TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Caregivers/Healthy Children
Brief Summary: Background: Many unhealthy dietary and physical activity habits that foster the development of obesity are established by the age of five. Presently, approximately 70 percent of children in the United States are currently enrolled in early childcare facilities, making this an ideal setting to implement and evaluate childhood obesity prevention efforts. We describe here the methods for conducting an obesity prevention intervention randomized trial in the child care setting.

Methods/Design: A randomized, controlled obesity prevention trial in 28 low-income, ethnically diverse child care centers located throughout Miami-Dade County, FL is currently being conducted over two years (2010-present) to test the efficacy of an intervention that poises teachers and parents as lifestyle change agents. The Healthy Caregivers-Healthy Children (HC2) program includes a curriculum focusing specifically on healthy food choices, increased exercise, and role modeling. The program targets food policy changes throughout the school, and via the child, caregiver, and teacher. Major outcome measures include child body mass index percentile and z score, fruit and vegetable and other nutritious food intake, and amount of physical activity.

Discussion: Although few attempts have been made to prevent obesity during the first years of life, this period may represent the best opportunity for obesity prevention. Findings from this investigation should inform both the fields of childhood obesity prevention and early childhood research about the effects of an obesity prevention program housed in the childcare setting. (H1) A child care center-based obesity prevention intervention program that includes a teacher and parent nutritional gatekeeper and role modeling program will be more effective in maintaining BMI in 3-5 year olds compared to a control group.

(H2) Role modeling (teacher and parent) will be identified as a significant mediator in preventing obesity among intervention children versus controls.

(H3) A child care center-based multi-level obesity prevention intervention program will improve child nutrition (increased consumption of fruits and vegetables, decreased consumption of sweetened beverages) and increase physical activity level compared to a control group.


Options:
A: Maintenance of a Child's Body Mass Index as a result of the intervention (up to two years)
B: Breastfeeding Initiation (first month after birth of child)
C: Increase physical activity (2010); Increase the intake of fiber (2010); Decrease fat intake (2010); Decrease television and other screen time (2010); Decrease obesity (2010)
D: BMI percentile at 3 years (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Caregivers/Healthy Children
Brief Summary: Background: Many unhealthy dietary and physical activity habits that foster the development of obesity are established by the age of five. Presently, approximately 70 percent of children in the United States are currently enrolled in early childcare facilities, making this an ideal setting to implement and evaluate childhood obesity prevention efforts. We describe here the methods for conducting an obesity prevention intervention randomized trial in the child care setting.

Methods/Design: A randomized, controlled obesity prevention trial in 28 low-income, ethnically diverse child care centers located throughout Miami-Dade County, FL is currently being conducted over two years (2010-present) to test the efficacy of an intervention that poises teachers and parents as lifestyle change agents. The Healthy Caregivers-Healthy Children (HC2) program includes a curriculum focusing specifically on healthy food choices, increased exercise, and role modeling. The program targets food policy changes throughout the school, and via the child, caregiver, and teacher. Major outcome measures include child body mass index percentile and z score, fruit and vegetable and other nutritious food intake, and amount of physical activity.

Discussion: Although few attempts have been made to prevent obesity during the first years of life, this period may represent the best opportunity for obesity prevention. Findings from this investigation should inform both the fields of childhood obesity prevention and early childhood research about the effects of an obesity prevention program housed in the childcare setting. (H1) A child care center-based obesity prevention intervention program that includes a teacher and parent nutritional gatekeeper and role modeling program will be more effective in maintaining BMI in 3-5 year olds compared to a control group.

(H2) Role modeling (teacher and parent) will be identified as a significant mediator in preventing obesity among intervention children versus controls.

(H3) A child care center-based multi-level obesity prevention intervention program will improve child nutrition (increased consumption of fruits and vegetables, decreased consumption of sweetened beverages) and increase physical activity level compared to a control group.


Options:
A: 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))
B: Maintenance of a Child's Body Mass Index as a result of the intervention (up to two years)
C: Number of parents engaging with the HENRY programme measured using Centre level process data (12 month post randomisation (allowing 3 months for Optimisation intervention implementation and collecting data from 1- 2 HENRY courses per site).)
D: Exhibited emotion, Feeding decisions, self-reported attitudes, beliefs and intentions; perceptual responses (At lab visit)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Community-embedded Reproductive Health Care for Adolescents in Latin America (CERCA).
Brief Summary: Adolescents in Latin America are at major risk for unwanted pregnancies leading to unsafe abortions and maternal health risks. Mostly, adolescent health programmes tend to focus on unidirectional interventions aiming at a single determinant of adolescents´ sexual and reproductive health. However, evidence exists that a complex health problem should be addressed by an equally nuanced and multipronged response. Knowledge is lacking on how to develop a comprehensive approach to promote adolescents' sexual health.

The CERCA study will conduct an implementation based on the hypothesis that a comprehensive strategy of community-embedded interventions helps to improve the sexual health of adolescents. We will test this hypothesis and describe the development, implementation and testing of interventions in three Latin American cities: Cochabamba (Bolivia), Cuenca (Ecuador) and Managua (Nicaragua).

The research methodology has been designed based on the methodological frameworks of action research, community based participatory research and intervention mapping.

The interventions are complex addressing different target groups (adolescents, parents, authorities and health providers) and focussing on various behaviours that are related to communication about sexuality, information seeking, access to health care and safe sexual intercourse.

For the evaluation of effectiveness a randomised and non-randomised controlled study was developed for respectively Managua and the two other cities. Furthermore a process evaluation is conducted.

This research will result in a framework that will contribute to the planning of interventions that are effective and responsive to adolescents' sexual health needs.


Options:
A: Appropriate treatment of malaria, pneumonia and diarrhoea in children under five years of age (1 year)
B: Change in Emergency Department Visits + Hospital Days (Pre-Intervention (09/01/2012 to 03/09/2014); Post-Intervention (03/10/2014-09/30/2015)
C: Self-reported use of modern contraceptives at 18 months of interventions. (At 18 months of intervention)
D: glycosylated hemoglobin (36 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Recovery After Laparoscopic Hysterectomy With Deep Neuromuscular Blockade and Low Intra-abdominal Pressure
Brief Summary: The purpose of this study on laparoscopic hysterectomy is to investigate postoperative pain. Patients are allocated to either deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) or moderate neuromuscular blockade and usual intra-abdominal pressure (12 mmHg).

Primary hypothesis:

Deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) reduces postoperative pain compared to moderate neuromuscular blockade and intra-abdominal pressure (12 mmHg).


Options:
A: The severity and frequency of upper abdominal and shoulder pain after laparoscopic surgery (The first 48 hours after the surgery)
B: Shoulder Pain (within 14 days)
C: the severity and frequency of shoulder-tip pain after laparoscopic surgery (the first 48 hours after the surgery)
D: Intensity of shoulder pain (48 hours after discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Multicenter Placebo-controlled Trial on the Effect of Adalumumab on Vascular Inflammation in Patient With Moderate to Severe Psoriasis
Brief Summary: This study is a double-blinded randomized multicenter placebo controlled trial to determine the effect of adalimumab on vascular inflammation (ascending aorta and carotides) in patients with moderate to severe psoriasis.


Options:
A: Change from baseline in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the ascending aorta at Week 16 for patients randomized to adalimumab as compared to patients randomized to placebo (Baseline, Week 16 and Week 52 or 68)
B: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 (At Week 16); Percentage of Participants With an Investigator's Global Assessment (IGA) Response at Week 16 (At Week 16)
C: PASI 75 (16 weeks); Physician Global Assessment, PGA (16 weeks)
D: Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 (Week 12, as compared to Week 0 (baseline))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Multicenter Placebo-controlled Trial on the Effect of Adalumumab on Vascular Inflammation in Patient With Moderate to Severe Psoriasis
Brief Summary: This study is a double-blinded randomized multicenter placebo controlled trial to determine the effect of adalimumab on vascular inflammation (ascending aorta and carotides) in patients with moderate to severe psoriasis.


Options:
A: Change from baseline in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the ascending aorta at Week 16 for patients randomized to adalimumab as compared to patients randomized to placebo (Baseline, Week 16 and Week 52 or 68)
B: Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria (Week 24)
C: The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo. (13 weeks)
D: Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B) (Weeks 4, 8 12, and 16 (Period B)); Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B) (Weeks 4, 8, 12, and 16 (Period B)); Percentage of Participants Achieving a PASI75 Response During CP-690,550 Re-Treatment (Period C) Among Those Who Had a Greater Than (>)50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B) (Baseline and Weeks 4, 8, and 16 (Period C)); Percentage of Participants Achieving a PGA Response of Clear or Almost Clear During CP-690,550 Re-treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe During Double-Blind Treatment Withdrawal (Period B) (Baseline and Weeks 4, 8, and 16 (Period C))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Multicenter Placebo-controlled Trial on the Effect of Adalumumab on Vascular Inflammation in Patient With Moderate to Severe Psoriasis
Brief Summary: This study is a double-blinded randomized multicenter placebo controlled trial to determine the effect of adalimumab on vascular inflammation (ascending aorta and carotides) in patients with moderate to severe psoriasis.


Options:
A: Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B) (Weeks 4, 8 12, and 16 (Period B)); Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B) (Weeks 4, 8, 12, and 16 (Period B)); Percentage of Participants Achieving a PASI75 Response During CP-690,550 Re-Treatment (Period C) Among Those Who Had a Greater Than (>)50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B) (Baseline and Weeks 4, 8, and 16 (Period C)); Percentage of Participants Achieving a PGA Response of Clear or Almost Clear During CP-690,550 Re-treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe During Double-Blind Treatment Withdrawal (Period B) (Baseline and Weeks 4, 8, and 16 (Period C))
B: Change from baseline in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the ascending aorta at Week 16 for patients randomized to adalimumab as compared to patients randomized to placebo (Baseline, Week 16 and Week 52 or 68)
C: Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 (Week 16)
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Multicenter Placebo-controlled Trial on the Effect of Adalumumab on Vascular Inflammation in Patient With Moderate to Severe Psoriasis
Brief Summary: This study is a double-blinded randomized multicenter placebo controlled trial to determine the effect of adalimumab on vascular inflammation (ascending aorta and carotides) in patients with moderate to severe psoriasis.


Options:
A: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 (Week 16); Percentage of Participants With an Investigator's Global Assessment (IGA) Response (Clear or Almost Clear With at Least 2-Category Improvement Relative to Baseline) at Week 16 (Week 16)
B: Change from baseline in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the ascending aorta at Week 16 for patients randomized to adalimumab as compared to patients randomized to placebo (Baseline, Week 16 and Week 52 or 68)
C: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) (Week 16)
D: Number of Patients Experiencing One or More Adverse Events Occurring From Week 0 Through Week 12 (from week 0 to week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 64-Week, Phase 3, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-010)
Brief Summary: This study is being conducted to evaluate the efficacy and safety/tolerability of subcutaneous tildrakizumab (MK-3222), followed by an optional long-term safety extension study, in participants with moderate-to-severe chronic plaque psoriasis.


Options:
A: Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48 (Week 48)
B: N/A
C: 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)
D: Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study) (Week 12 (or end of trial if prior to 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 (Base Study) (Baseline and Week 12 (or end of trial if prior to Week 12)); Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study) (Up to 12 weeks); Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study) (Up to 12 weeks); Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study) (Up to 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 64-Week, Phase 3, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-010)
Brief Summary: This study is being conducted to evaluate the efficacy and safety/tolerability of subcutaneous tildrakizumab (MK-3222), followed by an optional long-term safety extension study, in participants with moderate-to-severe chronic plaque psoriasis.


Options:
A: Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study) (Week 12 (or end of trial if prior to 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 (Base Study) (Baseline and Week 12 (or end of trial if prior to Week 12)); Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study) (Up to 12 weeks); Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study) (Up to 12 weeks); Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study) (Up to 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 a PASI 75 Response at Week 12 (Baseline and week 12)
D: Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12 (Baseline and Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 64-Week, Phase 3, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-010)
Brief Summary: This study is being conducted to evaluate the efficacy and safety/tolerability of subcutaneous tildrakizumab (MK-3222), followed by an optional long-term safety extension study, in participants with moderate-to-severe chronic plaque psoriasis.


Options:
A: 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)
B: Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study) (Week 12 (or end of trial if prior to 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 (Base Study) (Baseline and Week 12 (or end of trial if prior to Week 12)); Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study) (Up to 12 weeks); Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study) (Up to 12 weeks); Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study) (Up to 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: Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12 (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 64-Week, Phase 3, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-010)
Brief Summary: This study is being conducted to evaluate the efficacy and safety/tolerability of subcutaneous tildrakizumab (MK-3222), followed by an optional long-term safety extension study, in participants with moderate-to-severe chronic plaque psoriasis.


Options:
A: 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)
B: Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 (Baseline, Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Week 16); Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Week 52)
C: Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study) (Week 12 (or end of trial if prior to 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 (Base Study) (Baseline and Week 12 (or end of trial if prior to Week 12)); Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study) (Up to 12 weeks); Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study) (Up to 12 weeks); Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study) (Up to 12 weeks)
D: Long-term Safety and Tolerability of Secukinumab (Week 268)

Answer: C