TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Subjects Assessed to be at Imminent Risk for Suicide
Brief Summary: The purpose of the study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo in addition to comprehensive standard of care in reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in participants who are assessed to be at imminent risk for suicide, as measured by the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24 hours post first dose.


Options:
A: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 in the Double-blind Induction Phase- Mixed-Effects Model Using Repeated Measures (MMRM) Analysis (Baseline up to Day 28 of Double-blind Induction Phase); Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- Analysis of Covariance (ANCOVA) Analysis (Baseline up to Endpoint (Double-blind Induction Phase [Day 28]))
B: Change in 24 item Hamilton Depression Rating Scale (HAMD) scores. Safety measures: UKU scale, vital signs assessments, laboratory parameters (SMA-20, CBC, UA) (6 weeks); Change in Hamilton Rating Scale for Anxiety (HAMA) scores. (6 weeks)
C: Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours After the First Dose (Day 2) (Last Observation Carried Forward [LOCF] Data) During Double-blind Phase (Baseline (Day 1, predose) and 24 hours first post dose (Day 2))
D: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Day 14 (Day 1 and Day 14)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Subjects Assessed to be at Imminent Risk for Suicide
Brief Summary: The purpose of the study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo in addition to comprehensive standard of care in reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in participants who are assessed to be at imminent risk for suicide, as measured by the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24 hours post first dose.


Options:
A: MADRS Score - Baseline (Baseline); MADRS Score - Day 1 Following Intervention (Day 1)
B: Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours Post First Dose (Last Observation Carried Forward [LOCF] Data): Double-blind (DB) Treatment Phase (Baseline (Day 1, predose) and 24 hours first post dose (Day 2)); Change From Baseline in Clinical Global Impression-Severity of Suicidality - Revised (CGI-SS-R) Scale at 24 Hours Post First Dose (LOCF Data): DB Treatment Phase (Baseline (Day 1, predose) and 24 hours first post dose (Day 2))
C: Change in Scale for Suicidal Ideation (Day 1 (24 hours) post-treatment)
D: Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours After the First Dose (Day 2) (Last Observation Carried Forward [LOCF] Data) During Double-blind Phase (Baseline (Day 1, predose) and 24 hours first post dose (Day 2))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Electronic Cigarette Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers
Brief Summary: Electronic cigarette is proposed as a bridge to smoking cessation. In this study we examine its effects on aortic elasticity, glycocalyx integrity, and exhaled carbon monoxide (CO) concentration and platelet function, both acutely and after 1 month of use.


Options:
A: Number of Participants With Smoking Cessation (12 WEEK)
B: Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F).
C: Acute electronic cigarette vaping effects on arterial stiffness. (7 minutes); Acute electronic cigarette vaping effects on endothelial integrity. (7 minutes); Chronic electronic cigarette vaping effects on arterial stiffness. (1 month); Chronic electronic cigarette vaping effects on endothelial integrity. (1 month); Chronic electronic cigarette vaping effects on platelet aggregation. (1 month); Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function. (1 month)
D: Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 (7-day point prevalence)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Electronic Cigarette Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers
Brief Summary: Electronic cigarette is proposed as a bridge to smoking cessation. In this study we examine its effects on aortic elasticity, glycocalyx integrity, and exhaled carbon monoxide (CO) concentration and platelet function, both acutely and after 1 month of use.


Options:
A: Number of cigarettes smoked per day (End of 6 week intervention)
B: Intervention effect on Flow-mediated dilatation (FMD) assessed via ultrasound (%FMD). (6 months following quit day.)
C: Acute electronic cigarette vaping effects on arterial stiffness. (7 minutes); Acute electronic cigarette vaping effects on endothelial integrity. (7 minutes); Chronic electronic cigarette vaping effects on arterial stiffness. (1 month); Chronic electronic cigarette vaping effects on endothelial integrity. (1 month); Chronic electronic cigarette vaping effects on platelet aggregation. (1 month); Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function. (1 month)
D: Toxicant Exposure (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Electronic Cigarette Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers
Brief Summary: Electronic cigarette is proposed as a bridge to smoking cessation. In this study we examine its effects on aortic elasticity, glycocalyx integrity, and exhaled carbon monoxide (CO) concentration and platelet function, both acutely and after 1 month of use.


Options:
A: Smoking Status (at week 48)
B: Acute electronic cigarette vaping effects on arterial stiffness. (7 minutes); Acute electronic cigarette vaping effects on endothelial integrity. (7 minutes); Chronic electronic cigarette vaping effects on arterial stiffness. (1 month); Chronic electronic cigarette vaping effects on endothelial integrity. (1 month); Chronic electronic cigarette vaping effects on platelet aggregation. (1 month); Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function. (1 month)
C: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
D: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Electronic Cigarette Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers
Brief Summary: Electronic cigarette is proposed as a bridge to smoking cessation. In this study we examine its effects on aortic elasticity, glycocalyx integrity, and exhaled carbon monoxide (CO) concentration and platelet function, both acutely and after 1 month of use.


Options:
A: Change in Metabolic Syndrome Prevalence (Changes in the prevalence of Metabolic Syndrome from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years)
B: Acute electronic cigarette vaping effects on arterial stiffness. (7 minutes); Acute electronic cigarette vaping effects on endothelial integrity. (7 minutes); Chronic electronic cigarette vaping effects on arterial stiffness. (1 month); Chronic electronic cigarette vaping effects on endothelial integrity. (1 month); Chronic electronic cigarette vaping effects on platelet aggregation. (1 month); Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function. (1 month)
C: Electronic cigarette use (weekly measurements from baseline to 10 weeks and a final assessment at 24 weeks); electronic cigarette acceptability (Baseline, week 2, week6, week 10 and week 24); Respiratory symptoms (weekly measures from baseline to 10 weeks and at 24 weeks); Cotinine (Baseline, week 2, 6, 10 and 24); Nitrosamines (Baseline and at 6 week); Side effects of antipsychotics (weekly the first 10 weeks and at 24 weeks); Withdrawal symptoms (weekly the first 10 weeks and at 24 weeks); Respiratory symptoms (weekly the first 10 weeks and at 24 weeks)
D: smoking status (baseline, 3, 6, 12, and 18 months follow-up); commitment to abstinence (baseline, 3, 6, 12, and 18 months); quit attempts (3, 6, 12, and 18 months follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Electronic Cigarette Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers
Brief Summary: Electronic cigarette is proposed as a bridge to smoking cessation. In this study we examine its effects on aortic elasticity, glycocalyx integrity, and exhaled carbon monoxide (CO) concentration and platelet function, both acutely and after 1 month of use.


Options:
A: smoking cessation (52 weeks)
B: Continuous abstinence (Russell Standard) (Six months post quit date)
C: Acute electronic cigarette vaping effects on arterial stiffness. (7 minutes); Acute electronic cigarette vaping effects on endothelial integrity. (7 minutes); Chronic electronic cigarette vaping effects on arterial stiffness. (1 month); Chronic electronic cigarette vaping effects on endothelial integrity. (1 month); Chronic electronic cigarette vaping effects on platelet aggregation. (1 month); Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function. (1 month)
D: Number of Participants With Smoking Cessation (12 WEEK)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Electronic Cigarette Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers
Brief Summary: Electronic cigarette is proposed as a bridge to smoking cessation. In this study we examine its effects on aortic elasticity, glycocalyx integrity, and exhaled carbon monoxide (CO) concentration and platelet function, both acutely and after 1 month of use.


Options:
A: Cigarette use (Weeks 1-3); Ecigarette use (Weeks 1-3)
B: Electronic cigarette use (weekly measurements from baseline to 10 weeks and a final assessment at 24 weeks); electronic cigarette acceptability (Baseline, week 2, week6, week 10 and week 24); Respiratory symptoms (weekly measures from baseline to 10 weeks and at 24 weeks); Cotinine (Baseline, week 2, 6, 10 and 24); Nitrosamines (Baseline and at 6 week); Side effects of antipsychotics (weekly the first 10 weeks and at 24 weeks); Withdrawal symptoms (weekly the first 10 weeks and at 24 weeks); Respiratory symptoms (weekly the first 10 weeks and at 24 weeks)
C: reducers (week-24 from baseline)
D: Acute electronic cigarette vaping effects on arterial stiffness. (7 minutes); Acute electronic cigarette vaping effects on endothelial integrity. (7 minutes); Chronic electronic cigarette vaping effects on arterial stiffness. (1 month); Chronic electronic cigarette vaping effects on endothelial integrity. (1 month); Chronic electronic cigarette vaping effects on platelet aggregation. (1 month); Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function. (1 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Automated Closed-Loop Versus Restrictive Fluid Therapy in Abdominal Surgery: a Pilot Randomized Controlled Trial
Brief Summary: The aim of this study is to compare hemodynamic variables and outcome in patients undergoing laparoscopic and/or robotic elective abdominal surgery. Patients will receive either an automated closed-loop goal-directed fluid therapy (GDFT) guided by non-invasive flow monitoring or a restrictive fluid therapy of 4ml/kg/h.


Options:
A: Preload independent state (6 hours)
B: The volume of crystalloid solutions administered intraoperatively. (Start of Anesthesia until the doppler is removed at the end of surgery, approximately 8 hours)
C: Composite of morbidity and mortality on day 28 (28 days)
D: The primary outcome measure is the duration of postoperative hospital stay. (at days 1,2, and 5, as well as at ICU discharge, and hospital discharge.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Interventions to Promote Healthy Eating and Physical Activity in Lebanese School Children Targeting Overweight and Obesity.
Brief Summary: Evaluate the feasibility and effectiveness of a multi-component school-based intervention to promote healthy eating and physical activity with school children ages 9 to 11 years in Lebanon.


Options:
A: Change in knowledge score (One school year); Change in dietary habits (One school year); Change in self-efficacy score (One school year)
B: Executive function (One year)
C: Intake of unhealthy foods, unhealthy drinks, healthy foods assessed by a photo-based method (volume) (6 months post baseline); Intake of unhealthy foods, unhealthy drinks, healthy foods assessed by a photo-based method (volume) (18 months post baseline)
D: Decrease in children's sedentary time during school hours (One schoolyear)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Study Between Nifedipine and Ritodrine as Maintenance Tocolytic Therapy in Preterm Labor: A Randomized Controlled Trial
Brief Summary: A randomized controlled double blinded study included 200 women with preterm contractions. After successful arrest of contractions women were randomized into 2 equal groups: GI women received nifedipine 20 mg tablets twice daily and GII women received Ritodrine 5 mg tablets every 6 hours. The primary outcome was gestational age at delivery and the secondary outcomes include episodes of recurrent preterm labor, mode of delivery, maternal side effects and neonatal outcome


Options:
A: N/A
B: gestational age at delivery (8 weeks)
C: The time of delivery (6 months)
D: Time to delivery (through study completion, approximately 1 year); Gestational age (through study completion, approximately 1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Influence of Manual Fascial Manipulation on the Function of the Pelvic Floor in Pregnant Women
Brief Summary: Pregnancy and vaginal delivery are considered as the main risk factors for damage to the pelvic floor. There are various ways to measure the strength of the pelvic floor and to evaluate functional problems. Manual mobilization of the pelvic floor is a well-known treatment modality, however, ample knowledge exists on the efficacy of physiotherapy and exercise for improvement of pelvic floor function and strength. The aim of this study is to analyze the influence of pelvic floor fascial mobilization (PFFM) technique on the function and strength of the pelvic floor muscles as well as parameters presumed to be influenced by the strength of the pelvic floor in pregnant women.


Options:
A: UI reduction (12 months)
B: Number of micturitions in a 24 hour bladder diary and number of urge urinary incontinence episodes by subjects' reports per week. (Phase I, II, and III)
C: Contraction strength (Change of contraction strength is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )); Contraction pressure (Change of contraction pressure is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month ))
D: Change from level of depression at the end of the pregnancy (Up to 36 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Pedometer-Based Walking Intervention on Functional Capacity and Neurohumoral Modulation in Patients With Chronic Heart Failure With Preserved Ejection Fraction: a Multicenter Randomized Controlled Trial
Brief Summary: A multicenter randomized controlled trial, with follow-up at 6 and 12 months. Physically inactive participants with chronic heart failure with preserved or mid-range ejection fraction will be randomly assigned to intervention or control arms.

The six-month intervention will consist of an individualized pedometer-based walking program with weekly step goals, monthly face-to-face sessions with the physician, and monthly telephone calls with the research nurse. The intervention will be based on effective behavioral principles (goal setting, self-monitoring, personalized feedback).

The primary outcome is the change in 6-minute walk distance at 6 months. Secondary outcomes include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound, average daily step count measured by accelerometry, anthropometric measures, symptoms of depression, health-related quality of life, self-efficacy, and MAGGIC Risk Score.


Options:
A: HF-specific quality of life (baseline, midpoint, endpoint, 6mo); functional capacity (baseline and endpoint); Walking Test (baseline, midpoint, endpoint)
B: functional capacity (6 months)
C: Change in VO2max every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change in Left ventricular ejection fraction every 6 months over the 24 months of outpatient follow-up (every 6 months over the 24 months of outpatient follow-up); Change on 6-min walk test every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on Minnesota index of quality of life every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on heart rate every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on systolic blood pressure every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on diastolic blood pressure every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on body mass index every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on creatine clearance every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up)
D: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Pedometer-Based Walking Intervention on Functional Capacity and Neurohumoral Modulation in Patients With Chronic Heart Failure With Reduced Ejection Fraction: a Multicenter Randomized Controlled Trial
Brief Summary: A multicenter randomized controlled trial, with follow-up at 6 and 12 months. Physically inactive participants with chronic heart failure with reduced ejection fraction will be randomly assigned to intervention or control arms.

The six-month intervention will consist of an individualized pedometer-based walking program with weekly step goals, monthly face-to-face sessions with the physician, and monthly telephone calls with the research nurse. The intervention will be based on effective behavioral principles (goal setting, self-monitoring, personalized feedback).

The primary outcome is the change in 6-minute walk distance at 6 months. Secondary outcomes include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound, average daily step count measured by accelerometry, anthropometric measures, symptoms of depression, health-related quality of life, self-efficacy, and MAGGIC Risk Score.


Options:
A: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)
B: functional capacity (6 months)
C: 6 Minute Walk Test (up to 3 months)
D: Peak exercise capacity (16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Corneal Collagen Crosslinking to Increase the Resistance of the Graft Used as a Support for the Boston Keratoprosthesis Type I Against Corneal Melting
Brief Summary: The purpose of this study is to demonstrate the safety and efficacy of the corneal collagen crosslinking with riboflavin and ultraviolet A in aim to increase the resistance of the graft used as a support for the Boston keratoprosthesis (KPro) type I against corneal melting (keratolysis or sterile necrosis).


Options:
A: Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button (1 day); Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button (1 week); Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button (2 weeks); Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button (1 month); Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button (1 month); Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button (3 months); Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button (Every 2-4 months depending on the judgment of the surgeon for at least 5 years); Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button (1 year); Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button (2 years); Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button (5 years)
B: Maximum Keratometry (12 months)
C: size of infiltrate or scar, corneal structural integrity (6 months)
D: time of complete healing (days) (180 days)

Answer: A