TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Risk Reduction for Drug Use and Sexual Revictimization
Brief Summary: The investigator proposes to evaluate Risk Reduction through Family Therapy (RRFT), which integrates: 1) an ecologically-based intervention for treatment of substance abuse behaviors in high risk adolescents, 2) exposure-based cognitive-behavioral therapy for sexually assaulted youth, and 3) psychoeducation strategies for prevention of risky sexual behaviors and revictimization. The principal purpose of this research proposal is to evaluate the efficacy of RRFT in reducing the risk of drug abuse and other risky behaviors, PTSD, and revictimization among adolescents who have been sexually assaulted. The Research Plan will be conducted based on Stage 1a and Stage 1b from NIDA's Behavioral Therapies Development Program as described in Rounsaville, Carroll, \& Onken (2001). The final phase of the research will involve conducting a pilot randomized controlled trial of RRFT in a sample of adolescents, comparing primary outcome measures of youth receiving RRFT to youth receiving usual care in the community. Participants will be adolescents (12-17 years) who have experienced a sexual assault. Assessment of substance use and other risk behaviors, trauma-related psychopathology, and incidents of revictimization will be collected at pre- and post- treatment, as well as 6-week and 3-month follow-ups. Hierarchical Linear Modeling will be the primary method used to test study hypotheses. Development and evaluation of the proposed intervention will have significant implications for addressing public health problems in adolescent substance abuse and related high risk behaviors.


Options:
A: Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index (baseline, post-intervention and 3-months)
B: Change from baseline on PTSD symptoms utilizing the Child PTSD Symptom Scale-Interview (CPSS-I) (Baseline, mid-treatment, post-treatment, 3-, 6-, and 12-month follow-ups)
C: Time Line Follow Back and urine screen (Pre and post-treatment, 3 and 6 month follow-ups)
D: depression (pre, post and 6 months post treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Risk Reduction for Drug Use and Sexual Revictimization
Brief Summary: The investigator proposes to evaluate Risk Reduction through Family Therapy (RRFT), which integrates: 1) an ecologically-based intervention for treatment of substance abuse behaviors in high risk adolescents, 2) exposure-based cognitive-behavioral therapy for sexually assaulted youth, and 3) psychoeducation strategies for prevention of risky sexual behaviors and revictimization. The principal purpose of this research proposal is to evaluate the efficacy of RRFT in reducing the risk of drug abuse and other risky behaviors, PTSD, and revictimization among adolescents who have been sexually assaulted. The Research Plan will be conducted based on Stage 1a and Stage 1b from NIDA's Behavioral Therapies Development Program as described in Rounsaville, Carroll, \& Onken (2001). The final phase of the research will involve conducting a pilot randomized controlled trial of RRFT in a sample of adolescents, comparing primary outcome measures of youth receiving RRFT to youth receiving usual care in the community. Participants will be adolescents (12-17 years) who have experienced a sexual assault. Assessment of substance use and other risk behaviors, trauma-related psychopathology, and incidents of revictimization will be collected at pre- and post- treatment, as well as 6-week and 3-month follow-ups. Hierarchical Linear Modeling will be the primary method used to test study hypotheses. Development and evaluation of the proposed intervention will have significant implications for addressing public health problems in adolescent substance abuse and related high risk behaviors.


Options:
A: Time Line Follow Back and urine screen (Pre and post-treatment, 3 and 6 month follow-ups)
B: PTSD Symptom Severity according to UPID; DSM IV Diagnosis of Posttraumatic Stress disorder (pre-treatment, 1 month post, 6 months follow up)
C: Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI (Post-intervention and 3 month)
D: Evaluation of Child mental health, social & behavioral functioning and quality of life as measured from multiple informants and sources. (Immediately post-intervention and 6-months post intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Risk Reduction for Drug Use and Sexual Revictimization
Brief Summary: The investigator proposes to evaluate Risk Reduction through Family Therapy (RRFT), which integrates: 1) an ecologically-based intervention for treatment of substance abuse behaviors in high risk adolescents, 2) exposure-based cognitive-behavioral therapy for sexually assaulted youth, and 3) psychoeducation strategies for prevention of risky sexual behaviors and revictimization. The principal purpose of this research proposal is to evaluate the efficacy of RRFT in reducing the risk of drug abuse and other risky behaviors, PTSD, and revictimization among adolescents who have been sexually assaulted. The Research Plan will be conducted based on Stage 1a and Stage 1b from NIDA's Behavioral Therapies Development Program as described in Rounsaville, Carroll, \& Onken (2001). The final phase of the research will involve conducting a pilot randomized controlled trial of RRFT in a sample of adolescents, comparing primary outcome measures of youth receiving RRFT to youth receiving usual care in the community. Participants will be adolescents (12-17 years) who have experienced a sexual assault. Assessment of substance use and other risk behaviors, trauma-related psychopathology, and incidents of revictimization will be collected at pre- and post- treatment, as well as 6-week and 3-month follow-ups. Hierarchical Linear Modeling will be the primary method used to test study hypotheses. Development and evaluation of the proposed intervention will have significant implications for addressing public health problems in adolescent substance abuse and related high risk behaviors.


Options:
A: Efficacy of Motivation and Problem Solving (MAPS) in Cancer Risk Reduction (6 months)
B: Time Line Follow Back and urine screen (Pre and post-treatment, 3 and 6 month follow-ups)
C: the number and spacing of subsequent pregnancies and births (When first child is 12); the rates of marriage and cohabitation with the father of the child (When first child is 12); mothers' employment, career growth, economic self-sufficiency, and welfare dependence (When first child is 12); mothers' behavioral problems due to substance abuse (When first child is 12); children's academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement (At age 12); rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children (At age 12); mothers' arrests for serious misdemeanors and felonies (When first child is 12)
D: Primary outcome variables include alcohol misuse and violent behaviors. (12-months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Child Weight Through Improved Parent Practices and Environmental Change
Brief Summary: This purpose of this project is to determine whether this 8-month parenting for healthy weight intervention is able to help parents improve their parenting skills and make positive changes in the nutrition and physical activity environment at home.


Options:
A: BMI z score (24 months (end of intervention)); BMI z score (60 months of age (followup at 5 years of age)); BMI z score (Follow-up at 11 years of age)
B: Child percent body fat after the 8-month intervention period, controlling for baseline percent body fat. Percent body fat will be calculated using Dezenberg's equation which takes into account child height, weight, gender, race, and tricep skinfolds. (baseline, 8 months and 14 months)
C: Change in glycemic control, change in dietary intake (18 months)
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Child Weight Through Improved Parent Practices and Environmental Change
Brief Summary: This purpose of this project is to determine whether this 8-month parenting for healthy weight intervention is able to help parents improve their parenting skills and make positive changes in the nutrition and physical activity environment at home.


Options:
A: Maintenance of a Child's Body Mass Index as a result of the intervention (up to two years)
B: Primary Outcome Measure: BMI (6 months, 1 year, 2 year, 5 year)
C: Stunting in Children at 18 mo (18 months of age)
D: Child percent body fat after the 8-month intervention period, controlling for baseline percent body fat. Percent body fat will be calculated using Dezenberg's equation which takes into account child height, weight, gender, race, and tricep skinfolds. (baseline, 8 months and 14 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Child Weight Through Improved Parent Practices and Environmental Change
Brief Summary: This purpose of this project is to determine whether this 8-month parenting for healthy weight intervention is able to help parents improve their parenting skills and make positive changes in the nutrition and physical activity environment at home.


Options:
A: Physical Activity Level (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.); Physical Literacy (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.); Dietary Intake (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.)
B: Child percent body fat after the 8-month intervention period, controlling for baseline percent body fat. Percent body fat will be calculated using Dezenberg's equation which takes into account child height, weight, gender, race, and tricep skinfolds. (baseline, 8 months and 14 months)
C: Primary Outcome Measure: BMI (6 months, 1 year, 2 year, 5 year)
D: Change from baseline in Total Kilocalorie intake at 16 weeks (16 weeks); Change from baseline in reported levels of household food security at 16 weeks (16 weeks); Change from baseline in Healthy Eating Index (HEI) Score at 16 weeks (16 weeks); Change from baseline in daily servings of fruits and vegetable (added together) at 16 weeks (16 weeks); Change from baseline in daily total, in grams, of added sugars at 16 weeks (16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Child Weight Through Improved Parent Practices and Environmental Change
Brief Summary: This purpose of this project is to determine whether this 8-month parenting for healthy weight intervention is able to help parents improve their parenting skills and make positive changes in the nutrition and physical activity environment at home.


Options:
A: Body fat (At the end of the intervention and at a six month follow-up)
B: Child BMI
C: Child percent body fat after the 8-month intervention period, controlling for baseline percent body fat. Percent body fat will be calculated using Dezenberg's equation which takes into account child height, weight, gender, race, and tricep skinfolds. (baseline, 8 months and 14 months)
D: Body mass index (2005, 2006, 2007, 2008); nutrition behavior (2005, 2006, 2007, 2008); physical activity (2005, 2006, 2007, 2008)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Child Weight Through Improved Parent Practices and Environmental Change
Brief Summary: This purpose of this project is to determine whether this 8-month parenting for healthy weight intervention is able to help parents improve their parenting skills and make positive changes in the nutrition and physical activity environment at home.


Options:
A: Waist Circumference (5 months)
B: Child percent body fat after the 8-month intervention period, controlling for baseline percent body fat. Percent body fat will be calculated using Dezenberg's equation which takes into account child height, weight, gender, race, and tricep skinfolds. (baseline, 8 months and 14 months)
C: School-time and total daily MVPA (5 months and 1.5 years)
D: Body fat percentage (One year (interim analysis))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Child Weight Through Improved Parent Practices and Environmental Change
Brief Summary: This purpose of this project is to determine whether this 8-month parenting for healthy weight intervention is able to help parents improve their parenting skills and make positive changes in the nutrition and physical activity environment at home.


Options:
A: Child percent body fat after the 8-month intervention period, controlling for baseline percent body fat. Percent body fat will be calculated using Dezenberg's equation which takes into account child height, weight, gender, race, and tricep skinfolds. (baseline, 8 months and 14 months)
B: Food and energy intake (Food weight (grams) and energy (kcal) (Once a week for four weeks)
C: Intake of nutrients; Serum lipid and lipoprotein concentrations; Growth and development; Smoking; Physical activity level and fitness; Intima-media thickness of arteries and rate of NO-induced vasodilatation
D: 1 Year change in insulin resistance via HOMA-IR (Change during first year); 2 year change in insulin resistance via HOMA-IR (Change during 2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Secondary Prevention of Asthma in Overweight/Obese Children by a Combined Dietary-behavioural-physical Activity Intervention
Brief Summary: The purpose of this study is to determine the efficacy of a multifactorial intervention with weight reduction, behavioural therapy, and physical exercise on the severity and control of asthma in obese children.


Options:
A: depressed mood (baseline, posttreatment , 6 month follow-up)
B: exercise adherence (Longitudinal and following the 16-week intervention)
C: Change in Adolescent Body Mass Index (BMI) (12 and 24 months)
D: Forced Expiratory Volume in the first second (FEV1 %) predicted value (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Secondary Prevention of Asthma in Overweight/Obese Children by a Combined Dietary-behavioural-physical Activity Intervention
Brief Summary: The purpose of this study is to determine the efficacy of a multifactorial intervention with weight reduction, behavioural therapy, and physical exercise on the severity and control of asthma in obese children.


Options:
A: Number of Symptom Free Days (Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February))
B: Change in asthma control from baseline at 3 months (3 months); Change in asthma control from baseline at 6 months (6 months); Change in asthma control from baseline at 9 months (9 months); Change in asthma control from baseline at 12 months (12 months)
C: Asthma exacerbations (Measured at 15 months)
D: Forced Expiratory Volume in the first second (FEV1 %) predicted value (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cardiovascular Disease Risk Factors and the Effects of a Cross-curricular Physical Activity Intervention in 11-14 Year Olds. Activity Knowledge Circuit
Brief Summary: The purpose of this study is to investigate the effects of a cross-curricular physical activity intervention on cardiovascular disease risk factors in 11-14 year olds. The null hypothesis states that the intervention will have no effect on cardiovascular disease risk factors.


Options:
A: Body mass index (BMI) >= 85th percentile, adjusted for gender and age (baseline, end of 7th grade, end of study); Fasting glucose (mg/dL) (baseline, end of study); Fasting insulin (mU/mL) (baseline, end of study)
B: standardized body mass index (zbmi)
C: Our outcome measure was reduction of screen time (4 waves of data)
D: Cardiovascular disease risk factors (obesity, blood pressure, blood lipid & lipoprotein) (6 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of a Novel Fortified Blended Flour to Ready-to-use Supplemental Foods for the Treatment of Moderate Acute Malnutrition in Rural Malawian Children: a Randomized, Investigator-blinded, Clinical Effectiveness Trial
Brief Summary: The purpose of this study is to compare the recovery rates of moderately malnourished Malawian children treated with either milk-enriched corn/soy blend, soy/peanut fortified spread or a commercially produced ready-to-use therapy food.


Options:
A: Number of Participants With Nutritional Recovery (12 weeks or upon completion of recovery); Number of Patients With Absence of Bilateral Pedal Pitting Edema (12 weeks or recovery)
B: All-cause mortality over the first 24 weeks after starting ART (Week 24)
C: Recovery by 16 weeks after enrollment (defined as achieving weight for height greater than or equal to -2 SD and absence of oedema of both feet) (Weekly till recovery or 16 weeks after enrollment, whichever is earlier)
D: Total long chain PUFA in erythrocyte membranes at 3 months (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of a Novel Fortified Blended Flour to Ready-to-use Supplemental Foods for the Treatment of Moderate Acute Malnutrition in Rural Malawian Children: a Randomized, Investigator-blinded, Clinical Effectiveness Trial
Brief Summary: The purpose of this study is to compare the recovery rates of moderately malnourished Malawian children treated with either milk-enriched corn/soy blend, soy/peanut fortified spread or a commercially produced ready-to-use therapy food.


Options:
A: Weight gain (3 months); Continuation in treatment (3 months)
B: Postpartum weight loss between delivery and 28 weeks (between delivery and 28 weeks); Infant HIV status at 28 weeks. (Infants found to have HIV at birth or 2 weeks after delivery will have been disenrolled.) (birth to 28 weeks); Exclusive breastfeeding and breastfeeding cessation by 28 weeks (birth to 28 weeks)
C: 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)
D: Number of Participants With Nutritional Recovery (12 weeks or upon completion of recovery); Number of Patients With Absence of Bilateral Pedal Pitting Edema (12 weeks or recovery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pathway Driven Study to Evaluate the Incidence of Wound Infections and Incisional Hernias After Laparotomy and Fascial Closure With PDS*Plus Sutures
Brief Summary: The aim of this study is to ascertain if the use of PDS plus® reduces the number of wound infections and incisional hernia after midline and transverse laparotomy comparing to polyglactin suture.


Options:
A: Frequency of wound infection (Within the first 30 days after surgery); Frequency of incisional hernia (One year after surgery)
B: Incisional hernia occurrence within one year after operation clinical and/or radiographically detected (one year)
C: Incisional hernia or burst abdomen within 12 months (12 months)
D: The number of wound infections (30 days after the operation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Trial in Phase I-IIa to Study the Feasibility and Security of the Allogenic Use of Adipose-derived Stem Cells for the Local Treatment of Recto-vaginal Fistula in Crohn´s Disease
Brief Summary: The purpose of this study is to determine safety and efficacy of allogenic eASCs (expanded adult stem cells) for the treatment of recto-vaginal fistula in patients with Crohn´s disease.


Options:
A: Survival (6 months, then yearly x 5 years after transplant)
B: Percentage of subjects in whom the external openings of the treated rectovaginal fistula have closed (12 weeks)
C: Clinical healing (6 months after last injection)
D: Closure of fistulas defined as absence of suppuration and re-epithelization of the external opening and absence of collections>2 cm directly related to the fistula tract treated, as measured by MRI (healing) (weeks 1, 4, 12 and 24. Week 26 in patients with a second dose)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of HPN-100 for Maintaining Remission in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy
Brief Summary: This is a phase 2 study of HPN-100 in subjects with hepatic encephalopathy (HE) consisting of an open label safety lead-in (Part A), followed by randomized, double-blind, placebo-controlled treatment (Part B).


Options:
A: Part A: The Rate of AEs and Tolerability of HPN-100 (Part A: 28 days); Part B: Proportion of Subjects Who Exhibit an HE Episode, Defined as Either of the Following During the Treatment Phase: WH ≥2; WH Grade and Asterixis Grade Increase of 1 Each, if Baseline WH = 0 (Part B: 112 Days)
B: The rate of adverse events (33 Days)
C: Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours (Baseline to 24 hours); Change in HE Grade at 24 Hours (Baseline to 24 hours)
D: The rate of adverse event

Answer: A