TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo Controlled, Multicenter, Phase 3 Study of Rosuvastatin (CRESTOR®) 20 mg in the Prevention of Cardiovascular Events Among Subjects With Low Levels of Low Density Lipoprotein(LDL) Cholesterol & Elevated Levels of C-Reactive Protein
Brief Summary: The purpose of this study is to determine the safety and effectiveness of long-term therapy with rosuvastatin compared with a placebo, and to evaluate whether treatment with rosuvastatin might be effective in reducing the risk of major cardiovascular events.


Options:
A: Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization) (up to 5 years)
B: Post operative atrial fibrillation detected on continuous ECG monitoring. (Monitoring will commence soon after surgery and will be continued until the end of post operative day 5); Myocardial injury assessed by Troponin release (Serial blood samples for Troponin assay will be collected at 6, 24, 48 and 120 hours after surgery)
C: Endothelial Progenitor Cells (EPCs) Count (Cells/µl) (Postoperative 6th hours)
D: plasma troponin T level (within the first 7 days after surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Urinary Incontinence After Radical Prostatectomy. - Effect of Pelvic Floor Muscle Training. A Randomised Controlled Trial
Brief Summary: The aim of this study is to evaluate the effect of pelvic floor muscle training in the treatment of urinary incontinence after radical prostatectomy.


Options:
A: Erectile function score by a validated symptom questionnaire (IIEF) (At 3 months, 6 months and 1 year); Time to continence after surgery (At 3 months, 6 months and 1 year)
B: self reported continence (no need for wearing a pad)at 3 months (One year)
C: HRQOL urinary irritative score (12 month)
D: Subjective report of urinary continence at 12 months; Incremental cost per quality-adjusted year

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized Study of Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)
Brief Summary: Epithelial ovarian carcinoma (EOC) is the 5th leading cause of death among women. Long-term survival is poor for the majority of women with EOC because many present with advanced disease. Chemotherapy and cytoreductive surgery produces a 50% - 60% response rate but relapse is not uncommon. Adding more systemic agents has failed to show a clear benefit in survival and is associated with unacceptable toxicity. This phase II, dose-finding, open label trial will enrol women with newly diagnosed EOC and randomize them to receive one of 3 doses of a LMWH dalteparin in conjunction with standard adjuvant taxane- and platinum-based chemotherapy. The primary outcome is disease response, measured according to Gynaecologic Cancer Intergroup (GCIG) Cancer Antigen (CA)-125 response criteria. Secondary outcomes include symptomatic venous thromboembolism, bleeding, and compliance. The dose of dalteparin associated with the best response will be tested further in a phase III randomized clinical trial in the same patient population.


Options:
A: efficacy: progression-free survival in months (measurements of the size of the effect will be done using the Kaplan Meier method and the difference between the means of this time) (efficacy); safety: will be the incidence, during randomized treatment period (from day 1 to the last day of treatment + 7 days), of major bleedings. (safety)
B: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death (From randomization up to 3 days after last study drug injection); Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function) (From randomization up to 3 days after last study drug injection)
C: disease response (up to day 1 of cycle 6)
D: Progression free survival (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized Study of Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)
Brief Summary: Epithelial ovarian carcinoma (EOC) is the 5th leading cause of death among women. Long-term survival is poor for the majority of women with EOC because many present with advanced disease. Chemotherapy and cytoreductive surgery produces a 50% - 60% response rate but relapse is not uncommon. Adding more systemic agents has failed to show a clear benefit in survival and is associated with unacceptable toxicity. This phase II, dose-finding, open label trial will enrol women with newly diagnosed EOC and randomize them to receive one of 3 doses of a LMWH dalteparin in conjunction with standard adjuvant taxane- and platinum-based chemotherapy. The primary outcome is disease response, measured according to Gynaecologic Cancer Intergroup (GCIG) Cancer Antigen (CA)-125 response criteria. Secondary outcomes include symptomatic venous thromboembolism, bleeding, and compliance. The dose of dalteparin associated with the best response will be tested further in a phase III randomized clinical trial in the same patient population.


Options:
A: disease response (up to day 1 of cycle 6)
B: Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding (From first dose to 2 days following last dose of study drug)
C: DVT/TVE event rate (After 12 events and after 24 events or after 540 pts recruited)
D: Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy (Events occurring during the four months of treatment plus 10 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Ventral Incisional Hernia Repair: Comparison Of Laparoscopic and Open Repair With Mesh
Brief Summary: The purpose of this research is to compare open ventral incisional hernia repair to the laparoscopic repair with respect to complications, recurrence, pain, return to normal activities of daily living, and return to work.


Options:
A: Overall complication rates at eight weeks and the odds of complications, adjusted for study site, body mass index, and hernia type (Eight (8) weeks post-operatively)
B: Assessment of postoperative pain (one year)
C: Postoperative pain VAS 0-100 mm (1 year)
D: Pain (1 measurement, 2nd postoperative day)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes Who Are Not Achieving Glycemic Targets
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes who are not achieving glycemic targets.


Options:
A: Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF]) (Baseline to Week 24)
B: To evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes. (16 Weeks)
C: Time to the Composite of All Cause Mortality, Non-Fatal Myocardial Infarction, Stroke, Acute Coronary Syndrome, Major Leg Amputation, Cardiac Intervention, Bypass Surgery or Leg Revascularization. (At First Occurrence)
D: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 104-Week, Open-label, Multi-centre, Phase IIIb Study Evaluating the Effect of Treatment With Rosuvastatin 40 mg on Atherosclerotic Disease as Measured by Intravascular Ultrasound and Quantitative Coronary Angiography in Subjects Undergoing Coronary Angiography Who Have Coronary Artery Disease
Brief Summary: The purpose of this study is to see if 40 mg of rosuvastatin taken daily will reduce the atherosclerosis (fatty deposits) in your arteries


Options:
A: plasma troponin T level (within the first 7 days after surgery)
B: to evaluate whether 2 years of treatment with 40 mg rosuvastatin results in regression of coronary artery atheroma burden via the total atheroma volume in the most diseased segment or the percent atheroma volume, as measured by IVUS
C: Number of Participants With Acute Kidney Injury (postoperative day 2); Number of Participants With Delirium (while in ICU (about 2 days))
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: A Study to Evaluate the Use of Rosuvastatin in Subjects On Regular Haemodialysis: an Assessment of Survival and Cardiovascular Events (AURORA). A Double Blind, Randomised, Phase 3b, Parallel-group Study to Compare the Effects of Rosuvastatin With Placebo on Assessment of Survival & Cardiovascular Events When Given to Subjects With End-stage Renal Failure on Chronic Haemodialysis Treatment
Brief Summary: The purpose of this study is to see if rosuvastatin helps to reduce the number of heart attacks, strokes and cardiovascular deaths in patients undergoing haemodialysis.


Options:
A: Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death) (Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years)
B: a composite of mortality with the change over 12 months in left ventricular mass (12 months); a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite. (12 months)
C: all cause mortality (entire follow up (until dead or end of study, 1-7 years))
D: N-balances (20 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Comparison of 12-week Treatment of Two Doses (5 Mcg and 10 Mcg) of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) i
Brief Summary: The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the safety of tiotropium inhalation solution delivered by the Respimat to placebo and ipratropium bromide MDI.


Options:
A: Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean (From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal)
B: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337 (Baseline and Day 337); Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (During actual study treatment period (planned Day 1 to Day 337))
C: Trough FEV1 (L) at 28 Weeks on Treatment (Week 28); Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment (Week 12)
D: Trough FEV1 response after 12 weeks of treatment. (after 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Comparison of 12-week Treatment of Two Doses (5 Mcg and 10 Mcg) of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) i
Brief Summary: The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the safety of tiotropium inhalation solution delivered by the Respimat to placebo and ipratropium bromide MDI.


Options:
A: Trough FEV1 response after 12 weeks of treatment. (after 12 weeks)
B: Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment. (Day 15)
C: Trough FEV1 response (after 12 weeks)
D: Change from baseline in trough FEV1 (Forced expiratory volume in one second) (after 12 weeks); Change from baseline in FEV1 2 hours post inhalation (after 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study Evaluating Acetaminophen Extended Release (3900 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee.
Brief Summary: The purpose of this study is to evaluate acetaminophen extended release (3900 mg/day) compared to placebo for safety and effectiveness in the relief of signs and symptoms of osteoarthritis of the hip or knee over 12 weeks


Options:
A: OA pain intensity in target hand at Week 4 and 6; Total AUSCAN score in target hand at Week 4 and 6; Global rating of disease activity by patient at Week 4 and 6
B: Average change from baseline through Week 12 for WOMAC pain subscale score. Average change from baseline through Week 12 for WOMAC physical function subscale score. Subject's average global assessment of response to therapy through Week 12.
C: Sum of Pain Intensity Difference (SPID) at Hour 48 (Hour 48)
D: Change From Baseline in KOOS4 (Knee Injury and Osteoarthritis Outcome Score) (Primary: 12months.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Testosterone Replacement for Older Men With Sarcopenia
Brief Summary: The purpose of this study is to determine whether testosterone replacement in older men with low testosterone levels will increase muscle strength, improve physical performance and overall sense of well being, and reduce fatigue.


Options:
A: Changes in Physical Performance Measured by an Exercise Testing Regimen (baseline and 6 months)
B: Body Composition at the End of Each Study Phase (end of each study phase: Day 11 for Phase 1, Day 39 for Phase 2, up to Day 85 for Phase 3)
C: Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF) (Week 0, week 8, week 11, week 14)
D: Insulin Resistance (40 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Double Dummy, Parallel Group, Active-Controlled Study To Evaluate The Effectiveness Of Morning Versus Evening Doses Of 320 Mg Valsartan Versus 40 Mg Lisinopril On The 24 Hour Blood Pressure Profile In Patients With Hypertension And Non-Insulin Dependent Diabetes
Brief Summary: A study comparing the antihypertensives Valsartan and Lisinporil when doses are in the morning and comparing a morning dose of Valsartan with an evening dose.


Options:
A: Average 24 hour blood pressure less than 130/80 mmHg after 26 weeks; Change from baseline in systolic 24 hour blood pressure after 12 weeks
B: To evaluate the impact of circadian time of treatment in cardiovascular, cerebrovascular, metabolic, and renal risk assessment. (Yearly evaluation for at least ten years)
C: coronary mortality (ICD 10 I20-I25) (up to 15 years from entry into cohort)
D: To demonstrate the efficacy of bedtime administration of ramipril in subjects with essential hypertension by testing the hypothesis of superior nocturnal SBP lowering in ABPM measurements compared with ramipril administered on awakening (Three months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of High-volume Veno-venous Continuous Hemofiltration in the Early Management of Septic Shock Patients With Acute Renal Failure
Brief Summary: Sepsis and septic shock are still important causes of mortality in intensive care medicine. Renal replacement therapy by standard volume haemofiltration is currently used, but a higher-volume haemofiltration may improve the prognosis. The study is a prospective randomized multicenter trial comparing two treatments in patients suffering from septic shock complicated with acute renal failure admitted to ICU. One group will be treated by early high volume haemofiltration (70 ml/kg/h) and the second group by standard volume haemofiltration (35 ml/kg/h). The main outcome will be one-month mortality.


Options:
A: 60-day All-cause Mortality (60 days)
B: all-cause mortality. (28-day)
C: Death from all causes at 90 days after randomisation. (Within 90 days after randomisation)
D: Death from all causes at 30 days after randomisation (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of High-volume Veno-venous Continuous Hemofiltration in the Early Management of Septic Shock Patients With Acute Renal Failure
Brief Summary: Sepsis and septic shock are still important causes of mortality in intensive care medicine. Renal replacement therapy by standard volume haemofiltration is currently used, but a higher-volume haemofiltration may improve the prognosis. The study is a prospective randomized multicenter trial comparing two treatments in patients suffering from septic shock complicated with acute renal failure admitted to ICU. One group will be treated by early high volume haemofiltration (70 ml/kg/h) and the second group by standard volume haemofiltration (35 ml/kg/h). The main outcome will be one-month mortality.


Options:
A: Death from all causes at 30 days after randomisation (30 days)
B: all-cause mortality. (28-day)
C: 60-day All-cause Mortality (60 days)
D: Death from all causes at 90 days after randomisation. (Within 90 days after randomisation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Two-arm, Multicenter, Randomized Trial to Evaluate Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Recent Secondary Progressive Multiple Sclerosis: P.R.OM.E.S.S Study
Brief Summary: Preliminary not-controlled clinical studies of the efficacy of monthly intravenous cyclophosphamide administration in secondary progressive multiple sclerosis reported encouraging results, but no randomized controlled trial has been conducted so far. The primary objective of this trial is to evaluate the efficacy of IV cyclophosphamide as compared to IV methylprednisolone administered every 4 weeks during 1 year and every 8 weeks during 1 year, on the delay to confirmed disability deterioration as assessed by the Expanded Disability Status Scale (EDSS) in patients with secondary progressive multiple sclerosis. The secondary objectives are to evaluate safety, tolerability and efficacy at 2 years on the Multiple Sclerosis Functional Composite (MSFC), the percentage of patients with disability deterioration (EDSS) and the number of relapses. An intention-to-treat statistical analysis will be carried out.


Options:
A: Analysis of Changes in CSF CXCL13 Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration (3 months); Analysis of Changes in CSF BAFF Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration (3 months)
B: Part 1: Percentage of Participants With Confirmed Progression of Disability in One or More of the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), or 9-Hole Peg Test (9HPT) (Up to 96 weeks (2 years)); Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (218 weeks)
C: Small effect of an intervention (immediate after completion of study); Moderate effect of an intervention (immediate after completion of study); Large effect of an intervention (immediate after completion of study)
D: Delay to disability deterioration as assessed by the Expanded Disability Status Scale (EDSS: 0.5 or 1 point increase, depending on baseline score) (every 4 weeks for one year, then every 8 weeks for one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Two-arm, Multicenter, Randomized Trial to Evaluate Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Recent Secondary Progressive Multiple Sclerosis: P.R.OM.E.S.S Study
Brief Summary: Preliminary not-controlled clinical studies of the efficacy of monthly intravenous cyclophosphamide administration in secondary progressive multiple sclerosis reported encouraging results, but no randomized controlled trial has been conducted so far. The primary objective of this trial is to evaluate the efficacy of IV cyclophosphamide as compared to IV methylprednisolone administered every 4 weeks during 1 year and every 8 weeks during 1 year, on the delay to confirmed disability deterioration as assessed by the Expanded Disability Status Scale (EDSS) in patients with secondary progressive multiple sclerosis. The secondary objectives are to evaluate safety, tolerability and efficacy at 2 years on the Multiple Sclerosis Functional Composite (MSFC), the percentage of patients with disability deterioration (EDSS) and the number of relapses. An intention-to-treat statistical analysis will be carried out.


Options:
A: Annualized Relapse Rate (2 years)
B: Total number of new Gadolinium-enhancing lesions over 4 scans at Weeks 12, 16, 20, and 24. (Part I (Week 24)); Incidence of treatment-emergent adverse events and serious adverse events (Part II (Up to 4.5 years))
C: To investigate the efficacy of rituximab compared with placebo, as measured by MRI scans of the brain for the total number of lesions observed, and to evaluate the safety and tolerability of rituximab in subjects with RRMS.
D: Delay to disability deterioration as assessed by the Expanded Disability Status Scale (EDSS: 0.5 or 1 point increase, depending on baseline score) (every 4 weeks for one year, then every 8 weeks for one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: : An Open-Label, Randomised, Multi-Centre, Phase IIIb/IV, Parallel Group Study to Compare the Efficacy and Safety of Rosuvastatin and Atorvastatin in Subjects With Type IIa and IIb Hypercholesterolaemia (DISCOVERY)
Brief Summary: This clinical trial is being performed to investigate the effect of 12 weeks treatment with rosuvastatin and atorvastatin in bringing subjects to their established EAS LDL-C target goal.


Options:
A: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment (Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward))
B: The primary objective of the study is to compare the efficacy of rosuvastatin 10 mg with atorvastatin 10 mg by assessment of the percentage of subjects who reach EAS LDL-C target goals after 12 weeks of therapy
C: LDL-C lowering efficacy after 6 weeks.
D: Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8) (8 weeks)

Answer: B