TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Community-Academic Partnership to Address Disparities in Obesity Among Youth
Brief Summary: Objectives: We conducted a randomized controlled trial (RCT) of Students for Nutrition and eXercise (SNaX), a middle-school-based obesity-prevention intervention combining school-wide environmental changes, multimedia, encouragement to eat healthy school cafeteria foods, and peer-led education and marketing.

Methods: We randomly selected schools from the Los Angeles Unified School District (LAUSD) and assigned five to the intervention group and five to a wait-list control group. School records were obtained for number of fruits and vegetables served, students served lunch, and snacks sold per attending student. Pre- and post-intervention surveys assessed psychosocial variables among 2,997 seventh-graders (75% of all seventh-graders across schools).

Hypotheses: For the RCT of SNaX, we hypothesized that SNaX would lead to increases in the proportion of students served in the cafeteria (because SNaX markets cafeterias' healthy foods); increased fruit and vegetable servings (because SNaX increases access to sliced/bite-sized fruits and vegetables); decreased school store snack sales; and greater water consumption. We also hypothesized that SNaX would lead to more positive attitudes about the cafeteria and water, improve obesity-prevention knowledge, and increase intentions to drink water.


Options:
A: Number of students obtaining lunch per day by National School Lunch Program (NSLP) eligibility (5 months); Number of fruits and vegetables served per day (5 months)
B: Change in Body Mass Index From T1 to T3 (T1 (Baseline) to T3 (9 months-post baseline)); Change in Total Body Weight From T1 to T3 (T1 (baseline) to T3 (9-month post baseline)); Change in Pounds of Body Fat From T1 to T3 (T1 ( Baseline) to T3 (9-months post baseline))
C: Minutes of Moderate to Vigorous Physical Activity (MVPA) Post-intervention (Minutes of moderate to vigorous physical activity per hour at post-intervention (after 17-week intervention))
D: standardized body mass index (zbmi)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Randomized, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Asthmatic Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist (CALIMA)
Brief Summary: The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers.


Options:
A: Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control (Week 28)
B: Maximum Percentage Decrease in Forced Expiratory Volume in 1 Second (FEV1) at 3 to 7 Hours Post Allergen Challenge (Days 42 and 84 at pre-allergen challenge and at 180, 240, 300, 360, and 420 minutes (3-7 hours) post allergen challenge); Time-Adjusted Area Under the Curve for the Percent Decrease From Pre-Allergen Challenge in Forced Expiratory Volume in 1 Second (FEV1) From 3 to 7 Hours Post Allergen Challenge (Days 42 and 84 at pre-challenge and at 180, 240, 300, 360, and 420 minutes (3-7 hours) post challenge)
C: Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL (Immediately following the first administration of study drug through Study Week 56.)
D: Percentage of Participants With First Clinically Significant Exacerbation in Part C (Weeks 12, 24, 36 and 52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Randomized, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Asthmatic Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist (CALIMA)
Brief Summary: The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers.


Options:
A: Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants (Week 1 up to Week 52)
B: Incidence and nature of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results (Throughout study or until early discontinuation); Incidence, nature, and severity of adverse events (Throughout study or until early discontinuation)
C: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in Full Analysis Set (Baseline (Day 1), Week 16)
D: Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL (Immediately following the first administration of study drug through Study Week 56.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder
Brief Summary: This 3-year study is a trial of cognitive behavioral therapy (CBT), with or without oxytocin (OT) augmentation, in young adults with autism spectrum disorders. Participants will be randomly assigned to receive either a social skills-focused CBT intervention or a stress management/relaxation training CBT intervention. Participants will also be randomized to receive either a) intranasal oxytocin or b) a placebo drug, prior to the psychotherapy. The design of the study will enable examination of the efficacy of CBT for young adults with autism spectrum disorders. The design of the study will also allow examination of whether oxytocin enhances the efficacy of CBT.

The investigators will perform functional (fMRI) and structural (MRI) imaging with all participants prior to treatment. This will enable examination of the relations between measures of brain function and structure, and improvements in target symptoms over the course of treatment. The aim is to discover whether there are neural characteristics that can identify which participants with autism spectrum disorders are most likely to respond to CBT interventions and/or oxytocin treatment.


Options:
A: Efficacy: Behavior assessments (up to 24 hours post-dose); Safety: Incidence of adverse events (up to 24 hours post-dose)
B: Change From Baseline in Brain Activity During Task (Task-based fMRI) After a Single Dose of Nasal Spray (Value at 30 minutes minus value at baseline); Change From Baseline in Brain Activity During Task (Task-based fMRI) After 4 Weeks of Nasal Spray (Value at 4 weeks minus value at baseline); Change From Baseline in Brain Activity During Task (Task-based fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray (Value at 8 weeks minus value at baseline); Change From Baseline in Brain Activity During Task (Task-based fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray (Value at 52 weeks minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray (Value at 30 minutes minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 4 Weeks of Nasal Spray (Value at 4 weeks minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray (Value at 8 weeks minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray (Value at 52 weeks minus value at baseline)
C: Social Responsiveness Scale (SRS) Change (Completed at Baseline and Week 11); Social Responsiveness Scale (SRS) at Follow-Up (Completed at Week 22)
D: Changes in the Autism Diagnostic Observation Schedule (ADOS) (At baseline and after 12 weeks of treatment); Clinical Global Impression Scale (CGI) (At baseline and every 4 week up to 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder
Brief Summary: This 3-year study is a trial of cognitive behavioral therapy (CBT), with or without oxytocin (OT) augmentation, in young adults with autism spectrum disorders. Participants will be randomly assigned to receive either a social skills-focused CBT intervention or a stress management/relaxation training CBT intervention. Participants will also be randomized to receive either a) intranasal oxytocin or b) a placebo drug, prior to the psychotherapy. The design of the study will enable examination of the efficacy of CBT for young adults with autism spectrum disorders. The design of the study will also allow examination of whether oxytocin enhances the efficacy of CBT.

The investigators will perform functional (fMRI) and structural (MRI) imaging with all participants prior to treatment. This will enable examination of the relations between measures of brain function and structure, and improvements in target symptoms over the course of treatment. The aim is to discover whether there are neural characteristics that can identify which participants with autism spectrum disorders are most likely to respond to CBT interventions and/or oxytocin treatment.


Options:
A: Rate of Recruitment (19 months)
B: Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity (Least Mean Squares Double-blind phase: change from baseline to week 24); Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity (Least mean squares for Open Label: Change between weeks 24-48)
C: Changes in the Autism Diagnostic Observation Schedule (ADOS) (At baseline and after 12 weeks of treatment); Clinical Global Impression Scale (CGI) (At baseline and every 4 week up to 12 weeks)
D: Yale-Brown Obsessive Compulsive Scale (YBOCS): to measure repetitive behaviors (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks); Aberrant Behavior Checklist (ABC): to measure aggression and irritability (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks); Clinical Global Impression - Improvement (CGI-I): to measure global functioning (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder
Brief Summary: This 3-year study is a trial of cognitive behavioral therapy (CBT), with or without oxytocin (OT) augmentation, in young adults with autism spectrum disorders. Participants will be randomly assigned to receive either a social skills-focused CBT intervention or a stress management/relaxation training CBT intervention. Participants will also be randomized to receive either a) intranasal oxytocin or b) a placebo drug, prior to the psychotherapy. The design of the study will enable examination of the efficacy of CBT for young adults with autism spectrum disorders. The design of the study will also allow examination of whether oxytocin enhances the efficacy of CBT.

The investigators will perform functional (fMRI) and structural (MRI) imaging with all participants prior to treatment. This will enable examination of the relations between measures of brain function and structure, and improvements in target symptoms over the course of treatment. The aim is to discover whether there are neural characteristics that can identify which participants with autism spectrum disorders are most likely to respond to CBT interventions and/or oxytocin treatment.


Options:
A: Changes in the Irritability Subscale of the Larger ABC (Abberent Behavior Checklist) That Occur From Baseline to 10 Weeks (baseline to 10 weeks)
B: Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents (week 10); Percentage of Participants Who Were Autism Spectrum Disorder Respondents (week 10)
C: Changes in the Autism Diagnostic Observation Schedule (ADOS) (At baseline and after 12 weeks of treatment); Clinical Global Impression Scale (CGI) (At baseline and every 4 week up to 12 weeks)
D: Number of Participants Reporting Improvement on the Clinical Global Impression (Baseline to end of study (week 15)); Change in Aberrant Behaviors as Measured by the Aberrant Behavior Checklist Scores (Baseline and End of Study (week 15))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Determining Optimal Post-Stroke Exercise (DOSE)
Brief Summary: The investigators will conduct a proof-of-concept study to provide preliminary evidence of efficacy of physical exercise dose on ambulatory function in adults undergoing sub-acute stroke rehabilitation.


Options:
A: Fugl-Meyer Assessment (upper extremity subscale) (0-, 4- week)
B: Disability (three months)
C: Ambulatory function measured by the Six Minute Walk Test (Rehabilitation discharge (average 4-5 weeks post admission))
D: Change in peak walking speed (At baseline, following 8 weeks of training and a 2 month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Determining Optimal Post-Stroke Exercise (DOSE)
Brief Summary: The investigators will conduct a proof-of-concept study to provide preliminary evidence of efficacy of physical exercise dose on ambulatory function in adults undergoing sub-acute stroke rehabilitation.


Options:
A: Change from baseline in walking abilities, balance and mobility in Six minutes walking test (6MWT) (1)A week prior to treatment beginning 2) the week after treatment end 3) three months follow up.)
B: Ambulatory function measured by the Six Minute Walk Test (Rehabilitation discharge (average 4-5 weeks post admission))
C: Change in the Reintegration to Normal Living Index (RNL) from baseline (baseline, 12 weeks, 24 weeks)
D: Change in Rivermead Mobility index (Baseline, 6 months, 9 months); Change in Timed Up and Go Test (Baseline, 6 months, 9 months); Change in Modified Patient Specific Functional Scale (Baseline, 6 months, 9 months); Change in Physical Activity Diary (Baseline, 6 months, 9 months); Change in Physical activity - 7-day accelerometry (Baseline, 6 months, 9 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Determining Optimal Post-Stroke Exercise (DOSE)
Brief Summary: The investigators will conduct a proof-of-concept study to provide preliminary evidence of efficacy of physical exercise dose on ambulatory function in adults undergoing sub-acute stroke rehabilitation.


Options:
A: Ambulatory function measured by the Six Minute Walk Test (Rehabilitation discharge (average 4-5 weeks post admission))
B: Trunk Impairment Scale Norwegian Version (12 weeks); ActiGraph WgtX-BT (13 weeks)
C: The change in Tinetti Performance Oriented Mobility Assessment (week 0, week 5, and week 9)
D: Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK (between day 0 and month 3)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Randomized, Assessor-blind, Comparator-Controlled, Parallel-Group Clinical Trial to Establish the Efficacy and Safety of Duac™(1% Clindamycin as Clindamycin Phosphate and 5% Benzoyl Peroxide) Once Daily Gel Compared With Clindamycin Phosphate Gel (1% Clindamycin as Clindamycin Phosphate) Twice Daily in the Treatment of Mild to Moderate Acne Vulgaris.
Brief Summary: This is a multicentre, randomized, assessor-blind, comparator-controlled evaluation of the efficacy, safety, and tolerability of Duac™Once Daily Gel and clindamycin phosphate gel in the topical treatment of mild to moderate facial acne vulgaris. A total of 1020 subjects will be enrolled, 510 per study arm. The subjects will be males and females between 12 and 45 years of age, inclusive, at the time of consent, who have mild to moderate facial acne vulgaris.

Subjects will use Duac™Once Daily Gel (once daily in the evening) or clindamycin phosphate gel twice daily (once in the morning and once in the evening) for 12 weeks. The subjects will be evaluated for change in lesion counts, investigator's static global assessment (ISGA), subject's global assessment (SGA), local tolerability and AEs/SAEs at Weeks0, 1, 2, 4, 8, and 12 (or at early withdrawal). In addition, quality of life measures will be performed at every study visit.


Options:
A: Percent Change in Total Lesion Counts (TLs) From Baseline to Week 2 (Baseline (Day 1) and Week 2)
B: Absolute Change in Total Lesion Count From Baseline to Week 12 (Baseline (Week 0) and Week 12); Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12 (Baseline (Week 0) and Week 12); Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12 (Baseline (Week 0) and Week 12)
C: Part 1: Total Atrophic Acne Scar Count Per Half-face (Week 24)
D: Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward) (At Week 12); Change in Inflammatory Lesion Count From Baseline to Week 12 (Baseline to Week 12); Change in Noninflammatory Lesion Count From Baseline to Week 12 (Baseline to Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Complex Mental and Social Activities to Promote Cognitive Function in Older Adults With Chronic Stroke: A Randomized Controlled Trial
Brief Summary: The investigators will conduct a randomized controlled trial study to provide preliminary evidence of efficacy of exercise training or a complex mental and social activities program for improving cognitive function in older adults with chronic stroke, compared with a stretch and relaxation program.


Options:
A: Canadian Occupational Performance Measure (COPM) (enrollment)
B: Patient Participation (12 and 36 weeks)
C: Change from baseline in cognitive function as measured by the Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus) at 6 months (Baseline and 6 months)
D: Stroke Self-efficacy questionnaire (Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Foley OR MisO for the Management of Induction (FOR MOMI) Trial
Brief Summary: The percentage of women undergoing an induction of labor (IOL) is estimated to be 20% and continues to rise. Simultaneously, the cesarean delivery (CD) rate has continued to increase (2). Induction is a known risk factor for CD. Despite numerous studies evaluating time periods to define a failed IOL, there are no guidelines or accepted definitions of when to call an IOL failed given the incremental gain in vaginal delivery when IOL is prolonged. While decreasing the CD rate is an important primary focus in obstetrics, attention must also be paid to the overall length of labor given that prolonged labor is associated with adverse maternal and neonatal outcomes. Furthermore, a prolonged labor is associated with an increase in direct hospital costs and healthcare utilization. The use of cervical ripening agents, such as vaginal prostaglandin and mechanical dilators, has been demonstrated to reduce labor time and CD rate. In addition to specific individual agents, certain dosing and regimens for IOL and active labor have been compared to evaluate whether a particular dose or regimen can decrease the length of labor and decrease the CD rate. Most of these regimens; however, focus on individual induction agents and few have compared the efficacy of using more than one agent simultaneously. Given the associated risks of prolonged labor and limited data evaluating the use of combined cervical ripening agents, our objective is to evaluate the difference in time to delivery among women who undergo an IOL with four different methods.


Options:
A: Time Of Start Of Induction Of Labor To Delivery (Hours)
B: Number of Participants With a Need for Cesarean Delivery (Induction to delivery)
C: To evaluate and compare the efficacy of the Atad Ripening Device (ARD), of the double balloon instillation device (AID) with concomitant continuous extra-amniotic NS instillation - 50 Ml/hour and of the folly catheter combined with continuous extra-a (2 years)
D: Time to Delivery (Hours between start of induction to delivery); Length of Stay (Days between admit to hospital and discharge); Severe RDS (enrollment through neonatal discharge)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Foley OR MisO for the Management of Induction (FOR MOMI) Trial
Brief Summary: The percentage of women undergoing an induction of labor (IOL) is estimated to be 20% and continues to rise. Simultaneously, the cesarean delivery (CD) rate has continued to increase (2). Induction is a known risk factor for CD. Despite numerous studies evaluating time periods to define a failed IOL, there are no guidelines or accepted definitions of when to call an IOL failed given the incremental gain in vaginal delivery when IOL is prolonged. While decreasing the CD rate is an important primary focus in obstetrics, attention must also be paid to the overall length of labor given that prolonged labor is associated with adverse maternal and neonatal outcomes. Furthermore, a prolonged labor is associated with an increase in direct hospital costs and healthcare utilization. The use of cervical ripening agents, such as vaginal prostaglandin and mechanical dilators, has been demonstrated to reduce labor time and CD rate. In addition to specific individual agents, certain dosing and regimens for IOL and active labor have been compared to evaluate whether a particular dose or regimen can decrease the length of labor and decrease the CD rate. Most of these regimens; however, focus on individual induction agents and few have compared the efficacy of using more than one agent simultaneously. Given the associated risks of prolonged labor and limited data evaluating the use of combined cervical ripening agents, our objective is to evaluate the difference in time to delivery among women who undergo an IOL with four different methods.


Options:
A: Delivery Rate (Within 24 hours)
B: Time to Delivery (an average of 20 hours, up to 40 hours)
C: Time to Delivery (Hours between start of induction to delivery); Length of Stay (Days between admit to hospital and discharge); Severe RDS (enrollment through neonatal discharge)
D: caesarean section rate (1 year)

Answer: C