TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) Trial of Cardiovascular Events in High-Risk Hypertensive Patients
Brief Summary: The purpose of this study is to compare an angiotensin II receptor antagonist (candesartan cilexetil- Blopress®) and a calcium channel blocker (amlodipine besilate- Norvasc®/Amlodin®) in terms of the incidence of cardiovascular events among high-risk hypertensive patients.


Options:
A: Sudden death: death of endogenous origin within 24 hours after acute onset; Cerebrovascular events: new occurrence or recurrence of a stroke or transient ischemic attack; Cardiac events: new occurrence, aggravation, or recurrence of heart failure, angina pectoris, or acute myocardial infarction; Renal dysfunction: serum creatinine ≥4.0 mg/dl, end stage renal disease, doubling of serum creatinine (however, creatinine ≤2.0 mg/dl is not regarded as an event); Vascular events: new occurrence or aggravation of dissecting aneurysm of aorta, arteriosclerotic occlusion of peripheral artery
B: Composite of fatal and non-fatal stroke (During the study period)
C: Primary composite outcome (4 years)
D: Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event (For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) Trial of Cardiovascular Events in High-Risk Hypertensive Patients
Brief Summary: The purpose of this study is to compare an angiotensin II receptor antagonist (candesartan cilexetil- Blopress®) and a calcium channel blocker (amlodipine besilate- Norvasc®/Amlodin®) in terms of the incidence of cardiovascular events among high-risk hypertensive patients.


Options:
A: Medication Appropriateness Index (MAI) score (Change from baseline MAI score at 6 months)
B: The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At inclusion); The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At 1 month); The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At 6 months); The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At 18 months); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At inclusion); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At 1 month); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At 6 months); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At 18 months)
C: N/A
D: Sudden death: death of endogenous origin within 24 hours after acute onset; Cerebrovascular events: new occurrence or recurrence of a stroke or transient ischemic attack; Cardiac events: new occurrence, aggravation, or recurrence of heart failure, angina pectoris, or acute myocardial infarction; Renal dysfunction: serum creatinine ≥4.0 mg/dl, end stage renal disease, doubling of serum creatinine (however, creatinine ≤2.0 mg/dl is not regarded as an event); Vascular events: new occurrence or aggravation of dissecting aneurysm of aorta, arteriosclerotic occlusion of peripheral artery

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Heart and Renal Protection (SHARP): The Effects of Lowering LDL-cholesterol With Simvastatin 20mg Plus Ezetimibe 10mg in Patients With Chronic Kidney Disease: a Randomized Placebo-controlled Trial
Brief Summary: The chief aim of SHARP was to determine whether lowering blood LDL cholesterol with simvastatin (20mg) plus ezetimibe (10mg) daily could safely reduce the risk of coronary heart disease, non-hemorrhagic stroke and the need for revascularization procedures in patients with chronic kidney disease (CKD). It also aimed to assess whether lowering LDL cholesterol reduced the rate of loss of renal function in people with CKD who had not commenced dialysis treatment.


Options:
A: Coronary Heart Disease(CHD)[fatal/non-fatal MI, sudden/cardiac death, angina, revascularization]
B: Key Outcome as Per Statistical Analysis Plan = Major Atherosclerotic Events Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo (Median follow-up 4.9 years)
C: Relative reduction in circulating osteoprotegerin levels (18 weeks)
D: Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization) (up to 5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Heart and Renal Protection (SHARP): The Effects of Lowering LDL-cholesterol With Simvastatin 20mg Plus Ezetimibe 10mg in Patients With Chronic Kidney Disease: a Randomized Placebo-controlled Trial
Brief Summary: The chief aim of SHARP was to determine whether lowering blood LDL cholesterol with simvastatin (20mg) plus ezetimibe (10mg) daily could safely reduce the risk of coronary heart disease, non-hemorrhagic stroke and the need for revascularization procedures in patients with chronic kidney disease (CKD). It also aimed to assess whether lowering LDL cholesterol reduced the rate of loss of renal function in people with CKD who had not commenced dialysis treatment.


Options:
A: Changing LDL Cholesterol (36 months)
B: Key Outcome as Per Statistical Analysis Plan = Major Atherosclerotic Events Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo (Median follow-up 4.9 years)
C: Change in ultrasound-determined average carotid artery intima-media thickness (IMT) on a per subject basis between baseline and endpoint. (24 months)
D: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis (From Baseline to Week 52)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Measuring Reading Rehabilitation Outcomes
Brief Summary: The purpose of this study is to measure the effectiveness of a newly-designed oculomotor training program for patients with age-related macular degeneration.


Options:
A: Visual field (6 months)
B: VA LV VFQ-48 Reading Domain Scores (4 months from baseline)
C: Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12 (Baseline through the end of study (Month 12)); Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 24 Month Extension Study (Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]); Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 24 Month Extension Study (Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months])
D: Participants will be given the following assessment tests at 4 different times during the assessment (at baseline, after 6 weeks, after 12 weeks, and after 18 weeks): eye tracking measures, daily performance measures and reading measures.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Trial of Warfarin Plus Antiplatelet Therapy Versus Antiplatelet Therapy Alone in Patients With Peripheral Vascular Disease
Brief Summary: The purpose of this study is to evaluate whether the addition of warfarin (a blood-thinning medication) to an antiplatelet therapy like aspirin is better than antiplatelet therapy alone (i.e. usual treatment) for the prevention of leg surgery, heart attacks, stroke and death in people with peripheral vascular disease.


Options:
A: The primary efficacy endpoint was the composite of symptomatic recurrent DVT or symptomatic fatal and non-fatal PE at 12 weeks and deterioration in thrombotic burden, as assessed by CUS and PLS, at baseline and at 12 weeks. (12 weeks)
B: The composite of cardiovascular death, myocardial infarction (MI) and stroke
C: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (6- or 12-month study treatment period)
D: The composite of cardiovascular (CV) death, first occurrence of myocardial infarction (MI), or stroke; The composite of CV death, first occurrence of MI, stroke, or severe ischemia requiring urgent intervention of the coronary (PTCA, CABG) or peripheral artery circulation (thrombolytic therapy, angioplasty, bypass surgery, limb amputation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of L Glutamine Therapy for Sickle Cell Anemia and Sickle ß0-Thalassemia
Brief Summary: The purpose of this research is to evaluate the effects of L-glutamine as a therapy for sickle cell anemia and sickle ß0-thalassemia. as evaluated by the number of occurrences of sickle cell crises.


Options:
A: Gardos Channel Activity (12 weeks after randomization); Nitric Oxide (12 weeks after randomization); Mean Corpuscular Hemoglobin Concentration (12 weeks after randomization)
B: Time-to-crisis Resolution (From study drug delivery to last IV opioid treatment (up to 2 months))
C: Evaluate safety & tolerability of SC411 & determine change from Baseline in the blood cells omega-3 fatty acids index in subjects, treated with active SC411 doses or placebo in Part A and safety and tolerability in Part B. (Week 0 (baseline) through Month 52 (end of treatment))
D: Number of Occurrences of Painful Sickle Cell Crises (From Week 0 through Week 48 (cumulative))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Stepped Primary Care Smoking Cessation Intervention Based on an Evidence Based Clinical Practice Guideline (ISTAPS Project)
Brief Summary: Primary care centers can play a very important role in helping people to stop smoking. There is a large body of research on the effectiveness of specific interventions especially addressed to people who want to stop smoking. In addition to that, there are no studies with a large sample of individuals included that tested the complete range of interventions recommended nowadays for helping people in the different smoking cessation stages of change and with different degrees of physical and psychological dependence, especially including motivational interviewing in those not interested in cessation in the very next weeks. This study will test a complex intervention that at first classifies smokers in stages and after that treats every smoker according to what stage he/she is in at the moment, his/her degree of dependence and his/her own characteristics.


Options:
A: Smoking abstinence (6 months)
B: Bioverified 12-Month Prolonged Abstinence Between 6 and 18 Months Postrandomization (between 6 and 18 months)
C: Self reported abstinence confirmed by an expired air carbon monoxide concentration of 10 parts per millions or less; Point prevalence at the end of intervention, 1 and 2 years after the beginning of intervention; Continuous abstinence rate for 1 year; Change of stage in the smoking cessation process
D: Frequency of women receiving the cessation smoking advice (Interviews during the first 12 hours after delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: PHIRST-1: Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment in Patients With Pulmonary Arterial Hypertension
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the treatment of pulmonary arterial hypertension.


Options:
A: Peak 6-minute Walk Distance (12 weeks)
B: Change from baseline at Week 12 of six minute walk distance
C: 6 minute walk distance change from baseline to Week 16 (16 weeks)
D: Digital Micro-vascular Flow (Baseline and 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: PHIRST-1: Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment in Patients With Pulmonary Arterial Hypertension
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the treatment of pulmonary arterial hypertension.


Options:
A: Frequently Reported (15% or More Overall) Adverse Events by Severity (Baseline to Week 295); Serum Aminotransferases Relative to the Upper Limit of the Normal Range (ULN) (Baseline to Week 295)
B: 6 minute walk distance change from baseline to Week 16 (16 weeks)
C: Change from baseline to End-of-Study in 6-minute walk distance.
D: Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event) (Up to end of treatment (data presented up to month 36))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Study to Assess the Acute and Chronic Effects of Intravenous Iron Supplementation in Anaemic and Non-Anaemic Iron Deficient Patients With Chronic Heart Failure
Brief Summary: This is a two-center, randomised, single-blind (physician), prospective, controlled study to assess the acute (8 weeks) and chronic (16 weeks) effects of intravenous (IV) iron sucrose supplementation in anaemic and non-anaemic iron deficient patients with chronic heart failure (CHF).

The hypotheses are:

* Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose improves exercise capacity as measured by peak VO2.
* IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF.


Options:
A: Change in Peak VO2 (mL/kg/min) from baseline to Week 24 (Week 24)
B: To assess the efficacy of a single intravenous (IV) administration of FCM (1,000 mg) compared with placebo in improving fatigue symptoms in IDNA women of child bearing age. (Day 56)
C: Change in peak VO2 from baseline to week 18
D: Change in six minute walk test from baseline to week 24 (24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Study to Assess the Acute and Chronic Effects of Intravenous Iron Supplementation in Anaemic and Non-Anaemic Iron Deficient Patients With Chronic Heart Failure
Brief Summary: This is a two-center, randomised, single-blind (physician), prospective, controlled study to assess the acute (8 weeks) and chronic (16 weeks) effects of intravenous (IV) iron sucrose supplementation in anaemic and non-anaemic iron deficient patients with chronic heart failure (CHF).

The hypotheses are:

* Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose improves exercise capacity as measured by peak VO2.
* IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF.


Options:
A: Efficacy of maintenance treatment of iron deficiency (8 months)
B: Haemoglobin and Hematocrit values (2 years)
C: Change in peak VO2 from baseline to week 18
D: The primary endpoint of the IRON-HF study is to assess the impact of iron supplementation alone (IV or PO) on changes in oxygen maximal consumption (peak VO2) assessed by ergospirometry over a 3-month follow-up period.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Study to Assess the Acute and Chronic Effects of Intravenous Iron Supplementation in Anaemic and Non-Anaemic Iron Deficient Patients With Chronic Heart Failure
Brief Summary: This is a two-center, randomised, single-blind (physician), prospective, controlled study to assess the acute (8 weeks) and chronic (16 weeks) effects of intravenous (IV) iron sucrose supplementation in anaemic and non-anaemic iron deficient patients with chronic heart failure (CHF).

The hypotheses are:

* Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose improves exercise capacity as measured by peak VO2.
* IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF.


Options:
A: Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy (24 weeks)
B: Change in peak VO2 from baseline to week 18
C: Risk of blood transfusion or death (From randomisation until 30-days following the index operation); Blood transfusion rate (including repeat transfusions) (From randomisation until 30-days following the index operation)
D: Haemoglobin and Hematocrit values (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evidence Based Amputee Rehabilitation (EBAR) Program
Brief Summary: The purpose of this study is to determine if an evidence based exercise intervention improves the functional mobility of diabetic amputees (single lower leg amputation) who have already completed standard rehabilitation and prosthetic training.


Options:
A: Step Length Symmetry (Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.)
B: Prosthetic Limb Users Survey of Mobility (PLUS-M) (5-10 minutes); Patient-Reported Outcomes Measurement Information System (PROMIS)-29 (5-10 minutes)
C: Timed Up-and-Go Test (Baseline, 12-weeks, and 24 weeks)
D: Amputee Mobility Predictor (8 weeks for intervention and for wait-list control)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Treatment Strategy for Chemotherapy in Colorectal Cancer, FFCD 2000-05
Brief Summary: The standard treatment of metastatic colorectal cancer is based on systemic chemotherapy. Several effective drugs are currently available and can be administered either sequentially or in combination. Most patients receive 2 or 3 lines of chemotherapy. The aim of this randomized trial is to evaluate the potential benefit of a bitherapy with 5-fluorouracil (5-FU) and oxaliplatin as first line chemotherapy compared with a sequential chemotherapy with 5-FU alone as first line chemotherapy followed by the combination of 5-FU with oxaliplatin in case of progressive disease, in terms of progression-free survival and overall survival in patients with advanced colorectal cancer.


Options:
A: Overall Survival (From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA).)
B: Progression-free Survival Time (From randomization to the data cut-off date of 30 June 2005. The median follow-up time was 20.0 weeks in the panitumumab plus BSC group and 18.2 weeks in the BSC alone group.)
C: Progression-free survival after two lines of chemotherapy, defined as the time duration from randomization until progression after two lines of chemotherapy or death whatever the cause in the absence of progression or last-follow-up
D: Overall Survival (OS) (Randomization to Date of Death from Any Cause Up to 39.36 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this trial is to determine whether a conservative or a liberal blood transfusion strategy is better for patients with a heart attack and a low blood count.


Options:
A: Postoperative Functional mobility; Restricting factors for functional mobility
B: the proportion of patients transfused with homologous red blood cells (RBC) (At 30 days post-operatively)
C: Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction (Within 30 days of randomization)
D: In-hospital death (In-hospital); Recurrent myocardial infarction (MI) (In-hospital); New or worsening heart failure (In-hospital)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this trial is to determine whether a conservative or a liberal blood transfusion strategy is better for patients with a heart attack and a low blood count.


Options:
A: Occurrence of a composite endpoint (90 days)
B: In-hospital death (In-hospital); Recurrent myocardial infarction (MI) (In-hospital); New or worsening heart failure (In-hospital)
C: A Composite of In-hospital Postoperative Morbidity and Mortality (After surgery until hosptal discharge)
D: Hemoglobin difference (14 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this trial is to determine whether a conservative or a liberal blood transfusion strategy is better for patients with a heart attack and a low blood count.


Options:
A: Reduce red-cell transfusion packs (60 days after hospital discharge)
B: FACT-G, FACT-An, Numeric Rating Scale on symptoms of anaemia, Performance status (Before each cylces of chemotherapy in up to six months, and before transfusion, and daily in seven days after transfusion)
C: In-hospital death (In-hospital); Recurrent myocardial infarction (MI) (In-hospital); New or worsening heart failure (In-hospital)
D: Mortality (90 day)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Clinical Trial to Evaluate the Efficacy of BAY 43-9006 With or Without Low Dose Interferon in Metastatic Renal Cell Carcinoma
Brief Summary: This randomized phase II trial is studying sorafenib and interferon alfa-2b to see how well they work compared to sorafenib alone in treating patients with metastatic kidney cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib and interferon alfa-2b may also block blood flow to the tumor. Giving sorafenib together with interferon alfa-2b may kill more tumor cells.


Options:
A: Objective Response Rate (ORR) Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST) (Tumor restaging performed at 8 weeks following baseline, responding or stable participants restaged at 8 week intervals, up to 12 months.)
B: Progression-free Survival (PFS) Based on Independent Radiological Review for the First Intervention Period (From randomization of the first subject until 15 months later, assessed every 8 weeks)
C: Progression Free Survival (PFS) (From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause; assessed up to 3 years)
D: Overall Survival (5 years)

Answer: A