TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Prospective, Placebo-controlled, Multi-center Study to Test the Efficacy of n-3 PUFA for the Maintenance of Normal Sinus Rhythm in Patients With Persistent Atrial Fibrillation
Brief Summary: To demonstrate that in patients with persistent atrial fibrillation who had recovered normal sinus rhythm and treated with the best recommended therapies, the addition of 1 gram / daily of n-3 PUFA is superior to the corresponding placebo for the maintenance of normal sinus rhythm at one year of follow up.


Options:
A: 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)
B: Cumulative incidence of Major depressive Disorder (12 months)
C: Inflammatory Response (1 year)
D: Survival free of atrial fibrillation (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Prospective, Placebo-controlled, Multi-center Study to Test the Efficacy of n-3 PUFA for the Maintenance of Normal Sinus Rhythm in Patients With Persistent Atrial Fibrillation
Brief Summary: To demonstrate that in patients with persistent atrial fibrillation who had recovered normal sinus rhythm and treated with the best recommended therapies, the addition of 1 gram / daily of n-3 PUFA is superior to the corresponding placebo for the maintenance of normal sinus rhythm at one year of follow up.


Options:
A: Survival free of atrial fibrillation (12 months)
B: 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)
C: Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect (baseline and 12 weeks)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Prospective, Placebo-controlled, Multi-center Study to Test the Efficacy of n-3 PUFA for the Maintenance of Normal Sinus Rhythm in Patients With Persistent Atrial Fibrillation
Brief Summary: To demonstrate that in patients with persistent atrial fibrillation who had recovered normal sinus rhythm and treated with the best recommended therapies, the addition of 1 gram / daily of n-3 PUFA is superior to the corresponding placebo for the maintenance of normal sinus rhythm at one year of follow up.


Options:
A: Percentage of Liver Fat (Baseline and 18 months); Liver Fibrosis Score (Baseline and 18 months); NAFLD Fibrosis Score (Baseline and 18 months)
B: 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)
C: Survival free of atrial fibrillation (12 months)
D: Rate of Change on the ADAS-Cog 11. (Baseline, 6, 12, 18 months); Rate of Change on CDR-SOB (18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Prospective, Placebo-controlled, Multi-center Study to Test the Efficacy of n-3 PUFA for the Maintenance of Normal Sinus Rhythm in Patients With Persistent Atrial Fibrillation
Brief Summary: To demonstrate that in patients with persistent atrial fibrillation who had recovered normal sinus rhythm and treated with the best recommended therapies, the addition of 1 gram / daily of n-3 PUFA is superior to the corresponding placebo for the maintenance of normal sinus rhythm at one year of follow up.


Options:
A: Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality
B: Differences in mean systolic blood pressure in the two diet/sport arms (4 months)
C: Survival free of atrial fibrillation (12 months)
D: cardiovascular deaths and hospitalization for cardiovascular causes (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Prospective, Placebo-controlled, Multi-center Study to Test the Efficacy of n-3 PUFA for the Maintenance of Normal Sinus Rhythm in Patients With Persistent Atrial Fibrillation
Brief Summary: To demonstrate that in patients with persistent atrial fibrillation who had recovered normal sinus rhythm and treated with the best recommended therapies, the addition of 1 gram / daily of n-3 PUFA is superior to the corresponding placebo for the maintenance of normal sinus rhythm at one year of follow up.


Options:
A: Survival free of atrial fibrillation (12 months)
B: 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.)
C: Change in cognitive function at 36 months determined by a composite score (sum of Z-score of 4 tests: FCRST test (free recall + total recall) score, MMSE orientation score, Wais-R score (Digit Substitution Symbol test), and the Category Naming Test score (Baseline, 6, 12, 24, 36 months)
D: Number of Participants With First Occurrence of Any Serious Vascular Event (SVE) (Randomized treatment phase during a mean of 7.4 years); Number of Participants With First Occurrence of Any Major Bleed (Aspirin Comparison Only) (Randomized treatment phase during a mean of 7.4 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial on the Diaphragm Training With Threshold for Patient With Post-Cardiac Surgery Diaphragmatic Paralysis
Brief Summary: Diaphragm paralysis is a possible complication of cardiac surgery. The spontaneous recovery of the diaphragm mobility is slow and partial or absent in most cases. We hypothesize that a program of diaphragm muscle training by means of the Threshold variable resistance device could improve the rate of complete diaphragm mobility recovery in a shorter time period. Patient with post-cardiosurgical diaphragm paralysis will be random assigned to the specific training protocol or to a generic non-training physical activity.


Options:
A: chest x-ray mobility of the diaphragm (6 and 12 months)
B: Change of peak oxygen uptake (Baseline to 8 weeks)
C: Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study (Randomized Controlled Trial - 24 months Continued Access Study - 12 months)
D: Improvement in mean daily number of steps (Improvement between baseline (during the last preoperative month) and first 3 (and 12) months after discharge.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Should Intervention Through RADial Approach be Denied to Patients With Negative Allen's Test Results?
Brief Summary: The study will evaluate the feasibility and safety of radial approach in patients undergoing coronary catheterisation without any restrictions based on the results of Allen's test.


Options:
A: Success rate of arterial or femoral catheter placement (1 day)
B: elevation of thumb capillary lactate after the procedure (30 days)
C: Incidence of major vascular complications (up to 30 days post-procedure)
D: Time to Successful Radial Arterial Catheterization (up to 5 minutes)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: AFX01-14: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.


Options:
A: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline to Weeks 29-36)
B: Local pain due to s.c. injection (by VAS). (After each injection)
C: Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period (Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36))
D: hemoglobin variability (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: AFX01-14: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.


Options:
A: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline and Weeks 25-36)
B: Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen (From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21))
C: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline and Weeks 25-36)
D: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline to Weeks 29-36)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Mucosal Decontamination With Chlorhexidine for Prevention of Ventilator Associated Pneumonia in Children - A Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine if oral mucosal application of chlorhexidine gel will prevent the development of ventilator associated pneumonia in children.


Options:
A: Prevention of ventilator-associated pneumonia (60 days)
B: Nosocomial Infection
C: Feasibility (duration of study, for up to 30 months); Duration of Mechanical Ventilation (3 days)
D: Occurrence of ventilator associated pneumonia as defined by CDC diagnostic criteria (21 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Mucosal Decontamination With Chlorhexidine for Prevention of Ventilator Associated Pneumonia in Children - A Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine if oral mucosal application of chlorhexidine gel will prevent the development of ventilator associated pneumonia in children.


Options:
A: Occurrence of ventilator associated pneumonia as defined by CDC diagnostic criteria (21 days)
B: Rate of ventilator associated pneumonia (30 days)
C: Ventilator associated pneumonia (48 hours after tracheal intubation)
D: Feasibility (duration of study, for up to 30 months); Duration of Mechanical Ventilation (3 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: AFX01-12: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin Alfa
Brief Summary: The purpose of the study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.


Options:
A: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline and Weeks 29-36)
B: Local pain due to s.c. injection (by VAS). (After each injection)
C: Median Time to First Cardiovascular Event (Up to 4 years)
D: Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA) (Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first); Time to All-cause Mortality or End Stage Renal Disease (ESRD) (Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: AFX01-12: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin Alfa
Brief Summary: The purpose of the study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.


Options:
A: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline and Weeks 25-36)
B: Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen (From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21))
C: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline and Weeks 29-36)
D: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline to Weeks 29-36)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial: A Randomized Trial of Sacrospinous Ligament Fixation (SSLF) Versus Uterosacral Ligament Suspension (ULS) With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training
Brief Summary: Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Pelvic organ prolapse often involves a combination of support defects involving the anterior, posterior and/or apical vaginal segments. While the anterior vaginal wall is the segment most likely to demonstrate recurrent prolapse after reconstructive surgery, reoperations are highest among those who require apical suspension procedures with or without repair of other vaginal segments (12%-33%). Despite the substantial health impact, there is a paucity of high quality evidence to support different practices in the management of prolapse, particularly surgery. Thus, the objectives of the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) Trial are:

1. to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS); and
2. to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence.


Options:
A: Surgical Success (24 months); Anatomic Failure (24 months); Urinary Distress Inventory at 6 Months (6 months)
B: Comparison of surgical time (Up to four months (2 weeks before surgery until 3 months post-surgery).)
C: anatomic outcomes,graft-related complications between the two materials, changes in pelvic organ prolapse-related quality of life,subjective changes in sexual function,changes in bowel function and the prolapse related pain present after sacral colpopexy (One year)
D: Mesh Attachment Time (Assessed at one time point, during the participants surgery.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial: A Randomized Trial of Sacrospinous Ligament Fixation (SSLF) Versus Uterosacral Ligament Suspension (ULS) With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training
Brief Summary: Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Pelvic organ prolapse often involves a combination of support defects involving the anterior, posterior and/or apical vaginal segments. While the anterior vaginal wall is the segment most likely to demonstrate recurrent prolapse after reconstructive surgery, reoperations are highest among those who require apical suspension procedures with or without repair of other vaginal segments (12%-33%). Despite the substantial health impact, there is a paucity of high quality evidence to support different practices in the management of prolapse, particularly surgery. Thus, the objectives of the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) Trial are:

1. to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS); and
2. to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence.


Options:
A: Pelvic floor muscle changes (3 months after the begining of treatment)
B: Urinary Tract Infections (three weeks post-operative)
C: Surgical Success (24 months); Anatomic Failure (24 months); Urinary Distress Inventory at 6 Months (6 months)
D: Surgeon assessment of bowel preparation (Will be evaluated at 1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial: A Randomized Trial of Sacrospinous Ligament Fixation (SSLF) Versus Uterosacral Ligament Suspension (ULS) With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training
Brief Summary: Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Pelvic organ prolapse often involves a combination of support defects involving the anterior, posterior and/or apical vaginal segments. While the anterior vaginal wall is the segment most likely to demonstrate recurrent prolapse after reconstructive surgery, reoperations are highest among those who require apical suspension procedures with or without repair of other vaginal segments (12%-33%). Despite the substantial health impact, there is a paucity of high quality evidence to support different practices in the management of prolapse, particularly surgery. Thus, the objectives of the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) Trial are:

1. to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS); and
2. to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence.


Options:
A: Stress urinary continence (3 months)
B: Number of Participants With Anatomic Cure at 3 Years (3 year)
C: anatomic outcomes,graft-related complications between the two materials, changes in pelvic organ prolapse-related quality of life,subjective changes in sexual function,changes in bowel function and the prolapse related pain present after sacral colpopexy (One year)
D: Surgical Success (24 months); Anatomic Failure (24 months); Urinary Distress Inventory at 6 Months (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Pioglitazone on Insulin Resistance, Insulin Secretion and Atherosclerosis in Renal Allograft Recipients Without History of Diabetes
Brief Summary: The aim of this study was to evaluate the effect of pioglitazone treatment on insulin secretion, insulin resistance, and progression of atherosclerosis in renal allograft recipients without preoperative history of diabetes.


Options:
A: Insulin Resistance and Insulin Secretion (1 year)
B: Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular (CV) Death (Up to 4.6 years)
C: Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) (From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years))
D: Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (Time from randomisation up to end of follow-up (scheduled at week 109))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Pioglitazone on Insulin Resistance, Insulin Secretion and Atherosclerosis in Renal Allograft Recipients Without History of Diabetes
Brief Summary: The aim of this study was to evaluate the effect of pioglitazone treatment on insulin secretion, insulin resistance, and progression of atherosclerosis in renal allograft recipients without preoperative history of diabetes.


Options:
A: To assess whether monotherapy with Vildagliptin improve glycemic control in kidney transplanted patients with newly diagnosed NODAT as judged in OGTT 3 months after treatment start compared to placebo. (3 months)
B: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)
C: Insulin Resistance and Insulin Secretion (1 year)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Avastin and Chemotherapy Followed by Avastin Alone or in Combination With Tarceva for the Treatment of Metastatic Colorectal Cancer.
Brief Summary: Chemotherapy and bevacizumab is given for 4 months. Patients who have not progressed will continue with maintenance treatment with either bevacizumab (Avastin) alone, or bevacizumab and erlotinib (Tarceva).


Options:
A: the rate of patients converted to resection for liver metastases (3 years)
B: To demonstrate that maintenance treatment with bevacizumab + erlotinib following first line chemo- and anti-angiogenetic therapy results in a significant increase in progression free survival (PFS) compared to treatment with only bevacizumab. (3 years)
C: progression-free survival (3 years)
D: progression free survival (study duration); toxicity (study duration)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Open Label, Randomized Trial to Investigate the Dose-Response Relationship of a Single Injection of Org 36286 (Corifollitropin Alfa) to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or ICSI.
Brief Summary: The primary objective of this trial is to investigate the dose -response relationship of a single injection of Org 38286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyperstimulation (COH) protocol for IVF or ICSI.


Options:
A: Frequency of Moderate to Severe OHSS. (From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test)
B: Number of cumulus-oocyte-complexes retrieved (1 cycle)
C: Number of Bleeding Episodes (Up to year)
D: Ongoing pregnancy rate (12 weeks)

Answer: B