TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: GOG-0262: A Phase III Trial of Every-3-Weeks Paclitaxel Versus Dose Dense Weekly Paclitaxel in Combination With Carboplatin With or Without Concurrent and Consolidation Bevacizumab (NSC #704865) in the Treatment of Primary Stage II, III or IV Epithelial Ovarian, Peritoneal or Fallopian Tube Cancer and ACRIN 6695: Perfusion CT Imaging to Evaluate Treatment Response in Patients Participating in GOG-0262
Brief Summary: This phase III clinical trial studies two different dose schedules of paclitaxel to see how well they work in combination with carboplatin with or without bevacizumab in treating patients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab is a type of drug called a monoclonal antibody and blocks tumor growth by stopping the growth of blood vessels that tumors need to grow. It is not yet known whether giving paclitaxel with combination chemotherapy once every three weeks is more effective than giving paclitaxel once a week in treating patients with ovarian, primary peritoneal, or fallopian tube cancer.


Options:
A: Progression Free Survival (For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, Up to 5 years)
B: Progression-Free Survival (8 Months on average)
C: Progression-Free Survival (The timeframe is from enrollment onto the study up to 3 years following enrollment.)
D: Progression free survival (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomised, Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 10773 Compared to Glimepiride Administered Orally During 104 Weeks With a 104 Week Extension Period in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Metformin Treatment
Brief Summary: This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.


Options:
A: Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 (Baseline and Week 52)
B: Change in HbA1c From Baseline to Week 52 (Day 1 (Baseline) and Week 52)
C: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26)
D: The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment. (Baseline and 104 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Placebo-Controlled Crossover Trial of Levetiracetam on Ethanol Intake
Brief Summary: The overall goals of this study are to (1) expand knowledge about interactions of levetiracetam with alcohol by assessing the effects of levetiracetam compared to placebo in moderate and heavy social alcohol users and (2) to test the AccuswayTM platform as a tool to measure postural control (which has been used as a marker of intoxication) and the effects of levetiracetam on postural control.


Options:
A: Time to Relapse to Drinking (16 weeks)
B: Percent days abstinent; Time to relapse to heavy drinking
C: Standard Alcoholic Drinks Per Treatment Period (During each 14 day treatment period)
D: The change in percentage of heavy drinking days (5 or more standard drinking units per day for men and 4 or more standard drinking units per day for women) from baseline at 12 weeks or final visit.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Oral CEM-101 Compared to Oral Levofloxacin in the Treatment of Patients With Community-Acquired Bacterial Pneumonia
Brief Summary: Study to evaluate the safety and efficacy of oral CEM-101 compared to oral Levofloxacin in the treatment of adults with moderate to moderately severe community-acquired bacterial pneumonia.


Options:
A: Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population (8-15 days after last dose of study drug); Clinical Cure Rate for Ceftaroline Compared With That for Ceftriaxone at TOC in the Clinically Evaluable (CE) Population (8-15 days after last dose of study drug)
B: Clinical Success in the Intent to Treat (ITT) population at the Treatment of Cure (TOC) visit (5 to 10 days after the last dose of study drug); Clinical Success in the Clinically Evaluable (CE) population at the Treatment of Cure (TOC) Visit (5 to 10 days after the last dose of study drug)
C: Antibiotic treatment prescriped at initial visit (Within 2 days of initial visit)
D: Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations (8 to 15 days after last dose of study drug); Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (TOC) in the Clinically Evaluable (CE) Population (8-15 days after last dose of study drug)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: BIOTRONIKS-Safety and Clinical Performance Of the First Drug-Eluting Generation Absorbable Metal Stent In Patients With de Novo Lesions in NatiVE Coronary Arteries (BIOSOLVE - I)
Brief Summary: First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety


Options:
A: First occurrence of all-cause mortality and non-fatal myocardial infarction (composite) (After five years of follow-up)
B: Composite of death, myocardial infarction or stroke occurring in the time window from 31 days and up to 24 months after intervention. (24 months)
C: Target Lesion Failure (6 and 12 months)
D: Non inferiority OCT Number of uncovered Stent struts for Endeavor drug eluting stent vs Driver BMSbare metal stent (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2 Clinical Trial of Sildenafil for Cardiac Dysfunction in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy
Brief Summary: This study, supported by Charley's Fund, Inc., is being done to determine if the drug Revatio®(also known as Sildenafil), as compared to placebo (an inactive substance that looks like the study drug, but contains no medication), improves heart function in people with Duchenne Muscular Dystrophy and Becker Muscular Dystrophy (DBMD).

In people with DBMD, dystrophin is not present or lacking in heart and muscle. This is associated with abnormalities in an enzyme called "neuronal nitric oxide synthase" or nNOS, and leads to decreases in "cyclic GMP," which is necessary for proper function of those muscles. Revatio blocks an enzyme called phosphodiesterase 5 (PDE5), and helps to restore the normal amounts of cyclic GMP. The purpose of this research is to determine if Revatio is safe for people with DBMD and if it can improve heart function.

Hypothesis : PDE5 inhibition, with the use of Revatio, will improve cardiac function in patients with DBMD.


Options:
A: Change in Cardiac Left Ventricular End-systolic Volume (LVESV) by Cardiac Magnetic Resonance (CMR) Imaging. (6 months compared to baseline)
B: To assess the efficacy of 2 different dosing regimens of subcutaneous GSK2402968 administered over 24 weeks in ambulant subjects with DMD (48 weeks)
C: Number of Surviving Participants That Completed the Study (5 Years); Six Minute Walk Test (6 Months); Cardiopulmonary Exercise Testing (6 Months); Kansas City Cardiomyopathy Questionnaire (KCCQ) (6 Months)
D: 12-month Change in Myocardial Strain (baseline and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: AMES + Brain Stimulation: Treatment for Profound Plegia in Stroke
Brief Summary: The procedure involves: (1) assisted hand movement by a mechanical device, (2) mechanical vibration applied to the surface of the forearm, and (3) stimulation of the brain with either transcranial magnetic stimulation (TMS) or transcortical direct current stimulation (DCS). These 3 components of the procedure are carried out simultaneously. Each subject will be evaluated pre- and post-treatment with several clinical tests of functional movement. The hypotheses of this project are that the AMES+rTMS and AMES+tDCS procedures are safe and will enable most of the stroke patients to recover finger extension.


Options:
A: Change in Upper Limb function (Baseline and posttest (an average of 2 weeks from baseline))
B: Maximum volitional EMG in the extensor digitorum and the finger flexors (Following each treatment with the AMES device)
C: Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months); Rivermead Motor Assessment Battery (RMAB) (reporting a change on motricity of gross function, arm, leg and trunk at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months); Tinetti Test (reporting a change on balance and gait tasks at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months)
D: Timed-up-and-go test with and without dual-task (week 0); Timed-up-and-go test with and without dual-task (week 8); Timed-up-and-go test with and without dual-task (week 16)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: AMES + Brain Stimulation: Treatment for Profound Plegia in Stroke
Brief Summary: The procedure involves: (1) assisted hand movement by a mechanical device, (2) mechanical vibration applied to the surface of the forearm, and (3) stimulation of the brain with either transcranial magnetic stimulation (TMS) or transcortical direct current stimulation (DCS). These 3 components of the procedure are carried out simultaneously. Each subject will be evaluated pre- and post-treatment with several clinical tests of functional movement. The hypotheses of this project are that the AMES+rTMS and AMES+tDCS procedures are safe and will enable most of the stroke patients to recover finger extension.


Options:
A: Total score in a neglect test battery (Change from baseline at Day 8 (post-treatment)); Functional independence score (Change from baseline at Day 8 (post-treatment))
B: Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months (Baseline, 1,3 and 6 months); Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months (Baseline, 1,3 and 6 months); Change From Baseline in Picture Identification Task at 1,3, and 6 Months (Baseline, 1,3 and 6 months)
C: Fugl-Meyer Assessment Upper Extremity (6 weeks)
D: Maximum volitional EMG in the extensor digitorum and the finger flexors (Following each treatment with the AMES device)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D and Omega-3 Trial (VITAL)
Brief Summary: The VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. The 5-year intervention phase (study pill-taking, median 5.3 years) has ended; post-intervention observational follow-up of study participants is ongoing.


Options:
A: Development of Advanced AMD in People at Moderate to High Risk for Progression. (5 years of follow-up)
B: Number of Participants With Invasive Cancer of Any Type (5 years); Number of Participants With a Major Cardiovascular Event (5 years)
C: Survival free of atrial fibrillation (12 months)
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: Vitamin D and Omega-3 Trial (VITAL)
Brief Summary: The VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. The 5-year intervention phase (study pill-taking, median 5.3 years) has ended; post-intervention observational follow-up of study participants is ongoing.


Options:
A: Number of Participants With Invasive Cancer of Any Type (5 years); Number of Participants With a Major Cardiovascular Event (5 years)
B: Atrial tachycardia and atrial fibrillation burden (18 months)
C: Percentage of Liver Fat (Baseline and 18 months); Liver Fibrosis Score (Baseline and 18 months); NAFLD Fibrosis Score (Baseline and 18 months)
D: cardiovascular deaths and hospitalization for cardiovascular causes (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D and Omega-3 Trial (VITAL)
Brief Summary: The VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. The 5-year intervention phase (study pill-taking, median 5.3 years) has ended; post-intervention observational follow-up of study participants is ongoing.


Options:
A: Number of Participants With Invasive Cancer of Any Type (5 years); Number of Participants With a Major Cardiovascular Event (5 years)
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: Optical density of macular pigment (12 months)
D: Time to first relapse of atrial fibrillation (After a three weeks loading phase)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D and Omega-3 Trial (VITAL)
Brief Summary: The VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. The 5-year intervention phase (study pill-taking, median 5.3 years) has ended; post-intervention observational follow-up of study participants is ongoing.


Options:
A: Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions (1 year)
B: Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies (12 months); Alanine Transaminase (ALT) Levels (3 month endpoint); Alanine Transaminase (ALT) Levels (6 months)
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 Invasive Cancer of Any Type (5 years); Number of Participants With a Major Cardiovascular Event (5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D and Omega-3 Trial (VITAL)
Brief Summary: The VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. The 5-year intervention phase (study pill-taking, median 5.3 years) has ended; post-intervention observational follow-up of study participants is ongoing.


Options:
A: Number of Participants With Invasive Cancer of Any Type (5 years); Number of Participants With a Major Cardiovascular Event (5 years)
B: Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months (12 months)
C: Changes in the Interleukin-6 Level Between Groups (Changes from baseline to month 12); Number of Participants Experiencing Major Mobility Disability (12 months)
D: Sudden cardiac death (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessing The Effect Of Educational Intervention Based On Supportive Behaviour Leadership Model On Head Nurses' Performance In TUMS Hospitals: RCT In 2010
Brief Summary: Hypothesis Applying Educational Intervention Based On Supportive behaviour Leadership Model has positive effect on Head Nurses' performance in TUMS Hospitals.

Specific objectives

1. Assessing the impact of supportive leadership behaviour on individual head nurse
2. Assessing the impact of supportive leadership behaviour on nursing team
3. Assessing the impact of supportive leadership behaviour on TUMS organizational success, especially in cross-functional environments
4. Develop a specific plan for effectively supportive leadership behaviour the efforts of others to sustain and encourage productive performance and employee satisfaction


Options:
A: Change in team cohesion (Change from baseline to 6 months)
B: Supportive leadership behaviour questionnaire for assessing head nurses performance (10 months)
C: Fraction of Pulseless Time With no Chest Compressions (From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes))
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Open-label, Randomized, 24 Months Follow-up, Two Arm Study to Compare the Efficacy of Everolimus in Improving the Cardiovascular Profile in a Regimen With Mycophenolic Acid vs. a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients.
Brief Summary: The objective of the study is to compare the cardiovascular profile of an everolimus and mycophenolic acid immunosuppressive regimen with a calcineurin inhibitor and mycophenolic acid regimen in maintenance renal transplant patients


Options:
A: incidence of CMV infection or disease (1 year)
B: Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis (12 months); Non-inferiority Analysis on Percentage of Participants With Composite Efficacy Endpoints (12 months)
C: Change From Baseline in Left Ventricular Mass Index (LVMI) (Baseline, Month 24)
D: To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR); Non-inferiority of the composite of graft loss and death at 52 weeks

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of 6-Day Oral TR-701 Free Acid and 10-Day Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Brief Summary: This is a randomized, double-blind, double dummy, multicenter Phase 3 study of oral TR-701 FA 200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults.

Approximately 75 to 100 sites globally will participate in this study. Patients with an ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be randomized 1:1 to study treatment


Options:
A: Clinical success at follow-up (six months)
B: Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population (14 - 28 days after last dose of study medication)
C: Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit (up to 6 weeks)
D: Early Clinical Response Rate (48-72 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Contraceptive Effectiveness in Obese Women
Brief Summary: The main hypothesis for this study is that increased Body Mass Index (BMI) alters oral contraceptive metabolism in a manner which results in decreased effectiveness in obese women.


Options:
A: insulin resistance (12 months)
B: Prostate-specific antigen (PSA) (3 months)
C: Assessment of acceptability of Implanon in comparison to the TCu380A IUD and the LNG-IUS (Participants will receive counseling before admission and at 12 months after)
D: LNG Steady State at Baseline and Then Post-randomization (baseline (2 months) and post-randomization (4 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Contraceptive Effectiveness in Obese Women
Brief Summary: The main hypothesis for this study is that increased Body Mass Index (BMI) alters oral contraceptive metabolism in a manner which results in decreased effectiveness in obese women.


Options:
A: Pearl Index up to 3 Years (Up to 3 years); Pearl Index for LCS16 up to 5 Years (Up to 5 years)
B: Pregnancy (AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year)
C: LNG Steady State at Baseline and Then Post-randomization (baseline (2 months) and post-randomization (4 months))
D: Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression. (Up to 8 biweekly visits from start of OCP therapy)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine
Brief Summary: This is a Phase III randomized multicenter double-blind, placebo controlled trial evaluating the safety and efficacy of paclitaxel plus ramucirumab (IMC-1211B) drug product (DP) compared to paclitaxel plus placebo.


Options:
A: overall survival (median)
B: Overall Survival Time (OS) (Randomization up to 27.5 months)
C: Number of Participants Experiencing Adverse Events (AEs) (Serious AEs: Up to 90 days after last dose of treatment (Up to 28 months); nonserious AEs: Up to 30 days after last dose of treatment (Up to 26 months) - through final analysis (FA) cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C)); Number of Participants Discontinuing From Study Treatment Due to an AE (Up to last dose of study treatment (Up to approximately 25 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C)); Overall Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Response Rate Based on Blinded Independent Central Radiology (BICR) Review (Cohorts A, B, C, and D) (Every 8 weeks until disease progression (Cohorts A, B, D: Up to ~ 35 months; Cohort C: Up to ~ 28 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, D) & 01 Sep 2015 (Cohort C)); Overall RECIST 1.1 Response Rate Based on BICR Review for Participants in Cohort B2 (Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016)
D: Recurrence of the original cancer (From the beginning to end of the study); Development of a new gastric cancer (From beginning to end of study); Death due to any cause (From the beginning to the end of study); Adverse events (From beginning to end of study); Clinical laboratory tests (From beginning to end of study)

Answer: B