TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Nutrition and Physical Activity Policies, Obesogenic Behaviors and Weight Outcomes
Brief Summary: The investigators long-term goal is to advance the adoption and successful implementation of policies that promote PA and nutrition in after school programs (ASP) nationwide. The investigators objective here is two fold. First, the investigators will test the effectiveness of two promising strategies designed to 1) increase the amount of PA children accumulate while attending an ASP and 2) promote changes in the nutritional quality of the snacks served. This represents a fundamental step in establishing practice-based guidelines (best practices) for the uptake and achievement of public health policy goals (CA and Harvard). Second, the investigators will examine the barriers and facilitators to implementing these strategies. The expected outcome of this study is evidence supporting best practices for ASPs to employ to meet policy goals.


Options:
A: Fruit and Vegetable Consumption, servings per week (3 weeks); Perceived Behavioral Control scale score (3 weeks); Attitudes scale score (3 weeks); Intrinsic Motivation scale score (3 weeks); Fruit and vegetable consumption, servings per week (5 weeks); Perceived Behavioral Control scale score (5 weeks); Attitudes scale score (5 weeks); Intrinsic Motivation scale score (5 weeks)
B: Change in grams of fruit and vegetables consumed (Baseline (prior to randomization allocation of installation of salad bars), Time 2 (6 weeks after randomization), and Time 3 (10 weeks after randomization))
C: Change in Percentage of Children Meeting Physical Activity Policy (Spring of Year 1, Year 2, and Year 3)
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: Nutrition and Physical Activity Policies, Obesogenic Behaviors and Weight Outcomes
Brief Summary: The investigators long-term goal is to advance the adoption and successful implementation of policies that promote PA and nutrition in after school programs (ASP) nationwide. The investigators objective here is two fold. First, the investigators will test the effectiveness of two promising strategies designed to 1) increase the amount of PA children accumulate while attending an ASP and 2) promote changes in the nutritional quality of the snacks served. This represents a fundamental step in establishing practice-based guidelines (best practices) for the uptake and achievement of public health policy goals (CA and Harvard). Second, the investigators will examine the barriers and facilitators to implementing these strategies. The expected outcome of this study is evidence supporting best practices for ASPs to employ to meet policy goals.


Options:
A: Body mass index (2005, 2006, 2007, 2008); nutrition behavior (2005, 2006, 2007, 2008); physical activity (2005, 2006, 2007, 2008)
B: Primary Outcome Measure: BMI (6 months, 1 year, 2 year, 5 year)
C: Change in Percentage of Children Meeting Physical Activity Policy (Spring of Year 1, Year 2, and Year 3)
D: BMI and aerobic fitness (1 schoolyear)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Behavioral Intervention to Reduce Risk of Antepartum Depression
Brief Summary: The hypotheses were as follows:

H1. Women at low-moderate risk for APD at T1 (baseline EPDS scores of 5-9) in the cognitive behavioral intervention (CBI) group will maintain low-moderate risk status and have significantly fewer APD symptoms at T2 and T3 than women at low-moderate risk for APD in the (TAU) control group (as measured by percent of participants with EPDS scores \<9 at T2 and T3 and mean score changes).

H2: Women at high risk for APD at T1 (baseline EPDS scores ≥10) in the CBI group will have a significantly greater reduction in APD symptoms at T2 and T3 than women at high risk for APD in the TAU control group (as measured by percent of participants with EPDS scores \<10 at T2 and T3 and mean score changes).


Options:
A: Infant Gestational Age (Time of delivery)
B: Reduction in perinatal and neonatal mortality (3 years)
C: Sexual behavior risk (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Lab tested STDs (Measured at 3rd trimester); Rapid repeat pregnancy (Measured at Months 6 and 12 postpartum); Low birthweight (Measured at delivery); Preterm labor (Measured at delivery); Breastfeeding (Measured at Months 6 and 12 postpartum)
D: Mean change in Edinburgh Postpartum Depression Scale (EPDS) Scores from baseline to post intervention and 1-month follow-up (Post-treatment and 1-month follow-up and an equivalent time frame for the TAU group)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Treatment With Biological Agents on Endothelial Glycocalyx,Arterial Elastic Properties, Coronary Flow, Myocardial Deformation and Twisting in Psoriasis. Comparative Study With Patients With CAD or Untreated Hypertension.
Brief Summary: Psoriasis has been associated with an increasing risk for atherosclerosis. The investigators investigated whether surrogate markers of subclinical atherosclerosis, vascular dysfunction and myocardial dysfunction are impaired in patients with psoriasis compared to normal controls ,coronary artery disease patients and untreated hypertension subjects. The investigators also examined the effect of treatment with biological vs no biological agents on vascular and LV function in psoriasis.


Options:
A: Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks (12 weeks); Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1 (12 weeks)
B: Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on endothelial function in psoriasis (12 weeks); Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on vascular function in psoriasis (12 weeks); Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on cardiac function in psoriasis (12 weeks)
C: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 (Week 12); Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status (Week 12)
D: Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1) (Week 12); Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Part 1) (Week 12); Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1) (Up to Week 12); Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1) (Up to Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Treatment With Biological Agents on Endothelial Glycocalyx,Arterial Elastic Properties, Coronary Flow, Myocardial Deformation and Twisting in Psoriasis. Comparative Study With Patients With CAD or Untreated Hypertension.
Brief Summary: Psoriasis has been associated with an increasing risk for atherosclerosis. The investigators investigated whether surrogate markers of subclinical atherosclerosis, vascular dysfunction and myocardial dysfunction are impaired in patients with psoriasis compared to normal controls ,coronary artery disease patients and untreated hypertension subjects. The investigators also examined the effect of treatment with biological vs no biological agents on vascular and LV function in psoriasis.


Options:
A: Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in Psoriasis Area and Severity Index (PASI) at Week 16 (Week 0 and Week 16)
B: Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on endothelial function in psoriasis (12 weeks); Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on vascular function in psoriasis (12 weeks); Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on cardiac function in psoriasis (12 weeks)
C: Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Number of Participants With Treatment Emergent Adverse Events (3 months); Pharmacokinetics Parameter : Skin Flux of INCB018424 (Days 8, 15, 22, and 28); Pharmacokinetics Parameter : Bioavailability of INCB018424 (Days 8, 15, 22, and 28)
D: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (12 Weeks); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 (12 Weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Treatment With Biological Agents on Endothelial Glycocalyx,Arterial Elastic Properties, Coronary Flow, Myocardial Deformation and Twisting in Psoriasis. Comparative Study With Patients With CAD or Untreated Hypertension.
Brief Summary: Psoriasis has been associated with an increasing risk for atherosclerosis. The investigators investigated whether surrogate markers of subclinical atherosclerosis, vascular dysfunction and myocardial dysfunction are impaired in patients with psoriasis compared to normal controls ,coronary artery disease patients and untreated hypertension subjects. The investigators also examined the effect of treatment with biological vs no biological agents on vascular and LV function in psoriasis.


Options:
A: Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 (12 weeks); Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 (12 Weeks)
B: Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at Week 16 (Week 16); Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16 (Week 16)
C: Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on endothelial function in psoriasis (12 weeks); Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on vascular function in psoriasis (12 weeks); Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on cardiac function in psoriasis (12 weeks)
D: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) (Week 16); Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) (Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Treatment With Biological Agents on Endothelial Glycocalyx,Arterial Elastic Properties, Coronary Flow, Myocardial Deformation and Twisting in Psoriasis. Comparative Study With Patients With CAD or Untreated Hypertension.
Brief Summary: Psoriasis has been associated with an increasing risk for atherosclerosis. The investigators investigated whether surrogate markers of subclinical atherosclerosis, vascular dysfunction and myocardial dysfunction are impaired in patients with psoriasis compared to normal controls ,coronary artery disease patients and untreated hypertension subjects. The investigators also examined the effect of treatment with biological vs no biological agents on vascular and LV function in psoriasis.


Options:
A: Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment (12 weeks); Participants With IGA Mod 2011 0 or 1 After 12 Weeks of Treatment (12 weeks)
B: Proportion of subjects with clinical response relative to Baseline PASI score (Week 12, Week 40 and Week 60)
C: Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on endothelial function in psoriasis (12 weeks); Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on vascular function in psoriasis (12 weeks); Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on cardiac function in psoriasis (12 weeks)
D: Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12 (Week 12); Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Telephone Counseling for Pregnant Smokers
Brief Summary: This purpose of the study was to investigate the efficacy of telephone counseling to help pregnant women quit smoking. The investigators tested two hypotheses: 1) telephone counseling increases the overall cessation rate during pregnancy, and 2) the counseling effects can be maintained postpartum.


Options:
A: evaluate and provide a model of smoking cessation interventions
B: Blood Pressure, Health-Related Quality of Life(Medical outcome Study Short Form-36) (Baseling, 12month, 24month)
C: 30 days prolonged abstinence (6-months postpartum)
D: proportion of smokers in each group who call the Minnesota Quitline, and changes in supportive behaviors among the support persons as measured by the Support Provided Measure. (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis Among Infants in Niger
Brief Summary: The study is a double-blinded, randomized, placebo-controlled, trial with two groups of infants receiving vaccine or placebo to assess the efficacy and safety of BRV-PV. Three doses of BRV-PV containing ≥ Log10 5.6 FFU/Dose of each serotype G1, G2, G3, G4 and G9 will be administered at 4 week intervals between doses. The first administration will occur at 6-8 weeks of age.

We hypothesize a difference in vaccine efficacy of three doses of BRV-PV vaccine vs. placebo against severe rotavirus gastroenteritis in healthy infants in Niger.

Active surveillance for gastroenteritis episodes will be conducted throughout the trial. Surveillance for adverse events will be carried out among all children from the time of first vaccination and 28 days post-Dose 3. Surveillance for all serious adverse events, including intussusception and death, will be conducted on all participants until they each reach two years of age.

To assess the effect of prenatal nutrition supplementation on infant immune response to the BRV-PV vaccine, study villages in the immunogenicity sub-cohort will be randomized in a 1:1:1 ratio to provide pregnant women with daily iron-folate, multiple micronutrients or a lipid-based nutrition supplement. Infants of participating women, if eligible at 6-8 weeks of age, will be randomized in a 1:1 ratio to receive three doses of vaccine or placebo and enter the main trial as part of the immunogenicity sub-cohort.


Options:
A: Laboratory-confirmed episode of severe rotavirus gastroenteritis (From 28 days post-Dose 3 until 117 cases are accrued or when all participating infants reach 2 years of age if 117 cases are not attained)
B: Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype (28 days after the second dose of MCC vaccine (approximately 20 weeks))
C: Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea (Within the 15-day solicited follow-up period after any dose)
D: Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay (3-6 weeks after the last vaccination); Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay (3-6 weeks after the last vaccination); Geometric Mean Serum Anti-rotavirus IgA Titer (3-6 weeks after the last dose of vaccine)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis Among Infants in Niger
Brief Summary: The study is a double-blinded, randomized, placebo-controlled, trial with two groups of infants receiving vaccine or placebo to assess the efficacy and safety of BRV-PV. Three doses of BRV-PV containing ≥ Log10 5.6 FFU/Dose of each serotype G1, G2, G3, G4 and G9 will be administered at 4 week intervals between doses. The first administration will occur at 6-8 weeks of age.

We hypothesize a difference in vaccine efficacy of three doses of BRV-PV vaccine vs. placebo against severe rotavirus gastroenteritis in healthy infants in Niger.

Active surveillance for gastroenteritis episodes will be conducted throughout the trial. Surveillance for adverse events will be carried out among all children from the time of first vaccination and 28 days post-Dose 3. Surveillance for all serious adverse events, including intussusception and death, will be conducted on all participants until they each reach two years of age.

To assess the effect of prenatal nutrition supplementation on infant immune response to the BRV-PV vaccine, study villages in the immunogenicity sub-cohort will be randomized in a 1:1:1 ratio to provide pregnant women with daily iron-folate, multiple micronutrients or a lipid-based nutrition supplement. Infants of participating women, if eligible at 6-8 weeks of age, will be randomized in a 1:1 ratio to receive three doses of vaccine or placebo and enter the main trial as part of the immunogenicity sub-cohort.


Options:
A: Endpoint: immunogenicity and reactogenicity; Proportion of subjects with vaccine take
B: Laboratory-confirmed episode of severe rotavirus gastroenteritis (From 28 days post-Dose 3 until 117 cases are accrued or when all participating infants reach 2 years of age if 117 cases are not attained)
C: Immunogenicity of rotavirus vaccine (28 days post dose 3)
D: Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea (Within the 15-day solicited follow-up period after any dose)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis Among Infants in Niger
Brief Summary: The study is a double-blinded, randomized, placebo-controlled, trial with two groups of infants receiving vaccine or placebo to assess the efficacy and safety of BRV-PV. Three doses of BRV-PV containing ≥ Log10 5.6 FFU/Dose of each serotype G1, G2, G3, G4 and G9 will be administered at 4 week intervals between doses. The first administration will occur at 6-8 weeks of age.

We hypothesize a difference in vaccine efficacy of three doses of BRV-PV vaccine vs. placebo against severe rotavirus gastroenteritis in healthy infants in Niger.

Active surveillance for gastroenteritis episodes will be conducted throughout the trial. Surveillance for adverse events will be carried out among all children from the time of first vaccination and 28 days post-Dose 3. Surveillance for all serious adverse events, including intussusception and death, will be conducted on all participants until they each reach two years of age.

To assess the effect of prenatal nutrition supplementation on infant immune response to the BRV-PV vaccine, study villages in the immunogenicity sub-cohort will be randomized in a 1:1:1 ratio to provide pregnant women with daily iron-folate, multiple micronutrients or a lipid-based nutrition supplement. Infants of participating women, if eligible at 6-8 weeks of age, will be randomized in a 1:1 ratio to receive three doses of vaccine or placebo and enter the main trial as part of the immunogenicity sub-cohort.


Options:
A: To assess immunogenicity of a new rotavirus vaccine Rotavin-M1 in terms of anti-rotavirus IgA antibody seroconversion 1 month after complete the vaccination schedule (up to 7 months)
B: Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. (30 Days post-dose 3 vaccination); Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) (30 Days post-dose 3 vaccination); Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. (30 Days post-dose 3 vaccination.)
C: Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] (42 days after vaccination 3 (up to 185 days))
D: Laboratory-confirmed episode of severe rotavirus gastroenteritis (From 28 days post-Dose 3 until 117 cases are accrued or when all participating infants reach 2 years of age if 117 cases are not attained)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN) Junior
Brief Summary: The main purpose of this study is to investigate whether and in which doses vitamin D intake is needed in order to maintain an adequate vitamin D status in 4-8 year-old Danish children during wintertime.


Options:
A: Change in vitamin D status (Baseline and 20 weeks)
B: Examine the effect of D2 vs D3 supplementation on serum 25-OH and 1,25 OH vitamin D levels (During acute phase postburn)
C: Vitamin D plasma concentrations (12 months)
D: Weight gain in children (2 Months)

Answer: A