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NCT01187615
|
[
{
"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 carcinoma\n\n**ICD Codes:** \"D02.20, D02.21, D02.22\"\n\n**Drugs:** regorafenib (bay73-4506) - sequential / cisplatin / pemetrexed, regorafenib (bay73-4506) - continuous / cisplatin / pemetrexed\n\n**SMILES:** HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1, HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1\n\n**CT Criteria:** Inclusion Criteria:\n - Age >= 18 years.\n - Histological or cytological diagnosis of metastatic Stage IV or locally advanced, unresectable confirmed Stage IIIB nonsquamous Non-Small Cell Lung Cancer (NSCLC) not amenable to local therapy with curative intent.\n - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 2\n - Life expectancy of at least 12 weeks.\n - Adequate bone marrow, liver, and renal function\n - Controlled blood pressure defined as systolic Blood Pressure (BP) <=150 mmHg and diastolic Blood Pressure (BP) <= 90 mmHg\n - Men and women of childbearing potential enrolled in this study must use adequate barrier birth control measures during the course of the study\n Exclusion Criteria:\n - Sensory neuropathy with sensory alterations or paresthesia (including tingling), interfering with function\n - Hearing impairment\n - Persistent proteinuria of Common Toxicity Criteria (CTC) Grade 3 or higher\n - Cardiac disease: congestive heart failure > New York Heart Association (NYHA) Class II; patients must not have unstable angina (anginal symptoms at rest) or new-onset angina (began within the last 3 months) or myocardial infarction within the past 6 months; cardiac ventricular arrhythmias requiring anti-arrhythmic therapy\n - Brain metastasis: patients with neurological symptoms should undergo a Computerized Tomography (CT) scan / Magnetic Resonance Imaging (MRI) of the brain to exclude any new or progressive brain metastasis. Patients with brain metastases are excluded from the trial\n - Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication\n - Pulmonary hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 within 4 weeks prior to the start of study treatment. Clinically significant hemoptysis (1 teaspoon or more) in the past 3 months\n - Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks prior to the start of study treatment\n - Evidence or history of bleeding diathesis or coagulopathy\n - Centrally located tumors with radiologic evidence (CT or MRI) of local invasion of major blood vessels\n - The effect of third space fluid, such as pleural effusion and ascites, on pemetrexed is unknown. In patients with clinically significant third space fluid, consideration should be given to draining the effusion prior to study start\n - Patients with phaeochromocytoma Excluded Therapies and Medications, Previous and Concomitant\n - Prior treatment with a systemic chemotherapy for metastatic NSCLC. Patients who underwent prior systemic treatment or radiotherapy for NSCLC in a neoadjuvant or adjuvant setting are eligible, but no chemotherapy treatment within the last 6 month prior to study entry is allowed \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] |
Failure
|
NCT01046487
|
[
{
"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:** imatinib mesylate, cyclophosphamide (dosing level 1 ), imatinib mesylate, cyclophosphamide (dosing level 2), imatinib mesylate, cyclophosphamide (dosing level 3)\n\n**SMILES:** CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1, CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1, CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1\n\n**CT Criteria:** Inclusion Criteria:\n - Rare tumor\n - metastatic disease or locally advanced disease, inoperable, with no standard treatment\n - At least 28 days since the prior treatment\n - Measurable disease with at least one measurable lesion\n Exclusion Criteria:\n - Medullary insufficiency\n - Cystitis, haemorrhagic cystitis\n - Hepatic porphyria \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT01381887
|
[
{
"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 300mg/placebo, canagliflozin 300mg/canagliflozin 150mg, canagliflozin 300mg\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, 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, 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\n\n**CT Criteria:** Inclusion Criteria:\n - Patients with T2DM with inadequate glycemic control (based upon fasting glucose measurements >=130 mg/dL and <=250 mg/dL) on metformin monotherapy or on metformin in dual combination with other glucose lowering agents (sulphonylurea SU or a meglitinide or a dipeptidyl peptidase-4 DPP-4 inhibitor) are eligible for enrollment in the study.\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 - history of a severe hypoglycemic episode within 6 months before screening\n - Has repeated (ie, 2 or more over a 1-week period) fasting plasma glucose (FPG) and/or fasting self-monitored blood glucose (SMBG) measurements >=250 mg/dL (13.88 mmol/L) during the pre-treatment phase, despite reinforcement of diet and exercise counseling\n - History of or current illness considered to be clinically significant by the investigator \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT02015676
|
[
{
"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:** trastuzumab, paclitaxel, myocet\n\n**SMILES:** HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1, HC@@1(CC@@H(C)C@2(H)CC(=O)C@H(C)\\\\C=C(C)\\\\C@@H(O)C@@H(OC)C(=O)C@H(C)CC@H(C)\\\\C=C\\\\C=C\\\\C=C(C)\\\\C@H(CC@3(H)CCC@@H(C)C@@(O)(O3)C(=O)C(=O)N3CCCCC@@3(H)C(=O)O2)OC)CCC@@H(OCCO)C@@H(C1)OC, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(CC@(O)(CC@@H3OC@H3CC@H(N)C@H(O)C@H(C)O3)C(=O)CO)C(O)=C1C2=O\n\n**CT Criteria:** Inclusion Criteria:\n - women 18-70 years of age;\n - metastatic or locally advanced breast cancer;\n - HER2 overexpression;\n - >= 1 measurable lesion.\n Exclusion Criteria:\n - prior treatment for advanced breast cancer;\n - prior treatment with Herceptin;\n - bone or central nervous system metastasis as the only site of disease;\n - history of another malignancy (except basal cell skin cancer and cancer in situ of the uterine cervix, and contralateral breast cancer) within 5 years of study. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT01813955
|
[
{
"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, cognitive deficits\n\n**ICD Codes:** \"F20.0, F20.1, F20.2, F20.3, F20.5, F20.89, F20.9\", \"R41.841, R41.81, G31.84, I69.315, I69.015, I69.115, I69.815\"\n\n**Drugs:** papaverine or placebo\n\n**SMILES:** COC1=C(OC)C=C(CC2=NC=CC3=CC(OC)=C(OC)C=C23)C=C1\n\n**CT Criteria:** Inclusion Criteria:\n - Diagnosed Schizophrenia (WHO ICD 10)\n - Treatment stable (no regulation in medicine for 6 weeks prior)\n - Mono antipsychotic treatment\n - No regular Antidepressants (PN accepted)\n - No regular Benzodiazepines (PN accepted)\n Exclusion Criteria:\n - Dependence syndrome\n - Severe physical illness\n - MRI incompatible, non removable objects above shoulders \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] |
Failure
|
NCT01213160
|
[
{
"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, advanced solid malignancies\n\n**ICD Codes:** \"C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2\"\n\n**Drugs:** azd4547\n\n**SMILES:** COC1=CC(OC)=CC(CCC2=CC(NC(=O)C3=CC=C(C=C3)N3CC@H(C)NC@H(C)C3)=NN2)=C1\n\n**CT Criteria:** Inclusion Criteria:\n - Japanese patients with advanced solid malignancies Over 25 years old Relatively good overall health other than cancer\n Exclusion Criteria:\n - Poor bone marrow function (not producing enough blood cells). Poor liver or kidney function. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the IP or previous significant bowel resection. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] |
Failure
|
NCT00722293
|
[
{
"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:** neoplasms, breast\n\n**ICD Codes:** \"C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60\"\n\n**Drugs:** doxorubicin, pazopanib (gw786034), epirubicin\n\n**SMILES:** COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(CC@(O)(CC@@H3OC@H3CC@H(N)C@H(O)C@H(C)O3)C(=O)CO)C(O)=C1C2=O, CN(C1=CC2=NN(C)C(C)=C2C=C1)C1=CC=NC(NC2=CC=C(C)C(=C2)S(N)(=O)=O)=N1, 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 - Patients must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up\n - Histologically or cytologically confirmed diagnosis of advanced solid tumor that has failed standard therapy or for which there is no standard therapy and is indicated for treatment with anthracyclines.\n - Age greater than or equal to 18 years.\n - Adequate organ system function as defined by the protocol.\n - ECOG performance value of 0 or 1.\n - Less than or equal to one prior line of chemotherapy for advanced disease. Patients with metastatic disease to the brain should have definitive therapy for their brain metastases, should be asymptomatic. (Patients with previously treated brain metastases who are asymptomatic, off steroids and anti-seizure medications for greater than 3 months are eligible for the study).\n - There must be measurable disease or evaluable disease for subjects to be included in the cohort expansion phase. Measurable disease is not a criterion for subjects enrolling in the dose escalation phase.\n - Has a left ventricular ejection fraction (LVEF) greater than or equal to 50% or greater than or equal to the institutions LLN.\n - Women of childbearing potential must have a negative pregnancy test within 2 weeks of starting study drug and use acceptable birth control methods as outlined in the protocol.\n - Women may participate if they are of non childbearing potential (bilateral tubal ligation, hysterectomy, post menopausal or bilateral ovariectomy.\n - Males with female partners of childbearing potential may participate if they practice acceptable methods of birth control as outlined in the study protocol.\n - Able to swallow and retain oral medications.\n - Less than or equal to one prior line of chemotherapy for advanced disease.\n - Life expectancy of at least 12 weeks.\n Exclusion Criteria:\n - Prior use of pazopanib or prior treatment with anthracyclines. Prior therapy with other angiogenesis inhibitors is permitted.\n - Clinically significant gastrointestinal abnormalities which might interfere with oral dosing.\n - Any unstable or serious concurrent condition (e.g., active infection requiring systemic therapy).\n - QTc > 480 msecs.\n - History of any one or more of the following cardiovascular conditions within the past 6 months:\n - Cardiac angioplasty or stenting\n - Myocardial infarction\n - Unstable angina\n - Symptomatic peripheral vascular disease\n - Class III or IV congestive heart failure\n - Any major surgery or trauma within the last 28 days and or presence of non-healing wound, fracture, or ulcer.\n - Any unstable or serious concurrent condition.\n - Poorly controlled hypertension defined as systolic blood pressure (SBP) of =140mmHg or diastolic blood pressure (DBP) of = 90mmHg.\n - History of cerebrovascular accident (CVA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Subjects with a recent DVT who have been treated with therapeutic agents (excluding therapeutic warfarin) for at least 6 weeks are eligible.\n - Prior major surgery or trauma within 28 days prior to first dose of study drug and /or presence of any non-healing wound, fracture, or ulcer.\n - Hemoptysis within 6 weeks prior to first dose of study drug.\n - Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with patients safety, provision of informed consent, or compliance to study procedures.\n - Is unable or unwilling to discontinue prohibited medications for 14 days or five half-lives of a drug prior to Visit 1 and for the duration of the study.\n - Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.\n - Is now undergoing and/or has undergone within 28 days immediately prior to first dose of study drug, any cancer therapy (major surgery, investigational agent, tumor embolization, chemotherapy, radiation therapy, immunotherapy, biological therapy, or hormonal therapy).\n - Clinically assessed as having inadequate venous access for PK sampling.\n - Lactating and pregnant women should discontinue lactation prior to first use of study drug and refrain from nursing throughout the treatment period and for 14 days after final dose. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT00451880
|
[
{
"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, non-small-cell lung cancer, colorectal cancer, papillary thyroid cancer, melanoma\n\n**ICD Codes:** \"C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2\", \"C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2\", \"C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2\", \"C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4\"\n\n**Drugs:** xl281, famotidine\n\n**SMILES:** NC(N)=NC1=NC(CSCCC(N)=NS(N)(=O)=O)=CS1\n\n**CT Criteria:** Key Inclusion Criteria:\n - The subject has a histologically confirmed solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no therapies known to prolong survival. Subjects treated at the MTD (once- or twice- daily) must have a diagnosis of colorectal cancer, non-small-cell lung cancer (no longer recruiting), melanoma, or papillary thyroid cancer. Certain other eligibility requirements must also be met.\n - The subject is ≥18 years old.\n - The subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n - The subject has adequate organ and marrow function.\n - The subject is capable of understanding the protocol and has signed the informed consent document.\n - Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study and for 3 months after study drug discontinuation.\n - Female subjects of childbearing potential must have a negative pregnancy test at screening.\n - The subject has had no other diagnosis of malignancy (unless non-melanoma skin cancer, carcinoma in situ of the cervix, or a malignancy diagnosed ≥5 years ago, and has had no evidence of disease for 5 years prior to screening for this study).\n - The subject must meet certain other eligibility requirements.\n Key Exclusion Criteria:\n - The subject has received anticancer treatment (eg, chemotherapy, radiotherapy, cytokines, or hormones) within 28 days (6 weeks for nitrosoureas or mitomycin C) before the first dose of study drug.\n - The subject has received treatment with a small molecule kinase inhibitor or a hormonal therapy (including investigational kinase inhibitors or hormones) within a certain amount of time before the first dose of study drug.\n - The subject has received any other investigational agent within 28 days of first dose of XL281.\n - The subject has not recovered to Grade ≤1 from adverse events (AEs) or to within 10% of baseline values due to investigational or other agents administered more than 30 days prior to study enrollment. Some irreversible toxicities from previous treatment may be allowed.\n - The subject requires treatment with antacids (continual treatment), proton pump inhibitors, or H2 receptor antagonists.\n - The subject has a primary brain tumor or known brain metastases.\n - The subject has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n - The subject is pregnant or breastfeeding.\n - The subject is known to be positive for the human immunodeficiency virus (HIV).\n - The subject has an allergy or hypersensitivity to components of the XL281 formulation or to famotidine.\n - The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.\n - The subject is receiving anticoagulation with warfarin or coumarin-related compounds (low-dose warfarin ≤ 1 mg/day, heparin, and low-molecular weight heparin are permitted)\n - The subject must meet certain other eligibility requirements. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT00096304
|
[
{
"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:** prostate cancer\n\n**ICD Codes:** \"C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5\"\n\n**Drugs:** docetaxel, epirubicin hydrochloride\n\n**SMILES:** HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(CC@(O)(CC@@H3OC@H3CC@H(N)C@@H(O)C@H(C)O3)C(=O)CO)C(O)=C1C2=O\n\n**CT Criteria:** DISEASE CHARACTERISTICS:\n - Histologically confirmed adenocarcinoma of the prostate\n - Meets 1 of the following criteria:\n - Measurable disease with any prostate-specific antigen (PSA) value\n - Unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan\n - Histologic confirmation required if measurable disease is confined to a solitary lesion\n - Non-measurable disease with PSA ≥ 5 ng/mL*\n - The following are considered non-measurable disease:\n - Bone lesions\n - Pleural or pericardial effusion\n - Ascites\n - CNS lesions\n - Leptomeningeal disease\n - Irradiated lesions unless disease progression was documented after prior radiotherapy NOTE: *Patients with PSA ≥ 5 ng/mL only are not eligible\n - Progressive systemic disease despite ≥ 1 prior standard endocrine therapy with orchiectomy, luteinizing hormone-releasing hormone (LHRH) agonist, or diethylstilbestrol, as indicated by 1 of the following criteria:\n - Objective evidence of increase > 20% in the sum of the longest diameters of target lesions from the time of maximal regression OR the appearance of 1 or more new lesions\n - One or more new lesions on bone scan secondary to prostate cancer AND PSA ≥ 5 ng/mL\n - Elevated PSA (≥ 5 ng/mL) with 2 consecutive increases from baseline (taken ≥ 1 week apart)\n - Serum testosterone ≤ 50 ng/dL for patients without bilateral orchiectomy\n - Patients who have not had a bilateral orchiectomy should continue therapy with primary testicular androgen suppression (e.g., LHRH analogues)\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 - Granulocyte count ≥ 1,500/mm^3\n - Platelet count ≥ 100,000/mm^3\n Hepatic\n - Meets 1 of the following criteria:\n - AST or ALT normal AND alkaline phosphatase ≤ 5 times upper limit of normal (ULN)\n - AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN\n - AST or ALT ≤ 5 times ULN AND alkaline phosphatase normal\n - Bilirubin normal\n Renal\n - Creatinine ≤ 1.5 times ULN\n Cardiovascular\n - No uncontrolled high blood pressure\n - No unstable angina\n - No symptomatic congestive heart failure\n - No myocardial infarction within the past 6 months\n - No serious uncontrolled cardiac arrhythmia\n - No New York Heart Association class III or IV heart disease\n Other\n - Fertile patients must use effective contraception during and for at least 3 months after study participation\n - No peripheral neuropathy ≥ grade 2\n - No prior severe hypersensitivity reaction to docetaxel or other drug formulated with polysorbate 80\n PRIOR CONCURRENT THERAPY:\n Biologic therapy\n - No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)\n Chemotherapy\n - No prior chemotherapy, including estramustine or suramin for prostate cancer\n - No other concurrent chemotherapy\n Endocrine therapy\n - See Disease Characteristics\n - At least 4 weeks since prior antiandrogen therapy\n - No concurrent hormonal therapy except steroids for adrenal insufficiency, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic\n Radiotherapy\n - See Disease Characteristics\n - At least 4 weeks since prior radiotherapy\n - At least 8 weeks since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium\n - No concurrent palliative radiotherapy\n Surgery\n - See Disease Characteristics\n - At least 4 weeks since prior surgery and recovered \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] |
Failure
|
NCT00129896
|
[
{
"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:** myocet, taxotere, herceptin\n\n**SMILES:** COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(CC@(O)(CC@@H3OC@H3CC@H(N)C@H(O)C@H(C)O3)C(=O)CO)C(O)=C1C2=O, HN(H)(H)Pt(Cl)(Cl)N(H)(H)H\n\n**CT Criteria:** Inclusion Criteria:\n - Written informed consent.\n - Breast cancer stages II and IIIA with histological diagnoses by true-cut.\n - Breast cancer tumours overexpressing HER2neu, centrally confirmed by FISH.\n - No evidence of metastasis: bilateral mammography, thorax x-ray, computed tomography (CT)-scan or abdominal echography and bone scintigraphy.\n - Estrogen and progesterone hormone receptor status, determined before study registration.\n - Age >= 18 years old.\n - Performance status (Karnofsky index) >= 80.\n - Adequate cardiac function by LVEF in the previous 14 days.\n - Hematology: neutrophils >= 2.0 x10^9/l; platelets >= 100 x10^9/l; hemoglobin >= 10 g/dl.\n - Adequate hepatic function: total bilirubin <= 1x upper normal limit (UNL); SGOT and SGPT <= 2.5xUNL; alkaline phosphatase <= 2.5xUNL.\n - Adequate renal function: creatinine <= 1xUNL; creatinine clearance >= 60 ml/min.\n - Patients able to comply with study treatment and follow-up.\n - Negative pregnancy test in the previous 14 days.\n - Adequate contraceptive method during the study and up to 3 months after definitive surgery.\n Exclusion Criteria:\n - HER2neu negative tumours.\n - Prior systemic therapy for breast cancer.\n - Prior treatment with anthracyclines or taxanes (paclitaxel, docetaxel) for any previous malignancy.\n - Prior radiotherapy for breast cancer.\n - Bilateral invasive breast cancer.\n - Pregnant or lactating women.\n - Previous grade >= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria NCI CTC).\n - Other serious comorbidities: congestive heart failure or unstable angina; prior history of myocardial infarction in previous year; uncontrolled hypertension (HT); high risk arrhythmias; history of significant neurological or psychiatric disorders; uncontrolled active infection; active peptic ulcer; unstable diabetes mellitus; dyspnea at rest; or chronic therapy with oxygen.\n - Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumor curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.\n - Chronic treatment with corticosteroids.\n - Contraindications for administration of corticosteroids, anthracyclines, docetaxel, trastuzumab or egg derivates.\n - Concomitant treatment with other therapy for cancer.\n - Males. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT00315861
|
[
{
"role": "user",
"content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- **Diseases:** A list of diseases targeted by the clinical trial.\n- **ICD Codes:** A list of ICD codes associated with the diseases.\n- **Drugs:** A list of drugs used in the clinical trial.\n- **SMILES:** A list of SMILES strings representing the chemical structures of the drugs\n- **CT Criteria:** The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\n**Diseases:** ovarian cancer, endometrial cancer, cervical cancer, lung cancer\n\n**ICD Codes:** \"C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2\", \"N85.00, N85.01, N85.02, N99.85\", \"M50.20, M50.21, M50.30, M50.31, M50.80, M50.81, M50.90\", \"C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2\"\n\n**Drugs:** pemetrexed, topotecan\n\n**SMILES:** HN(H)(H)Pt(Cl)(Cl)N(H)(H)H, CCC@@1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=C(C=CC(O)=C4CN(C)C)N=C13)C2=O\n\n**CT Criteria:** Inclusion Criteria:\n - Histologically proven advanced solid tumors\n - Measurable or evaluable disease\n - Age ≥ 18 years\n - Karnofsky performance status ≥ 80% (ECOG 0 or 1)\n - Adequate liver, bone marrow and kidney function\n Exclusion Criteria:\n - More than 3 prior chemotherapy regimens in the metastatic setting\n - Prior treatment with topotecan or pemetrexed\n - Clinically significant third space fluid present at the time of treatment\n - Unable to interrupt aspirin, other non-steroidal anti-inflammatory drugs\n - Inability to take steroid premedications or vitamin supplementation\n - The presence of active brain metastases\n - Prior radiotherapy within 4 weeks prior to the first day of treatment\n - Prior surgery within 3 weeks prior to the first day of treatment\n - Prior chemotherapy within 3 weeks prior to the first day of treatment \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT01064622
|
[
{
"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:** adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage iv pancreatic cancer\n\n**ICD Codes:** \"C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31\", \"C25.3\", \"C25.3\"\n\n**Drugs:** vismodegib, gemcitabine hydrochloride\n\n**SMILES:** CS(=O)(=O)C1=CC(Cl)=C(C=C1)C(=O)NC1=CC=C(Cl)C(=C1)C1=CC=CC=N1, NC1=NC(=O)N(C=C1)C@@H1OC@H(CO)C@@H(O)C1(F)F\n\n**CT Criteria:** Inclusion Criteria:\n - Patients must have histologically or cytologically confirmed adenocarcinoma of the pancreas\n - Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan\n - Patients must have either:\n - Newly diagnosed chemo-naïve metastatic pancreatic cancer; only patients who have not received any chemotherapy for their metastatic disease are eligible\n - Recurrent disease after curative-intent surgery which has now recurred and is metastatic; patients who have recurrent disease may have received adjuvant chemotherapy or adjuvant chemoradiation, but may not have received any chemotherapy for metastatic disease; adjuvant therapy must have been completed >= 6 months prior to the diagnosis of recurrent disease, or if not adjuvant therapy received, surgery must have been performed >= 6 months prior to the diagnosis of recurrent disease\n - Age >= 21 years\n - Life expectancy > 3 months\n - Karnofsky performance status >= 80%\n - Granulocytes >= 1,500/mcL\n - Platelet count >= 100,000/mcL\n - Total bilirubin =< 1.5 times upper limit of normal (ULN)\n - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 times upper limit of normal (ULN) (=< 5 times ULN in the presence of liver metastases)\n - Creatinine within normal institutional limit (< 1.5) OR creatinine clearance >= 65 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal\n - International normalized ratio (INR) =< 1.5 (=< 3 for patients on warfarin)\n - Patients who are on warfarin anticoagulation are allowed to participate as long as they fit the following 4 criteria:\n - They are therapeutic on a stable warfarin dose\n - Their INR target range is no greater than 3\n - They are monitored with weekly INR testing\n - They have no active bleeding or pathological condition that carries high risk of bleeding Other anticoagulants, including enoxaparin (Lovenox) and fondaparinux (Arixtra) are also permitted\n - Women of child-bearing potential and men must use at least one form of contraception (i.e., barrier contraception) at least 4 weeks prior to study entry and then two forms of contraception (i.e barrier contraception and one other method of contraception), for the duration of study participation, and for at least 12 months post-treatment; for appropriate methods of contraception considered acceptable; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n - Pregnancy Testing: Women of childbearing potential are required to have a negative serum pregnancy test (with a sensitivity of at least 25 mIU/mL) within 10-14 days (at initial screening/consideration for the trial - serum or urine); a pregnancy test (serum or urine) will be administered every 4 weeks if their menstrual cycles are regular or every 2 weeks if their cycles are irregular while on study within the 24-hour period prior to the administration of GDC-0449; a positive urine test must be confirmed by a serum pregnancy test; prior to dispensing GDC-0449, the investigator must confirm and document the patients use of two contraceptive methods, dates of negative pregnancy test, and confirm the patients understanding of the teratogenic potential of GDC-0449\n - Ability to understand and the willingness to sign a written informed consent document\n - Patients with recurrent disease after curative-intent surgical resection must have sufficient archival material for correlative studies (20 unstained 5 micron slides and 20 unstained 10 micron slides, or an archival tissue block\n Exclusion Criteria:\n - No prior chemotherapy for metastatic pancreatic cancer; patients who have received any chemotherapy and/or radiation therapy in the adjuvant setting must have completed this therapy ≥6 months prior to enrollment on the trial at the time of recurrence\n - Patients may not be receiving (or received prior to enrollment) any other investigational agents for metastatic disease\n - Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events\n - History of allergic reactions attributed to compounds of similar chemical or biologic composition to hedgehog antagonist GDC-0449 or any other agents used in this study\n - History of allergic reactions attributed to compounds of similar chemical or biologic composition to GDC-0449 or other agents used in the study\n - GDC-0449 inhibits CYP2C8, CYP2C9, and CYP2C19 drug metabolism enzymes in vitro at concentrations that may be clinically relevant. Therefore, caution should be exercised when dosing GDC-0449 concurrently with medications that are substrates of CYP2C8, CYP2C9, and CYP2C19 and have narrow therapeutic windows\n - Patients with malabsorption syndrome or other condition that would interfere with intestinal absorption; patients must be able to swallow capsules\n - Patients with clinically active liver disease, including active viral or other hepatitis or cirrhosis are ineligible\n - Patients with uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, or hypokalemia, defined as less than the lower limit of normal for the institution, despite adequate electrolyte supplementation are excluded from this study\n - No currently active second malignancy other than non-melanoma skin cancer or carcinoma in-situ of the cervix; patients are not considered to have a \"currently active\" malignancy if they have completed therapy and have no evidence of recurrence for at least 5 years\n - Uncontrolled intercurrent illness including, but not limited to,\n - Ongoing or active infection,\n - Symptomatic congestive heart failure\n - Unstable angina pectoris\n - Cardiac arrhythmia\n - Psychiatric illness or social situation that would limit compliance with study requirements\n - Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with GDC-0449; these potential risks may also apply to other agents used in this study\n - Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with GDC-0449; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] |
Failure
|
NCT01925300
|
[
{
"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:** healthy\n\n**ICD Codes:** \"Z76.3, Z76.2\"\n\n**Drugs:** concor 5mg(bisoprolol hemifumarate 5mg) 2tab, crestor 20mg(rosuvastatin calcium 20.80mg) 1tab, concor 5mg 2t and crestor 20 mg 1tab\n\n**SMILES:** CC(C)C1=NC(=NC(C2=CC=C(F)C=C2)=C1\\\\C=C\\\\C@@H(O)CC@@H(O)CC(=O)O)N(C)S(C)(=O)=O, CC(C)C1=NC(=NC(C2=CC=C(F)C=C2)=C1\\\\C=C\\\\C@@H(O)CC@@H(O)CC(=O)O)N(C)S(C)(=O)=O\n\n**CT Criteria:** Inclusion Criteria:\n - Male volunteers in the age between 20 and 55 years old(inclusive)\n - Body mass index (BMI) in the range of 18.5 to 27 kg/m2(inclusive)\n - Medically healthy with no clinically significant vital signs (sitting position blood pressure, pulse rate) (90 mmHg ≤ systolic blood pressure ≤ 150 mmHg, 60 mmHg ≤ diastolic blood pressure ≤ 100 mmHg, 50 beats per minute ≤ pulse rate ≤ 100 beats per minute)\n - Available for the entire study period\n - Understand the requirements of the study and voluntarily consent to participate in the study\n Exclusion Criteria:\n - Subjects with a history of gastrointestinal diseases which might significantly change ADME(Absorption, Distribution, Metabolism and Excretion) of medicines\n - History of clinically significant arrhythmic, peripheral vascular,thyroid, bronchospasm, asthma disease\n - Subjects with anaphylaxis to bisoprolol and/or rosuvastatin\n - History of drug abuse\n - History of caffeine, alcohol, smoking abuse\n - caffeine(coffee,tea,coke) or grapefruit juice > 4cups/day\n - smoking > 20 cigarettes/day\n - alcohol > 140g/week\n - Clinical laboratory test values are outside the accepted normal range\n - AST(Aspartate Transaminase), ALT(ALanine Transaminase)( > 1.5 times to normal range\n - CK(Creatine Kinase) > 1.5 times to normal range\n - Estimated GFR(Glomerular Filtration Rate) < 60 mL/min\n - Subjects with whole blood donation within 60days, component blood donation within 30days and blood transfusion within 30days prior to study medication dosing\n - Subjects considered as unsuitable based on medical judgement by investigators \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] |
Failure
|
NCT01111188
|
[
{
"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:** mantle cell lymphoma\n\n**ICD Codes:** \"S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S\"\n\n**Drugs:** pd 0332991, bortezomib\n\n**SMILES:** CC(=O)C1=C(C)C2=CN=C(NC3=NC=C(C=C3)N3CCNCC3)N=C2N(C2CCCC2)C1=O, ClCCN(CCCl)P1(=O)NCCCO1\n\n**CT Criteria:** Inclusion Criteria:\n - Patients must have histologically or cytologically confirmed mantle cell lymphoma as defined by the World Health Organization. All patients must have either a demonstrated t(11;14) by karyotype, fluorescent in-situ hybridization (FISH) or positive immunohistochemistry for cyclin D1.\n - Subjects must have measurable disease, defined as at least one tumor mass of > 1.5 cm in diameter.\n - Subjects must have received at least one prior chemotherapy-containing regimen and at least one prior rituximab-containing regimen.\n - Age > = 18 years.\n - Accessible disease, defined as at least one of the following:\n - Adenopathy accessible to core needle biopsy\n - Bone marrow involvement\n - Circulating lymphoma cells in the peripheral blood\n - ECOG performance status < = 2\n - Patients must have normal organ and marrow function as defined below within 14 days before enrollment:\n - ANC > = 750 cells/uL\n - platelets > = 75,000 cells/uL\n - Hemoglobin > = 8.0 g/dL\n - total bilirubin < = 1.5 times upper limit of normal\n - AST(SGOT)/ALT(SGPT) < = 3 times upper limit of normal\n - Calculated creatinine clearance > = 30 mL/min\n - The effects of bortezomib and PD 0332991 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, female subjects must either be post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) prior to study entry and for the duration of the study. Male subjects must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a female subject become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n - Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.\n - Subjects must be willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other procedures\n Exclusion Criteria:\n - Patients who have had chemotherapy, radiotherapy, antibodies, or investigational agents within 4 weeks prior to entering the study unless progression has been documented while on treatment, or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Patients may be receiving prednisone at a maximum dose of 10 mg/day orally, provided the dose has been stable during the prior two weeks before starting treatment.\n - Patients may not be receiving any other investigational agents.\n - Prior exposure to PD 0332991\n - Prior exposure to bortezomib will only be permitted if there was a documented complete or partial response and progression occurred off therapy\n - Patients must not have experienced significant hematologic (grade 4) or neuropathic toxicities (grade 3 or 4) due to prior bortezomib therapy\n - Peripheral neuropathy > = grade 2 (CTCAEv3.0) within 14 days before enrollment.\n - History of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib (e.g. boron or mannitol).\n - Contraindication to serial core needle biopsies\n - Known HIV infection\n - Known malabsorption syndrome that may affect absorption of the drug\n - Known or suspected CNS involvement\n - Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n - Pregnant and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown. Confirmation that the subject is not pregnant must be established by a negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.\n - QTc > 470 msec\n - Current use or anticipated need for food or drugs that are known potent CYP3A4 inhibitors, including their administration within 7-days prior to the first PD 0332991dose (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, nefazodone, diltiazem, atazanavir, amprenavir,and fosamprenavir)\n - Current use or anticipated need for drugs that are known potent CYP3A4 inducers, including their administration within 14-days prior to the first PD 0332991 dose (i.e. carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, primidone, rifabutin, rifampin, and St. Johns Wort).\n - Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see Appendix 7), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.\n - Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT00560352
|
[
{
"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 myeloma\n\n**ICD Codes:** \"C90.01, C90.02, C90.00\"\n\n**Drugs:** dasatinib, bortezomib, dexamethasone\n\n**SMILES:** CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1, ClCCN(CCCl)P1(=O)NCCCO1, CC@@H(OC@H1OCCN(CC2=NNC(=O)N2)C@H1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F\n\n**CT Criteria:** Key Inclusion Criteria:\n - Confirmed diagnosis of multiple myeloma with measurable disease\n - Evidence of relapsed or refractory disease and at least 2 prior therapies for multiple myeloma\n - Eastern Cooperative Oncology Group Performance Status of 0 - 2\n - Last treatment for multiple myeloma not within 21 days prior to study treatment initiation\n - Bone marrow transplant not within 3 months prior to study treatment initiation\n - Required baseline hematology and chemistry parameters.\n Key Exclusion Criteria:\n - Clinically significant cardiac disease (New York Heart Association Class III or IV)\n - Abnormal QT interval corrected for heart rate using Fridericias formula prolonged (>450 msec) after electrolytes have been corrected on baseline electrocardiogram\n - Malabsorption syndrome or uncontrolled gastrointestinal toxicities\n - Dementia, chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation\n - Clinically significant pleural effusion in the previous 12 months or current ascites\n - Clinically significant coagulation or platelet function disorder\n - Intolerance to dasatinib and/or bortezomib\n - Acute diffuse infiltrative pulmonary disease\n - Prior or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer currently in complete remission, cervical carcinoma in situ, or any other cancer from which the participant has been disease-free for 3 years. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] |
Failure
|
NCT01292798
|
[
{
"role": "user",
"content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- **Diseases:** A list of diseases targeted by the clinical trial.\n- **ICD Codes:** A list of ICD codes associated with the diseases.\n- **Drugs:** A list of drugs used in the clinical trial.\n- **SMILES:** A list of SMILES strings representing the chemical structures of the drugs\n- **CT Criteria:** The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\n**Diseases:** diabetic macular edema\n\n**ICD Codes:** \"E10.311, E10.319, E11.311, E11.319, E13.311, E13.319, E10.3513\"\n\n**Drugs:** ranibizumab\n\n**SMILES:** CN\\\\C(NCCSCC1=CC=C(CN(C)C)O1)=C/N+(O-)=O\n\n**CT Criteria:** Inclusion Criteria:\n - Ability to provide written informed consent and comply with study assessments for the full duration of the study\n - Age > 18 years\n - Diagnosis of diabetes mellitus (type 1 or 2)Any one of the following will be considered to be sufficient evidence that diabetes is present:Current regular use of insulin for treatment of diabetes or current regular use of oral anti-hyperglycemia agent for the treatment of diabetes\n - Clinical evidence of retinal thickening due to macular edema involving the center of the macula, associated with diabetic retinopathy.\n - Previous history of two consecutive intravitreal bevacizumab injections for the treatment of diabetic macular edema with documented incomplete resolution of central subfield thickening by OCT (consecutive injections administered < 7 weeks apart and within the past 12 months).\n - Central diabetic macular edema present on clinical examination and OCT testing with central 1mm subfield thickness greater than 300 microns as measured on SD-OCT.\n - Visual acuity score greater than or equal to 19 letters (20/400) and less than or equal to 73 letters (20/40) by the ETDRS visual acuity protocol.\n - Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography\n Exclusion Criteria:\n - Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception.\n - Participation in another ocular investigation or trial simultaneously\n - Blood pressure > 180/110 (systolic above 180 OR diastolic above 110)\n - Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse)\n - Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema\n - An eye that, in the investigators opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of subretinal fibrosis or geographic atrophy)\n - Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (e.g. AMD, uveitis, Irvine-Gas)\n - Evidence of neovascularization of the iris or retina\n - Evidence of central atrophy or fibrosis in the study eye\n - Presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study.\n - History of vitreous surgery in the study eye\n - History of cataract surgery within 6 months of enrollment.\n - History of YAG capsulotomy within 2 months of enrollment.\n - Visual acuity <20/400 in the fellow eye\n - Uncontrolled glaucoma (pressure >30) despite treatment with glaucoma medications.\n - History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT01273558
|
[
{
"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:** canagliflozin\n\n**SMILES:** 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\n\n**CT Criteria:** Inclusion Criteria:\n - Patients with T2DM who are not receiving treatment with any anti-hyperglycemic agents (AHAs) for at least 12 weeks, or who are receiving treatment with a stable dose and regimen of metformin monotherapy for at least 12 weeks and have a hemoglobin A1c (HbA1c) in the range of >=7% to <=10%\n Exclusion Criteria:\n - History of Type 1, \"brittle\" diabetes or secondary forms of diabetes\n - History of 1 or more severe hypoglycemic episodes\n - History of diabetic complications considered to be clinically significant by the Investigator\n - History of or current illness considered to be clinically significant by the investigator \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT00730392
|
[
{
"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 1 diabetes\n\n**ICD Codes:** \"E10.65, E10.9, E10.21, E10.36, E10.41, E10.42, E10.44\"\n\n**Drugs:** etanercept, placebo\n\n**SMILES:** O-N+(=O)OCC@@H(ON+(O-)=O)C@H(CON+(O-)=O)ON+(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 - Males and females subjects with T1DM aged 3-18 years\n - Positive GAD 65 and/or islet cell antibody\n - HbA1c at diagnosis above 6%\n - Insulin regimen with 3 injection of insulin daily (as described below)\n - White blood count between 3,000-10,000 and platelets > 100,000\n - Normal ALT and AST, creatinine < 1.8 mg/dl\n - T1DM duration equal or less than 4 weeks\n Exclusion Criteria:\n - Infection requiring IV antibiotics at diagnosis or within past 14 days from study entry\n - BMI over 85th percentile for age and gender\n - Unstable household\n - Unable to provide compliance with study drug, insulin and study visits,\n - Evidence of psychiatric disease in the potential study subject and/or primary care taker\n - And chronic diseases, including additional autoimmune disorders with the exception of euthyroid autoimmune thyroiditis \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT01101594
|
[
{
"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 myeloma\n\n**ICD Codes:** \"C90.01, C90.02, C90.00\"\n\n**Drugs:** hll1-dox (the doxorubicin conjugate of milatuzumab)\n\n**SMILES:** COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(CC@(O)(CC@@H3OC@H3CC@H(N)C@H(O)C@H(C)O3)C(=O)CO)C(O)=C1C2=O\n\n**CT Criteria:** Inclusion Criteria:\n - Able to provide signed, informed consent;\n - Male or female, >/= 18 years old;\n - Multiple myeloma with one or more criteria for measurable disease (serum M protein > 0.5 gm/dl, urinary M protein excretion > 200 mg/24 hours, serum free light chain measurement >20 mg/dl,);\n - Refractory or relapsed to at least two prior standard systemic anti-myeloma treatment regimens one of which must include either thalidomide, lenalidomide or bortezomib;\n - Adequate performance status (Karnofsky Scale >/= 70%);\n - Life expectancy at least 6 months;\n - Adequate cardiac function: MUGA scan or 2D-ECHO with LVEF 55%, EKG with no medically relevant arrhythmia uncontrolled on medications;\n - Adequate hematologic status within 2 weeks before study drug administration:\n - Hemoglobin >/=8.0 g/dL and platelets >/=75,000/mm3 (both without transfusion or other hematologic support within 7 days of laboratory testing)\n - White blood count (WBC) >/= 2,000/mm3and absolute neutrophil count (ANC) >/=1,500/mm3 (both without the use of colony stimulating factors within 7 days of laboratory testing);\n - Adequate renal function: serum creatinine </+ 2.5 mg/mL;\n - Adequate hepatic function\n - AST and ALT </= 2.5 x the ULN\n - Total bilirubin </= 1.5 x the ULN\n Exclusion Criteria:\n - 1. Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test Pregnancy testing is not required for post-menopausal or surgically sterilized women;\n - Patients who are eligible for stem cell transplant.\n - Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study until at least 12 weeks after the last hLL1-dox infusion;\n - Prior local radiotherapy within 14 days; chemotherapy or kyphoplasty within 21 days, immunotherapy, plasmapheresis, or major surgery within 28 days; prior stem cell transplant within 12 weeks.\n - Must have no persistent ≥ Grade 2 toxicity from prior treatments;\n - Prior treatment with any other therapeutic agents for MM or investigational agents within 4 weeks, unless off study, and agreed by Sponsor;\n - A history of allergic or adverse reactions to anthracycline/anthracenedione agents;\n - Cumulative life-time anthracycline/anthracenedione exposure exceeding 300 mg/m2 (including daunorubicin, idarubicin, epirubicin or mitoxantrone);\n - Known to be HIV positive, or any prior hepatitis B or C infection;\n - Any history of clinically significant autoimmune disease (e.g., collagen vascular disorders, autoimmune hepatitis, Coombs positive anemia/thrombocytopenia, etc.)\n - Prior history of mediastinal or pericardial external beam radiation therapy.\n - Prior history of treatment with trastuzumab, unless discussed with and agreed to by Medical Monitor.\n - Systemic infection or requiring anti-infectives within 7 days before first dose of study drug;\n - Substance abuse or other concurrent medical conditions that, in the Investigators opinion, could confound study interpretation or affect the patients ability to tolerate or complete the study. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] |
Failure
|
NCT00379080
|
[
{
"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:** adult brain tumor, adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma, recurrent adult brain tumor\n\n**ICD Codes:** \"G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2\"\n\n**Drugs:** tandutinib\n\n**SMILES:** COC1=C(OCCCN2CCCCC2)C=C2N=CN=C(N3CCN(CC3)C(=O)NC3=CC=C(OC(C)C)C=C3)C2=C1\n\n**CT Criteria:** Criteria:\n - Histologically confirmed glioblastoma:\n - Progressive or recurrent disease after prior radiotherapy (with or without chemotherapy)\n - Patients with a previous low-grade glioma that progressed after prior radiotherapy (with or without chemotherapy) and are found to have glioblastoma by biopsy are eligible\n - Measurable disease, defined as contrast-enhancing progressive or recurrent glioblastoma by MRI or CT imaging within the past 2 weeks\n - Must be maintained on a stable corticosteroid regimen from the time of baseline scan to the start of study treatment\n - Feasibility study only:\n - Planning to undergo surgical resection or biopsy\n - Stereotactic biopsy for confirmation of tumor progression or differentiation of tumor progression from treatment-induced effects allowed\n - Corticosteroids must be tapered to the lowest required steroid dose and patient must be maintained on a stable dose after surgery or biopsy\n - Karnofsky performance status 60-100%\n - Absolute neutrophil count >= 1,500/mm^3\n - Hemoglobin >= 10 mg/dL\n - Bilirubin =< 1.5 mg/dL\n - AST and ALT =< 4 times upper limit of normal\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective barrier method contraception during and for 3 months after completion of study treatment\n - Mini Mental State Exam score >= 15\n - Mean QTc =< 500 msec (with Bazetts correction) by screening electrocardiogram\n - LVEF >= 40%\n - No history of familial long QT syndrome\n - No myocardial infarction within the past 6 months\n - No severe uncontrolled ventricular arrhythmias\n - No uncontrolled angina\n - No electrocardiographic evidence of acute ischemia or active conduction system abnormalities\n - No ongoing vomiting or nausea >= grade 2\n - No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous alimentation\n - No active peptic ulcer disease\n - No other condition that would impair ability to swallow pills or absorb oral medications\n - No muscular dystrophy\n - No myasthenia gravis\n - No other known or suspected primary muscular or neuromuscular disease\n - No history of allergic reactions attributed to compounds of similar chemical or biologic composition to tandutinib (e.g., erlotinib hydrochloride, gefetinib, or doxazosin mesylate)\n - Patients who developed an acneiform/maculopustular rash while receiving either gefitinib or erlotinib hydrochloride are eligible unless the rash is considered an allergic reaction (angioedema/urticaria) or Stevens-Johnson syndrome\n - No ongoing or active infections\n - No psychiatric illness or social situations that would preclude study compliance\n - No other serious infection or medical illness\n - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)\n - No other uncontrolled illness\n - No other malignancy within the past 5 years except for basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast\n - Recovered from prior therapy\n - At least 3 months since prior radiotherapy\n - No prior surgical procedures affecting absorption\n - No concurrent combination antiretroviral therapy for HIV-positive patients\n - No other concurrent investigational agents\n - No concurrent agent that would cause QTc prolongation\n - No concurrent prophylactic growth factors (e.g., filgrastim G-CSF or sargramostim GM-CSF)\n - At least 10 days since prior and no concurrent anticonvulsant drugs that induce hepatic metabolic enzymes (e.g., primidone, oxcarbazepine, phenytoin, carbamazepine, or phenobarbital)\n - No prior treatment with small molecule inhibitors of platelet-derived growth factor receptor (e.g., sunitinib malate, sorafenib, or imatinib mesylate)\n - Platelet count >= 100,000/mm^3\n - No New York Heart Association class III or IV heart failure\n - Creatinine =< 1.5 mg/dL OR creatinine clearance >= 60mL/min \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] |
Failure
|
NCT00735878
|
[
{
"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, 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:** abt-751 and carboplatin\n\n**SMILES:** COC1=CC=C(C=C1)S(=O)(=O)NC1=C(NC2=CC=C(O)C=C2)N=CC=C1\n\n**CT Criteria:** Inclusion Criteria:\n 1. At least 18 years of age.\n 2. Pathologically or cytologically confirmed diagnosis of NSCLC .\n 3. At least one measurable lesion (not amenable to resection) for Response Evaluation Criteria in Solid Tumors (RECIST) tumor assessments. Target lesions must not have been in the previous radiation port.\n 4. Advanced stage of disease (IIIB with malignant pleural effusion or Stage IV) with no known curative treatment that has progressed despite therapy for recurrent/metastatic disease or prior therapy was discontinued due to intolerable toxicities. During the phase II portion of the study, previously untreated patients with IIIB with malignant pleural effusion or Stage IV NSCLC may be enrolled.\n 5. For patients participating in the phase I part of the study, no alternative therapy is available that is expected to prolong overall or progression-free survival. Unacceptable toxicities during first- or second-line therapy or evidence for disease progression.\n 6. Adequate hematologic, renal and hepatic function as follows:\n - Hematologic: ANC (absolute neutrophil count) ≥ 1200/mm3; Platelets; ≥ 100,000/mm3; hemoglobin: ≥ 8.5 g/dL;\n - Renal function: serum creatinine ≤ 2.0 mg/dL; renal (CrCl > 50 ml/min by Jelliffe or Cockcroft Gault Formula),\n - Hepatic function: Bilirubin ≤ 2.0 mg/dL (≤ 3.0 mg/dL for patients with liver metastases); AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤ 2.5 X the upper limits of normal (ULN) (≤ 5 X ULN for patients with liver metastases).\n 7. Adequate performance status, Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.\n 8. Prior platinum (cisplatin, carboplatin or oxaliplatin) therapy is allowed.\n 9. Patient or patients legally acceptable representative has voluntarily signed and dated an informed consent form approved by an Institutional Review Board (IRB), prior to any study-specific procedures.\n Exclusion Criteria:\n 1. Any other malignancy within 3 years except in situ carcinoma.\n 2. Untreated central nervous system (CNS) metastasis.\n 3. A greater than Grade 1 National Cancer Institute Common Toxicity Criteria (NCI CTC) neurology category findings at baseline.\n 4. Concurrent anti-cancer therapy or radiotherapy.\n 5. Concurrent therapy with colchicines.\n 6. Prior therapy with ABT-751.\n 7. Cytotoxic chemotherapy within 3 weeks of initiating investigational treatment.\n 8. Any investigational therapy within 4 weeks.\n 9. Female patients that are pregnant or breastfeeding.\n 10. Patients of childbearing potential (male and female) that do not agree to use a contraceptive method deemed acceptable by the investigator while in the study and for up to three months following completion of therapy.\n 11. Documented allergy or hypersensitivity to carboplatin or sulfa.\n 12. Patient has received more than 2 prior chemotherapy regimens for advanced disease. Adjuvant chemotherapy administered more than 6 months prior to enrollment does not count towards this limit.\n 13. Patient is classified as 3 or 4 by New York Heart Association (NYHA) Functional Classification, defined as:\n - Class 3: Patients with marked limitation of physical activity, comfortable at rest, but less than ordinary activity causes symptoms.\n - Class 4: Patients are unable to carry on any physical activity without symptoms and symptoms are present even at rest.\n 14. Evidence of clinically significant medical condition(s) that compromises safety, compliance, or study conduct, and/or is considered by the investigator to be unable to tolerate the proposed treatment or procedures. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] |
Failure
|
NCT00494221
|
[
{
"role": "user",
"content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- **Diseases:** A list of diseases targeted by the clinical trial.\n- **ICD Codes:** A list of ICD codes associated with the diseases.\n- **Drugs:** A list of drugs used in the clinical trial.\n- **SMILES:** A list of SMILES strings representing the chemical structures of the drugs\n- **CT Criteria:** The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\n**Diseases:** metastatic colorectal cancer\n\n**ICD Codes:** \"C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2\"\n\n**Drugs:** azd2171, folfox (5-fluorouracil, leucovorin, oxaliplatin), placebo cediranib\n\n**SMILES:** COC1=CC2=C(C=C1OCCCN1CCCC1)N=CN=C2OC1=C(F)C2=C(NC(C)=C2)C=C1, HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1, 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 - Metastatic colorectal cancer\n - WHO performance status 0-1\n - Life expectancy is 12 weeks or longer\n Exclusion Criteria:\n - Patient with uncontrolled brain metastases\n - Patient with inappropriate laboratory tests values\n - Patient with poorly controlled hypertension \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT02012166
|
[
{
"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:** mk-0893 10 mg, mk-0893 40 mg, mk-0893 200 mg, mk-0893 1000 mg, placebo\n\n**SMILES:** COC1=CC2=CC=C(C=C2C=C1)C1=CC(=NN1C@@H(C)C1=CC=C(C=C1)C(=O)NCCC(O)=O)C1=CC(Cl)=CC(Cl)=C1, COC1=CC2=CC=C(C=C2C=C1)C1=CC(=NN1C@@H(C)C1=CC=C(C=C1)C(=O)NCCC(O)=O)C1=CC(Cl)=CC(Cl)=C1, COC1=CC2=CC=C(C=C2C=C1)C1=CC(=NN1C@@H(C)C1=CC=C(C=C1)C(=O)NCCC(O)=O)C1=CC(Cl)=CC(Cl)=C1, COC1=CC2=CC=C(C=C2C=C1)C1=CC(=NN1C@@H(C)C1=CC=C(C=C1)C(=O)NCCC(O)=O)C1=CC(Cl)=CC(Cl)=C1, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O\n\n**CT Criteria:** Inclusion Criteria:\n - Good health\n - Body Mass Index of between 18 and 28 kg/m^2, or up to 30 kg/m^2 with approval of sponsor\n - Non-smoker for at least 6 months\n - Willing to avoid strenuous physical activity\n - Willing to avoid alcohol, caffeine, and grapefruit juice consumption\n Exclusion Criteria:\n - History of renal, neurologic, gastrointestinal or respiratory disease or any gastrointestinal surgery\n - History of multiple and/or severe allergies to a prescription, nonprescription or investigational drug or food\n - History of any cardiovascular/cardiac disease\n - History of any hepatic disease and primary biliary cirrhosis\n - History of hypoglycemia or glucose intolerance, type 1 diabetes, or type 2 diabetes\n - Requires or anticipates use of prescription or nonprescription medications, including herbal remedies\n - A user of any illicit drugs or a history of drug or alcohol abuse\n - Surgery, donated a unit of blood, or participated in another clinical study within 4 weeks prior to study participation\n - History of hypersensitivity to insulin, glucagon, or Sandostatine®. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT00543114
|
[
{
"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 lymphocytic leukemia, small lymphocytic leukemia\n\n**ICD Codes:** \"C91.11, C91.12, C91.10\", \"A87.2, K52.832, D72.111, C91.11, C91.12, C91.10\"\n\n**Drugs:** lenalidomide, fludarabine, rituximab\n\n**SMILES:** NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O, ClCCN(CCCl)P1(=O)NCCCO1, ClCCN(CCCl)P1(=O)NCCCO1\n\n**CT Criteria:** Inclusion Criteria:\n - 18 years of age or older\n - Diagnosed with B-CLL/SLL based on the standard histologic and immunophenotypic criteria described in the WHO classification\n - No prior systemic therapy for CLL/SLL, including chemotherapy or antibody therapy\n - Currently needs therapy based on 1996 NCI-WG criteria\n - Measurable disease\n - ECOG Performance Status of 0-2\n - Laboratory test results within parameters outlined in protocol\n - Able to take aspirin daily as prophylactic anticoagulation\n Exclusion Criteria:\n - Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document\n - Pregnant or breast-feeding females\n - Any condition, including the presence of abnormal laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study\n - Use of any other experimental drug or therapy within 28 days of baseline\n - Known hypersensitivity to thalidomide\n - Development of erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drugs\n - Prior use of lenalidomide\n - Concurrent use of other anti-cancer agents or treatments\n - Known positive for HIV\n - Chronic active Hep B patients not on prophylactic lamivudine\n - Diagnosis of Mantle Cell Lymphoma \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] |
Failure
|
NCT01575405
|
[
{
"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 prevention\n\n**ICD Codes:** \"B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4\"\n\n**Drugs:** rectal formulation (rf) of tenofovir 1% gel, vaginal formulations (original vf and reduced vaginal glycerin formulation rgvf) of tenofovir 1% gel, universal hec placebo gel formulation\n\n**SMILES:** CC@H(CN1C=NC2=C1N=CN=C2N)OCP(O)(O)=O, OCC(O)CO, 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. ≥ Age of 18 at screening\n 2. Willing and able to communicate in English\n 3. Willing and able to provide written informed consent to take part in the study\n 4. Willing and able to provide adequate locator information\n 5. Understands and agrees to local sexually transmitted infection (STI) reporting requirements\n 6. HIV-1 uninfected at screening according to the standard DAIDS algorithm in Appendix II\n 7. Must have been vaccinated for or have natural immunity to Hepatitis B, which will be verified by a positive Hepatitis B surface antibody (HBsAb) test at screening (Note: One re-screen will be allowed for individuals who are non immune to Hepatitis B but undergo vaccination.)\n 8. Availability to return for all study visits, barring unforeseen circumstances\n 9. Willing to abstain from RAI and practices involving insertion of anything in rectum (drug, enema, penis, or sex toy) for 72 hours before and 72 hours after each flexible sigmoidoscopy and study product exposure.\n 10. Must agree to use study provided condoms for the duration of the study\n 11. Must be in general good health\n 12. Must agree not to participate in other concurrent interventional and/or drug trials\n 13. Per participant report at screening, a history of consensual RAI at least once in the last three months.\n In addition to the criteria listed above, female participants must meet the following criteria:\n 14. Willing to abstain from insertion of anything into vagina (drug, douche, penis, or sex toy) other than the swabs/sponges for study related specimen collection for 24 hours before and after each study product exposure\n 15. Post-menopausal or using (or willing to use) an acceptable form of contraception (e.g., intrauterine device (IUD), hormonal contraception, surgical sterilization, or vasectomization of male partner). If the female participant has female partners only, the method of contraception will be noted as a barrier method in the study documentation. Temporary abstinence due to absence of partner(s) for the duration of the study will be acceptable.\n Exclusion Criteria:\n 1. Abnormalities of the colorectal mucosa, or significant colorectal symptom(s), which in the opinion of the clinician represents a contraindication to biopsy (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, and presence of symptomatic external hemorrhoids).\n 2. At screening: participant-reported symptoms and/or clinical or laboratory diagnosis of active rectal or reproductive tract infection requiring treatment per current CDC guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include symptomatic bacterial vaginosis, symptomatic vaginal candidiasis, other vaginitis, trichomoniasis, Chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions, chancroid, pelvic inflammatory disease, genital sores or ulcers, cervicitis, or symptomatic genital warts requiring treatment. Note that an HSV-1 or HSV-2 seropositive diagnosis with no active lesions is allowed, since treatment is not required. (Note: In cases of non-anorectal GC/CT identified at screening, one re-screening 2 months after screening visit will be allowed.)\n 3. Per participant report and/or clinical or laboratory diagnosis, anorectal STI within six months prior to the Screening Visit\n 4. At screening:\n 1. Hemoglobin < 10.0 g/dL\n 2. Platelet count less than 100,000/mm3\n 3. White blood cell count < 2,000 cells/mm3 or > 15,000 cells/mm3\n 4. For females: calculated creatinine clearance less than 60 mL/min by the Cockcroft-Gault formula where creatinine clearance in mL/min (140- age in years) x (weight in kg) x (0.85 for female)/72 x (serum creatinine in mg/dL)\n 5. For males: calculated creatinine clearance less than 60 mL/min by the Cockcroft-Gault formula where creatinine clearance in mL/min = (140 - age in years) x (weight in kg) x (1 for male)/72 x (serum creatinine in mg/dL)\n 6. Serum creatinine > 1.3× the site laboratory upper limit of normal (ULN)\n 7. Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) > 2.5× the site laboratory ULN\n 8. +1 glucose or +1 protein on urinalysis (UA)\n 9. History of bleeding problems (verified via prothrombin time (PT)/ International Normalized Ratio (INR) test)\n 10. Positive for Hepatitis B surface antigen (HBsAg)\n 5. History of significant gastrointestinal bleeding in the opinion of the investigator\n 6. Known allergic reaction to methylparaben, propylparaben, sorbic acid, glycerin, glycerol, or tenofovir\n 7. Current known HIV-infected partner(s)\n 8. By participant report at enrollment, history of excessive daily alcohol use (as defined by the CDC as heavy drinking consisting of an average consumption of more than 2 drinks per day for men, and more than 1 drink per day for women), frequent binge drinking or illicit drug use that includes any injection drugs, methamphetamines (crystal meth), heroin, or cocaine including crack cocaine, within the past 12 months\n 9. Per participant report at screening, anticipated use and/or unwillingness to abstain from the following medications during the period of study participation:\n 1. Heparin, including Lovenox®\n 2. Warfarin\n 3. Plavix® (clopidogrel bisulfate)\n 4. Rectally administered medications (including over-the-counter products)\n 5. Acyclovir, valacyclovir, famciclovir, and TDF\n 6. >81 mg of aspirin per day AND unwillingness and/or inability to completely stop all use of aspirin or aspirin-containing medications for 3 days before and 3 days after the biopsy collection procedure\n 7. Non-steroidal anti-inflammatory drugs (NSAIDS)\n 8. Any other drugs that are associated with increased likelihood of bleeding following mucosal biopsy\n 10. By participant report at screening, use of systemic immunomodulatory medications, rectally administered medications, rectally administered products (including condoms) containing N-9, or any investigational products within the 4 weeks prior to the Enrollment/Baseline Evaluation Visit and throughout study participation\n 11. History of recurrent urticaria\n 12. Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease\n In addition to the criteria listed above, female participants will be excluded if they meet any of the following criteria:\n 13. Pregnant at the Enrollment/Baseline Visit\n 14. Breastfeeding at screening or intend to breastfeed during study participation per participant report. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT00068757
|
[
{
"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:** lonafarnib, paclitaxel\n\n**SMILES:** NC(=O)N1CCC(CC(=O)N2CCC(CC2)C@H2C3=C(CCC4=C2C(Br)=CC(Cl)=C4)C=C(Br)C=N3)CC1, 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:** DISEASE CHARACTERISTICS:\n - Histologically or cytologically confirmed breast cancer\n - Stage IIIB, IIIC, or IV\n - HER2/neu overexpression\n - 3+ by immunohistochemistry\n - 2+ allowed if positive fluorescent in situ hybridization\n - Disease meets the following treatment criteria:\n - Paclitaxel/trastuzumab (Herceptin®) may be appropriate therapy\n - Anthracycline therapy is not a suitable approach\n - No clinical signs of CNS involvement\n - Hormone receptor status:\n - Not specified\n PATIENT CHARACTERISTICS:\n Age\n - 18 and over\n Sex\n - Male or female\n Menopausal status\n - Not specified\n Performance status\n - ECOG 0-2 OR\n - WHO 0-2\n Life expectancy\n - Not specified\n Hematopoietic\n - Neutrophil count at least 1,500/mm^3\n - Platelet count at least 100,000/mm^3\n - Hemoglobin at least 10.0 g/dL (6.2 mmol/L)\n Hepatic\n - Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n - Alkaline phosphatase less than 2.5 times ULN (5 times ULN if liver metastases are present)\n - AST and ALT less than 2.5 times ULN (5 times ULN if liver metastases are present)\n Renal\n - Creatinine clearance at least 40 mL/min\n Cardiovascular\n - Cardiac ejection fraction normal by MUGA\n - QTc interval no greater than 440 msec\n - No cardiac dysfunction\n Other\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective contraception during and for up to 3 months after study participation\n - No concurrent severe/unstable systemic disease\n - No infection\n - No circumstances that would preclude study participation (e.g., alcoholism or substance abuse)\n - No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up\n PRIOR CONCURRENT THERAPY:\n Biologic therapy\n - More than 1 year since prior trastuzumab\n - No concurrent prophylactic growth factors\n Chemotherapy\n - More than 1 year since prior paclitaxel\n - More than 4 weeks since other prior chemotherapy\n Endocrine therapy\n - More than 1 day since prior hormonal therapy\n - More than 2 days since prior high-dose chronic steroids\n - More than 2 days since prior ethinyl estradiol\n - No concurrent high-dose chronic steroids\n - No concurrent ethinyl estradiol\n Radiotherapy\n - More than 4 weeks since prior radiotherapy\n Surgery\n - Not specified\n Other\n - More than 2 days since prior administration of and no concurrent CYP3A4 inducers or inhibitors, including any of the following:\n - Gestodene\n - Itraconazole\n - Ketoconazole\n - Cimetidine\n - Erythromycin\n - Carbamazepine\n - Phenobarbital\n - Phenytoin\n - Rifampin\n - Sulfinpyrazone\n - No concurrent grapefruit juice\n - No other concurrent anticancer agents\n - No other concurrent investigational therapy \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT00096707
|
[
{
"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:** lung cancer, breast cancer, pancreatic cancer, head and neck cancer, gastric cancer\n\n**ICD Codes:** \"C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2\", \"C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60\", \"C25.3\", \"C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11\", \"C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2\"\n\n**Drugs:** 2-deoxy-d-glucose (2dg)\n\n**SMILES:** HC(H)(C=O)C@@(H)(O)C@(H)(O)C@(H)(O)CO\n\n**CT Criteria:** Inclusion Criteria:\n - Males and females, at least 18 years of age\n - Histologically confirmed, locally advanced or metastatic solid malignancy\n - Previously treated with at least one chemotherapy regimen for advanced or metastatic disease OR no curative standard treatment is available\n - Recovered from reversible toxicities of prior therapy\n - Life expectancy of at least 3 months\n - ECOG performance status of 0, 1, or 2\n - Measurable or nonmeasurable disease by RECIST criteria\n - Ability to understand the purposes and risks of the study and having signed a written informed consent form\n - All women of childbearing potential and all men must agree to use effective means of contraception from entry into the study through 3 months after the last dose\n Exclusion Criteria:\n - Previous or current CNS metastases (screening CT or MRI is not required in asymptomatic subjects)\n - Active clinically significant infection requiring antibiotics\n - Known glucose-6-phosphate dehydrogenase deficiency or history of anemia of unknown etiology\n - History of clinically significant unexplained episodes of hypotension, fainting, dizziness, or lightheadedness\n - History or symptoms of cardiovascular disease, particularly coronary artery disease, arrhythmias, or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure\n - History of transient ischemic attack, stroke, or seizure disorder or any other CNS disease considered to be significant by the investigator\n - Known autonomic dysfunction or chronic orthostatic hypotension\n - Evidence of hypoglycemia, clinically significant renal disease, clinically significant liver disease (other than liver metastases), diabetes mellitus, gastrointestinal disorder (that could affect absorption or elimination of orally-administered medications), or obstructive uropathy with significant post-void residual during the past 5 years\n - Known HIV infection\n - Other primary malignancies (other than treated basal cell carcinoma of the skin or treated in situ cervical cancer) within the past 5 years\n - Major surgery within 4 weeks of the start of study treatment, without complete recovery\n - Antitumor therapy within 21 days of the start of study treatment\n - Disease progression/relapse on docetaxel therapy within the past 12 months\n - A history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80\n - Known sensitivity to methylparaben or propylparaben\n - Inability to discontinue prohibited medications for 24 hours before and after dosing on Day 1 of Weeks 1, 2, and 3 and Day 5 of Week 1. In addition, patients who cannot discontinue medications known to induce or inhibit CYP 3A4, such as cyclosporine, terfenadine, ketoconazole, erythromycin, and troleandomycin, for the duration of the study are not eligible.\n - Peripheral neuropathy >= Grade 2\n - Hemoglobin <9 g/dL\n - ANC <1500/μL\n - Platelet count <100,000/μL\n - Total bilirubin >1.5 mg/dL\n - Abnormal liver function\n - Serum creatinine >1.5 mg/dL unless creatinine clearance is >= 60 mL/min\n - Serum potassium < lower limit of normal\n - Elevated fasting blood glucose\n - Pregnant or nursing women\n - Participation in an investigational drug or device study within 28 days of the first day of dosing on this study\n - Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.\n - Unwillingness or inability to comply with the study protocol for any other reason\n - Subjects who live alone \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT01192165
|
[
{
"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:** trametinib (gsk1120212), docetaxel, erlotinib, pemetrexed, carboplatin, nab-paclitaxel, cisplatin\n\n**SMILES:** CN1C(=O)C(C)=C2N(C(=O)N(C3CC3)C(=O)C2=C1NC1=CC=C(I)C=C1F)C1=CC(NC(C)=O)=CC=C1, HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1, COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2, HN(H)(H)Pt(Cl)(Cl)N(H)(H)H, NC@@H(CCCNC(N)=N)C(O)=O, 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, 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 - The subject has a solid tumor. Expansion cohorts are limited to non-small cell lung cancer and/or pancreatic cancer with or without a KRAS mutation.\n - Tumor progression following at least one prior standard therapy, the subject refuses standard therapy, or no standard therapy exists.\n - The subject has a radiographically measurable tumor.\n - The subject is able to carry out daily life activities without difficulty.\n - The subject is able to swallow and retain oral medication.\n - The subject does not have significant side effects from previous anti-cancer treatment.\n - The subject has adequate organ and blood cell counts.\n - Sexually active subjects must use medically acceptable methods of contraception during the course of the study.\n Exclusion Criteria:\n - The subject has had major surgery or received certain types of cancer therapy within 2-3 weeks before starting the study.\n - The subject has a brain tumor.\n - Current severe, uncontrolled systemic disease.\n - History of clinically significant heart, lung, or eye/vision problems.\n - The subject has high blood pressure that is not well-controlled with medication.\n - The subject has a permanent pacemaker.\n - The subject is pregnant or breastfeeding.\n - Positive for Hepatitis B, Hepatitis C, or HIV. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT00473486
|
[
{
"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:** pemetrexed, carboplatin, sorafenib, pemetrexed, carboplatin, placebo\n\n**SMILES:** CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1, HN(H)(H)Pt1(OC(=O)C2(CCC2)C(=O)O1)N(H)(H)H\n\n**CT Criteria:** Inclusion Criteria:\n - Histologically or cytologically confirmed NSCLC\n - Locally advanced (stage IIIB with malignant pleural or pericardial effusion) or metastatic (stage IV) NSCLC\n - No prior systemic chemotherapy\n - Prior local radiotherapy is allowed if it is completed at least 3 weeks prior to the first dose of study medication; also concomitant palliative radiotherapy to an existing bone lesion for pain control is allowed\n - Prior surgery is allowed if it is performed at least 4 weeks prior to the first dose of study medication and patient should be fully recovered.\n - Must have measurable disease with at least one lesion with a longest diameter measured as ≥ 2 cm with conventional techniques or as ≥ 1 cm with spiral CT\n - Age ≥18 years old\n - ECOG performance score (PS) 0-1\n - Life expectancy of at least 12 weeks\n - Adequate bone marrow, renal and hepatic function\n - hemoglobin ≥ 9.0 g/dl\n - absolute neutrophil count ≥1,500/mm3\n - platelet count ≥ 100,000/mm3\n - total bilirubin ≤ 1.5 times the upper limit of normal\n - ALT and AST ≤ 2.5 times the upper limit of normal (≤ 5 x upper limit of normal for patients with liver involvement)\n - INR ≤ 1.5 and aPTT within normal limits\n - serum creatinine ≤ 1.5 the upper limit of normal\n - Patients with creatinine clearance ≥ 45 mL/min\n - Not pregnant or nursing patients\n - Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment\n - Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least six months after the last administration of sorafenib\n - Signed informed consent prior to any study specific procedures\n - Compliance and geographic proximity that allow adequate follow-up\n Exclusion Criteria:\n - Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents, experimental therapy (treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study enrollment), adjuvant, or neo-adjuvant therapy for NSCLC\n - Any participation in a clinical trial 30 days prior to study entry and concomitantly to the study\n - Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (angina symptoms at rest) or new-onset angina (began within the last 3 months) or myocardial infarction within the past 6 months\n - Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy\n - Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal medical management\n - Documented brain metastases (unless the patient is > 6 months from definitive therapy for brain metastases, has a negative imaging study within 4 weeks of study entry and has been off corticosteroids for at least 4 weeks before study enrolment). Brain imaging (CT scan/MRI) is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients.\n - Patients with seizure disorder requiring medication (such as steroids or antiepileptics)\n - Known HIV infection or chronic hepatitis B or C\n - Active clinically serious infections > CTCAE Grade 2\n - Presence of clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study enrolment\n - Pulmonary hemorrhage/bleeding event >= CTCAE Grade 2 within 4 weeks of first dose of study drug\n - Any other hemorrhage/bleeding event > =Grade 3 within 4 weeks of first dose of study drug\n - Evidence or history of bleeding diathesis or coagulopathy\n - Therapeutic anticoagulation with vitamin K antagonists such as phenprocoumon, warfarin, or with heparins or heparinoids. Low dose anticoagulation is permitted\n - Serious, non-healing wound, ulcer, or bone fracture\n - Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug\n - Known or suspected allergy to sorafenib, carboplatin or pemetrexed\n - Previous or current cancer that is distinct in primary site or histology from NSCLC except cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis) or any cancer curatively treated > 3 years prior to study entry\n - Substance abuse, medical, psychological or social conditions that may interfere with the patients participation in the study\n - Significant weight loss (> or equal 10% body weight during preceeding 6 weeks)\n - Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose ≤ 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)\n - Inability or unwillingness to take folic acid, vitamin B12 supplementation or corticosteroids\n - Recent (within 30 days of enrolment) or concurrent yellow fever vaccination\n - Serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patients ability to adhere to the protocol. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] |
Failure
|
NCT01028248
|
[
{
"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:** central retinal vein occlusion\n\n**ICD Codes:** \"H34.8132, H34.8131, H34.8111, H34.8121, H34.8191, H34.8112, H34.8122\"\n\n**Drugs:** ranibizumab (lucentis)\n\n**SMILES:** CN\\\\C(NCCSCC1=CC=C(CN(C)C)O1)=C/N+(O-)=O\n\n**CT Criteria:** Inclusion Criteria:\n - Ability to provide written informed consent and comply with study assessments for the full duration of the study\n - Age > 18 years\n - Clinical evidence of perfused central retinal vein occlusion. A central retinal vein occlusion (CRVO) is defined as an eye that has retinal hemorrhages and a dilated retinal venous system in all 4 quadrants. Other evidence of a CRVO may include telangiectatic capillary bed and collateral vessels at the optic nerve head.\n - Central macular edema present on clinical examination and OCT testing with a central point thickness and/or central 1mm subfield thickness > 250 microns.\n - Visual acuity score greater than or equal to 19 letters (20/400) and less than or equal to 73 letters (20/40) by the ETDRS visual acuity protocol.\n - Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography\n Exclusion Criteria:\n - Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception.\n - Participation in another ocular investigation or trial simultaneously\n - Uncontrolled hypertension\n - Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse)\n - Significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy\n - Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema\n - An eye that, in the investigators opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of subretinal fibrosis or geographic atrophy)\n - Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (e.g. AMD, uveitis, Irvine-Gas)\n - Evidence of neovascularization of the iris or retina (presence of ischemic CRVO)\n - Evidence of central atrophy or fibrosis in the study eye\n - Presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study.\n - History of grid/focal laser or panretinal laser in the study eye\n - History of vitreous surgery in the study eye\n - History of use of intravitreal, peribulbar, or retrobulbar steroids within six months of the study.\n - History of cataract surgery within 6 months of enrollment.\n - History of YAG capsulotomy within 2 months of the surgery.\n - Visual acuity <20/400 in the fellow eye\n - Uncontrolled glaucoma (pressure >30) despite treatment with glaucoma medications.\n - History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT00612794
|
[
{
"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:** exenatide once weekly, 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:** Inclusion Criteria:\n - Body weight ≥50 kg.\n - Have suboptimal glycemic control as evidenced by an HbA1c defined by the following criteria: *6.5% to 10.0%, inclusive, at study start for patients managed with diet modification and exercise or treated with oral antidiabetics drug but not alpha glucosidase inhibitor or meglitinide derivatives; *6.5% to 9.5%, inclusive, at study start for patients treated with oral antidiabetics including alpha glucosidase inhibitor or meglitinide derivatives.\n - Have been treated with diet modification and exercise alone or in combination with a stable regimen of oral antidiabetic drugs (sulfonylurea, metformin and thiazolidinedione) for at least 2 months prior to study start. In the case of patients with concomitant use of sulfonylurea, the dose of sulfonylurea must not be more than maximum recommended dose. The patients with concomitant use of alpha glucosidase inhibitors (Glucobay® acarbose, Basen® voglibose, or Seibule® miglitol) or meglitinide derivatives (Glufast® mitiglinide or Fastic®/Starsis® nateglinide) can be included in this study, but these drugs must be discontinued after confirmation of eligibility at study start.\n Exclusion Criteria:\n - Subjects who have donated more than 200 mL of blood and component blood donation within one month of study start, or those who have donated more than 400 mL of blood within three months of study start.\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 - Have participated and received at least one dose of exenatide or other GLP-1 analogs in this study previously, or any other study using exenatide or other GLP-1 analogs.\n - Are treated with any exogenous insulin within 3 months of screening.\n - Are continuously treated with any of the following excluded medications within 3 months of screening (more than 7 days per 1 month): *Drugs that directly affect gastrointestinal motility, including Nauzelin® (domperidone), Primperan®/Terperan® (metoclopramide), Ganaton® (itopride), Acenalin® (cisapride), Gasmotin® (mosapride), or Cerekinon® (trimebutine).\n - Females who are breastfeeding. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT00361244
|
[
{
"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 carcinoma\n\n**ICD Codes:** \"C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31\"\n\n**Drugs:** su011248, irinotecan, cetuximab\n\n**SMILES:** CCN(CC)CCNC(=O)C1=C(C)NC(\\\\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C, CCC@@1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=CC=CC=C4N=C13)C2=O, 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:** Inclusion Criteria:\n - Histologic proof of adenocarcinoma of the colon or rectum with evidence of metastatic disease. The site of the primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel\n - Patients must have received one (and only one) prior chemotherapy regimen for metastatic disease using 5-FU/LV or Xeloda in combination with oxaliplatin and Avastin.\n - > 4 weeks must have elapsed from the time of major surgery\n - > 2 weeks must have elapsed from the time of minor surgery\n - > 4 weeks must have elapsed from the time of major radiotherapy\n - Normal organ and marrow function\n - Measurable disease be RECIST criteria\n - Older than 18 years of age\n - ECOG performance status of 0-1\n - Life expectancy > 12 weeks\n Exclusion Criteria:\n - Previous treatment with irinotecan, cetuximab or SU011248\n - Any of the following within the 12 months prior to study drug administration: severe/unstable angina; myocardial infarction; symptomatic congestive heart failure; cerebrovascular accident; or transient ischemic attack.\n - Known brain metastases or carcinomatous meningitis\n - Uncontrolled serious medical or psychiatric illness\n - NCI CTCAE grade 3 or greater hemorrhage within 4 weeks of starting study treatment\n - Uncontrolled hypertension\n - Diagnosis of any secondary malignancies with the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, localized prostate cancer with a normal PSA within the past 3 months, in situ bladder cancer, or in situ cervical cancer\n - Pregnant or breastfeeding\n - Concurrent treatment on another clinical trial \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] |
Failure
|
NCT01154062
|
[
{
"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:** macular degeneration\n\n**ICD Codes:** \"H35.30, H35.353, H35.351, H35.352, H35.359, H35.3130, H35.3230\"\n\n**Drugs:** pazopanib\n\n**SMILES:** ClCCN(CCCl)P1(=O)NCCCO1\n\n**CT Criteria:** Inclusion Criteria:\n - Age-related macular degeneration patients diagnosed with subfoveal choroidal neovascularization in the study eye, with all of the following characteristics required and confirmed by a central reading center:\n - CNV caused by AMD that extends under the geometric center of the foveal avascular zone\n - CNV comprises ≥ 50% of lesion area\n - Total lesion area no greater than 12 disc areas on fluorescein angiography, where the lesion complex includes CNV, blood, blocked fluorescence not from blood, and serous detachment of the retinal pigment epithelium\n - classic CNV comprises <50% of the lesion area\n - fibrosis comprises ≤ 25% of lesion area\n - Center subfield > 320 microns on SD-OCT (inclusive of subretinal fluid)\n - if no evidence of classic CNV, then presumed to have recent disease progression because of deterioration (≥ 5 letter decrease in vision or evidence of growth of a CNV lesion on fluorescein angiography ) within last 3 months or evidence of hemorrhage from CNV\n - Best-corrected ETDRS visual acuity score in the study eye of between 25 and 73 letters (approximately equivalent to Snellen VA of 20/320 to 20/32) at screening.\n - Male or female ≥ 50 years of age.\n - A female subject is eligible to participate if she is of non-childbearing potential defined as either pre-menopausal with a documented tubal ligation or hysterectomy, or postmenopausal defined as 12 months of spontaneous amenorrhea. In questionable cases of postmenopausal status a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) or value consistent with local laboratory recommended value is confirmatory.\n - Subject is willing and able to return for all study visits, and is willing and able to comply with all protocol requirements and procedures.\n - Subject is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. If the subject is unable to read the consent form due to visual impairment then the consent must be read to the subject verbatim by person administering the consent, a family member or legally acceptable representative. (Note: Consent by legally acceptable representative is allowed where this is in accordance with local laws, regulations and ethics committee policy.)\n - QTcF <450msec; or QTcF<480msec in subjects with Bundle Branch Block.\n - AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).\n Exclusion Criteria:\n - Additional eye disease in the study eye that could compromise best-corrected visual acuity (e.g. glaucoma with documented visual field loss, clinically significant diabetic retinopathy, ischemic optic neuropathy, infection or retinitis pigmentosa).\n - CNV in the study eye due to other causes unrelated to age-related macular degeneration.\n - The presence of retinal angiomatous proliferation (RAP) in the study eye, as determined by the investigator (confirmation by indocyanine green angiography is not required).\n - Geographic atrophy involving the center of the fovea in the study eye.\n - Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation of the fundus for photographs, fluorescein angiography and SD-OCT.\n - Vitreous, subretinal or retinal hemorrhage in the study eye that is unrelated to AMD. Any previous treatment in the study eye for neovascular AMD, approved or investigational.\n - Current intravitreal anti-VEGF therapy in the fellow eye.\n - Within 6 months prior to the Screening Visit, use of any systemically administered anti-angiogenic agent (e.g., bevacizumab, sunitinib, cetuximab, sorafenib, pazopanib), approved or investigational.\n - Intraocular surgery in the study eye within 3 months of dosing.\n - Aphakia or total absence of the posterior capsule (Yttrium aluminum garnet (YAG) capsulotomy permitted) in the study eye.\n - History of vitrectomy in the study eye.\n - Presence of RPE tear in the study eye.\n - Subject has uncontrolled glaucoma (intraocular pressure >25 mmHg) despite treatment with anti-glaucoma medication.\n - Within 6 months prior to the Screening Visit, use of medications known to be toxic to the retina, lens or optic nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol).\n - Use of systemic steroids (>10 mg prednisone or equivalent/day) within 14 days of first dose.\n - A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.\n - Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones).\n Medical history or unresolved medical condition, for example:\n - Uncontrolled Diabetes Mellitus, with hemoglobin A1c (HbA1c) > 10%\n - Myocardial infarction or stroke within 6 months of screening\n - Active bleeding disorder\n - Major surgery within 3 months of screening\n - Hepatic impairment\n - Clinically relevant thyroid disease\n - Uncontrolled hypertension, based on criteria provided in Section 4.4.1.2.\n - Subject has a history within the past 2 years of alcohol, substance abuse, or psychiatric disorder likely to confound the efficacy or safety assessments. A history of known HIV infection.\n - Use of prohibited medications listed in Section 9.2 within the restricted timeframe relative to the first dose of study medication.\n - History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.\n - A condition or situation, which, in the opinion of the investigator, may result in significant risk to the patient, confound the study results or interfere significantly with participation.\n - History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT01130818
|
[
{
"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:** healthy\n\n**ICD Codes:** \"Z76.3, Z76.2\"\n\n**Drugs:** glpg0492, placebo, glpg0492, glpg0492\n\n**SMILES:** CN1C(=O)N(C(=O)C@@1(CO)C1=CC=CC=C1)C1=CC=C(C#N)C(=C1)C(F)(F)F, CN1C(=O)C=C(N2CCCC@@H(N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1C(=O)N(C(=O)C@@1(CO)C1=CC=CC=C1)C1=CC=C(C#N)C(=C1)C(F)(F)F, CN1C(=O)N(C(=O)C@@1(CO)C1=CC=CC=C1)C1=CC=C(C#N)C(=C1)C(F)(F)F\n\n**CT Criteria:** Inclusion Criteria:\n - healthy male, age 18-50 years (young subjects) OR ≥60 years (elderly subjects)\n - BMI between 18-30 kg/m², inclusive\n - non-smoker\n Exclusion Criteria:\n - elevated PSA\n - drug or alcohol abuse \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT00482014
|
[
{
"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, carboplatin\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, NC@@H(CCCNC(N)=N)C(O)=O\n\n**CT Criteria:** Inclusion Criteria:\n - Inoperable non small cell lung cancer\n - No weight loss greater than 10% in 3 months prior to enrolling in trial\n - Adequate kidney function\n - Adequate liver function\n - Adequate lung function\n Exclusion Criteria:\n - Previous surgery to remove lung tumor\n - Previous chemotherapy or radiation therapy or lung cancer\n - Inability to take vitamin supplementation\n - Heart attack within past 6 months\n - Active infection \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT00201838
|
[
{
"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 neoplasms, adenocarcinoma\n\n**ICD Codes:** \"C25.3\", \"C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31\"\n\n**Drugs:** gemcitabine, etanercept\n\n**SMILES:** HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1, O-N+(=O)OCC@@H(ON+(O-)=O)C@H(CON+(O-)=O)ON+(O-)=O\n\n**CT Criteria:** Inclusion Criteria:\n - Must have pathological diagnosis recurring or metastatic Pancreatic Adenocarcinoma\n - No prior chemotherapy, immunology treatments or hormonal treatments\n - Measurable disease\n - Must be >18 years old\n - ONLY CONTROL ARM IS OPEN TO ACCRUAL\n Inclusion Criteria:\n - Pregnant and nursing mothers.\n - Psychiatric disorders that would interfere with consent ability.\n - Patients with known brain or leptomeningeal disease.\n - Patients with history of myocardial infarction with in six previous months.\n - Any concurrent illness that would constitute a hazard to participation in study.\n - Known sensitivity to gemcitabine or etanercept.\n - Prior treatment with etanercept. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] |
Failure
|
NCT01235039
|
[
{
"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\n\n**ICD Codes:** \"P70.2, O24.92, Z83.3, E10.65, E10.9, E11.65, E11.9\"\n\n**Drugs:** viaject®25, viaject®7, insulin lispro\n\n**SMILES:** Na+.Na+.O-P(O-)(F)=O\n\n**CT Criteria:** Inclusion Criteria:\n - Age: ≥19 to ≤65 years\n - Body Mass Index: ≥18 - ≤28 kg/m2\n - Diagnosed with Type 1 Diabetes Mellitus for at least 1 year\n - Insulin antibody less than or equal to 10 µU/mL at screening\n - Non-smoker, defined as no nicotine consumption for at least one year.\n - Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)\n Exclusion Criteria:\n - Type 2 Diabetes Mellitus\n - C-peptide value of >1.0 ng/mL\n - HbA1c value of > 10.0%\n - History of hypersensitivity to any of the components in the study medication\n - History of severe or multiple allergies\n - Treatment with any other investigational drug in the last 3 months before study entry\n - Any systemic treatment with drugs known to interfere with glucose metabolism such as systemic corticoids, non-selective beta-blockers, and monoamine oxidase (MAO) inhibitors within 3 months prior to randomization.\n - Changes (type of drug or dose) in concomitant medication other than insulin or insulin analogues in the last 3 weeks prior to randomization.\n - Use of non-prescription drugs, except routine vitamins, within 3 weeks prior to the first dose of the test drug. Occasional use of paracetamol/acetaminophen is permitted.\n - Progressive disease likely to prove fatal (e.g. malignancies)\n - Current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the Investigator will impair subject safety or protocol compliance\n - Significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the Investigator\n - Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator. In particular, subjects with elevated liver enzymes (AST or ALT >2 times the upper limit of normal) or impaired renal function (serum creatinine values above the upper limit of normal) will not be allowed to enter the trial.\n - Any serious systemic infectious disease during the four weeks prior to the first dose of study drug, as judged by the Investigator.\n - History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose a risk in administering the trial drug to the subject. In particular, subjects with significant cardiovascular disease, anemia (hemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.\n - Blood donation within the last 30 days\n - A woman who is lactating\n - Pregnant women or women intending to become pregnant during the study\n - A sexually active woman - not using adequate contraceptive methods (adequate contraceptive measures include: implants, injectables, combined oral contraceptives, hormonal intrauterine device IUD, sexual abstinence or vasectomized partner)\n - Positive serology for HIV, Hepatitis B or Hepatitis C\n - Abnormal ECG, safety lab or physical examination results that are deemed clinically significant by the Investigator\n - Lack of compliance or other reasons which, in the opinion of the Investigator, prevent the participation of the subject in the study. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT00179608
|
[
{
"role": "user",
"content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- **Diseases:** A list of diseases targeted by the clinical trial.\n- **ICD Codes:** A list of ICD codes associated with the diseases.\n- **Drugs:** A list of drugs used in the clinical trial.\n- **SMILES:** A list of SMILES strings representing the chemical structures of the drugs\n- **CT Criteria:** The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\n**Diseases:** malignant melanoma\n\n**ICD Codes:** \"C43.0, C43.31, C43.51, C43.9, C43.4, C43.52, C43.10\"\n\n**Drugs:** cc-5013\n\n**SMILES:** NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O\n\n**CT Criteria:** Inclusion Criteria:\n 1. Understand and voluntarily sign an informed consent document\n 2. Age greater than or equal to 18 years at the time of signing Informed Consent\n 3. Be able to adhere to the study visit schedule and other protocol requirements\n 4. Histological documentation of malignant melanoma with evidence of metastatic disease\n 5. For the 10 patients enrolled at the MTD, at least one measurable lesion must be present (see Appendix II)\n 6. ECOG performance status of 0, 1 or 2 (see Appendix I)\n 7. Laboratory tests within these ranges:\n 1. Absolute neutrophil count greater than or equal to 1,500/uL\n 2. Platelet count greater than or equal to 100,000/uL\n 3. Serum creatinine less than or equal to 1.5 mg/dL\n 4. Total bilirubin less that or equal to 1.5 mg.dL\n 5. AST (SGOT) / ALT (SGPT) less than or equal to to 2 times upper limit of normal (ULN)\n 8. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug.\n In addition, sexually active WCBP must agree to use at least two methods of adequate contraceptive (oral, injectable, or implantable hormonal contraceptive, tubal ligation, intra-uterine device, barrier contraceptive with spermicide, contraceptive skin patch or vasectomized partner) while on study drug\n 9. All acute adverse effects (excluding alopecia of any prior therapy must have resolved to less than or equal to grade 1 (NCI CTCAE v3.0)\n 10. Patients must be able to take medications orally\n Exclusion Criteria:\n 1. Pregnant or lactating females\n 2. Any serious medical condition, including psychiatric illnesses that will prevent the patient from signing the informed consent or place the patient at an unacceptable risk if he/she participates in the study.\n 3. Prior treatment with systemic chemotherapy. Patients who have received prior immunotherapy, including thalidomide, or radiotherapy remain eligible.\n Lesions within a prior field of radiation may only be used as indicator lesions if there has been evidence of disease progression at that site.\n 4. Prior history of malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the patient has been free of the disease for at least 3 years.\n 5. Use of thalidomide or biologic response modifier therapy within 14 days of Day 1, Cycle 1\n 6. Prior greater than or equal to grade 2 allergic reaction to thalidomide\n 7. Prior desquamating rash while taking thalidomide\n 8. Any prior use of lenalidomide\n 9. Concurrent use of any other anti-cancer agents\n 10. Radiation or surgical treatment of melanoma within 28 days of starting study treatment\n 11. Active infection\n 12. Central nervous system (CNS) metastases\n 13. Patients with > grade-2 neuropathy\n 14. Patients with known HIV positivity or AIDS-related illness \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT00411762
|
[
{
"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:** capecitabine, phy906\n\n**SMILES:** HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1\n\n**CT Criteria:** Inclusion Criteria:\n - Men or women ≥18 years of age with either a histologic or cytologic diagnosis of locally advanced or metastatic pancreatic adenocarcinoma. However, patients with other solid malignancies will be allowed to participate during the dose escalating Phase I part of the study, who had failed to respond to standard therapy or for which no standard therapy exists.\n - In the phase I portion, patients may either have had no prior chemotherapy (chemotherapy naive), or have been refractory to or relapsed from standard chemotherapy, including capecitabine-based regimens. However, in the phase II portion of the study, only pancreatic cancer patients with prior gemcitabine therapy will be eligible. No prior 5-FU/capecitabine chemotherapy will be allowed EXCEPT previous adjuvant treatment with 5-FU or capecitabine (radiosensitizing dose) with radiation completed at least 6 weeks prior to study entry.\n - All patients in both the phase I and phase II portions of this study must have at least one previously unirradiated, unidimensionally measurable lesion by computerized tomography (CT) or magnetic resonance imaging (MRI) scan of ≥ 20 mm (if conventional CT scan) or ≥ 10 mm (if spiral CT scan).\n - Patients with biliary or gastro-duodenal obstruction must have drainage or by pass prior to starting chemotherapy.\n - Patients with adequate hepatic function defined as\n - AST/ALT ≤ 2.5 X ULN;\n - Total Bilirubin ≤ 2.0 XULN;\n - Alkaline Phosphatase ≤ 5 X ULN (in presence of liver metastasis); or\n - Alkaline Phosphatase ≤ 2.5 X ULN (in absence of liver metastasis).\n - Patients should have an adequate renal function as indicated by a serum creatinine <1.6 mg/dL or calculated creatinine clearance ≥ 50 mL/min. (Calculated by Cockcroft-Gault equation).\n - Baseline performance status must be Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2.\n - Women patients who are known to be capable of conception should have a negative serum pregnancy test (beta-human chorionic gonadotropin beta-hCG) within 2 weeks of starting the study; all patients should agree to use adequate non-estrogenic birth control methods, consistent with the institutes standard form of contraception if conception is possible during the study.\n - Provide written informed consent prior to screening.\n - Patients with adequate hematologic tests:\n - Hemoglobin ≥ 9.0 g/dL;\n - Absolute neutrophil count (ANC) ≥ 1.5 x 10 9/L;\n - Platelet count ≥ 100.0 x 10 9/L;\n Exclusion Criteria:\n - Patients who are pregnant or breastfeeding.\n - Any prior palliative radiation therapy (other than used in the adjuvant therapy of pancreatic cancer > 6 weeks) must have been completed more than 21 days before entry into the study and evaluable lesions must not have been included in the radiation portal.\n - Patients with prior capecitabine therapy for pancreatic cancer (Phase II).\n - Patients with active CNS metastases.\n - Patients with known hypersensitivity or a history of marked intolerance to 5-FU are ineligible.\n - Because cimetidine can decrease the clearance of 5-FU, patients should not enter on this study until cimetidine is discontinued.\n - Patients should not receive concurrent therapy with either sorivudine or brivudine, while receiving capecitabine. If a patient has received prior sorivudine or brivudine, then at least four weeks must elapse before the patient receives capecitabine therapy.\n - Exclude sexually active males unwilling to practice contraception during the study.\n - Lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome.\n - Clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias) or myocardial infarction within the last 12 months.\n - No concurrent radiotherapy is allowed.\n - Known DPD (dihydropyrimidine dehydrogenase) deficiency.\n - Patients who have received any previous treatment consisting of standard chemotherapy (gemcitabine in Phase II study; others in Phase I) within 21 days or an investigational agent (Phase I) within 30 days on study. Toxicity related to the previous therapy must have resolved prior to study entry.\n - Patients with previous or concurrent malignancy except for inactive non-melanoma skin cancer and/or in situ carcinoma of the cervix, or other solid tumor treated curatively and without evidence of recurrence within the last 3 years prior to study entry.\n - Patients taking herbal medicine(s), including supplement(s), are eligible if they discontinue the herbal medicine(s)/supplement(s) at least 7 days prior to study entry.\n - Known allergy or hypersensitivity to PHY906 or any of the components used in the PHY906 formulations, or to capecitabine.\n - Serious concurrent medical illness, which would jeopardize the ability of the patient to receive the chemotherapy program outlined in this protocol with reasonable safety.\n - Patients with active infections requiring intravenous antibiotic therapy are not eligible until the infection has resolved. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT01273948
|
[
{
"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\n\n**ICD Codes:** \"B18.2, B17.10, B17.11, B19.20, B19.21, B15.0, B15.9\"\n\n**Drugs:** bavituximab, pegylated interferon (peg-ifn)\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:** Inclusion Criteria:\n 1. Male or female between the ages of 18 and 65 years\n 2. Chronic hepatitis C virus (HCV) genotype 1 infection\n 3. HCV RNA level >10,000 IU/mL\n 4. Chronic HCV infection, defined as:\n - Previous documentation of positive HCV serology (HCV antibody or RNA) at least 6 months (24 weeks) previously, or\n - Positive HCV serology (HCV antibody or RNA) with a prior remote (more than 6 months previously) risk factor for acquisition of HCV or\n - Historical biopsy consistent with chronic HCV infection\n 5. No clinically significant abnormalities in hematology, coagulation, or chemistry variables:\n - Hemoglobin >12 g/dL for women; >13 g/dL for men\n - Total white cell count >3000/mm3 and absolute neutrophil count >1500/mm3\n - Platelets >100,000/mm3\n - Prothrombin time (PT) and/or international normalized ratio (INR) less than or equal to 1.2 times the local upper limit of normal (ULN)\n - Conjugated (direct) bilirubin less than or equal to 1.5 times the ULN\n - Serum creatinine within normal limits\n - Thyroid-stimulating hormone (TSH) and free thyroxine (T4) within normal limits\n 6. Female patients: negative urine pregnancy test\n 7. Ability to provide informed consent\n Exclusion Criteria:\n 1. Previous interferon-based antiviral therapy for chronic HCV infection\n 2. Previous treatment with known immunogenic drugs\n 3. Concomitant human immunodeficiency (HIV) or hepatitis B virus (HBV) infection\n 4. Cause of liver disease other than chronic HCV infection, such as autoimmune or alcoholic liver disease\n 5. Decompensated clinical liver disease, including a history of encephalopathy, bleeding esophageal or gastric varices, or ascites\n 6. Recipient of liver or other solid-organ transplantation\n 7. Evidence of clinically significant bleeding, defined as gross hematuria, hemoptysis, or gastrointestinal bleeding\n 8. History of bleeding diathesis or coagulopathy (eg, von Willebrand disease or hemophilia)\n 9. History of thromboembolic events (eg, deep-vein thrombosis DVT or pulmonary embolism). Previous central venous catheter-related thrombosis is acceptable if there is resolution recorded at least 12 months before enrollment.\n 10. Requirement for concurrent treatment with oral or parenteral anticoagulants or hormones (estrogen-containing contraceptives, hormone replacement, antiestrogen agents, progestins)\n 11. Condition requiring daily therapy with antiplatelet agents (eg, thienopyridines, dipyridamole, cilostazol; cardiovascular prophylaxis with aspirin is allowed) or corticosteroids\n 12. Investigational therapy within 28 days before the first planned dose of study drug\n 13. Major surgery within 28 days before the first planned dose of study drug\n 14. Uncontrolled intercurrent disease (eg, diabetes, hypertension, thyroid disease)\n 15. Ongoing angina pectoris or other symptoms of coronary artery disease (CAD); history of stroke, or transient ischemic attack (TIA)\n 16. History of suicidal ideation or attempt\n 17. Condition requiring treatment (past or current) with coumarin-type agents\n 18. Cardiac arrhythmia requiring medical therapy\n 19. Serious nonhealing wound (including wound healing by secondary intention, ulcer, or bone fracture)\n 20. Cancer, autoimmune disease, or any disease or concurrent therapy known to cause significant alteration in immune function (corticosteroids are allowed before study enrollment and during the study to treat an AE)\n 21. Female patients and female partners of male patients: pregnancy, lactation, or inability/unwillingness to practice effective contraception \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT01176903
|
[
{
"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:** glycopyrrolate, tiotropium, placebo\n\n**SMILES:** CN+1(C)CCC(C1)OC(=O)C(O)(C1CCCC1)C1=CC=CC=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 - Males and females patients aged 40-75 years;\n - Written informed consent obtained;\n - Diagnosis of moderate-severe COPD, according to the GOLD guidelines;\n - Current or ex-smokers with a smoking history of ≥ 10 pack-years\n - Post bronchodilator FEV1 between 40% and 80% predicted values (40% ≤ FEV1 < 80%), documented at screening visit ;\n - Post bronchodilator FEV1/Forced Vital Capacity (FEV1/FVC) ≤ 0.70 (absolute value) documented at screening visit;\n - Airway reversibility of at least 100 mL within 30 to 45 minutes after inhalation of ipratropium 80µg.\n Exclusion Criteria:\n - History of chronic or seasonal allergy\n - Blood eosinophil count above 600 per µl\n - Clinically relevant findings on physical examination laboratory and ECG parameters at screening\n - Occurrence of clinically relevant abnormalities in the 24-h Holter ECG recording at screening;\n - Significant disease not related to COPD (eg. Myocardial infarction, stroke within the preceding 6 months);\n - Respiratory tract infection (including upper tract) 4 weeks prior to study entry requiring changing treatment;\n - Patients requiring oxygen therapy on a daily basis for chronic hypoxemia;\n - History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which is considered to be clinically significant by the investigator.\n - Intolerance/hypersensitivity or any contra-indication to treatment with M3 Antagonist or any of the excipients contained in the formulations used in the study.\n - History of alcohol or substance abuse that in the opinion of the Investigator may be of clinical significance.\n - Patients treated with slow-release oral or parental corticosteroids 8 weeks prior to Screening Visit.\n - Patients treated with tiotropium in the 10 days prior to the Screening Visit;\n - Pregnant or lactating women and female or male subjects not willing to use an acceptable method of contraception. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT00477386
|
[
{
"role": "user",
"content": "You are an expert medical assistant specialized in predicting clinical trial outcomes. Your task is to predict the outcome in binary format (Success or Failure), based on the provided information on the clinical trial.\n\nYou will be provided with the following:\n- **Diseases:** A list of diseases targeted by the clinical trial.\n- **ICD Codes:** A list of ICD codes associated with the diseases.\n- **Drugs:** A list of drugs used in the clinical trial.\n- **SMILES:** A list of SMILES strings representing the chemical structures of the drugs\n- **CT Criteria:** The inclusion and exclusion criteria for the clinical trial.\n\nFocus on the biomedical knowledge you possess and the information provided to make your prediction. The outcome should be based on the scientific plausibility of the trial's design, the relevance of the diseases and drugs involved, and the appropriateness of the criteria set for patient selection. Be as exact and accurate as possible.\n\n**Diseases:** ovarian cancer\n\n**ICD Codes:** \"C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2\"\n\n**Drugs:** decitabine\n\n**SMILES:** CN(C)\\\\N=N\\\\C1=C(N=CN1)C(N)=O\n\n**CT Criteria:** Inclusion Criteria:\n - Have recurrent epithelial ovarian cancer, primary peritoneal carcinomatosis or fallopian tube cancer. - Have platinum-resistant (recurrence within 6 months of a platinum-containing regimen) or platinum refractory (progression while on platinum) disease - Have measurable disease according to RECIST or detectable disease. o Measurable disease is defined as the presence of at least one uni-dimensionally measurable lesion greater than or equal to 20 mm by conventional techniques, including palpation, plain x-ray, CT scan or MRI, or greater than or equal to 10 mm by spiral CT scan. o Detectable disease is defined in a patient as one who does not have measurable disease but has at least one of the following conditions: 1) Baseline values of cancer antigen 125 (CA-125) at least twice the upper limit of normal; 2) Ascites and/or pleural effusion attributed to tumor; 3) solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST definitions for target lesions. - >/= 18 years of age. - Give written, informed consent for participation in the protocol. - Be at least 4 weeks from last treatment to allow recovery from prior toxicity (with the exception of hormonal therapy, where a 1-week wash-out period and radiation therapy where a 3-week wash-out period are sufficient). Patients coming off experimental therapy with biological agents not expected to cause myelotoxicity should have been off treatment for at least 3 weeks as wash-out period. - Have had disease that has progressed within 6 months platinum-based chemotherapeutic regimen. - Have no history of platinum allergy. - Have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception if hysterectomy and/or oophorectomy were not part of the prior treatment. It is expected that the overwhelming majority of ovarian cancer patients would have had hysterectomy and oophorectomy as part of the original surgery. - Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Have acceptable organ function, as evidenced by laboratory data: o Aspartate aminotransferase and alanine aminotransferase less than 2.5 times upper limit of normal (ULN) o Direct bilirubin less than 1.5 times ULN o Alkaline phosphatase less than 2.5 times ULN o Absolute neutrophil count greater than or equal to 1500 cells/mm3 o White cell blood count greater than 3000cells/mm3 o Hemoglobin greater than or equal to 9.0 g/dL (can be post-transfusion) o Platelets greater than 100,000/mm3 (can not be post-transfusion) o Creatinine levels less than 1.5 times ULN\n Exclusion Criteria:\n - Not have participated in any clinical trial involving conventional or investigational drugs or devices within the previous 3 weeks. - Not have grade 2 or greater neuropathy. - Have no additional active cancer in addition to the epithelial ovarian cancer within the last 5 years, with the exception of superficial skin cancer (basal cell or squamous cell skin carcinoma), carcinoma in situ of the cervix, Stage I endometrial cancer with less than 50% invasion of the myometrium, or other adequately treated Stage I or II cancer in complete remission. - Be free of active infection requiring antibiotic treatment. - Not have an additional uncontrolled serious medical condition or psychiatric illness. - Not have an immune deficiency and be receiving combination anti-retroviral therapy - Not have known brain metastases, as progressive neurologic dysfunction may develop, that would confound the evaluation of neurologic and other adverse events. - Absence of uncontrolled hypertension, arrhythmia, congestive heart failure or angina. Patients who have had a myocardial infarction or cardiac surgery should be at lease 6 months from the event and free of active symptoms. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT01054300
|
[
{
"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, adult\n\n**ICD Codes:** \"E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44\"\n\n**Drugs:** ertugliflozin 2 mg single dose, ertugliflozin 2 mg split into twice daily, ertugliflozin 4 mg single dose, ertugliflozin 4 mg split into twice daily, placebo\n\n**SMILES:** CCOC1=CC=C(CC2=CC(=CC=C2Cl)C@23OCC@(CO)(O2)C@@H(O)C@H(O)C@H3O)C=C1, CCOC1=CC=C(CC2=CC(=CC=C2Cl)C@23OCC@(CO)(O2)C@@H(O)C@H(O)C@H3O)C=C1, CCOC1=CC=C(CC2=CC(=CC=C2Cl)C@23OCC@(CO)(O2)C@@H(O)C@H(O)C@H3O)C=C1, CCOC1=CC=C(CC2=CC(=CC=C2Cl)C@23OCC@(CO)(O2)C@@H(O)C@H(O)C@H3O)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 - Participants with type 2 diabetes mellitus, either treatment-naïve or on up to 2 acceptable oral anti-diabetes drugs for at least 8-weeks prior to study.\n Exclusion Criteria:\n - Participants with type 1 diabetes mellitus, participants with stroke, unstable angina, heart attack in last 6-months, uncontrolled blood pressure. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT00732784
|
[
{
"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:** healthy\n\n**ICD Codes:** \"Z76.3, Z76.2\"\n\n**Drugs:** imatinib mesylate\n\n**SMILES:** CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1\n\n**CT Criteria:** Inclusion Criteria:\n - Healthy men or women 18 years of age or older. Healthy subjects are defined as individuals who are free from clinically significant illness or disease (such as coronary arterial disease, chronic heart failure, bleeding disorder, hypertension, chronic renal failure etc.) as determined by their medical history, physical examination, and laboratory studies. For the purposes of this protocol, \"clinically significant\" is defined as any history or indication of illness or disease, such as those listed above.\n - Body Mass Index (BMI) < 31 kg/m2 (weight/height2).\n - Female patients of childbearing potential must have negative pregnancy test within 14 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 7 days following discontinuation of study drug.\n - Written, voluntary informed consent.\n Exclusion Criteria:\n - Abnormal marrow function as defined by leucocyte, neutrophil, or platelet counts outside of normal limits.\n - Any evidence of renal dysfunction (proteinuria; serum creatinine > upper limit of normal; or if serum creatinine > upper limit of normal, a calculated creatinine clearance < 60 mL/min/1.73 m2).\n - Impaired hepatic function (liver enzymes greater than the upper limit of normal or bilirubin outside the normal range).\n - Taking any medications (including over the counter products), herbal products, mineral supplements or vitamins (other than a daily multivitamin preparation), other than contraceptives (for women), within 2 weeks of start of the study. All forms of contraceptive medication are permissible for this study and would not result in a females exclusion from participation. Patients who take medications on a chronic basis, such as antihypertensive medications or thyroid replacement therapy, etc. are not eligible for the study.\n - Subjects has received any other investigational agents within 28 days of first day of study drug dosing.\n - Female subjects who are pregnant or breast-feeding. \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT00642655
|
[
{
"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:** kidney transplant\n\n**ICD Codes:** \"T86.11, T86.12, T86.13, Z94.0, T86.10, T86.19, Z48.22\"\n\n**Drugs:** ivig and rituximab\n\n**SMILES:** ClCCN(CCCl)P1(=O)NCCCO1\n\n**CT Criteria:** Inclusion Criteria:\n - Patients eligible for the study will be those who have anti-HLA antibody (Panel Reactive Antibody PRA) of >30% and are eligible for transplantation at Cedars-Sinai Medical Center. We currently anticipate entering 20 patients over the course of the study. We currently have ~100 patients on our wait list that would meet the above criteria. Patients will be selected based on the ability of IVIG to inhibit the cytotoxic anti-HLA antibody activity in vitro. They will then receive IVIG 2gm/kg X1 on day 1 while on hemodialysis. Seven days later, the patients will receive Rituxan® 1gm in the CSMC Cancer Infusion Center as per protocol for Rituxan® infusion. The second Rituxan® infusion will be on day#22. The patients will have monitoring of anti-HLA antibody and outlined tests as shown above.\n - Able and willing to give written informed consent and comply with the requirements of the study protocol\n - Adequate liver function, as indicated by normal liver function tests (NL: AST, ALT, Bilirubin and negative tests for hepatitis C and hepatitis B.\n - Negative serum pregnancy test (for women of child bearing age)\n - Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.\n Exclusion Criteria:\n - Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)\n - Receipt of a live vaccine within 4 weeks prior to randomization\n - Previous Treatment with Rituximab (MabThera® / Rituxan®)\n - Prior antibody therapy\n - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies\n - History of HIV (positive HIV, HIV conducted during screening)\n - History of Hepatitis B and/or Hepatitis C\n - History of recurrent significant infection or history of recurrent bacterial infections\n - Known active bacterial, viral fungal mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening\n - Lack of peripheral venous access\n - History of drug, alcohol, or chemical abuse within 6 months prior to screening\n - Pregnancy (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment) or lactation\n - Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.\n - History of psychiatric disorder\n - Significant cardiac or pulmonary disease (including obstructive pulmonary disease)\n - Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications\n - Inability to comply with study and follow-up procedures\n Laboratory Exclusion Criteria (at Screening)\n - Hemoglobin: < 8.5 gm/dL\n - Platelets: < 100,000/mm\n - AST or ALT >2.5 x Upper Limit of Normal unless related to primary disease.\n - Positive Hepatitis B or C serology\n - Positive HIV \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT00567879
|
[
{
"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:** panobinostat, trastuzumab\n\n**SMILES:** H\\\\C(=C(\\\\H)C1=CC=C(CNCCC2=C(C)NC3=CC=CC=C23)C=C1)C(O)=NO, HN1(H)C@@H2CCCCC@H2N(H)(H)Pt11OC(=O)C(=O)O1\n\n**CT Criteria:** Key Inclusion criteria:\n - Age > 18 year old\n - Confirmed HER2+ ve metastatic breast cancer\n - Prior treatment and progression on trastuzumab\n - Patients must have adequate laboratory values\n - Eastern Cooperative Oncology Group (ECOG) performance status of <2\n Key Exclusion criteria:\n - Patients with active central nervous system (CNS) disease or brain metastases except those who have been previously treated and have been stable for at least 3 months.\n - Impaired heart function or clinically significant heart disease\n - Impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of LBH589\n - Ongoing diarrhea\n - Liver or renal disease with impaired hepatic or renal functions\n - Concomitant use of any anti-cancer therapy or certain drugs\n - Female patients who are pregnant or breast feeding\n - Patients not willing to use an effective method of birth control \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Failure\n"
}
] |
Failure
|
NCT00694980
|
[
{
"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:** placebo, rhumab beta7\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 - Able and willing to provide written informed consent\n - 18-70 years of age\n - Males and females with reproductive potential: Willing to use a reliable method of contraception\n - Diagnosis of ulcerative colitis\n - Eligible to receive biologic therapy\n - Disease duration of >=12 weeks\n Exclusion Criteria:\n - Requirement for hospitalization due to severity of ulcerative colitis\n - Moderate to severe anemia\n - Any manifestation of ulcerative colitis or other conditions likely to require, in the investigators judgment, treatment with >20 mg/day of prednisone, or prednisone equivalent, during the course of the study\n - Pregnant or lactating\n - Lack of peripheral venous access\n - Inability to comply with study protocol\n - History or presence of contraindicated diseases\n - Congenital immune deficiency\n - Active or prior infection with HIV or hepatitis B or C\n - History of severe systemic bacterial, fungal, viral, or parasitic infections\n - History of any other opportunistic infections within 12 weeks prior to initiation of study treatment\n - Received a live attenuated vaccine within 4 weeks prior to screening\n - Hospitalized within 4 weeks prior to screening\n - Received any contraindicated therapy within 12 weeks prior to screening \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
NCT00607308
|
[
{
"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:** \"alzheimers disease\"\n\n**ICD Codes:** \"G30.8, G30.9, G30.0, G30.1\"\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 - Japanese male or females of non-childbearing potential, ages 50-85\n - Diagnosis of probable Alzheimers disease, consistent with criteria from both: (1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimers Disease and Related Disorders Association (NINCDS-ADRDA) 2) Text Revision of The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR)\n - Mini-Mental Status Exam score of 16-26 inclusive\n - Rosen-Modified Hachinski Ischemia score < or = 4\n Exclusion Criteria:\n - Diagnosis or history of other dementia or neurodegenerative disorders\n - Diagnosis or history of clinically significant cerebrovascular disease\n - Specific findings on magnetic resonance imaging (MRI): cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities\n - History of autoimmune disorders\n - History of allergic or anaphylactic reactions \n\nPlease answer with a single outcome prediction, either \"Success\" or \"Failure\"\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Success\n"
}
] |
Success
|
Clinical trials are crucial for drug development but are time consuming, expensive, and often burdensome on patients. More importantly, clinical trials face uncertain outcomes due to issues with efficacy, safety, or problems with patient recruitment. If we were better at predicting the results of clinical trials, we could avoid having to run trials that will inevitably fail more resources could be devoted to trials that are likely to succeed. In this paper, we propose Hierarchical INteraction Network (HINT) for more general, clinical trial outcome predictions for all diseases based on a comprehensive and diverse set of web data including molecule information of the drugs, target disease information, trial protocol and biomedical knowledge. HINT first encode these multi-modal data into latent embeddings, where an imputation module is designed to handle missing data. Next, these embeddings will be fed into the knowledge embedding module to generate knowledge embeddings that are pretrained using external knowledge on pharmaco-kinetic properties and trial risk from the web. Then the interaction graph module will connect all the embedding via domain knowledge to fully capture various trial components and their complex relations as well as their influences on trial outcomes. Finally, HINT learns a dynamic attentive graph neural network to predict trial outcome. Comprehensive experimental results show that HINT achieves strong predictive performance, obtaining 0.772, 0.607, 0.623, 0.703 on PR-AUC for Phase I, II, III, and indication outcome prediction, respectively. It also consistently outperforms the best baseline method by up to 12.4\% on PR-AUC.
{
'TO:DO': ...,
...
}
TO:DO
@article{fu2021hint,
title={HINT: Hierarchical Interaction Network for Trial Outcome Prediction Leveraging Web Data},
author={Fu, Tianfan and Huang, Kexin and Xiao, Cao and Glass, Lucas M and Sun, Jimeng},
journal={arXiv preprint arXiv:2102.04252},
year={2021}
}
Thanks to araag2 for adding this dataset.