id stringlengths 11 11 | prompt listlengths 1 1 | completion listlengths 1 1 | Label stringclasses 2 values |
|---|---|---|---|
NCT00344968 | [
{
"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\n**Diseases:** diabetic macular edema\n\n**ICD Codes:** \"E10.311, E10.319, E11.311, E11.319, E13.311, E13.319, E10.3513\"\n\n**Drugs:** fluocinolone acetonide, fluocinolone acetonide\n\n**SMILES:** HC@@12CC@@3(H)C@4(H)CC@H(F)C5=CC(=O)C=CC@5(C)C@@4(F)C@@H(O)CC@3(C)C@@1(OC(C)(C)O2)C(=O)CO, HC@@12CC@@3(H)C@4(H)CC@H(F)C5=CC(=O)C=CC@5(C)C@@4(F)C@@H(O)CC@3(C)C@@1(OC(C)(C)O2)C(=O)CO\n\n**CT Criteria:** Inclusion Criteria:\n - Age >= 18 years with diabetic macular edema\n - Diagnosis of diabetes mellitus types 1 or 2\n - Best corrected visual acuity of 19-68 letters\n - Retinal thickness > 250 micron by OCT\n - Investigator is comfortable deferring macular laser treatment for 6 weeks\n Exclusion Criteria:\n - Glaucoma, ocular hypertension, IOP >21 mmHg or concurrent therapy at screening with IOP lowering agents\n - Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy\n - Prior intravitreal, subtenon, or periocular steroid therapy within 6 months\n - Any ocular surgery within the last 3 months\n - Retinal laser treatment within the last 3 months\n - History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy\n - Any lens opacity which impairs visualization of the posterior pole \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00003034 | [
{
"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\n**Diseases:** malignant mesothelioma\n\n**ICD Codes:** \"C45.9, C45.0, C45.1, C45.2, C45.7\"\n\n**Drugs:** doxorubicin hydrochloride, ranpirnase\n\n**SMILES:** 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\n\n**CT Criteria:** DISEASE CHARACTERISTICS:\n - Histologically confirmed malignant pleural or peritoneal mesothelioma\n - Measurable or evaluable disease\n - CALGB groups 1-4\n - No CNS metastases\n PATIENT CHARACTERISTICS:\n Age:\n - 21 and over\n Performance status:\n - ECOG 0-1\n Life expectancy:\n - Not specified\n Hematopoietic:\n - WBC greater than 3,500/mm^3\n - Absolute neutrophil count at least 1,500/mm^3\n - Platelet count at least 100,000/mm^3\n Hepatic:\n - SGOT no greater than 2 times upper limit of normal\n - Bilirubin no greater than 2 mg/dL\n - PT and PTT normal\n Renal:\n - Creatinine normal\n Cardiovascular:\n - No symptomatic New York Heart Association class II-IV cardiovascular disease\n - No congestive heart failure\n - No angina pectoris\n - No cardiac arrhythmias\n - No uncontrolled hypertension\n - No cerebrovascular disease\n Metabolic:\n - No serum calcium, phosphate, electrolyte, or other metabolic abnormalities, such as metabolic acidosis\n Other:\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective contraception\n - No serious infection\n - No uncontrolled psychosis or neurologic disease (e.g., seizure disorders)\n - No uncontrolled diabetes mellitus\n - No other primary malignancy within the past 5 years except nonmelanoma skin cancer\n - No senility or emotional instability\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - Not specified\n Chemotherapy:\n - No more than one prior systemic chemotherapy regimen\n - No prior doxorubicin\n - At least 6 weeks since prior chemotherapy\n Endocrine therapy:\n - Not specified\n Radiotherapy:\n - Prior radiotherapy for progressive or recurrent disease allowed except myocardium radiotherapy\n Surgery:\n - Prior surgical resection allowed \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01180634 | [
{
"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\n**Diseases:** cystic fibrosis\n\n**ICD Codes:** \"E84.9, Z14.1, E84.0, E84.11, E84.8, E84.19, P09.4\"\n\n**Drugs:** mp-376 (levofloxacin solution for inhalation), placebo\n\n**SMILES:** CC@H1COC2=C3N1C=C(C(O)=O)C(=O)C3=CC(F)=C2N1CCN(C)CC1, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\n**CT Criteria:** Inclusion Criteria (selected):\n - >/= 12 years of age\n - Confirmed Diagnosis of Cystic Fibrosis\n - Positive sputum culture for P. aeruginosa at screening and within the past 12 months\n - Patients are able to elicit an FEV1 >/= 25% but </= 85% of predicted value at screening\n - Have received at least 3 courses of inhaled antimicrobials over the preceding 12 months\n - Clinically stable with no changes in health status within the last 28 days\n - Able to reproducibly produce sputum and perform spirometry\n Exclusion Criteria (selected):\n - Use of any nebulized or systemic antibiotics within 28 days prior to baseline\n - History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication\n - Evidence of respiratory infections within 14 days prior to dosing\n - CrCl < 20ml/min or < 20ml/min/1.73 m2 at Screening \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00645229 | [
{
"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\n**Diseases:** schizophrenia, schizoaffective disorder\n\n**ICD Codes:** \"F20.0, F20.1, F20.2, F20.3, F20.5, F20.89, F20.9\", \"F25.9, F25.0, F25.1, F25.8\"\n\n**Drugs:** ziprasidone\n\n**SMILES:** ClC1=C(CCN2CCN(CC2)C2=NSC3=CC=CC=C23)C=C2CC(=O)NC2=C1\n\n**CT Criteria:** Inclusion Criteria:\n - Patients not currently being treated with antipsychotic medication and neuroleptic naive patients\n - Diagnosis of schizophrenia or schizoaffective disorder\n - Antipsychotic treatment prior to screening was to be for a cumulative period of less than 5 years\n Exclusion Criteria:\n - Patients at immediate risk of committing harm to self or others\n - Treatment with clozapine within 3 months prior to baseline\n - History of neuroleptic treatment\n - Current antipsychotic treatment \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00301223 | [
{
"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\n**Diseases:** neuropathic pain\n\n**ICD Codes:** \"E85.1, E85.0, N31.0, N31.1, N31.2, E10.610, E11.610\"\n\n**Drugs:** pregabalin\n\n**SMILES:** NCC1(CC(O)=O)CCCCC1\n\n**CT Criteria:** Inclusion Criteria:\n - Chinese outpatient of age 18 to 75\n - At screening and baseline, a score of greater than 40 mm on the visual log scale of SF-MPQ\n Exclusion Criteria:\n - Neurologic disorders unrelated to neuropathic pain, which in the opinion of the investigator, might impair the assessment of pain\n - Serum creatinine clearance greater than 60 ml/min \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01687296 | [
{
"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\n**Diseases:** asthma\n\n**ICD Codes:** \"J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40\"\n\n**Drugs:** fluticasone propionate inhalation solution, oral prednisone, placebo inhalation solution, placebo tablet, salbutamol\n\n**SMILES:** HC@@12CC@@H(C)C@(OC(=O)CC)(C(=O)SCF)C@@1(C)CC@H(O)C@@1(F)C@@2(H)CC@H(F)C2=CC(=O)C=CC@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, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CC1=CC(O)=CC(C)=C1Cl, CC(C)(C)NCC(O)C1=CC(CO)=C(O)C=C1\n\n**CT Criteria:** Inclusion Criteria:\n - Chinese male and female pediatric or adolescent subjects aged 4 to 16 years, inclusive\n - Subjects have an established diagnosis of asthma\n - The definition of asthma. According to Chinese Guideline for the diagnosis and optimal management of asthma in children Respiratory branch of pediatric society,Chinese Medical. Association. 2008, revised version, the subjects can be diagnosed when meeting the criteria. The diagnosis criteria is listed in the protocol.\n - The severity of an acute exacerbation of asthma is defined as PEF of 50% to 75% predicted via a peak flow meter, with a clinical scoring index of ≥2. The clinical scoring index represents the sum of the score for each of four signs: respiratory rate (0=low to 3=high, dependent on age), wheezing (0=none to 3=severe), inspiration/expiration ratio (0=2:1 to 3=1:3), and accessory muscle (0=none to 3=marked use).\n - Subjects can properly use a mini-wright peak flow meter, nebulizer and MDI with/without a spacer, and accurately complete a diary card with parental assistance, if required.\n - Subjects parents/guardians are willing to give written informed consent.\n Exclusion criteria:\n - Severe respiratory dysfunction.\n - History of mechanical ventilation due to respiratory failure.\n - Admission to hospital due to respiratory disease within the previous 2 weeks, including asthmatic exacerbations.\n - Clinical or lab evidence of a serious, uncontrolled systemic disease or presence of any disease likely to interfere with the objectives of this study, such as pulmonary cystic fibrosis and bronchopulmonary dysplasia.\n - Known or suspected hypersensitivity to glucocorticosteroids or β2 agonists.\n - Clinical visual evidence of oral candidiasis at Visit1.\n - Use of the medications below in Table 1 according to the following defined time intervals prior to presentation. The list is provided in the protocol. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01183858 | [
{
"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\n**Diseases:** non-small cell lung cancer\n\n**ICD Codes:** \"C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2\"\n\n**Drugs:** erlotinib tarceva\n\n**SMILES:** COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2\n\n**CT Criteria:** Inclusion Criteria:\n - Adult patients aged ≥18 years\n - inoperable, locally advanced (stage IIIB/IV) with supraclavicular lymph node metastases or malignant pleural or pericardial effusion) or metastatic (stage IV) non-small cell lung cancer (NSCLC)\n - Disease must be characterized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria\n - Patients have received one prior platinum-based chemotherapy regimen for advanced NSCLC, but must have recovered from any treatment-related toxicity\n - Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n - Life expectancy ≥12 weeks\n - Current cigarette smoker (having smoked >100 cigarettes in entire lifetime and currently smoking on average ≥1 cigarette per day), not intending to stop during the study\n Exclusion Criteria:\n - Prior antibody or small molecule therapy against Epidermal growth factor receptor (EGFR)\n - Radiotherapy within 28 days prior to enrollment\n - Received more than one line of chemotherapy for locally advanced/metastatic NSCLC (first-line maintenance chemotherapy after first-line platinum-based chemotherapy is allowed) \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT01618162 | [
{
"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\n**Diseases:** diabetes, diabetes mellitus, type 2\n\n**ICD Codes:** \"E23.2, N25.1, P70.2, O24.92, Z83.3, Z86.32, E10.65\", \"E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44\"\n\n**Drugs:** insulin degludec/liraglutide, placebo\n\n**SMILES:** CN(C)C(=N)NC(N)=N, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\n**CT Criteria:** Inclusion Criteria:\n - Subjects with type 2 diabetes mellitus\n - HbA1c 7.0-9.0% (53-75 mmol/mol) (both inclusive)\n - Subjects on stable daily dose of sulphonylurea (above or equal to half of the max approved dose according to local label) with or without metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening visit (Visit 1)\n - Body Mass Index (BMI) below or equal to 40 kg/m^2\n Exclusion Criteria:\n - Any use of oral anti-diabetic drugs (OADs) (other than SU in monotherapy or in combinationwith metformin) below or equal to 90 days prior to screening visit (Visit 1)\n - Use of any drug (other than SU in monotherapy or in combination with metformin), which in the Investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)\n - Previous treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (e.g. exenatide, liraglutide)\n - Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)\n - Screening calcitonin above or equal to 50 ng/l\n - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)\n - Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary,carotid or peripheral artery revascularisation procedures\n - Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigators opinion\n - Subjects with a clinical significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the Type 2 Diabetes Mellitus),neurological, genitourinary or haematological system that in the opinion of the Investigator,may confound the results of the trial or pose additional risk in administering trial product\n - History of chronic pancreatitis or idiopathic acute pancreatitis \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00058201 | [
{
"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\n**Diseases:** pancreatic cancer\n\n**ICD Codes:** \"C25.3\"\n\n**Drugs:** fluorouracil, gemcitabine hydrochloride, leucovorin calcium\n\n**SMILES:** HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1, NC1=NC(=O)N(C=C1)C@@H1OC@H(CO)C@@H(O)C1(F)F, NC1=NC(=O)C2=C(NCC@H(CNC3=CC=C(C=C3)C(=O)NC@@H(CCC(O)=O)C(O)=O)N2C=O)N1\n\n**CT Criteria:** DISEASE CHARACTERISTICS:\n - Histologically confirmed ductal adenocarcinoma of the pancreas OR\n - Histologically confirmed diagnosis of 1 of the following types of cancer:\n - Acinar cell carcinoma or cystadenocarcinoma of the pancreas\n - Cancers of the periampullary region\n - Cancers of the intrapancreatic part of the bile duct\n - Periampullary cancers of uncertain origin\n - Complete macroscopic resection (R0 or R1 resection)\n - Histological examination of all resection margins required\n - No stage IVB disease\n - No evidence of malignant ascites\n - No liver or peritoneal metastases\n - No evidence of spread to other distant abdominal or extra-abdominal organs\n - No pancreatic lymphoma\n PATIENT CHARACTERISTICS:\n Age\n - 18 and over\n Performance status\n - WHO 0-2\n Life expectancy\n - More than 3 months\n Hematopoietic\n - Not specified\n Hepatic\n - Not specified\n Renal\n - Not specified\n Other\n - Not pregnant\n - Able to participate in long-term follow-up\n - No other prior or concurrent malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix\n - No serious medical or psychological condition that would preclude study treatment\n PRIOR CONCURRENT THERAPY:\n Biologic therapy\n - Not specified\n Chemotherapy\n - No neoadjuvant chemotherapy\n - No other concurrent chemotherapy\n Endocrine therapy\n - Not specified\n Radiotherapy\n - Not specified\n Surgery\n - See Disease Characteristics\n - Recovered from prior resection \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT01116206 | [
{
"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\n**Diseases:** constipation\n\n**ICD Codes:** \"K59.00, K59.09, K59.01, K59.02, K59.03, K59.04, K58.1\"\n\n**Drugs:** prucalopride, placebo\n\n**SMILES:** COCCCN1CCC(CC1)NC(=O)C1=C2OCCC2=C(N)C(Cl)=C1, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\n**CT Criteria:** Inclusion Criteria:\n - History of chronic constipation, defined as on average, 2 or fewer spontaneous bowel movements (SBMs) per week and 1 or more of the following for at least a quarter of the time for the last 3 months, while symptom onset was more than 6 months before the screening visit: in more than 25 percent (%) of BMs, participants had very hard (little balls) and/or hard stools, sensation of incomplete evacuation, straining at defecation (making a bowel movement), sensation of ano-rectal obstruction or blockade, and/or need for digital manipulation to facilitate evacuation\n - Participants who were considered as constipated (who never had SBMs)\n - Participants constipation is functional\n - Participants with the diagnosis of irritable bowel syndrome (bowel disorder in which there is pain and diarrhea or constipation) with constipation and with no other organic diseases can potentially be included depending on the decision of the investigator\n - Female participants must be postmenopausal (for at least 1 year) or surgically sterile or practicing a highly effective method of birth control\n Exclusion Criteria:\n - Secondary to other diseases/conditions (endocrine disorders, metabolic disorders or neurologic disorders or drug-induced or suspected organic disorders of the large bowel, i.e., obstruction, carcinoma (type of cancer), or inflammatory bowel disease)\n - - Participants Using or intending to use disallowed medications that may influence the bowel habit during the study\n - Participants with severe (very serious, life threatening) and clinically uncontrolled cardiovascular, liver, or lung disease, neurologic or psychiatric disorders (including active alcohol or drug abuse), cancer (abnormal tissue that grows and spreads in the body until it kills) or acquired immune deficiency syndrome (AIDS: illness that results in decreased ability of the body to protect itself from other illnesses; development of the disease or conditions associated with the disease results from Human Immunodeficiency Virus HIV), or other gastrointestinal or endocrine disorders\n - Participants with impaired renal function, that is, serum creatinine greater than 2 milligram per deciliter (greater than 180 micro mole per liter)\n - Participants with clinically significant abnormalities of hematology, urinalysis, or blood chemistry \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01287260 | [
{
"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\n**Diseases:** hypertension\n\n**ICD Codes:** \"I15.0, I97.3, K76.6, P29.2, G93.2, H40.053, I10\"\n\n**Drugs:** nifedipine (adalat, baya1040), nifedipine (adalat, baya1040)\n\n**SMILES:** COC(=O)C1=C(C)NC(C)=C(C1C1=CC=CC=C1N+(O-)=O)C(=O)OC, COC(=O)C1=C(C)NC(C)=C(C1C1=CC=CC=C1N+(O-)=O)C(=O)OC\n\n**CT Criteria:** Inclusion Criteria:\n - 20 years or older\n - Japanese male or female\n - Outpatient with essential hypertension\n - Patients whose sitting diastolic blood pressure (DBP) is 90 mmHg or more despite more than 4 weeks of treatment with antihypertensive drug\n Exclusion Criteria:\n - Sitting diastolic blood pressure (DBP) is 110 mmHg or more or sitting systolic blood pressure (SBP) is 180 mmHg or more\n - Patients with secondary hypertension or hypertensive emergency \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01417663 | [
{
"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\n**Diseases:** cardiovascular disease, aging, endothelial dysfunction, physical activity\n\n**ICD Codes:** \"A52.00, A52.09, A50.54, Z01.810, Q87.418, Z13.6, R94.30\", \"H18.513, H18.511, H18.512, H18.519\"\n\n**Drugs:** alt-711\n\n**SMILES:** CC1=C(C)N+(CC(=O)C2=CC=CC=C2)=CS1\n\n**CT Criteria:** Inclusion Criteria:\n - Healthy sedentary elderly\n - Age 65 yrs and older\n Exclusion Criteria:\n - Cardiovascular disease\n - Cerebrovascular disease\n - Changes on ECG indicating cardiomyopathy or ischemia\n - No cardiovascular medication\n - Diabetes Mellitus\n - Hypercholesterolemia\n - BMI > 33 kg/m2\n - Intensive exercise > 1 hour a week \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00362466 | [
{
"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\n**Diseases:** leukemia\n\n**ICD Codes:** \"C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01\"\n\n**Drugs:** dasatinib, imatinib\n\n**SMILES:** CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1, CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1\n\n**CT Criteria:** Inclusion Criteria:\n - Men and women ≥18 years diagnosed with Chronic Phase Philadelphia chromosome positive (CP Ph+) CML who have failed to achieve CCyR after 3-18 months of therapy with imatinib 400 mg\n - Treatment initiation with imatinib 400 mg within 6 months of initial CML diagnosis\n - Able to tolerate chronic administration of imatinib at the highest dose (400-600 mg) the subject has received in the past\n - Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2\n - Adequate hepatic and renal function\n Exclusion Criteria:\n - Eligible and willing to undergo immediate autologous/allogeneic stem cell transplant\n - Previous diagnosis of accelerated/blast crisis CML\n - Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases\n - Previous documentation of T315I mutation\n - Uncontrolled or significant cardiovascular disease\n - Serious uncontrolled medical disorder/active infection\n - History of significant bleeding disorder unrelated to CML\n - Intolerance to imatinib ≥400 mg\n - Concurrent malignancies other than CML \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00041938 | [
{
"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\n**Diseases:** heart disease, stroke, ischemic heart disease, myocardial infarction\n\n**ICD Codes:** \"I11.0, I11.9, I27.1, I51.9, I09.9, I27.9, I01.8\", \"G46.4, G46.3, Z82.3\", \"I24.9, I25.9, I24.8, I25.89, Z82.49\", \"I25.2, I21.9, I21.A1, I21.A9, I21.4, I22.2, I23.8\"\n\n**Drugs:** aspirin, warfarin\n\n**SMILES:** CC(=O)OC1=CC=CC=C1C(O)=O, S1SSSSSSS1\n\n**CT Criteria:** Inclusion Criteria\n - Cardiac EF <=35% by radionuclide ventriculography, left ventriculography or quantitive echocardiographic measurement or an echocardiographic Wall Motion Index of <=1.2, within three months of enrollment. The patients clinical cardiac state at enrollment should be similar to their state at the time of the qualifying echocardiogram. The qualifying left ventricular function measurement must be obtained at least three months after an MI, coronary bypass grafting, PTCA, and at least one month after pacemaker insertion. Patients scheduled for mitral valve repair should have qualifying echo after surgery.\n - Modified Rankin score <=4.\n - Patient must be taking ACE inhibitors. If intolerant of ACE inhibitor, patient must be on angiotensin II receptor blockers or hydralazine and nitrates.\n - Patient is able to follow an outpatient protocol (requiring monthly blood tests and clinic visits every four months for the duration of the study) and is available by telephone.\n - Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent.\n - Patients with recent stroke or TIA within twelve (12) months will be eligible to be included in the recent stroke (RS) subgroup.\n - Chronic CHF patients (NYHA I * IV) admitted to the hospital can be randomized prior to discharge if the patient is stable, taking oral medications for 24 hours and ambulatory at the time of discharge. Stable New York Heart Association Class IV patients will be eligible for randomization.\n Exclusion Criteria\n - The presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal AF, mechanical valve, endocarditis, intracardiac mobile or pedunculated thrombus, and valvular vegetation.\n - Cyanotic congenital heart disease, Eisenmengers syndrome.\n - Decompensated heart failure.\n - Cardiac surgery, angioplasty, or MI within the past 3 months prior to randomization.\n - A contraindication to the use of either warfarin or aspirin, e.g. active peptic ulcer disease, active bleeding diathesis, platelets <100,000*, hematocrit <30, INR >1.3 (if not on warfarin), clotting factor abnormality that increases the risk of bleeding, alcohol or substance abuse, severe gait instability, cerebral hemorrhage, systemic hemorrhage within the past year, severe liver impairment (AST >3x normal*, cirrhosis), any condition requiring regular use of non-steroidal anti-inflammatory agents, allergy to aspirin or warfarin, uncontrolled severe hypertension (systolic pressure >180 mm Hg or diastolic pressure > 110 mm Hg), positive stool guaiac not attributable to hemorrhoids, creatinine >3.0*. *on most recent test done within 30 days prior to randomization\n - Patient needs continuing therapy with intravenous heparin or low molecular weight heparin or a specific antiplatelet agent.\n - Dementia or psychiatric or physical problem that prevents the patient from following an outpatient program reliably.\n - Comorbid conditions that may limit survival to less than five years.\n - Pregnancy, or female of childbearing potential who is not sterilized or is not using a medically accepted form of contraception* (see procedure manual). *A pregnancy test is required for all women of childbearing age.\n - Enrollment in another study that would conflict with WARCEF.\n - Hospitalization for new diagnosis of onset CHF within the past one month or carotid endarterectomy or pacemaker insertion within the past one month prior to randomization .\n - Person under 18 years of age. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00501345 | [
{
"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\n**Diseases:** thrombocytopenia, myocardial infarction\n\n**ICD Codes:** \"D69.6, D69.49, D69.59, P61.0, D75.82, D69.42, O36.8211\", \"I25.2, I21.9, I21.A1, I21.A9, I21.4, I22.2, I23.8\"\n\n**Drugs:** aspirin\n\n**SMILES:** CC(=O)OC1=CC=CC=C1C(O)=O\n\n**CT Criteria:** Inclusion Criteria:\n 1. Presenting for Cardiology consult at M.D. Anderson Cancer Center.\n 2. Platelet count between 100,000 and 20,000.\n 3. Acute Coronary Syndrome diagnosed with their first 12 lead EKG.\n 4. Patients that continue to show evidence of MI by cardiac enzymes with CPK levels > 2 normal limits, CK-MB levels 10% above normal limits, and Troponin I levels > 1.4ug/L will be considered positive for MI.\n 5. Ability to give consent.\n Exclusion Criteria:\n 1. Contraindications to aspirin including severe intolerance or true allergy, active bleeding, hemophilia, active retinal bleeding, severe untreated hypertension, active peptic ulcer, or other significant source of gastrointestinal or genitourinary bleeding, brain metastasis, and altered mental status.\n 2. Unwillingness or inability to give consent.\n 3. Progressive heart failure, unstable angina not responding to medical therapy for 24 hours, or ventricular tachycardia, necessitating thrombolysis, and angioplasty.\n 4. Patients that rule out for MI by cardiac enzymes panel after the first 24 hours.\n 5. Patients that rule in for MI and have Platelet count > 100,000.\n 6. Patients with platelet count < 20,000. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT01462942 | [
{
"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\n**Diseases:** chronic obstructive pulmonary disease (copd)\n\n**ICD Codes:** \"G91.1, I42.1, N11.1, J05.0, G47.33, J44.9, N13.8\"\n\n**Drugs:** aclidinium bromide/formoterol fumarate, aclidinium bromide/formoterol fumarate, aclidinium bromide, placebo, formoterol fumarate\n\n**SMILES:** COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1, COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1, OC(C(=O)OC@H1CN+2(CCCOC3=CC=CC=C3)CCC1CC2)(C1=CC=CS1)C1=CC=CS1, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1\n\n**CT Criteria:** Inclusion Criteria:\n - Adult male or non-pregnant, non-lactating female aged ≥40. Women of childbearing potential are allowed to enter the trial if they show to have a negative serum pregnancy test at the Screening Visit and are using, during the last two months before the Screening Visit, at least one medically approved and highly effective method of birth control defined as those which result in a low failure rate (i.e less than 1% per year) when used consistently and correctly such as implants, injectables, oral contraceptives combined with at least one barrier method, hormonal Intrauterine Devices (IUDs), sexual abstinence or vasectomy of the partner.\n - Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years.\n - Patient with a clinical diagnosis of stable COPD according to the Global Initiative for Chronic Lung Disease \"GOLD\" Guidelines at the Screening Visit.\n - Patient whose FEV1/FVC (Forced Vital Capacity) at the Screening Visit measured between 10-15 minutes post inhalation of 400 micrograms of salbutamol is < 70% (i.e., 100 x Post-salbutamol FEV1 /FVC < 70%).\n - Patient with a diagnosis of moderate to severe COPD according to the GOLD Guidelines classification (stages II and III) at the Screening Visit: FEV1 measured between 10-15 minutes post inhalation of 400 micro grams of salbutamol is 30% < FEV1 < 80% of the predicted normal value (i.e., 100 x Post-salbutamol FEV1/ Predicted FEV1 must be < 80% and ≥ 30%).\n - Patient must be able to perform repeatable pulmonary function testing for FEV1 according to American Thoracic Society/European Respiratory Society \"ATS/ERS\" 2005 criteria at Screening Visit.\n - Patient who is eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained.\n Exclusion Criteria:\n - History or current diagnosis of asthma.\n - Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Screening Visit.\n - Patient hospitalised for COPD exacerbation within 3 months prior to Screening Visit.\n - Clinically significant respiratory conditions defined as:\n - Known active tuberculosis.\n - History of interstitial lung or massive pulmonary thromboembolic disease.\n - Pulmonary resection or lung volume reduction surgery within 12 months prior to Screening Visit.\n - History of lung transplantation.\n - History of bronchiectasis secondary to respiratory diseases others than COPD (e.g., cystic fibrosis, Kartageners syndrome, etc).\n - Known a1-antitrypsin deficiency.\n - Patients who in the Investigators opinion might have needed to start a pulmonary rehabilitation program during the study and/or patients who started/finished it within 3 months prior to screening.\n - Use of long-term oxygen therapy (≥ 15 hours/day).\n - Patients who did not maintain regular day/night, waking/sleeping cycles including night shift workers (eg, history of sleep apnoea syndrome, any condition related to sleep disturbances such as restless-legs syndrome or somnambulism).\n - Clinically significant cardiovascular conditions defined as:\n - Myocardial infarction within the 6 months prior to screening.\n - Thoracic surgery within 12 months prior to screening.\n - Unstable angina or unstable arrhythmia which had required changes in the pharmacological therapy or other intervention within 12 months prior to screening, or newly diagnosed arrhythmia within the previous 3 months prior to screening.\n - Hospitalisation within 12 months prior to screening for heart failure functional classes III (marked limitation of activity and only comfortable at rest) and IV (need of complete rest, confinement to bed or chair, discomfort at any physical activity and presence of symptoms at rest) as per the New York Heart Association.\n - Patients (with or without pharmacological therapy) with resting systolic blood pressure (SBP)\n ≥200 mmHg, a resting diastolic blood pressure (DBP) ≥120 mmHg, or a resting heart rate ≥105 beats per minute (bpm) at screening and at Visit 1 prior to randomisation.\n - Patients with interval corrected for heart rate \"QTc\" calculated according to formulae (QTc=QT/RR1/2) > 470 msec as indicated in the centralised reading report assessed at Screening Visit.\n - Patients with clinically relevant abnormalities in the clinical laboratory tests, ECG parameters (other than QT interval corrected using Bazetts formula QTcB) or in the physical examination at screening, if the abnormality defined a disease state listed as exclusion criteria, except for those related to COPD.\n - Patients with a history of hypersensitivity reactions to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm). Patients with known narrow-angle glaucoma, symptomatic bladder neck obstruction or acute urinary retention.\n - Patients with symptomatic non-stable prostate hypertrophy. (However, patients with well-controlled, stable, asymptomatic benign prostatic hypertrophy were not excluded).\n - Patients with known uncontrolled history of infection with human immunodeficiency virus and/or active hepatitis.\n - Current diagnosis of cancer other than basal or squamous cell skin cancer.\n - Life expectancy of less than 1 year.\n - Patients with any other serious or uncontrolled physical or mental dysfunction that, as judged by the Investigator, could have placed the patient at higher risk from his/her participation in the study, could have confounded the results of the study, or is likely to prevent the patient from complying with the requirements of the study, or completing the study.\n - Patients with a history (within 2 years prior to screening) of drug and/or alcohol abuse that might have prevented study compliance based on the Investigator judgment.\n - Patients unlikely to be cooperative (eg, take the medication, complete the Patient Diaries or attend the clinic at the required times).\n - Patients unable to properly use a DPI or pMDI inhaler device or to perform spirometry measurements.\n - Patients previously randomised in a study involving aclidinium bromide/formoterol FDC.\n - Patients previously randomised in a study involving aclidinium bromide monotherapy except when participation finished at least 6 months before screening.\n - Patients treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to screening.\n - Patients who intended to use any concomitant medication not permitted by this protocol or who had not undergone the required washout period for a particular prohibited medication.\n - Patients unable to give consent, or patients of consenting age but under guardianship, or vulnerable patients.\n - Patients employed, or relatives of employees at the study centre, Almirall or Forest Laboratories.\n - Any other conditions that, in the Investigators opinion, might have indicated the patient to be unsuitable for the study. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01103323 | [
{
"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\n**Diseases:** metastatic colorectal cancer\n\n**ICD Codes:** \"C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2\"\n\n**Drugs:** regorafenib (stivarga, bay73-4506), placebo\n\n**SMILES:** O=Zn, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\n**CT Criteria:** Inclusion Criteria:\n - Histological or cytological documentation of adenocarcinoma of the colon or rectum\n - Progression during or within 3 months following the last administration of approved standard therapies. Patients treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy\n - Patients with measurable or non measurable disease\n - Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 1\n - Life expectancy of at least 3 months\n - Adequate bone marrow, liver and renal function\n Exclusion Criteria:\n - Unstable/uncontrolled cardiac disease\n - History of arterial or venous thrombotic or embolic events\n - Symptomatic metastatic brain or meningeal tumors\n - Patients with evidence or history of bleeding diathesis\n - Interstitial lung disease - Persistent proteinuria >/= grade 3\n - Unresolved toxicity > grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity </= Grade 2 \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01451398 | [
{
"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\n**Diseases:** type 2 diabetes\n\n**ICD Codes:** \"E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44\"\n\n**Drugs:** technosphere® insulin, technosphere powder\n\n**SMILES:** Na+.Na+.O-P(O-)(F)=O\n\n**CT Criteria:** Inclusion Criteria:\n - HbA1c > or = to 7.5% and < or = to 10.0%\n - Body mass index (BMI) < or = to 45 kg/m2\n - Non smoker for at least 6 months before Screening\n - Clinical diagnosis of type 2 diabetes mellitus for more than 12 months\n - Currently receiving as diabetes treatment only metformin or 2 or more OADs and on stable doses for at least 3 months before enrollment\n - Subjects receiving metformin must be on at least 1.5gm daily, or up to the maximum tolerated dose\n - Subjects treated with a sulfonylurea must be on at least 50% of the total maximum approved dose for a given agent\n - Subjects receiving a DPP-4 inhibitor must receive the maximum approved dose specific for that agent\n - Metiglinide and alpha-glucoside inhibitors must be taken at the highest tolerated dose within the approved dose range\n - No previous or current treatment with insulin, except during an acute illness, gestational diabetes, or at time of initial diagnosis of diabetes\n - Forced expiratory volume in one second (FEV1) > or = to 70% Third National Health and Nutrition Examination Survey (NHANES III) predicted\n - Forced vital capacity (FVC) > or = to 70% NHANES III predicted\n - Forced expiratory volume in one second as a percentage of forced vital capacity (FEV1/FVC) > or = to NHANES III lower limit of normal (LLN)\n Exclusion Criteria:\n - History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, or any other clinically important pulmonary disease (eg, pulmonary fibrosis)\n - Any clinically significant radiological findings on screening chest x-ray\n - Use of medications for asthma, COPD, or any other chronic respiratory conditions\n - Evidence of serious complications of diabetes (proliferative retinopathy, autonomic neuropathy with symptoms of gastroparesis or cardiac arrhythmia; sensory neuropathy that makes manipulation of the Gen2C inhaler difficult)\n - Renal disease or renal dysfunction\n - Significant cardiovascular dysfunction or history thereof within 12 months of screening; serious arrhythmia, treatment with medications to control/treat arrhythmias; myocardial infarction; cardiac surgery; history of valvular heart disease\n - Previous or current use of amiodarone\n - Treatment with glucagon-like peptide-1 (GLP-1) analogs, thiazolidinediones (TZD), or weight loss drugs (eg, sibutramine, orlistat) within 3 months of screening\n - History of pulmonary embolism or deep venous thrombosis in the 12 months before Screening\n - History of recent blood transfusion (within previous 3 months) or diagnosis of hemoglobinopathies that may affect HbA1c measurements \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00379769 | [
{
"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\n**Diseases:** diabetes mellitus, type 2\n\n**ICD Codes:** \"E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44\"\n\n**Drugs:** rosiglitazone, sulfonylurea, metformin\n\n**SMILES:** CCN1C=C(C(O)=O)C(=O)C2=C1C=C(C=C2)C1=CC=NC=C1, HC@1(C)CCC@@(H)(CC1)N=C(O)NS(=O)(=O)C1=CC=C(CCN=C(O)N2CC(C)=C(CC)C2=O)C=C1, CSCCC@H(N)C(O)=O\n\n**CT Criteria:** Inclusion Criteria:\n - Patients with type II diabetes mellitus as defined by 1999 World Health Organisation criteria.\n - Glycated haemoglobin (HbA1c) >7.0 % to = 9.0 % at visit 1.\n - Use of an oral glucose lowering agent for a minimum of 6 months prior to screening and unchanged for 2 months prior to screening.\n - Body mass index >25.0 kg/m2.\n Exclusion Criteria:\n - Patients receiving any other glucose lowering therapy which is not metformin or a sulfonylurea.\n - Patients with systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg.\n - Patients who have required the use of insulin for glycaemic control at any time in the past.\n - Hospitalisation for any major cardiovascular event in the last 3 months. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00518323 | [
{
"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\n**Diseases:** schizophrenia\n\n**ICD Codes:** \"F20.0, F20.1, F20.2, F20.3, F20.5, F20.89, F20.9\"\n\n**Drugs:** paliperidone er, placebo, paliperidone er, paliperidone er\n\n**SMILES:** CC1=C(CCN2CCC(CC2)C2=NOC3=C2C=CC(F)=C3)C(=O)N2CCCC(O)C2=N1, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CC1=C(CCN2CCC(CC2)C2=NOC3=C2C=CC(F)=C3)C(=O)N2CCCC(O)C2=N1, CC1=C(CCN2CCC(CC2)C2=NOC3=C2C=CC(F)=C3)C(=O)N2CCCC(O)C2=N1\n\n**CT Criteria:** Inclusion Criteria:\n - Must meet the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) criteria for schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90) for 1 year (the diagnosis will be established using the K-SADS-PL, including all supplements)\n - Must not be a danger to themselves or others, and must have family support available to be maintained as an outpatient\n - Should have had at least 1 adequate treatment with an antipsychotic before participation in this study\n - Must have a PANSS score between 60 and 120, inclusive, at screening and baseline\n - Weight >=29 kg\n Exclusion Criteria:\n - Meet the DSM-IV criteria at screening for dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, or primary substance induced psychotic disorder. Other comorbid disorders e.g., attention-deficit hyperactivity disorder (ADHD) are allowed as long as the diagnosis of schizophrenia is the primary diagnosis and the comorbid disorders in the investigators judgment do not require medication\n - Mild, moderate, or severe mental retardation (i.e., documented intelligence quotient IQ <70) established by previous IQ testing or history\n - Women who are pregnant (as confirmed by urine pregnancy test performed at screening or baseline), planning to become pregnant or are nursing\n - Have a known or suspected history of seizure disorder, or neuroleptic malignant syndrome, encephalopathic syndrome, tardive dyskinesia, or insulin dependent diabetes mellitus\n - Presence of any significant or unstable cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00090129 | [
{
"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\n**Diseases:** arthritis, psoriatic\n\n**ICD Codes:** \"L40.52\"\n\n**Drugs:** onercept, placebo\n\n**SMILES:** CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\n**CT Criteria:** Inclusion Criteria:\n - Written informed consent, given prior to any study-related procedure not part of the subjects normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his or her future medical care\n - At least 18 years of age\n - Female subjects must be neither pregnant nor breast-feeding, and must lack childbearing potential, as defined by either:\n - Being post-menopausal (that is at least 12 months passed last menses) or surgically sterile, or\n - Using an effective form of contraception (that is, condoms, oral contraceptives or intrauterine device) (Confirmation that the subject is not pregnant must be established by a negative urinary human chorionic gonadotrophin test within 7 days before Study Day 1. A pregnancy test is not required if the subject is post-menopausal or surgically sterile)\n - An out-patient status at the time of enrollment\n - Plaque psoriasis for at least 12 months\n - Plaque psoriasis covering at least 10 percent of total body surface area and a PASI score of 12.0 or more\n - Candidate for phototherapy or systemic therapy\n - Static Physicians Global Assessment (sPGA) of 3 or more\n Exclusion Criteria:\n - Use of more than one Non-steroidal anti-inflammatory drug (NSAID) to treat psoriatic arthritis or having a change in chronic NSAID regimen during the 28 days before Study Day 1 to treat psoriatic arthritis\n - Previous systemic treatment with biologics, including interferon, and/or cytokines/anti cytokines (for example, anti- tumor necrosis factor-alpha, anti-cluster of differentiation CD4, interleukin IL-10, IL-1ra, anti-CD11a, etc.) within 3 months before Study Day 1\n - Participation in any other investigational study or experimental therapeutic procedure considered to interfere with the study within 3 months before Study Day 1\n - Treatment with any systemic corticosteroids or intra-articular corticosteroid injection during the 28 days before Study Day 1\n - Experimental or off-label treatments for psoriasis and/or psoriatic arthritis such as azathioprine, hydroxyurea / hydroxycarbamide, mycophenolate, chlorambucil, leflunomide or cyclophosphamide within 1 year prior to Study Day 1\n - Treatment with cyclosporin, methotrexate, oral retinoids (that is, acitretin), or fumaric acid esters within 28 days (3 months for acitretin) before Study Day 1\n - Treatment with any topical therapies, such as Vitamin D derivatives, corticosteroids, tars and tar oils, dithranol for chronic or short contact therapy, salicylic acid and topical retinoids, within 14 days before Study Day 1\n - Phototherapy within 28 days before Study Day 1\n - Use of tanning booths within 14 days before Study Day 1\n - Abnormal liver function, defined by a total bilirubin greater than or equal to 1.2 times the upper limit of normal values, (except in the case of Gilberts syndrome), or aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase levels greater than or equal to 2.5 times the upper limit of normal values\n - Inadequate bone marrow reserve, defined as:\n - Leukocytes less than or equal to 3.5 * 10^9 per liter (/L), or\n - Thrombocytes less than or equal to 100 * 10^9 /L, or\n - Hemoglobin less than or equal to 5 millimole per liter (mmol/L) (8.9 gram per deciliter).\n - Abnormal renal function, defined by serum creatinine greater than 150 micromole per liter.\n - Sero-positivity for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV)\n - Planned major surgery within the treatment period of the study.\n - History of cancer in the preceding 5 years (except adequately treated basal cell carcinoma of the skin or squamous cell carcinoma in situ of the skin). Any history of hematopoietic cancer\n - History of active tuberculosis, current active tuberculosis or candidacy for prophylactic therapy for tuberculosis\n - Active severe infection (or non-severe infection at the discretion of the Investigator).\n - History of any opportunistic infection (for example, viral, fungal, protozoal, or bacterial) in the 6 months preceding Study Day 1 related to any clinical condition of immunodeficiency\n - Clinically significant and serious abnormalities on electrocardiography or chest X-ray, (at the discretion of the Investigator)\n - Other serious concomitant disorders incompatible with the study. In particular, subjects with congestive heart failure, prior or current history of blood dyscrasia or central nervous system demyelinating disorders should not be included in the study\n - History of or current drug (including narcotics) abuse, or current active problems with alcohol abuse\n - Requirement for immunization, allergy desensitization or vaccination during the entire study period (it is recommended that these procedures be scheduled at least 14 days prior to Study Day 1 or greater than 3 months after the last injection of study drug), with the exception of killed influenza vaccines which are allowed at any time during the study\n - Guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis.\n - Evidence of skin conditions other than psoriasis (for example, eczema) that would interfere with psoriasis disease assessments\n - Clinically significant psoriasis flares during screening or at the time of enrollment necessitating immediate relief (at the Investigators discretion)\n - Live or killed virus or bacteria vaccines (within 14 days before Study Day 1) with the exception of killed influenza vaccines which are allowed both prior to Study Day 1 and at any time during the study\n - Bedridden status\n - Previous use of onercept \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT01323634 | [
{
"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\n**Diseases:** pulmonary disease, chronic obstructive\n\n**ICD Codes:** \"J44.9, J44.1, J44.0\"\n\n**Drugs:** fluticasone furoate 100mcg / gw642444 (vilanterol) 25mcg, fluticasone propionate 250mcg/ salmeterol 50mcg\n\n**SMILES:** OCC1=C(O)C=CC(=C1)C@@H(O)CNCCCCCCOCCOCC1=C(Cl)C=CC=C1Cl, HC@@12CC@@H(C)C@(OC(=O)CC)(C(=O)SCF)C@@1(C)CC@H(O)C@@1(F)C@@2(H)CC@H(F)C2=CC(=O)C=CC@12C\n\n**CT Criteria:** Inclusion Criteria:\n - Signed and dated written informed consent\n - Male or females ≥ 40 years of age\n - Established clinical history of COPD by ATS/ERS definition\n - Females are eligible to enter and participate if of non-childbearing potential, or if of child bearing potential, has a negative serum pregnancy test at screening, and agrees to one of the acceptable contraceptive methods listed in protocol, used consistently and correctly\n - Former or current smoker > 10 pack years\n - Post-albuterol spirometry criteria: FEV1/FVC ratio ≤ 0.70 and FEV1 ≤ 70% of predicted normal (NHANES III)\n Exclusion Criteria:\n - Current diagnosis of asthma\n - Subjects with other respiratory disorders including active tuberculosis, α1-antitrypsin deficiency, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases\n - Lung volume reduction surgery within previous 12 months\n - Clinically significant abnormalities not due to COPD by chest x-ray\n - Hospitalized for poorly controlled COPD within 12 weeks of Screening\n - Poorly controlled COPD 6 weeks prior to Screening, defined as acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician\n - Lower respiratory infection requiring antibiotics 6 weeks prior to Screening\n - Uncontrolled or clinically significant (in opinion of PI) cardiovascular, hypertension, neurological, psychiatric, renal, hepatic, immunological, endocrine, peptic ulcer disease, or hematological abnormalities\n - Carcinoma not in complete remission for at least 5 years\n - Subjects with history of hypersensitivity to study medications (e.g., beta-agonists, corticosteroid) or components of inhalation powder (e.g., lactose, magnesium stearate)\n - Subjects with history of severe milk protein allergy that, in opinion of study physician, contraindicates subjects participation\n - Known/suspected history of alcohol or drug abuse in the last 2 years\n - Women who are pregnant or lactating or plan to become pregnant\n - Subjects medically unable to withhold albuterol and/or ipratropium 4 hours prior to spirometry testing at each study visit\n - Use of certain medications such as bronchodilators and corticosteroids for the protocol-specific times prior to Visit 1 (the Investigator will discuss the specific medications)\n - Long Term Oxygen Therapy (LTOT) or nocturnal oxygen therapy >12 hours a day\n - Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening or during the study\n - Non-compliance or inability to comply with study procedures or scheduled visits\n - Affiliation with investigator site \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00033735 | [
{
"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\n**Diseases:** pancreatic cancer\n\n**ICD Codes:** \"C25.3\"\n\n**Drugs:** fluorouracil, irofulven\n\n**SMILES:** HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1, CC1=C(CO)C2=C(C)C3(CC3)C@@(C)(O)C(=O)C2=C1\n\n**CT Criteria:** DISEASE CHARACTERISTICS: Histologically or cytologically confirmed ductal carcinoma of the exocrine pancreas Locally advanced or metastatic Failed 1, but no more than 1, prior gemcitabine-containing chemotherapy regimen (either as a single agent or in combination with another agent) (See criteria for prior radiation using gemcitabine or fluorouracil at diminished doses in Prior/Concurrent Therapy section) No neuroendocrine or islet cell tumors or lymphoma of the pancreas\n PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Absolute neutrophil count at least 1,500/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL AST or ALT no greater than 5.0 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5.0 times ULN Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No clinically significant active heart disease Other: Fertile patients must use effective contraception No history of retinopathy or macular degeneration No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No other significant medical and/or psychiatric condition that would preclude study\n PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy No concurrent biologic therapy Chemotherapy: See Disease Characteristics At least 21 days since prior chemotherapy and recovered No prior systemic treatment with fluorouracil, fluorouracil-uracil, raltitrexed, or capecitabine in combination with gemcitabine Prior fluorouracil or gemcitabine allowed as radiosensitizing agents when given 2 weeks before, during, or 2 weeks after radiotherapy No prior cumulative mitomycin dose greater than 25 mg/m2 Endocrine therapy: Not specified Radiotherapy: At least 21 days since prior radiotherapy and recovered Surgery: No prior surgery No concurrent surgery Other: At least 21 days since prior participation in other investigational study \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00629278 | [
{
"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\n**Diseases:** breast cancer\n\n**ICD Codes:** \"C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60\"\n\n**Drugs:** aromatase inhibition therapy, cyclophosphamide, docetaxel, doxorubicin hydrochloride, epirubicin hydrochloride, fluorouracil, paclitaxel, releasing hormone agonist therapy, tamoxifen citrate\n\n**SMILES:** ClCCN(CCCl)P1(=O)NCCCO1, HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1, 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, 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, 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, COC1=CC(NCC2=C(C)C3=C(C=C2)N=C(N)N=C3N)=CC(OC)=C1OC\n\n**CT Criteria:** DISEASE CHARACTERISTICS:\n - Diagnosis of infiltrating primary breast cancer\n - Stage I-IIIA disease\n - Resected tumor with free margins (i.e., no neoplastic cells on the resected margin)\n - Must have node-negative sentinel node or complete axillary clearance\n - Axillary clearance required for micrometastasis (between 0.2 and 2 mm) in the sentinel node but not for isolated tumor cells\n - Treatment is scheduled to begin within 10 weeks from the date of surgery\n - Date of the last surgery will be taken into account for patients undergoing re-excision of positive margins or axillary lymph node dissection after positive sentinel node biopsy\n - Node positivity or node negativity AND ≥ 1 of the following:\n - T > 2 cm\n - Grade 3\n - Presence of lymphovascular invasion\n - Ki 67 > 20%\n - Age 35 years\n - Hormone receptor negativity (<10%)\n - HER2-positive tumor (3+ by IHC or FISH+ according to the American Society of Clinical Oncology guidelines i.e., > 2.2; in case of polysomy, with ≥ 6 gene copies)\n - Estrogen receptor-positive and/or progesterone receptor-positive disease\n PATIENT CHARACTERISTICS:\n - Female\n - Pre- or postmenopausal status\n - Postmenopausal status defined by ≥ 1 of the following:\n - At least 60 years of age\n - Less than 60 years of age and amenorrheic for ≥ 12 months prior to day 1\n - Less than 60 years of age and amenorrheic for < 12 months prior to day 1 with luteinizing hormone and follicle-stimulating hormone values within postmenopausal range OR without a uterus\n - Prior bilateral oophorectomy\n - Prior radiation castration with amenorrhea for ≥ 6 months\n - ECOG performance status 0-1\n - Suitable for adjuvant chemotherapy\n - WBC > 3,000/mcL\n - ANC > 1,500/mcL\n - Platelet count >100,000/mcL\n - Total bilirubin normal\n - AST and ALT 2.5 times upper limit of normal\n - Creatinine normal\n - Cardiac ejection fraction normal as measured by ECHO or MUGA scan\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective contraception during and for ≥ 3 months after completion of study therapy\n - No contraindication to anthracycline, cyclophosphamide, fluorouracil, paclitaxel, or trastuzumab (Herceptin®) treatment\n - No uncontrolled intercurrent illness including, but not limited to, the following:\n - Ongoing or active infection\n - Symptomatic congestive heart failure\n - Unstable angina pectoris\n - Cardiac arrhythmia\n - Psychiatric illness/social situations that would limit compliance with study requirements\n PRIOR CONCURRENT THERAPY:\n - See Disease Characteristics\n - See Patient Characteristics\n - No prior chemotherapy, endocrine therapy, or radiotherapy\n - No other concurrent investigational agents \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00363142 | [
{
"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\n**Diseases:** hiv infection, infection, human immunodeficiency virus\n\n**ICD Codes:** \"Z21\", \"Z21\"\n\n**Drugs:** half-boosted fosamprenavir, full boosted fosamprenavir\n\n**SMILES:** CC(C)CN(CC@@H(OP(O)(O)=O)C@H(CC1=CC=CC=C1)NC(=O)OC@H1CCOC1)S(=O)(=O)C1=CC=C(N)C=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\n\n**CT Criteria:** Inclusion criteria:\n - Subjects with HIV-1 infection.\n - Are willing and able to understand and provide written consent prior to participation in this study.\n Exclusion criteria:\n - Are pregnant or breastfeeding.\n - Have an active AIDS condition, pancreatitis, poor kidney function, or clinically relevant hepatitis.\n - Have certain medical conditions that may make participation unsafe.\n - Take medication that may interact with the study medication.\n - Have a history of allergy to any of the study drugs or any excipients therein.\n - Other inclusion/exclusion criteria to be evaluated by the physician. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01305408 | [
{
"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\n**Diseases:** depression\n\n**ICD Codes:** \"F32.A, F53.0, P91.4, Z13.31, Z13.32\"\n\n**Drugs:** armodafinil, placebo\n\n**SMILES:** NC(=O)CS(=O)C(C1=CC=CC=C1)C1=CC=CC=C1, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\n**CT Criteria:** Inclusion Criteria:\n - The patient has a diagnosis of bipolar I disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria and is currently experiencing a major depressive episode.\n - Documentation that the patient has had at least 1 previous manic or mixed episode.\n - The patient has had no more than 6 mood episodes in the last year.\n - The patients current major depressive episode must have started no less than 2 weeks and no more than 12 months prior to the screening visit. The current depressive episode must have begun after the patients current mood stabilizer regime began.\n - The patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met:\n 1. The mood stabilizer(s) must have been taken a minimum 4 weeks before the onset of the major depressive episode and still be taken at the time of the screening visit at dose or blood level considered appropriate for maintenance therapy by the patients physician.\n 2. The patient must continue to take the same mood stabilizer(s) during the screening period; no mood stabilizer may be added during the screening period.\n 3. The mood stabilizer(s) must be taken for a minimum of at least 8 weeks prior to the baseline visit.\n 4. The dosage of the mood stabilizer(s) must be stable for a minimum of 4 weeks prior to the baseline visit.\n 5. The mood stabilizer(s) must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long-acting injection formulation.\n 6. The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine.\n Exclusion Criteria:\n - The patient has any Axis I disorder apart from bipolar I disorder that was the primary focus of treatment within 6 months of the screening visit or during the screening period.\n - The patient has psychotic symptoms or has had psychosis within 4 weeks of the screening visit or during the screening period.\n - The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.\n - The patient has a history of an eating disorder or obsessive compulsive disorder (OCD) within 6 months of the screening visit or during the screening period. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00244621 | [
{
"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\n**Diseases:** hypertension\n\n**ICD Codes:** \"I15.0, I97.3, K76.6, P29.2, G93.2, H40.053, I10\"\n\n**Drugs:** candesartan cilexetil (atacand), candesartan cilexetil (atacand), candesartan cilexetil (atacand)\n\n**SMILES:** CCOC1=NC2=C(N1CC1=CC=C(C=C1)C1=CC=CC=C1C1=NN=NN1)C(=CC=C2)C(=O)OC(C)OC(=O)OC1CCCCC1, CCOC1=NC2=C(N1CC1=CC=C(C=C1)C1=CC=CC=C1C1=NN=NN1)C(=CC=C2)C(=O)OC(C)OC(=O)OC1CCCCC1, CCOC1=NC2=C(N1CC1=CC=C(C=C1)C1=CC=CC=C1C1=NN=NN1)C(=CC=C2)C(=O)OC(C)OC(=O)OC1CCCCC1\n\n**CT Criteria:** Inclusion Criteria:\n - Signed informed consent by a parent or a legal guardian.\n - Weight > 10 kg and < 40 kg.\n - SiSBP and/or SiDBP > 95th percentile and < 20 mm Hg (systolic) and/or 10 mm Hg (diastolic) above the 95th percentile at screening and at randomization based on height-adjusted charts for age and gender.\n Exclusion Criteria:\n - Any situation, clinical condition or laboratory abnormality that, in the opinion of the investigator or sponsor, may interfere with the subjects participation in the study or would pose a significant risk to the subject or interfere with the assessment of safety and efficacy endpoints.\n - Weight < 10 kg and > 40 kg.\n - Less than 80% compliance with study medication during single-blind placebo screening as assessed by residual medication volume.\n - Hypertension secondary to pheochromocytoma, hyperthyroidism, or Cushings Syndrome.\n - Uncorrected coarctation of the aorta, bilateral renal artery renal artery stenosis in a single kidney.\n - Estimated glomerular filtration rate (GFR) < 50 mL/min/1.73m 2 based on the Schwartz Formula (Schwartz et al, 1987).\n - Renal transplant < 6 months prior to study entry. Subjects who have received a renal transplant > 6 months prior to study entry may participate in the study if: 1) renal function is stable, 2) estimated GFR >50 mL/min/1.73m 2, 3) stable doses of immunosuppressive medications are anticipated throughout the 4-week, double-blind period of the study, 4) no episodes of acute allograft rejection have occurred within 30 days of study entry, and 5) the renal allograft has no documented renal artery stenosis.\n Nephrotic syndrome not in remission.\n - Unstable insulin dependent diabetes mellitus.\n - Known bleeding, coagulation, or platelet disorder that could interfere with blood sampling.\n - Clinically significant valvular heart disease.\n - Clinical diagnosis of heart failure.\n - Clinically significant arrhythmia (eg, any arrhythmia requiring medical therapy or that causes symptoms).\n - Second or third degree AV block.\n - Impaired liver function defined as either acute liver disease or chronic liver disease with persistent liver enzyme values greater than 1½ times the upper limit of the reference range for aspartate aminotransferase (AST) or alanine aminotransferase (ALT).\n - Known hypersensitivity to ARBs.\n - Currently receiving an angiotensin receptor blocker or an angiotensin converting enzyme inhibitor that in the investigators judgment cannot safely be withdrawn during the study.\n - Subjects receiving an angiotensin receptor blocker or an angiotensin converting enzyme inhibitor may be eligible if they undergo withdrawal of the antihypertensive medication over a 2-week washout period and subsequently meet BP inclusion/exclusion criteria.\n - Subjects currently receiving other classes of antihypertensive medications (eg, diuretics, calcium channel blockers or beta-blockers) and whose BP values meet inclusion/exclusion criteria may participate in the study while continuing their current antihypertensive medication regimen. Up to 2 concomitant antihypertensive medications are permitted. Doses and dose regimens of concomitant antihypertensive medications must remain unchanged during the 4-week double-blind period of the study.\n - Currently using, or used within 14 days prior to receiving double-blind medication, any concomitant medications which in the opinion of the investigator could negatively affect the subject.\n - Unable or unwilling to comply with the study requirements including blood sampling and swallowing study drug suspension. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01033825 | [
{
"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\n**Diseases:** perennial allergic rhinitis\n\n**ICD Codes:** \"D69.0, L50.0, B44.81, J30.89, J30.9, L20.84, H10.45\"\n\n**Drugs:** ciclesonide hfa nasal aerosol 320 mcg, ciclesonide hfa nasal aerosol 160 mcg, hfa nasal aerosol placebo, ciclesonide aqueous nasal spray 200 mcg, aq nasal spray placebo, placebo plus dexamethasone hfa, placebo aq plus dexamethasone 6 mg\n\n**SMILES:** HC@@12CC@@3(H)C@4(H)CCC5=CC(=O)C=CC@5(C)C@@4(H)C@@H(O)CC@3(C)C@@1(OC@@H(O2)C1CCCCC1)C(=O)COC(=O)C(C)C, HC@@12CC@@3(H)C@4(H)CCC5=CC(=O)C=CC@5(C)C@@4(H)C@@H(O)CC@3(C)C@@1(OC@@H(O2)C1CCCCC1)C(=O)COC(=O)C(C)C, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, HC@@12CC@@3(H)C@4(H)CCC5=CC(=O)C=CC@5(C)C@@4(H)C@@H(O)CC@3(C)C@@1(OC@@H(O2)C1CCCCC1)C(=O)COC(=O)C(C)C, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, HC@@12CC@@H(C)C@(O)(C(=O)CO)C@@1(C)CC@H(O)C@@1(F)C@@2(H)CCC2=CC(=O)C=CC@12C, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\n**CT Criteria:** Inclusion Criteria:\n - Give written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.\n - Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on screening physical examination, medical history, and clinical laboratory values (Hematology, Chemistries and Urinalysis).\n - If any of the screening Hematology, Chemistries, or Urinalysis are not within the clinical laboratorys reference range, then the subject can be included only if the Investigator judges the deviations to be not clinically significant.\n - A history of PAR to a relevant perennial allergen (house dust mites, cockroach, molds, animal dander) for a minimum of two years immediately preceding the study Screening visit. The PAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and require treatment throughout the entire study period.\n - A demonstrated sensitivity to at least one allergen known to induce PAR (house dust mite, animal dander, cockroach, and molds) based on a documented result with a standard skin-prick test either within 90 days prior to screening or performed at the Screening visit. A positive test is defined as a wheal diameter at least 3 mm larger than the negative control wheal for the skin prick test. The subjects positive allergen test must be consistent with the medical history of PAR and must be present in the subjects environment throughout the study.\n - Subject, if female, must have a negative serum pregnancy test at screening. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control.\n 1. An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation.\n 2. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.\n 3. Abstinence.\n Exclusion Criteria:\n - Female subject who is pregnant or lactating.\n - History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations; recent nasal biopsy; nasal trauma; or nasal ulcers or perforations. Surgery and atrophic rhinitis or rhinitis medicamentosa are not permitted within the last 120 days prior to the Screening visit.\n - Subject is, in the investigators judgement, having a seasonal exacerbation at the time of screening.\n - Participation in any investigational drug trial within the 30 days preceding the Screening visit or planned participation in another investigational drug trial at any time during this trial.\n - A known hypersensitivity to any corticosteroid or any of the excipients in the formulation of ciclesonide.\n - History of a respiratory infection or disorder including, but not limited to bronchitis, pneumonia, influenza, severe acute respiratory syndrome (SARS) within the 14 days preceding the Screening visit.\n - History of alcohol or drug abuse within 2 years preceding the Screening visit.\n - History of a positive test for HIV, hepatitis B or hepatitis C.\n - Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta agonists and any controller drugs (eg, theophylline, leukotriene antagonists, etc.); intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists is acceptable. Use of short acting beta-agonists for exercise-induced bronchospasm will be allowed.\n - Expected use of any disallowed concomitant medications during the treatment period.\n - Initiation of immunotherapy during the study period or dose escalation during the study period. However, initiation of immunotherapy 90 days or more prior to the Screening Visit and use of a stable (maintenance) dose (30 days or more) may be considered for inclusion.\n - Previous randomization in an intranasal ciclesonide HFA nasal aerosol study.\n - Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit.\n - Initiation of pimecrolimus cream 1% or greater or tacrolimus ointment 0.03% or greater during the study period or planned dose escalation during the study period. However, initiation of these creams/ointments 30 days or more prior to screening and use of a stable (maintenance) dose during the study period may be considered for inclusion.\n - Study participation by clinical investigator site employees and/or their immediate relatives who reside in the same household.\n - Study participation by more than one subject from the same household.\n - Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the subjects ability to participate in the clinical trial: impaired hepatic function including alcohol related liver disease or cirrhosis; history of ocular disturbances, eg, glaucoma or posterior subcapsular cataracts; any systemic infection hematological, hepatic, renal, endocrine (except for controlled diabetes mellitus or postmenopausal symptoms or hypothyroidism; gastrointestinal disease; malignancy (excluding basal cell carcinoma); current neuropsychological condition with or without drug therapy\n - Any condition that, in the judgment of the investigator, would preclude the subject from completing the protocol with capture of the assessments as written. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT01736514 | [
{
"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\n**Diseases:** gout\n\n**ICD Codes:** \"M10.9, M10.08, M10.00, M10.011, M10.012, M10.019, M10.021\"\n\n**Drugs:** febuxostat, allopurinol\n\n**SMILES:** CC(C)COC1=C(C=C(C=C1)C1=NC(C)=C(S1)C(O)=O)C#N, O=C1N=CN=C2NNC=C12\n\n**CT Criteria:** Inclusion Criteria:\n - Subjects will also have a history or presence of gout as defined by the American College of Rheumatology (ACR) criteria\n - Subject has serum urate level >= 8.0 mg/dL at the screening Visit\n Exclusion Criteria:\n - Female subject who is breast-feeding or pregnant\n - Subject has a history of xanthinuria\n - Subject who is intolerant of allopurinol, ie hypersensitivity, Steven-Johnson syndrome/topic epidermal necrolysis\n - Subject who takes allopurinol > 300 mg/day and with serum urate level > 8mg/dL\n - Subject who is HLA B*5801 positive\n - Subject who is receiving thiazide diuretic therapy\n - Subject who has secondary hyperuricemia\n - Subject who requires concurrent therapy with any systemic or topical medications, prescribed or non-prescribed, containing aspirin or other salicylates (low doses of aspirin will be allowed(ie. =< 325mg/day)\n - Subject who requires therapy with prednisone > 10 mg/ day during the study\n - Subject who has active liver disease or hepatic dysfunction, defined as both ALT and AST > 1.5 times the upper limit of normal\n - Subject who has serum creatinine >= 1.5mg/dL\n - Subject who has any another significant medical condition as defined by the investigator that would interfere with the treatment, safety or compliance with the protocol (eg. A clinically significant ECG result)\n - Subject who has a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the study, or has taken any systemic cancer chemotherapy within 5 years prior to the study\n - Subject who has previously participated in a clinical study in which febuxostat was administered\n - Subject who has participated in another investigational trial within the 30 days prior to the study \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00309244 | [
{
"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\n**Diseases:** diabetes type 2\n\n**ICD Codes:** \"E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44\"\n\n**Drugs:** technosphere® insulin inhalation powder, 70% insulin aspart protamine suspension and 30% insulin aspart injection (rdna origin)\n\n**SMILES:** Na+.Na+.O-P(O-)(F)=O, Na+.Na+.O-P(O-)(F)=O\n\n**CT Criteria:** Inclusion Criteria:\n - Men or women ≥ 18 and ≤ 80 years old\n - Clinical diagnosis of type 2 diabetes mellitus\n - HbA1c > 7.0% and ≤ 11.0%\n - BMI ≤ 40 kg/m2\n - Negative smoking status and urine cotinine test\n - Written informed consent\n - Receiving sc insulin 2-3 times daily administered as any of the following 3 regimens: self-mix regimen, pre-mix regimen, or long-acting analogue and regular or rapid-acting insulin analogue not to exceed 3 daily injections. Subjects may also have received oral antidiabetic agents including metformin or thiazolidinediones.\n - No dose adjustments for insulin and oral antidiabetic agents within the preceding 6 weeks.\n - FEV1 ≥ 70% of NHANES III predicted; TLC) ≥ 80% of predicted (Intermountain Thoracic Society); DLCO uncorrected ≥ 70% of predicted\n Exclusion Criteria:\n - Total daily dose of insulin ≥1.4 IU/kg body weight\n - Treatment with any sulfonylureas and/or meglitinides and/or alpha-glucosidase inhibitors within the preceding 8 weeks\n - Treatment with pramlintide acetate (Symlin®), and/or any incretins (e.g., exenatide Byetta®) within the preceding 8 weeks\n - Unstable diabetes mellitus control, defined as 2 or more episodes of severe hypoglycemia (requiring third party intervention) and/or any hospitalization or emergency room visit due to poor diabetic control or hyperglycemia requiring hospitalization within the preceding 6 months\n - Exposure to an inhaled insulin at any time, treatment with an investigational drug within the preceding 3 months, and/or current participation in another clinical trial\n - Allergy to insulin or to any drugs to be used as part of the clinical trial, or history of hypersensitivity to the investigational drug or to drugs of similar chemical structures\n - History of active viral and/or cirrhotic hepatic disease and/or abnormal liver enzymes as evidenced by serum aspartate aminotransferase (AST)and/or alanine aminotransferase (ALT) ≥ 3 x Upper Limit of Normal (ULN)(Includes active hepatitis A, positive hepatitis B and/or hepatitis C serology)\n - Serum creatinine > 1.8 mg/dL in women and > 2.0 mg/dL in men History of chronic obstructive pulmonary disease (COPD), asthma (any history of bronchospasm or asthma after the age of 14), and/or any other clinically important pulmonary disease confirmed by documented history, pulmonary function testing, or radiologic findings\n - Congestive heart disease graded as class III or class IV according to New York Heart Association criteria and subjects currently being treated pharmacologically for ventricular dysrhythmias using amiodarone\n - History of myocardial infarction, cardiac surgery, coronary angioplasty, and/or stroke within the preceding 3 months\n - Symptomatic coronary artery disease, including crescendo angina, unstable angina, and/or unstable or symptomatic cardiac arrhythmias\n - Poorly controlled arterial hypertension despite pharmacologic treatment, defined as systolic blood pressure (BP) > 180 mm Hg and/or diastolic BP > 110 mm Hg at screening\n - History of malignancy within the preceding 5 years (other than excised basal cell carcinoma of the skin), any history of lung neoplasm, and/or subjects with current or previous chemotherapy or radiation therapy that may result in pulmonary toxicity\n - History of acquired immunodeficiency syndrome (AIDS), AIDS-related complex (ARC), or positive human immunodeficiency virus (HIV) serology\n - Prior diagnosis of systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine\n - Visit 1/Screening (Week -3), but prior to Visit 1 PFTs and before Visit 3/Baseline (Week 0), subject will be scheduled for PFTs after 30 days from resolution of respiratory infection. An additional hemoglobin and urine β-HCG (for women of childbearing potential age only) will be required\n - Women who are pregnant, lactating or planning to become pregnant\n - Women of childbearing potential (defined as pre-menopausal and not surgically sterilized or postmenopausal for less than 2 years) not practicing adequate birth control. Adequate birth control is defined as using oral, percutaneous and/or transdermal contraceptives; condoms and diaphragms with a spermicide, or intrauterine devices\n - Current drug and/or alcohol abuse\n - Subjects who in the opinion of the Investigator will be unable to comply with the requirements of the protocol\n - Severe complications of diabetes mellitus, in the opinion of the Investigator, including: symptomatic autonomic neuropathy, disabling peripheral neuropathy, active proliferative retinopathy; nephropathy with renal failure, renal transplant and/or dialysis; history of foot ulcers; nontraumatic amputations due to gangrene;and/or vascular claudication\n - Any other concurrent medical or major psychiatric condition which, in the opinion of the Investigator, makes the subject unsuitable for the clinical trial, or could limit the validity of the ICF and/or impair the subjects ability to participate in the trial\n - Inability to perform PFT maneuvers meeting recommended American Thoracic Society (ATS) acceptability and repeatability criteria. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00713830 | [
{
"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\n**Diseases:** diabetes mellitus, type 2\n\n**ICD Codes:** \"E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44\"\n\n**Drugs:** lixisenatide (ave0010), placebo, sulfonylurea, metformin\n\n**SMILES:** V.HC@(C)(O)C@(H)(N=C(O)CN=C(O)C@(H)(CCC(O)=O)N=C(O)CN=C(O)C@@(H)(N)CC1=CN=CN1)C(O)=NC@@(H)(CC1=CC=CC=C1)C(O)=NC@(H)(C(O)=NC@@(H)(CO)C(O)=NC@@(H)(CC(O)=O)C(O)=NC@@(H)(CC(C)C)C(O)=NC@@(H)(CO)C(O)=NC@@(H)(CCCCN)C(O)=NC@@(H)(CCC(O)=N)C(O)=NC@@(H)(CCSC)C(O)=NC@@(H)(CCC(O)=O)C(O)=NC@@(H)(CCC(O)=O)C(O)=NC@@(H)(CCC(O)=O)C(O)=NC@@(H)(C)C(O)=NC@@(H)(C(C)C)C(O)=NC@@(H)(CCCNC(N)=N)C(O)=NC@@(H)(CC(C)C)C(O)=NC@@(H)(CC1=CC=CC=C1)C(O)=NC@(H)(C(O)=NC@@(H)(CCC(O)=O)C(O)=NC@@(H)(CC1=CNC2=CC=CC=C12)C(O)=NC@@(H)(CC(C)C)C(O)=NC@@(H)(CCCCN)C(O)=NC@@(H)(CC(O)=N)C(O)=NCC(O)=NCC(=O)N1CCCC@@1(H)C(O)=NC@@(H)(CO)C(O)=NC@@(H)(CO)C(O)=NCC(O)=NC@@(H)(C)C(=O)N1CCCC@@1(H)C(=O)N1CCCC@@1(H)C(O)=NC@@(H)(CO)C(O)=NC@@(H)(CCCCN)C(O)=NC@@(H)(CCCCN)C(O)=NC@@(H)(CCCCN)C(O)=NC@@(H)(CCCCN)C(O)=NC@@(H)(CCCCN)C(O)=NC@@(H)(CCCCN)C(O)=N)C@@(H)(C)CC)C@@(H)(C)O, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, HC@1(C)CCC@@(H)(CC1)N=C(O)NS(=O)(=O)C1=CC=C(CCN=C(O)N2CC(C)=C(CC)C2=O)C=C1, CSCCC@H(N)C(O)=O\n\n**CT Criteria:** Inclusion Criteria:\n - Type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit, insufficiently controlled with a sulfonylurea alone or a sulfonylurea in association with metformin\n Exclusion Criteria:\n - HbA1c less than (<) 7% or greater than (>) 10% at screening\n - At the time of screening age less than legal age of majority\n - Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method\n - Type 1 diabetes mellitus\n - Sulfonylurea less than the maximum effective dose according to local labeling\n - Sulfonylurea not at a stable (unchanged) dose for at least 3 months prior to screening\n - In case of treatment with metformin in association with sulfonylurea, no stable (unchanged) treatment with metformin of at least 1.5 gram per day (except at least 0.75 gram per day in Japan and at least 1.0 gram per day in South Korea), for at least 3 months prior to screening visit\n - FPG at screening >250 milligram per deciliter (mg/dL) (>13.9 millimole per liter mmol/L)\n - History of hypoglycemia unawareness\n - Body mass index less than or equal to (<=) 20 kilogram per square meter (kg/m^2)\n - Weight change of >5 kg during the 3 months preceding the screening visit\n - History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease\n - History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening\n - Hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to the time of screening\n - Within the last 6 months prior to screening, history of myocardial infarction, stroke, or heart failure requiring hospitalization\n - Known history of drug or alcohol abuse within 6 months prior to the time of screening\n - Cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period\n - Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic blood pressure (SBP) or diastolic blood pressure (DBP) >180 millimeter of mercury (mmHg) or >95 mmHg, respectively\n - Laboratory findings at the time of screening: aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase: >2 times upper limit of the normal (ULN) laboratory range; amylase and/or lipase: >3 times ULN; total bilirubin: >1.5 times ULN (except in case of Gilberts syndrome); hemoglobin <11 gram/deciliter and/or neutrophils <1500 per cubic millimeter (mm^3) and/or platelets <100 000/mm^3; positive test for Hepatitis B surface antigen and/or Hepatitis C antibody\n - Any clinically significant abnormality identified on physical examination, laboratory tests or vital signs at the time of screening that in the judgment of the Investigator or any sub investigator precludes safe completion of the study or constrains efficacy assessment\n - Patients who are considered by the Investigator or any sub investigator as inappropriate for this study for any reason (for example, impossibility to meet specific protocol requirements, such as scheduled visits, being able to do self-injections, likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol, Investigator or any sub investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol)\n - Patients with condition/concomitant diseases making them non-evaluable for the efficacy assessment\n - Use of oral or injectable antidiabetic or hypoglycemic agents other than sulfonylurea and metformin (for example, alpha glucosidase inhibitor, thiazolidinedione, rimonabant, exenatide, dipeptidyl-peptidase 4 (DPP-4) inhibitors, insulin) within 3 months prior to the time of screening\n - Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to the time of screening\n - Use of any investigational drug within 3 months prior to study\n - Any previous treatment with lixisenatide (for example, participation in a previous study with lixisenatide)\n - Renal impairment defined with serum creatinine >1.4 mg/dL in women and serum creatinine >1.5 mg/dL in men (applicable only for patients with metformin treatment)\n - End-stage renal disease as defined by a serum creatinine clearance of <15 milliliter/minute (calculated by the Cockcroft and Gault formula) and/or patients on dialysis (if no treatment with metformin)\n - Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to gastroparesis and gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening\n - Allergic reaction to any glucagon like peptide-1 (GLP-1) agonist in the past (for example, exenatide, liraglutide) or to metacresol\n - Additional exclusion criteria at the end of the run-in phase: informed consent withdrawal; lack of compliance during the single-blind placebo run-in phase (>2 injections missed); and patient with any adverse event which precludes the inclusion in the study, as assessed by the investigator \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01099722 | [
{
"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\n**Diseases:** asthma\n\n**ICD Codes:** \"J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40\"\n\n**Drugs:** flutiform, symbicort turbohaler\n\n**SMILES:** COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1\n\n**CT Criteria:** Inclusion Criteria:\n 1. Male or female subjects at least 12 years old\n 2. Female subjects less than 1 year post-menopausal must have a negative urine pregnancy test recorded at the screening visit prior to the first dose of study medication, be non-lactating, & willing to use adequate & highly effective methods of contraception throughout the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently & correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner.\n 3. Known history of moderate to severe persistent, reversible asthma for ≥ 6 months prior to the Screening Visit characterised by:\n Treatment with an inhaled corticosteroid (ICS) at a dose of 250 - 1000 µg fluticasone or equivalent OR Treatment wth ICS at a dose of 200-500 µg fluticasone or equivalent in combination with a Long Acting β2-Agonist (LABA).\n 4. Demonstrated a FEV1 of ≥ 50% to ≤ 80% for predicted normal values (Quanjer et al., 1993 (adults), & 1995 (adolescents)) during the Screening Period (Visit 1 or Visit 2) following appropriate withholding of asthma medications (if applicable).\n - No β2-agonist use on day of testing\n - No use of inhaled combination asthma therapy on day of testing.\n - Inhaled corticosteroids are allowed on day of testing.\n 5. Documented reversibility of ≥ 15% in FEV1 at visit 1 or visit 2.\n 6. Demonstrated satisfactory technique in the use of the study medications i.e. pMDI and Dry Powder Inhaler (DPI) devices.\n 7. Willing & able to enter information in the electronic diary & attend all study visits.\n 8. Willing & able to substitute study medication for their pre study prescribed asthma medication for the duration of the study.\n 9. Written informed consent obtained. Inclusion criteria required following run-in: Subject has used rescue medication for at least 3 days & had at least 1 night with sleep disturbance (i.e., sleep disturbance score of ≥ 1) during the last 7 days of the run in period,OR subject has used rescue medication for at least 3 days & had at least 3 days with asthma symptoms (i.e., a symptom score of ≥ 1) during the last 7 days of the run-in period.\n Exclusion criteria:\n 1. Near fatal or life-threatening (including intubation) asthma within the past year.\n 2. Hospitalisation or an emergency visit for asthma within the 4 weeks before the Screening Visit.\n 3. Known history of systemic (injectable or oral) corticosteroid medication use within 1 month of the Screening Visit.\n 4. Known history of omalizumab use within the past 6 months.\n 5. Current evidence or known history of any clinically significant disease or abnormality including uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia. Clinically significant is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study.\n 6. In the investigators opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the Screening Visit.\n 7. Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis).\n 8. Known Human Immunodeficiency Virus (HIV)-positive status.\n 9. Subject has a smoking history equivalent to \"10 pack years\" (i.e., at least 1 pack of 20 cigarettes/day for 10 years or 10 packs/day for 1 year, etc.).\n 10. Current smoking history within 12 months prior to the Screening Visit.\n 11. Current evidence or known history of alcohol and/or substance abuse within 12 months prior to the Screening Visit.\n 12. Subject has taken B-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, astemizole (Hismanal), quinidine type antiarrhythmics, or potent CYP 3A4 inhibitors such as ketoconazole within the past week.\n 13. Current use of medications other than those allowed in the protocol that will have an effect on bronchospasm &/or pulmonary function.\n 14. Current evidence or known history of hypersensitivity or idiosyncratic reaction to test medications or components.\n 15. Subject has received an investigational drug within 30 days of the Screening Visit (12 weeks if an oral or injectable steroid).\n 16. Subject is currently participating in a clinical study. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00415623 | [
{
"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\n**Diseases:** hypertension\n\n**ICD Codes:** \"I15.0, I97.3, K76.6, P29.2, G93.2, H40.053, I10\"\n\n**Drugs:** amlodipine, amlodipine\n\n**SMILES:** COC(=O)C1=C(C)NC(C)=C(C1C1=CC(=CC=C1)N+(O-)=O)C(=O)OC(C)(C)CN(C)CCC(C1=CC=CC=C1)C1=CC=CC=C1, COC(=O)C1=C(C)NC(C)=C(C1C1=CC(=CC=C1)N+(O-)=O)C(=O)OC(C)(C)CN(C)CCC(C1=CC=CC=C1)C1=CC=CC=C1\n\n**CT Criteria:** Inclusion Criteria:\n - Untreated Hypertensive Patients: An systolic blood pressure of >=160 mmHg or diastolic blood pressure >=100mmHg.\n - Treated Hypertensive Patients: An systolic blood pressure of >=140 mmHg or diastolic blood pressure of >= 90 mmHg.\n - Patients with insufficient response to 5 mg of amlodipine in the screening period:Two successive systolic blood pressure measurements at Visit 4 (Week -2) and Visit 5 (Week 0 = baseline) >=140 mmHg\n - Patients with a screening treatment compliance rate >= 80%\n Exclusion Criteria:\n - Subjects with secondary hypertension (renal disease, pheochromocytoma, and Cushings syndrome, etc.), severe hypertension (systolic blood pressure of 180 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher), and malignant hypertension \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00139880 | [
{
"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\n**Diseases:** \"parkinsons disease\"\n\n**ICD Codes:** \"G20\"\n\n**Drugs:** parcopa\n\n**SMILES:** CC@@(CC1=CC(O)=C(O)C=C1)(NN)C(O)=O\n\n**CT Criteria:** Inclusion Criteria:\n - Stable Parkinsons disease\n Exclusion Criteria:\n - idiopathic PD with Hoehn and Yahr state II or III \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01586364 | [
{
"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\n**Diseases:** atrophy, vaginal diseases\n\n**ICD Codes:** \"H21.29, H31.23, H47.20, H47.22, N50.0, N64.2, N90.5\"\n\n**Drugs:** ospemifene 60mg oral tablet\n\n**SMILES:** OCCOC1=CC=C(C=C1)C(=C(\\\\CCCl)C1=CC=CC=C1)\\\\C1=CC=CC=C1\n\n**CT Criteria:** Inclusion Criteria:\n - Postmenopausal women aged 40 to 80 years with a diagnosis of vulvar and vaginal atrophy (VVA) as assessed by vaginal pH, maturation index of vaginal smear, and self-reported symptoms at Baseline for Protocol 15-50310\n - Did not have a uterus\n - Met the inclusion and exclusion criteria for Protocol 15-50310\n - Had completed Protocol 15-50310 without any clinically significant abnormal findings at the end-of-study visit for Protocol 15-50310\n - Provided written informed consent to participate in the study and agreed to follow dosing instructions and complete all required study visits\n Exclusion Criteria:\n - Had clinically significant abnormal findings at the Week 12 End of Study visit for Protocol 15-50310\n - Had any physical or mental condition which, in the opinion of the investigator, may have interfered with the subjects ability to comply with the study procedures \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01353469 | [
{
"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\n**Diseases:** type 2 diabetes mellitus\n\n**ICD Codes:** \"E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44\"\n\n**Drugs:** insulin human/insuman comb 25 (hr1799), insulin human/novolin® 30r\n\n**SMILES:** Na+.Na+.O-P(O-)(F)=O, Na+.Na+.O-P(O-)(F)=O\n\n**CT Criteria:** Inclusion criteria:\n - Type 2 diabetes mellitus patients, as defined by World Health Organization (WHO), diagnosed for at least 1 year at the time of screening visit who are under premix insulin therapy, with or without oral anti-diabetic drug (OAD)\n - Signed written informed consent\n Exclusion criteria:\n - HbA1c <7% or HbA1c >10% at screening\n - No self-monitoring of blood glucose within 3 months prior to screening visit\n - Premix insulin treatment for less than 3 months. Insulins other than premix insulin treatment within 3 months prior to screening visit\n - In case of treatment with OAD, treatment with a stable OAD dose and regimen for less than 3 months prior to screening visit\n The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00423488 | [
{
"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\n**Diseases:** hypercholesterolemia, diabetes mellitus, type 2, coronary disease\n\n**ICD Codes:** \"E78.01, E78.00, Z83.42\", \"E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44\", \"I25.10, I25.110, I25.119, I25.111, I25.118\"\n\n**Drugs:** ezetimibe 10 mg, simvastatin 20 mg, ezetimibe placebo, simvastatin 20 mg, simvastatin placebo\n\n**SMILES:** OC@@H(CCC@@H1C@H(N(C1=O)C1=CC=C(F)C=C1)C1=CC=C(O)C=C1)C1=CC=C(F)C=C1, HC@12C@H(CC@@H(C)C=C1C=CC@H(C)C@@H2CCC@@H1CC@@H(O)CC(=O)O1)OC(=O)C(C)(C)CC, CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CCC@@H(O)CC@@H(O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1, HC@12C@H(CC@@H(C)C=C1C=CC@H(C)C@@H2CCC@@H1CC@@H(O)CC(=O)O1)OC(=O)C(C)(C)CC, CC1=CC(O)=CC(C)=C1Cl\n\n**CT Criteria:** Inclusion Criteria:\n - Subject must have diabetes mellitus type 2 (fasting plasma glucose >7 mmol/L 126 mg/dL) of at least 12 months duration at Visit 3 and must be adequately controlled (glycated hemoglobin HbA1c <=9.0%). Subjects must not have had a change in antidiabetic pharmacotherapy i.e. changes in dosage (with the exception of +/- 10 units of insulin) or addition of new medication or experience recent history of repeated hypoglycemia or unstable glycemic control within 3 months of Visit (Baseline Visit).\n - Subjects must have documented coronary heart disease (CHD). For the purposes of this study, CHD will include one or more of the following features: documented stable angina with evidence of ischemia on exercise testing); history of myocardial infarction; history of percutaneous transluminal coronary intervention (PCTI) with or without stent placement); symptomatic peripheral vascular disease (claudication); documented history of atherothrombotic cerebrovascular disease; and/or documented history of unstable angina or non-Q wave myocardial infarction.\n - Subjects must have a low-density lipoprotein cholesterol (LDL-C) concentration >=2.6 mmol/L (100 mg/dL) to <=4.1 mmol/L (160 mg/dL) using the Friedewald calculation available at the time of randomization Visit 3 (Baseline Visit).\n - Subjects must have triglyceride concentrations of <3.99 mmol/L (350 mg/dL) at Visit 3 (Baseline Visit).\n - Subject must be currently taking simvastatin 20 mg daily and by history has taken 80% of daily evening doses for the 6 weeks prior to Visit 3 (Baseline Visit).\n - Subject must be >=18 years and <=75 years of age.\n - Subjects must have maintained a cholesterol lowering diet and exercise program for at least 4 weeks prior to Screening (Visit 2) and be willing to continue the same diet and exercise program during the study.\n - Subjects must have liver transaminases (alanine aminotransferase ALT, aspartate aminotransferase AST) <50% above the upper limit of normal, with no active liver disease, and creatinine kinase (CK)<50% above the upper limit of normal at Visit 3 (Baseline Visit).\n - Clinical laboratory tests (complete blood count (CBC), blood chemistries, urinalysis) must be within normal limits or clinically acceptable to the investigator at Visit 3 (Baseline Visit).\n - Subjects must report a stable weight history for at least 4 weeks prior to entry into study at Visit 3 (Baseline Visit).\n - Women receiving hormonal therapy, including hormone replacement, any estrogen antagonist/agonist, or oral contraceptives, must have been maintained on a stable dose and regimen for at least 8 weeks and be willing to continue the same regimen for the duration of the study.\n - Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically-prescribed intrauterine device (IUD), condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).\n - Subjects must be free of any clinically significant diseases other than diabetes mellitus or coronary heart disease that would interfere with study evaluations.\n - Subjects must understand and be able to adhere to the dosing and visit schedules, and must agree to remain on their cholesterol-lowering diet and their exercise regimen for the duration of the study\n - Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.\n Exclusion Criteria:\n - Subjects whose body mass index (BMI = weightkg/heightm**2) is >=35 kg/m**2 at Visit 3 (Baseline Visit).\n - Subjects who consume >14 alcoholic drinks per week. (A drink is: a can of beer, glass of wine, or single measure of spirits).\n - Any condition or situation which, in the opinion of the investigator, might pose a risk to the subject or interfere with participation in the study.\n - Women who are pregnant or nursing.\n - Congestive heart failure defined by New York Heart Association (NYHA) as Class III or IV.\n - Uncontrolled cardiac arrhythmia.\n - Myocardial infarction, acute coronary insufficiency, coronary artery bypass surgery, or angioplasty within 3 months of Visit 3 (Baseline Visit).\n - Unstable or severe peripheral artery disease within 3 months of Visit 3 (Baseline Visit).\n - Newly diagnosed or currently unstable angina pectoris.\n - Uncontrolled hypertension (treated or untreated) with systolic blood pressure >160 mmHg or diastolic >100 mmHg at Visit 3 (Baseline Visit).\n - Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins, i.e., secondary causes of hyperlipidemia, such as secondary hypercholesterolemia due to hypothyroidism (thyroid stimulating hormone TSH above upper limit of normal) at Visit 3. Subjects with a history of hypothyroidism who are on a stable therapy of thyroid hormone replacement for at least 6 weeks are eligible for enrollment if TSH levels are within normal limits at Visit 3 (Baseline Visit).\n - Impaired renal function (creatinine >2.0 mg/dL) or nephrotic syndrome at Visit 3 (Baseline Visit).\n - Disorders of the hematologic, digestive, or central nervous systems including cerebrovascular disease and degenerative disease that would limit study evaluation or participation.\n - Known human immunodeficiency virus (HIV) positive.\n - Cancer within the past 5 years (except for successfully treated basal and squamous cell carcinomas).\n - History of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy.\n - Subjects who have not observed the designated wash-out period for any of the prohibited medications.\n - Subjects currently consuming large amounts of grapefruit juice (>1 liter/day).\n - Oral corticosteroids, unless used as replacement therapy for pituitary/adrenal disease and the subject is on a stable regimen for at lest 6 weeks prior to Visit 3 (Baseline Visit).\n - Subjects who are currently using cardiovascular medication (e.g., antihypertensive, antiarrhythmic) and have not been on a stable regimen for at least 6 weeks prior to Visit 3 (Baseline Visit) and it is expected to change during the study.\n - Subjects who are currently using psyllium, other fiber-based laxatives, and/or any other over-the-counter (OTC) therapy known to affect serum lipid levels (phytosterol margarine), and have not been on a stable regimen for at least 5 weeks prior to study entry Visit 3 (Baseline Visit) and who do not agree to remain on this regimen throughout the study. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00408421 | [
{
"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\n**Diseases:** osteoarthritis knee pain\n\n**ICD Codes:** \"M15.4, M15.0, M16.9, M17.9, M19.011, M19.012, M19.019\"\n\n**Drugs:** duloxetine, placebo\n\n**SMILES:** CN(C)CCCC@1(OCC2=C1C=CC(=C2)C#N)C1=CC=C(F)C=C1, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\n**CT Criteria:** Inclusion Criteria:\n - Male or female outpatients with osteoarthritis knee pain.\n Exclusion Criteria:\n - Cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.\n - Acute liver injury (such as hepatitis) or severe cirrhosis.\n - Previous exposure to duloxetine.\n - Body Mass Index (BMI) over 40.\n - Major depressive disorder.\n - Daily use of narcotics. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01015118 | [
{
"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\n**Diseases:** ovarian neoplasms, peritoneal neoplasms\n\n**ICD Codes:** \"C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2\", \"K65.1, K66.0, N99.4, N73.6, R88.0, Z49.32, Z49.02\"\n\n**Drugs:** placebo, paclitaxel, bibf 1120, carboplatin, paclitaxel, carboplatin\n\n**SMILES:** CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=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, COC(=O)C1=CC=C2C(NC(=O)\\\\C2=C(/NC2=CC=C(C=C2)N(C)C(=O)CN2CCN(C)CC2)C2=CC=CC=C2)=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, NC@@H(CCCNC(N)=N)C(O)=O\n\n**CT Criteria:** Inclusion criteria:\n - first diagnosis of histologically confirmed epithelial ovarian cancer, fallopian tube or primary peritoneal cancer\n - International Federation of Gynecology and Obstetrics (FIGO) Stages IIB - IV\n - females, age 18 years or older\n - life expectancy of at least 6 months\n - Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2\n - prior surgery, defined as either (a) debulking surgery with maximum surgical effort at cytoreduction with the goal of no residual disease or (b) biopsy or limited surgery in patients with stage IV disease for whom surgical debulking was not considered appropriate, if diagnosis is confirmed by histology and no surgery is planned prior to disease progression (including interval debulking surgery)\n - patient has given written informed consent which must be consistent with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and local legislation\n - planned application of first dose of chemotherapy after wound healing, but no later than 10 weeks after surgery\n Exclusion criteria:\n - histologic diagnosis of a benign or borderline tumour or of a malignant tumour of non-epithelial origin of the ovary, the fallopian tube or the peritoneum\n - planned surgery within 124 weeks after randomisation in this trial, including interval debulking surgery\n - clinically relevant non-healing wound, ulcer or bone fracture\n - clinical symptoms or signs of gastrointestinal obstruction that require parenteral nutrition or hydration\n - brain metastases\n - pre-existing sensory or motor neuropathy Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher, except due to trauma\n - history of major thromboembolic event\n - known inherited or acquired bleeding disorder\n - significant cardiovascular diseases\n - clinically relevant pericardial effusion\n - history of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months\n - inadequate safety laboratory values\n - serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy, including Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV)\n - poorly controlled diabetes mellitus or other contraindication to high dose corticosteroid therapy\n - gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug\n - other malignancy diagnosed within the past 5 years. In exception to this rule, the following malignancies may be included if adequately treated: non-melanomatous skin cancer, cervical carcinoma in situ, carcinoma in situ of the breast, low risk endometrial cancer\n - prior systemic therapy for ovarian cancer (e.g. chemotherapy, monoclonal antibody therapy, oral targeted therapy, hormonal therapy)\n - prior systemic cytotoxic chemotherapy\n - prior treatment with BIBF 1120 or any other angiogenesis inhibitor\n - prior radiotherapy\n - serious illness or concomitant non-oncological disease such as neurologic, psychiatric or infectious disease or a laboratory abnormality that may increase the risk associated with study participation or study drug administration\n - Women of childbearing potential who are sexually active and not using a highly effective method of birth control during the trial and for at least twelve months after the end of active therapy.\n - pregnancy or breast feeding\n - psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule\n - active alcohol or drug abuse\n - patients unable to comply with the protocol\n - any contraindications for therapy with paclitaxel or carboplatin\n - treatment with other investigational drugs or participation in another clinical trial testing a drug within the past four weeks before start of therapy or concomitantly with this trial \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01127217 | [
{
"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\n**Diseases:** hypertension\n\n**ICD Codes:** \"I15.0, I97.3, K76.6, P29.2, G93.2, H40.053, I10\"\n\n**Drugs:** amlodipine/losartan, amlodipine\n\n**SMILES:** CCCCC1=NC(Cl)=C(CO)N1CC1=CC=C(C=C1)C1=CC=CC=C1C1=NNN=N1, COC(=O)C1=C(C)NC(C)=C(C1C1=CC(=CC=C1)N+(O-)=O)C(=O)OC(C)(C)CN(C)CCC(C1=CC=CC=C1)C1=CC=CC=C1\n\n**CT Criteria:** Inclusion Criteria:\n - 18 aged or over\n - Patients with blood pressure measured at Visit 1; MSSBP≤180mmHg and MSDBP≤110 mmHg if on anti-hypertensive drugs, 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg if not on anti-hypertensive drugs\n - Patients with blood pressure measured at Visit 2 were 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg\n Exclusion Criteria:\n - Inability to stop all prior anti-hypertensive drugs safely during wash out period of 3 to 7 days\n - ≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening\n - History of hypersensitivity to dihydropyridines, angiotensin II receptor blockers or thiazide diuretics\n - Secondary hypertension or suspected to be\n - Continuously took medicinal drugs that might affect blood pressure rather than anti-hypertensive drugs more than 3 months\n - Type 2 diabetes mellitus which is not controlled or with type 1 diabetes mellitus\n - History of severe neurovascular disease, severe heart disease\n - Known as moderate or malignant retinopathy.\n - Renal diseases; serum creatinine ≥ 2mg/dl\n - Hepatic diseases; increase in ALT or AST ≥ 2xUNL\n - Anuria\n - Hyponatremia/hypokalemia or hypercalcemia\n - Active Gout\n - Surgical or medical diseases which might significantly change ADME of medicines\n - History of malignant tumor\n - Autoimmune diseases\n - History of alcohol or drug abuse\n - Positive to pregnancy test, nursing mother, woman with an intention of pregnancy\n - Considered inappropriate to participate in the clinical trial with any reason, based on investigators decision\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 |
NCT01187953 | [
{
"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\n**Diseases:** renal failure\n\n**ICD Codes:** \"P96.0, O03.32, O04.82, O08.4, O03.82, O07.32, I13.11\"\n\n**Drugs:** prograf (tacrolimus), lcp-tacro\n\n**SMILES:** COC@@H1CC@@H(CCC@H1O)\\\\C=C(/C)C@H1OC(=O)C@@H2CCCCN2C(=O)C(=O)C@2(O)OC@@H(C@H(CC@H2C)OC)C@H(CC@@H(C)C\\\\C(C)=C\\\\C@@H(CC=C)C(=O)CC@H(O)C@H1C)OC, COC@@H1CC@@H(CCC@H1O)\\\\C=C(/C)C@H1OC(=O)C@@H2CCCCN2C(=O)C(=O)C@2(O)OC@@H(C@H(CC@H2C)OC)C@H(CC@@H(C)C\\\\C(C)=C\\\\C@@H(CC=C)C(=O)CC@H(O)C@H1C)OC\n\n**CT Criteria:** Inclusion Criteria:\n 1. informed consent\n 2. 18 and 70 years, inclusive\n 3. receiving primary or secondary renal allograft from a deceased donor or non-human leukocyte antigen (HLA) identical living donor\n 4. no known contraindications to the administration of IL-2 receptor antagonist induction therapy, MMF, corticosteroids or tacrolimus\n 5. negative pregnancy test\n 6. Negative cross match test, and compatible (A, B, AB or O) blood type\n 7. Able to swallow tablets and capsules\n Exclusion Criteria:\n 1. Recipients of any non-renal transplant (solid organ or bone marrow) ever\n 2. Panel reactive antibody (PRA) >30%\n 3. Patients with any condition that may affect study drug absorption (e.g. gastrectomy or clinically significant diabetic gastroenteropathy)\n 4. Body mass index (BMI) 18 kg/m2\n 5. History of alcohol abuse\n 6. History of recreational drug abuse\n 7. Screening 12-lead electrocardiogram (ECG) demonstrating clinically relevant abnormalities\n 8. WOCBP who are either pregnant, lactating, planning to become pregnant\n 9. Patients with an oral temperature (prior to study drug dosing) of 38.0 ºC (100.4 ºF) or higher\n 10. Patients with clinically significant active infections\n 11. Patients with a known hereditary immunodeficiency\n 12. Patients with malignancies or with a history of malignancies (within the last 5 years)\n 13. Patients who are receiving or expect to receive sirolimus, everolimus, azathioprine,or cyclophosphamide within 3 months prior to enrollment\n 14. Patients with evidence of clinically significant disease (e.g., cardiac, gastrointestinal or hepatic disorders)\n 15. Patients with reversible cardiac ischemia (history of untreated reversible ischemia on stress test)\n 16. Patients with clinically symptomatic congestive heart failure or documented ejection fraction of less than 45%\n 17. Patients with significant chronic obstructive pulmonary disease, pulmonary restrictive disease or significant pulmonary hypertension\n 18. Treatment with an investigational drug, device or regimen within 1 year preceding the first dose of study drug\n 19. Patients who are unwilling to refrain from consumption of grapefruit or grapefruit containing juices\n 20. Patients receiving concomitant drugs that may affect concentrations of tacrolimus in whole blood, as listed in Appendix 2\n 21. Laboratory variables that are abnormal (outside laboratory reference range) and clinically relevant, as judged by the Investigator\n 22. Patients with positive results of any of the following serological tests: human immunodeficiency virus (HIV)-1 antibody, hepatitis B virus (HBV) surface antigen (HBsAg), anti-hepatitis B core antibody (HBcAb), and anti-hepatitis C virus (HCV)antibody (HCV Ab).\n 23. Patients who experienced graft loss within 1 year of transplant, due to acute rejection or due to BK nephropathy\n 24. Patients having experienced focal segmental glomerulosclerosis (FSGS)\n 25. Donor with positive serological test result for HIV-1, HBV or HCV\n 26. Donor with history of malignant disease (current or historical)\n 27. Centers for Disease Control and Prevention high-risk donor\n 28. Patients with mental dysfunction or inability to cooperate with the study\n 29. Cold ischemia time >30 hours\n 29. Non-heart-beating donor \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01364649 | [
{
"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\n**Diseases:** treatment outcome\n\n**ICD Codes:** \"Z01.12, Z92.89, Z75.2, M27.59, Z53.9, Z91.19, M27.51\"\n\n**Drugs:** vortioxetine, escitalopram, placebo\n\n**SMILES:** CC1=CC=C(SC2=CC=CC=C2N2CCNCC2)C(C)=C1, CN(C)CCCC1(OCC2=C1C=CC(=C2)C#N)C1=CC=C(F)C=C1, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\n**CT Criteria:** Inclusion Criteria:\n 1. Is a man or a woman aged between 18 and 55 years, inclusive, who is currently being treated with selective serotonin reuptake inhibitor (SSRI) monotherapy (only citalopram, paroxetine, or sertraline allowed) for at least 8 weeks, which was prescribed to treat a major depressive episode (MDE), according to the DSM-IV-TR criteria.\n 2. Is currently stable; and has a Clinical Global Impression Scale-Severity of Illness Scale (CGI-S) score of ≤3.\n 3. Is currently experiencing treatment-emergent sexual dysfunction (TESD; defined as a Changes in Sexual Functioning Questionnaire (CSFQ-14) total score ≤41 for women and ≤47 for men), considered to be attributable to the current SSRI monotherapy and is suitable for a switch.\n Exclusion Criteria:\n 1. Has previously participated in a Lu AA21004 clinical study.\n 2. Has 1 or more the following: any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR; as assessed by the Mini International Neuropsychiatric Interview Version 6.0.0); current or history of manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR; current diagnosis of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV-TR that has not been in sustained full remission for at least 2 years prior to Screening (subject must also have negative urine drug screen prior to Baseline); presence or history of a clinically significant neurological disorder (including epilepsy); neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc); or any Axis II disorder that might compromise the study.\n 3. Has sexual dysfunction associated with an etiology other than SSRI treatment or current MDE (e.g., due to a medical condition, such as diabetes or hypertension, a medication, a genital anatomical deformity, or alcohol abuse).\n 4. Is nonsexually active or anticipates decreasing frequency of sexual activity (ie, sexual activity anticipated to lead to orgasm or that would normally lead to orgasm, which can include sexual intercourse, oral sex, masturbation, sexual fantasies, and/or thinking of sexual activity) during the course of the study below the level at study initiation.\n 5. Is a male with a history of premature ejaculation in the past year.\n 6. Has had major relationship changes during the preceding SSRI treatment period or plans to have major relationship changes during the course of the study.\n 7. Has a sexual partner(s) who plans to initiate treatment for sexual dysfunction during the study. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01097018 | [
{
"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\n**Diseases:** colorectal cancer\n\n**ICD Codes:** \"C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2\"\n\n**Drugs:** capecitabine, perifosine, placebo\n\n**SMILES:** HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1, CCCCCCCCCCCCCCCCCCOP(O-)(=O)OC1CCN+(C)(C)CC1, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\n**CT Criteria:** Inclusion Criteria:\n - Patients must have failed available therapy for the treatment of advanced colorectal cancer, including fluoropyrimidine, irinotecan, oxaliplatin, bevacizumab and for K-ras wild-type (WT) patients, anti-EGFR antibody (cetuximab or panitumumab) containing therapies.\n - For oxaliplatin-based therapy, failure of therapy will also include patients who had oxaliplatin discontinued secondary to toxicity.\n - No prior exposure to capecitabine in the metastatic colorectal cancer setting, except limited-course radiosensitizing capecitabine\n - Patients must have at least one measurable lesion by RECIST criteria\n Exclusion Criteria:\n - Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5-FU \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
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