) prior to screening\n - Prescription medications for other health conditions are allowed as long as the subject has been on a stable dose at least 30 days prior to screening\n - Has taken any drugs known to induce hepatic drug metabolism (i.e., rifampin) within 30 days prior to screening\n - BMI > 29 Kg/M^2\n - Current use of medication that affects driving performance\n - Smokes more than 10 cigarettes/day\n - Uses tobacco products during periods of nighttime awakening\n - Consumes more than 6 cups of coffee/day\n - Consumes more than 21 glasses of alcohol/week\n - Has received an investigational drug within 60 days or 5 half-lives (whichever is longer) prior to screening\n - Has any additional condition(s) that in the Investigators opinion would:\n - Affect sleep/wake function\n - Prohibit the subject from completing the study\n - Not be in the best interest of the subject to participate in the study \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT00650923	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma, adult mixed glioma, recurrent adult brain tumor\n\nICD Codes: \"C84.67, C84.77, C84.7A, C84.60, C84.70, C84.62, C84.66\", \"C84.67, C84.77, C84.7A, C84.60, C84.70, C84.62, C84.66\", \"G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2\"\n\nDrugs: ziv-aflibercept, temozolomide\n\nSMILES: CSCCC@H(N)C(O)=O\n\nCT Criteria: Criteria:\n - Creatinine < = 1.5 mg/dL or creatinine clearance = > 60 mL/min\n - At least 28 days since prior major surgery or open biopsy\n - INR < = 1.5\n - Not pregnant or nursing\n - Negative pregnancy test\n - Karnofsky performance status 60-100%\n - SGOT and SGPT < 2 times upper limit of normal (ULN)\n - Bilirubin < 2 times ULN\n - Life expectancy = > 12 weeks\n - WBC = > 3,000/μL\n - ANC= > 1,500/mm³\n - Platelet count = > 100,000/mm³\n - Hemoglobin = > 10 g/dL (transfusion allowed)\n - At least 21 days since prior radiotherapy (groups 2 and 3)\n - No prior Gliadel® wafers\n - No concurrent major surgery\n - Fertile patients must use effective contraception prior to, during, and for at least 6 months after completion of study treatment\n - At least 28 days since prior significant traumatic injury No evidence of bleeding diathesis or coagulopathy\n - No serious or nonhealing wound, ulcer, or bone fracture\n - No history of other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years\n - No history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess gastrointestinal bleeding or diverticulitis within the past 6 months\n - No prior cranial radiotherapy (group 1 only)\n - No prior aflibercept\n - No prior treatment for brain tumors, except concurrent radiotherapy and temozolomide or 2 or fewer 28-day courses of adjuvant temozolomide (groups 2 and 3)\n - No prior or concurrent cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy for brain tumors (group 1 only)\n - No concurrent major surgery\n - No known hypersensitivity to CHO cell products or other recombinant human antibodies\n - No history of hypersensitivity to a recombinant protein whereby reaction occurs during or immediately after infusion\n - No history of allergic reactions attributed to compounds of similar chemical or biological composition to other study agents\n - No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness or social situation that would limit compliance with study requirements\n - No clinically significant cardiovascular disease within the past 6 months, including any of the following:\n History of ischemic or hemorrhagic stroke\n - Myocardial infarction, coronary artery bypass graft, or unstable angina\n - New York Heart Association class III-IV congestive heart failure, serious cardiac arrhythmia requiring medication, or unstable angina pectoris\n - Clinically significant peripheral vascular disease\n - Pulmonary embolism, deep vein thrombosis, or other thromboembolic event\n - No disease that will obscure toxicity or dangerously alter drug metabolism\n - Recovered from all prior therapy\n - More than 28 days since prior and no concurrent investigational agents\n - More than 7 days since prior core biopsy\n - At least 23 days since prior temozolomide (groups 2 and 3)\n - No concurrent combination antiretroviral therapy for HIV-positive patients\n - No concurrent full-dose anticoagulants (e.g., warfarin or low molecular-weight heparin)\n - Prophylactic doses allowed\n - No concurrent routine prophylactic use of filgrastim (G-CSF)\n - No other concurrent anticancer therapy (including chemotherapy, radiotherapy, hormonal treatment, or immunotherapy)\n - Concurrent enzyme-inducing antiepileptic drugs (EIAED) or non-EIAED allowed\n - Urine protein:creatinine ratio < = 1 or 24-hour urine protein < = 500 mg\n - No significant medical illnesses that in the investigators opinion cannot be adequately controlled with appropriate therapy or would compromise the patients ability to tolerate therapy \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success
NCT01404390	[ { "role": "user", "content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- Diseases: A list of diseases targeted by the clinical trial.\n- ICD Codes: A list of ICD codes associated with the diseases.\n- Drugs: A list of drugs used in the clinical trial.\n- SMILES: A list of SMILES strings representing the chemical structures of the drugs\n- CT Criteria: The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\nDiseases: neoplasms\n\nICD Codes: \"C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2\"\n\nDrugs: bay80-6946, bay80-6946\n\nSMILES: COC1=C(OCCCN2CCOCC2)C=CC2=C1N=C(NC(=O)C1=CN=C(N)N=C1)N1CCN=C21, COC1=C(OCCCN2CCOCC2)C=CC2=C1N=C(NC(=O)C1=CN=C(N)N=C1)N1CCN=C21\n\nCT Criteria: Inclusion Criteria:\n - Cancer patients\n - Japanese patients, who are at least 20 years of age\n - Histological or cytological documentation of non-hematologic, malignant solid tumours, excluding primary brain or spinal tumours, with no past or current involvement in the central nervous system (CNS)\n - At least one measurable lesion or evaluable disease according to RECIST (version 1.1)\n - Eastern Cooperative Oncology performance status (ECOG-PS) of 0 or 1\n - Life expectancy of at least 12 weeks\n - Advanced or refractory solid tumours not amenable to standard therapy, at the first screening examination/visit\n Exclusion Criteria:\n - Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of first study treatment. Patients must have recovered from the toxic effects of the previous anti-cancer chemotherapy or immunotherapy by the investigator (with the exception of alopecia).\n - Radiotherapy to target lesions during study or within 4 weeks of first study treatment\n - Investigational drug therapy outside of this trial during or within 4 weeks of first study treatment\n - Current diagnosis of Type I or II diabetes mellitus or fasting blood glucose level >125 mg/dL at screening, and/or HbA1c>/= 6.5%\n - Past and current histories of cardiac disease congestive heart failure > New York Heart Association (NYHA) Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset of angina within 3 months prior to study entry or unstable angina or ventricular cardiac arrhythmias requiring anti-arrhythmic therapy\n - Active and clinically serious infections >Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events NCI-CTCAE version 4.03)\n - Uncontrolled hypertension defined as systolic blood pressure >150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal medical management\n - Patients undergoing renal dialysis\n - Pregnant or breast feeding women \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n" } ]	[ { "role": "assistant", "content": "Answer: Success\n" } ]	Success

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