TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, 3-Arm Parallel-Group, 2-Year (104-Week), Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 Compared With Glimepiride in the Treatment of Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled on Metformin Monotherapy
Brief Summary: The purpose of this study is to demonstrate the efficacy, safety, and tolerability of canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin.


Options:
A: Change in HbA1c From Baseline to Week 52 (Day 1 (Baseline) and Week 52)
B: Average Blood Glucose Over 6 Days (6 Days)
C: Major macrovascular events -a composite of non-fatal myocardial infarction, non-fatal stroke and death from any cardiovascular cause (based on investigator diagnosis) (2014); Death from any cause (2014)
D: Hemoglobin A1c (A1C) Changes From Baseline at Week 24 (Baseline, Week 24); A1C Changes From Baseline at Week 24 - Open Label Cohort (Baseline, Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14 - 21 Weeks LMP): A Randomized-controlled Double-blinded Trial
Brief Summary: The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 120 women in each country comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.


Options:
A: Preterm delivery (37 weeks of gestation) (6 mo. after end of recruitment)
B: Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention. (48 hours); Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus. (48 hours)
C: The chance of miscarriage before 20 weeks of gestation (At 20 weeks of gestation)
D: Change in subchorionic hematoma from baseline at 20 days and 40 days, assessed as %improvement/worsening by ultrasoud examination (T1 (20 days); T2 (40 days))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase 2/3 Study of Apatinib as Third Line Treatment in Patients With Metastatic Gastric Carcinoma
Brief Summary: Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.


Options:
A: Progression free survival (8 weeks)
B: 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)
C: response (WHO criteria) (staging every 8 weeks)
D: Progression-Free Survival (PFS) Determined by an Independent Review Facility (Tumor assessments every 9 weeks from randomization to IRF-determined PD or death from any cause, whichever occurred first, up to the primary completion date (up to 3 years, 3 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase 2/3 Study of Apatinib as Third Line Treatment in Patients With Metastatic Gastric Carcinoma
Brief Summary: Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.


Options:
A: Progression free survival (8 weeks)
B: The primary endpoint is the Progression-free survival (PFS) according to RECIST V1.1. (Average time period: up to one year (participants are followed until progression or death))
C: progression-free survival (every 8 weeks)
D: Time to Progression (every 8 weeks up to a maximum of 36 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-term, Randomized, Double-blind Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide at Two Dose Levels When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Brief Summary: The purpose of this extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.


Options:
A: Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1) (Change from baseline (Week 0) to Week 12); Part B: Morning Predose (Trough) FEV1 (Change from baseline (Week 0) to 52 Weeks)
B: Number of Par. With Chronic Obstructive Pulmonary Disease (COPD) EXs Requiring Hospitalization That Occurred >21 Days Post-discharge/Physician's Office Visit for a COPD EX Requiring Treatment With Oral Corticosteroids (OCSs) or OCSs and Antibiotics (ABs) (From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks); Number of Participants With the Indicated Number of EXs of COPD Requiring Hospitalization That Occurred More Than 21 Days Post-discharge or Physician's Office Visit for an EX of COPD Requiring Treatment With OCSs or OCSs and ABs (From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks); Number of EXs of COPD Requiring Hospitalization That Occurred More Than 21 Days Post-discharge or Physician's Office Visit for an EX of COPD Requiring Treatment With OCSs or OCSs and ABs (From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks)
C: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) (Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks)
D: The primary efficacy variable was forced expiratory volume in one second (FEV1). There were two co-primary endpoints: FEV1 area under the curve for the time period 0 to 12 hours [FEV1 AUC (0-12)] and peak FEV1 measured after 6 weeks of treatment.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-term, Randomized, Double-blind Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide at Two Dose Levels When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Brief Summary: The purpose of this extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.


Options:
A: Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1) (Baseline and Week 24); Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) (Baseline and Week 24)
B: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) (Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks)
C: Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment (Day 7)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Infant Formula With Bovine Milk Osteopontin on Infant Growth, Health and Immune functions-a Double-blind Randomized Trial
Brief Summary: The specific objectives of this study are to evaluate the effects of bovine milk osteopontin added to infant formula on infant growth, health and immune functions.


Options:
A: The percentage of subjects who develop tolerance to cow's milk protein by 12 months post randomization to study formula. (12 months post randomization)
B: Growth (5 years)
C: Concentrations of immune cells and cytokines of IL-6, IL-10, and IL-12 in infant's blood samples will be measured to evaluate immune functions. (1, 4, and 6 postnatal months)
D: Practical handling,ease of use and safety information (number of participants with adverse events) (measurements were taken on day 0-5 and up to day 10 on preterms and through 2 days after the last infusion of study product)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and System of Supportive Psychotherapy (SYSP) for Early Onset Chronic Depression
Brief Summary: The purpose of this study is to compare the efficacy of the Cognitive Behavioural Analysis System of Psychotherapy (CBASP) with the non-specific System of Supportive Psychotherapy (SYSP)in early onset chronically depressives.


Options:
A: Paid Work Hours at Week 12 (Week 12); Paid Work Hours at Week Baseline (Baseline)
B: Depressive Relapse or MDD (Measured at month 8); Depressive Relapse/Recurrence or MDD (Measured at month 20); Depressive Relapse/Recurrence or MDD (Measured at month 32)
C: N/A
D: Depressive symptoms as measured by the HRSD (24-item Hamilton Rating Scale of Depression) (20 weeks after randomization (after acute treatment phase))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and System of Supportive Psychotherapy (SYSP) for Early Onset Chronic Depression
Brief Summary: The purpose of this study is to compare the efficacy of the Cognitive Behavioural Analysis System of Psychotherapy (CBASP) with the non-specific System of Supportive Psychotherapy (SYSP)in early onset chronically depressives.


Options:
A: Hamilton Depression Scale (HAM-D) - continuous (End point week 19 and Week 24)
B: N/A
C: Depressive symptoms as measured by the HRSD (24-item Hamilton Rating Scale of Depression) (20 weeks after randomization (after acute treatment phase))
D: Relapse/recurrence of Major Depressive Episode (3, 6, 9, 12, 15 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Brief Summary: The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full etc.)


Options:
A: International Prostate Symptom Score (IPSS) (12 weeks)
B: Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks (Baseline, 12 weeks)
C: Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks (Baseline and 12 weeks)
D: Change in baseline total score on the International Prostate Symptom Score (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Brief Summary: The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full etc.)


Options:
A: Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks (Baseline, 12 weeks)
B: Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis (Baseline and 12 weeks); Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis (Baseline and 12 weeks)
C: Change From Baseline to 8-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone (Baseline, Week 8)
D: Comparison of change in EF domain of IIEF at Week 12 between Viagra and placebo

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind Randomized Controlled Trial of Recombinant Human Platelet Derived Growth Factor-BB Gel (Regranex Gel®) Versus Hydrogel (Duoderm Hydrogel®) for Healing of MARTORELL's Hypertensive Leg Ulcers. ERAN Trial.
Brief Summary: Background: No medical treatment has proved its efficacy for the treatment of hypertensive leg ulcers in a well designed trial.

Primary aim of the study: to compare the rate of healing in hypertensive leg ulcers treated with becaplermin gel (Regranex Gel®) daily application versus the application of the same quantity of an hydrogel (Duoderm Hydrogel™), corresponding to the excipient of becaplermin gel.

Method: Ambulatory or hospitalized patients presenting with an hypertensive leg ulcer, were randomized to receive either a daily application of becaplermin gel or hydrogel during 8 weeks. At week 8, a pinch graft was proposed to patients whom the ulcer has not healed.

Primary aim of the study: Complete closure at week 8

Secondary aims: percentage of wound area reduction at week 8, complete closure at week 12, pain and quality of life during treatment

Study hypothesis: becaplermin gel may promote the healing of hypertensive leg ulcers and be an alternative medical treatment to the skin graft usually proposed


Options:
A: Change in Six-Minute Walk Performance at 12-week Follow-up (change from baseline to week 12)
B: Placebo-adjusted change from baseline in PASP (estimated by transthoracic echocardiography) under normoxic conditions following 5 days of GSK1278863 (Day 5)
C: Complete wound closure rate at week 8 of treatment (week 9)
D: Time to major amputation of the treated leg or death from any cause, whichever comes first (From randomization up to 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind Randomized Controlled Trial of Recombinant Human Platelet Derived Growth Factor-BB Gel (Regranex Gel®) Versus Hydrogel (Duoderm Hydrogel®) for Healing of MARTORELL's Hypertensive Leg Ulcers. ERAN Trial.
Brief Summary: Background: No medical treatment has proved its efficacy for the treatment of hypertensive leg ulcers in a well designed trial.

Primary aim of the study: to compare the rate of healing in hypertensive leg ulcers treated with becaplermin gel (Regranex Gel®) daily application versus the application of the same quantity of an hydrogel (Duoderm Hydrogel™), corresponding to the excipient of becaplermin gel.

Method: Ambulatory or hospitalized patients presenting with an hypertensive leg ulcer, were randomized to receive either a daily application of becaplermin gel or hydrogel during 8 weeks. At week 8, a pinch graft was proposed to patients whom the ulcer has not healed.

Primary aim of the study: Complete closure at week 8

Secondary aims: percentage of wound area reduction at week 8, complete closure at week 12, pain and quality of life during treatment

Study hypothesis: becaplermin gel may promote the healing of hypertensive leg ulcers and be an alternative medical treatment to the skin graft usually proposed


Options:
A: Compare the Treatment Groups for the Number of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline (Weekly, over 12 Weeks or until wound closure, which ever occurred first)
B: Wound Closure (16 Weeks)
C: The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period. (Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first)
D: Complete wound closure rate at week 8 of treatment (week 9)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Vaasa Childhood Obesity Primary Prevention Study
Brief Summary: This study aims to prevent childhood obesity with early life (pregnancy) intensified counselling. The recruited intervention group is pregnant mothers who are at risk to get gestational diabetes. Lifestyle intervention (nutritional and physical activity) begins during pregnancy in maternity clinics and continues in child wellfare clinics until the child is 5 years of age.


Options:
A: Preventing childhood obesity (Offspring age until six years)
B: Body fat percentage (One year (interim analysis))
C: Physical activity (baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention); motor skills (baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention)
D: Change in Infant Growth (Baby is less than 2 months; baby is 3 months; baby is 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Remote Ischemic Postconditioning During Percutaneous Coronary Interventions.
Brief Summary: Angioplasty is a commonly performed procedure for treating blockage of the blood vessels in the heart. Although this procedure is usually successful, it is often accompanied by a small degree of damage to the heart (i.e., small heart attack).

The purpose of this study is to find out if inflating a blood pressure cuff on the arm or the leg at the time of angioplasty for several minutes has a beneficial effect.

Patients will be assigned to one of three treatment groups: inflating blood pressure cuff on the arm, inflating blood pressure cuff on the leg and a control group.


Options:
A: Myocardial injury after PCI. (24 hours)
B: Salvage index (%): Difference in infarct growth (PWI-DWI) after 24 hours among patients treated with preconditioning and those not treated. (February 2012)
C: Troponin-T release over the perioperative 72-hour period. (3 days)
D: In-hospital death (Postoperative 30 days); Myocardial infarction (Postoperative 30 days); Stroke (Postoperative 30 days); Respiratory failure (Postoperative 30 days); Renal dysfunction (Postoperative 30 days); Renal failure (Postoperative 30 days); Cardiogenic shock (Postoperative 30 days); Gastrointestinal complication (Postoperative 30 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Lipid-based Nutrient Supplements (LNS) for Pregnant and Lactating Women and Their Infants
Brief Summary: In Ghana, low micronutrient intakes among pregnant women are a major problem. The standard nutritional intervention during pregnancy is iron-folic acid tablets, but adherence is low. The investigators have pioneered the use of multiple micronutrient-fortified semi-solid pastes called Lipid-based Nutrient Supplements (LNS) (made using vegetable oil, groundnut, milk, sugar, and micronutrients), and the investigators' previous studies show that the approach could have great potential for use by pregnant and lactating women.

This study aims to evaluate the effects of LNS-P\&L designed for pregnant and lactating women and LNS-20gM designed for infants. Pregnant women (n=864) randomly selected from ante-natal clinics in Yilo and Manya Krobo districts of Ghana will be randomized to receive daily (a) Group 1: Iron/ Folic Acid tablets during pregnancy, and a tablet containing calcium (Ca) only (akin to a placebo) during lactation (6 mo), (b) Group 2: Multiple Micronutrient tablets during pregnancy and the first six months of lactation, or (c) Group 3: LNS-P\&L during pregnancy and lactation, whilst their infants receive LNS-20gM daily from 6 to 18 months. There are two primary outcomes namely:

1. Maternal primary outcome: Birth length
2. Child primary outcome: Child length-for-age z-score at 18 mo.

The investigators hypothesize that a) mean birth length and length-for-age at 18 mo will be greater in children whose mothers are in Group 2 than those whose mothers are in Group 1, and b) children whose mothers are in Group 3 will have greater birth length and length-for-age at 18 mo than the children in either of the other two groups.


Options:
A: child nutritional status (Burundi: 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo)
B: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence (Measured 12- and 24-months after intervention)
C: Change in length and length-for-age Z-score (9 to 18 mo of age); Change in weight and weight-for-age Z-score (9 to 18 mo of age); Incidence of diarrhea and laboratory-confirmed malaria infection (9 to 18 mo of age); Change in plasma zinc concentration (9 to 18 mo of age); Change in body composition (9 to 18 mo of age)
D: Maternal primary outcome is child length at birth (0 - 48 hr after birth); Child primary outcome is child length-for-age Z-score (LAZ, based on WHO 2006 growth standards) at 18 months of age (18 months after birth)

Answer: D