TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Nurse-Led Intervention Programme on Compassion Fatigue, Burnout, Compassion
Brief Summary: Nurses are at risk in terms of burnout and empathic fatigue. Therefore, efforts to protect the mental health of nurses are very important. It is stated that the studies conducted are mostly descriptive and not interventional.

In addition, the evidence levels of interventional studies are low.


Options:
A: State-Trait Anxiety Inventory (week 0 (baseline)); Hamilton Anxiety Rating Scale (week 0 (baseline)); Clinical Global Impression - Severity scale (week 0 (baseline)); Clinical Global Impression - Improvement scale (week 0 (baseline)); Mini-International Neuropsychiatric Interview 5 (week 0 (screening)); Becks Depression Inventory II (week 0 (screening)); State-Trait Anxiety Inventory (week 12 (end of treatment)); Hamilton Anxiety Rating Scale (week 12 (end of treatment)); Clinical Global Impression - Severity scale (week 12 (end of treatment)); Clinical Global Impression - Improvement scale (week 12 (end of treatment)); Mini-International Neuropsychiatric Interview 5 (week 12 (end of treatment)); Becks Depression Inventory II (week 12 (end of treatment)); State-Trait Anxiety Inventory (week 24 (follow-up)); Hamilton Anxiety Rating Scale (week 24 (follow-up)); Clinical Global Impression - Severity scale (week 24 (follow-up)); Clinical Global Impression - Improvement scale (week 24 (follow-up)); Mini-International Neuropsychiatric Interview 5 (week 24 (follow-up)); Becks Depression Inventory II (week 24 (follow-up))
B: 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)
C: Resilience - Brief Resilience Scale (BRS) (20 weeks); General Health - General Health Questionnaire (GHQ-12). (20 weeks)
D: PTSD Symptoms (CAPS, SCID, PDS, IESR) (1.5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Nurse-Led Intervention Programme on Compassion Fatigue, Burnout, Compassion
Brief Summary: Nurses are at risk in terms of burnout and empathic fatigue. Therefore, efforts to protect the mental health of nurses are very important. It is stated that the studies conducted are mostly descriptive and not interventional.

In addition, the evidence levels of interventional studies are low.


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: 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)
C: Professional Quality of Life Scale-IV (ProQoL), "change" is being assessed. (Change from Baseline up to 1 year); Perceived Stress Scale, "change" is being assessed. (Change from Baseline up to 1 year); Resilience Scale for Adults, "change" is being assessed. (Change from Baseline up to 1 year)
D: Resilience - Brief Resilience Scale (BRS) (20 weeks); General Health - General Health Questionnaire (GHQ-12). (20 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% and ARQ-151 Cream 0.15% Administered QD (Quaque Die) in Adolescent and Adult Subjects With Atopic Dermatitis
Brief Summary: The study will assess the safety, pharmacokinetics (PK), and efficacy of different doses of roflumilast (ARQ-151) cream (0.05% and 0.15%) vs placebo applied once daily (QD) for 28 days by adolescents and adults with atopic dermatitis.


Options:
A: Pharmacokinetic parameter Cmax will be calculated (Until Day 13); Pharmacokinetic parameter tmax will be calculated (Until Day 13); Pharmacokinetic parameter AUC(0-t) will be calculated (Until Day 13); Pharmacokinetic parameter t1/2 will be calculated (Until Day 13)
B: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions (Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days)); Number of Participants With Clinically Significant Height Values Meeting Pre-defined Criteria (Baseline (Day 1) up to Day 29 (end of treatment)); Number of Participants With Clinically Significant Weight Values Meeting Pre-defined Criteria (Baseline (Day 1) up to Day 29 (end of treatment)); Number of Participants With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria (Baseline (Day 1) up to Day 29 (end of treatment)); Number of Participants With Clinically Significant Pulse Rate Values Meeting Pre-defined Criteria (Baseline (Day 1) up to Day 29 (end of treatment)); Number of Participants With Clinically Significant Respiratory Rate Values Meeting Pre-defined Criteria (Baseline (Day 1) up to Day 29 (end of treatment)); Number of Participants With Clinically Significant Body Temperature Values Meeting Pre-defined Criteria (Baseline (Day 1) up to Day 29 (end of treatment)); Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria (Baseline (Day 1) up to Day 29 (end of treatment)); Number of Participants With Clinically Significant Laboratory Parameters Meeting Pre-defined Criteria (Baseline (Day 1) up to Day 29 (end of treatment))
C: The incidence of atopic dermatitis (Measure will be reported annually by year from 2008-2018); The prevalence of atopic dermatitis (Measure will be reported annually by year from 2008-2018); The prevalence of diagnosed co-morbidities in people with and without atopic dermatitis (Prevelence reported annually by year from 2008-2018); Annual rates of service utilisation (number of primary and secondary care visits) in people with atopic dermatitis (Measures will be reported annually by year from 2008-2018); Annual prescription rates for atopic dermatitis related treatments (Measures will be reported annually by year from 2008-2018)
D: Mean Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4 (Baseline and Week 4)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Nurse-coordinated Integrated Care Model to Support Decision-making and Self-care in Patients With Atrial Fibrillation: A Randomized Controlled Trial
Brief Summary: This study aims to evaluate the effects of a nurse-coordinated, empowerment-based integrated care model on self-care behaviors and psychosocial outcomes in patients with atrial fibrillation (AF), and to explore how this intervention affects the self-care behaviors and quality of life from the patients' perspective.

Stroke prevention by oral anticoagulants (OAC) and control of arrhythmia and risk factors remain the cornerstones of AF management. However, under-prescription, non-adherence to treatment, and suboptimal anticoagulation control limit the efficacy of OACs. The poor abilities of patients regarding the self-control of arrhythmia and risk factors further contributes to worse outcomes. According to the World Health Organization, the best approach to chronic disease management involves the empowerment of patients to become active self-care agents. The literature indicates that a multifaceted, nurse-coordinated care model integrating all important care components with an empowerment approach could most effectively and actively engage patients in self-care.

This mixed-methods study comprises a randomized controlled trial and an exploratory qualitative study. A total of 392 community-dwelling patients aged ≥65 years with a confirmed diagnosis of AF, a high stroke risk, and no OAC treatment will be recruited from the medical outpatient clinics of a university-affiliated teaching hospital. The patients will be randomly allocated to intervention or control groups, which will receive treatment via the nurse-coordinated integrated care model or standard care, respectively. We hypothesize that compared to patients receiving standard care, AF patients exposed to the nurse-coordinated care model will be more likely to achieve compatible patient and physician decisions regarding the use of OAC, as well as better changes in medication adherence, anxiety, depression and health-related quality of life both immediately and 6 months post intervention.

This study will uniquely adopt an empowerment-based approach to equip patients as active agents in AF management through a nurse-coordinated integrated care model that comprehensively addresses their needs. The findings will advance our knowledge of patients' self-care behaviors in the context of AF and will provide a new model of care to improve health outcomes in this population.


Options:
A: Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes. (minimum of 1 year)
B: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire (Change from Baseline AFEQT at the 13th week (after the intervention) and 6 months (follow up))
C: Change in proportion of patients taking oral anticoagulants (1 year)
D: Difference in change in Atrial Fibrillation Effect on Quality of Life (AFEQT) scores between groups (At 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial to Investigate if a Pre-operative Wash With Chlorhexidine vs Povidone-iodine Vaginal Scrub Decreases Infectious Morbidity in Patients Undergoing Cesarean Section After Ruptured Membranes
Brief Summary: The objective of this study is to investigate if the rate of infectious morbidity is decreased with the use of chlorhexidine or povidone-iodine vaginal scrub before cesarean section after ruptured membranes.


Options:
A: Post-intervention Aerobic Bacterial Colony Counts (From intervention to 7 days post); Post-intervention Anaerobic Bacterial Colony Counts (From intervention to 7 days post)
B: rate of postpartum endometritis (6 weeks)
C: Postpartum Endometritis (30 day postoperative)
D: Surgical site infection (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Lunchtime Meal Feeding Study for Preschool Children
Brief Summary: The aim of the study is to determine the effect of varying both the palatability and portion size of vegetables served to preschool children at a meal on the outcomes of food and energy intake at the meal.


Options:
A: Change in children's Knowledge, attitude, habit (KAH) scores (baseline and 5 months)
B: 1-year, and 3-year changes from baseline in questionaires scores for knowledge, attitudes, and habits of children, parents and teachers in regards to a healthy lifestyle. (3 years)
C: Absolute change in mean accelerometry counts over 6 days (baseline, end of intervention, six months after end of intervention)
D: Difference Between Interventions in Vegetable Intake (One meal per week for each intervention (Study weeks 1, 2, 3, and 4))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Lunchtime Meal Feeding Study for Preschool Children
Brief Summary: The aim of the study is to determine the effect of varying both the palatability and portion size of vegetables served to preschool children at a meal on the outcomes of food and energy intake at the meal.


Options:
A: Difference Between Interventions in Vegetable Intake (One meal per week for each intervention (Study weeks 1, 2, 3, and 4))
B: Change in self-reported nutrition practices (baseline, post 3-months, post 12-months)
C: Mean Nutrition Environment Score (Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up)); Mean Physical Activity Environment Score (Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up))
D: Change in Body Mass Index Z-score (9 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Mindful Eating Program to Reduce Emotional Eating in Patients Suffering From Overweight or Obesity in Primary Care Settings: a Cluster Randomized Controlled Clinical Trial Protocol
Brief Summary: Mindfulness-Based Interventions have been applied in different fields to improve physical and psychological health. However, little is known about its applicability and effectiveness in Spanish adults with overweight and obesity. The aim of the present study protocol is to evaluate the feasibility and efficacy of an adapted MBI programme to reduce emotional eating in adults with overweight and obesity in primary care (PC) settings.


Options:
A: Success meeting recruitment goals (20 patients within 3-4 months) (4-month recruitment window); Willingness to participate in study (>10% of eligible) (4-month recuitment window); Adherence rate (≥70% attendance, 7 of 10 classes) (12-weeks); Retention (≤25% drop-out) (6-months)
B: composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke (every six months for an average of 5.4 years)
C: The Dutch Eating Behavior Questionnaire (Baseline in experimental and control groups.); The Dutch Eating Behavior Questionnaire (Post-treatment 8 weeks from baseline in experimental and control groups); The Dutch Eating Behavior Questionnaire (twelve-months follow-up in experimental and control groups)
D: frequency of eating in response to cravings (primary mechanistic outcome) (change from baseline to 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Text-Based Adherence Game for Young People Living With HIV in Ghana
Brief Summary: This study will develop and evaluate a game-based, text message intervention to promote adherence to HIV care among young people living with HIV (YPLH) in Ghana. Intervention development will be guided by feedback from YPLH, their treatment supporters, and clinic staff, consultation with a mobile health services team, and Social Action Theory. Patient participants will be recruited from an urban HIV clinic in Accra, Ghana to complete a randomized pilot of the intervention. All participants will receive a brief adherence counseling session and complete three assessments over the course of 12 months following enrollment. During this time, intervention participants will receive text messages and phone calls from a semi-automated text message system, clinic staff, and other individuals in their life (e.g., family, friends, and partners) who they have identified as supportive of their treatment. The study will provide a wealth of knowledge about YPLH in Ghana, a group vulnerable to poor treatment outcomes, and provide preliminary data on a novel adherence promotion intervention.


Options:
A: Acceptability of at least one method of effective contraception (4 months)
B: Use of long acting and reversible contraceptive at 4 months (4 months)
C: Change in ART Adherence - Clever Cap (Up to 6 months)
D: HIV-1 Viral Load (log10 Transformed) (Past 90 days); Self-reported Medication Adherence (Past 30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Text-Based Adherence Game for Young People Living With HIV in Ghana
Brief Summary: This study will develop and evaluate a game-based, text message intervention to promote adherence to HIV care among young people living with HIV (YPLH) in Ghana. Intervention development will be guided by feedback from YPLH, their treatment supporters, and clinic staff, consultation with a mobile health services team, and Social Action Theory. Patient participants will be recruited from an urban HIV clinic in Accra, Ghana to complete a randomized pilot of the intervention. All participants will receive a brief adherence counseling session and complete three assessments over the course of 12 months following enrollment. During this time, intervention participants will receive text messages and phone calls from a semi-automated text message system, clinic staff, and other individuals in their life (e.g., family, friends, and partners) who they have identified as supportive of their treatment. The study will provide a wealth of knowledge about YPLH in Ghana, a group vulnerable to poor treatment outcomes, and provide preliminary data on a novel adherence promotion intervention.


Options:
A: Patient retention in care (12 months)
B: MV Coverage at 12 months of age (12 months of age)
C: Adherence to cervical cancer screening (step1) (Up to 20 months)
D: HIV-1 Viral Load (log10 Transformed) (Past 90 days); Self-reported Medication Adherence (Past 30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Text-Based Adherence Game for Young People Living With HIV in Ghana
Brief Summary: This study will develop and evaluate a game-based, text message intervention to promote adherence to HIV care among young people living with HIV (YPLH) in Ghana. Intervention development will be guided by feedback from YPLH, their treatment supporters, and clinic staff, consultation with a mobile health services team, and Social Action Theory. Patient participants will be recruited from an urban HIV clinic in Accra, Ghana to complete a randomized pilot of the intervention. All participants will receive a brief adherence counseling session and complete three assessments over the course of 12 months following enrollment. During this time, intervention participants will receive text messages and phone calls from a semi-automated text message system, clinic staff, and other individuals in their life (e.g., family, friends, and partners) who they have identified as supportive of their treatment. The study will provide a wealth of knowledge about YPLH in Ghana, a group vulnerable to poor treatment outcomes, and provide preliminary data on a novel adherence promotion intervention.


Options:
A: HIV-1 Viral Load (log10 Transformed) (Past 90 days); Self-reported Medication Adherence (Past 30 days)
B: Adherence to cervical cancer screening (step1) (Up to 20 months)
C: The primary outcome will measure the number of children who got vaccinated for routine immunization scheduled at 6, 10 and 14 weeks of life (Vaccination status at 20th week of life of the particpants)
D: 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.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Personalized Mobility Interventions Using Smart Sensor Resources for Lower-Limb Prosthesis Users
Brief Summary: The goal of this research is to analyze data from smartphone-based and wearable sensors, using advanced machine-learning and data-mining techniques, and to combine this information with performance-based measures, participant-reported measures, and structured interviews to create a clinical toolbox to (i) identify individuals who exhibit reduced prosthesis use (compared to expected usage levels based on K-level designation and/or participant goals of community mobility and social interaction), (ii) identify prosthetic/physical and psychological factors that limit prosthesis use, and (iii) determine the effect of targeted interventions to increase prosthesis use and facilitate achievement of participant goals. Objective sensor-based measurement of home and community activities will allow for the correlation of real-world function to in-clinic assessments and to monitor changes resulting from rehabilitation interventions in real time. Machine-learning and data mining techniques will be used to identify a subset of measures from this toolbox that sensitively and accurately reflect real-world function, enabling clinicians to predict and assess activity and provide effective interventions to optimize prosthesis use. The goal of this project, to improve overall performance with respect to activities of daily living and other real-world activities, thus addresses the Fiscal Year 2017 (FY17) Orthotics and Prosthetics Outcomes Research Program (OPORP) Focus Area of Orthotic or Prosthetic Device Function.


Options:
A: Retention Rate (3 months); Dose Goal Attainment (3 months); Acceptability (3 months); Study-Related Adverse Events (3 months)
B: Amputee Mobility Predictor (8 weeks for intervention and for wait-list control)
C: Pre-intervention:10 Meter Walk Test (10MWT) (Week 12-13); Pre-intervention: 6 Minute Walk Test (6MWT) (Week 12-13); Pre-intervention: Berg Balance Scale Test (Week 12-13); Post-intervention:10 Meter Walk Test (10MWT) (Week 24-25); Post-intervention: 6 Minute Walk Test (6MWT) (Week 24-25); Post-intervention: Berg Balance Scale Test (Week 24-25); Delayed post-intervention:10 Meter Walk Test (10MWT) (Week 40-41); Delayed post-intervention: 6 Minute Walk Test (6MWT) (Week 40-41); Delayed post-intervention: Berg Balance Scale Test (Week 40-41)
D: Timed Up & Go Test (TUG) (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Adapting and Expanding the Algorithmic Software Tool to Help Manage Asthma (ASTHMAXcel) for Youth With Asthma
Brief Summary: This project seeks to test and refine an adapted/expanded version of a previously created ASTHMAXcel app.


Options:
A: Asthma-related morbidity (Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest)
B: Percentage Changed in Adherence Score (Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores); Number of Symptom-free Days (Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores)
C: Change from Baseline in adherence rate to entire treatment period (From baseline to end of participation (up to 3 months))
D: Change from Baseline Asthma Control to 3 Month Asthma Control (Post-Refinement Baseline, 3 Months); Change from Baseline Asthma Control to 3 Month Asthma Control (Post-Refinement Baseline, 4 Months)

Answer: D