TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Parallel Group, Open-label, Active Controlled, Multicenter Phase III Trial of Patupilone (EPO906) Versus Pegylated Liposomal Doxorubicin in Taxane/Platinum Refractory/Resistant Patients With Recurrent Epithelial Ovarian, Primary Fallopian or Primary Peritoneal Cancer
Brief Summary: The objective of this study is to assess the safety and efficacy of patupilone compared to pegylated liposomal doxorubicin. Additionally, this study will assess the ability of patupilone to extend the survival time and potential beneficial effects in women who have nonresponsive or recurrent ovarian, primary fallopian, or primary peritoneal cancer.


Options:
A: Progression-Free Survival (PFS) Comparison (2 Years)
B: To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer (every 8 weeks)
C: Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by an Independent Review Committee (IRC) - Simon's Cohort (From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)); Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by the IRC - Efficacy Evaluable Population (From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months))
D: Progression Free Survival (PFS) (Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Parallel Group, Open-label, Active Controlled, Multicenter Phase III Trial of Patupilone (EPO906) Versus Pegylated Liposomal Doxorubicin in Taxane/Platinum Refractory/Resistant Patients With Recurrent Epithelial Ovarian, Primary Fallopian or Primary Peritoneal Cancer
Brief Summary: The objective of this study is to assess the safety and efficacy of patupilone compared to pegylated liposomal doxorubicin. Additionally, this study will assess the ability of patupilone to extend the survival time and potential beneficial effects in women who have nonresponsive or recurrent ovarian, primary fallopian, or primary peritoneal cancer.


Options:
A: Progression-free Survival (3 years)
B: Overall Survival (Survival is measured from date of enrollment and randomization on the study until death from any cause, or if alive at last contact, date of last contact.)
C: To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer (every 8 weeks)
D: Overall Objective Response (1 year after end inclusion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Parallel Group, Open-label, Active Controlled, Multicenter Phase III Trial of Patupilone (EPO906) Versus Pegylated Liposomal Doxorubicin in Taxane/Platinum Refractory/Resistant Patients With Recurrent Epithelial Ovarian, Primary Fallopian or Primary Peritoneal Cancer
Brief Summary: The objective of this study is to assess the safety and efficacy of patupilone compared to pegylated liposomal doxorubicin. Additionally, this study will assess the ability of patupilone to extend the survival time and potential beneficial effects in women who have nonresponsive or recurrent ovarian, primary fallopian, or primary peritoneal cancer.


Options:
A: Progression-Free Survival (PFS): Independent Radiologist Review (From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years)
B: To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer (every 8 weeks)
C: To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin (Once 244 planned pts. received at least 2 cycles of study treatment(s))
D: Progression-free survival based on investigator assessment using RECIST and clinical findings (Assessed within 12 months following completion of accrual)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Multinational, Multicenter, Double-blind, Placebo-controlled, Two-arm Parallel Group Trial of Rimonabant 20 mg OD for Reducing the Risk of Major Cardiovascular Events in Abdominally Obese Patients With Clustering Risk Factors
Brief Summary: The primary objective is to show whether rimonabant reduces the risk of a heart attack (MI), stroke, or death from an MI or stroke in patients with abdominal obesity with other cardiovascular (CV) risk factors.

The secondary objective is to show whether rimonabant reduces the risk of MI, stroke, CV death, or CV hospitalization in these patients.


Options:
A: Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) (from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days))
B: First occurrence of any of myocardial infarction, stroke or cardiovascular (CV) death (From randomization up to common study end date (33-50 months))
C: Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 (Baseline and Week 52)
D: Absolute change from baseline in averaged per patient carotid artery intima-media thickness (CIMT) (Month 30)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Multinational, Multicenter, Double-blind, Placebo-controlled, Two-arm Parallel Group Trial of Rimonabant 20 mg OD for Reducing the Risk of Major Cardiovascular Events in Abdominally Obese Patients With Clustering Risk Factors
Brief Summary: The primary objective is to show whether rimonabant reduces the risk of a heart attack (MI), stroke, or death from an MI or stroke in patients with abdominal obesity with other cardiovascular (CV) risk factors.

The secondary objective is to show whether rimonabant reduces the risk of MI, stroke, CV death, or CV hospitalization in these patients.


Options:
A: Body weight (52 days)
B: Change from baseline shear wave elastography (SWE) at 8 weeks (Change from baseline at 8-week); Change from baseline liver steatosis at 8 weeks (Change from baseline at 8-week); Concentration of high-density lipoprotein (HDL) (Change from baseline at 8-week); Concentration of low-density lipoprotein (LDL) (Change from baseline at 8-week); Concentration of triglycerides (TG) (Change from baseline at 8-week); Concentration of total cholesterol (TC) (Change from baseline at 8-week); Concentration of fasting blood sugar (FBS) (Change from baseline at 8-week); Concentration of alanine aminotransferase (ALT) (Change from baseline at 8-week); Concentration of aspartate aminotransferase (AST) (Change from baseline at 8-week)
C: Decrease in high sensitivity C-reactive protein (hsCRP) (16 weeks-- Baseline, 8 weeks, 16 weeks)
D: First occurrence of any of myocardial infarction, stroke or cardiovascular (CV) death (From randomization up to common study end date (33-50 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Primary Health Care Intervention for the Prevention of Cardiovascular Disease in Rural Andhra Pradesh
Brief Summary: This study will evaluate the effectiveness of a novel cardiovascular disease prevention program designed for delivery through existing primary health care services in rural villages in Andhra Pradesh.

The primary aim is to increase the number of high-risk individuals in the population that are appropriately managed with proven, low-cost preventive interventions. The corresponding null hypothesis is therefore that the prevention program will result in no change in the proportion of high-risk individuals identified and treated in villages assigned to intervention compared with those villages assigned to control.


Options:
A: Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II) (End of program (6 months))
B: The proportion of high-risk individuals that have been assessed for cardiovascular risk (12 months after intevention); The proportion of individuals with correct knowledge about the effects of behavioural determinants of the risk of cardiovascular disease (12 months from intervention)
C: Framingham Risk Score (15 months)
D: The proportion of subjects who attain "optimal BP and lipid control" (defined as systolic BP < 140 mm Hg AND fasting LDL cholesterol < 2.0 mmol/L) compared to baseline. (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Primary Health Care Intervention for the Prevention of Cardiovascular Disease in Rural Andhra Pradesh
Brief Summary: This study will evaluate the effectiveness of a novel cardiovascular disease prevention program designed for delivery through existing primary health care services in rural villages in Andhra Pradesh.

The primary aim is to increase the number of high-risk individuals in the population that are appropriately managed with proven, low-cost preventive interventions. The corresponding null hypothesis is therefore that the prevention program will result in no change in the proportion of high-risk individuals identified and treated in villages assigned to intervention compared with those villages assigned to control.


Options:
A: Processes of clinical care for diabetes; Cardiovascular risk as determined by UKPDS Risk; Metabolic outcomes (HgbA1c); Metabolic outcomes (LDL Cholesterol); Metabolic Outcomes (Systolic Blood Pressure)
B: Main outcome variable: control of blood pressure (Baseline and 1 year)
C: The proportion of high-risk individuals that have been assessed for cardiovascular risk (12 months after intevention); The proportion of individuals with correct knowledge about the effects of behavioural determinants of the risk of cardiovascular disease (12 months from intervention)
D: The comparison of change in vascular monitoring process total score (proportion of process targets met in group) between intervention and control groups. (6 months to 1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Psychosoziale Intervention Zur Reduktion Diabetischer Spätschäden Bei Diabetes Mellitus Typ 2
Brief Summary: The purpose of this study is to determine whether a structured stress relief management program can prevent the progression of late diabetic complications in patients with type 2 diabetes.


Options:
A: Progression of albuminuria (1,2,3,4 and 5 year)
B: Change from baseline in self-rated sense of coherence (13-item); The sense of coherens scale, SOC 13-item at week 52. (baseline and after 12 months); Changes from baseline in self-rated Health related quality of Life (36 item); The SF 36 - item short-form health status survey at week 52 (baseline and after 12 mounth); Changes from baseline in self-rated mastering (7 item); The 7-item Mastery scale at week 52 (baseline and after 12 months)
C: coronary blood flow as measured by PET (12 weeks)
D: Changes in weight self-stigma (9 months (from Baseline to 6-months follow-up)); Changes in eating behaviours (9 months (from Baseline to 6-months follow-up)); Changes in obesity-related quality-of-life (9 months (from Baseline to 6-months follow-up))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Psychosoziale Intervention Zur Reduktion Diabetischer Spätschäden Bei Diabetes Mellitus Typ 2
Brief Summary: The purpose of this study is to determine whether a structured stress relief management program can prevent the progression of late diabetic complications in patients with type 2 diabetes.


Options:
A: Systolic Blood Pressure (SBP) (one year)
B: Progression of albuminuria (1,2,3,4 and 5 year)
C: Change in blood pressure measurement at baseline and at one year follow-up (Baseline and one year follow-up)
D: Knowledge of increased risk donor kidney transplants (1 week)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2 Study of the Effect of 7-Methylxanthine on the Progression of Childhood Myopia
Brief Summary: 7-methylxanthine has been shown to increase the concentration and thickness of collagen fibrils in rabbit sclera. Deficient collagen in the sclera may be the cause of progression of childhood myopia. The study hypothesis is that treatment with 7-methylxanthine will stabilize the sclera and prevent further progression of myopia.


Options:
A: Axial growth
B: N/A
C: Axial Length of the Eye (Baseline and every 6 months post-baseline up to 18 months); Spherical Equivalent Refractive Error (Baseline and every 6 months up to 18 months)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Reactogenicity and Immunogenicity of Three Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine
Brief Summary: The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines including OPV in HIV positive infants. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain (From 2 weeks after the last vaccine or placebo dose up to 1 year of age)
B: Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains (From Month 1 ½ to Month 21)
C: Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea (Within the 15-day solicited follow-up period after any dose)
D: Demonstrate lot-to-lot consistency of HRV vaccine liquid formulation and non-inferiority of liquid formulation versus the lyophilised formulation of the HRV vaccine.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Reactogenicity and Immunogenicity of Three Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine
Brief Summary: The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines including OPV in HIV positive infants. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay (3-6 weeks after the last vaccination); Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay (3-6 weeks after the last vaccination); Geometric Mean Serum Anti-rotavirus IgA Titer (3-6 weeks after the last dose of vaccine)
B: Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until 1 year old.
C: Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea (Within the 15-day solicited follow-up period after any dose)
D: Proportion of subjects who seroconvert as measured by a 4-fold rise in serum anti-VP6 IgA antibodies between baseline and 4 weeks after the second dose of Rotarix®. (14-18 weeks of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Reactogenicity and Immunogenicity of Three Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine
Brief Summary: The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines including OPV in HIV positive infants. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] (42 days after vaccination 3 (up to 185 days))
B: Proportion of subjects who seroconvert as measured by a 4-fold rise in serum anti-VP6 IgA antibodies between baseline and 4 weeks after the second dose of Rotarix®. (14-18 weeks of age)
C: Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea (Within the 15-day solicited follow-up period after any dose)
D: To assess immunogenicity of a new rotavirus vaccine Rotavin-M1 in terms of anti-rotavirus IgA antibody seroconversion 1 month after complete the vaccination schedule (up to 7 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Phase III Study of Erlotinib Versus Observation in Patients With no Evidence of Disease Progression After First Line, Platinum-Based Chemotherapy For High-Risk Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Brief Summary: RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sometimes after treatment, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether erlotinib is more effective than observation after first-line chemotherapy in treating patients with ovarian cancer, peritoneal cancer, or fallopian tube cancer.

PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to observation in treating patients who have undergone first-line chemotherapy for ovarian cancer, peritoneal cancer, or fallopian tube cancer.


Options:
A: Progression Free Survival (Time from first dose to date of progression, the longest time frame of 3.9 years)
B: Overall survival as measured by Kaplan Meier every 3 months for 2 years, every 6 months for 3 years, and then annually
C: Number of Participants With the Indicated Tumor Response at 12 Weeks From First Dose (Week 12); Percentage of Participants Who Remained Progression-free 12 Weeks After Randomization (Week 12 after randomization.)
D: Progression-free survival

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Self-care Intervention for Latino Adults With Diabetes
Brief Summary: The purpose of this study is to modify and evaluate a culturally appropriate intervention that is designed to improve diabetes self-care practices by enhancing the self-efficacy, empowerment and diabetes knowledge among Latino adults over the age of 55 years.


Options:
A: Framingham Risk Score (15 months)
B: Change in hemoglobin A1c.
C: Systolic blood Pressure (Baseline and 12 months); Glycated haemoglobin (HbA1c) (Baseline and 12 months)
D: Hemoglobin A1c

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of UK-500,001 Dry Powder For Inhalation (DPI) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).
Brief Summary: This initial proof of concept, phase II study aims to assess the safety and efficacy of UK-500,001 for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary Disease.


Options:
A: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 24 weeks of treatment)
B: Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue. (16 weeks); Change in Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue (Baseline to 16 weeks)
C: Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year (52 weeks)
D: Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of UK-500,001 Dry Powder For Inhalation (DPI) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).
Brief Summary: This initial proof of concept, phase II study aims to assess the safety and efficacy of UK-500,001 for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary Disease.


Options:
A: Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo
B: change in FEV1 from baseline during the treatment period; number of COPD exacerbations.
C: Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline (baseline); Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization. (1 month after baseline); Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization (3 months after baseline)
D: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 24 weeks of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: D-dimer Test to Establish Duration of Anticoagulation After a First Idiopathic Episode of Venous Thromboembolism; the Prospective Randomized "Prolong" Study
Brief Summary: The optimal duration of oral anticoagulant treatment in patients with idiopathic venous thromboembolism is still uncertain. The present study addresses the possible role of the D-dimer test in assessing the need for continuation of anticoagulation.The study aims at assessing whether D-dimer assay may have a role in guiding the duration of anticoagulation in these patients


Options:
A: Death due to DVT/PE; Failures of resolution, extension or recurrence of DVT and/or PE during and after treatment.; Number of major haemorrhages.
B: The main efficacy outcome is objectively confirmed recurrent thromboembolism from randomization up to completion of 33 months of follow-up. (33 months)
C: Confirmed recurrent proximal deep vein thrombosis and/or pulmonary embolism at 18 months follow up; Confirmed major bleeding events at 18 months follow up
D: Recurrent Venous Thromboembolism; major and minor haemorrhage; death

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomised, Controlled Study of Autologous Bone Marrow-Derived Stem Cell Transfer In Patients With ST-Segment Elevation Myocardial Infarction.
Brief Summary: The benefit of reperfusion therapies for ST-elevation acute myocardial infarction (STEMI) is limited by postinfarction left ventricular (LV) dysfunction.The purpose of this study is to determine whether intracoronary transfer of bone marrow cells will augment left ventricular function recovery of the heart.


Options:
A: increase in global LV ejection fraction fraction; evaluation by magnetic resonance (MRI) after 4 months
B: Change in global left ventricular ejection fraction (LVEF) at 4 months relative to baseline measured by quantitative MRI (4 months)
C: Freedom from occurrence of major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, re-infarction, revascularization and stroke (12 months)
D: difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 6 months follow-up (6 months)

Answer: A