TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Cognitive-behavioral Treatment Programme CANDIS in the German Outpatient Treatment Service System (CANDIS-II)
Brief Summary: The purpose of this study is to evaluate the effectiveness of the cognitive-behavioral treatment program CANDIS among n=450 patients with cannabis use disorders in a mulicenter randomized-controlled clinical trial (n=11 outpatient treatment centers).


Options:
A: Marijuna use (marijuana use at 6 months)
B: abstinence, defined as no evidence of cannabis use during the past 4 weeks as evidenced by self report and a negative urine screen; number of times a cannabis product was used in the past 4 weeks; retention rate (at the end of treatment)
C: the number of joints consumed per month (at 12 months)
D: Craving for cannabis (1 hour)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study Comparing the Edwards Self-ExpandIng LifeStent Versus Angioplasty-alone In LEsions INvolving The SFA and/or Proximal Popliteal Arter
Brief Summary: The main objective of this study is to assess the safety and effectiveness of the Edwards Lifesciences LifeStent nitinol self expandable stent device and its delivery system in the treatment of occlusive superficial femoral artery (SFA) disease by reducing the re-intervention rate as compared to percutaneous transluminal angioplasty (PTA) alone


Options:
A: Event-free Survival Rate (12 months); Primary Patency (12 months)
B: Safety: Freedom from death at 30 days post-procedure. Effectiveness: Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure. (30 Day, 6 Month, and 12 Month)
C: Primary Safety Endpoint (Day 0 through 6 Months); Primary Effectiveness Endpoint: Technical Success (Day 0)
D: (re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass (5 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Misoprostol for Treatment of Incomplete Abortion
Brief Summary: This study aims to compare the efficacy, side effects profile and acceptability of a single dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local protocols for the treatment of incomplete abortion.


Options:
A: Incidence of intrauterine adhesion (3 months after dilatation and curettage)
B: Complete abortion without recourse to surgical intervention. (follow up visit 7 days after initial treatment)
C: Progressive intrauterine pregnancy > 22 WA (Until 2 years post surgery)
D: complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason (one week after initial treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Misoprostol for Treatment of Incomplete Abortion
Brief Summary: This study aims to compare the efficacy, side effects profile and acceptability of a single dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local protocols for the treatment of incomplete abortion.


Options:
A: complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason (one week after initial treatment)
B: Gestational Sac Expulsion With One Treatment Dose on Day 3 (Visit 2) and no Need for Additional Medical or Surgical Intervention Within 30 Days of Treatment. (Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done); Gestational Sac Expulsion by the Second Follow-up Visit at Day 8 (Day 8 (visit 3) and up to 30 day to ensure additional measures were not done (surgical)); Gestational Sac Expulsion by the 30-day Telephone Call (30 Days); Uterine Asperation (30 Days)
C: complete miscarriage (10 days)
D: Complete abortion without recourse to surgical intervention (follow up visit 7 days after initial treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Misoprostol for Treatment of Incomplete Abortion
Brief Summary: This study aims to compare the efficacy, side effects profile and acceptability of a single dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local protocols for the treatment of incomplete abortion.


Options:
A: Number of surgical evacuation in each group (during de study)
B: Complete abortion without recourse to surgical intervention. (follow up visit 7 days after initial treatment)
C: Complete abortion without recourse to surgical intervention (follow up visit 7 days after initial treatment)
D: complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason (one week after initial treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Misoprostol for Treatment of Incomplete Abortion
Brief Summary: This study aims to compare the efficacy, side effects profile and acceptability of a single dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local protocols for the treatment of incomplete abortion.


Options:
A: doxycycline side effects (24 hours)
B: complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason (one week after initial treatment)
C: Complete abortion without recourse to surgical intervention. (follow up visit 7 days after initial treatment)
D: Number of surgical evacuation in each group (during de study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group, 52-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid Arthritis
Brief Summary: To assess the clinical efficacy and safety of certolizumab pegol as add-on therapy with stable-dose disease-modifying antirheumatic drugs (DMARDs) for achieving clinical remission in patients with moderate to low disease activity rheumatoid arthritis


Options:
A: American college of Rheumatolofy (ACR)-20 responder rate at Week 24
B: Change in disease activity. (6 months)
C: Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24 (Week 20 and Week 24)
D: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group, 52-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid Arthritis
Brief Summary: To assess the clinical efficacy and safety of certolizumab pegol as add-on therapy with stable-dose disease-modifying antirheumatic drugs (DMARDs) for achieving clinical remission in patients with moderate to low disease activity rheumatoid arthritis


Options:
A: Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24 (Week 20 and Week 24)
B: Number of patients who achieve a DAS28 < 3.2 (0, 1, 3, 6, 9, 12 and 24 months (DAS28))
C: Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo (Baseline, Week 12)
D: Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 (Week 14)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group, 52-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid Arthritis
Brief Summary: To assess the clinical efficacy and safety of certolizumab pegol as add-on therapy with stable-dose disease-modifying antirheumatic drugs (DMARDs) for achieving clinical remission in patients with moderate to low disease activity rheumatoid arthritis


Options:
A: Double-blind Period: Mean Synovitis Scores at Baseline As Measured by the Rheumatoid Arthritis Clinical Trials 6 (OMERACT 6) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) (At baseline); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Planned Analysis Using Non-Parametric ANCOVA (Baseline to Day 113); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Post Hoc Sensitivity Analysis Using Parametric ANCOVA Analysis (Baseline to Day 113)
B: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6 (Week 6)
C: Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks (16 weeks)
D: Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24 (Week 20 and Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group, 52-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid Arthritis
Brief Summary: To assess the clinical efficacy and safety of certolizumab pegol as add-on therapy with stable-dose disease-modifying antirheumatic drugs (DMARDs) for achieving clinical remission in patients with moderate to low disease activity rheumatoid arthritis


Options:
A: Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline to Week 12); Part B: Percentage of Participants Achieving ACR20 Response at Week 24 (Baseline to Week 24); Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16 (Baseline, Week 16); Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52 (Baseline, Week 52)
B: Double-blind Period: Mean Synovitis Scores at Baseline As Measured by the Rheumatoid Arthritis Clinical Trials 6 (OMERACT 6) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) (At baseline); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Planned Analysis Using Non-Parametric ANCOVA (Baseline to Day 113); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Post Hoc Sensitivity Analysis Using Parametric ANCOVA Analysis (Baseline to Day 113)
C: Change From Month 6 to Month 12 in Disease Activity Sscore 28 (DAS28) (Month 6 (randomization) and Month 12)
D: Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24 (Week 20 and Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of a Lifestyle Intervention in Preschool Children on Physiological and Psychological Parameters (Ballabeina)
Brief Summary: Childhood obesity and low fitness tracks into adulthood and carries significant co-morbidities. The investigators test the hypothesis that a multidisciplinary multilevel lifestyle intervention in preschool children in the French and German speaking part of Switzerland during one school-year results in a smaller increase in body mass index (BMI) and a larger increase in aerobic fitness.


Options:
A: Change in Observed Child Dietary Intake (8 Months); Change in Measured Child Physical Activity in Child Care (8 months); Change in Observed Child Dietary Intake (12 Months); Change in Measured Child Physical Activity in Child Care (12 Months)
B: Change in self-reported nutrition practices (baseline, post 3-months, post 12-months)
C: BMI and aerobic fitness (1 schoolyear)
D: Absolute change in mean accelerometry counts over 6 days (baseline, end of intervention, six months after end of intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of a Lifestyle Intervention in Preschool Children on Physiological and Psychological Parameters (Ballabeina)
Brief Summary: Childhood obesity and low fitness tracks into adulthood and carries significant co-morbidities. The investigators test the hypothesis that a multidisciplinary multilevel lifestyle intervention in preschool children in the French and German speaking part of Switzerland during one school-year results in a smaller increase in body mass index (BMI) and a larger increase in aerobic fitness.


Options:
A: BMI and aerobic fitness (1 schoolyear)
B: Breastfeeding Initiation (first month after birth of child)
C: Change in glycemic control, change in dietary intake (18 months)
D: Group differences in percentage of mothers who meet breastfeeding and complementary feeding recommendations and percentage of mothers who introduce sugar sweetened beverages over time as assessed by the Child Feeding Assessment. (2 weeks - 24 months postpartum); Group differences in mean scores for infant feeding style subscales assessed using the Infant Feeding Behavior Questionnaire. (2 months-12 months postpartum); Group differences in in mean scores for toddler feeding style subscales assessed using the Toddler Feeding Behavior Questionnaire (TFBQ). (24 months postpartum); Group differences in children's fruit and vegetable intake, sugar sweetened beverage (SSB) consumption, snacks, and desserts over time. (6 and 24 months postpartum); Group differences in children's physical activity levels as assessed by accelerometry. (18 months-24 months postpartum); Group differences in children's reported physical activity, screen time and other sedentary activities over time as assessed by the Child Physical Activity Assessment. (2 weeks-24 months postpartum); Group differences in children's mean BMI z-scores over time as assessed through child weight and length measurements over time. (2 weeks-24 months postpartum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of a Lifestyle Intervention in Preschool Children on Physiological and Psychological Parameters (Ballabeina)
Brief Summary: Childhood obesity and low fitness tracks into adulthood and carries significant co-morbidities. The investigators test the hypothesis that a multidisciplinary multilevel lifestyle intervention in preschool children in the French and German speaking part of Switzerland during one school-year results in a smaller increase in body mass index (BMI) and a larger increase in aerobic fitness.


Options:
A: Change from baseline in energy dense food consumption at 12 months (12 months); Change from baseline in nutrient dense food consumption at 12 months (12 months)
B: Percent of children overweight or obese (BMI ≥ 85th%) at 2 years of life (2 years)
C: BMI and aerobic fitness (1 schoolyear)
D: 1-year, and 3-year changes from baseline in questionaires scores for knowledge, attitudes, and habits of children, parents and teachers in regards to a healthy lifestyle. (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of a Lifestyle Intervention in Preschool Children on Physiological and Psychological Parameters (Ballabeina)
Brief Summary: Childhood obesity and low fitness tracks into adulthood and carries significant co-morbidities. The investigators test the hypothesis that a multidisciplinary multilevel lifestyle intervention in preschool children in the French and German speaking part of Switzerland during one school-year results in a smaller increase in body mass index (BMI) and a larger increase in aerobic fitness.


Options:
A: Change in Nutrition and Physical Activity Policies (Baseline, Year 1, Year 2)
B: Change in Observed Child Dietary Intake (8 Months); Change in Measured Child Physical Activity in Child Care (8 months); Change in Observed Child Dietary Intake (12 Months); Change in Measured Child Physical Activity in Child Care (12 Months)
C: Change in Child Physical Activity (Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.); Change in Child Dietary Intake (Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.)
D: BMI and aerobic fitness (1 schoolyear)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of a Lifestyle Intervention in Preschool Children on Physiological and Psychological Parameters (Ballabeina)
Brief Summary: Childhood obesity and low fitness tracks into adulthood and carries significant co-morbidities. The investigators test the hypothesis that a multidisciplinary multilevel lifestyle intervention in preschool children in the French and German speaking part of Switzerland during one school-year results in a smaller increase in body mass index (BMI) and a larger increase in aerobic fitness.


Options:
A: Child anthropometry (Baseline. Up to 12 months. Up to 24 months.); Child food intake (Baseline. Up to 12 months. Up to 24 months.); Child health (Baseline. Up to 12 months. Up to 24 months.); Distribution of food intake within the household (Baseline. Up to 12 months. Up to 24 months.); Household food security (Baseline. Up to 12 months. Up to 24 months.); Maternal nutrition knowledge (Baseline. Up to 12 months. Up to 24 months.)
B: Infant weight for height (One year after study entry)
C: Differences in Food and Beverage Intake by Energy (Days 1-5 in Periods 1 and 2)
D: BMI and aerobic fitness (1 schoolyear)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of a Lifestyle Intervention in Preschool Children on Physiological and Psychological Parameters (Ballabeina)
Brief Summary: Childhood obesity and low fitness tracks into adulthood and carries significant co-morbidities. The investigators test the hypothesis that a multidisciplinary multilevel lifestyle intervention in preschool children in the French and German speaking part of Switzerland during one school-year results in a smaller increase in body mass index (BMI) and a larger increase in aerobic fitness.


Options:
A: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)
B: Vitamin D plasma concentrations (12 months)
C: Change in child adiposity from baseline measured via BMI z-score (Enrollment, 6 months, 12 months, 18 months, 24 months); Change in adult adiposity from baseline measured via BMI (Enrollment, 12 months, 24 months)
D: BMI and aerobic fitness (1 schoolyear)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of a Lifestyle Intervention in Preschool Children on Physiological and Psychological Parameters (Ballabeina)
Brief Summary: Childhood obesity and low fitness tracks into adulthood and carries significant co-morbidities. The investigators test the hypothesis that a multidisciplinary multilevel lifestyle intervention in preschool children in the French and German speaking part of Switzerland during one school-year results in a smaller increase in body mass index (BMI) and a larger increase in aerobic fitness.


Options:
A: BMI and aerobic fitness (1 schoolyear)
B: Body mass index (2005, 2006, 2007, 2008); nutrition behavior (2005, 2006, 2007, 2008); physical activity (2005, 2006, 2007, 2008)
C: Child BMI
D: 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

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of a Lifestyle Intervention in Preschool Children on Physiological and Psychological Parameters (Ballabeina)
Brief Summary: Childhood obesity and low fitness tracks into adulthood and carries significant co-morbidities. The investigators test the hypothesis that a multidisciplinary multilevel lifestyle intervention in preschool children in the French and German speaking part of Switzerland during one school-year results in a smaller increase in body mass index (BMI) and a larger increase in aerobic fitness.


Options:
A: N/A
B: Body fat percentage (One year (interim analysis))
C: BMI and aerobic fitness (1 schoolyear)
D: Changes in Brain function and structure using magnetic resonance imaging (MRI) (20 days during baselines and Post-evaluations (after intervention).); Brain and cognitive functioning assessment by electroencephalogram (EEG) (20 days during baselines and Post-evaluations (after intervention).); Cognitive performance (DKEFS test battery) (20 days during baselines and Post-evaluations (after intervention).); Academic achievement (20 days during baselines and Post-evaluations (after intervention).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of a Lifestyle Intervention in Preschool Children on Physiological and Psychological Parameters (Ballabeina)
Brief Summary: Childhood obesity and low fitness tracks into adulthood and carries significant co-morbidities. The investigators test the hypothesis that a multidisciplinary multilevel lifestyle intervention in preschool children in the French and German speaking part of Switzerland during one school-year results in a smaller increase in body mass index (BMI) and a larger increase in aerobic fitness.


Options:
A: Body fat percentage (One year (interim analysis))
B: Our outcome measure was reduction of screen time (4 waves of data)
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: BMI and aerobic fitness (1 schoolyear)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of a Lifestyle Intervention in Preschool Children on Physiological and Psychological Parameters (Ballabeina)
Brief Summary: Childhood obesity and low fitness tracks into adulthood and carries significant co-morbidities. The investigators test the hypothesis that a multidisciplinary multilevel lifestyle intervention in preschool children in the French and German speaking part of Switzerland during one school-year results in a smaller increase in body mass index (BMI) and a larger increase in aerobic fitness.


Options:
A: standardized body mass index (zbmi)
B: 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)
C: BMI and aerobic fitness (1 schoolyear)
D: MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET) (Post-2 year intervention); MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET) (Post-3 year intervention)

Answer: C