TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An Analysis of Behavioral Economic Interventions at Client-Choice Food Pantries
Brief Summary: The investigators run a series of behavioral economic interventions at client-choice food pantries to encourage clients to choose targeted foods.


Options:
A: Change in the selection of meal components (Selection of entrees, milk, fruits, and vegetables) (baseline, up to 3 months post-implementation, and up to 7 months post-implementation); Change in the consumption of meal components (consumption of entrees, milk, fruits, and vegetables) (baseline, up to 3 months post-implementation, and up to 7 months post-implementation)
B: Energy density of the diet (Weeks 0 and 13)
C: Number of Targeted Products Selected Relative to Others (up to 8 months)
D: Intake of vegetables and fruit (One month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Analysis of Behavioral Economic Interventions at Client-Choice Food Pantries
Brief Summary: The investigators run a series of behavioral economic interventions at client-choice food pantries to encourage clients to choose targeted foods.


Options:
A: Number of Targeted Products Selected Relative to Others (up to 8 months)
B: Change in the selection of meal components (Selection of entrees, milk, fruits, and vegetables) (baseline, up to 3 months post-implementation, and up to 7 months post-implementation); Change in the consumption of meal components (consumption of entrees, milk, fruits, and vegetables) (baseline, up to 3 months post-implementation, and up to 7 months post-implementation)
C: Overweight and obesity according to IOTF references (0-1-2 years)
D: Change of Child Body Composition (Baseline to 6 months); Change Parent Body Composition (Baseline to 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-blind, Placebo Controlled Multi-center Study of Subcutaneous Secukinumab (150 mg and 300 mg) in Prefilled Syringe to Demonstrate Efficacy (Including Inhibition of Structural Damage), Safety, and Tolerability up to 2 Years in Subjects With Active Psoriatic Arthritis (FUTURE 5)
Brief Summary: The purpose of this study was to demonstrate efficacy including effect on inhibition of progression of structural damage, safety and tolerability up to 2 years with primary focus at Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled syringe (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in subjects with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD therapy and/or previous anti-TNFα therapy. Long term efficacy up to 2 years was based on signs and symptoms of joint/bone structure preservation (X-ray) and improvement in physical function measured by Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well as skin and nail improvement for psoriasis signs.


Options:
A: Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. (Baseline to week 16)
B: Subject incidence of serious adverse events, including serious infections, non-melanoma skin cancer, and all malignancies, and all adverse events.
C: Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12 (Week 0 to Week 12)
D: Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 (Week 16)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-blind, Placebo Controlled Multi-center Study of Subcutaneous Secukinumab (150 mg and 300 mg) in Prefilled Syringe to Demonstrate Efficacy (Including Inhibition of Structural Damage), Safety, and Tolerability up to 2 Years in Subjects With Active Psoriatic Arthritis (FUTURE 5)
Brief Summary: The purpose of this study was to demonstrate efficacy including effect on inhibition of progression of structural damage, safety and tolerability up to 2 years with primary focus at Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled syringe (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in subjects with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD therapy and/or previous anti-TNFα therapy. Long term efficacy up to 2 years was based on signs and symptoms of joint/bone structure preservation (X-ray) and improvement in physical function measured by Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well as skin and nail improvement for psoriasis signs.


Options:
A: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 (Week 16); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 (Week 16)
B: Number of Participants Achieving a Greater Than or Equal to 75 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 (Baseline and Week 12)
C: Percentage of Participants With a PASI 75 Response at Week 12 (Baseline and week 12)
D: Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 (Week 16)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-blind, Placebo Controlled Multi-center Study of Subcutaneous Secukinumab (150 mg and 300 mg) in Prefilled Syringe to Demonstrate Efficacy (Including Inhibition of Structural Damage), Safety, and Tolerability up to 2 Years in Subjects With Active Psoriatic Arthritis (FUTURE 5)
Brief Summary: The purpose of this study was to demonstrate efficacy including effect on inhibition of progression of structural damage, safety and tolerability up to 2 years with primary focus at Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled syringe (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in subjects with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD therapy and/or previous anti-TNFα therapy. Long term efficacy up to 2 years was based on signs and symptoms of joint/bone structure preservation (X-ray) and improvement in physical function measured by Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well as skin and nail improvement for psoriasis signs.


Options:
A: 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)
B: Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 (Week 16)
C: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 (Week 16); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 (Week 16)
D: Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) (Week 12); Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-blind, Placebo Controlled Multi-center Study of Subcutaneous Secukinumab (150 mg and 300 mg) in Prefilled Syringe to Demonstrate Efficacy (Including Inhibition of Structural Damage), Safety, and Tolerability up to 2 Years in Subjects With Active Psoriatic Arthritis (FUTURE 5)
Brief Summary: The purpose of this study was to demonstrate efficacy including effect on inhibition of progression of structural damage, safety and tolerability up to 2 years with primary focus at Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled syringe (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in subjects with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD therapy and/or previous anti-TNFα therapy. Long term efficacy up to 2 years was based on signs and symptoms of joint/bone structure preservation (X-ray) and improvement in physical function measured by Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well as skin and nail improvement for psoriasis signs.


Options:
A: Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 (Week 16)
B: 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)
C: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 (Baseline, Week 4)
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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Vitamin D Administration to Premature Infants on Vitamin D Status and Respiratory Morbidity During the First Year of Life
Brief Summary: This trial objective is to assess whether doubling the daily intake of vitamin D improves serum vitamin D levels and serves as primary prevention of respiratory infections and asthma in premature infants.

This is a prospective randomized (1:1) double-blinded trial.

The study population will be randomized into two groups (1:1):

* Intervention Group - 800 IU of Vitamin D once daily
* Control Group - 400 IU of Vitamin D once daily Patients will be followed up for one year after randomization for serum Vitamin D levels and respiratory morbidity.


Options:
A: Number of asthma exacerbations per child treated with rescue oral corticosteroids (7 months)
B: Improved serum vitamin D levels in the intervention group (receiving 800 IU daily) in comparison to the control group (receiving 400 IU daily) (12 months of age)
C: SCORAD score (May - August 2012 (3 months))
D: Mortality (weekly); Incidence of disease requiring hospitalization; Morbidity and hospitalization (weekly)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Evaluation of Web Based Pulmonary Rehabilitation- Pilot Study
Brief Summary: The purpose of this pilot study is to compare a six week web-based pulmonary rehabilitation programme with traditional hospital-based pulmonary rehabilitation classes for people affected by COPD.


Options:
A: 6 Minutes Walk Test (9 weeks)
B: Change from baseline in Shuttle Walk test at 6 weeks (6 weeks)
C: The dyspnea of the chronic respiratory questionnaire (CRQ) at 12 months is the primary outcome variable. (The data collection was terminated in January 2007 and publication was done December 2008)
D: Difference in COPD admission rates and death over one year between patients treated with supported self-management, in addition to usual care, and those treated with usual care alone? (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Evaluation of Web Based Pulmonary Rehabilitation- Pilot Study
Brief Summary: The purpose of this pilot study is to compare a six week web-based pulmonary rehabilitation programme with traditional hospital-based pulmonary rehabilitation classes for people affected by COPD.


Options:
A: Self-management and Activation (6 Months)
B: Change from baseline in Shuttle Walk test at 6 weeks (6 weeks)
C: COPD Assessment Test (CAT) (Baseline and 6 months)
D: Changes in EQ ED From Baseline to 3 Months Endpoint (Baseline and change at 3 months); Changes in the Symptom Burden of Disease From Baseline to 3 Months (Baseline with change at 3 months); Changes in Quality of Life (Mood) From Baseline to 3 Month Endpoint (Baseline and change at 3 months); Changes in Quality of Life (Anxiety) From Baseline to 3 Month Endpoint (Baseline and change at 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical and Neural Changes Associated With Dialectical Behavioral Therapy in Adolescents With Suicidal Behaviors
Brief Summary: Suicidal behaviors among adolescents represents a public health problem due to its high prevalence and its low predictability. It is also known that brain development continues during adolescence, therefore, a therapeutic intervention during this period might propitiate neural changes that might favor the emotional regulation involved in suicidal behaviors. Dialectical Behavioral Therapy has proved to be effective regarding this problem.

For this reason, the investigators aimed to study the clinical, neuropsychological and neural effects of Dialectical Behavioral Therapy in adolescents with suicidal behaviors.


Options:
A: suicidal ideation - Suicidal Ideation Questionnaire-JR (3 month)
B: Suicidal thoughts or attempts (Measured at Year 2)
C: Suicidal behaviour (2-year follow-up); Suicidal behaviour (1-year follow-up)
D: Clinical changes after 16 sessions of Dialectical Behavioral Therapy. (4 months); Neural changes after 16 sessions of Dialectical Behavioral Therapy. (4 months); Neuropsychological changes after 16 sessions of Dialectical Behavioral Therapy. (4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical and Neural Changes Associated With Dialectical Behavioral Therapy in Adolescents With Suicidal Behaviors
Brief Summary: Suicidal behaviors among adolescents represents a public health problem due to its high prevalence and its low predictability. It is also known that brain development continues during adolescence, therefore, a therapeutic intervention during this period might propitiate neural changes that might favor the emotional regulation involved in suicidal behaviors. Dialectical Behavioral Therapy has proved to be effective regarding this problem.

For this reason, the investigators aimed to study the clinical, neuropsychological and neural effects of Dialectical Behavioral Therapy in adolescents with suicidal behaviors.


Options:
A: Change on the severity of borderline personality disorder measured by Borderline Personality Symptom List (BSL-23). (Baseline and up to 12 months after inclusion.)
B: Clinical changes after 16 sessions of Dialectical Behavioral Therapy. (4 months); Neural changes after 16 sessions of Dialectical Behavioral Therapy. (4 months); Neuropsychological changes after 16 sessions of Dialectical Behavioral Therapy. (4 months)
C: Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation (Baseline, 4 months post baseline, 12 months post baseline)
D: Parasuicidal behaviour (intermittent)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: H-SENSES PROJECT Self Care Mediated by the Senses: Assessing the Impact on Self-esteem, Stress and Well-being of Female Health Professionals
Brief Summary: Randomized clinical trial about self-care mediated by the senses in female health professionals and their influence on stress, self-esteem, mood states, life satisfaction and levels of salivary cortisol.


Options:
A: Change from baseline compassion fatigue at 1 and 6 months assessed by compassion fatigue subscale of Professional quality of life scale (Data collected before the program starts and one months after the end of the program and six months); Change from baseline burnout at 1 and 6 months assessed by burnout subscale of Professional quality of life scale (Data collected before the program starts (pretest) and one months after the end of the program and six months); Change from baseline compassion satisfaction at 1 and 6 months assessed by compassion satisfaction subscale of Professional quality of life scale (Data collected before the program starts (pretest) and one months after the end of the program and six months)
B: Level of psychological stress measured by psychometric questionnaires (PSM, PSS, COPE, PSQI, SWLS, STAI) (five weeks); quality of life questionnaire (5 weeks); psychophysiological measures (heart rate and heart rate variability indexes) (5 weeks)
C: Change in perceived stress (Lipp Stress Inventory and Symptoms of Stress List) (baseline, 30 days, 60 days)
D: Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks (Baseline and after 4, 8 weeks later)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Helicobacter Pylori Eradication on Glandular Atrophy and Metachronous Cancer in Patients Undergoing Endoscopic Mucosal Resection for Gastric Cancer
Brief Summary: This study evaluates whether Helicobacter pylori eradication improves precancerous lesions including glandular atrophy and intestinal metaplasia as well as metachronous cancers or dysplasias after endoscopic mucosal resection for gastric cancer.


Options:
A: Gastric cancer incidence (6 years after last participant enrollment)
B: Successful helicobacter eradication, change in premalignant gastric lesion, and change in gastric cancer incidence rate (12 years)
C: Improvement (histological) of glandular atrophy (3 years after enrollment); Incidence of metachronous gastric cancer (3 years after last patient enrollment)
D: Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of gastric tumor. (we set the time frame as at least three years.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Subjects With Active Nonradiographic Axial Spondyloarthritis
Brief Summary: The purpose of this study is to assess the efficacy and safety of ustekinumab in adult participants with active nonradiographic axial spondyloarthritis (nr-AxSpA) measured by the reduction in signs and symptoms of nonradiographic axial spondyloarthritis (nr-AxSpA).


Options:
A: Percentage of Participants Who Achieved an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 24 (Week 24)
B: Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 20 Response at Week 24 (Week 24)
C: Number of Participants With Adverse Events (From Start of the Study up to Study Termination (up to 42 Weeks))
D: Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24 (Week(W) 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in maintenance study in participants with moderately to severely active Ulcerative Colitis (UC) who have demonstrated a clinical response to Induction treatment with IV ustekinumab.


Options:
A: Number of Participants in Clinical Response Through Week 54 (Induction Baseline, Week 0 through Week 54)
B: Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per Global Definition) (Week 8); Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per US Definition) (Week 8); Maintenance Study: Number of Participants With Clinical Remission at Week 44 (As Per Global Definition) (Week 44); Maintenance Study: Number of Participants With Clinical Remission at Week 44 (as Per US Definition) (Week 44)
C: Clinical response (8 weeks)
D: Induction Phase: Percentage of Participants With a Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52 (Week 52)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Collaborative Care for the Detection and Management of Depression Among Adults Receiving Antiretroviral Therapy in South Africa: a Pragmatic Cluster Randomized Controlled Trial
Brief Summary: With increasing access to antiretroviral therapy (ART) in South Africa, HIV has transitioned from a terminal illness to a long-term condition. It is likely to be accompanied by higher levels of disability and other chronic non-communicable diseases, resulting from the HIV itself, as well as adverse effects of medication. This requires an expansion of the purview of HIV care beyond direct HIV clinical care to also include a more comprehensive and integrated package of treatment and care for physical and mental conditions and their consequences. COBALT is a pragmatic cluster randomized controlled trial (RCT) in public sector primary care clinics in the North West Province of SA. It will assess mental health and HIV outcomes for depressed adults receiving ART by measuring the real-world effectiveness of a facility-based stepped care intervention combining depression case detection by non-physician clinicians with group counselling intervention delivered by lay-health workers.


Options:
A: Dried Blood Spot Analysis of Medication Adherence- Mother and Infant (32 weeks gestation); Infant HIV Seroconversions (12 months postpartum)
B: Viral load suppression (12 months); Patient Health Questionnaire 9 (PHQ-9) response (6 months)
C: Brief Psychiatric Rating Scale, Expanded Version (BPRS-E) (12 months post-randomisation (18 months for secondary outcome))
D: Sustained change weight (for less) of 5% of previous body weight. This is a level known to improve physical health (metabolic) outcomes. (Baseline, 25-weeks (end) treatment, 6 and12 months follow-up.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Trial of a Home-based Physical Activity Intervention in Breast Cancer Survivors
Brief Summary: The aim of this current study was to investigate the effects of a pragmatic home-based physical activity programme on primarily physical activity levels and secondarily weight maintenance, health-related quality of life (HRQoL), insulin resistance (IR) and lipid concentrations in post-adjuvant therapy breast cancer survivors.


Options:
A: Physical activity questionnaire (International Physical Activity Questionnaire) (Baseline and 6 months)
B: physical activity (baseline and 3 months); muscle strength (baseline and 3 months); fatigue (baseline and 3 months); sleep dysfunction (baseline and 3 months)
C: Baseline to post intervention (12 weeks) and follow-up (32 weeks) change in Body Composition. (Change from baseline to post intervention (12 weeks) and follow-up (32 weeks))
D: Abdominal isometric endurance (Baseline- 8 weeks)

Answer: A