TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Family Intervention for Pediatric Asthma Self-Management in Puerto Ricans
Brief Summary: This study compares an asthma self-management intervention, delivered to the family and tailored to their needs and cultural beliefs, to standard asthma education on two risk factors for asthma exacerbations in high-risk Puerto Rican children in high school. The self-management intervention will be a series of home visits provided by Puerto Rican community health workers. During home visits, the family will be educated using a standard asthma Core Curriculum which is tailored to individual needs, strengths, and beliefs. Specific Aim 1 is to test the ability of this tailored community health worker self-management intervention to reduce home asthma triggers and increase medication adherence in Puerto Rican adolescents with asthma. Specific Aim 2 is to test if any changes in triggers and adherence associated with this intervention are sustained 8 months after the completion of the active intervention. Another goal of the study is to build community capacity for asthma management in the target high-risk community.


Options:
A: asthma medication adherence (before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance))
B: Pediatric Asthma Quality of Life Questionnaire (PAQLQ) (9 months post camp); Asthma Control Questions (9 months post camp)
C: medication adherence (1 year)
D: Number of Participants With Unscheduled Use of Healthcare (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Family Intervention for Pediatric Asthma Self-Management in Puerto Ricans
Brief Summary: This study compares an asthma self-management intervention, delivered to the family and tailored to their needs and cultural beliefs, to standard asthma education on two risk factors for asthma exacerbations in high-risk Puerto Rican children in high school. The self-management intervention will be a series of home visits provided by Puerto Rican community health workers. During home visits, the family will be educated using a standard asthma Core Curriculum which is tailored to individual needs, strengths, and beliefs. Specific Aim 1 is to test the ability of this tailored community health worker self-management intervention to reduce home asthma triggers and increase medication adherence in Puerto Rican adolescents with asthma. Specific Aim 2 is to test if any changes in triggers and adherence associated with this intervention are sustained 8 months after the completion of the active intervention. Another goal of the study is to build community capacity for asthma management in the target high-risk community.


Options:
A: Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up (Baseline, 12)
B: N/A
C: Adherence rate (at three months)
D: asthma medication adherence (before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Paramedic Initiated Lisinopril For Acute Stroke Treatment: a Pilot Randomised Controlled Trial
Brief Summary: This study aims to investigate the use of lisinopril to lower blood pressure in stroke patients, pre-hospital, by research-trained paramedics.


Options:
A: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) (time since randomization; follow-up period is 1.5 to 4.4 years); Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) (time since randomization; follow-up period is 1.5 to 4.4 years)
B: A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS) (90 days)
C: Number of participants enrolled per month (1 year)
D: A Combination of Death Within 14 Days After Randomization and Major Disability at 14 Days or at Hospital Discharge if Earlier Than 14 Days. (2 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Optimal Levels of Dietary Dairy on Modulation of Adolescent Weight
Brief Summary: SPECIFIC AIM The aim of this study is to determine if increasing calcium intake to recommended levels with dairy foods in adolescent females with habitually low calcium intake and above-the-median body mass index (BMI) for sex and age will decrease body fat gain compared to similar females who continue their low calcium intake. .

HYPOTHESIS Post-menarcheal adolescent girls with habitually low calcium intake who consume dairy foods providing at least 1200 mg of calcium per day will have a smaller increase in percent body fat, as measured by dual energy absorptiometry, during one year than post-menarcheal adolescent girls on a usual diet of 600 mg of calcium per day or less.


Options:
A: Change in body mass index (BMI) z-score (Up to 2 years)
B: percent change in body fat (1 year)
C: Parent and child health behaviors (Baseline, 6 months); TV Viewing Time (Baseline, 6 months)
D: Change in Fruit and Vegetable Consumption at School Lunch (assessed 4 times each 9-month school year; once prior to intervention beginning (i.e., September), approximately 10 weeks and then 20 weeks later, and finally once after the intervention ends (i.e., May).); Change in Student Activity Level (assessed 3 times over 1 year; initially prior to the intervention beginning (i.e., September), a 2nd time once the intervention ends (i.e., May), and then again at the beginning of the following school year (i.e., September))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Optimal Levels of Dietary Dairy on Modulation of Adolescent Weight
Brief Summary: SPECIFIC AIM The aim of this study is to determine if increasing calcium intake to recommended levels with dairy foods in adolescent females with habitually low calcium intake and above-the-median body mass index (BMI) for sex and age will decrease body fat gain compared to similar females who continue their low calcium intake. .

HYPOTHESIS Post-menarcheal adolescent girls with habitually low calcium intake who consume dairy foods providing at least 1200 mg of calcium per day will have a smaller increase in percent body fat, as measured by dual energy absorptiometry, during one year than post-menarcheal adolescent girls on a usual diet of 600 mg of calcium per day or less.


Options:
A: Behavioural determinants of physical activity and nutrition by determinant questionnaire (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention); Physical activity, physical fitness and sedentarity (questionnaire and accelerometer) (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention); Food intake by 24h recall (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention)
B: percent change in body fat (1 year)
C: Change From Baseline in Percent Students Eating the School Breakfast Per School (Change from baseline (SY1) in average school year school-level breakfast participation at the end of one school year (SY2).)
D: BMI (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Transcutaneous Mechanical Nerve Stimulation (TMNS) by Vibration in the Preservation and Restoration of Urinary Continence and Erectile Function and in the Treatment of Erectile Dysfunction and Urinary Incontinence in Conjunction With Nerve Sparing Radical Prostatectomy
Brief Summary: After radical prostatectomy nerve damage in the pelvic floor usually occurs. This causes side effects in the form of incontinence and erectile dysfunction.

It has previously been shown that one can stimulate the nerves of the pelvic floor by means of transcutaneous mechanical nerve stimulation (TMNS) done through vibration. This study will examine the effect of TMNS in the preservation and restoration of urinary continence and erectile function and in the treatment of urinary incontinence and erectile dysfunction in conjunction with radical prostatectomy.

The theory is that by means of TMNS one can stimulate the nerves of the pelvic floor and the penis which may improve their function and there by prevent or minimize the occurrence of incontinence and erectile dysfunction following pelvic surgery. Vibration may also help to eliminate these symptoms once they have occurred. It is possible that TMNS will also directly increase the blood flow in the cavernosal tissue thus aiding in the preservation of this tissue. In case the improved nerve function is not great enough to secure satisfactory erectile function in itself it may still improve the effect of PDE-5-inhibitors.

In pilot studies TMNS has already shown an effect in the treatment of urinary continence.

In this study the patients will be randomized to either TMNS treatment or no TMNS treatment. In both groups the patients will participate in a pelvic floor muscle training program. In the group receiving active treatment this will be supplemented by TMNS treatment. The two groups will be evaluated and compared with regard to erectile function time to continence after surgery.


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

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Peer Debriefing Versus Instructor Debriefing for Interprofessional Simulation Based Education (PICS
Brief Summary: Crisis management is important for operating room practice and non-technical skills are acknowledged as key to ensure patient safety in these situations. Unfortunately, it can be difficult to find instructors with appropriate experience. A peer-led team debriefing is led by the team it self rather than an external expert instructor but remains a reflective process. Incorporating peer-led debriefing compared to expert-led debriefing may increase access to an interprofessional crisis resource management course using simulation.

The goals of the study are to observe the effect of an interprofessional peer-led team debriefing in the change in performance of non-technical skills of team performance and to compare it with the "gold standard" of expert-led debriefing on the performance of non-technical skills during a simulated operating room crisis.

The investigators hypothesize that interprofessional peer-led debriefing will improve the performance of non-technical skills of the team during simulated intraoperative crisis management and that this improvement will be equivalent to the "gold standard" expert-led debriefing.


Options:
A: Composite of readmission to hospital or death. (30 days after hospital discharge)
B: Performance of non-technical skills of the teams. (1 year)
C: Change in Chronic Heart Failure Health Status Between Baseline and 12 Months. (12 months)
D: functional gain as measured by motor FIM score (One year post team training intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Multicenter, Randomized, Parallel-group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo in a Double-blind Design
Brief Summary: The study is designed to assess the efficacy of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in subjects with RRMS, as measured by the number of confirmed relapses during the 12 month placebo controlled period. The study has two periods:

* Placebo Controlled Period: 12 months of 40 mg administered three times a week by subcutaneous injection or matching placebo.
* Open Label Extension Period: All subjects will continue treatment with GA 40 mg administered three times a week, until this dose strength is commercially available for the treatment of relapsing remitting multiple sclerosis (RRMS) patients or until the development of this GA dose regimen is stopped by the Sponsor


Options:
A: Adjusted Annualized Relapse Rate (ARR) During the Treatment Period (12 months)
B: Adjusted Annualized Relapse Rate Between Baseline and Week 52 (Baseline through Week 52)
C: Annualized Relapse Rate (2 years)
D: Total Number of Confirmed Relapses During the Placebo Controlled (PC) Treatment Period Estimated by Negative Binomial Regression (Day 1 to 12 months); Annualized Rate of Confirmed Relapses Comparing Early Starters to Delayed Starters Estimated by Negative Binomial Regression (Day 1 up to 6.5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Multicenter, Randomized, Parallel-group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo in a Double-blind Design
Brief Summary: The study is designed to assess the efficacy of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in subjects with RRMS, as measured by the number of confirmed relapses during the 12 month placebo controlled period. The study has two periods:

* Placebo Controlled Period: 12 months of 40 mg administered three times a week by subcutaneous injection or matching placebo.
* Open Label Extension Period: All subjects will continue treatment with GA 40 mg administered three times a week, until this dose strength is commercially available for the treatment of relapsing remitting multiple sclerosis (RRMS) patients or until the development of this GA dose regimen is stopped by the Sponsor


Options:
A: The primary objectives of this study are to determine whether natalizumab, when compared with placebo, is effective in reducing the rate of clinical relapses at 1 year and, in slowing the progression of disability at 2 years. (1 year and 2 years)
B: Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study (Baseline to Month 12)
C: Total Number of Confirmed Relapses During the Placebo Controlled (PC) Treatment Period Estimated by Negative Binomial Regression (Day 1 to 12 months); Annualized Rate of Confirmed Relapses Comparing Early Starters to Delayed Starters Estimated by Negative Binomial Regression (Day 1 up to 6.5 years)
D: Total Number of Adverse Events During Evaluation of Long Term Safety and Tolerability of BAF312A in Extension Study. (Baseline up to approximately 5 years); Number of Participants With Cardiac Conduction Abnormalities During the Titration Phase of the Study (Without Washout) (Baseline Extension up to day 10); Number of Participants With Cardiac Conduction-IVCD Abnormality During the Titration Phase of the Study (With Washout) (Baseline Extension up to day 10); Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set) (Baseline Extension up to approximately 5 years); Number of Participants With Viral Infections of Interest Greater or Equal to 5% in Any Dose Group (Extension Set) (Baseline Extension up to approximately 5 years); Number of Participants With Dermatologic Alterations - Basal Cell Carcinoma (Extension Set) (Baseline Extension up to approximately 5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Remote Ischaemic Preconditioning for Heart Surgery
Brief Summary: The purpose of this study is to evaluate the effects of Remote Ischaemic Preconditioning on perioperative ischaemic injury in patients undergoing cardiac surgery compared to control intervention.


Options:
A: The incidence of explicit recall of events during the surgical and anesthetic periods. (30 days)
B: Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure (In-hospital)
C: We will use a composite endpoint by these two instruments: Clinical Dementia Rating Scale (CDR), and the 10 words memory task from the Consortium to Establish a Registry for Alzheimer's Disease battery (CERAD) (4 and 12 months)
D: Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method (Postoperative days up to hospital discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Remote Ischaemic Preconditioning for Heart Surgery
Brief Summary: The purpose of this study is to evaluate the effects of Remote Ischaemic Preconditioning on perioperative ischaemic injury in patients undergoing cardiac surgery compared to control intervention.


Options:
A: Troponin-T release over the perioperative 72-hour period. (3 days)
B: Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure (In-hospital)
C: Post-operative atrial fibrillation (72 hours)
D: Cardiopulmonary exercise capacity (time to complete time trail, lactate anaerobic threshold, cardio-pulmonary exercise capacity (7 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Remote Ischaemic Preconditioning for Heart Surgery
Brief Summary: The purpose of this study is to evaluate the effects of Remote Ischaemic Preconditioning on perioperative ischaemic injury in patients undergoing cardiac surgery compared to control intervention.


Options:
A: troponin level (within the 1 day after operation)
B: Salvage index (%): Difference in infarct growth (PWI-DWI) after 24 hours among patients treated with preconditioning and those not treated. (February 2012)
C: Impact of RIPC on length of hospital stay. (Assessed through post-operative hospitalization.)
D: Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure (In-hospital)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Low Glycemic Load Diets in Latino Children at Risk for Type 2 Diabetes
Brief Summary: The purpose of this study are to:

1. compare two diet plans - a low-glycemic load (low-GL) diet and a low-fat diet. A low-GL diet is expected to keep blood sugar levels more normal, and because the sugar levels stay normal, prevent rapid rises of insulin in the blood. We want to test if Hispanic children at-risk for type 2 diabetes who are given a low-GL diet will have less insulin resistance, will lose more weight, and will decrease their chance of getting type 2 diabetes.
2. compare the effects of Low-GL and high-GL meals on appetitive, hormonal, and metabolic responses of obese Hispanic youth under controlled, standardized conditions. We want to test if children fed low-GL meals would have lower glucose and lower insulin responses, report less hunger and consume less energy than those fed high-GL meals.


Options:
A: Fasting Insulin (6 months)
B: Insulin sensitivity (IVGTT and minimal model)
C: Change in insulin sensitivity between the two dietary arms (at 3-, 12- and 24 months); Change in BMI z-score between the two dietary groups (3-, 12-, and 24 months)
D: Change in Body Weight (Change from baseline weight to weeks 6, 10, 16, 20, 24.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Care Treatment for Overweight Adolescent Females
Brief Summary: This project will examine the effectiveness of a primary care based intervention to help overweight teen girls adopt healthy lifestyle practices. Participants are adolescent females at select Kaiser Permanente Northwest primary care clinics with a body mass index above the 90th percentile. Teens will be randomly assigned to (1) a behavioral weight control program (enriched intervention), (or 2) usual-care (control). Primary care providers of teens in the intervention condition are given customized plans describing the teen's eating and physical activity habits and instructions on how to best work with these teens and their families. The behavioral weight control program is specifically tailored for teen girls and includes separate group meetings for teens and parents, follow-up telephone contacts with their group leader, and coordinated feedback from the teen's primary care provider.


Options:
A: body mass index (change from baseline to 12 months)
B: BMI z-score (2 years)
C: BMI SDS or Z-score (12 months primary/ 18 months secondary outcome)
D: Change in Body Mass Index (z-BMI) in Adolescents (Baseline to 2 months); Change in Body Mass Index (z-BMI) in Adolescents (Baseline to 4 months); Change in Body Mass Index (z-BMI) in Adolescents (Baseline to 6-month follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Forearm Exercise on Flow Mediated Vasodilation Prior to Arteriovenous Fistula Placement for Hemodialysis
Brief Summary: The study hypothesis is that 6 weeks of repetitive handgrip exercise will improve endothelial function and venous compliance in pre-dialysis patients with an estimated glomerular filtration rate of less than or equal to 20 ml/min. If proven correct then arm exercise might be useful to improve the success rate for a surgically created arteriovenous fistula in the forearm to become usable as a vascular access for hemodialysis.


Options:
A: Changes in blood flow of AVF draining vein (from Baseline to 3 months)
B: Brachial artery flow-mediated dilatation (6 weeks)
C: Increasing the diameter of the cephalic vein (8 weeks of training for each patient)
D: Impact of PIE on AVF primary failure comparing the control group and the PIE group. (12 weeks after AVF surgery (visit 6))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label Phase IIb Trial of Maintenance Therapy With a MUC1 Dendritic Cell Vaccine (Cvac™) for Epithelial Ovarian Cancer Patients in First or Second Remission
Brief Summary: The purpose of this study is to determine the safety and efficacy of an investigational therapeutic agent (Cvac) in ovarian cancer patients in first or second remission and to determine its ability to prevent cancer from returning.

Study objectives

Primary objectives:

* To confirm the safety of administering Cvac in this population.
* To determine the effects of Cvac on progression-free survival (PFS).

Secondary objectives:

* To determine overall survival (OS) for ovarian cancer patients who receive Cvac after achieving remission in the first or second-line setting.
* Evaluation of host immunologic response to Cvac administration.


Options:
A: Recurrence Free Survival Evaluated by Clinical Event Adjudication Committee (CEAC) (Every 12 weeks up to recurrence or up to 3 months after last administered dose)
B: Occurrence of adverse events (side effects) (12 weeks (1 cycle of study treatment))
C: N/A
D: Progression-free Survival (Baseline to 48 weeks after the last visit or dose of Cvac (up to 104 weeks))

Answer: D