TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension on Standard Medical Therapy (SPYRAL HTN-ON MED)
Brief Summary: The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the presence of up to three standard antihypertensive medications.


Options:
A: To document that renal denervation achieved via the delivery of RF energy is safe, and not associated with clinically significant adverse events, in patients with refractory hypertension. (3 years)
B: Change in BP (measured by ABPM) (6 months)
C: Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events (From baseline to 1 month post-procedure (6 months for new renal artery stenosis)); Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) (From baseline to 6 months post-procedure)
D: Change in systolic blood pressure (ABPM mean value) (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension on Standard Medical Therapy (SPYRAL HTN-ON MED)
Brief Summary: The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the presence of up to three standard antihypertensive medications.


Options:
A: Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events (From baseline to 1 month post-procedure (6 months for new renal artery stenosis)); Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) (From baseline to 6 months post-procedure)
B: Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring from baseline (3 months post-randomization)
C: Change in Systolic Blood Pressure From Baseline to 6 Months on 24-h Ambulatory Measurement (Follow-up Minus Baseline Measurement) (The primary endpoint has been assessed 6 months after randomization.); Change in Glomerular Filtration Rate (This endpoint has been assessed 6 months after randomization.)
D: Freedom of AF or other atrial arrhythmias (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The "Fortaleça Sua Saúde" Program: A Cluster-randomized Controlled Trial to Promote Active and Healthy Lifestyle Among Brazilian Students
Brief Summary: Background:

Interventions on lifestyle among adolescents are important, but the main mechanisms that explain the changes (mediating variables) on lifestyle have been little explored. Investigators present the rationale and methods of a cluster-randomized controlled trial aimed to promote promotion active and healthy lifestyle (especially physical activity \[PA\] practice and reducing screen time use) among Brazilian students - the "Fortaleça sua Saúde" ("Strengthen Your Health" in Portuguese) program.

Methods/Design:

This is a school-based cluster-randomized controlled trial that included students from six elementary full-time public schools (7-9 grades) in Fortaleza, northeastern Brazil. The intervention duration was one academic semester (approximately four months) in 2014. The intervention strategies focused on teachers' training and activities on health in curriculum (including a specific training to Physical Education teachers), active opportunities in the school environment (availability of spaces and materials for PA) and health education (production and exhibition of health material at school, and distributing pamphlets to patients). Data collection will be performed before and immediately after 4 months of intervention. The primary variables include the practice of PA (weekly PA volume) and the screen time use (TV/computer/video games). Intrapersonal, interpersonal and environmental variables associated to PA and screen time use will be evaluated by standardized questionnaire. Other components of the lifestyle (e.g., eating habits), psychological (e.g., self-rated health, body satisfaction), biological (general and abdominal obesity) and academic performance will be also evaluated in the patients. Depressive symptoms, eating disorders, sleep quality, objectively-measured physical activity will be evaluated in obese patients.

Discussion:

Is effective, this program will contribute to the development of public policies for active and health lifestyle promotion among young population, especially from low- and middle-income countries. The main variables (intrapersonal, interpersonal and/or environmental stimulus) that help the young people to adopt an active lifestyle also may be indicated. Finally, investigators expect that the proposed strategies may be adaptable to the public school reality and they may be extended to the entire school system.


Options:
A: Body fat percentage (One year (interim analysis))
B: Change from baseline in weekly time in moderate-to-vigorous physical activity at 4 months (baseline and after 4-months of intervention); Change from baseline in the daily time using TV/computer/video games at 4 months (baseline and after 4-months of intervention)
C: Academic performance (October 2014 - June 2015 (8 months))
D: body mass index trajectory (change) (baseline, 1, 2 and 3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The "Fortaleça Sua Saúde" Program: A Cluster-randomized Controlled Trial to Promote Active and Healthy Lifestyle Among Brazilian Students
Brief Summary: Background:

Interventions on lifestyle among adolescents are important, but the main mechanisms that explain the changes (mediating variables) on lifestyle have been little explored. Investigators present the rationale and methods of a cluster-randomized controlled trial aimed to promote promotion active and healthy lifestyle (especially physical activity \[PA\] practice and reducing screen time use) among Brazilian students - the "Fortaleça sua Saúde" ("Strengthen Your Health" in Portuguese) program.

Methods/Design:

This is a school-based cluster-randomized controlled trial that included students from six elementary full-time public schools (7-9 grades) in Fortaleza, northeastern Brazil. The intervention duration was one academic semester (approximately four months) in 2014. The intervention strategies focused on teachers' training and activities on health in curriculum (including a specific training to Physical Education teachers), active opportunities in the school environment (availability of spaces and materials for PA) and health education (production and exhibition of health material at school, and distributing pamphlets to patients). Data collection will be performed before and immediately after 4 months of intervention. The primary variables include the practice of PA (weekly PA volume) and the screen time use (TV/computer/video games). Intrapersonal, interpersonal and environmental variables associated to PA and screen time use will be evaluated by standardized questionnaire. Other components of the lifestyle (e.g., eating habits), psychological (e.g., self-rated health, body satisfaction), biological (general and abdominal obesity) and academic performance will be also evaluated in the patients. Depressive symptoms, eating disorders, sleep quality, objectively-measured physical activity will be evaluated in obese patients.

Discussion:

Is effective, this program will contribute to the development of public policies for active and health lifestyle promotion among young population, especially from low- and middle-income countries. The main variables (intrapersonal, interpersonal and/or environmental stimulus) that help the young people to adopt an active lifestyle also may be indicated. Finally, investigators expect that the proposed strategies may be adaptable to the public school reality and they may be extended to the entire school system.


Options:
A: Percent Body Fat (Baseline and One year)
B: standardized body mass index (zbmi)
C: Change from baseline in weekly time in moderate-to-vigorous physical activity at 4 months (baseline and after 4-months of intervention); Change from baseline in the daily time using TV/computer/video games at 4 months (baseline and after 4-months of intervention)
D: Number of students obtaining lunch per day by National School Lunch Program (NSLP) eligibility (5 months); Number of fruits and vegetables served per day (5 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Different Doses of IVIG for Kawasaki Disease: a Multicentre, Prospective, Randomised Trial
Brief Summary: The objective of this study is to investigate the effect of different doses of intravenous immunoglobulin (IVIG) (1g/kg once, 1g/kg twice, 2g/kg once) for Kawasaki disease (KD) in a multicentre, prospective,randomised trial.


Options:
A: Duration of fever subsided to normal after initial IVIG finished (36 hours after IVIG finished); incidence of coronary artery lesions(CAL) after IVIG finished (start from IVIG finished, ended by the end of 2 weeks)
B: Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration (Up to 48hours)
C: Number of Participants With Cessation of Fever Within 24h of Initiation of Study Treatment With no Fever Recurrence Within Next 7 Days. (7 days)
D: Percentage of coronary artery lesions(CAL) at one month of illness (at one month of illness)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Latino Mothers as Primary Agents of Change
Brief Summary: Entre Familia was a 4-year randomized controlled trial funded by the American Cancer Society. The study was conducted in Imperial County, California, and involved a partnership between the Institute for Behavioral and Community Health at San Diego State University and Clínicas de Salud del Pueblo, Inc. a private, non-profit corporation providing comprehensive primary care services to residents throughout Imperial and Riverside Counties. The investigators enrolled 361 Latina mothers and one of their children aged between 7 and 13 years old; in 25% of families, the father was also enrolled. Participants were randomly assigned to either an intervention or delayed-treatment control condition. The intervention consisted of a community health worker (or promotora)-delivered home-based intervention to promote healthy eating. The promotoras used a telenovela DVD series and accompanying manual, both written and produced by study staff. The intervention was delivered through 11 home visits and 4 support telephone calls over a 4 month period. Participants in the delayed-treatment condition received intervention materials when evaluation assessments had been completed. Evaluation measures were taken at baseline, 4 months (immediate post-intervention) and 10 months (6-months post intervention). Participants completed a self-report interview with study staff at each time point. Height and weight measurements were also collected for the mothers and children. The primary outcomes were changes in mothers' daily fruit and vegetable intake. Secondary outcomes for mothers, children and fathers included changes in fat intake, sugary beverage intake, parenting strategies, and perceived barriers to healthy eating.


Options:
A: Percent of children overweight or obese (BMI ≥ 85th%) at 2 years of life (2 years)
B: BMI and aerobic fitness (1 schoolyear)
C: BMI percentile at 3 years (3 years)
D: Change in mother daily fruit and vegetable intake in the past month between baseline, immediate-post intervention and 6-months post-intervention, assessed using the NCI Fruit and Vegetable All-Day Screener (Baseline, 4 months, 10 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Latino Mothers as Primary Agents of Change
Brief Summary: Entre Familia was a 4-year randomized controlled trial funded by the American Cancer Society. The study was conducted in Imperial County, California, and involved a partnership between the Institute for Behavioral and Community Health at San Diego State University and Clínicas de Salud del Pueblo, Inc. a private, non-profit corporation providing comprehensive primary care services to residents throughout Imperial and Riverside Counties. The investigators enrolled 361 Latina mothers and one of their children aged between 7 and 13 years old; in 25% of families, the father was also enrolled. Participants were randomly assigned to either an intervention or delayed-treatment control condition. The intervention consisted of a community health worker (or promotora)-delivered home-based intervention to promote healthy eating. The promotoras used a telenovela DVD series and accompanying manual, both written and produced by study staff. The intervention was delivered through 11 home visits and 4 support telephone calls over a 4 month period. Participants in the delayed-treatment condition received intervention materials when evaluation assessments had been completed. Evaluation measures were taken at baseline, 4 months (immediate post-intervention) and 10 months (6-months post intervention). Participants completed a self-report interview with study staff at each time point. Height and weight measurements were also collected for the mothers and children. The primary outcomes were changes in mothers' daily fruit and vegetable intake. Secondary outcomes for mothers, children and fathers included changes in fat intake, sugary beverage intake, parenting strategies, and perceived barriers to healthy eating.


Options:
A: Daily intakes of dairy products, vegetables and fruits measured by a validated web-based food frequency questionnaire (6 months)
B: BMI variation from baseline (12 months)
C: Change in mother daily fruit and vegetable intake in the past month between baseline, immediate-post intervention and 6-months post-intervention, assessed using the NCI Fruit and Vegetable All-Day Screener (Baseline, 4 months, 10 months)
D: Breastfeeding Initiation (first month after birth of child)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Acute Basilar Artery Occlusion: Endovascular Interventions vs Standard Medical Treatment
Brief Summary: This trial will provide valuable insights into the safety and efficacy of endovascular treatment for acute ischemic stroke patients with basilar artery occlusion within 8 hours of estimated occlusion time.


Options:
A: modified Rankin Scale (mRS) (at 90 days from randomization)
B: The Modified Rankin Scale Score (at 90 days post-stroke)
C: Revascularization Status (Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment)
D: 90-day global disability assess via the modified Rankin Scale score (mRS) (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Acute Basilar Artery Occlusion: Endovascular Interventions vs Standard Medical Treatment
Brief Summary: This trial will provide valuable insights into the safety and efficacy of endovascular treatment for acute ischemic stroke patients with basilar artery occlusion within 8 hours of estimated occlusion time.


Options:
A: Reperfusion at 24 hours (CT or MR perfusion imaging) (24 hours post stroke onset); Favourable clinical response at 3 days(National Institutes of Health Stroke Score - NIHSS) (3 days post stroke onset)
B: modified Rankin Scale (mRS) (at 90 days from randomization)
C: modified Rankin Scale (Day 90 +/-7)
D: Feasibility of enrolling 12 subjects with major vessel occlusion within 1 year and random 1:1 assignment to treatment with IV (N=6) and IA (N=6) IA Activase using the following criteria: Time to clinical and radiological assessments (3 years); Time to IA Activase treatment (3 years); Preliminary safety assessment: 24 hour symptomatic ICH (3 years); Resources utilized and risk-benefit of IA Activase treatment. (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness Based Childbirth and Parenting Education - RCT of Effects on Parent and Child Health
Brief Summary: The purpose of this study is to explore if an intervention using Mindfulness Based Childbirth and Parenting education (MBCP) targeted to stressed pregnant women is effective in: 1) reducing prenatal stress, 2) preventing perinatal maternal mental ill-health, 3) preparing the mother for labor and 4) promoting positive infant-caregiver attachment.


Options:
A: Change in Fear of labor (childbirth self-efficacy and pain catastrophizing) (Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth)); Perceived labor pain (Postpartum (average of 6 weeks post-birth)); Pain medication use during labor (Labor (during childbirth)); Childbirth satisfaction (Postpartum (average of 6 weeks post-birth)); Change in Depression (Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth))
B: The use of epidural analgesia during birth (At birth)
C: Level of childbirth related fear (FOBS) (36 weeks of gestation)
D: Change in Perceived Stress Scale 14-item (From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old); Parent Child Early Relational Assessment (When infant is 12 months old)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessing the Health Impact of a Combined Water and Sanitation Intervention in Rural Odisha, India
Brief Summary: This is a matched-cohort study designed to assess the health impact of a rural demand-driven water and sanitation intervention that provides piped treated water and household level pour-flush latrines and bathing rooms, as implemented by Gram Vikas.


Options:
A: Diarrhoea (<5s) (21 months)
B: Diarrhea in Children Under 5 (one year after the intervention)
C: Reported diarrhoea in children <5 years (7-day recall, assessed 4 times during 3-month follow-up rounds)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessing the Health Impact of a Combined Water and Sanitation Intervention in Rural Odisha, India
Brief Summary: This is a matched-cohort study designed to assess the health impact of a rural demand-driven water and sanitation intervention that provides piped treated water and household level pour-flush latrines and bathing rooms, as implemented by Gram Vikas.


Options:
A: 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)
B: Reduction in hookworm prevalence and intensity of infection in intervention arm (6 months)
C: Reported diarrhoea in children <5 years (7-day recall, assessed 4 times during 3-month follow-up rounds)
D: Diarrhea in Children Under 5 (one year after the intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Granulocyte-colony Stimulating Factor in Patients With Severe Alcoholic Hepatitis With Null or Partial Response to Steroid: A Randomized, Double-blind, Placebo-controlled, Nationwide Multi-center Study
Brief Summary: Steroid is the treatment of choice in patients with severe alcoholic hepatitis. However, null- or partial responder of steroid treatment is recommended to consider liver transplantation. The yearly demand for liver transplants far exceeds the supply of available organs and alcoholic liver disease has been a controversial indication for transplantation. Granulocyte-Colony Stimulating Factor (G-CSF) has been reported to have effect of proliferation of hepatic progenitors in alcoholic steatohepatitis. The aim of this study is to investigate the efficacy of G-CSF in patients with severe alcoholic hepatitis with null or partial response to steroid.


Options:
A: 2-month survival rate of null responder to steroid treatment and 6-month survival rate of partial responder to steroid treatment (After 2 months of G-CSF or placebo treatment in patients with null responder to steroid treatment and after 6 months of G-CSF+steroid or only steroid treatment in patients with partial responder to steroid treatment)
B: Survival rates (12 weeks)
C: The primary end point will be transplant free survival rate at 1 year in patients with decompensated cirrhosis. (1 Year)
D: Adverse events, especially infection and renal failure, Change in MELD Score and DF between Day 1 and Day 29, Lille score (at Day 8) (Day 1, Day 8, Day 29, and Day 90)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Respiratory Syncytial Virus Bronchiolitis in Young Infants With Humanized Monoclonal Antibody: A Randomized Clinical Trial (Palivizumab Study)
Brief Summary: There is a growing body of literature suggesting that monoclonal antibody could be efficacious in infants with RSV-bronchiolitis, well tolerated with no or clinically insignificant adverse effects.

"The investigators hypothesize that a single dose of iv palivizumab 15 mg/kg in diagnosed infants \<3 months old with RSV bronchiolitis will result in fewer infants with readmissions to infirmary/observation or hospital for relapse during 3 weeks of follow-up after discharge".


Options:
A: Number of Subjects Reporting Serious Adverse Events (SAEs) (Day 0 - Day 150); Number of Subjects Reporting Adverse Events (AEs) (Day 0 - Day 150); Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs. (Day 0 - Day 150)
B: Readmission to either infirmary/observation or hospital or PICU during 3 weeks of follow-up after discharge (3 weeks)
C: Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI) (From Day 1 through Day 151)
D: The incidence of atopic asthma after three years old in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy (For three years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: STRIDER Canada: A Randomized Controlled Trial of Sildenafil Therapy In Dismal Prognosis Early-Onset Intrauterine Growth Restriction (Canada)
Brief Summary: Early-onset placental intrauterine growth restriction (EO IUGR) is associated with a high risk of perinatal morbidity and mortality. In association with reduced circulating placental growth factor (PlGF) EO IUGR results from abnormal placentation with inadequate remodelling of the maternal uteroplacental arteries. There is no known treatment for placental IUGR. Management involves intensive fetal surveillance with delivery with evidence of serious fetal compromise. However, remote from term, delivery is associated with significant perinatal mortality and morbidity. Sildenafil vasodilates the uteroplacental vessels of IUGR-affected pregnancies and may represent a novel therapy.


Options:
A: compare the gestational age at delivery (d) between sildenafil- and placebo-treated groups (6 weeks after postpartum)
B: Primary endpoint is the time from randomization to delivery.
C: The principal outcome is birth weight at delivery and neonatal morbidity (Crib Score) (6 weeks)
D: improvement of the Doppler indices following treatment (9 months)

Answer: A