id stringlengths 11 11 | prompt listlengths 1 1 | completion listlengths 1 1 | Label stringclasses 2 values |
|---|---|---|---|
NCT01024608 | [
{
"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:** seasonal allergic rhinitis, hay fever\n\n**ICD Codes:** \"J30.2\"\n\n**Drugs:** beclomethasone dipropionate, placebo nasal aerosol\n\n**SMILES:** HC@@12CC@H(C)C@(OC(=O)CC)(C(=O)COC(=O)CC)C@@1(C)CC@H(O)C@@1(Cl)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 - Informed Consent\n - Male or female subjects 12 years of age or older\n - Documented history of season allergic rhinitis to mountain cedar pollen\n - General good health\n - Other criteria apply\n Exclusion Criteria:\n - History of physical findings of nasal pathology (within 60 days prior to screening visit)\n - Participation in any investigational drug study 30 days preceding screening visit\n - History of respiratory infection/disorder with 14 days preceding screening visit\n - Use of any prohibited concomitant medications\n - Other criteria apply \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01010633 | [
{
"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:** inflammation, pain\n\n**ICD Codes:** \"H01.9, H30.93, H05.00, H30.003, H30.013, H30.033, H30.103\", \"N50.82, R07.2, R07.82, R10.13, R10.33, R14.1, R52\"\n\n**Drugs:** vehicle of loteprednol etabonate, loteprednol etabonate\n\n**SMILES:** CC1=CC(O)=CC(C)=C1Cl, HC@@12CCC@(OC(=O)OCC)(C(=O)OCCl)C@@1(C)CC@H(O)C@@1(H)C@@2(H)CCC2=CC(=O)C=CC@12C\n\n**CT Criteria:** Inclusion Criteria:\n - Subjects who are at least 18 years of age.\n - Subjects who are candidates for routine, uncomplicated cataract surgery.\n - Subjects who, in the Investigators opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.\n Exclusion Criteria:\n - Subjects who have known hypersensitivity or contraindication to the study drug or components.\n - Subjects with a severe/serious ocular condition, or any other unstable medical condition, that in the investigators opinion may preclude study treatment or follow-up.\n - Subjects with elevated intraocular pressure (>/= 21mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.\n - Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00676338 | [
{
"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:** exenatide once weekly, metformin, sitagliptin, pioglitazone\n\n**SMILES:** NC@@H(CCCNC(N)=N)C(O)=O, CSCCC@H(N)C(O)=O, NC@@H(CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F, NC@@H(CCCNC(N)=N)C(O)=O\n\n**CT Criteria:** Inclusion Criteria:\n - have type 2 diabetes and are treated with diet and exercise alone.\n - at least 18 years of age.\n - HbA1c between 7.1% and 11.0%, inclusive.\n - Body mass index (BMI) of 23 kg/m2 to 45 kg/m2, inclusive.\n - Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).\n Exclusion Criteria:\n - Have history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty\n - Have a history of renal transplantation or are currently receiving renal dialysis\n - Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.\n - Have history of severe GI disorder (e.g., gastroparesis)\n - Have a history of acute or chronic pancreatitis.\n - Have active proliferative retinopathy.\n - Have been treated with drugs that promote weight loss (e.g., Xenical®orlistat, Meridia® sibutramine, Acomplia® rimonabant, Acutrim® phenylpropanolamine, or similar over-the-counter medications) within 3 months of screening.\n - Have been treated with any antidiabetic agent for more than 7 days within 3 months prior to screening.\n - Have had an organ transplant.\n - Have previously completed or discontinued study drug in this study, withdrawn from this study or any other study investigating exenatide once weekly.\n - Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.\n - Are currently enrolled in any other clinical study. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01318083 | [
{
"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:** alogliptin and glimepiride, alogliptin and glimepiride, glimepiride\n\n**SMILES:** 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, 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, 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\n\n**CT Criteria:** Inclusion Criteria:\n 1. Had been taking a sulfonylurea for at least 4 weeks prior to the initiation of the observation period (Week -12).\n 2. Had been taking glimepiride at a stable dose regimen (1, 2, 3 or 4 mg/day, once or twice daily in the morning or in the morning and evening, before or after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).\n 3. Had glycosylated hemoglobin (HbA1c) of 7.0% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).\n 4. Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place).\n 5. Was receiving specific diet and exercise (if any) therapies during the observation period.\n Exclusion Criteria:\n 1. Had taken other diabetic medications than glimepiride within 12 weeks before the initiation of the treatment period (Week 0). \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00383578 | [
{
"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:** vildagliptin 100 mg qd, metformin 1500 mg daily\n\n**SMILES:** OC12CC3CC(C1)CC(C3)(C2)NCC(=O)N1CCCC@H1C#N, CN(C)C(=N)NC(N)=N\n\n**CT Criteria:** Inclusion Criteria:\n - Age from 65 years to the upper age limit recommended by local prescribing information for metformin\n - Drug naive patients with type 2 diabetes.\n - Body mass index (BMI) in the range of 22-40 kg/m2.\n - HbA1c in the range of 7 to 9% inclusive\n - FPG <270 mg/dL (15 mmol/L)\n Exclusion Criteria:\n - A history of type 1 diabetes\n - Evidence of significant diabetic complications\n - Treatment with insulin or any other oral antidiabetic agents\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 |
NCT00374907 | [
{
"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:** saxagliptin, placebo, metformin (blinded), metformin (open-label)\n\n**SMILES:** NC@H(C(=O)N1C@H2CC@H2CC@H1C#N)C12CC3CC(CC(O)(C3)C1)C2, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN(C)C(=N)NC(N)=N, CN(C)C(=N)NC(N)=N\n\n**CT Criteria:** Inclusion Criteria:\n - Type 2 diabetes mellitus\n - Drug naive\n - Hemoglobin A1c (HbA1c) ≥6.0% and ≤8.0%\n - Fasting C-peptide ≥1.0 ng/mL\n - Body mass index ≤40 kg/m²\n Exclusion Criteria:\n - Recent cardiac or cerebrovascular event\n - Elevated serum creatinine \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01521559 | [
{
"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:** branch retinal vein occlusion\n\n**ICD Codes:** \"H34.8332, H34.8331, H34.8311, H34.8321, H34.8391, H34.8312, H34.8322\"\n\n**Drugs:** intravitreal aflibercept injection (iai;eylea®;bay86-5321)\n\n**SMILES:** NC@@H(CCCNC(N)=N)C(O)=O\n\n**CT Criteria:** Inclusion Criteria:\n The following inclusion criteria include, but are not limited to:\n 1. Adults ≥ 18 years of age with foveal center-involved macular edema (ME) secondary to BRVO diagnosed within 12 months before the screening visit\n 2. ETDRS BCVA: letter score of 73 to 24 (20/40 to 20/320) in the study eye at screening and at day 1\n 3. Provide signed informed consent\n Exclusion Criteria:\n The following exclusion criteria include, but are not limited to:\n 1. Current bilateral manifestation of BRVO\n 2. Uncontrolled glaucoma defined as ≥ 25 mmHg on optimal medical regimen, or previous filtration surgery in either the study eye or the fellow eye\n 3. Insufficient clearing of macular hemorrhage that would prevent the patient from receiving laser treatment safely on day 1 (patients that meet this criterion may be rescreened once the macular hemorrhage resolves)\n 4. Uncontrolled diabetes mellitus (DM)\n 5. Previous use of intraocular corticosteroids or anti-angiogenic drugs in the study eye\n 6. Use of periocular corticosteroids in the study eye within 3 months before day 1\n 7. Use of intraocular or periocular corticosteroids or anti-angiogenic drugs in the fellow eye within 3 months before day 1\n 8. Previous administration of systemic anti-angiogenic medications\n 9. Panretinal scatter photocoagulation, sector laser photocoagulation, or macular grid photocoagulation in the study eye \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00625404 | [
{
"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 infections\n\n**ICD Codes:** \"Z21\"\n\n**Drugs:** truvada\n\n**SMILES:** HC@@(C)(CN1C=NC2=C(N)N=CN=C12)OCP(=O)(OCOC(=O)OC(C)C)OCOC(=O)OC(C)C\n\n**CT Criteria:** Inclusion Criteria:\n 1. Willing and able (see criterion 2) to provide written informed consent to be screened for and to participate in the trial\n 2. Able to answer a percentage of informed consent screening (75%) and enrollment (100%) comprehension quiz questions correctly\n 3. Between 18-35 years old, inclusive\n 4. At higher risk of becoming HIV infected\n 5. Have a final negative result according to the site-specific screening HIV testing algorithm and a final negative result at enrollment according to the study HIV testing algorithm\n 6. Willing to participate in all aspects of the study and to comply with study procedures, for up to 60 weeks, including:\n - Be randomized\n - Use study product as directed\n - Adhere to follow-up schedule and willing to be contacted by site staff between study visits (by phone and/or in person)\n - Use a study-approved effective non-barrier method of contraception for the duration of the study\n - Take study product, as evidenced by swallowing a vitamin tablet that is similar in size to the study product at enrollment\n - Provide contact information and agrees to some form of contact method throughout the study\n 7. Not intending to relocate out of the area for the duration of the study participation and does not have a job or other obligations that may require long absences from the area ( > 1 month at a time)\n 8. In general good health and have no condition (social or medical) which, in the opinion of the Site Investigator, would make study participation unsafe or complicate data interpretation\n 9. Not pregnant or breastfeeding, and does not anticipate a desire for pregnancy during the 52 weeks of on-product participation\n 10. Medically eligible at screening including:\n - Adequate renal function (serum creatinine ≤ upper limit of normal (ULN) of local range and creatinine clearance ≥ 60ml/min estimated by the Cockcroft-Gault Creatinine Clearance Formula\n - Adequate hepatic function (hepatic transaminases ALT and AST < 2x ULN according to local normal ranges)\n - HBsAg negative\n - Serum phosphorus levels above the lower limit of the local normal range (according to local normal ranges - grade 3 & 4 hypophosphatemia will be excluded even if within normal local ranges)\n 11. Not received or receiving an experimental HIV vaccine, participating in another HIV prevention study or participating in any other clinical trial with a biomedical intervention\n 12. No clinical signs of liver disease (e.g., ascites, spider angiomata, hepatomegaly, jaundice)\n 13. No definite evidence of glycosuria or proteinuria (i.e., no repeated positive ≥ + 1 urine dipstick). If a urine dipstick is positive for either glucose and/or protein at the first test, a second urine sample will be tested.\n 14. No history of pathological bone fractures\n 15. No history of adverse reaction to latex\n 16. Not taking any of the following medications: nephrotoxic agents; aminoglycoside antibiotics (including gentamicin); intravenous (IV) amphotericin B; cidofovir; cisplatin; foscarnet; IV pentamidine; oral or IV vancomycin; oral or IV gancyclovir; other agents with significant nephrotoxic potential; drugs that slow renal excretion; probenecid; immune system modulators; systemic chemotherapeutic agents (i.e. cancer treatment medications); systemic corticosteroids; interleukin-2 (IL-2); immunomodulators; interferon (alpha, beta, or gamma); other antiretrovirals (including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents) \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT01153217 | [
{
"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\n\n**ICD Codes:** \"B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4\"\n\n**Drugs:** switch from tenofovir to abacavir\n\n**SMILES:** NC1=NC2=C(N=CN2C@@H2CC@H(CO)C=C2)C(NC2CC2)=N1\n\n**CT Criteria:** Inclusion Criteria:\n 1. Adult patients (=/+18 years old) having a diagnosis of HIV-1 infection.\n 2. Current HAART including tenofovir plus emtricitabine/lamivudine plus a PI, a NNRTI or raltegravir started at least 12 months before.\n 3. T-score ≤-2 measured by DEXA (within the last 6 months).\n 4. Maintained undetectable plasma HIV-1 RNA (VL < 50 copies/mL) for at least 12 months.\n 5. Absence of suspected or documented resistance mutations in the RT associated to abacavir.\n 6. Voluntary written informed consent.\n Exclusion Criteria:\n 1. History of intolerance, toxicity or virological failure to abacavir.\n 2. HLA B*5701 positive.\n 3. Secondary osteoporosis/osteopenia (vitamin D or testosterone deficit, thyroid disease, …)\n 4. Therapy with biphosphonates within the last 12 months. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00492024 | [
{
"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:** sinusitis\n\n**ICD Codes:** \"J01.80, J01.90, J32.0, J32.1, J32.2, J32.3, J32.8\"\n\n**Drugs:** moxifloxacin (avelox, bay12-8039), placebo\n\n**SMILES:** HC@12CN(CC@@1(H)NCCC2)C1=C(F)C=C2C(=O)C(=CN(C3CC3)C2=C1OC)C(O)=O, 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 must meet all the following criteria at the time of enrollment:\n - Age >/= 18 years\n - Clinical diagnosis of acute bacterial sinusitis with signs and symptoms present for = 7 days but < 28 days as defined by A), radiographic, and B) clinical criteria, as follows:\n - Radiographic Criteria: The presence of one or more of the following on a radiographic paranasal sinus film (Waters view): - Evidence of air-fluid levels - Opacification\n - Clinical Criteria: The presence of two major symptoms, or the presence of at least one major and one minor symptom as defined in the list below:\n - Major symptoms: - Purulent anterior or posterior nasal discharge - Unilateral facial pain or malar tenderness\n - Minor symptoms: - Frontal headache - Fever (oral = 38.0°C/100.4°F, tympanic = 38.5°C/101.2°F, axillary = 37.5°C/99.5°F) - Culture material obtained by sinus puncture; the aspirated specimen sent for Gram stain, quantitative culture and susceptibility testing prior to initiation of antimicrobial therapy\n Exclusion Criteria:\n Subjects with one or more of the following criteria will not be eligible for this study:\n - History of chronic sinusitis defined as greater than four weeks of continuous symptoms (subjects with recurrent acute sinusitis will be included)\n - History of sinus surgery (antral sinus puncture is not considered as a surgery)\n - Any symptoms that suggest the subjects current illness is allergic rhinitis (e.g. repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis\n - Known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT02860624 | [
{
"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:** gastroesophageal reflux disease\n\n**ICD Codes:** \"K21.9, K21.00, K21.01\"\n\n**Drugs:** 10 mg ilaprazole, 40mg esomeprazole\n\n**SMILES:** COC1=C(C)C(CS+(O-)C2=NC3=CC(=CC=C3N2)N2C=CC=C2)=NC=C1, COC1=CC2=C(NC(=N2)S@@(=O)CC2=NC=C(C)C(OC)=C2C)C=C1\n\n**CT Criteria:** Inclusion Criteria:\n - Consenting patients will be eligible for enrollment if they:\n - are 18-70 years of age,\n - have at least one of the two symptoms, heartburn and reflux,\n - have photographically documented erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD), and graded according to the Los Angeles (LA) Classification (A-D), within 5 days before randomization to treatment. Female patients are required to be nonpregnant, nonlactating, postmenopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator. Women of child- bearing potential will receive a pregnancy test.\n Exclusion Criteria:\n - Patients will be ineligible if they:\n - have cancerous or peptic ulcers, Zollinger-Ellison syndrome, varices of esophagus or fundus of stomach\n - have a known history of gastric acid suppression operation, esophageal operation or peptic operation other than simple closure of perforation,\n - have severe complications, severe other diseases of digestive tract such as Crohns disease and ulcerative colitis, and severe other systemic diseases,\n - have taken proton pump inhibitors within the 5 days or for more than three consecutive days within the two weeks immediately preceding start of study drug,\n - participated in a clinical trial with an investigational drug or device within the past three months,\n - have hypersensitivity or idiosyncratic reaction to ilaprazole, esomeprazole or any other benzimidazole,\n - have alcoholic intemperance, drug addiction or any other improper habits. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01636713 | [
{
"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:** gsk573719/vi 62.5/25, gsk573719/vi 125/25, 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 1. Type of subject: outpatient.\n 2. Informed Consent: A signed and dated written informed consent prior to study participation.\n 3. Age: 40 years of age or older at Screening (Visit 1).\n 4. Gender: Male or female subjects are eligible to participate in the study.\n 5. COPD History: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society Celli, 2004 as follows:\n 6. Tobacco Use and Smoking History: Current or former cigarette smokers with a history of cigarette smoking of more than or equal to 10 pack-years\n 7. Severity of Disease: A post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and a post-albuterol/salbutamol FEV1 of less than or equal to 70% of predicted normal values calculated using NHANES III reference equations at Visit 1 Hankinson1999,Hankinson, 2010.\n 8. Dyspnea: A score of ≥2 on the Modified Medical Research Council Dyspnoea Scale (mMRC) at Screening (Visit 2)\n Exclusion Criteria:\n 1. Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.\n 2. Asthma: A current diagnosis of asthma.\n 3. Other Respiratory Disorders: Known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis) and lung cancer are absolute exclusionary conditions. A subject, who in the opinion of the investigator has any other significant respiratory conditions in addition to COPD should be excluded. Examples may include clinically significant, bronchiectasis, pulmonary hypertension, sarcoidosis or interstitial lung disease.\n 4. Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for < 5 years prior to Visit 1 (localized carcinoma of the skin that has been resected for cure is not exclusionary).\n 5. Chest X-Ray: A chest X-ray or computed tomography (CT) scan that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray must be taken at Visit 1 if a chest X-ray or CT scan is not available within 6 months prior to Visit 1.\n 6. Contraindications: A history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholinergic.\n 7. Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.\n 8. Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1).\n 9. 12-Lead ECG: An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1, including the presence of a paced rhythm on a 12-lead electrocardiogram (ECG) which causes the underlying rhythm and ECG to be obscured. Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility.\n 10. Screening Labs: Significantly abnormal finding from clinical chemistry and haematology tests at Visit 1.\n 11. Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit.\n 12. Medications prior to Screening: List are provided in the protocol\n 13. Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., less than 12 hours per day) is not exclusionary.\n 14. Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g., albuterol/salbutamol) via nebulized therapy.\n 15. Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.\n 16. Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.\n 17. Affiliation with Investigator Site: Is an investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the aforementioned that is involved in this study. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00081458 | [
{
"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:** short bowel syndrome\n\n**ICD Codes:** \"D68.61, D69.41, D81.4, E24.1, E26.01, E26.81, E34.0\"\n\n**Drugs:** placebo, teduglutide 0.05 mg/kg/d, teduglutide 0.1 mg/kg/d\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 - Men and women, aged 18 years of age or older at the time of signing the informed consent form (ICF)\n - SBS as a result of major intestinal resection resulting in at least 12 months intravenous feeding\n - Body weight must be less than 90 kg\n - At baseline, subjects must require PN treatment to meet their caloric or electrolyte needs due to ongoing malabsorption at least 3 times weekly and to be on a stable PN regimen for 4 weeks before dosing\n - Body mass index (BMI) 18 to 27 kg/m2\n - Adequate hepatic and renal function\n Exclusion Criteria:\n - History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state\n - History of alcohol or drug abuse (within previous year)\n - Participation in a clinical study within 30 days prior to signing the ICF, or concurrent participation in any clinical study\n - Clinically significant laboratory abnormalities at the time of randomization\n - Previous use of teduglutide (ALX-0600)\n - Prior use of native GLP-2 within 3 months of screening visit\n - Hospital admission within 1 month prior to screening visit\n - Pregnant or lactating women\n - Any condition or circumstance, which in the investigators opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results.\n - Presence of excluded disease: Radiation enteritis, Scleroderma, Celiac disease, Refractory/Tropical sprue, Pseudo-obstruction, Active inflammatory bowel disease (IBD), Pre-malignant/malignant change in colonoscopy biopsy or polypectomy, Surgery scheduled within the time frame of the study, Human immunodeficiency virus (HIV) positive test, Immunological disorders, Possible allergies to teduglutide or its constituents, Significant, active, uncontrolled, untreated systemic diseases \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00646009 | [
{
"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:** budesonide/formoterol, fluticasone/salmeterol, albuterol\n\n**SMILES:** COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1, OCC1=C(O)C=CC(=C1)C(O)CNCCCCCCOCCCCC1=CC=CC=C1, CC(C)(C)NCC(O)C1=CC(CO)=C(O)C=C1\n\n**CT Criteria:** Inclusion Criteria:\n - At least 18 years of age\n - Diagnosis of asthma and baseline lung function test results as determined by the protocol\n - Required and received inhaled corticosteroids within timeframe and doses specified in the protocol\n Exclusion Criteria:\n - Severe asthma or asthma that is markedly effected by seasonal factors\n - Has required and received non-inhaled corticosteroids within the previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01202188 | [
{
"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:** indacaterol and glycopyrronium (qva149), glycopyrronium (nva237), indacaterol (qab149), tiotropium, placebo\n\n**SMILES:** CN+1(C)CCC(C1)OC(=O)C(O)(C1CCCC1)C1=CC=CC=C1, CN+1(C)CCC(C1)OC(=O)C(O)(C1CCCC1)C1=CC=CC=C1, CCC1=C(CC)C=C2CC(CC2=C1)NCC@H(O)C1=C2C=CC(=O)NC2=C(O)C=C1, HC@12OC@@1(H)C@1(H)CC@@(H)(CC@@2(H)N+1(C)C)OC(=O)C(O)(C1=CC=CS1)C1=CC=CS1, 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 adults aged ≥40 yrs\n - Smoking history of at least 10 pack years\n - Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)\n - Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%\n Exclusion Criteria:\n - Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1\n - Patients with concomitant pulmonary disease\n - Patients with a history of asthma\n - Any patient with lung cancer or a history of lung cancer\n - Patients with a history of certain cardiovascular co-morbid conditions\n - Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency\n - Patients in the active phase of a supervised pulmonary rehabilitation program\n - Patients contraindicated for inhaled anticholinergic agents and β2 agonists\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 |
NCT00499109 | [
{
"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:** docetaxel, vinorelbine, carboplatin, gemcitabine\n\n**SMILES:** HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1, HC@@12N(C)C3=CC(OC)=C(C=C3C@@11CCN3CC=CC@(CC)(C@@13H)C@@(H)(OC(C)=O)C@2(O)C(=O)OC)C@1(CC@@2(H)CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, NC@@H(CCCNC(N)=N)C(O)=O, HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1\n\n**CT Criteria:** Inclusion Criteria:\n - Histologically confirmed Non-Small Cell Lung Cancer (NSCLC) of adenocarcinoma, squamous cell carcinoma, large cell carcinoma, or NSCLC not otherwise specified. Patients with suspected NSCLC may enroll prior to the diagnostic biopsy in order to obtain both the diagnostic and molecular analysis-required specimen during the same procedure. Must have blood work within 30 days prior to biopsy to eliminate any unnecessary biopsies on patients that do not qualify (screen failures) due to laboratory values that do not meet the inclusion/exclusion criteria. If a patient has blood work obtained at an outside facility, this can be utilized for the preliminary assessment prior to biopsy, but final inclusion/exclusion values must be obtained within 14 days of start of treatment.\n - Willing to undergo biopsy to enable customization of chemotherapy\n - Stage IV or IIIB (malignant pleural effusion) NSCLC\n - Measurable or evaluable disease by Response Evaluation Criteria In Solid Tumors (RECIST)\n - Performance status 0 or 1 by Eastern Cooperative Oncology Group (ECOG) criteria\n - Adequate bone marrow function as evidenced by the following (assessed within 14 days of starting treatment): Absolute neutrophil count >= 1,500/mm³, Platelet count >= 100,000/mm³, Hemoglobin >= 8.0 gm/dL\n - Prothrombin time (PT) and activated prothrombin time with thromboplastin and kaolin (APTT) within normal laboratory ranges\n - Serum creatinine <= 1.5 x upper limit of normal (ULN) assessed within 14 days of starting treatment\n - Adequate liver function as evidenced by the following (assessed within 14 days of starting treatment): Total bilirubin must be within normal limits; aspartic transaminase (AST) and alanine transaminase (ALT) <= 2.5 x ULN with a normal alkaline phosphatases; alkaline phosphatases <= 4 x upper limit of normal with normal AST and ALT; patients with elevations of alk phos and AST and/or ALT will be excluded\n - Serum calcium <= 1.1 x ULN\n - Signed informed consent document\n - Women of childbearing potential must have a negative pregnancy test. Men with partners in the childbearing age group and women of childbearing potential must use effective contraception while on treatment and for 6 months thereafter.\n - Previous surgery for NSCLC (more that 30 days before study entry)\n - Previous radiotherapy (RT) is allowed if: the time between completion of RT and initiation of chemotherapy is at least 7 days; the patient has fully recovered from all toxic effects; at least one target lesion or evaluable disease is outside the radiation field\n - Previous chemotherapy allowed if the last dose was administered equal to or greater than 12 months ago. This chemotherapy must have been given in an adjuvant or neoadjuvant mode prior to or after a complete surgical resection (R0 resection) for a NSCLC.\n - Patients with stable brain metastases will be allowed to enroll. Stable brain metastases being defined as no progression of brain metastases 28 days after conclusion of definitive treatment as documented by a computed tomography (CT) scan or magnetic resonance imaging (MRI) of the brain. Patients with incidentally discovered asymptomatic brain metastases may be enrolled and treated with chemotherapy without prior brain irradiation if deemed feasible by the treating physician.\n Exclusion Criteria:\n - Pregnant or lactating\n - Prior systemic chemotherapy or immunotherapy for advanced NSCLC.\n - Prior malignancies, except: cured non-melanoma skin cancer curatively treated in situ carcinoma of the cervix any other curatively treated malignancy with no evidence of disease recurrence for at least 3 years\n - Presence of uncontrolled brain or leptomeningeal metastases\n - Peripheral neuropathy or hearing loss of neural origin equal to or greater than grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) v3.0 except if due to trauma\n - Other serious illness or medical condition, including but not limited to: congestive heart failure, myocardial infarction within 6 months, significant neurologic or psychiatric disorders that would impact study participation as judged by the treating physician or study chair, infection requiring intravenous (IV) antibiotics, tuberculosis with ongoing therapy at study entry, superior vena cava syndrome (except if controlled with radiation), active peptic ulcer disease, uncontrolled diabetes mellitus as judged by the treating oncologist, any contraindication to high dose corticosteroid therapy (such as herpes simplex, herpes zoster, hepatitis, or other disease)\n - Hypercalcemia requiring therapeutic intervention\n - Clinically significant ascites and/or pericardial effusion\n - Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80\n - Concurrent treatment with other investigational drugs \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00092859 | [
{
"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:** obesity\n\n**ICD Codes:** \"E66.8, E66.9, E66.1, O99.214, O99.215, O99.210, O99.211\"\n\n**Drugs:** mk0557\n\n**SMILES:** FC1=C(C=CC=C1)N1C=CC(NC(=O)C@H2CCC@@3(CC2)OC(=O)C2=C3C=NC=C2)=N1\n\n**CT Criteria:** Inclusion Criteria:\n - Obese men and nonpregnant women at least 18 years of age with a specific body mass index (height and weight ratio) required by the study\n Exclusion Criteria:\n - Patients with uncontrolled high blood pressure and/or diabetes mellitus (high blood sugar) \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00002646 | [
{
"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:** fenretinide, tamoxifen citrate\n\n**SMILES:** C\\\\C(\\\\C=C\\\\C1=C(C)CCCC1(C)C)=C/C=C/C(/C)=C/C(=O)NC1=CC=C(O)C=C1, COC1=CC(NCC2=C(C)C3=C(C=C2)N=C(N)N=C3N)=CC(OC)=C1OC\n\n**CT Criteria:** DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast Pathologic stage T1-3, N1-2, M0 No clinical or pathologic T4 disease No primary tumor fixed to chest wall No axillary nodes fixed to chest wall or neurovascular bundle No preoperative arm edema No clinical skin involvement (microscopic focal dermal invasion or dermal lymphatic involvement eligible) No clinical N2 disease Modified radical mastectomy or lumpectomy required prior to entry Sentinel node biopsy allowed Randomization required within 12 weeks from definitive surgery Surgery dated from mastectomy or axillary dissection for lumpectomy No positive deep mastectomy margins Radiotherapy planned within 12 weeks following axillary node dissection for lumpectomy patients Synchronous bilateral breast cancer eligible If tumor is at least 2 cm, then nodes not involved If no tumor is at least 2 cm, then at least 1 node must be involved Both invasive primaries receptor-positive Previously treated, noninvasive breast cancer eligible No prior invasive breast cancer No adenoid cystic, squamous, or sarcomatous histology Hormone receptor status: Estrogen- or progesterone-receptor positive, i.e.: At least 10 fmole/mg cytosol protein by ligand-binding assay OR Receptor positive by immunocytochemistry\n PATIENT CHARACTERISTICS: Age: 65 and over OR Postmenopausal and ineligible/inappropriate for or declined other active node positive adjuvant studies Sex: Female Menopausal status: Postmenopausal, defined as: At least 1 year since last menstrual period Hysterectomized with bilateral oophorectomy Hysterectomized with 1 or both ovaries remaining and either: Over 60 FSH in postmenopausal range Not surgically castrated, under 60, and on HRT FSH elevated 2 weeks after HRT discontinued Performance status: Not specified Life expectancy: At least 7 years except for breast cancer Hematopoietic: WBC greater than 3,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL AST less than 2 times normal Renal: Creatinine no greater than 2.0 mg/dL BUN no greater than 25.0 mg/dL Other: No extensive macular degeneration on exam within 1 year of entry, e.g.: No exudative or atrophic macular lesions that reduce corrected vision to less than 20/40 Health adequate for protocol treatment No nutritional supplementation except single daily multivitamin No other vitamin A supplements Gynecologic exam within the past year required of women who retain a uterus No second malignancy within the past 10 years except: Inactive nonmelanomatous skin cancer Carcinoma in situ of the cervix Prior noninvasive contralateral breast cancer\n PRIOR CONCURRENT THERAPY: No prior chemotherapy or hormonal therapy for breast cancer except: Up to 1 month of tamoxifen if started by a non participating physician At least 2 weeks since hormone replacement therapy No concurrent megestrol \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00562692 | [
{
"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 failure\n\n**ICD Codes:** \"I50.814, I09.81, I50.82, I50.89, I50.9, T86.22, I11.0\"\n\n**Drugs:** nesiritide, 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 1. Males and females\n 2. Over 18 years of age\n 3. Confirmed written informed consent.\n 4. Acute decompensated heart failure based on physicians assessment and requiring treatment as per standard emergency department protocols for this condition.\n 5. Requirement for intravenous therapy of HF, e.g. diuretic, vasodilator.\n 6. COAD based on physicians assessment and requiring treatment as per standard emergency department protocols for this condition. Must have at least 2 of the following criteria:\n - history of smoking > 20 pack years,\n - prior history of PFTs within last 1 year consistent with COAD,\n - history of chronic cough and sputum production,\n - progressive dyspnea, episodes of acute bronchitis over at least 2 yrs\n Exclusion Criteria:\n 1. Women lactating, pregnant or of childbearing potential not using 2 reliable contraceptive methods.\n 2. Patients who had received an investigational new drug within the last 4 weeks.\n 3. Patients with a history of a psychological illness or condition such as to interfere with the patients ability to understand the requirements of the study.\n 4. SBP <90mmHg\n 5. Creatinine >0.25mmol/L\n 6. Sp02 < 80% on supplemental oxygen or known cor pulmonale with TR \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT01888107 | [
{
"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:** risperidone long-acting injectable (lai) 25 mg, risperidone lai 37.5 mg, risperidone lai 50 mg\n\n**SMILES:** OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12, OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12, OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12\n\n**CT Criteria:** Inclusion Criteria:\n - Schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)\n - Required long-term antipsychotic therapy at the time of recruitment\n - Symptomatically stable and taking the same dose of antipsychotic agents for at least one month before the baseline visit (considered stable if there have been no appreciable change in symptoms over the previous month, regardless of the severity of their symptoms)\n - Patients or their legal representatives provided their written informed consent prior to enrollment in the study\n Exclusion Criteria:\n - Patients who had received clozapine during the previous 3 months\n - Participated in an investigational drug trial in the previous 30 days\n - Previously been shown to be either intolerant or non-responsive to risperidone therapy\n - Presence of a serious unstable medical condition, such as a history or current symptoms of tardive dyskinesia or a history of neuroleptic malignant syndrome\n - Pregnant or breast-feeding; female patients of childbearing potential not using adequate contraception \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00112554 | [
{
"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:** cytarabine, laromustine\n\n**SMILES:** ClCCN(CCCl)P1(=O)NCCCO1, CNC(=O)N(N(CCCl)S(C)(=O)=O)S(C)(=O)=O\n\n**CT Criteria:** DISEASE CHARACTERISTICS:\n - Histologically confirmed acute myeloid leukemia (AML)\n - Any WHO classification, excluding acute promyelocytic leukemia\n - At least 10% blasts by bone marrow aspirate and/or biopsy\n - In first relapse after achieving a first complete response (CR) OR CR (with platelet count < 100,000/mm³ but ≥ 20,000/mm³ transfusion independent for ≥ 7 consecutive days) (CRp) that lasted ≥ 3 months but ≤ 24 months after completion of the initial induction regimen\n - Relapse confirmed by recurrence of blasts in peripheral blood, bone marrow histopathology, and/or histologically confirmed CNS or extramedullary disease\n PATIENT CHARACTERISTICS:\n Age\n - 18 and over\n Performance status\n - ECOG 0-2\n Life expectancy\n - Not specified\n Hematopoietic\n - See Disease Characteristics\n Hepatic\n - Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n - AST ≤ 3 times ULN\n - Chronic hepatitis allowed\n Renal\n - Creatinine ≤ 2.0 mg/dL\n Cardiovascular\n - No myocardial infarction within the past 3 months\n - No uncontrolled arrhythmias\n - No uncontrolled congestive heart failure\n Pulmonary\n - No severe chronic obstructive pulmonary disease\n - No requirement for supplemental oxygen at rest\n Immunologic\n - No uncontrolled active infection\n - Infections that are controlled and under active treatment with antibiotics allowed\n - No evidence of invasive fungal infection by blood or tissue cultures\n Other\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 treatment\n - No clinical evidence of another active malignancy by tumor marker, pathology, or radiologic studies\n - No other severe medical condition that would preclude study treatment\n PRIOR CONCURRENT THERAPY:\n Biologic therapy\n - Not specified\n Chemotherapy\n - At least 12 hours since prior hydroxyurea\n Endocrine therapy\n - Not specified\n Radiotherapy\n - Not specified\n Surgery\n - Not specified\n Other\n - No prior treatment while in first relapse except hydroxyurea\n - No other concurrent standard or investigational treatment for AML\n - No concurrent disulfiram (Antabuse®) \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00530946 | [
{
"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, hypercholesterolemia\n\n**ICD Codes:** \"I15.0, I97.3, K76.6, P29.2, G93.2, H40.053, I10\", \"E78.01, E78.00, Z83.42\"\n\n**Drugs:** amlodipine 2.5mg/atorvastatin 5mg, amlodipine 2.5mg/atorvastatin 10mg, amlodipine 5mg/atorvastatin 5mg, amlodipine 5mg/atorvastatin 10mg\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, 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 - The out-patient with concurrent hypertension and hyper-LDL-cholesterolemia is a male or female >=20 to <80 years of age at Visit 1.\n - The SBP at Visit 4 (Week -1) and Visit 5 (Week 0) is continuously SBP >=140 mmHg and <180 mmHg,\n - LDL-C >=140 mg/dL and <250 mg/dL at Visit 3 (Week -2) and 4 (Week -1).\n Exclusion Criteria:\n - Subjects who had experienced the following coronary artery disease within the past 3 months.\n - Myocardial infarction\n - Receiving PCI（percutaneous coronary intervention）or CABG (coronary artery bypass grafting)\n - Any clinically meaningful valvular disease\n - Subjects with a history of cerebrovascular diseases such as stroke or transient ischemic attack within the past 3 months. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00647127 | [
{
"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:** pain\n\n**ICD Codes:** \"N50.82, R07.2, R07.82, R10.13, R10.33, R14.1, R52\"\n\n**Drugs:** buprenorphine, fentanyl, placebo\n\n**SMILES:** NCC1(CC(O)=O)CCCCC1, 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, 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\n - men > 18 years\n Exclusion Criteria:\n - women\n - known allergy against the investigated drugs\n - ongoing participation in other experiments or participation in other experiments 14 days before screening\n - previously pain or psychiatric conditions\n - simultaneously use of pain killers\n - alcohol\n - previously drug-addict or member of family with drug-addicts\n - chronic constipation\n - ileus\n - inflammatory bowel syndrome\n - abdominal surgery within the last three months \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00328627 | [
{
"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:** alogliptin, alogliptin placebo, pioglitazone, pioglitazone placebo\n\n**SMILES:** CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, NC@@H(CCCNC(N)=N)C(O)=O, NC@@H(CCCNC(N)=N)C(O)=O\n\n**CT Criteria:** Inclusion Criteria:\n - Men or women with a historical diagnosis of type 2 diabetes mellitus who were treated with metformin greater than or equal to 1500 mg alone but were experiencing inadequate glycemic control.\n - A stable dose of metformin of greater than or equal to 1500 mg or maximum tolerated dose.\n - No treatment with antidiabetic agents other than metformin within the 2 months prior to Screening.\n - A body mass index greater than or equal to 23 kg/m^2 and less than or equal to 45 kg/m^2.\n - Fasting C-peptide greater than or equal to 0.8 ng/mL.\n - Regular use of other, non-excluded medications was allowed if a stable dose had been established for at least 4 weeks prior to Screening.\n - Systolic blood pressure less than or equal to 160 mmHg and diastolic pressure less than or equal to 100 mmHg.\n - Hemoglobin greater than or equal to 12 g/dL for men and greater than or equal to 10 g/dL for women.\n - Alanine aminotransferase less than or equal to 2.5 times the upper limit of normal.\n - Serum creatinine less than 1.5 mg/dL for men and less than 1.4 mg/dL for women.\n - Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject was clinically euthyroid.\n - Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.\n - Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.\n - No major illness or debility that in the investigators opinion prohibited the patient from completing the study.\n Exclusion Criteria:\n - Urine albumin/creatinine ratio greater than 113 mg/mmol at Screening.\n - A history of cancer, other than squamous cell or basal cell carcinoma of the skin, that had not been in full remission for at least 5 years prior to Screening.\n - A history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.\n - A history of treated diabetic gastroparesis.\n - New York Heart Association Class III or IV heart failure regardless of therapy.\n - History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening.\n - History of any hemoglobinopathy.\n - History of infection with hepatitis B, hepatitis C or human immunodeficiency virus.\n - History of a psychiatric disorder that could have affected the patients ability to participate in the study.\n - History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.\n - A history of alcohol or substance abuse within 2 years prior to Screening.\n - Receipt of any investigational drug within 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within 3 months prior to Screening.\n - Previous participation in an investigational study of alogliptin.\n - Hypersensitive to pioglitazone, alogliptin, or other excipients. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00406783 | [
{
"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:** rhinitis, allergic, seasonal, rhinitis, allergic, perennial\n\n**ICD Codes:** \"J30.2\", \"J30.0, J31.0, J30.89, J30.9, A50.05, J30.2, J30.1\"\n\n**Drugs:** 5-mg desloratadine, placebo\n\n**SMILES:** ClC1=CC2=C(C=C1)C(=C1CCNCC1)C1=C(CC2)C=CC=N1, 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 subject must meet ALL of the criteria listed below for entry:\n - For this study, the diagnosis of IAR is not based solely on the current episode of AR. Subjects must have at least a 2 year history of AR consistent with IAR (defined as symptoms of allergic rhinitis present less than four days per week or for less than four consecutive weeks per year); the current episode can count as the second year.\n - Subjects must be 12 years of age and older, of either sex and of any race.\n - At the Run-In Visit, subjects must be sufficiently symptomatic, with a T5SS 12-hour AM-PRIOR (reflective) symptoms severity score of at least 6.\n - In order for a subject to qualify at the Baseline Visit, the sum of the daily averages of the diary recordings of the 12-hour AM PRIOR + PM-PRIOR (reflective) T5SS collected during Days -4 to -1 and the AM PRIOR T5SS on the morning of the Baseline Visit (Day 1) must be >= 30.\n - Subjects must have a positive skin-prick test at screening to one or more allergens in the GA2LEN (or the usually used local) panel of seasonal and perennial allergens. Subjects must demonstrate an antigen-induced skin prick wheal at least 3 mm in diameter greater than diluent control. The positive tests must include the allergen(s) prevalent while this study is active.\n - Subjects must be free of any clinically significant disease, other than IAR, which would interfere with the study evaluations.\n - Subjects, or parents/legal guardians, must give written informed consent. Subjects must be able to adhere to dose and visit schedules and meet study requirements.\n - In females of childbearing potential, the urine pregnancy test (hCG) must be negative at the Screening Visit.\n - Nonsterile or premenopausal female subjects must be using a medically accepted method of birth control, that is, oral contraceptive, hormonal implant, medically prescribed intrauterine device (IUD), or depot injectable during the entire study. A female subject who is not currently sexually active must agree and consent to use one of the above-mentioned methods, if she becomes sexually active while participating in the study. A female subject who is not of childbearing potential must have a medical record of being surgically sterile (for example, hysterectomy and tubal ligation), or be at least 1 year postmenopausal.\n Exclusion Criteria:\n The subject will be excluded from entry if ANY of the criteria listed below are met:\n - Subjects with a history of anaphylaxis and/or severe local reaction(s) to skin testing with allergens.\n - Subjects with intolerable symptoms that would make participating in the study unbearable.\n - Subjects who have had an upper respiratory tract or sinus infection that required antibiotic therapy, and have not had at least a 14-day washout prior to the run-in period, or who have had a viral upper respiratory infection within 7 days prior to screening.\n - Subjects with asthma who require chronic use of inhaled or systemic corticosteroids.\n - Subjects with current or a history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.\n - Subjects on immunotherapy (desensitization therapy) unless on a regular maintenance schedule prior to Visit 1 and staying on this schedule for the remainder of the study.\n - Subjects who, in the opinion of the investigator, are dependent on nasal, oral or ocular decongestants, nasal topical antihistamines or nasal steroids.\n - Subjects who have used any drug or device in an investigational protocol in the 30 days prior to Visit 1.\n - Female subjects who are pregnant or nursing.\n - Subjects with a history of hypersensitivity to the study drug or to their excipients or known to not tolerate any antihistamines.\n - Subject is a member of the Investigational Study Staff (currently involved with this study) or a member of the staffs family.\n - Subjects with current evidence of clinically significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disease, or other diseases that preclude the subjects participation in the study.\n - Subjects whose ability to provide informed consent is compromised.\n - Subjects with a history of noncompliance with medications or treatment protocols.\n - Subjects with rhinitis medicamentosa.\n - Subjects who have, in the opinion of the investigator or designee, clinically significant nasal structural abnormalities, including large nasal polyps or marked septum deviation, that significantly interferes with nasal air flow.\n - Subjects who have not observed the medication washout times outlined in the protocol prior to Visit 2. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00279916 | [
{
"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:** otitis media, serous, negative middle ear pressure, rhinitis, otitis media with effusion, otitis media, secretory\n\n**ICD Codes:** \"H65.03, H65.23, H65.00, H65.01, H65.02, H65.06, H65.20\", \"A41.50, A41.59, E70.320, Z17.1, Z67.11, Z67.21, Z67.31\", \"J30.0, J31.0, J30.89, J30.9, A50.05, J30.2, J30.1\", \"J94.0, I31.3, J91.0, M25.40, M25.411, M25.412, M25.419\"\n\n**Drugs:** triamcinolone acetonide nasal spray, placebo nasal spray\n\n**SMILES:** H\\\\C(=C(\\\\H)C1=CC=C(OC)C=C1)C(=O)OCC(CC)CCCC, 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, age 0-18 years\n - Patients with serous otitis media and/or negative middle ear pressure as documented by otoscopic examination and tympanometry will be considered for enrollment\n - Pregnant\n Exclusion Criteria:\n - Unwilling to discontinue breast feeding, when applicable\n - Active upper respiratory infection\n - Nasopharyngeal mass\n - Chronic infectious otitis media\n - Cholesteatoma\n - Acute infectious otitis media\n - History of otologic surgery other than placement of a pressure equalizer tube in the affected ear\n - History of radiation therapy to the head and neck region\n - Neuromuscular disease\n - Cystic fibrosis\n - Immunodeficiency\n - Mucociliary disorders\n - Craniofacial disorders/syndromes\n - Cleft palate\n - Development delay and/or symptoms suggestive of perilymph fistula \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT01667731 | [
{
"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:** hepatitis c, human immunodeficiency virus\n\n**ICD Codes:** \"B18.2, B17.10, B17.11, B19.20, B19.21, B15.0, B15.9\", \"B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4\"\n\n**Drugs:** sof, rbv\n\n**SMILES:** CC(C)OC(=O)C@H(C)NP@(=O)(OCC@H1OC@@H(N2C=CC(=O)NC2=O)C@(C)(F)C@@H1O)OC1=CC=CC=C1, NC(=O)C1=NN(C=N1)C@@H1OC@H(CO)C@@H(O)C@H1O\n\n**CT Criteria:** Inclusion Criteria:\n - Willing and able to provide written informed consent\n - Male or female, age ≥ 18 years with chronic HCV and HIV-1 infection\n - HCV RNA > 1 x 10^4 IU/mL at screening\n - Infection with HCV genotype 1, 2 or 3 as determined at screening\n - HIV-1 infection confirmed with positive ELISA or Western blot at screening\n - Medical records must be sufficient to be categorized on interferon (IFN) eligibility or prior treatment history with PEG/RBV.\n - Confirmation of chronic HCV infection\n - Ability to determine presence/absence of cirrhosis.\n - HIV antiretroviral therapy (ARV) criteria of one of the following:\n - ARV untreated with a CD4 T-cell count > 500 cells/mm^3\n - On a stable, protocol-approved, ARV for > 8 weeks prior to screening with a CD4 T-cell count > 200 cells/mm^3 and a documented undetectable plasma HIV-1 RNA level for ≥ 8 weeks preceding the screening visit\n - Approved HIV antiretroviral medications based on drug interaction studies\n - Not been treated with any investigational drug or device within 30 days of the screening visit\n - Females if confirmed that she is not pregnant or nursing of non-childbearing potential or of childbearing potential but has a negative serum pregnancy test at screening and agrees to use protocol approved method of birth control from screening through 6 months after the last dose of RBV\n - Males who agree to consistently and correctly use a condom while their female partner agrees to use protocol approved method of birth control from screening through 7 months after the last dose of RBV\n - Must be of generally good health as determined by the investigator.\n - Liver imaging within 6 months of baseline/Day 1 is required in cirrhotic patients only, to exclude hepatocellular carcinoma (HCC)\n Exclusion Criteria:\n - Non-genotype 1/2/3 or mixed genotype at screening\n - Genotype 1 with prior treatment for HCV\n - Poor control with ARV regimen\n - Prior exposure to a direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase\n - Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilsons disease, α1 antitrypsin deficiency, cholangitis)\n - A new AIDS-defining condition diagnosed within 30 days prior to screening\n - Active, serious infection (other than HIV or HCV) requiring parenteral antibiotics, antivirals or antifungals within 30 days prior to baseline\n - Infection with hepatitis B virus (HBV)\n - Contraindication to RBV therapy\n - Chronic use of systemically administered immunosuppressive agents (eg, prednisone equivalent > 10 mg/day)\n - History of solid organ transplantation or malignancy diagnosed or treated within 5 years\n - Current or prior history of clinical hepatic decompensation or other significant gastrointestinal disorder \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00389168 | [
{
"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:** irbesartan, atenolol\n\n**SMILES:** CCCCC1=NC(Cl)=C(CO)N1CC1=CC=C(C=C1)C1=CC=CC=C1C1=NNN=N1, CC(C)NCC(O)COC1=CC=C(CC(N)=O)C=C1\n\n**CT Criteria:** Inclusion Criteria:\n - At least 18 ys old\n - Male or female with no child bearing potential\n - Seated blood pressure diastolic 90-115 mm Hg\n - Left ventricular mass above 131 g/m2 for men, above 100 g/m2 for women\n - Informed consent\n Exclusion Criteria:\n - Coronary artery disease, heart failure or other significant cardiac disorder\n - Cerebrovascular accident within the past 6 months\n - A seated systolic blood pressure above 200 mm Hg\n - Significant renal disease, collagen or vascular disease, or gastrointestinal condition\n - Significant allergy or intolerance to study drug\n - Alcohol or drug abuse\n - Uncontrolled diabetes mellitus \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00049517 | [
{
"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:** busulfan, cyclophosphamide, cytarabine, gemtuzumab ozogamicin (go), daunorubicin\n\n**SMILES:** CS(=O)(=O)OCCCCOS(C)(=O)=O, ClCCN(CCCl)P1(=O)NCCCO1, ClCCN(CCCl)P1(=O)NCCCO1, 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(C)=O)C(O)=C1C2=O\n\n**CT Criteria:** Inclusion Criteria:\n - Morphologically confirmed acute myeloid leukemia (AML) (greater than 20% blasts in the peripheral blood or marrow) meeting any of the following criteria:\n - Recurrent cytogenetic translocations\n - t(8;21)(q22;q22)\n - Bone marrow eosinophil abnormalities\n - inv(16)(p13;q22)\n - t(16;16)(p13;q22)\n - 11q23 abnormalities\n - Multilineage dysplasia without presence of myelodysplastic syndromes (MDS)\n - Minimally differentiated AML\n - AML without maturation\n - AML with maturation\n - AML not otherwise categorized\n - Acute myelomonocytic leukemia\n - Acute monocytic leukemia\n - Acute erythroid leukemia\n - Acute megakaryocytic leukemia\n - Acute basophilic leukemia\n - Patients undergoing allogeneic transplantation must have a sibling donor match defined as human leukocyte antigen (HLA) match or haplotype match with one locus mismatch on other haplotype\n - Age 16 to 60\n - Eastern Cooperative Oncology Group (ECOG) performance status 0-4\n - Aspartate aminotransferase (AST) less than 4 times upper limit of normal (ULN)\n - Alkaline phosphatase less than 4 times ULN\n - Creatinine no greater than 2.0 mg/dL\n - Creatinine clearance at least 50 mL/min\n - Left ventricular ejection fraction (LVEF) at least 45% by post-induction multigated acquisition (MUGA) scan\n - Negative pregnancy test\n - Fertile patients must use effective contraception\n - HIV negative\n - Prior hydroxyurea allowed\n - Prior corticosteroids allowed\n Exclusion Criteria:\n - Recurrent cytogenetic translocations\n - Acute promyelocytic leukemia (PML) with t(15;17)(q22;q21)\n - Variant acute PML with t(v;17)\n - Multilineage dysplasia with prior MDS\n - Acute panmyelosis with myelofibrosis\n - Blastic transformation of chronic myelogenous leukemia\n - Secondary AML (chemotherapy-induced or evolved from MDS)\n - Pregnant or nursing\n - Bilirubin greater than 2.0 mg/dL (unless related to Gilberts syndrome or hemolysis)\n - Significant cardiac disease requiring active therapy (e.g., digoxin, diuretics, antiarrhythmics, or antianginal medications)\n - Prior biologic therapy\n - Prior cytotoxic chemotherapy for any malignancy\n - Prior radiotherapy for any malignancy \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00360568 | [
{
"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:** dyskinesias, \"parkinsons disease\", severe motor fluctuations\n\n**ICD Codes:** \"G20\"\n\n**Drugs:** levodopa-carbidopa intestinal gel\n\n**SMILES:** CC@@(CC1=CC(O)=C(O)C=C1)(NN)C(O)=O\n\n**CT Criteria:** Inclusion Criteria:\n - Idiopathic Parkinsons disease (PD) according to United Kingdon Parkinsons Disease Society (UKPDS) Brain Bank Criteria\n - Levodopa-responsive with severe motor fluctuations\n - Completion of protocol S187.3.001 (NCT00357994) or S187.3.002 (NCT00660387) and continue to meet the inclusion criteria for the preceding study\n Exclusion Criteria:\n - Patients with medically relevant abnormal findings (labs, electrocardiogram ECG, physical examination, adverse events, psychiatric, neurological or behavioral disorders, etc.) at end of the double-blind phase (Week 12) of Study S187.3.001 (NCT00357994) or Study S187.3.002 (NCT00660387) \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01282151 | [
{
"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:** carcinoma, non small cell lung\n\n**ICD Codes:** \"D02.20, D02.21, D02.22\"\n\n**Drugs:** taxotere, pemetrexed\n\n**SMILES:** HN(H)(H)Pt(Cl)(Cl)N(H)(H)H, HN(H)(H)Pt(Cl)(Cl)N(H)(H)H\n\n**CT Criteria:** Inclusion Criteria:\n - Age >= 18 years old\n - ECOG performance status 0-2\n - Non-squamous cell type non-small cell lung cancer (NSCLC)\n - Stage IV, Stage IIIB cannot be treated with curative intent or Relapsed after surgery or radiation therapy\n - No prior chemotherapy except adjuvant chemotherapy and concurrent chemoradiation treatment. The last dose of adjuvant chemotherapy should be at least 6 months earlier from randomization, and the regimen should not contain docetaxel or pemetrexed.\n - No prior immunotherapy, biologic therapy\n - Measurable lesion with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1\n - Hemoglobin >=9.0g/dl, Platelet >=100,000/uL, neutrophil >=1,500 /uL Creatinine <=1.5 x upper normal limit or creatinine clearance >=60 mL/min Bilirubin <=1.5 x upper normal limit, Transaminases <=2 x upper normal limit Alkaline phosphatase <=2 x upper normal limit\n - Written informed consent\n Exclusion Criteria:\n - Pregnancy, Lactating woman\n - Woman in child bearing age who refuses to do pregnancy test\n - Moderate or greater than grade 1 motor or sensory neurotoxicity\n - Hypersensitivity to taxane\n - Comorbidity or poor medical conditions\n - Other malignancy (except cured basal cell carcinoma or uterine cervical carcinoma in situ)\n - Concurrent treatment with other investigational drugs within 30 days before randomization\n - Active treatment with other anticancer chemotherapy\n - EGFR mutation (exon 19 deletion, L858R, L861Q, G719A/C/S) \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00657501 | [
{
"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:** hypoactive sexual desire disorder\n\n**ICD Codes:** \"F52.0\"\n\n**Drugs:** testosterone gel, placebo gel\n\n**SMILES:** HC@@12CCC@H(O)C@@1(C)CCC@@1(H)C@@2(H)CCC2=CC(=O)CCC@12C, HC@@12C@@H(C)C3=C(C(O)=CC=C3)C(=O)C1=C(O)C@1(O)C(=O)C(C(N)=O)=C(O)C@@H(N(C)C)C@1(H)C@H2O\n\n**CT Criteria:** Inclusion Criteria:\n - Must be between the ages of 30 to 65 years\n - Must have undergone hysterectomy and bilateral salpingo-oophorectomy\n Exclusion Criteria:\n - A history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation\n - Any systemic skin diseases or local skin abnormalities in the area of application\n - Diagnosed with another primary female sexual dysfunction (e.g., Sexual Aversion Disorder, Female Sexual Arousal Disorder).\n - A medical condition that could affect or interfere with sexual function\n - Using a systemic transdermal gel or cream estrogen therapy. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00264537 | [
{
"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:** rheumatoid arthritis\n\n**ICD Codes:** \"M06.9, M05.9, M06.08, M06.00, M06.011, M06.012, M06.019\"\n\n**Drugs:** placebo injections, placebo capsules, methotrexate capsules\n\n**SMILES:** CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)NC@@H(CCC(O)=O)C(O)=O\n\n**CT Criteria:** Inclusion Criteria:\n - Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ACR) for at least 3 months prior to first administration of study agent\n - Are methotrexate (MTX)-naïve (ie, have not received more than 3 weekly doses of MTX for RA at any time)\n - Have active RA as defined by persistent disease activity with at least 4 swollen and 4 tender joints, at the time of screening and baseline, and at least 2 of the following 4 criteria: a) C-reactive protein (CRP) >=1.5 mg/dL at screening or erythrocyte sedimentation rate (ESR) by Westergren method of >= 28 mm in the first hour at screening or baseline, b)Morning stiffness of >= 30 minutes at screening and baseline, c)Bone erosion by x-ray and/or MRI prior to first administration of study agent, d)Anti-cyclic citrullinated peptide (anti-CCP) antibody-positive or rheumatoid factor (RF) positive at screening\n - If using oral corticosteroids, must be on a stable dose equivalent to <= 10 mg of prednisone/day for at least 2 weeks prior to first administration of study agent.\n Exclusion Criteria:\n - Can not have inflammatory diseases other than RA that might confound the evaluation of the benefit of golimumab therapy\n - No treatment with disease-modifying anti-rheumatic drugs (DMARDs)/systemic immunosuppressives during the 4 weeks prior to the first administration of study agent\n - No prior treatment with biologic anti-TNF drugs (infliximab, etanercept, adalimumab)\n - No history of, or ongoing, chronic or recurrent infectious disease\n - No serious infection within 2 months prior to first administration of study agent. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT01106690 | [
{
"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:** placebo, canagliflozin, sitagliptin, metformin, pioglitazone\n\n**SMILES:** CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, HC@1(OC@H(CO)C@@H(O)C@H(O)C@H1O)C1=CC=C(C)C(CC2=CC=C(S2)C2=CC=C(F)C=C2)=C1, NC@@H(CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F, CSCCC@H(N)C(O)=O, NC@@H(CCCNC(N)=N)C(O)=O\n\n**CT Criteria:** Inclusion Criteria:\n - All patients must have a diagnosis of T2DM and be currently treated with PPAR gamma agent ((pioglitazone or rosiglitazone) and another anti-diabetes agent (metformin)\n - Patients in the study must have a HbA1c between >=7 and <=10.5% and a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)\n Exclusion Criteria:\n - History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy\n - or a severe hypoglycemic episode within 6 months before screening \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00382109 | [
{
"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:** b-cell childhood acute lymphoblastic leukemia, childhood acute lymphoblastic leukemia in remission, graft versus host disease, l1 childhood acute lymphoblastic leukemia, l2 childhood acute lymphoblastic leukemia, t-cell childhood acute lymphoblastic leukemia\n\n**ICD Codes:** \"C83.57, C83.50, C91.01, C91.02, C83.52, C83.56, C83.53\", \"D89.810, D89.811, D89.813, D89.812\"\n\n**Drugs:** thiotepa, cyclophosphamide, tacrolimus, methotrexate, sirolimus\n\n**SMILES:** CN(C)CCOC(C)(C1=CC=CC=C1)C1=CC=CC=N1, ClCCN(CCCl)P1(=O)NCCCO1, COC1=CC2=C(C(OC)=C1OC)C1=CC=C(OC)C(=O)C=C1C(CC2)NC(C)=O, CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)NC@@H(CCC(O)=O)C(O)=O, CC(=O)CC(C1=CC=CC=C1)C1=C(O)C2=C(OC1=O)C=CC=C2\n\n**CT Criteria:** Inclusion Criteria:\n - Histologically or cytologically confirmed acute lymphoblastic leukemia (ALL) in second complete remission (CR2) (M1 bone marrow, < 5% blasts by morphology) meeting the following criteria:\n - Intermediate risk relapsed ALL in CR2 (may receive matched sibling transplantation only) meeting 1 of the following criteria:\n - B-lineage ALL in CR2 after a late first bone marrow (BM) relapse (≥ 36 months after the initiation of primary chemotherapy) with or without associated extramedullary disease\n - B-lineage ALL in CR2 after a very early isolated extramedullary relapse (<18 months from the initiation of primary chemotherapy)\n - High risk relapsed ALL in CR2 (may receive other related donor, unrelated donor, or matched sibling transplantation) meeting 1 of the following criteria:\n - In CR2 after an early first BM relapse (< 36 months from initiation of primary chemotherapy)\n - T-lineage ALL in CR2 after a first BM relapse occurring at any time after initiation of primary chemotherapy\n - Philadelphia chromosome-positive ALL in CR2 after a first BM relapse occurring at any time after the initiation of primary chemotherapy\n - T-lineage ALL in CR2 after a very early isolated extramedullary relapse (<18 months from the initiation of primary chemotherapy)\n - High risk de novo ALL in CR1 (may receive matched sibling, other related/unrelated BM/PBSC or unrelated CB transplantation) meeting 1 of the following criteria:\n - Patients with the presence of t(9;22) translocation (Ph+) detected by cytogenetic or PCR analysis at initial diagnosis. For patients on AALL0622, the criteria for transplant are 1) any patient with Ph+ ALL with an available matched sibling donor or 2) any patient with Ph+ ALL that is defined as high risk (MRD > 1% Day 29 or MRD > 0.01% end-Consolidation Block 2) with any available donor, related or unrelated. Patients enrolled on AALL0622 are only eligible if they follow this algorithm.\n - Patients with the presence of extreme hypodiploidy (< 44 chromosomes or DNA index of < 0.81) detected by cytogenetic/ploidy analysis at initial diagnosis.\n - Patients with the presence of 11q23 (MLL) rearrangements detected by cytogenetic or PCR analysis at initial diagnosis who are slow early responders (M2/M3 at Day 14 or MRD > 0.1% at Day 29).\n - Enrolled on an appropriate COG relapsed ALL clinical trial after completing the required study therapy (i.e., minimum 1 re-induction course (4-6 weeks) and 1 round of intensive consolidation chemotherapy (3-6 weeks). Patients with high risk ALL in CR1 are eligible as soon as they have achieved a CR.\n - Patients not on a COG relapsed ALL clinical trial are eligible provided they have received ≥ 1 round of re-induction lasting 4-6 weeks and 1 round of intensive consolidation chemotherapy lasting 3-6 weeks\n - No B-cell ALL L3 morphology with evidence of myc translocation by molecular or cytogenetic technique\n - No Down syndrome\n - No evidence of active CNS or other extramedullary disease (i.e., no CNS2)\n - Karnofsky performance status (PS) 60-100% (for patients > 16 years of age) OR Lansky PS 60-100% (for patients ≤ 16 years of age)\n - Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram\n - ALT or AST < 5 times upper limit of normal\n - Bilirubin < 2.5 mg/dL (unless an increase is attributable to Gilberts syndrome)\n - Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min\n - FEV_1 ≥ 60% by pulmonary function tests (PFTs)\n - FVC ≥ 60% by PFTs\n - DLCO ≥ 60% by PFTs\n - For children who are unable to cooperate for PFTs all of the following criteria must be met:\n - No evidence of dyspnea at rest\n - No exercise intolerance\n - No requirement for supplemental oxygen therapy\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective contraception\n - No HIV or uncontrolled fungal, bacterial, or viral infection\n - Fungal infection acquired during induction therapy allowed provided there is a significant response to antifungal therapy with minimal or no evidence of disease by CT scan\n - Other concurrent immunosuppressants allowed\n - No prior allogeneic or autologous stem cell transplantation\n - No prior or concurrent voriconazole unless prior voriconazole therapy is completed or a different agent is substituted for voriconazole prior to study entry\n - No concurrent grapefruit juice during sirolimus administration \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00314860 | [
{
"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:** restless legs syndrome, restless legs syndrome (rls)\n\n**ICD Codes:** \"G25.81\", \"G25.81, R45.1\"\n\n**Drugs:** ropinirole extended release (xr)\n\n**SMILES:** CCCN(CCC)CCC1=C2CC(=O)NC2=CC=C1\n\n**CT Criteria:** Inclusion Criteria:\n - Diagnosis of primary RLS according to RLS Diagnostic Clinical Interview and International Restless Legs Syndrome Study Group Diagnostic Criteria.\n - Disturbed sleep, with both evening (between 5:00 pm and 8:00 pm) and night time (between 8:00 pm and 8:00 am) symptoms requiring treatment.\n Exclusion criteria:\n - Signs of secondary RLS.\n - Primary sleep disorder or movement disorder other than RLS.\n - Unstable medical conditions.\n - Inability to tolerate dopamine agonists or dopamine antagonists.\n - Unwilling to discontinue any medications currently being taken to treat RLS symptoms. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00131391 | [
{
"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:** obesity\n\n**ICD Codes:** \"E66.8, E66.9, E66.1, O99.214, O99.215, O99.210, O99.211\"\n\n**Drugs:** comparator: taranabant, comparator: placebo\n\n**SMILES:** CC@H(NC(=O)C(C)(C)OC1=CC=C(C=N1)C(F)(F)F)C@@H(CC1=CC=C(Cl)C=C1)C1=CC=CC(=C1)C#N, CN(C)C(=N)NC(N)=N\n\n**CT Criteria:** Inclusion Criteria:\n - Body Mass Index (BMI) between 30-43 kg/m2\n Exclusion Criteria:\n - History of major psychiatric disorder\n - History of seizures or at high risk of developing seizures\n - Blood pressure greater than 160/100\n - Fasting blood glucose greater than 126 mg/dL\n - Triglycerides greater than 600 mg/dL \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00065507 | [
{
"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:** hepatitis b\n\n**ICD Codes:** \"B18.0, B18.1, B19.10, B19.11, B17.0, B16.0, B16.1\"\n\n**Drugs:** entecavir (etv), adefovir (adv)\n\n**SMILES:** NC1=NC(=O)C2=C(N1)N(C=N2)C@H1CC@H(O)C@@H(CO)C1=C, CC(C)(C)C(=O)OCOP(=O)(COCCN1C=NC2=C(N)N=CN=C12)OCOC(=O)C(C)(C)C\n\n**CT Criteria:** Inclusion\n - Child-Pugh (CP) score >= 7\n - Hepatitis B virus (HBV) viremia\n Exclusion\n - Alanine aminotransferase (ALT) > 15 x upper limit of normal (ULN)\n - Human immunodeficiency virus (HIV)/hepatitis C virus (HCV)/hepatitis D virus (HDV) coinfection \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01093651 | [
{
"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, insulin resistance\n\n**ICD Codes:** \"E23.2, N25.1, P70.2, O24.92, Z83.3, Z86.32, E10.65\", \"Z16.11, Z16.21, D68.51, Z16.20, Z16.24, Z16.22, Z16.23\"\n\n**Drugs:** sitagliptin, placebo\n\n**SMILES:** NC@@H(CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F, 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. Thirty 18-65 yr old HIV-infected men and women (with source documentation of HIV status) who are stable on any antiretroviral therapy (cART) regimen\n 2. Have stable (at least the past 12-months) immunologic (>350 CD4+ T-cells/µL) and virologic (<50 copies HIV RNA/mL) status.\n 3. BMI 18-42kg/m2;\n 4. Normal blood chemistry for at least 1 month prior to enrollment;\n 5. Platelet count > 30,000/mm3, absolute neutrophil count >750/mm3, transaminases < 2.5x the upper limit of normal (ULN).\n 6. Long-term non-progressors (not on ART) are not eligible.\n Exclusion Criteria:\n 1. CD4+ T-cell count <350 cells/µL or detectable plasma HIV RNA (>50 copies HIV RNA/mL) within the past 12-months. During the study, if CD4+ T-cell count declines by >100 cells/µL, or if plasma HIV RNA becomes detectable (>50 copies HIV RNA/mL after repeat analysis 2wks apart), and the participant denies any lapse in their anti-HIV medication regimen, the study medication will be stopped and an adverse event documented. If at any time during the study, two participants experience a reduction in T-cell count >100 cells/µL, or their plasma HIV RNA levels become detectable (>50 copies HIV RNA/mL after repeat analysis 2wks apart), and they are confirmed (by unblinding) to have received sitagliptin, the study will be stopped for serious safety concerns.\n 2. Systemic, secondary or opportunistic infection within past 12-months.\n 3. Fasting glucose intolerance (FBG >100mg/dL), fasting hyperinsulinemia (>15µU/mL), or fasting insulin resistance (Homeostasis model for insulin resistance (HOMA) >3.0). Any agents that might alter glucose metabolism (insulin, TZDs, metformin, glucocorticoids, sulfonylurea, corticosteroids, megace, rhGH, GH-secretagogue) during the 3 months prior to enrollment or at any time during enrollment. Volunteers with T2DM, IDDM or diabetic ketoacidosis will not be enrolled.\n 4. History of serious CV disease or NYHA Functional Class III or IV, (e.g., recent MI, unstable angina, edema, CHF, CAD, CABG, valve disease (murmur), stroke, uncontrolled high blood pressure (resting >160/95 mmHg), irregular heart rhythm, resting ST-segment depression >1mm). Treatment with medications for a CV condition (cardiac glycosides α- or ß-blockers). Some antihypertensive medications (calcium-channel blocker, diuretic, angiotensin II receptor blockers (ARB), angiotensin converting enzyme inhibitors (ACE)) will be permitted.\n 5. Moderate to severe renal insufficiency. Serum creatinine >1.7 mg/dL (men) >1.5 mg/dL (women).\n 6. Known allergy or hypersensitivity to DPPIV-inhibitors.\n 7. Plan to change anti-HIV medication regimen or prophylaxis for opportunistic infection within 6-months of starting study.Transitions among efavirenz-based regimens will be allowed (e.g., Efavirenz + lamivudine + zidovudine (combivir) to Efavirenz + emtricitabine + tenofovir (Atripla)).\n 8. Lipid-lowering medications are permitted (fibrate or statin or niacin), but must be stable on that agent for at least 3 months prior to enrollment. Lipid-lowering agents cannot be started during the treatment period.\n 9. Chronic hepatitis B infection (HB surface antigen positive). Active hepatitis C infection (detectable Hep C RNA). Those who have cleared hepatitis B or C infection are eligible.\n 10. Hematocrit <34% in men or <25% in women with symptoms (fatigue, \"tired-legs\", shortness of breath). Hemoglobin <10 gm/100ml with symptoms.\n 11. Nausea, vomiting, diarrhea (>4 loose stools/day) that are unresponsive to treatment. History of eating disorder or significant GI-disease.\n 12. Pregnant or nursing mothers. Women must agree to use an acceptable form of birth control during the study. If birth control pills are used, the woman must be stable on these medications for at least 6 months prior to enrollment.\n 13. Active malignancy or treatment with chemotherapeutic agents or radiation therapy (within past 12 months).\n 14. >10% unintentional body weight loss during the 12 months prior to enrollment.\n 15. \"Blinded\" investigational drugs/medications during the 3 months prior to enrollment that will not be unblinded before enrollment. Open-label investigational drugs are permitted (within past 3 months, no plan to stop during enrollment and not known to affect glucose, lipid, adipose tissue or liver metabolism).\n 16. Over the counter agents that might alter glucose, lipid, or adipose tissue metabolism (e.g., creatine monohydrate, chromium picolinate, amino acid/protein supplements, medium- or long-chain fatty acids) within 1 month of enrollment. These supplements are not permitted during the treatment period.\n 17. Reduced cognitive function/unable to provide voluntary informed consent. Prisoners are excluded.\n 18. Active substance abuse that the physician-scientist believes may compromise safety, compliance, or interfere with study drug or data interpretation.\n 19. Any cytokine or anti-cytokine therapy during 3 months prior to enrollment. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00309686 | [
{
"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:** affective psychosis, bipolar, bipolar disorder, mania\n\n**ICD Codes:** \"F31.81, F31.89, F31.9, F25.0, F31.0, F31.31, F31.32\"\n\n**Drugs:** paliperidone er\n\n**SMILES:** CC1=C(CCN2CCC(CC2)C2=NOC3=C2C=CC(F)=C3)C(=O)N2CCCC(O)C2=N1\n\n**CT Criteria:** Inclusion Criteria:\n - Meets Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria for Bipolar I Disorder, Most Recent Episode Manic or Mixed (with or without psychotic features)\n - History of at least 1 previously documented manic or mixed episode requiring medical treatment within the past 3 years\n - Must have been taking lithium or valproate as part of treatment for Bipolar I Disorder for at least 2 weeks before screening, with drug levels at screening within therapeutic range\n - Total YMRS score of at least 20 at screening and at baseline (Day 1)\n - Women must be postmenopausal for at least 2 years or agree to practice an effective method of birth control throughout the study.\n Exclusion Criteria:\n - Meets DSM-IV criteria for rapid cycling and schizoaffective disorder\n - In the opinion of the study doctor, is at significant risk for suicidal or violent behavior during the course of the study\n - Has used cocaine, phencyclidine, amphetamine, methylphenidate, pemoline, an opioid (excluding codeine), hallucinogen, or any other drug that may be associated with manic symptoms as evidenced by a positive urine drug screen\n - Has received benzodiazepines at doses equal to 4 mg/day of lorazepam or higher for a period of 3 months or longer immediately before the screening phase. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00546286 | [
{
"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:** glaucoma, ocular hypertension\n\n**ICD Codes:** \"H40.9, Q15.0, B73.02, H40.823, H40.89, H44.513, H40.821\", \"H40.053, H40.051, H40.052, H40.059\"\n\n**Drugs:** dorzolamide hydrochloride (+) timolol maleate, comparator: dorzolamide hcl/timolol maleate + prostaglandin\n\n**SMILES:** CCNC@H1CC@H(C)S(=O)(=O)C2=C1C=C(S2)S(N)(=O)=O, CCNC@H1CC@H(C)S(=O)(=O)C2=C1C=C(S2)S(N)(=O)=O\n\n**CT Criteria:** Inclusion Criteria:\n - Patient has been recently diagnosed and is presently untreated for Open-Angle Glaucoma Or Ocular Hypertension With An iop of at least 27 mmhg in at least one eye (patients worse eye)\n - Patient Already Diagnosed With Open-Angle Glaucoma Or Ocular Hypertension And Untreated For At Least 30 Days Are Eligible For The Study If They Have An Iop Of 27 Mmhg Or More In At Least One Eye\n Exclusion Criteria:\n - A History Of Any Illness That, In The Opinion Of The Investigator, Might Confound The Results Of The Study Or Pose Additional Risk By Administering Dorzolamide-Timolol (Cosopt®) Or Prostaglandins\n - The Presence Of Any Fundus Pathology Likely To Change During The Study Or To Influence Iop (Background Of Diabetic Retinopathy Is Permitted)\n - Any Contraindication To The Use Of Cosopt® Including: - Bronchospasm, Including Bronchial Asthma Or A History Of Bronchial Asthma Or Chronic Obstructive Pulmonary Disease. - Sinus Bradycardia, Second Or Third Degree Av Block, Cardiac Failure (Grade Iii And Iv), Cardiogenic Shock\n - Patient On Oral Carbonic Anhydrase Inhibitor, Concomitant Systemic Or Dermatological Medication Known To Affect The Iop, E.G. Clonidine, Corticosteroids, Oral Beta-Blocking Agents\n - Pregnant Woman Or A Woman Of Childbearing Potential Who Is Sexually Active And Not Using An Acceptable Method Of Contraception (For Ex: Oral Contraceptive, Diaphragm, Contraceptive Sponge, Intra-Uterine Device, Long-Acting Contraceptive Injections, Double-Barrier Methods) Beginning At Least 7 Days Prior To Treatment And Continuing At Least 14 Days After The Last Visit Or The Discontinuation Visit. (Women Who Are Postmenopausal Or Have Received A Hysterectomy Or Have Undergone Tubal Ligature Are Considered As Not Having Childbearing Potential.)\n - Severe Renal Impairment (Serum Creatinine > 150 umol/L Or Creatinine Clearance < 30 ml/min) \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01360554 | [
{
"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:** dacomitinib (pf-00299804), active comparator (erlotinib), placebo erlotinib, placebo pf00299804\n\n**SMILES:** COC1=C(NC(=O)\\\\C=C\\\\CN2CCCCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1, COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\n**CT Criteria:** Inclusion Criteria:\n - Evidence of pathologically confirmed, advanced NSCLC (with known histology).\n - Prior treatment with at least one and no more than two systemic therapy regimens (at least one must be standard chemotherapy for advanced NSCLC).\n - Adequate tissue sample must be submitted prior to randomization for tumor biomarker analyses.\n - Adequate renal, hematologic, liver function.\n - ECOG PS of 0-2.\n - Radiologically measurable disease.\n Exclusion Criteria:\n - Small cell histology.\n - Symptomatic brain mets or known leptomeningeal mets.\n - Prior therapy with agent known or proposed to be active by action on EGFR tyrosine kinase or other HER family proteins.\n - Uncontrolled medical disorders. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00650104 | [
{
"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:** parkinson disease\n\n**ICD Codes:** \"G20\"\n\n**Drugs:** ropinirole xl (formerly cr)\n\n**SMILES:** CCCN(CCC)CCC1=C2CC(=O)NC2=CC=C1\n\n**CT Criteria:** Inclusion Criteria:\n - Males or non-pregnant/non-breast feeding females\n - At least 30 years of age\n - Diagnosis of idiopathic Parkinsons disease (Hoehn & Yahr criteria)\n - Completed either Study 167 or Study 164\n Exclusion Criteria:\n - Presence of uncontrolled psychiatric, hematological, renal, hepatic,endocrinological, neurological, cardiovascular disease or active malignancy\n - Dizziness or fainting due to orthostatic hypotension on standing\n - Significant sleep disorder\n - Drug abuse or alcoholism \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00734162 | [
{
"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:** hepatitis b virus (hbv)\n\n**ICD Codes:** \"B00.81, B25.1, B26.81, B58.1, K75.4, A51.45, B17.2\"\n\n**Drugs:** tenofovir disoproxil fumarate (tdf), placebo\n\n**SMILES:** HC@@(C)(CN1C=NC2=C(N)N=CN=C12)OCP(=O)(OCOC(=O)OC(C)C)OCOC(=O)OC(C)C, 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, 12 through 17 years of age, inclusive (consent of parent/legal guardian required)\n - Documented chronic HBV infection\n - HBeAg positive or HBeAg negative\n - Weight > 35 kg\n - Able to swallow oral tablets\n - HBV DNA > 100,000 copies/mL (polymerase chain reaction (PCR) method)\n - Alanine aminotransferase (ALT) > 2 × upper limit of normal (ULN) at screening, OR any history of ALT > 2 × ULN over the past 24 months\n - Willing and able to provide written informed consent/assent (child and parent/legal guardian)\n - Negative serum pregnancy test (for postmenarchal females only)\n - Estimated glomerular filtration rate (creatinine clearance using the Schwartz formula) > 80 mL/min/1.73m^2\n - Adequate hematologic function (absolute neutrophil count ≥ 1,500/mm^3; hemoglobin ≥ 10.0 g/dL)\n - No prior TDF therapy (participants may have received prior interferon or oral anti-HBV nucleoside/nucleotide therapy; participants must have discontinued interferon therapy ≥ 6 months prior to screening; participants experienced on anti-HBV nucleoside/nucleotide therapy must have discontinued therapy ≥ 16 weeks prior to screening to avoid flare if randomized to the placebo arm)\n Exclusion Criteria\n - Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study\n - Males and females of reproductive potential who are not willing to use an effective method of contraception during the study\n - Decompensated liver disease\n - Receipt of interferon (pegylated or not) therapy within 6 months of the Screening Visit\n - Receipt of anti-HBV nucleoside/nucleotide therapy within 16 weeks of the Screening Visit\n - Alpha fetoprotein > 50 ng/mL\n - Evidence of hepatocellular carcinoma (HCC)\n - Coinfection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)\n - History of significant renal disease (eg, nephrotic syndrome, renal dysgenesis, polycystic kidney disease, congenital nephrosis, acute tubular necrosis, other renal disease)\n - History of significant bone disease (eg, osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochondroses, multiple bone fractures)\n - Significant cardiovascular, pulmonary, or neurological disease\n - Evidence of a gastrointestinal malabsorption syndrome that may interfere with absorption of orally administered medications\n - History of solid organ or bone marrow transplantation\n - Ongoing therapy with nephrotoxic agents, competitors of renal excretion, systemic chemotherapeutic agents, systemic corticosteroids, interleukin-2 (IL-2), or other immunomodulating or investigational agents\n - Known hypersensitivity to the study drugs, the metabolites or formulation excipients\n - Any other condition (including alcohol or substance abuse) or prior therapy that, in the opinion of the Investigator, would make the participants unsuitable for the study or unable to comply with dosing requirements \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01494857 | [
{
"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:** ulcerative colitis\n\n**ICD Codes:** \"K51.80, K51.813, K51.814, K51.90, K51.913, K51.914, K51.811\"\n\n**Drugs:** adalimumab\n\n**SMILES:** O\n\n**CT Criteria:** Inclusion Criteria:\n 1. Male or female ≥ 18 years of age.\n 2. Diagnosis of ulcerative colitis for greater than 90 days prior to Baseline.\n 3. Diagnosis of active UC confirmed by colonoscopy with biopsy or flexible sigmoidoscopy with biopsy during the Screening Period, with exclusion of infection.\n 4. Active UC with a Mayo score of 6 to 12 points and endoscopy subscore of 2 to 3 points, despite concurrent treatment with at least 1 of the following (oral corticosteroids or immunosuppressants or both as defined below):\n - Stable oral corticosteroid dose (prednisone dose of >= 20 mg/day or equivalent) for at least 14 days prior to Baseline or stable oral corticosteroid dose (prednisone of < 20 mg/day) for at least 40 days prior to Baseline, and/or\n - At least a consecutive 90 day course of azathioprine or 6-mercaptopurine (6 MP) prior to Baseline, with a dose of azathioprine >= 1.5 mg/kg/day or 6 MP >= 1 mg/kg/day (rounded to the nearest available tablet formulation), or a dose that is the highest tolerated by the participant (e.g., due to leukopenia, elevated liver enzymes, nausea) during that time. Participant was to be on a stable dose for at least 28 days prior to Baseline.\n 5. Concurrent therapy was not required for participants who were previously treated with corticosteroids or immunosuppressants (azathioprine or 6-MP) during the previous 5 years and, in the judgment of the investigator, have failed to respond to or could not tolerate their treatment.\n 6. Has to be able to self-administer subcutaneous injections or has caregiver who can reliably administer subcutaneous injections.\n 7. Has to be able and willing to give written informed consent and to comply with the requirements of this study protocol.\n Exclusion Criteria:\n 1. History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC or is planning bowel surgery.\n 2. Received previous treatment with adalimumab or previous participation in an adalimumab clinical study.\n 3. Received cyclosporine, tacrolimus, or mycophenolate mofetil, within 30 days prior to Baseline.\n 4. Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.\n 5. Received therapeutic enema or suppository, other than required for endoscopy, within 14 days prior to the Screening endoscopy and during the remainder of Screening Period.\n 6. Current diagnosis of fulminant colitis and/or toxic megacolon.\n 7. Subject with disease limited to the rectum (ulcerative proctitis).\n 8. Current diagnosis of indeterminate colitis.\n 9. Current diagnosis and/or history of Crohns disease.\n 10. Currently receiving total parenteral nutrition (TPN).\n 11. Subject using aminosalicylates for less than 90 days prior to Baseline or not on a stable dose for at least 28 days prior to Baseline or discontinued use within 28 days of Baseline.\n 12. Subject with positive Clostridium difficile (C. difficile) stool assay.\n 13. Subject who has previously used infliximab or any anti-TNF agent within 56 days of Baseline.\n 14. Subject who has previously used infliximab or any anti-TNF agent and has not clinically responded at any time (\"primary non-responder\") unless subject experienced a treatment limiting reaction. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00323037 | [
{
"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:** congestive heart failure\n\n**ICD Codes:** \"I50.20, I50.21, I50.22, I50.30, I50.31, I50.32, I50.40\"\n\n**Drugs:** carvedilol controlled release, carvedilol immediate release\n\n**SMILES:** COC1=CC=CC=C1OCCNCC(O)COC1=CC=CC2=C1C1=CC=CC=C1N2, COC1=CC=CC=C1OCCNCC(O)COC1=CC=CC2=C1C1=CC=CC=C1N2\n\n**CT Criteria:** Inclusion Criteria:\n - Male or non-pregnant female\n - At least 18 years of age at the time informed consent is signed\n - Stable, chronic, mild to severe heart failure as defined as subjects with symptoms of heart failure who do not require IV diuretics, inotropes, or vasodilators or those that require support with a left ventricular assist device\n - Angiotensin converting enzyme inhibitors or angiotensin receptor blockers should be prescribed to all patients with HF due to LV systolic dysfunction with reduced LVEF unless contraindicated or intolerant to use\n - At screening, subject has an LVEF < 40 as measured by 2-D echocardiography\n - Willing to provide written informed consent\n Exclusion Criteria:\n - On beta-blocker therapy for greater than 42 days prior to consent\n - Acute ischemic coronary event or coronary revascularization (PTCA, CABG, thrombolysis) within 1 week of screening echocardiography\n - Scheduled or expected to be scheduled coronary revascularization within 4 weeks\n - Unstable angina (angina characterized by sudden changes in the severity or length of angina attacks or a decrease in level of exertion that precipitates an episode\n - Uncorrected primary obstructive or severe regurgitant valvular disease, nondilated (restrictive) or hypertrophic cardiomyopathies\n - Uncontrolled ventricular arrhythmias (symptomatic or sustained ventricular arrhythmias not controlled with antiarrhythmic therapy or an implantable defibrillator)\n - Current treatment of calcium channel blockers except for long acting dihydropyridines\n - Current treatment on any Class I or III antiarrhythmic, except amiodarone\n - History of sick sinus syndrome unless a pacemaker is in place\n - Second or third degree heart block unless a pacemaker is in place\n - Current clinical evidence of obstructive pulmonary disease (e.g., asthma or bronchitis) requiring inhaled or oral bronchodilator or steroid therapy; or having a history of bronchospastic disease not undergoing active therapy in whom, in the investigators opinion, treatment with study medication could provoke bronchospasm\n - Expected biventricular pacemaker placement within 8 months of enrollment\n - Resting systolic blood pressure <90 mmHg (based on the average of 3 readings\n - Resting heart rate <50 beats per minute (bpm) (based on the average of 3 readings)\n - Current decompensated heart failure\n - Elevated liver enzymes (i.e., ALT or AST levels greater than 3 times upper limit of normal)\n - History of drug sensitivity or allergic reaction to alpha or beta-blockers\n - Contraindication or intolerance to beta-blockers\n - Pregnant or lactating women and women planning to become pregnant. NOTE: Female subjects must be post-menopausal (i.e., no menstrual period for a minimum of 6 months prior to screening), surgically sterilized, using a double barrier method contraceptive, or using Depo-Provera or implanted contraceptives for at least one month prior to screening and agree to continue to use the same contraceptive method throughout the study.\n - Use of an investigational drug within 30 days of enrollment\n - Participation in an investigational device trial within 30 days of enrollment\n - Known drug or alcohol abuse 1 year prior to enrollment\n - In the opinion of the investigator the subject is known to be noncompliant with prescribed medication regimen\n - Has any systemic disease, including cancer, with reduced life expectancy (<12 months)\n - Has a history of psychological illness/condition that interferes with ability to understand or complete requirements of the study. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00372593 | [
{
"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:** asparaginase, cytarabine, daunorubicin hydrochloride, etoposide, gemtuzumab ozogamicin, mitoxantrone hydrochloride\n\n**SMILES:** NC@@H(CC(O)=O)C(O)=O, ClCCN(CCCl)P1(=O)NCCCO1, 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(C)=O)C(O)=C1C2=O, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, OCCNCCNC1=CC=C(NCCNCCO)C2=C1C(=O)C1=C(C(O)=CC=C1O)C2=O\n\n**CT Criteria:** DISEASE CHARACTERISTICS:\n - Newly diagnosed acute myeloid leukemia (AML)\n - Meets customary criteria for AML with ≥ 20% bone marrow blasts (by WHO classification)\n - Patients with < 20% bone marrow blasts and cytopenia or myelodysplastic syndromes (e.g., chronic myelomonocytic leukemia, refractory anemia (RA), RA with excess blasts, RA with ringed sideroblasts) are eligible provided 1 of the following criteria is met:\n - Karyotypic abnormality characteristic of de novo AML (t8;21q22;q22, inv16p13q22, t16;16p13;q22, or 11q23 abnormalities)\n - Unequivocal presence of megakaryoblasts (by WHO classification)\n - Isolated myeloid sarcoma (i.e., myeloblastoma or chloroma) allowed regardless of bone marrow results\n - Infants < 1 month of age with progressive disease* are eligible NOTE: *Infants < 1 month of age with AML may be given supportive care until it is clear that the leukemia is not regressing (i.e., the disappearance of peripheral blasts and the normalization of peripheral blood counts)\n - Patients with Down syndrome ≥ 4 years of age are eligible\n - No juvenile myelomonocytic leukemia\n - No Fanconis anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome\n - No promyelocytic leukemia (M3)\n - No secondary or treatment-related AML\n - Matched family donor criteria (for patients with intermediate-risk or high-risk disease):\n - HLA-A, -B, -C, and beta chain (-DRB1), identical or 1 antigen or allele mismatched by molecular high resolution technique\n - All available first-degree family members (parents and siblings) must be HLA typed\n - No syngeneic donors\n - Matched alternative donor criteria (for patients with high-risk disease):\n - HLA-A, -B, -C, and -DRB1, identical or 1 antigen or allele mismatched donor\n - HLA-A, -B, and -DRB1 4 of 6 antigen matched unrelated cord blood donor\n - Mismatched family member donor with ≥ 1 haplotype match or 5 of 6 antigen phenotypic match\n PATIENT CHARACTERISTICS:\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective contraception\n PRIOR CONCURRENT THERAPY:\n - No prior chemotherapy, radiation therapy, or any antileukemic therapy\n - Topical or inhalation steroids for other conditions allowed\n - Intrathecal cytarabine given at diagnosis allowed\n - No other prior treatment for AML\n - No concurrent peripheral blood stem cell transplantation in patients with matched family donor \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01768286 | [
{
"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 hepatitis c virus\n\n**ICD Codes:** \"B00.81, B25.1, B26.81, B58.1, K75.4, A51.45, B17.2\"\n\n**Drugs:** ldv/sof, rbv\n\n**SMILES:** CC(C)OC(=O)C@H(C)NP@(=O)(OCC@H1OC@@H(N2C=CC(=O)NC2=O)C@(C)(F)C@@H1O)OC1=CC=CC=C1, NC(=O)C1=NN(C=N1)C@@H1OC@H(CO)C@@H(O)C@H1O\n\n**CT Criteria:** Inclusion Criteria:\n - Age > 18, with chronic genotype 1 HCV infection\n - HCV treatment-experienced, including patients who have previously failed a nonstructural protein (NS)3/4A protease inhibitor plus pegylated interferon (PEG)/RBV regimen\n - HCV RNA > 10,000 IU/mL at screening\n - Cirrhosis determination; a liver biopsy may be required\n - Screening laboratory values within defined thresholds\n - Use of two effective contraception methods if female of childbearing potential or sexually active male\n Exclusion Criteria:\n - Pregnant or nursing female or male with pregnant female partner\n - Coinfection with HIV or hepatitis B virus\n - Current or prior history of clinical hepatic decompensation\n - Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)\n - Chronic use of systemic immunosuppressive agents\n - History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01223937 | [
{
"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:** nocturia\n\n**ICD Codes:** \"R35.1\"\n\n**Drugs:** desmopressin, placebo\n\n**SMILES:** NC(=O)CCC@@H1NC(=O)C@H(CC2=CC=CC=C2)NC(=O)C@H(CC2=CC=C(O)C=C2)NC(=O)CCSSCC@H(NC(=O)C@H(CC(N)=O)NC1=O)C(=O)N1CCCC@H1C(=O)NC@@H(CCCNC(N)=N)C(=O)NCC(N)=O, 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 prior to performance of any trial-related activity\n - Female sex 18 years of age or older\n - At least 2 voids every night in a consecutive 3-day period during the screening period\n Exclusion Criteria:\n 1. Evidence of severe daytime voiding dysfunction defined as:\n - Urge urinary incontinence (more than 1 episode/day in the 3-day diary period)\n - Urgency (more than 1 episode/day in the 3-day diary period)\n - Frequency (more than 8 daytime voids/day in the 3-day diary period)\n 2. Interstitial cystitis\n 3. Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention\n 4. Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours)\n 5. Central or nephrogenic diabetes insipidus\n 6. Syndrome of inappropriate anti-diuretic hormone secretion\n 7. Current or a history of urologic malignancies e.g. bladder cancer\n 8. Genitourinary tract pathology e.g., infection or stone in the bladder and urethra causing symptoms\n 9. Neurogenic detrusor activity (detrusor overactivity).\n 10. Suspicion or evidence of cardiac failure\n 11. Uncontrolled hypertension\n 12. Uncontrolled diabetes mellitus\n 13. Hyponatraemia: Serum sodium level must be within normal limits\n 14. Renal insufficiency: Serum creatinine must be within normal limits and estimated glomerular filtration rate must be more than or equal to 50 mL/min\n 15. Hepatic and/or biliary diseases: Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels must not be more than twice the upper limit of normal range. Total bilirubin level must not be more than 1.5 mg/dL\n 16. History of obstructive sleep apnea\n 17. Previous desmopressin treatment for nocturia\n 18. Treatment with another investigational product within 3 months prior to screening\n 19. Concomitant treatment with any prohibited medication e.g., loop diuretics (furosemide, torsemide, ethacrynic acid) and any other investigational drug\n 20. Pregnancy, breastfeeding, or a plan to become pregnant during the period of the clinical trial. Subjects of reproductive age must have documentation of a reliable method of contraception. All pre-and perimenopausal subjects have to perform pregnancy tests. Amenorrhea of more than 12 months duration based on the reported date of the last menstrual period is sufficient documentation of post-menopausal status and does not require a pregnancy test\n 21. Known alcohol or substance abuse\n 22. Work or lifestyle that may interfere with regular nighttime sleep e.g., shift workers\n 23. Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity, or language barrier that, in the judgment of the Investigator, would impair participation in the trial \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00357097 | [
{
"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:** restless legs syndrome, moderate to severe idiopathic restless legs syndrome (rls)\n\n**ICD Codes:** \"G25.81\", \"E20.0, I95.0, L50.1, D61.3, G24.2, G24.4, G60.3\"\n\n**Drugs:** ropinirole\n\n**SMILES:** CCCN(CCC)CCC1=C2CC(=O)NC2=CC=C1\n\n**CT Criteria:** Inclusion criteria:\n - diagnosis of idiopathic Restless Legs Syndrome, confirmed by a score of at least 11 on the RLS Diagnostic Index\n - certain severity of symptoms (at least score of 15 on the International Restless Legs Score (IRLS)\n - Have had RLS symptoms for at least 15 nights in the last four weeks.\n - < 6 hours of sleep in nights with RLS symptoms\n - MADRS (depression rating scale) score of at least 12 (= borderline to depression) at baseline\n Exclusion criteria:\n - any other sleep disorder that might interfere with the RLS symptoms or sleep (e.g. sleep apnea disorder, narcolepsy)\n - Secondary RLS due to diagnosis of renal insufficiency, polyneuropathy, pregnancy (see below), iron deficiency anemia\n - Any significant psychiatric disorders (e.g. schizophrenia, bipolar disorder); depression which by judgement of the investigator is caused by RLS, is not an exclusion criterion.\n - Current or past suicidality\n - medication known to trigger/aggravate/ cause or interfere with RLS symptoms (e.g. most antidepressants, lithium, neuroleptics, opioids, carbidopa, clonidine, antihistamines, anticonvulsants etc.).\n - daytime RLS symptoms which require treatment (daytime: 10 a.m. until 6 p.m.).\n - concomitant movement disorders (e.g. Parkinsons Disease, dyskinesia, dystonia).\n - medical conditions with symptoms which could affect assessments of efficacy (e.g. diabetes, rheumatoid arthritis, fibromyalgia syndrome, cancer etc.).\n - Subjects taking any medication known to induce drowsiness or to affect sleep.\n - Subjects who are pregnant, lactating or of childbearing potential. Women of childbearing potential must use adequate contraception\n - clinically significant or unstable medical conditions (e.g. severe heart disease, severe liver or kidney disease etc.).\n - pain syndromes, caused by other disorders than RLS\n - excessive caffeine intake\n - diastolic blood pressure >110mmHg or <50mmHg or systolic blood pressure >180mmHg or <90mmHg at baseline.\n - Withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) or the oral contraceptive pill (OCP) and/or certain drugs which are known to interact with ropinirole (e.g. ciprofloxacin, cimetidine, tobacco, omeprazole). \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01560195 | [
{
"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:** nsclc, neutropenia, febrile neutropenia\n\n**ICD Codes:** \"D70.4, D70.8, D70.9, P61.5, D70.3\"\n\n**Drugs:** pegylated rhg-csf: 100µg/kg, pegylated rhg-csf: 6mg, placebo and rhg-csf 5ug/kg/d\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 - Investigator diagnosis of staged III or IV NSCLC\n - Age 18 to 70 years\n - ECOG performance status ≤ 1\n - Chemotherapy naïve\n - Body weight ≥ 45kg\n - Hemoglobin ≥ 100g/L; white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥1.5 × 109/L; platelet count ≥ 100 × 109/L\n - Alanine transarninase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN; total bilirubin ≤1.5×ULN\n Exclusion Criteria:\n - History of systematic chemotherapy or radical radiation therapy\n - Prior bone marrow or stem cell transplantation\n - Received systemic antibiotics treatment within 72 h of chemotherapy\n - Pregnancy or lactation \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01170442 | [
{
"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, vitamin d deficiency\n\n**ICD Codes:** \"P70.2, O24.92, Z83.3, E10.65, E10.9, E11.65, E11.9\", \"E55.9, D51.0, D51.1, D51.3, D51.8, D51.9, E50.0\"\n\n**Drugs:** vitamin d3 2000 iu, vitamin d3 5000 iu, placebo\n\n**SMILES:** CC(C)CCCC@@H(C)C@@1(H)CCC@@2(H)\\\\C(CCCC@12C)=C\\\\C=C1\\\\CC@@H(O)CCC1=C, CC(C)CCCC@@H(C)C@@1(H)CCC@@2(H)\\\\C(CCCC@12C)=C\\\\C=C1\\\\CC@@H(O)CCC1=C, 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 - Type II diabetics living in Riyadh area who consume no more than one serving of milk/day\n - Do not take vitamin supplement\n - Habitually have less than 10 hour of sun exposure per week\n - Dont suffer from granulomatous conditions, liver disease, or kidney disease\n - Dont take anticonvulsants, barbiturates, or steroids.\n - Stable glycemic control (not more than 0.5% difference between current HA1c and a HA1c obtained 2-4 months earlier)\n - Current HA1c between 6.5 and 8%, and current total 25 OH vitamin D level between 10-30 nmol/L. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00660387 | [
{
"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:** \"advanced parkinsons disease\"\n\n**ICD Codes:** \"G20\"\n\n**Drugs:** levodopa carbidopa intestinal gel (lcig), placebo gel, levodopa-carbidopa (lc) oral encapsulated immediate release (ir) tablets, placebo (pbo) oral capsules\n\n**SMILES:** CC@@(CC1=CC(O)=C(O)C=C1)(NN)C(O)=O, HC@@12C@@H(C)C3=C(C(O)=CC=C3)C(=O)C1=C(O)C@1(O)C(=O)C(C(N)=O)=C(O)C@@H(N(C)C)C@1(H)C@H2O, 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 - Idiopathic Parkinsons disease (PD) according to United Kingdom Parkinsons Disease Society (UKPDS) Brain Bank Criteria\n - Levodopa-responsive participants who demonstrate some identifiable on response, established by Investigator observation\n - Demonstrate severe motor fluctuations in spite of individually optimized treatment and where therapy options are indicated\n Exclusion Criteria:\n - Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism\n - Undergone surgery for the treatment of PD\n - Contraindications to levodopa\n - Subjects with any neurological deficit that may interfere with the study assessments \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00200967 | [
{
"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:** salmeterol, beclomethasone hfa\n\n**SMILES:** OCC1=C(O)C=CC(=C1)C(O)CNCCCCCCOCCCCC1=CC=CC=C1, HC@@12CC@H(C)C@(OC(=O)CC)(C(=O)COC(=O)CC)C@@1(C)CC@H(O)C@@1(Cl)C@@2(H)CCC2=CC(=O)C=CC@12C\n\n**CT Criteria:** Inclusion Criteria:\n - Male or female, ages 18 and older\n - Clinical history consistent with asthma\n - For subjects regularly using inhaled corticosteroids, FEV1 50% of predicted, methacholine PC20 FEV1 16 mg/ml or 12% and 200 ml, improvement in FEV1 after 2 puffs of inhaled albuterol\n - For subjects not regularly using inhaled corticosteroids, FEV1 40% of predicted, methacholine PC20 FEV1 8 mg/ml or 12% and 200 ml, improvement in FEV1 after 2 puffs of inhaled albuterol\n - Genotype eligibility (determined during screening)\n Exclusion Criteria:\n - Smoker (total smoking history must be less than 10 pack years)\n - Significant unstable medical condition other than asthma\n - History of life-threatening asthma requiring treatment with intubation and mechanical ventilation in the past 10 years\n - Pregnant or lactating \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT03662763 | [
{
"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:** attention deficit disorder\n\n**ICD Codes:** \"F90.2, F90.8, F90.9, F90.0, F90.1\"\n\n**Drugs:** extended-release guanfacine hydrochloride (spd503), placebo oral capsule\n\n**SMILES:** NC(=N)NC(=O)CC1=C(Cl)C=CC=C1Cl, CC1=CC(O)=CC(C)=C1Cl\n\n**CT Criteria:** Inclusion Criteria:\n - male or female, aged 6-17 years at the time of consent/assent at Screening/Visit 1\n - subject meets DSM-IV-TR criteria for primaru diagnosis of ADHD\n - subject has a minimum ADHD-RS-IV total score of 32 at enrolment/visit 2\n - subject has a minimum CGI-S score of 4 at Enrolment/Visit 2\n - subject is able to swallow intact tablets\n Exclusion Criteria:\n - subject has a current controlled or uncontrolled, co-morbid psychiatric diagnosis.\n - subject has a know history or presence of structural cardiac abnormalities\n - subject with orthostatic hyupotension or a known history of controlled or uncontrolled hypertension\n - current use of any prohibited medication or other medications, including herbal supplements that affet blood pressure, or heart rate or that have CNS effects or affect cognitive performance\n - subject is significant overweight based on Centre for disease control and prevention BMI for age gender specific charts. Significantly overweight is defined as a BMI >95 th percentile Children aged 6-12 years with a body weight ,25,0kg, or adolescents aged 13-17 years with a body weight <43 kg or >91 kg at screening/visit 1\n - subject is currently considered a suicide risk in the opinion of the investigator\n - history of failure to respond to an adequate trial of an alfa2-agonist for the treatment of ADHD. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00395018 | [
{
"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:** hepatitis b, chronic\n\n**ICD Codes:** \"B18.0, B18.1, B18.2, B18.8, B18.9\"\n\n**Drugs:** entecavir\n\n**SMILES:** CCOC(=O)C1=CC=C(N)C=C1\n\n**CT Criteria:** Inclusion Criteria:\n - Patients receiving orthotopic liver transplant (OLT) due to end-stage liver disease because of chronic HBV infection, with HBV-DNA < 172 IU/mL (approximately < 1000 copies/mL) prior to liver transplant\n - Must have detectable hepatitis B surface antigen (HBsAg) at screening and for at least 24 weeks prior to screening\n Exclusion Criteria:\n - Patients with hepatocellular carcinoma with evidence of extrahepatic spread, multiple tumors ≥ 6.5 cm in diameter or there is up to three nodules ≥ 4.5 cm in diameter and total tumor diameter is ≥ 8 cm\n - Co-infection with human immunodeficiency virus (HIV), cytomegalovirus (CMV), Epstein-Barr virus (EBV) or hepatitis C virus (HCV) \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00312845 | [
{
"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-hodgkins lymphoma\"\n\n**ICD Codes:** \"S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S\"\n\n**Drugs:** bortezomib + rituximab, rituximab\n\n**SMILES:** CC(C)CC@H(NC(=O)C@H(CC1=CC=CC=C1)NC(=O)C1=CN=CC=N1)B(O)O, ClCCN(CCCl)P1(=O)NCCCO1\n\n**CT Criteria:** Inclusion Criteria:\n Subjects must satisfy the following criteria to be enrolled in the study:\n - Man or woman and age 18 years or older\n - Diagnosis of follicular B-NHL of the following subtypes (World Health Organization WHO classification 1997): follicular lymphoma (FL) (Grades 1 and 2).\n - Documented relapse or progression following prior antineoplastic treatment. New lesions or objective evidence of progression of existing lesions must document relapse or progression following the previous therapy.\n If any prior regimen included rituximab, the subject must have responded (complete response CR, unconfirmed complete response CRu, partial response PR), and the time to progression (TTP) from the first dose of rituximab must have been 6 months or more.\n - At least 1 measurable tumor mass (greater than 1.5 cm in the longest dimension and greater than 1.0 cm in the short axis) that has not been previously irradiated, or has grown since previous irradiation\n - In the opinion of the investigator the decision to initiate treatment is justified to manage the subjects lymphoma\n - No active central nervous system lymphoma\n - Eastern Cooperative Oncology Group ECOG status ≤ 2\n - Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at screening.\n - Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.\n - In countries where health authorities have approved the pharmacogenomic testing, subjects or their legally acceptable representatives must have signed a separate informed consent that they agree to participate in the genetic part and protein testing part of the study; participation in the genetic and protein testing component is mandatory for pharmacogenomics testing, but optional for serum protein testing and future testing.\n Exclusion Criteria:\n Potential subjects who meet any of the following criteria will be excluded from participating in the study:\n - Diagnosed or treated for a malignancy other than NHL within 1 year of randomization, or who were previously diagnosed with a malignancy other than NHL and have any radiographic or biochemical marker evidence of malignancy. Subjects with completely resected basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy are not excluded.\n - Clinical evidence of a transformation from indolent NHL to a more aggressive form of NHL.\n - History of disallowed therapies:\n - Prior treatment with VELCADE\n - Antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization\n - Nitrosoureas within 6 weeks before randomization\n - Radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization\n - Stem cell transplant within 6 months before randomization\n - Major surgery within 2 weeks before randomization\n - Residual toxic effects of previous therapy or surgery of Grade 3 or worse\n - Peripheral neuropathy or neuropathic pain of Grade 2 or worse\n - Have received an experimental drug or used an experimental medical device within 21 days before the planned start of treatment.\n - History of allergic reaction attributable to compounds containing boron or mannitol\n - Known anaphylaxis or immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab including polysorbate 80 and sodium citrate dihydrate\n - Concurrent treatment with another investigational agent\n - Female subject who is pregnant or breast-feeding \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00493974 | [
{
"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:** zileuton, placebo\n\n**SMILES:** CC(N(O)C(N)=O)C1=CC2=CC=CC=C2S1, 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 - Admitted to the hospital for a COPD exacerbation\n - FEV1 less than 60% of predicted level\n - At least 10 pack years of smoking\n Exclusion Criteria:\n - Any uncontrolled systemic disease\n - Known hypersensitivity to zileuton\n - Asthma\n - Lobar pneumonia or pulmonary edema\n - Interstitial lung disease\n - Medical condition that is likely to limit survival to less than 30 days at the time of study entry\n - History of liver disease\n - Current use of theophylline\n - Participation in another clinical trial in the COPD Clinical Research Network\n - Incarceration\n - Institutionalization\n - Pregnant\n - History of a suicide attempt\n - Prior inpatient admission for a psychiatric disorder\n - Bipolar disorder\n \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT01299376 | [
{
"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:** l50/h12.5/a5, l50/h12.5, placebo to l50/h12.5/a5, placebo to l50/h12.5\n\n**SMILES:** CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\n**CT Criteria:** Inclusion criteria:\n - Participant has a diagnosis of essential hypertension\n - Participant is being treated with a single, or dual combination treatment for hypertension and will be able to discontinue the prior antihypertensive medication\n - Participant has a mean trough SiDBP of ≥ 90 mmHg and < 110 mmHg\n - Participant has a mean trough SiSBP of ≥ 140 mmHg and < 200 mmHg\n - Participant has no clinically significant abnormality at screening visit\n Exclusion criteria:\n - Participant is currently taking >2 antihypertensive medications\n - Participant has a history of significant multiple and/or severe allergies to ingredients of Nu-Lotan or Preminent, amlodipine or dihydropyridine drug and thiazide drug or related drug (i.e., sulfonamide-containing \"chlortalidone\" medicines)\n - Participant is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history within the last year of drug or alcohol abuse or dependence\n - Participant is pregnant or breastfeeding, or expecting to conceive OR the pregnancy test is positive at screening visit (Visit 1)\n - Participant is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00282347 | [
{
"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:** lupus nephritis\n\n**ICD Codes:** \"B26.83, A51.44, N11.8, N11.9, N12\"\n\n**Drugs:** rituximab, placebo, mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, prednisone\n\n**SMILES:** ClCCN(CCCl)P1(=O)NCCCO1, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, NC@@H(CCCNC(N)=N)C(O)=O, HC@@12CCC@(O)(C(=O)CO)C@@1(C)CC@H(O)C@@1(H)C@@2(H)CCC2=CC(=O)CCC@12C, CN(C)CCOC(C1=CC=CC=C1)C1=CC=CC=C1, CC1=CC(O)=CC(C)=C1Cl, HC@@12CC=C(C3=CC=CN=C3)C@@1(C)CCC@@1(H)C@@2(H)CC=C2CC@@H(O)CCC@12C\n\n**CT Criteria:** Inclusion Criteria:\n - Diagnosis of systemic lupus erythematosus (SLE) according to current American College of Rheumatology (ACR) criteria.\n - Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis (LN), with either active or active/chronic disease.\n - Proteinuria.\n - 16-75 years of age.\n Exclusion Criteria:\n - Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE.\n - Unstable subjects with thrombocytopenia experiencing or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions.\n - Lack of peripheral venous access.\n - Pregnancy or lactation.\n - History of severe allergic or anaphylactic reactions to monoclonal antibodies.\n - Significant or uncontrolled medical disease in any organ system not related to SLE or LN, which, in the investigators opinion, would preclude subject participation.\n - Concomitant chronic conditions, excluding SLE (eg, asthma, Crohns disease) that require oral or systemic corticosteroid use in the 52 weeks prior to screening.\n - History of renal transplant.\n - Known human immunodeficiency virus (HIV) infection.\n - Known active infection of any kind (but excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous anti-infectives within 4 weeks of randomization or oral anti-infectives within 2 weeks of randomization.\n - History of deep space infection within 1 year of screening.\n - History of serious recurrent or chronic infection.\n - History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ (except basal cell carcinomas of the skin that have been treated or excised and have resolved).\n - Currently active alcohol or drug abuse or history of alcohol or drug abuse within 52 weeks prior to screening.\n - Major surgery requiring hospitalization within 4 weeks of screening (excluding diagnostic surgery).\n - Treatment with cyclophosphamide or calcineurin inhibitors within the 90 days prior to screening.\n - Use of mycophenolate mofetil (MMF) at a dose of > 2 grams daily for longer than the 90 days prior to screening.\n - Intolerance or history of allergic reaction to MMF.\n - Intolerance or history of allergic reaction to both angiotensin-converting enzyme (ACE) inhibitors and angiotensin-receptor blockers.\n - Use of oral prednisone (or corticosteroid equivalent) at a dose of > 20 mg/day for longer than the 14 days prior to screening.\n - Previous treatment with CAMPATH-1H (alemtuzumab).\n - Previous treatment with a B-cell targeted therapy.\n - Treatment with any investigational agent (including biologic agents approved for other indications) within 28 days of the start of the screening period or 5 half-lives of the investigational drug (whichever is longer).\n - Receipt of a live vaccine within the 28 days prior to screening.\n - Intolerance or contraindication to oral or IV corticosteroids.\n - Current therapy with a nonsteroidal anti-inflammatory agent.\n - Positive hepatitis B sAg or hepatitis C serology. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT01287221 | [
{
"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:** multiple system atrophy\n\n**ICD Codes:** \"G35, M15.3, M67.49, M89.09, M89.59, M94.29, Q78.6\"\n\n**Drugs:** rifampicin, placebo\n\n**SMILES:** NC(=O)C1=NC=CN=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 - Participants aged 30-80 years old with a diagnosis of Possible or Probable MSA of the parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) according to The Gilman Criteria (2008).\n - Participants who are less than 4 years from the time of documented MSA diagnosis.\n - Participants with an anticipated survival of at least 3 years in the opinion of the investigator.\n - Participants who are willing and able to give informed consent.\n - \"Normal\" cognition as assessed by Mini-Mental State Examination (MMSE). We will require a value >24.\n - Patients should be able to swallow capsules whole.\n Exclusion Criteria:\n - Pregnant or lactating females.\n - Unified Multiple System Atrophy Rating Scale (UMSARS) score >17 on modified UMSARS I (question 11 eliminated).\n - Participants with a clinically significant or unstable medical or surgical condition that, in the opinion of the investigator, might preclude safe completion of the study or might affect the results of the study. These include conditions causing significant Central Nervous System (CNS) or autonomic dysfunction, including congestive heart failure, recent (<6 months) myocardial infarct, thrombocytopenia (<50 x10(9)/L), immunosuppressed state, severe uncontrolled hypertension, severe cardiopulmonary disease, severe anemia (<8g/dl), severe liver or kidney disease (creatinine >2.3 mg/dl) uncontrolled diabetes mellitus (HbA1c >10g%), alcoholism, malignant neoplasms, amyloidosis, uncontrolled hypothyroidism, unstable peripheral neuropathies, concurrent infections, orthopedic problems that compromise mobility and activity of daily living, severe cerebrovascular accidents (such as hemiplegia, aphasia and non-dominant parietal lobe syndrome), and neurotoxins or neuroactive drug exposure, parkinsonism due to drugs (including neuroleptics, a-methyldopa, reserpine, metoclopramide).\n - Participants who have taken any investigational products within 60 days prior to baseline.\n - Women of child-bearing potential who do not practice an acceptable method of birth control. Acceptable methods of birth control in this study are: surgical sterilization, intrauterine devices, partners vasectomy, a double-protection method (condom or diaphragm with spermicide), hormonal contraceptive drug (i.e., oral contraceptive, contraceptive patch, long-acting injectable contraceptive) with a required second mode of contraception.\n - Participants taking Tetrabenazine, Rasagiline or Selegiline. The participant will qualify for the Rifampicin study after they have stopped these drugs for 3 months\n - Participants known to have porphyria.\n - Participants with abnormal liver function tests defined as 1.5 times the upper limit of normal.\n - Concomitant therapy with anticholinergic, alpha and beta adrenergic antagonists, or other medications that affect autonomic function will be stopped prior to autonomic evaluation.\n - The regular use of neuroleptics within the six months prior to the initial evaluation. Occasional use of a neuroleptic as an anti-emetic in the past is allowed, providing not more than three doses were taken within the previous 12 months.\n - Since Rifampicin has significant drug-drug interactions, particular attention has been devoted to the use of concomitant medications. Considering the target population, we will exclude participants taking antifungal medication (itraconazole), antiarrhythmics like amiodarone, digitalis and lorcainide, female hormones and quetiapine (Seroquel). Use of methylphenidate, cinnarizine, reserpine, amphetamine, atypical antipsychotics such as risperidone, olanzapine, and quetiapine or a Monoamine oxidase A (MAO-A) inhibitor within one month prior to the baseline visit are also exclusionary.\n - Diseases with features of Parkinsons Disease; e.g., progressive supranuclear palsy, essential tremor, inherited cerebellar degeneration, or postencephalitic parkinsonism.\n - Dementia (DSM-IV criteria - Amer. Psych. Association, 1994). The score on the MMSE must be >24. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT01611571 | [
{
"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:** osteoporosis\n\n**ICD Codes:** \"M81.6, Z82.62, Z13.820, M81.8, Z87.310, M81.0, M80.80XS\"\n\n**Drugs:** risedronate, teriparatide, placebo teriparatide, placebo risedronate\n\n**SMILES:** OC(CC1=CN=CC=C1)(P(O)(O)=O)P(O)(O)=O, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, OC(CC1=CN=CC=C1)(P(O)(O)=O)P(O)(O)=O\n\n**CT Criteria:** Inclusion Criteria:\n 1. Males, ages 30-85 with osteoporosis.\n 2. Osteoporosis can be due to hypogonadism, past steroid use, or idiopathic.\n 3. Patients with hypogonadism can be included if their replacement dosage of testosterone has been stable for at least 18 months.\n 4. Bone mineral density must be 2 or more standard deviations below (T-score 2.0) the young adult peak for men at the lumbar spine, the hip or the radius.\n 5. Normal renal (glomerular filtration rate >= 60 ml/min) and liver (less than or equal to twice the normal limits for ALT and AST) function.\n Exclusion Criteria:\n 1. Use of any specific osteoporosis drug in the previous 6 months.\n 2. Known or suspected metabolic bone diseases (such as renal osteodystrophy, osteomalacia) other than osteoporosis.\n 3. Preexisting hypercalcemia or an underlying hypercalcemic disorder, such as primary hyperparathyroidism.\n 4. Secondary hyperparathyroidism.\n 5. Pagets disease of bone or fibrous dysplasia. Teriparatide should not be given to patients with these conditions due to an increased risk of osteosarcoma.\n 6. Patients with any elevations of alkaline phosphatase that are secondary to bone disease, as such individuals may be at risk for osteosarcoma.\n 7. History or presence of any malignancy, except dermatological, but including melanoma. Known or suspected bone metastasis, or a history of skeletal malignancies.\n 8. Prior radiation therapy. Patients with prior radiation therapy should be excluded from treatment with teriparatide.\n 9. Any medical condition, which in the opinion of the investigator could preclude study participation, including but not limited to cardiovascular, gastric, renal and hepatic disorders, or abnormal PSA test. In particular, patients with active or recent (within the last 2 years) urolithiasis will be excluded.\n 10. History of previous major bowel surgery including bowel resection.\n 11. Oral use of systematic glucocorticoids for two or more weeks in the previous six months.\n 12. Parenteral use of systemic glucocorticoids on more than two occasions in the previous six months.\n 13. Use of anticonvulsant drugs.\n 14. History of uncontrolled diabetes mellitus (Patient with Type 2 diabetes who have HbA1C< 8 are permitted to be enrolled).\n 15. Hypercalciuria (> 4 mg/kg/day).\n 16. Impaired liver function (>twice the upper normal limits for ALT and AST).\n 17. Hyperadrenalism as assessed by physical examination.\n 18. Any other clinically significant laboratory abnormalities, which are deemed relevant to the design of the protocol.\n 19. Patients with known hypersensitivity to any of the test materials (teriparatide or risedronate) or related components (metacresol, mannitol, glacial acetic acid, sodium acetate).\n 20. Use of any investigational or unlicensed drug in the previous 30 days.\n 21. Patients who may be unreliable for the study, including those engaging in excessive alcohol consumption or drug abuse or patients who are unable to return for scheduled follow-up visits.\n 22. Patients who are unable or unwilling to comply fully with the protocol.\n 23. Inability to stand or sit upright for at least 30 minutes\n 24. Those with history of esophagitis, Barretts esophagus, esophageal/peptic ulcers or esophageal motility disorders\n 25. Hypocalcaemia\n 26. Renal dysfunction (GFR <60)\n 27. Patients planning invasive dental work such as implants, extractions or procedures involving the jaw bone or patients with poor oral hygiene\n 28. Use of digitalis.\n 29. Patients with HIV/AIDS. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00541021 | [
{
"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:** gemcitabine hydrochloride, sorafenib tosylate\n\n**SMILES:** NC1=NC(=O)N(C=C1)C@@H1OC@H(CO)C@@H(O)C1(F)F, CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1\n\n**CT Criteria:** DISEASE CHARACTERISTICS:\n Inclusion criteria:\n - Diagnosis of adenocarcinoma of the pancreas\n - Locally advanced or metastatic disease\n - Measurable disease, defined as at least 1 lesion measurable by RECIST criteria\n Exclusion criteria:\n - Brain metastases\n PATIENT CHARACTERISTICS:\n Inclusion criteria:\n - WHO performance status 0-2\n - Absolute neutrophil count > 1,500/mm^3\n - Platelet count > 100,000/mm^3\n - Creatinine < 1.5 times normal\n - Transaminases < 2 times normal (5 times normal if liver metastases)\n - Total bilirubin < 1.5 times normal\n - Fertile patients must use effective contraception\n Exclusion criteria:\n - Pregnant or nursing\n - Intestinal occlusion\n - Prior inflammatory intestinal disease\n - Crohns disease\n - Hemorrhagic rectal colitis\n - Peripheral neuropathy > grade 2\n - Other severe illness, including any of the following:\n - Unstable cardiac disease, even if treated\n - Psychological or neurological disease including dementia\n - Uncontrolled active infection\n - Other severe illness that would compromise study participation\n - Impossible to receive study therapy due to geographical, social, or psychological reasons\n - Other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix\n PRIOR CONCURRENT THERAPY:\n Inclusion criteria:\n - See Disease Characteristics\n - At least 6 months since prior chemotherapy or radiochemotherapy\n - At least 4 weeks since prior radiotherapy and/or surgery\n Exclusion criteria:\n - Prior therapy for advanced disease\n - Prior inhibitors of kinase signaling (e.g., ras/raf, MEK, AKT, mTOR, or farnesyl transferase)\n - Prior inhibitors of angiogenesis (e.g., bevacizumab)\n - Prior organ graft or allogeneic transplantation\n - Prior extensive intestinal resection\n - Concurrent participation in another therapeutic study\n - Concurrent inductors of CYP3A4 (e.g., barbiturates, anti-epileptics, or rifampicin) \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT01261611 | [
{
"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:** cervical dystonia\n\n**ICD Codes:** \"M50.20, M50.21, M50.30, M50.31, M50.80, M50.81, M50.90\"\n\n**Drugs:** 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 - Dystonia with at least 18 months duration since onset.\n - Previously untreated with Botulinum toxin-A (BTX-A) or -B or a minimum of 14 weeks since the last injection.\n - TWSTRS score at baseline of: Total score ≥ 30, Severity Sub-Scale score ≥ 15, Disability Sub-Scale score ≥ 3, Pain Sub-Scale score ≥ 2.\n Exclusion Criteria:\n - Known hypersensitivity to Botulinum toxin (BTX) or related compounds or any component in the study drug formulation (including cow milk protein).\n - Pure anterocollis or pure retrocollis.\n - In apparent remission from Cervical Dystonia.\n - Known clinically significant underlying swallowing or respiratory abnormality which might be exacerbated by BTX treatment.\n - Previous poor response to BTX treatment or known presence of BTX neutralising antibodies.\n - Previous phenol or alcohol injections into the neck muscles.\n - Previous myotomy or denervation surgery involving the neck or shoulder region. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00042302 | [
{
"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:** stage iiib non-small cell lung cancer, stage iv non-small cell lung cancer\n\n**ICD Codes:** \"C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2\", \"C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2\"\n\n**Drugs:** tariquidar + paclitaxel/carboplatin, placebo + paclitaxel/carboplatin\n\n**SMILES:** HN(H)(H)Pt1(OC(=O)C2(CCC2)C(=O)O1)N(H)(H)H, HN(H)(H)Pt1(OC(=O)C2(CCC2)C(=O)O1)N(H)(H)H\n\n**CT Criteria:** Inclusion Criteria:\n 1. Patients who have histologically or cytologically proven NSCLC, stage IIIb or stage IV, requiring first-line chemotherapy.\n 2. Patients who have a WHO performance status of 1 or 0 and life expectancy of greater than 3 months.\n 3. Patients who are 18 years of age or older and age of consent.\n 4. Patients who are women of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test (serum or urine) at screening, and must be practicing an adequate method of birth control.\n 5. Patients who have neutrophils greater or equal to 1.5 x 103/µL; platelets greater or equal to 100 x 103/µL; bilirubin less or equal to 1.5 times the upper limit of normal or less or equal to 26 µmol/L (1.5 mg/dL); transaminases less or equal to 2.5 times the upper limit of normal or, for patients with known liver metastases, less or equal to 5 times the upper limit of normal; and creatinine less or equal to 141 µmol/L (1.6 mg/dL) or calculated creatinine clearance greater or equal to 60 mL/min prior to study treatment.\n 6. Patients who are able to give written informed consent and comply with the protocol.\n Exclusion Criteria:\n 1. Patients who are eligible for radiotherapy or surgery for curative intent.\n 2. Patients who have had previous chemotherapy for NSCLC.\n 3. Patients who have a WHO performance status greater than 1.\n 4. Patients with bronchoalveolar carcinoma (an adenocarcinoma in which cylindrical tumor cells grow upon the walls of pre-existing alveoli, from WHO histological typing of lung tumors 1).\n 5. Patients who have previous or current primary malignancies at other sites within the last 5 years, with the exception of adequately treated cone-biopsied carcinoma of the cervix and basal or squamous cell skin carcinoma.\n 6. Patients who are a poor medical risk because of other nonmalignant systemic diseases or active uncontrolled infections.\n 7. Patients who have symptomatic brain metastases.\n 8. Patients who have peripheral neuropathy of CTC grade 2, 3, or 4.\n 9. Patients who have other medical or surgical conditions that would contraindicate chemotherapy.\n 10. Patients who have received experimental therapies within the last 4 weeks.\n 11. Patients who have known hypervitaminosis or known sensitivity to ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, d-panthenol, or vitamin E. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00708500 | [
{
"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:** hepatitis c, chronic\n\n**ICD Codes:** \"B18.2, B18.0, B18.1, B18.8, B18.9, K71.3, K71.4\"\n\n**Drugs:** boceprevir (sch 503034), ribavirin (sch 18908), boceprevir placebo\n\n**SMILES:** HC@12CN(C@H(C(=O)NC(CC3CCC3)C(=O)C(N)=O)C@@1(H)C2(C)C)C(=O)C@@H(NC(=O)NC(C)(C)C)C(C)(C)C, NC(=O)C1=NN(C=N1)C@@H1OC@H(CO)C@@H(O)C@H1O, NC(=O)C1=NN(C=N1)C@@H1OC@H(CO)C@@H(O)C@H1O\n\n**CT Criteria:** Inclusion Criteria:\n - Qualifying regimen defined as pegylated interferon alfa-2a plus ribavirin or pegylated interferon alfa-2b plus ribavirin for a minimum of 12 weeks.\n - During qualifying regimen, participants must have either a documented undetectable HCV-RNA within 30 days of end of treatment (EOT) and a subsequent detectable HCV-RNA during follow-up or a documented decline in HCV-RNA by >=2 log10 by Treatment Week 12\n - Previously documented CHC genotype 1 infection.\n - Liver biopsy with histology consistent with CHC and no other etiology.\n - Participants with bridging fibrosis or cirrhosis must have an ultrasound within 6 months of the Screening Visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC).\n - Participants participating in Schering-Plough Research Institute (SPRI) maintenance protocols P02570 (NCT00049842) or P02569 (NCT00048724) must have completed the study to be eligible for this protocol.\n - Participants must be >=18 years of age.\n - Participants must weigh between 40 kg and 125 kg.\n - Participants and participants partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations.\n - Participants must be willing to give written informed consent.\n Exclusion Criteria:\n - Coinfection with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B Surface Antigen HBsAg positive).\n - Discontinuation of previous interferon or ribavirin regimen for an adverse event (AE) considered by the investigator to be possibly or probably related to ribavirin and/or interferon.\n - Treatment with ribavirin within 90 days and any interferon-alpha within 1 month of Screening.\n - Treatment for hepatitis C with any investigational medication. Prior treatment with herbal remedies with known hepatotoxicity.\n - Treatment with any investigational drug within 30 days of the randomization visit.\n - Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial.\n - Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.\n - Diabetic and/or hypertensive participants with clinically significant ocular examination findings.\n - Pre-existing psychiatric conditions.\n - Clinical diagnosis of substance abuse of the specified drugs within the specified timeframes\n - Any known pre-existing medical condition that could interfere with the participants participation in and completion of the study.\n - Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin). Participants under evaluation for malignancy are not eligible.\n - Participants who are pregnant or nursing. Participants who intend to become pregnant during the study period. Male participants with partners who are, or intend to become, pregnant during the study period.\n - Any other condition which, in the opinion of a physician, would make the participant unsuitable for enrollment or could interfere with the participant participating in and completing the study.\n - Participants who are part of the site personnel directly involved with this study.\n - Participants who are family members of the investigational study staff.\n - Participants who had life-threatening serious adverse event (SAE) during screening period.\n - Protocol-specified hematologic, biochemical, and serologic criteria: Hemoglobin <12 g/dL for females and <13 g/dL for males; Neutrophils <1500/mm^3 (Blacks: <1200/mm^3); Platelets <100,000/mm^3; Direct bilirubin >1.5 x upper limit of normal (ULN).\n - Serum albumin <lower limit of normal (LLN)\n - Thyroid-stimulating hormone (TSH) >1.2 x ULN or <0.8 x LLN of laboratory reference range, with certain exceptions.\n - Serum creatinine >ULN of the laboratory reference.\n - Protocol-specified serum glucose concentrations.\n - Protocol-specified alpha fetoprotein range.\n - Prothrombin Time/Partial Thromboplastin Time (PT/PTT) values >10% above laboratory reference range.\n - Anti-nuclear antibodies (ANA) >1:320. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00714688 | [
{
"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:** attention deficit/ hyperactivity disorder\n\n**ICD Codes:** \"F90.2, F90.8, F90.9, F90.0, F90.1\"\n\n**Drugs:** prolonged release (pr) oros methylphenidate 54 mg, prolonged release (pr) oros methylphenidate 72 mg, placebo\n\n**SMILES:** HC@@(C(=O)OC)(C1=CC=CC=C1)C@@1(H)CCCCN1, HC@@(C(=O)OC)(C1=CC=CC=C1)C@@1(H)CCCCN1, 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 - Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV) and confirmed by the Conners Adult ADHD Diagnostic Interview for DSM IV\n - Described chronic course of ADHD symptomatology from childhood to adulthood, with some symptoms present before age 7 years and continue to meet DSM-IV criteria at the time of assessment\n - CAARS score of at least or equal to 24 as determined by investigator at screening visit\n - Patient agrees to take only the supplied study drug as treatment for ADHD during the study\n - Patient agrees not to initiate a new behavioral modification program during the study or if currently using a behavioral modification program agrees not to change this program during the study.\n Exclusion Criteria:\n - Known to be a non-responder to methylphenidate, or patient has a child known to be a non-responder to methylphenidate\n - Has been treated with any methylphenidate-containing medication within 1 month of screening visit\n - Participation in and premature withdrawal from 42603ATT3002, CR002479 or 42603ATT3004, CR011068 study\n - Known allergy or hypersensitivity to methylphenidate, or components of PR OROS methylphenidate\n - Any clinically unstable psychiatric condition including, but not limited to the following: acute mood disorder, bipolar disorder, acute obsessive-compulsive disorder (OCD), anti-social personality disorder, borderline personality disorder. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00442936 | [
{
"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:** migraine\n\n**ICD Codes:** \"G43.B1, G43.D1, G43.B0, G43.D0, G43.A1, G43.411, G43.419\"\n\n**Drugs:** telcagepant potassium 150 mg, telcagepant potassium 300 mg, zolmitriptan 5 mg, placebo to telcagepant 150 mg, placebo to tecagepant 300 mg, placebo to zolmitriptan 5 mg, rescue medication\n\n**SMILES:** HC@1(CCC@@(H)(N=C(O)N2CCC(CC2)N2C(O)=NC3=C2C=CC=N3)C(=O)N(CC(F)(F)F)C1)C1=C(F)C(F)=CC=C1, HC@1(CCC@@(H)(N=C(O)N2CCC(CC2)N2C(O)=NC3=C2C=CC=N3)C(=O)N(CC(F)(F)F)C1)C1=C(F)C(F)=CC=C1, CN(C)CCC1=CNC2=CC=C(CC@H3COC(=O)N3)C=C12, HC@1(CCC@@(H)(N=C(O)N2CCC(CC2)N2C(O)=NC3=C2C=CC=N3)C(=O)N(CC(F)(F)F)C1)C1=C(F)C(F)=CC=C1, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN(C)CCC1=CNC2=CC=C(CC@H3COC(=O)N3)C=C12\n\n**CT Criteria:** Inclusion Criteria:\n - Has at least 1 year history of migraine (with or without aura)\n - Females of child bearing potential must use acceptable contraception throughout trial.\n Exclusion Criteria:\n - Is pregnant/breast-feeding (or is a female expecting to conceive during study period)\n - Has history or evidence of stroke/transient ischemic attacks, heart disease, coronary artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled hypertension (high blood pressure), uncontrolled diabetes, or human immunodeficiency virus (HIV) disease\n - Has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)\n - Has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption\n - Has a history of cancer within the last 5 years. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00443703 | [
{
"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\n\n**ICD Codes:** \"Z21\"\n\n**Drugs:** mk0518 (raltegravir), comparator: kaletra™ (lopinavir (+) ritonavir ), comparator: placebo, comparator: placebo\n\n**SMILES:** CN1C(=O)C(O)=C(N=C1C(C)(C)NC(=O)C1=NN=C(C)O1)C(=O)NCC1=CC=C(F)C=C1, CC(C)C@H(N1CCCNC1=O)C(=O)NC@H(CC@H(O)C@H(CC1=CC=CC=C1)NC(=O)COC1=C(C)C=CC=C1C)CC1=CC=CC=C1, CN(C)C(=N)NC(N)=N, CN(C)C(=N)NC(N)=N\n\n**CT Criteria:** Inclusion Criteria:\n - Patient is at least 18 years of age\n - Patient is Human Immunodeficiency Virus (HIV) positive\n - Patient has documented Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 copies/milliliter (mL) for at least 3 months while on a KALETRA based regimen\n - Patient has been on a KALETRA based regimen for at least 3 months without a change in background antiretroviral therapy\n - Patient has no documentation of HIV RNA >50 copies/mL for at least 3 months while on the KALETRA based regimen\n Exclusion Criteria:\n - Patient is or plans to become pregnant, or nursing a child\n - Patient plans to donate eggs or impregnate/donate sperm\n - Patient is receiving Stavudine (d4T) as a component of the background antiretroviral therapy\n - Patient is currently receiving a second protease inhibitor in addition to KALETRA\n - Patient is currently receiving, or has received in the past twelve weeks, treatment for the management of elevated lipids\n - Patient has used another experimental HIV-integrase inhibitor\n - Patient has a current (active) diagnosis of acute hepatitis due to any cause\n - Patient has used systemic immunosuppressive therapy within one month prior to treatment in this study \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00443729 | [
{
"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\n\n**ICD Codes:** \"Z21\"\n\n**Drugs:** comparator: raltegravir, comparator: placebo, comparator: lopinavir (+) ritonavir, comparator: placebo\n\n**SMILES:** CN1C(=O)C(O)=C(N=C1C(C)(C)NC(=O)C1=NN=C(C)O1)C(=O)NCC1=CC=C(F)C=C1, CN(C)C(=N)NC(N)=N, CC(C)C@H(N1CCCNC1=O)C(=O)NC@H(CC@H(O)C@H(CC1=CC=CC=C1)NC(=O)COC1=C(C)C=CC=C1C)CC1=CC=CC=C1, CN(C)C(=N)NC(N)=N\n\n**CT Criteria:** Inclusion Criteria:\n - Patient is at least 18 years of age\n - Patient is human immunodeficiency virus (HIV) positive\n - Patient has documented Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 copies/milliliter (mL) for at least 3 months while on a KALETRA based regimen\n - Patient has been on a KALETRA based regimen for at least 3 months without a change in background antiretroviral therapy\n - Patient has no documentation of HIV RNA >50 copies/mL for at least 3 months while on the KALETRA based regimen\n Exclusion Criteria:\n - Patient is or plans to become pregnant, or is nursing a child\n - Patient plans to donate eggs or impregnate/donate sperm\n - Patient is receiving Stavudine (d4T) as a component of the background antiretroviral therapy\n - Patient is currently receiving a second protease inhibitor in addition to KALETRA\n - Patient is currently receiving, or has received in the past twelve weeks, treatment for the management of elevated lipids\n - Patient has used another experimental HIV-integrase inhibitor\n - Patient has a current (active) diagnosis of acute hepatitis due to any cause \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00384930 | [
{
"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:** benign prostatic hyperplasia\n\n**ICD Codes:** \"N40.0, N40.1\"\n\n**Drugs:** tadalafil, tadalafil, tadalafil, tadalafil, placebo\n\n**SMILES:** HC@12CC3=C(NC4=CC=CC=C34)C@H(N1C(=O)CN(C)C2=O)C1=CC2=C(OCO2)C=C1, HC@12CC3=C(NC4=CC=CC=C34)C@H(N1C(=O)CN(C)C2=O)C1=CC2=C(OCO2)C=C1, HC@12CC3=C(NC4=CC=CC=C34)C@H(N1C(=O)CN(C)C2=O)C1=CC2=C(OCO2)C=C1, HC@12CC3=C(NC4=CC=CC=C34)C@H(N1C(=O)CN(C)C2=O)C1=CC2=C(OCO2)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 - Males, 45 years or older, with benign prostatic hyperplasia, including lower urinary tract symptoms for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2.\n - Agree not to use approved or experimental benign prostatic hyperplasia or erectile dysfunction treatments anytime during the study\n - Have not taken finasteride or dutasteride therapy, any other lower urinary tract symptom (LUTS) therapy or phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to Visit 2.\n - Have a prostate specific antigen (PSA) score within acceptable range defined for study or negative biopsy of the prostate for cancer within 12 months of Visit 1.\n Exclusion Criteria:\n - History of urinary retention or lower urinary tract (bladder) stones 6 months before the start of the study\n - History of bladder outlet obstruction or urethral obstruction due to stricture, valves, sclerosis, or tumor.\n - History of cardiac conditions including angina requiring certain treatment with nitrates, heart disease or coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.\n - Certain neurological conditions associated with bladder problems or injuries to the brain or spinal cord within a specified time before starting the study.\n - Nitrate use \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01231464 | [
{
"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:** rhinitis, allergic, perennial, allergic rhinitis\n\n**ICD Codes:** \"J30.0, J31.0, J30.89, J30.9, A50.05, J30.2, J30.1\", \"J30.89, J30.9, J30.2, J30.1, J30.5, J30.81\"\n\n**Drugs:** fluticasone furoate nasal spray, placebo\n\n**SMILES:** HC@@12CC@@H(C)C@(OC(=O)C3=CC=CO3)(C(=O)SCF)C@@1(C)CC@H(O)C@@1(F)C@@2(H)CC@H(F)C2=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 - Subjects can be enrolled when meeting all criteria as below.\n 1. Chinese adolescent and adult (male or eligible female) outpatients with the age of >=12 years\n 2. Confirmative diagnosis of IAR or PER (as definitions from ARIA 2008 and the coming effective Chinese AR management guideline ), by medical history, symptoms, skin prick tests (SPTs)\n 3. Subject must be symptomatic at screening and willing to maintain same environment throughout the study\n 4. Ability to comply with study procedures\n 5. Literate\n Exclusion Criteria:\n - Subjects should be excluded when meeting one of criteria as below.\n 1. Having complications of nasal disease, or vasomotor rhinitis, rhinitis with eosinophilia, or drug rhinitis\n 2. Having complications of bacterial/viral infection of upper respiratory tract\n 3. Having significant systemic diseases\n 4. History of hypersensitivity to steroids and ingredients\n 5. Pregnant women or under lactation\n 6. Patients who started, discontinued or changed dose of desensitization therapy within 30 days before visit 1\n 7. Patients planning to travel outside the region\n 8. Patients judged to be inappropriate by investigators\n 9. Patients who participated in another study within 4 months before screening\n 10. Patients who could not withdraw drugs during screening period or secure withdrawal period until the initiation day of administration, e.g.\n 1. allergy medications\n 2. other medications that may affect allergic rhinitis or its symptoms\n 3. any medications that significantly inhibit CYP3A4, including ritonavir and ketoconazole \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00089141 | [
{
"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:** cancer\n\n**ICD Codes:** \"C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2\"\n\n**Drugs:** mycophenolate mofetil, placebo\n\n**SMILES:** NC@@H(CCCNC(N)=N)C(O)=O, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\n**CT Criteria:** DISEASE CHARACTERISTICS:\n - Newly diagnosed chronic-graft-versus host disease (GVHD)\n - Systemic immunosuppressive treatment indicated AND no contraindication to treatment with mycophenolate mofetil\n - Has undergone prior transplantation with any type of donor, hematopoietic stem cell graft, or conditioning regimen\n - No clinical, laboratory, or image-based evidence known to be present at the time of enrollment and indicating a high probability of subsequent recurrent or progressive disease\n PATIENT CHARACTERISTICS:\n Age\n - Any age\n Performance status\n - Not specified\n Life expectancy\n - Not specified\n Hematopoietic\n - Absolute neutrophil count ≥ 1,500/mm^3\n Hepatic\n - Not specified\n Renal\n - Not specified\n Pulmonary\n - No known bronchiolitis obliterans as a manifestation of chronic GVHD\n Immunologic\n - No fungal infection without radiographic evidence of improvement during continued antifungal therapy\n - No cytomegalovirus (CMV) pneumonia without major radiographic evidence of improvement\n - No other CMV infection without reduction of antigenemia or viral load during continued antiviral therapy\n - No active disseminated varicella zoster viral infection\n - No known hypersensitivity or allergy to MMF\n Gastrointestinal\n - Able to tolerate oral medication\n - No lactose-intolerant children who are too young to swallow capsules\n - No frank blood from the rectum\n - No melena\n - No known gastrointestinal ulceration\n Other\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective contraception\n - Female patients must use 2 forms of contraception 4 weeks prior to, during, and for 6 weeks after completion of study treatment\n - Not hospitalized at time of enrollment\n - No rare, hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT)\n PRIOR CONCURRENT THERAPY:\n Biologic therapy\n - See Disease Characteristics\n Chemotherapy\n - Not specified\n Endocrine therapy\n - Prior treatment with prednisone or equivalent allowed provided the dose was ≤ 1.0 mg/kg/day at the time of enrollment\n - Concurrent systemic glucocorticoids allowed\n Radiotherapy\n - Not specified\n Surgery\n - Not specified\n Other\n - Prior mycophenolate mofetil (MMF) for prevention or treatment of acute GVHD allowed provided MMF was discontinued at least 2 weeks before the diagnosis of chronic GVHD was made\n - No prior systemic treatment for chronic GVHD\n - No prior treatment for chronic GVHD\n - Concurrent antacids allowed provided there is at least a 2-hour interval before and after administration of MMF\n - No other concurrent systemic immunosuppressive treatment except cyclosporine, tacrolimus or sirolimus \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT01601990 | [
{
"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:** placebo group(once daily), lc15-0444 50mg qd\n\n**SMILES:** CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, NC@H(CN1CC(F)(F)CCC1=O)CC(=O)N1CCC2=C(C1)N=C(N=C2C(F)(F)F)C(F)(F)F\n\n**CT Criteria:** Inclusion Criteria:\n 1. Patients with Type 2 Diabetes Mellitus\n 2. Adults between 18 and 75 of age\n 3. Patients with HbA1c between 7 % and 11 %\n 4. Patient who had not received any diabetic medications within 6 weeks from screening\n 5. Patients who signed on the consent form after informed on the object, method, and risks of the clinical study\n Exclusion Criteria:\n 1. Patients with type 1 diabetes mellitus, gestational diabetes, or secondary diabetes\n 2. Patients who were taking or needed to take any drugs which may affect the control of blood glucose significantly (ex. glucocorticoids)\n 3. Patients who had experienced myocardial infarction, unstable angina or prior history of coronary artery bypass surgery within 6 months prior to screening, or patients with arrhythmia requiring treatment\n 4. Patients with NYHA class II-IV congestive heart failure\n 5. Patients with history of hepatic cirrhosis\n 6. Patients with renal failure or whose creatinine clearance was less than 60mL/min\n 7. Patients with dysfunctional thyroid gland (with abnormal level of TSH)\n 8. Patients with ALT, AST or CPK exceeding 2.5 times of the upper limit of the normal range\n 9. Patients with BMI below 20 kg/m2 or exceeding 40 kg/m2\n 10. Patients with history of asthma or major skin allergy\n 11. Patients taking thyroid hormone, warfarin, dicoumarin or digoxin.\n 12. Patients with history of hypersensitivity to metformin or biguanides.\n 13. Patients who took sodium channel blockers in the last 6 weeks prior to Visit 1.\n 14. Patients who were treated with insulin or glucagon-like peptide-1 (GLP-1) analogue or who took thiazolidinediones (Glitazone) in the last 6 months prior to Visit 1.\n 15. Patients with other reasons who the investigator decided not to be eligible for the study \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00038402 | [
{
"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:** herceptin, taxol, fluorouracil, cytoxan, epirubicin\n\n**SMILES:** HC@12C@H(OC(=O)C3=CC=CC=C3)C@3(O)CC@H(OC(=O)C@H(O)C@@H(NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C(C@@H(OC(C)=O)C(=O)C@1(C)C@@H(O)CC@H1OCC@@21OC(C)=O)C3(C)C, HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1, ClCCN(CCCl)P1(=O)NCCCO1, CN(C1=CC2=NN(C)C(C)=C2C=C1)C1=CC=NC(NC2=CC=C(C)C(=C2)S(N)(=O)=O)=N1\n\n**CT Criteria:** Inclusion Criteria:\n 1. All patients with histologic confirmation of invasive, but non-inflammatory carcinoma of the breast with T2-3 (greater than 2 cm), N0-1, M0 will be eligible. Patients with T1N1 (after histological confirmation of nodal disease) will be eligible for the study.\n 2. Histologic confirmation of invasive tumor will be done by core needle biopsy. On the tissue obtained, estrogen and progesterone receptors (ER/PR) as well as Her-2/neu (will be determined by immunohistochemistry (IH) and/or fluorescence in situ hybridization (FISH)) and p53 will be done (for research evaluation). Tumor proliferation rate will be evaluable by immunohistochemistry using paraffin-embedded sections and monoclonal antibody for ki-67. Residual tumor tissue will be saved in the tissue bank for further future studies.\n 3. All patients who are Her-2/neu positive will be eligible for the study. Her-2/neu positivity for protocol purposes will be determined by IHC and patients with tumors that are 3+ or FISH + will be eligible.\n 4. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.\n 5. All patients should have adequate bone marrow function, as defined by peripheral granulocyte count of >1,500/mm3, and platelet count > 100,000 mm3. Patients must have adequate liver function, with a bilirubin within normal laboratory values. In addition, patients should have adequate renal function, defined as serum creatinine <2.0 mg%.\n 6. Patients must have a normal cardiac ejection fraction as determined by baseline echocardiogram. Tape must be saved for review by central cardiologist.\n 7. Patients who underwent biopsy outside will be eligible if they had a measurable residual tumor.\n 8. Patients with multicentric disease and extensive Ductal Carcinoma in Situ (DCIS) will be eligible for study.\n 9. Patients with a history of cardiac arrhythmia will be eligible for study after being cleared by cardiology.\n Exclusion Criteria:\n 1. Patients with T1N0 disease are not eligible for the study.\n 2. Those patients with history of other invasive malignancies will be excluded except non-melanoma skin cancer and non-invasive cervical cancer.\n 3. Patients with a history of congestive heart failure will be excluded.\n 4. Patients who had surgical therapy prior to referral will be ineligible. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00372060 | [
{
"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:** sitagliptin phosphate, comparator: sitagliptin phosphate (mk0431), comparator: pioglitazone, comparator: placebo (unspecified)\n\n**SMILES:** NC@@H(CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F, NC@@H(CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F, CCC1=CN=C(CCOC2=CC=C(CC3SC(=O)NC3=O)C=C2)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 - Patients Have Type 2 Diabetes Mellitus\n - On Diet/Exercise Therapy And Pioglitazone As Monotherapy\n Exclusion Criteria:\n - Patients Have Type 1 Diabetes Mellitus \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01568073 | [
{
"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:** bia 9-1067, entacapone, placebo, levodopa, carbidopa, benserazide\n\n**SMILES:** CCN(CC)C(=O)C(=C\\\\C1=CC(=C(O)C(O)=C1)N+(O-)=O)\\\\C#N, CCN(CC)C(=O)C(=C\\\\C1=CC(=C(O)C(O)=C1)N+(O-)=O)\\\\C#N, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CC@@(CC1=CC(O)=C(O)C=C1)(NN)C(O)=O, CC@@(CC1=CC(O)=C(O)C=C1)(NN)C(O)=O, NC(CO)C(=O)NNCC1=C(O)C(O)=C(O)C=C1\n\n**CT Criteria:** Inclusion Criteria:\n V1 (Screening, up to 14 days before V2)\n - Able to comprehend and willing to sign an informed consent form.\n - Male and female subjects between 30 and 83 years old, inclusive.\n - Diagnosed with idiopathic PD according to the UK Parkinsons Disease Society Brain Bank Clinical Diagnostic Criteria for at least 3 years.\n - Disease severity Stages I-III (modified Hoehn &Yahr staging) at ON.\n - Treated with L-DOPA/DDCI for at least 1 year with clear clinical improvement as per investigators judgment.\n - Treated with 3 to 8 daily doses of L-DOPA/DDCI, which can include a slow-release formulation.\n - On a stable regimen of L-DOPA/DDCI and other anti-PD drugs for at least 4 weeks before screening.\n - Signs of \"wearing-off\" phenomenon (end-of-dose deterioration) for a minimum of 4 weeks before screening, with average total daily OFF time while awake of at least 1.5 hours, excluding the early morning pre-first dose OFF, despite optimal anti-PD therapy (based on the investigators judgment).\n - Able to keep reliable diaries of motor fluctuations (alone or with family/caregiver assistance).\n - Amenorrheic for at least 1 year or surgically sterile for at least 6 months before screening. Females of childbearing potential must be using an effective non-hormonal contraceptive method.\n V2 (Randomisation, Day 0)\n - Have filled-in self-rating diary charts in accordance with the diary chart instructions and with ≤ 3 errors per day.\n - At least 1.5 OFF hours per day, excluding the early morning pre-first dose OFF period (i.e. the time between wake-up and response to the first L DOPA/DDCI dosage), as recorded in the self-rating diary for at least 2 of the 3 days preceding V2.\n - Results of the screening laboratory tests are considered acceptable by the investigator (i.e. not clinically relevant for the well-being of the subject or for the purpose of the study).\n Exclusion Criteria:\n V1 (Screening, up to 14 days before V2)\n - Non-idiopathic PD (atypical parkinsonism, secondary acquired or symptomatic parkinsonism, Parkinson-plus syndrome).\n - Dyskinesia disability score > 3 in the Unified Parkinsons Disease Rating Scale (UPDRS) Sub-section IV A, item 33.\n - Severe and/or unpredictable OFF periods.\n - Treatment with prohibited medication: tolcapone, neuroleptics, venlafaxine, monoamine oxidase inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or rasagiline up to 1 mg/day), or antiemetics with antidopaminergic action (except domperidone) within the month before screening.\n - Previous use of entacapone.\n - Treatment with apomorphine, alpha-methyldopa, or reserpine within the month before screening or likely to be needed at any time during the study.\n - Dosage change of concomitant anti-PD medication within 4 weeks of screening.\n - Previous or planned (during the entire study duration, including the OL period) deep brain stimulation.\n - Previous stereotactic surgery (e.g. pallidotomy, thalamotomy) for PD or with planned stereotactic surgery during the study period.\n - Any IMP within the 3 months (or within 5 half-lives, whichever is longer) before screening.\n - Any medical condition that might place the subject at increased risk or interfere with assessments.\n - Past (within the past year) or present history of suicidal ideation or suicide attempts.\n - Current or previous (within the past year) diagnosis of major depressive disorder, mania, bipolar disorder, psychosis, dysthymia, generalised anxiety disorder, alcohol or substance abuse excluding caffeine or nicotine, impulse control disorders (e.g. pathological gambling), dementia or eating disorders according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV) American Psychiatric Association, 2000 criteria, as determined by the investigator.\n - A clinically relevant electrocardiogram (ECG) abnormality (relevance should be assessed by a cardiologist if needed).\n - Current evidence of unstable cardiovascular disease, including but not limited to uncontrolled hypertension, myocardial infarction with important systolic or diastolic dysfunction, unstable angina, congestive heart failure (New York Heart Association class ≥ III), and significant cardiac arrhythmia (Mobitz II 2nd or 3rd degree AV block or any other arrhythmia causing haemodynamic repercussions as symptomatic bradycardia or syncope).\n - Prior renal transplant or current renal dialysis.\n - Pheochromocytoma, paraganglioma, or other catecholamine secretive neoplasm.\n - Known hypersensitivity to the ingredients of IMPs used.\n - History of neuroleptic malignant syndrome (NMS) or NMS-like syndromes, or non-traumatic rhabdomyolysis.\n - History of or current cancer disease, which in the investigators opinion would exclude the subject from the study (e.g. melanoma, prostate cancer).\n - Unstable active narrow-angle or unstable wide-angle glaucoma.\n - History of or current evidence of any relevant disease in the context of this study, i.e. with respect to the safety of the subject or related to the study conditions, e.g. which may influence the absorption or metabolism (such as a relevant liver disease) of the IMP.\n - Pregnant or breastfeeding. V2 (Randomisation, Day 0)\n - Any abnormality in the liver enzymes (alanine aminotransferase and/or aspartate aminotransferase) > 2 times the upper limit of the normal range, in the screening laboratory tests results.\n - Plasma sodium < 130 mmol/L, white blood cell count < 3000 cells/mm3, or any other relevant clinical laboratory abnormality in the screening laboratory tests results that, in the investigators opinion, may compromise the subjects safety.\n - Inadequate compliance to concomitant L-DOPA/DDCI and other anti-PD drugs during the Screening period. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01624259 | [
{
"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:** ly2189265, liraglutide, metformin\n\n**SMILES:** CN(C)C(=N)NC(N)=N, CSCCC@H(N)C(O)=O\n\n**CT Criteria:** Inclusion Criteria:\n - Type 2 diabetes\n - Not optimally controlled on diet and exercise and a dose of metformin that is at least 1500 milligrams/day (mg/day) and has been at a stable dose for at least 3 months prior to the first study visit\n - Glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than or equal to 10.0%\n - Accept continued treatment with metformin throughout the trial, as required per protocol\n - Men and nonpregnant women aged greater than or equal to 18 years\n - Stable weight (plus or minus 5%) greater than or equal to 3 months prior to screening\n - Body Mass Index (BMI) less than or equal to 45 kilograms/square meter (kg/m^2)\n Exclusion Criteria:\n - Have type 1 diabetes mellitus\n - Have been treated with ANY other antihyperglycemic medications (other than metformin) at the time of the first study visit or within the 3 months prior to the first study visit\n - Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks; any insulin use within 3 months prior to the first study visit\n - Have been treated with drugs that promote weight loss within 3 months of the first study visit\n - Are receiving chronic (greater than 14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to the first study visit\n - Have had any of the following cardiovascular conditions within 2 months prior to the first study visit: acute myocardial infarction, New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident\n - Have a known clinically significant gastric emptying abnormality (such as, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery\n - Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or alanine transaminase level greater than or equal to 3 times the upper limit of normal\n - Have a history of chronic pancreatitis or acute idiopathic pancreatitis or were diagnosed with any type of acute pancreatitis within the 3 month period prior to the first study visit\n - Have a serum creatinine greater than or equal to 1.5 milligrams/deciliter (mg/dL) (male) or greater than or equal to 1.4 mg/dL (female), or a creatinine clearance less than 60 milliliters/minute (mL/minute)\n - Have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B, respectively) in the absence of known C-cell hyperplasia (this exclusion includes those participants with a family history of MEN 2A or 2B whose family history for the syndrome is Rearranged during Transfection (RET) negative; the only exception for this exclusion will be for participants whose family members with MEN 2A or 2B have a known RET mutation and the potential participant for the study is negative for that RET mutation)\n - Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)\n - Have a serum calcitonin greater than or equal to 20 picograms/milliliter (pg/mL) \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00550953 | [
{
"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:** telmisartan+amlodipine, telmisartan\n\n**SMILES:** CCCC1=NC2=C(C=C(C=C2C)C2=NC3=CC=CC=C3N2C)N1CC1=CC=C(C=C1)C1=CC=CC=C1C(O)=O, CCCC1=NC2=C(C=C(C=C2C)C2=NC3=CC=CC=C3N2C)N1CC1=CC=C(C=C1)C1=CC=CC=C1C(O)=O\n\n**CT Criteria:** Inclusion Criteria:\n 1. Essential hypertensive patients who satisfying non-responder criteria\n 2. Male or Female\n 3. Age 20 years or older\n 4. Outpatient\n Exclusion Criteria:\n 1. Taking four or more anti-hypertensive medications\n 2. Secondary hypertension\n 3. Mean seated diastolic blood pressure (DBP) > 114 mmHg and/or mean seated systolic blood pressure (SBP) > 200 mmHg at Visit 1, 2, 3, or 4, or mean seated DBP < 90 mmHg at Visit 3.\n 4. Sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias\n 5. Congestive heart failure patients with the New York Heart Association (NYHA) functional class III-IV\n 6. History of myocardial infarction or cardiac surgery within last 6 months\n 7. History of coronary artery bypass graft or percutaneous coronary intervention (PCI) within last 3 months\n 8. History of unstable angina within last 3 months\n 9. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve\n 10. History of stroke or transient ischemic attack within last 6 months\n 11. History of sudden exacerbation of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors, or patients with post-renal transplant or post-nephrectomy\n 12. Experienced characteristic symptoms of angioedema during treatment with ARBs or ACE inhibitors\n 13. Known hypersensitivity to any component of the investigational drug , or a known hypersensitivity to dihydropyridine -derived drugs\n 14. Hepatic and/or renal dysfunction\n 15. Diagnosed biliary atresia or cholestasis\n 16. Hyperkalemia\n 17. Dehydration\n 18. Sodium deficiency\n 19. Chronic administration of high doses of acidic nonsteroidal anti-inflammatory drugs (NSAIDs)\n 20. Patients who cannot change to the restricted administration and dosage during study period\n 21. Pre-menopausal women who meet any one of the following 1 - 3:\n - Pregnant or possibly pregnant (1)\n - Nursing (2)\n - Desire to become pregnant during study period (3)\n 22. Drug or alcohol dependency\n 23. Complication of malignant tumour or a disease requiring immunosuppressants\n 24. Compliance of < 80% or > 120% during the run-in period\n 25. Receiving any investigational therapy within 3 months\n 26. Judged to be inappropriate by the investigator or the sub-investigator \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00000173 | [
{
"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:** alzheimer disease\n\n**ICD Codes:** \"G30.8, G30.9, G30.0, G30.1\"\n\n**Drugs:** donepezil, vitamin e\n\n**SMILES:** O=S(=O)(C1=CC=CC=C1)C1=CN=C2C(C=CC=C2N2CCNCC2)=C1, CC(C)CCCC@@H(C)CCCC@@H(C)CCCC@1(C)CCC2=C(O1)C(C)=C(C)C(O)=C2C\n\n**CT Criteria:** Inclusion Criteria:\n - Memory complaints and memory difficulties which are verified by an informant.\n - Abnormal memory function documented by scoring below the education adjusted cutoff on the Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale - Revised (the maximum score is 25): a) less than or equal to 8 for 16 or more years of education, b) less than or equal to 4 for 8-15 years of education, c) less than or equal to 2 for 0-7 years of education.\n - Mini-Mental Exam score between 24 and 30 (inclusive) (Exceptions may be made for subjects with less than 8 years of education at the discretion of the project director.).\n - Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5.\n - General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimers disease cannot be made by the site physician at the time of the screening visit.\n - No significant cerebrovascular disease: Modified Hachinski score of less than or equal to 4.\n - Age between 55 and 90 (inclusive).\n - Permitted medications stable for at least 1 month prior to screening. In particular: a) Subjects may take stable doses of antidepressants lacking significant anticholinergic side effects (if they are not currently depressed and do not have a history of major depression within the past 2 years). b) Estrogen replacement therapy is permissible. c) Ginkgo biloba is permissible, but discouraged.\n - Hamilton Depression rating scale score of less than or equal to 12 on the 17-item scale.\n - Informant is available who has frequent contact with the subject (e.g. an average of 10 hours per week or more), agrees to monitor administration of study drug, observe for adverse events, and accompany the subject to all clinic visits for the duration of the protocol.\n - CT or MRI scans within 12 months prior to screening without evidence of infection, infarction, or other focal lesions and without clinical symptoms suggestive of intervening neurological disease. A lacune in a non-critical brain area which is not believed to contribute to the subjects cognitive impairment is permissible.\n - Adequate visual and auditory acuity to allow neuropsychological testing.\n - Good general health with no additional diseases expected to interfere with the study.\n - Normal B12, RPR, and Thyroid Function Tests or without any clinically significant abnormalities that would be expected to interfere with the study.\n - ECG without clinically significant abnormalities that would be expected to interfere with the study.\n - Subject is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile).\n - Agreement not to take other vitamin supplements (including Vitamin E), multivitamins, other than those provided by the study.\n Exclusion Criteria:\n - Any significant neurologic disease other than suspected incipient Alzheimers disease, such as Parkinsons disease, multi-infarct dementia, Huntingtons disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.\n - Major depression or another major psychiatric disorder as described in DSM IV within the past 2 years.\n - Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol.\n - History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria).\n - History of schizophrenia (DSM IV criteria).\n - Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol including: a) History of systemic cancer within the last 5 years (non-metastatic skin cancers are acceptable). b) History of myocardial infarction within the past year or unstable or severe cardiovascular disease including angina or CHF with symptoms at rest. c) Clinically significant obstructive pulmonary disease or asthma. d) Clinically significant and unstable gastrointestinal disorder such as ulcer disease or a history of active or occult gastrointestinal bleeding within two years. e) Clinically significant laboratory test abnormalities on the battery of screening tests (hematology, prothrombin time, chemistry, urinalysis, ECG). f) Insulin-requiring diabetes or uncontrolled diabetes mellitus. g) Uncontrolled hypertension (systolic BP greater than 170 or diastolic greater than 100). h) History of clinically significant liver disease, coagulopathy, or vitamin K deficiency within the past 2 years.\n - Medications a) Use of centrally active beta-blockers, narcotics, methyldopa and clonidine within 4 weeks prior to screening. b) Use of anti-Parkinsonian medications (e.g. Sinemet, amantadine, bromocriptine, pergolide and selegiline) within 2 months prior to screening. c) Use of neuroleptics or narcotic analgesics within 4 weeks prior to screening. d) Use of long-acting benzodiazepines or barbituates within 4 weeks prior to screening. e) Use of short-acting anxiolytics or sedative hypnotics more frequently than 2 times per week within 4 weeks prior to screening (note: sedative agents should not be used within 72 hours of screening).\n f) Initiation or change in dose of an antidepressant lacking significant cholinergic side effects within the 4 weeks prior to screening (use of stable doses of antidepressants for at least 4 weeks prior to screening is acceptable). g) Use of systemic corticosteroids within 3 months prior to screening. h) Medications with significant cholinergic or anticholinergic side effects (e.g. pyridostigmine, tricyclic antidepressants, meclizine, and oxybutynin) within 4 weeks prior to screening. i) Use of anti-convulsants (e.g. Phenytoin, Phenobarbital, Carbamazepine) within 2 months prior to screening. j) Use of warfarin (Coumadin) within 4 weeks prior to screening.\n - Vitamin Supplements a) Use of vitamin supplements other than standard multivitamin included as part of the treatment intervention used in this protocol within 2 weeks prior to screening.\n - Any prior use of any FDA approved medications for the treatment of Alzheimers disease (e.g. tacrine, donepezil, or other newly approved medications).\n - Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening.\n - Subjects who, in the investigators opinion, will not comply with study procedures. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00699751 | [
{
"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:** hormone refractory prostate cancer, bone metastases\n\n**ICD Codes:** \"C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5\"\n\n**Drugs:** radium-223 dichloride (xofigo, bay88-8223), placebo, best standard of care (bsoc)\n\n**SMILES:** Cl223RaCl, 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 - Histologically or cytologically confirmed adenocarcinoma of the prostate\n - Known hormone refractory disease\n - Multiple skeletal metastases (≥ 2 hot spots) on bone scintigraphy\n - No intention to use cytotoxic chemotherapy within the next 6 months\n - Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with EBRT (External Beam Radiation Therapy) for bone pain\n Exclusion Criteria:\n - Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period\n - Eligible for first course of docetaxel, i.e. patients who are fit enough, willing and where docetaxel is available\n - Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks ago\n - Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks\n - Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)\n - History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00431236 | [
{
"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:** nausea and vomiting, chemotherapy-induced\n\n**ICD Codes:** \"D61.810\"\n\n**Drugs:** oral casopitant (gw679769), iv casopitant (gw679769), iv ondansetron hydrochloride, oral dexamethasone\n\n**SMILES:** CC@@H(N(C)C(=O)N1CCC@@H(CC@@H1C1=CC=C(F)C=C1C)N1CCN(CC1)C(C)=O)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F, CC@@H(N(C)C(=O)N1CCC@@H(CC@@H1C1=CC=C(F)C=C1C)N1CCN(CC1)C(C)=O)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F, CN1C2=C(C3=CC=CC=C13)C(=O)C(CN1C=CN=C1C)CC2, 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\n\n**CT Criteria:** Inclusion criteria:\n - Subject understands the nature and purpose of this study and the study procedures and has signed an informed consent form for this study to indicate this understanding.\n - Males or females of at least 18 years of age.\n - Diagnosed with a malignant solid tumor and is scheduled to receive their first course of cytotoxic chemotherapy with cisplatin administered as a single intravenous dose of ≥ 70mg/m² over 1-4 hours on study Day 1, either alone or in combination with other chemotherapeutic agents. For combination regimens, non-cisplatin agents of moderate to high emetogenic potential will be allowed, but must be administered following the cisplatin infusion and be completed no more than 6 hours after the initiation of the cisplatin infusion. Chemotherapy agents of minimal to low emetogenic potential may be given on Day 1 following cisplatin or on any subsequent study day. Taxanes (e.g. paclitaxel, docetaxel) may be administered on study Day 1 only following cisplatin.\n - Has an ECOG Performance Status of 0, 1, or 2.\n - Hematologic and metabolic status must be adequate for receiving a highly emetogenic cisplatin-based regimen and meet the following criteria:\n - Total Neutrophils ≥ 1500/mm³ (Standard units : ≥1.5 x 10^9/L)\n - Platelets ≥ 100,000/mm (Standard units: ≥100.0 x 10^9/L)\n - Bilirubin ≤ 1.5 x ULN\n - Serum Creatinine ≤1.5 mg/dL (Standard units : ≤ 132.6 µMOL/L OR\n - Creatinine clearance ≥ 60 mL/min\n Creatinine clearance must be calculated using the Cockcroft-Gault formula:\n Clcreat (ml/min) = (140-age yr) x body wt kg 72 x serum creatinine mg/dl For females: multiply creatinine clearance by a factor of 0.85. OR Clcreat (ml/min) = (140-age yr) x body wt kg serum creatinine µmol/L K=1.05 for females K=1.23 for males\n - Liver enzymes must be below the following limits:\n - Without known liver metastases: Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal.\n - With known liver metastases: AST and/or ALT ≤ 5.0 x upper limit of normal.\n - Is willing and able to complete daily components of the subject diary for each study cycle.\n - Women of childbearing potential; must commit to consistent and correct use of an acceptable method of birth control; GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of a physician, are as follows:\n 1. non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal. For purposes of this study, postmenopausal is defined as one year without menses)\n 2. child-bearing potential: must have a negative serum pregnancy test result or negative urine dipstick pregnancy test within 24 hours prior to the first dose of investigational product of cycle 1 day 1, and agrees to one of the following:\n - male partner who is sterile prior to the female subjects entry into the study and is the sole sexual partner for that female subject oral contraceptives (e.g., oral, injectable, or implantable) with double-barrier method of contraception consisting of spermicide with either condom or diaphragm for a period after the trial to account for a potential drug interaction (minimum of six weeks)\n - double-barrier method of contraception consisting of spermicide with either condom or diaphragm\n - intra-uterine device (IUD) with a documented failure rate of less than 1% per year\n - complete abstinence from intercourse for two weeks before exposure to the investigational product throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of three days)\n - if subjects indicate they will remain abstinent during the period described above, they must agree to follow GSK guidelines for the consistent and correct use of an acceptable method of birth control should they become sexually active.\n obstruction\n Exclusion criteria:\n - Has previously received cytotoxic chemotherapy. Previous biological or hormonal therapy will be permitted.\n - Is scheduled to receive cisplatin treatment on more than one day during a single cycle of therapy.\n - If female, is pregnant or lactating.\n - Has received radiation therapy to the thorax, head & neck, abdomen, or the pelvis in the 10 days prior to receiving the first dose of study medication and/or will receive radiation therapy to the thorax, head & neck, abdomen or the pelvis in the 6 days following the first dose of study medication.\n - Emesis (i.e. vomiting and/or retching) experienced in the 24 hours prior to receiving the first dose of study medication.\n - Clinically significant nausea (e.g. ≥25 mm on a VAS) in the 24 hours prior to receiving the first dose of study medication.\n - A known central nervous system primary or malignancy metastatic to the CNS, unless successfully treated with excision or radiation and subsequently has been stable for at least 1 week prior to receiving the first dose of study medication.\n - Has history of documented peptic ulcer disease (via endoscopy or x-ray), active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, or any uncontrolled medical condition (other than malignancy) which in the opinion of the Investigator may confound the results of the study, represent another potential etiology for emesis and nausea (other than CINV) or pose an unwarranted risk to the subject.\n - Has a known hypersensitivity or contraindication to ZOFRAN, another 5-HT3 receptor antagonist, dexamethasone, or any component of casopitant.\n - Has previously received an NK-1 receptor antagonist.\n - An active systemic infection or any uncontrolled disease (other than malignancy) which, in the opinion of the investigator, may confound the results of the study or pose an unwarranted risk to the subject. Subjects with a previous, but not current, history of alcoholism may be permitted provided that, in the investigators opinion, the subjects disease state will not confound the results of the study.\n - Receiving or planning to receive a systemic corticosteroid therapy at any dose within 72 hours prior to the first dose of study medication, except where indicated as premedication for a taxane. However, topical steroids and inhaled corticosteroids with a steroid dose of≤10 mg prednisone daily or its equivalent are permitted.\n - Is scheduled to receive bone marrow transplantation and/or stem cell rescue with this course of cisplatin therapy.\n - Has received an investigational drug within the 30 days or five half-lives (whichever is longer) prior to receiving the first dose of study medication, and/or is scheduled to receive any investigational drug during the study.\n - Has received moderately and/or highly emetogenic medication within the 48 hours prior to the first dose of study medication. (Opioid narcotics for cancer pain will be permitted if the subject has been on such medication for at least 7 days and has not experienced nausea or emesis from the narcotics.)\n - Has taken/received any medication with known or potential antiemetic activity within the 24-hour period prior to receiving study drug. This includes, but is not limited to:\n - 5-HT3 receptor antagonists (e.g., ondansetron, granisetron, dolasetron, tropisetron, ramosetron). Palonestron is not permitted within 7 days prior to administration of investigational product.\n - benzamide / benzamide derivatives (e.g., metoclopramide, alizapride)\n - benzodiazepines (except if the subject is receiving such medication for sleep or anxiety and has been on a stable dose for at least seven days prior to the first dose of GW679769 investigational product; however, lorazepam is prohibited 24 hours prior to receiving study drug regardless of reason for use.)\n - phenothiazines (e.g., prochlorperazine, promethazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine)\n - butyrophenone (e.g., haloperidol, droperidol)\n - corticosteroids (e.g., dexamethasone, methylprednisolone; with the exception of topical steroids for skin disorders, inhaled steroids for respiratory disorders, and prophylactic treatment for taxane or pemetrexed therapy)\n - anticholinergics (e.g., scopolamine with the exception of inhaled anticholingerics for respiratory disorders e.g., ipratropium bromide)\n - antihistamines (e.g., cyclizine, hydroxyzine, diphenhydramine), except for prophylactic use for taxane therapy\n - domperidone\n - mirtazapine\n - olanzapine\n - cannabinoids\n - Has taken/received strong or moderate inhibitors of CYP3A4 and CYP3A5 prior to administration of casopitant (GW679769) investigational product\n - Has taken/received inducers of CYP3A4 and CYP3A5 within fourteen days prior to the administration of casopitant investigational product\n - Is taking the anti-diabetic agent repaglinide or the diuretic torsemide. Investigators are advised to exercise caution if including patients taking the anti-diabetic agents rosiglitazone or pioglitazone, or antimalarial agents such as chloroquine and amodiaquine, as the metabolite of casopitant is a potential inhibitor of CYP2C8\n - Is currently taking or plans to take any of the following CYP3A4 substrates: astemizole, cisapride, pimozide, terfenadine. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00420199 | [
{
"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:** active rheumatoid arthritis\n\n**ICD Codes:** \"M05.9, M06.08, M06.00, M06.011, M06.012, M06.019, M06.021\"\n\n**Drugs:** abatacept, placebo\n\n**SMILES:** HC@@12CCCN1C(=O)C@H(CC1=CC=CC=C1)N1C(=O)C@(C)(NC(=O)C@H3CN(C)C@4(H)CC5=CNC6=CC=CC(=C56)C@@4(H)C3)OC@@21O, 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 - Disease activity as defined by a Disease Activity Score 28-C-Reactive Protein (CRP) >3.2 or >6 swollen and ≥6 tender joints and CRP greater than the upper limit of normal\n - At least 1 erosion in hands/wrists or positive anticyclic citrullinated peptides or rheumatoid factor\n - Clinically detectable synovitis of at least 1 wrist/ankle at screening and baseline\n - Participants must have been treated with methotrexate, on a weekly dose of at least 15 mg or a maximum tolerated dose (such as, 10 mg weekly) for at least 3 months before screening. Dose of methotrexate must be stable for at least 28 days prior to the first study dose (Day 1) \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT01076075 | [
{
"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:** sitagliptin phosphate, comparator: placebo to pioglitazone, comparator: placebo to sitagliptin, comparator: pioglitazone, glimepiride or gliclazide, metformin, pioglitazone rescue therapy\n\n**SMILES:** NC@@H(CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F, CCC1=CN=C(CCOC2=CC=C(CC3SC(=O)NC3=O)C=C2)C=C1, NC@@H(CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F, CCC1=CN=C(CCOC2=CC=C(CC3SC(=O)NC3=O)C=C2)C=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, CCC1=CN=C(CCOC2=CC=C(CC3SC(=O)NC3=O)C=C2)C=C1\n\n**CT Criteria:** Inclusion Criteria:\n - Type 2 diabetes mellitus\n - Hemoglobin A1C of ≥7.5% and ≤10.5%\n - Currently taking a stable dose of metformin (at least 1500 mg/day) and either glimepiride (at least 2 mg/day) or gliclazide (at least 50% of maximum registered dose) for at least 10 weeks prior to study start\n - Male, or a female who is highly unlikely to conceive\n Exclusion Criteria:\n - Type 1 diabetes mellitus or ketoacidosis\n - Taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin) or a glucagon-like peptide-1 (GLP-1) mimetic (such as exenatide or liraglutide) or required insulin therapy within 12 weeks prior to study start\n - On a weight loss program not in the maintenance phase or on a weight loss medication\n - History of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer\n - HIV positive\n - Pregnant \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00277654 | [
{
"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:** bipolar disorder, anxiety disorder\n\n**ICD Codes:** \"F31.81, F31.89, F31.9, F25.0, F31.0, F31.31, F31.32\", \"F41.1, F41.9, F40.9, F43.22, F41.0, F93.0, F12.980\"\n\n**Drugs:** risperidone\n\n**SMILES:** OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12\n\n**CT Criteria:** Inclusion Criteria:\n 1. Subjects must be 18 years of age or older.\n 2. Subjects must have lifetime bipolar I, II, or NOS disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.\n 3. Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV criteria (except clause \"does not occur exclusively during a mood disorder\" of Criterion F for GAD) .\n 4. Subjects bipolar symptoms must be no more than moderately severe, defined as a CGI-BP < 4.\n 5. Subjects anxiety symptoms must be at least moderately severe, defined as a CGI-S > 4.\n 6. Subjects must not be receiving mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for > one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for > four weeks prior to baseline.\n 7. Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained.\n 8. If female, subjects must be:\n - postmenopausal,\n - surgically incapable of childbearing,\n - or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study.\n Exclusion Criteria:\n 1. Subjects who do not have lifetime bipolar disorder by DSM-IV-TR (text revision) criteria.\n 2. Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR criteria.\n 3. Subjects who are receiving treatment with an antimanic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators judgment, require ongoing treatment with that medication.\n 4. Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP > 5).\n 5. Subjects whose anxiety symptoms are presently less than moderately severe (CGI < 3).\n 6. Subjects with clinically significant suicidal or homicidal ideation.\n 7. Subjects with current psychotic symptoms.\n 8. Subjects with a current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV diagnosis of a substance dependence disorder within the past six months; or a lifetime DSM-IV psychotic disorder (e.g., schizophrenia or schizoaffective disorder).\n 9. Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement > 3 months.\n 10. Subjects with a clinically significant abnormality in their prestudy physical exam, vital signs, EKG, or laboratory tests.\n 11. Subjects who are allergic to or who have demonstrated hypersensitivity to risperidone.\n 12. Women who are pregnant or nursing.\n 13. Subjects who have received an experimental drug or used an experimental device within 30 days.\n 14. Subjects who have a history of neuroleptic malignant syndrome. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00168896 | [
{
"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:** 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:** carboplatin plus irinotecan vs carboplatin plus etoposide\n\n**SMILES:** NC@@H(CCCNC(N)=N)C(O)=O\n\n**CT Criteria:** Inclusion Criteria:\n - cytological or histological proven SCLC Stage I or II at 1st diagnosis\n - no prior chemotherapy\n - measurable tumor disease\n - karnofsky performance 70\n Exclusion Criteria:\n - second malignancy ( except basal cell carcinoma, CA in situ Cervix uteri)\n - NYHA III\n - chronic diarrhea, obstructive bowel syndrome \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT02181101 | [
{
"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 neoplasms\n\n**ICD Codes:** \"C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60\"\n\n**Drugs:** fec-docgemzar adjuvant chemotherapy, fec-doc adjuvant chemotherapy, zoledronic acid i.v. 2 years, zoledronic acid i.v. 5 years\n\n**SMILES:** HC@@12N(C)C3=CC(OC)=C(C=C3C@@11CCN3CC=CC@(CC)(C@@13H)C@@(H)(OC(C)=O)C@2(O)C(=O)OC)C@1(CC@@2(H)CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, HC@@12N(C)C3=CC(OC)=C(C=C3C@@11CCN3CC=CC@(CC)(C@@13H)C@@(H)(OC(C)=O)C@2(O)C(=O)OC)C@1(CC@@2(H)CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC\n\n**CT Criteria:** Inclusion Criteria:\n - Primary epithelial invasive carcinoma of the breast pT1-4, pM0\n - Histopathological proof of axillary lymph node metastases (pN1-3) or high risk pN0/NX, defined as: pT ≥ 2 or histopathological grade 3 or age ≤ 35 or negative hormone receptor status\n - Complete resection the primary tumor with margins of resection free of invasive carcinoma not more than 6 weeks ago\n - Females ≥ 18 years of age\n - Performance Status ≤ 2 on Eastern Cooperative Oncology Group (ECOG) Scale\n - Adequate bone marrow reserve: leucocytes ≥ 3.0 x 10^9/l and platelets ≥ 100 x 10^9/l\n - Bilirubin within one fold of the reference laboratorys normal range, aspartate aminotransferase (ASAT) (serum glutamate oxalacetate transaminase, SGOT), alanine aminotransferase (ALAT) (serum glutamate pyruvate transaminase, SGPT) and alkaline phosphatase (AP) within 1,5 fold of the reference laboratorys normal range for patients\n - Intention of regular follow-up visits for the duration of the study\n - Ability to understand the nature of the study and to give written informed consent\n Exclusion Criteria:\n - Inflammatory breast cancer\n - Previous or concomitant cytotoxic or other systemic antineoplastic treatment which is not part of or allowed within this study\n - History of treatment or disease affecting bone metabolism (e.g., Pagets disease, primary hyperparathyroidism)\n - Prior treatment with bisphosphonates within the last 6 months\n - Severe renal insufficiency as evidenced by creatinine clearance < 30 ml/min as calculated using the Cockcroft-Gault formula\n - Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)\n - Cardiomyopathy with impaired ventricular function (New York Heart Association Functional Classification Class (NYHA) > II), cardiac arrythmias influencing left ventricular ejection fraction (LVEF) and requiring medication, history of myocardial infarction or angina pectoris within the last 6 months, or arterial hypertension not being controlled by medication\n - Any known hypersensitivity against docetaxel, epirubicin, cyclophosphamide, fluorouracil, gemcitabine or any other medication included in the study protocol\n - Use of any investigational agent within 3 weeks prior to inclusion\n - Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured: intra uterine devices, surgical methods of sterilization, or, in hormone unsensitive tumors only, oral, subcutaneous or transvaginal hormonal, non estrogen containing contraceptives)\n - Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.\n - Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants) \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00518713 | [
{
"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:** epilepsy, epilepsy, generalized, seizures\n\n**ICD Codes:** \"G40.803, G40.804, G40.911, G40.919, G40.B11, G40.B19, G40.801\", \"G40.311, G40.319, G40.411, G40.419, G40.301, G40.309, G40.401\", \"G40.89, R56.1, F44.5, G40.501, G40.509, G40.111, G40.119\"\n\n**Drugs:** clobazam low dose, clobazam medium dose, clobazam high dose, placebo\n\n**SMILES:** CN1C2=C(C=C(Cl)C=C2)N(C2=CC=CC=C2)C(=O)CC1=O, CN1C2=C(C=C(Cl)C=C2)N(C2=CC=CC=C2)C(=O)CC1=O, CN1C2=C(C=C(Cl)C=C2)N(C2=CC=CC=C2)C(=O)CC1=O, 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 - Patient must have been <11 years of age at the onset of LGS.\n - Patient must have LGS.\n - Patient must be on at least 1 AED.\n - Parent or caregiver must be able to keep an accurate seizure diary.\n Exclusion Criteria:\n - Etiology of patients seizures is a progressive neurologic disease. Patients with tuberous sclerosis will not be excluded from study participation, unless there is a progressive tumor.\n - Patient has had an episode of status epilepticus within 12 weeks of baseline.\n - Patient has had an anoxic episode requiring resuscitation within 6 months of screening.\n - Patient has a clinically significant history of an allergic reaction or significant sensitivity to benzodiazepines.\n - Patient is taking more than 3 concurrent AEDs.\n - Patient has been on the ketogenic diet for less than 30 days prior to screening or suffers from frequent stooling.\n - If the patient has a Vagal Nerve Stimulator (VNS), the settings have not been stable for at least 30 days prior to screening.\n - Patient has taken corticotropins in the 6 months prior to screening.\n - Patient is currently taking long-term systemic steroids (excluding inhaled mediation for asthma treatment) or any other daily medication known to exacerbate epilepsy. An exception will be made of prophylactic medication, for example, for idiopathic nephrotic syndrome or asthma.\n - If the patient is taking felbamate, has been taking it for less than 1 year prior to screening.\n Other protocol-defined inclusion and exclusion criteria may apply. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00699426 | [
{
"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:** nexium, nexium, placebo+placebo\n\n**SMILES:** COC1=CC2=C(NC(=N2)S@@(=O)CC2=NC=C(C)C(OC)=C2C)C=C1, COC1=CC2=C(NC(=N2)S@@(=O)CC2=NC=C(C)C(OC)=C2C)C=C1\n\n**CT Criteria:** Inclusion Criteria:\n - Type 2 diabetes (WHO criteria) treated with metformin and/or sulfonylureas or diet\n - Males and females between 40 and 70 years\n - HbA1c between 6,0-10,0\n - Diabetes duration > 1 year\n Exclusion Criteria:\n - Kidney disease (s-creatinine above the upper limit of normal range).\n - Liver disease (ALAT increase > 3 times the upper limit of the normal range of ALAT).\n - Macroalbuminuria (urinary albumin excretion of > 300 mg/day).\n - Heart failure(NYHA class lll or lV)\n - Severe neuropathy (symptoms + vibration perception threshold > 50 measured by biothesiometer.)\n - Neutropenia (neutrophil count<2.0x10/l) or anemia (hemoglobin<8mM for men or <7mM for women.\n - Alcohol abuse\n - Drug abuse\n - Severe organic or metabolic diseases including cancer\n - C-peptide< 0,3 pmol/l\n - Medicine interaction\n - Treatment with insulin\n - PPI or other medications for ulcus diseases\n - Treatment with warfarin or other coumarin derivations\n - Pregnant or breastfeeding women\n - Allergy to medication used in the study\n - Participants may not participate in another clinical intervention trial \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00380068 | [
{
"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 hypertension\n\n**ICD Codes:** \"I27.0, I27.20, I27.21, I27.24, I27.29, P29.30, I27.22\"\n\n**Drugs:** ambrisentan\n\n**SMILES:** COC(C@H(OC1=NC(C)=CC(C)=N1)C(O)=O)(C1=CC=CC=C1)C1=CC=CC=C1\n\n**CT Criteria:** Summarized Inclusion Criteria:\n 1. 18 years of age or older\n 2. Current diagnosis of PH associated with an acceptable etiology as outlined in the protocol, including: PH due to the following etiologies: 1) PAH including idiopathic and familial PAH and PAH associated with collagen vascular disease, congenital systemic-to-pulmonary shunts (including Eisenmengers syndrome), human immunodeficiency virus (HIV) infection, drugs and toxins, thyroid disorders, glycogen storage disease, Gaucher disease, hemoglobinopathies, and splenectomy (WHO Group 1); 2) PH associated with lung diseases and/or hypoxemia, including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), sleep-disordered breathing, and alveolar hypoventilation disorders (WHO Group 3); 3) PH due to proximal or distal chronic thromboembolic obstruction (WHO Group 4); and 4) PH due to sarcoidosis (WHO Group 5).\n 3. Stable regimen (within four weeks) of chronic prostanoid, PDE-5 inhibitor, calcium channel blocker, or 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor therapy\n 4. Right heart catheterization completed prior to screening must meet pre-specified criteria\n 5. Female participants of childbearing potential must have a negative serum pregnancy test and must agree to use a reliable double method of contraception until study completion and for at least four weeks following their final study visit.\n 6. Male participants must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking ambrisentan and queried regarding his understanding of the potential risks as described in the Informed Consent Form.\n Summarized Exclusion Criteria:\n 1. Participation in a previous clinical study with ambrisentan\n 2. Bosentan or sitaxsentan use within four weeks prior to the screening visit\n 3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value that is greater than 3 times the upper limit of normal at the screening visit\n 4. Pulmonary function tests not meeting the following pre-specified criteria: 1) mean pulmonary arterial pressure (PAP) >= 25 mm Hg; 2) PVR > 3 mm Hg/L/min; 3) pulmonary capillary wedge pressure (PCWP) or left ventricle end diastolic pressure (LVEDP) < 15 mm Hg; 4) total lung capacity (TLC) >= 70% of predicted normal for participants without ILD or >= 60% of predicted normal in participants with ILD; forced expiratory volume in 1 second (FEV1) >= 65% of predicted normal in participants without COPD or >= 50% of predicted normal in participants with COPD\n 5. Contraindication to treatment with endothelin receptor antagonist (ERA)\n 6. History of malignancies other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the past five years\n 7. Female participant who is pregnant or breastfeeding \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01006291 | [
{
"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, insulin degludec, insulin glargine\n\n**SMILES:** Na+.Na+.O-P(O-)(F)=O, 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 (diagnosed clinically) for at least 6 months\n - Current treatment: oral anti-diabetic drug(s) (OAD(s)) alone, basal insulin alone or the combination of OAD(s) and basal insulin. Allowed OADs are: Metformin, insulin secretagogues (sulphonylureas (SU) or glinides), pioglitazone with unchanged dosing for at least 3 months prior to Visit 1\n - HbA1c: OADs only users 7.0-11.0 % (both inclusive), basal insulin with/without OADs users 7.0-10.0% (both inclusive) by central laboratory analysis\n - Body Mass Index (BMI) below or equal to 40.0 kg/m^2\n Exclusion Criteria:\n - Cancer and medical history of cancer hereof\n - Use within the last 3 months prior to Visit 1 of: glucagon-like peptide-1(GLP-1) receptor agonist (exenatide, liraglutide), rosiglitazone, dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase-inhibitors\n - Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty\n - Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)\n - Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements\n - Cancer and medical history of cancer hereof (except basal cell skin cancer and squamous cell skin cancer) \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT01155479 | [
{
"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:** parkinson disease\n\n**ICD Codes:** \"G20\"\n\n**Drugs:** preladenant 2 mg tablet, preladenant 5 mg tablet, preladenant 10 mg tablet, rasagiline 1 mg capsule, placebo for rasagiline 1 mg capsule, placebo for preladenant\n\n**SMILES:** COCCOC1=CC=C(C=C1)N1CCN(CCN2N=CC3=C2N=C(N)N2N=C(N=C32)C2=CC=CO2)CC1, COCCOC1=CC=C(C=C1)N1CCN(CCN2N=CC3=C2N=C(N)N2N=C(N=C32)C2=CC=CO2)CC1, COCCOC1=CC=C(C=C1)N1CCN(CCN2N=CC3=C2N=C(N)N2N=C(N=C32)C2=CC=CO2)CC1, C#CCNC@@H1CCC2=CC=CC=C12, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\n**CT Criteria:** Inclusion Criteria:\n - Has a diagnosis of idiopathic PD for < 5 years.\n - If receiving amantadine and/or anticholinergics, must have been on a stable regimen of treatment for at least the 5 weeks immediately before Screening. (Note: Participants who are not taking any medications for PD are permitted to enroll in this trial.)\n - Must have a UPDRS Part 3 score of ≥10, a Hoehn and Yahr Stage ≤3, be ≥30 to ≤85 years of age, and have results of Screening clinical laboratory tests drawn within 5 weeks prior to randomization, clinically acceptable to the investigator, and not within the parameters specified for exclusion.\n - If sexually active or plan to be sexually active, must agree to use a highly effective method of birth control while the participant is in the study and for 2 weeks after the last dose of study drug. A male participant must also not donate sperm during the trial and within 2 weeks after the last dose of study drug.\n Exclusion Criteria:\n - Must not have a form of drug-induced or atypical Parkinsonism, cognitive impairment (ie, Montreal Cognitive Assessment MoCA score <22), bipolar disorder, untreated major depressive disorder, schizophrenia, or other psychotic disorder; history of exposure to a known neurotoxin, or any neurological features not consistent with the diagnosis of PD as assessed by the investigator.\n - Must not have had surgery for PD.\n - Must not have a history of repeated strokes with stepwise progression of Parkinsonism or head injuries, or a stroke within 6 months of screening; poorly controlled diabetes; abnormal renal function; or a severe or ongoing unstable medical condition.\n - Must not have failed to show a therapeutic response if a diagnostic levodopa (L dopa) challenge had been done with a large test dose (>500 mg) of L dopa (if malabsorption excluded), or failed to respond to an adequate previous treatment with dopaminergic therapy.\n - Must not have been treated with L dopa or dopamine agonists for 30 days or more. A participant who has been treated with L-dopa or dopamine agonists for <30 days will be allowed to enter the study. These participants must stop taking dopaminergic medication 30 days prior to Randomization.\n - Must not be at imminent risk of self-harm or harm to others.\n - Must not have elevated blood pressure (BP) (systolic BP ≥150 mm Hg or diastolic BP ≥95 mm Hg) that cannot be adequately controlled with antihypertensive medication, as demonstrated by 2 BP measurements meeting acceptable BP criterion at consecutive scheduled or unscheduled visits between Screening and Randomization (a 5-6 week period), one of which must be the Randomization visit.\n - Must not have had any clinically significant cardiovascular event or procedure for 6 months prior to Randomization, including, but not limited to, myocardial infarction, angioplasty, unstable angina, or heart failure; and a participant must not have heart failure staged New York Heart Association Class III or IV.\n - Must not have an alanine aminotransferase (ALT) or aspartate amino transferase (AST) ≥ 3 x the upper limit of normal (ULN) or total bilirubin (T BIL) ≥ 1.5 x ULN.\n - Must not have active serologically-confirmed hepatic dysfunction (defined as viral infection Hepatitis B, C, or E; Epstein-Barr virus (EBV); cytomegalovirus CMV or a history of diagnosis of drug- or alcohol-induced hepatic toxicity or frank hepatitis, or a history of diagnosis of drug- or alcohol-induced hepatic toxicity or frank hepatitis.)\n - Must not have a history within the past 5 years of a primary or recurrent malignant disease with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ prostate cancer with a normal prostate-specific antigen (PSA) post resection.\n - Must not have received certain prespecified medications or ingested high tyramine-containing aged cheeses (eg, Stilton) for a prespecified time window before the trial, during the trial, and for 2 weeks after the trial.\n - Must not have an average daily consumption of more than three 4 ounce glasses (118 mL) of wine or the equivalent.\n - Must not have a severe or ongoing unstable medical condition (eg, any form of clinically significant cardiac disease, symptomatic orthostatic hypotension, seizures, or alcohol/drug dependence.)\n - Must not have allergy/sensitivity to investigational product(s) or its/their excipients.\n - Must not be breast-feeding, considering breast-feeding, pregnant or intending to become pregnant.\n - Must not have used preladenant ever, or any investigational drugs within 90 days immediately before screening. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT01017874 | [
{
"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:** pemetrexed, cisplatin, gefitinib, gefitinib\n\n**SMILES:** HN(H)(H)Pt(Cl)(Cl)N(H)(H)H, HC@@12N(C)C3=CC(OC)=C(C=C3C@@11CCN3CC=CC@(CC)(C@@13H)C@@(H)(OC(C)=O)C@2(O)C(=O)OC)C@1(CC@@2(H)CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1, COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1\n\n**CT Criteria:** Inclusion Criteria:\n - Histological diagnosis of NSCLC with locally advanced or metastatic disease that is of non-squamous histology.\n - Participants must be \"light ex-smokers\" or \"never-smokers\".\n - \"Light ex-smokers\" defined as having ceased smoking for greater than or equal to 5 years and not to have exceeded 10 pack-years.\n - \"Never-smokers\" are defined as having smoked <100 cigarettes or equivalent during his/her lifetime.\n - Participants must be of East Asian ethnicity.\n - No prior systemic therapy for lung cancer.\n - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n Exclusion Criteria:\n - Presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.\n - Any evidence of clinically active interstitial lung disease. Asymptomatic participants with chronic, stable, radiographic changes are eligible.\n - Participants whose Epidermal Growth Factor Receptor (EGFR) mutation status is known prior to study entry will be excluded. Participants in which EGFR mutation testing has not been performed, or whose EGFR mutation status is unknown or inconclusive at study entry are eligible. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT01006252 | [
{
"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:** melanoma\n\n**ICD Codes:** \"C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4\"\n\n**Drugs:** tasisulam-sodium, paclitaxel\n\n**SMILES:** ClC1=CC(Cl)=C(C=C1)C(=O)NS(=O)(=O)C1=CC=C(Br)S1, HC@@1(CC@@H(C)C@2(H)CC(=O)C@H(C)\\\\C=C(C)\\\\C@@H(O)C@@H(OC)C(=O)C@H(C)CC@H(C)\\\\C=C\\\\C=C\\\\C=C(C)\\\\C@H(CC@3(H)CCC@@H(C)C@@(O)(O3)C(=O)C(=O)N3CCCCC@@3(H)C(=O)O2)OC)CCC@@H(OCCO)C@@H(C1)OC\n\n**CT Criteria:** Inclusion Criteria:\n - Have a histologic and/or cytologic diagnosis of metastatic melanoma (Stage IV).\n - Have the presence of evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0).\n - Have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) Scale.\n - Have progressed after 1 previous systemic treatment containing dacarbazine or temozolomide for metastatic melanoma.\n - Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, or other investigational therapy for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) before study enrollment and recovered from the acute effects of therapy (except alopecia).\n - Have a serum albumin level greater than or equal to 3.0 grams per deciliter (g/dL) or greater than or equal to 30 grams per liter (g/L).\n Exclusion Criteria:\n - Have received greater than or equal to 2 previous chemotherapy-containing systemic treatment regimens for metastatic melanoma. An immunotherapy or antibody-based regimen (including biologic agents and vaccination-based treatments), or treatment with a targeted agent (for example, BRAF or c-Kit inhibitor is not counted as a prior treatment regimen for determining study eligibility, unless either was combined with a cytotoxic drug).\n - Have active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of study entry. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out occult brain metastasis. Participants with a history of a solitary CNS metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) and not requiring steroids are eligible.\n - Are receiving warfarin.\n - Have primary ocular or mucosal melanoma.\n - Any previous treatment with paclitaxel or a paclitaxel-containing regimen for metastatic melanoma.\n - Have serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator).\n - Have previously completed or withdrawn from this study or any other study investigating tasisulam-sodium.\n - Have a known hypersensitivity to paclitaxel or Cremophor EL (polyoxyethylated castor oil).\n - Are pregnant or lactating.\n - Have received a recent (within 30 days before enrollment) or are receiving concurrent yellow fever vaccination.\n - Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb).\n - Are unable to withhold dosing of non-steroidal anti-inflammatory drugs (NSAIDs) or proton-pump inhibitors (PPIs) for at least 72 hours before and after treatment with tasisulam-sodium. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT01431274 | [
{
"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:** tiotropium + olodaterol, tiotropium, olodaterol, tiotropium, tiotropium + olodaterol\n\n**SMILES:** HC@12OC@@1(H)C@1(H)CC@@(H)(CC@@2(H)N+1(C)C)OC(=O)C(O)(C1=CC=CS1)C1=CC=CS1, HC@12OC@@1(H)C@1(H)CC@@(H)(CC@@2(H)N+1(C)C)OC(=O)C(O)(C1=CC=CS1)C1=CC=CS1, COC1=CC=C(CC(C)(C)NCC@H(O)C2=C3OCC(=O)NC3=CC(O)=C2)C=C1, HC@12OC@@1(H)C@1(H)CC@@(H)(CC@@2(H)N+1(C)C)OC(=O)C(O)(C1=CC=CS1)C1=CC=CS1, HC@12OC@@1(H)C@1(H)CC@@(H)(CC@@2(H)N+1(C)C)OC(=O)C(O)(C1=CC=CS1)C1=CC=CS1\n\n**CT Criteria:** Inclusion criteria:\n 1. Diagnosis of chronic obstructive pulmonary disease.\n 2. Relatively stable airway obstruction with post FEV1< 80% predicted normal and post FEV1/FVC <70%.\n 3. Male or female patients, 40 years of age or older.\n 4. Smoking history of more than 10 pack years.\n Exclusion criteria:\n 1. Significant disease other than COPD\n 2. Clinically relevant abnormal lab values.\n 3. History of asthma.\n 4. Diagnosis of thyrotoxicosis\n 5. Diagnosis of paroxysmal tachycardia\n 6. History of myocardial infarction within 1 year of screening visit\n 7. Unstable or life-threatening cardiac arrhythmia.\n 8. Hospitalization for heart failure within the past year.\n 9. Known active tuberculosis.\n 10. Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years\n 11. History of life-threatening pulmonary obstruction.\n 12. History of cystic fibrosis.\n 13. Clinically evident bronchiectasis.\n 14. History of significant alcohol or drug abuse.\n 15. Thoracotomy with pulmonary resection\n 16. Oral ß-adrenergics.\n 17. Oral corticosteroid medication at unstable doses\n 18. Regular use of daytime oxygen therapy for more than one hour per day\n 19. Pulmonary rehabilitation program in the six weeks prior to the screening visit\n 20. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit\n 21. Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA\n 22. Pregnant or nursing women.\n 23. Women of childbearing potential not using a highly effective method of birth control\n 24. Patients who are unable to comply with pulmonary medication restrictions \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00460317 | [
{
"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:** amg 706, placebo, paclitaxel, carboplatin\n\n**SMILES:** CC1(C)CNC2=C1C=CC(=C2)N=C(O)C1=C(NCC2=CC=NC=C2)N=CC=C1, 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, NC@@H(CCCNC(N)=N)C(O)=O\n\n**CT Criteria:** Inclusion Criteria:\n - Histologically confirmed, unresectable stage 111B with pericardial or pleural effusion or stage IV or recurrent non squamous NSCLC.\n - Measurable or non-measurable disease per modified RECIST criteria\n - ECOG performance status of 0 or 1\n - Life expectancy of greater than or equal to 3 months as documented by the investigator\n - ability to take oral medications\n - competency to give written informed consent\n - able to start protocol directed therapy within 7 days from date of randomization\n - Hematological function, as follows:\n - Absolute neutrophil count (ANC) > = 1.5 x 109/L\n - Platelet count > = 100 x 109/L and < = 850 x 109/L\n - Hemoglobin > =9 g/dL\n - Renal function, as follows:\n - Creatinine clearance > 40 mL/min (calculated by Cockcroft Gault formula)\n - Urinary protein quantitative value of < = 30 mg in urinalysis or < = 1+ on dipstick unless quantitative protein is < 500 mg in a 24 hour urine sample\n - Hepatic function, as follows:\n - Aspartate aminotransferase (AST) < =2.5 x upper limit of normal (ULN) OR AST < 5 x ULN if liver metastases are present\n - Alanine aminotransferase (ALT) < =2.5 x ULN OR ALT < 5 x ULN if liver metastases are present\n - Alkaline phosphatase < = 2.0 x ULN OR alkaline phosphatase < 5 x ULN if liver or bone metastases are present\n - Total bilirubin < 1.5 x ULN OR total bilirubin < 3 X ULN if subject has UGT1A1 promoter polymorphism (ie, Gilbert syndrome) confirmed by genotyping or Invader UGT1A1 Molecular Assay prior to randomization Partial thromboplastin (PTT) or activated partial thromboplastin time (aPTT) < = 1 x ULN and international normalized ratio (INR) < = 1.5 x ULN\n Exclusion Criteria:\n - Subjects with adenosquamous histology or an unclear histology subtype (eg, not otherwise specified) containing greater than 10% squamous cells\n - untreated or symptomatic central nervous system metastases. Subjects with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastases, and the subject is clinically stable and is off corticosteroids for at least 2 weeks prior to randomization.\n - Prior chemotherapy as follows: Any prior chemotherapy for advanced non squamous NSCLC\n - Any prior adjuvant chemotherapy for non squamous NSCLC within 52 weeks prior to randomization. Adjuvant chemotherapy completed > 52 weeks prior to randomization is permitted. Any prior chemoradiation for locally advanced stage III disease.\n - Prior (within 30 days of randomization) yellow fever vaccination.\n - Central (chest) radiation therapy within 28 days prior to randomization, radiation therapy within 14 days prior to randomization for peripheral lesions.\n - History of pulmonary hemorrhage or gross hemoptysis (approximately 3 mL of bright red blood or more) within 6 months prior to randomization.\n - Prior targeted therapies, including but not limited to:\n - AMG 706, inhibitors of VEGF (eg, SU5416, SU6668, ZD6474, SU11248, PTK787, AZD2171, AEE 788, sorafenib, bevacizumab), or EGFr (eg, panitumumab, cetuximab, gefitinib, erlotinib).\n - Known history of allergy or hypersensitivity reaction to paclitaxel or carboplatin.\n - Any anticoagulation therapy within 7 days prior to randomization. The use of low-dose warfarin < = 2 mg daily or low molecular weight heparin or heparin flushes for prophylaxis against central venous catheter thrombosis is allowed.\n - History of arterial or venous thrombosis within 12 months prior to randomization.\n - History of bleeding diathesis or bleeding within 14 days prior to randomization.\n - Peripheral neuropathy > grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.\n - Clinically significant cardiac disease within 12 months of randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, percutaneous transluminal coronary angioplasty/stent, congestive heart failure, or ongoing arrhythmias requiring medication.\n - History of other primary cancer unless: Curatively resected non melanomatous skin cancer. Curatively treated cervical carcinoma in situ. Other primary solid tumor curatively treated with no known active disease present and no curative treatment administered for the last 3 years\n - Any kind of disorder that compromises the ability of the subject to comply with the study procedures.\n - Open wound, ulcer or fracture.\n - Uncontrolled hypertension as defined by resting blood pressure > 150/90 mm Hg. Antihypertensive medications are allowed if the subject is stable on their current dose at the time of randomization.\n - Surgery:\n - Major surgical procedures within 28 days prior to randomization\n - Minor surgical procedures within 14 days prior to randomization\n - Failure to recover from prior surgery\n - Placement of a central venous access device (including ports and tunneled or non-tunneled catheters) within 7 days prior to randomization\n - Planned elective surgery while on study treatment\n - Core needle biopsy within 7 days prior to randomization\n - Not recovered from all previous therapies (ie, radiation, surgery and medications). Adverse events related to previous therapies must be CTCAE grade < = 1 at screening or returned to the subjects baseline prior to their most recent previous therapy.\n - Participation in therapeutic clinical trials or currently receiving other investigational treatment(s) within 30 days prior to randomization.\n - Pregnant (eg, positive HCG test-serum or urine) or breast feeding woman.\n - Any subject not consenting to use adequate contraceptive precautions (eg, hormonal, barrier or abstinence) during the course of the study and for 6 months after the last treatment.\n - Known to be human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C positive.\n - Known chronic hepatitis.\n - Active infection requiring systemic treatment or any uncontrolled infection < = 14 days prior to randomization.\n - History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results.\n - Previously randomized to this study.\n - Not available for follow-up assessments or unable to comply with study requirements. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT00515619 | [
{
"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:** epilepsy\n\n**ICD Codes:** \"G40.803, G40.804, G40.911, G40.919, G40.B11, G40.B19, G40.801\"\n\n**Drugs:** lacosamide\n\n**SMILES:** COCC@@H(NC(C)=O)C(=O)NCC1=CC=CC=C1\n\n**CT Criteria:** Inclusion Criteria:\n - diagnosis of Epilepsy\n - completion of double blind trial\n Exclusion Criteria:\n - taking other investigational drug than Lacosamide\n - meeting withdrawal criteria from double blind trial \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00265811 | [
{
"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:** folfox, cetuximab\n\n**SMILES:** HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1, HC@12SCC(COC(C)=O)=C(N1C(=O)C@H2NC(=O)C(=N/OC)\\\\C1=CSC(N)=N1)C(O)=O\n\n**CT Criteria:** DISEASE CHARACTERISTICS:\n - Histologically confirmed stage III adenocarcinoma of the colon\n - Must have undergone curative resection (R0) within the past 28-56 days\n - No radiotherapy prior to surgery\n - carcinoembryonic antigen (CEA) ≤ 1.5 times upper limit of normal (ULN) after surgery\n - No rectal cancer located within 15 cm from the anal verge by endoscopy or under the peritoneal reflection at surgery\n - No metastatic spread at baseline assessment\n - No prior or concurrent CNS disease by physical exam\n PATIENT CHARACTERISTICS:\n Performance status\n - WHO 0-1\n Life expectancy\n - At least 5 years\n Hematopoietic\n - WBC ≥ 3,000/mm^3\n - Absolute neutrophil count ≥ 1,500/mm^3\n - Platelet count ≥ 100,000/mm^3\n - Hemoglobin ≥ 9 g/dL\n Hepatic\n - Bilirubin ≤ 1.5 times ULN\n - AST and ALT ≤ 2.5 times ULN\n - Alkaline phosphatase ≤ 1.5 times ULN\n Renal\n - Creatinine ≤ 1.5 times ULN\n Cardiovascular\n - No coronary artery disease\n - No myocardial infarction within the past 12 months\n - No high risk of uncontrolled arrhythmia\n Other\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective contraception\n - No inflammatory bowel disease\n - No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix\n - No significant traumatic injury within the past 28 days\n - No known hypersensitivity to any of the components of the study drugs\n - No medical, geographical, sociological, psychological, or legal condition that would preclude study participation\n - No peripheral neuropathy ≥ grade 1\n - No other significant disease that would preclude study participation\n PRIOR CONCURRENT THERAPY:\n Chemotherapy\n - No prior chemotherapy\n Radiotherapy\n - See Disease Characteristics\n - No prior abdominal or pelvic irradiation\n Surgery\n - See Disease Characteristics\n - Recovered from prior surgery\n - More than 28 days since prior major surgical procedure or open biopsy\n - No concurrent major surgical procedure \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
NCT01010061 | [
{
"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:** lymphocytic leukemia, chronic\n\n**ICD Codes:** \"C91.11, C91.12, C91.10\"\n\n**Drugs:** obinutuzumab, rituximab, chlorambucil\n\n**SMILES:** ClCCN(CCCl)P1(=O)NCCCO1, OC(=O)CCCC1=CC=C(C=C1)N(CCCl)CCCl\n\n**CT Criteria:** Inclusion Criteria:\n - Adults >/=18 years\n - Documented Cluster of Differentiation Antigen 20 (CD20) + B-Cell Chronic Lymphocytic Lymphoma (B-CLL)\n - Previously untreated Chronic Lymphocytic Leukemia (CLL) requiring treatment according to the National Cancer Institute (NCI) criteria\n - Total Cumulative Illness Rating Scale (CIRS) > 6 and/or creatinine clearance < 70 ml/min\n Exclusion Criteria:\n - Prior CLL therapy\n - Transformation of CLL to aggressive Non-Hodgkins Lymphoma (NHL) (Richters transformation)\n - History of other malignancy unless the malignancy has been in remission without treatment for >/=2 years prior to enrolment, and except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate cancer, or ductal carcinoma in situ (DCIS) of the breast treated with lymphectomy alone\n - Positive hepatitis serology (HBV, HCV) or positive HIV or Human T Cell Leukemia Virus (HTLV) testing\n - Patients with active infection requiring systemic treatment \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] | Success |
NCT00451867 | [
{
"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:** interstitial cystitis, painful bladder syndrome\n\n**ICD Codes:** \"N30.10, N30.11\", \"D68.61, D69.41, D81.4, E24.1, E26.01, E26.81, E34.0\"\n\n**Drugs:** mycophenolate mofetil, mycofenolate mofetil (mmf), placebo\n\n**SMILES:** NC@@H(CCCNC(N)=N)C(O)=O, COC1=C(C\\\\C=C(/C)CCC(=O)OCCN2CCOCC2)C(O)=C2C(=O)OCC2=C1C, 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 - Participant at least 18 years of age and received a diagnosis of PBS/IC, confirmed by cystoscopy and hydrodistention in the past with findings of glomerulations and/or ulceration.\n - Participant has symptoms of urinary frequency and pain/discomfort (at least 4 on each 0-10 Likert scale) at entry.\n - Participant failed at least 24 weeks of active treatment with a minimum of 3 standard forms of therapy (including hydrodistension) or combination of therapies for PBS/IC.\n - Participant will receive cystoscopy to be performed in the office at baseline visit before randomization if none has been conducted within the previous 24 weeks. Cystoscopy results must show no unevaluated lesions.\n - Female participants with a cervix are required to have Pap smear exam within the past 12 months prior to enrollment with normal results reported.\n - Participant (female) with child-bearing potential must agree to use two reliable/medically approved methods of birth control.\n Exclusion Criteria:\n - History of cancer or known pre-malignant conditions, including skin cancer.\n - History of bladder calculus, tuberculous cystitis; neurologic disease affecting bladder function.\n - Current immunocompromised condition, including current or chronic treatment with immunosuppressive agents, or known positive for HIV (positive antibody confirmed by Western Blot or IFA); active tuberculosis requiring on-going therapy; current systemic steroid treatment at any dose.\n - Liver function test or creatinine results greater than 2x the upper limit of normal at home institution laboratory.\n - Any baseline leukopenia (an absolute neutrophil count <1,500/µL), thrombocytopenia (a platelet count less than 150,000/microL), or anemia - HGB < 12 or < 11 g/dLin men and in women respectively.\n - Is seropositive for Hepatitis B surface antigen; or is seropositive for Hepatitis B surface antibody (if not previously vaccinated); is seropositive for Hepatitis C antibody or HIV antigen or antibody.\n - Allergy or hypersensitivity to study medication.\n - Unable to void spontaneously.\n - Active urethral or ureteral calculi, urethral diverticulum.\n - Any severe debilitating or urgent concurrent medical condition.\n - Previous cytoxan/cyclophosphamide treatment, pelvic radiation therapy; augmentation cystoplasty, cystectomy, or cystolysis; neurectomy.\n - Participants with history of treatment for genital tract dysplasia or genital warts or genital herpes.\n - Patients with active or a history of peptic ulcer disease, inflammatory bowel disease or gastrointestinal bleeding.\n - Patients with hypertension not adequately controlled with medication.\n - Patient currently taking H2 blockers or proton pump inhibitors.\n - Patients who cannot tolerate or refuse an office cystoscopy.\n Exclusion criteria for men only:\n - Currently being treated for chronic bacterial prostatitis, as documented by a positive urine culture or prior history of recurrent bacterial urinary infections.\n - Unevaluated suspicious prostate exam.\n Exclusion criteria for women only:\n - Lactation, pregnancy, or refusal of two types of (medically approved/reliable) birth control in women of child-bearing potential.\n - Pain, frequency, urgency symptoms present only during menses. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] | [
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] | Failure |
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