TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk People With Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes Mellitus: The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)
Brief Summary: The primary objectives of the ORIGIN study were:

* To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes;
* To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes.

The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce:

* total mortality (all causes);
* the risk of diabetic microvascular outcomes;
* the rate of progression of IGT or IFG to type 2 diabetes.


Options:
A: Major cardiovascular events, which comprises fatal cardiovascular diseases (CVD), non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal stroke and cardiac interventions (PCI and CABG) (monitored during intervention)
B: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))
C: Cardiovascular mortality (From entry into the study (baseline: 2002-2006) through study completion); All-cause mortality (From entry into the study (baseline: 2002-2006) through study completion); Major cardiovascular events (From entry into the study (baseline: 2002-2006) until November 2009)
D: cardiovascular deaths and hospitalization for cardiovascular causes (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk People With Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes Mellitus: The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)
Brief Summary: The primary objectives of the ORIGIN study were:

* To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes;
* To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes.

The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce:

* total mortality (all causes);
* the risk of diabetic microvascular outcomes;
* the rate of progression of IGT or IFG to type 2 diabetes.


Options:
A: Death, all-cause (Up to 7 years)
B: N/A
C: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))
D: Changes in body weight; Weight loss maintenance efficacy (>5% and >10%); Body composition (whole body DEXA-scanning); Drop-out rate; Glucose metabolism (Oral Glucose Tolerance Test); Endothelium function (flow-mediated vasodilatation, FMD)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk People With Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes Mellitus: The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)
Brief Summary: The primary objectives of the ORIGIN study were:

* To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes;
* To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes.

The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce:

* total mortality (all causes);
* the risk of diabetic microvascular outcomes;
* the rate of progression of IGT or IFG to type 2 diabetes.


Options:
A: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
B: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))
C: Change in cognitive scores; Change in insulin sensitivity
D: Blood Pressure (24-hour Ambulatory Blood Pressure Monitoring, ABPM)) (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk People With Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes Mellitus: The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)
Brief Summary: The primary objectives of the ORIGIN study were:

* To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes;
* To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes.

The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce:

* total mortality (all causes);
* the risk of diabetic microvascular outcomes;
* the rate of progression of IGT or IFG to type 2 diabetes.


Options:
A: Percentage of Participants Demonstrating A Meaningful Clinical Response (Baseline, Year 1)
B: PAP: Percent Change From Baseline in Spleen Volume (in Multiples of Normal [MN]) at Week 39 of the Primary Analysis Period With Eliglustat Tartrate Treatment as Compared to Placebo (PAP Baseline (Day 1), Week 39)
C: Change From Baseline in Spleen Volume Measured by MRI. (Baseline and 9 months)
D: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk People With Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes Mellitus: The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)
Brief Summary: The primary objectives of the ORIGIN study were:

* To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes;
* To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes.

The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce:

* total mortality (all causes);
* the risk of diabetic microvascular outcomes;
* the rate of progression of IGT or IFG to type 2 diabetes.


Options:
A: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))
B: Breast Cancer Recurrence (Lifetime)
C: N/A
D: Changes in body weight; Weight loss maintenance efficacy (>5% and >10%); Body composition (whole body DEXA-scanning); Drop-out rate; Glucose metabolism (Oral Glucose Tolerance Test); Endothelium function (flow-mediated vasodilatation, FMD)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk People With Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes Mellitus: The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)
Brief Summary: The primary objectives of the ORIGIN study were:

* To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes;
* To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes.

The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce:

* total mortality (all causes);
* the risk of diabetic microvascular outcomes;
* the rate of progression of IGT or IFG to type 2 diabetes.


Options:
A: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))
B: Time to first relapse of atrial fibrillation (After a three weeks loading phase)
C: All-cause mortality (from enrollment to 1252 deaths in R2 arm); All cause mortality or hospitalizations for any reason (from enrollment to 1252 deaths)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk People With Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes Mellitus: The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)
Brief Summary: The primary objectives of the ORIGIN study were:

* To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes;
* To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes.

The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce:

* total mortality (all causes);
* the risk of diabetic microvascular outcomes;
* the rate of progression of IGT or IFG to type 2 diabetes.


Options:
A: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)
B: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))
C: Cerebral vasospasms: Symptomatic vasospasm defined as documented arterial vasospasm consistent with new neurological deterioration. New low-density areas on CT scans associated with vasospasm. (Between 4 and 30 days after the onset of SAH)
D: Major coronary events (sudden cardiac death, fatal and nonfatal myocardial infarction, unstable angina pectoris including hospitalization for ischemic episodes,events of angioplasty/ stenting or coronary artery bypass grafting)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk People With Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes Mellitus: The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)
Brief Summary: The primary objectives of the ORIGIN study were:

* To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes;
* To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes.

The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce:

* total mortality (all causes);
* the risk of diabetic microvascular outcomes;
* the rate of progression of IGT or IFG to type 2 diabetes.


Options:
A: Health Assessment, Patient treatment satisfaction and Quality-of-Life (At baseline (visit 2: randomization), at 24 weeks after the randomization (visit 7: cross over visit) and 48 weeks after the randomization (visit 12: endpoint))
B: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))
C: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
D: Hemoglobin A1c Change From Baseline (Baseline to 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk People With Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes Mellitus: The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)
Brief Summary: The primary objectives of the ORIGIN study were:

* To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes;
* To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes.

The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce:

* total mortality (all causes);
* the risk of diabetic microvascular outcomes;
* the rate of progression of IGT or IFG to type 2 diabetes.


Options:
A: COPD exacerbations in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year); Airflow obstruction/change in pulmonary function (pre-randomization and after 2 years follow-up); Pneumonia in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year)
B: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))
C: Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months (12 months)
D: Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization. (Total follow-up time of up to approximately 6 years.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Study of Acid Reflux in Asthma
Brief Summary: The purpose of this study is to determine if subjects with symptomatic asthma who are assigned to treatment with a proton pump inhibitor (PPI) drug such as Nexium have fewer asthma attacks than similar subjects assigned to placebo treatment.


Options:
A: 7-item Juniper Asthma Control Questionnaire (ACQ) (6-months post-randomizaton)
B: Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Beta-agonists as a Criterion (Baseline to 24 Weeks)
C: Asthma Quality of Life Questionnaire (Baseline, 6 weeks, 3 months, 6 months)
D: asthma free days (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Study of Acid Reflux in Asthma
Brief Summary: The purpose of this study is to determine if subjects with symptomatic asthma who are assigned to treatment with a proton pump inhibitor (PPI) drug such as Nexium have fewer asthma attacks than similar subjects assigned to placebo treatment.


Options:
A: Change in Juniper Asthma Control Score (ACS) (Measured at Weeks 0, 4, 8, 12, 24)
B: Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Beta-agonists as a Criterion (Baseline to 24 Weeks)
C: Change in Juniper Asthma Control Score (ACS) (Measured at Weeks 0, 4, 8, 12, 24)
D: Mean Change in Morning Peak Expiratory Flow (mPEF (L/Minute)) From Baseline (Mean of the Last 7 Days in the run-in Period) to Treatment Period (Mean of All Available Data During the Treatment Period). (Baseline to 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis
Brief Summary: Clinical and experimental studies suggest that bosentan could delay the progression of interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a condition for which no established efficacious treatment is available. The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO Class III and IV, to a new category of patients suffering from ILD associated with SSc.


Options:
A: Change from baseline to End-of-Study in 6-minute walk distance.
B: Time to tumor progression (TTP) or death (progression free survival) after initiation of treatment. Tumor progression is defined per RECIST criteria. (6 weekly)
C: Peak 6-minute Walk Distance (12 weeks)
D: Change from baseline at Week 12 of six minute walk distance

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis
Brief Summary: Clinical and experimental studies suggest that bosentan could delay the progression of interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a condition for which no established efficacious treatment is available. The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO Class III and IV, to a new category of patients suffering from ILD associated with SSc.


Options:
A: Change in 6-minute walk distance (Baseline to End-of-Period 1)
B: Change from Baseline to End of Study in 6MWT distance. A mean difference from placebo of at least 35 m is considered clinically relevant. (16 weeks)
C: Change from baseline to End-of-Study in 6-minute walk distance.
D: 6 minute walk distance change from baseline to Week 16 (16 weeks)

Answer: C