TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Stimulation in the Elderly: Individual Intervention on Cognitive Frailty
Brief Summary: Cognitive Stimulation (CS) in the elderly, as a group intervention, shows benefits on the cognition and quality of life of people with neurocognitive disorder (NCD)(ie, dementia). The evidence of cognitive stimulation as an individualized intervention, conducted at home, by the caregiver is limited. The main objective of this trial is to evaluate the effectiveness of the Individual Cognitive Stimulation Therapy program - "Making a Difference 3 - individual Cognitive Stimulation Therapy (MD3), its acceptability and applicability by the dyad (people with NCD and their caregiver) in the Portuguese population. To achieve this purpose a pilot study will be conducted (randomized control trial), with two moments of evaluation - before the intervention of individual cognitive stimulation and after the intervention in both groups (Group 1 - group subject to intervention: individual cognitive stimulation program called "MD3"; Group 2 - group subject to usual care).The investigators intend to know the effect of the program on cognitive domains, quality of life and relationship between caregiver and care recipient. And, as well as understand the acceptability and applicability of the program by participants (dyad).


Options:
A: Change in cognition (person with dementia) (Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline); Change in quality of life (person with dementia) (Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline); Change in general health outcome (carer) (Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline)
B: World Health Organization Brief Quality of Life Scale (Baseline); World Health Organization Brief Quality of Life Scale (Immediately post-intervention)
C: N/A
D: Change from Baseline in the elderly participant's Cognition (Post-intervention assessment (week 13)); Change from Baseline in the elderly participant's Quality of Life (Post-intervention assessment (week 13)); Change from Baseline in the caregiver's overall health (Post-intervention assessment (week 13))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of Mobile Directly Observed Therapy (mDOT) for Immunosuppressant Adherence in Adult Liver Transplant Recipients
Brief Summary: The investigators are interested in whether or not the use of a mobile health (mHealth) application increases the rate of immunosuppressant medication adherence among adult liver transplant recipients. The investigators aim to test this by randomly assigning transplant recipients to the intervention (use of an mHealth app to manage and track their immunosuppression regimen) or control arm (standard of care) upon discharge from their initial transplant hospitalization, and tracking medication adherence over time. The study population will be approximately 50 adult liver transplant recipients at the Johns Hopkins Hospital.


Options:
A: 12-week immunosuppression medication adherence (12 weeks)
B: Time to First Occurrence of Acute Rejection, Failure, Death (1 year post-transplant)
C: Difference in adherence to immunosuppressant medications between intervention and control (self-report) (3 months and 12 months after enrolment); Difference in adherence to immunosuppressant medications between intervention and control (immunosuppressant blood levels) (3 months and 12 months after enrolment)
D: Taking Adherence (12 months); Timing Adherence (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Community Development and Nutrition Education in Banke District, Nepal: Effect on Child Health and Growth
Brief Summary: Heifer Project International is a globally active NGO with more than 400 projects in over 30 countries. The organization uses the introduction of livestock and related training in the development of social capital as tools for poverty alleviation, citizen empowerment, and community development. In a pilot project conducted in 2009-2012, these activities were found to promote some improvement in child health and nutritional status. However, robust enhancement of these important indicators was not observed. Heifer now intends to investigate the efficacy of a nutrition and child health education program in amplifying these effects.


Options:
A: Change from baseline in prevalence of child wasting (baseline, and then at each study visit (every 6 months over 36 months))
B: Extent of guideline adherence after approximately one year (measured by a specific set of guideline-derived indicators, formulated beforehand by the research group) (half year after intervention); Costs of both Implementation strategies (half year after intervention)
C: Change in stigmatizing attitudes, as measured by the Social Distance questionnaire (Baseline, post-training (immediately after 10-day training curriculum), +4 months, + 16 months)
D: Rate of First or Only Clinical Episode of Plasmodium Falciparum (P. Falciparum) Malaria Infection (CPFMI), or Clinical Malaria Episode of Primary Case Definition (CPFMI-PCD) (From Month 2.5 to Month 14); Rate of First or Only Clinical Episode of P. Falciparum Malaria Infection (CPFMI), or Clinical Malaria Episode of Primary Case Definition (CPFMI-PCD) (From Month 2.5 to Month 14)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Community Development and Nutrition Education in Banke District, Nepal: Effect on Child Health and Growth
Brief Summary: Heifer Project International is a globally active NGO with more than 400 projects in over 30 countries. The organization uses the introduction of livestock and related training in the development of social capital as tools for poverty alleviation, citizen empowerment, and community development. In a pilot project conducted in 2009-2012, these activities were found to promote some improvement in child health and nutritional status. However, robust enhancement of these important indicators was not observed. Heifer now intends to investigate the efficacy of a nutrition and child health education program in amplifying these effects.


Options:
A: Height-for-age z-score (At the end of one year); Child development outcomes (At the end of one year)
B: Change from baseline in prevalence of child wasting (baseline, and then at each study visit (every 6 months over 36 months))
C: Changes in body weight after 3 months of intervention in children (3 months); Changes in weight-for-age z score after 3 months of intervention in children (3 months); Changes in height-for-age z score after 3 months of intervention in children (3 months); Changes in weight-for-height z score after 3 months of intervention in children (3 months); Changes in dietary intake after 3 months of intervention in children (3 months); Changes in diet quality after 3 months of intervention in children (3 months)
D: To compare developmental outcomes of children who were enrolled in the PDC to children who did not receive PDC services and to the general population. (April 2014 to March 2019)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The REDIVAC Study-Reducing Delay in Vaccination of Children Study
Brief Summary: This study will assess the impact of automated reminders for the 6 month and 12 month vaccine visits to increase vaccination in parents experiencing logistic barriers to vaccination.


Options:
A: Vaccines received (Electronic Health Record) (up to a year of follow up)
B: Smoking status by collecting an expired carbon monoxide breath sample (3-Month Follow-Up)
C: Cumulative adverse event (AE) rate (moderate or severe) (≤ Day 14 for each participant with analysis completed in year 1.); Mean number of in-person visits (Before 42 day visit for each participant with analysis completed in year 1.); 2wT costs (The costing data collection will be completed by April 2018 at the completion of all study participant follow-up. Analysis will conclude in year 1); 2WT acceptability (The acceptability activities will be completed by April 2018 at the completion of all study participant follow-up with analysis to commence after that point. Analysis will conclude in year 1.); 2WT feasibility (The feasibility activities be completed by April 2018 at the completion of all study participant follow-up with analysis to commence after that point. Analysis will conclude in year 1.)
D: The rate of the Exclusive Breastfeeding (from birth of baby to 6 months post birth)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The REDIVAC Study-Reducing Delay in Vaccination of Children Study
Brief Summary: This study will assess the impact of automated reminders for the 6 month and 12 month vaccine visits to increase vaccination in parents experiencing logistic barriers to vaccination.


Options:
A: Patient retention in care (12 months)
B: Effect of SMS intervention on attendance rate to follow-up screening appointment (up to 14 months)
C: Self-reported adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (infant) (12 months post-partum); Retention in care (12 months post-partum); Adherence on antiretroviral therapy (dried blood spots) (12 months post-partum)
D: Vaccines received (Electronic Health Record) (up to a year of follow up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The REDIVAC Study-Reducing Delay in Vaccination of Children Study
Brief Summary: This study will assess the impact of automated reminders for the 6 month and 12 month vaccine visits to increase vaccination in parents experiencing logistic barriers to vaccination.


Options:
A: Measles - 2 Completion (When the participants reach 2 years of age)
B: Vaccines received (Electronic Health Record) (up to a year of follow up)
C: Proportion of timely and complete vaccine uptake after ISAP SMS Intervention (12 months)
D: Count of Women Who Have Excess Gestational Weight Gain (Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The REDIVAC Study-Reducing Delay in Vaccination of Children Study
Brief Summary: This study will assess the impact of automated reminders for the 6 month and 12 month vaccine visits to increase vaccination in parents experiencing logistic barriers to vaccination.


Options:
A: Vaccines received (Electronic Health Record) (up to a year of follow up)
B: Improved immunization coverage (At the completion of all recruitment and follow ups which will take an average time of 1 year)
C: Proportion of Children Under 5 Years in Vulnerable Households That Have a Birth Certificate (1 year); Proportion of Children Under 5 Years in Vulnerable Households That Have Up-to-date Vaccinations (1 year); Proportion of Children Aged 6-12 Years That Attended Primary School 80% of Days in the Last Month (1 year)
D: Proportion of timely and complete vaccine uptake after ISAP SMS Intervention (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The REDIVAC Study-Reducing Delay in Vaccination of Children Study
Brief Summary: This study will assess the impact of automated reminders for the 6 month and 12 month vaccine visits to increase vaccination in parents experiencing logistic barriers to vaccination.


Options:
A: Antiretroviral Therapy (ART) Adherence Levels (real time (for 9 months))
B: Vaccines received (Electronic Health Record) (up to a year of follow up)
C: Postpartum Contraceptive Uptake (Through study completion, an average of six months); Skilled Birth (Through study completion, an average of six months); Immunisation (Through study completion, an average of six months)
D: Plasma HIV-1 viral load (six months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy ResponSE in Hypogonadal Men (TRAVERSE) Study
Brief Summary: This is a double-blinded and placebo-controlled study of topical testosterone replacement therapy (TRT) in symptomatic hypogonadal men with pre-existing cardiovascular disease (CVD) or increased risk for CVD.


Options:
A: Lean body mass (approximately three years)
B: Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event (Randomization to event or last known date if no event (up to approximately 52 months)); Time From Randomization to the First Component Event of MACE (Randomization to event or last known date if no event (up to approximately 52 months))
C: Change From Baseline in Common Carotid Artery Intima-Media Thickness (IMT) (Baseline and Month 36); Change From Baseline in Coronary Artery Calcium Score (Baseline and Month 36)
D: Percentage of Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL (Following 90 days of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Risankizumab Versus Placebo in a Randomized, Double Blind, Parallel Group Trial in Moderate to Severe Plaque Psoriasis to Assess Safety and Efficacy After 16 Weeks of Treatment in the Russian Federation (IMMpress)
Brief Summary: The purpose of this study is to assess the safety and efficacy of risankizumab compared to placebo in subjects with moderate to severe chronic plaque psoriasis in the Russian Federation.


Options:
A: Proportion of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16 (Week 16)
B: 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))
C: PASI 75 Response After 12 Weeks of Treatment (12 weeks); IGA Mod 2011 0 or 1 Response After 12 Weeks of Treatment (12 weeks)
D: Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 (Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhanced Resilience Training to Improve Mental Health, Stress and Performance in Resident Physicians
Brief Summary: Burnout and overwhelming stress are growing issues in medicine and are associated with mental illness, performance deficits and diminished patient care. Among surgical trainees, high dispositional mindfulness decreases these risks by 75% or more, and formal mindfulness training has been shown feasible and acceptable. In other high-stress populations formal mindfulness training has improved well-being, stress, cognition and performance, yet the ability of such training to mitigate stress and burnout across medical specialties, or to affect improvements in the cognition and performance of physicians, remains unknown. To address these gaps and thereby promote the wider adoption of contemplative practices within medical training, investigators have developed Enhanced Stress Resilience Training, a modified form of MBSR - streamlined, tailored and contextualized for physicians and trainees. Investigators propose to test Enhanced Stress Resilience Training (ESRT), versus active control and residency-as-usual, in surgical and non-surgical residents evaluated for well-being, cognition and performance changes at baseline, post-intervention and six-month follow-up.


Options:
A: Patients' unplanned urgent visits to the health care system. (30 days after discharge)
B: Change in executive function: National Institutes of Health Examiner battery (Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.)
C: The Anxiety Disorder Scale (A week); The Grief Inventory (A week); The Coping Mechanisms Scale (A week); The Psychiatric Morbidity Scale (A week); The Physical Symptoms Scale (A week); The Insomnia Scale (A week); The Binge Eating Scale (A week); The Burnout Inventory (A week); Alcohol use (A week); Drug use (A week)
D: Change from baseline Burnout at 6 months, 12 months and 18 months (Baseline measurement, post-intervention measurements at 6 months, 12 months and 18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhanced Resilience Training to Improve Mental Health, Stress and Performance in Resident Physicians
Brief Summary: Burnout and overwhelming stress are growing issues in medicine and are associated with mental illness, performance deficits and diminished patient care. Among surgical trainees, high dispositional mindfulness decreases these risks by 75% or more, and formal mindfulness training has been shown feasible and acceptable. In other high-stress populations formal mindfulness training has improved well-being, stress, cognition and performance, yet the ability of such training to mitigate stress and burnout across medical specialties, or to affect improvements in the cognition and performance of physicians, remains unknown. To address these gaps and thereby promote the wider adoption of contemplative practices within medical training, investigators have developed Enhanced Stress Resilience Training, a modified form of MBSR - streamlined, tailored and contextualized for physicians and trainees. Investigators propose to test Enhanced Stress Resilience Training (ESRT), versus active control and residency-as-usual, in surgical and non-surgical residents evaluated for well-being, cognition and performance changes at baseline, post-intervention and six-month follow-up.


Options:
A: Number of Participants Who Stopped Smoking by 6 Month Post Treatment (6 months)
B: 30-day Point Prevalence Abstinence, Complete-case (12 months post randomization)
C: Change in executive function: National Institutes of Health Examiner battery (Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.)
D: Perceived Stress Scale (At the end of five days retreat); Self-compassion (At the end of five days retreat)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhanced Resilience Training to Improve Mental Health, Stress and Performance in Resident Physicians
Brief Summary: Burnout and overwhelming stress are growing issues in medicine and are associated with mental illness, performance deficits and diminished patient care. Among surgical trainees, high dispositional mindfulness decreases these risks by 75% or more, and formal mindfulness training has been shown feasible and acceptable. In other high-stress populations formal mindfulness training has improved well-being, stress, cognition and performance, yet the ability of such training to mitigate stress and burnout across medical specialties, or to affect improvements in the cognition and performance of physicians, remains unknown. To address these gaps and thereby promote the wider adoption of contemplative practices within medical training, investigators have developed Enhanced Stress Resilience Training, a modified form of MBSR - streamlined, tailored and contextualized for physicians and trainees. Investigators propose to test Enhanced Stress Resilience Training (ESRT), versus active control and residency-as-usual, in surgical and non-surgical residents evaluated for well-being, cognition and performance changes at baseline, post-intervention and six-month follow-up.


Options:
A: Job satisfaction (baseline to 3 month)
B: Change in level of stress per Perceived Stress Scale (PSS) (Baseline and at 2 months (immediately post-intervention))
C: Change in executive function: National Institutes of Health Examiner battery (Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.)
D: Stress Mindset Measure - General (SMM-G) (Change from Baseline SMM-G score at 6-months post CAR Training)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhanced Resilience Training to Improve Mental Health, Stress and Performance in Resident Physicians
Brief Summary: Burnout and overwhelming stress are growing issues in medicine and are associated with mental illness, performance deficits and diminished patient care. Among surgical trainees, high dispositional mindfulness decreases these risks by 75% or more, and formal mindfulness training has been shown feasible and acceptable. In other high-stress populations formal mindfulness training has improved well-being, stress, cognition and performance, yet the ability of such training to mitigate stress and burnout across medical specialties, or to affect improvements in the cognition and performance of physicians, remains unknown. To address these gaps and thereby promote the wider adoption of contemplative practices within medical training, investigators have developed Enhanced Stress Resilience Training, a modified form of MBSR - streamlined, tailored and contextualized for physicians and trainees. Investigators propose to test Enhanced Stress Resilience Training (ESRT), versus active control and residency-as-usual, in surgical and non-surgical residents evaluated for well-being, cognition and performance changes at baseline, post-intervention and six-month follow-up.


Options:
A: Rate of participant recruitment (1 year); Rate of retention (1 year); Completeness of data entry (1 year); Cost of interventions (1 year); Unexpected costs (1 year)
B: change from baseline in borderline symptoms after a 10 week intervention (10 weeks)
C: Change in executive function: National Institutes of Health Examiner battery (Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.)
D: Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks (Baseline and after 4, 8 weeks later)

Answer: C