TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Building Blocks for Healthy Preschoolers: Child Care and Family Models
Brief Summary: Pediatric obesity, a defining health problem of the century, leads to long-term health disparities. This application evaluates strategies to prevent health disparities early in life by developing environmental wellness-related interventions focused on child-care center staff and families.

Childcare centers provide an excellent opportunity to build healthy dietary and physical activity lifestyle habits and avoid the rapid weight gain that leads to health disparities. Building on a statewide survey among childcare centers and a pilot evaluation of an environmental intervention, this 3-cell randomized trial evaluates the impact of a staff-led wellness intervention and a staff-led and family-focused intervention, against a control condition.


Options:
A: Change from baseline in physical activity level at 12-weeks (Baseline, 6-weeks and 12-weeks after study initiation)
B: Absolute change in mean accelerometry counts over 6 days (baseline, end of intervention, six months after end of intervention)
C: Change in Fruit and Vegetable Consumption at School Lunch (assessed 4 times each 9-month school year; once prior to intervention beginning (i.e., September), approximately 10 weeks and then 20 weeks later, and finally once after the intervention ends (i.e., May).); Change in Student Activity Level (assessed 3 times over 1 year; initially prior to the intervention beginning (i.e., September), a 2nd time once the intervention ends (i.e., May), and then again at the beginning of the following school year (i.e., September))
D: Change of BMI Z-score for preschoolers (Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Building Blocks for Healthy Preschoolers: Child Care and Family Models
Brief Summary: Pediatric obesity, a defining health problem of the century, leads to long-term health disparities. This application evaluates strategies to prevent health disparities early in life by developing environmental wellness-related interventions focused on child-care center staff and families.

Childcare centers provide an excellent opportunity to build healthy dietary and physical activity lifestyle habits and avoid the rapid weight gain that leads to health disparities. Building on a statewide survey among childcare centers and a pilot evaluation of an environmental intervention, this 3-cell randomized trial evaluates the impact of a staff-led wellness intervention and a staff-led and family-focused intervention, against a control condition.


Options:
A: Physical Activity Level (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.); Physical Literacy (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.); Dietary Intake (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.)
B: Change in children's Knowledge, attitude, habit (KAH) scores (baseline and 5 months)
C: Change in Observed Child Dietary Intake (8 Months); Change in Measured Child Physical Activity in Child Care (8 months); Change in Observed Child Dietary Intake (12 Months); Change in Measured Child Physical Activity in Child Care (12 Months)
D: Change of BMI Z-score for preschoolers (Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Building Blocks for Healthy Preschoolers: Child Care and Family Models
Brief Summary: Pediatric obesity, a defining health problem of the century, leads to long-term health disparities. This application evaluates strategies to prevent health disparities early in life by developing environmental wellness-related interventions focused on child-care center staff and families.

Childcare centers provide an excellent opportunity to build healthy dietary and physical activity lifestyle habits and avoid the rapid weight gain that leads to health disparities. Building on a statewide survey among childcare centers and a pilot evaluation of an environmental intervention, this 3-cell randomized trial evaluates the impact of a staff-led wellness intervention and a staff-led and family-focused intervention, against a control condition.


Options:
A: Maintenance of a Child's Body Mass Index as a result of the intervention (up to two years)
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: Change of BMI Z-score for preschoolers (Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up)
D: Change in Body Mass Index Z-score (9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Building Blocks for Healthy Preschoolers: Child Care and Family Models
Brief Summary: Pediatric obesity, a defining health problem of the century, leads to long-term health disparities. This application evaluates strategies to prevent health disparities early in life by developing environmental wellness-related interventions focused on child-care center staff and families.

Childcare centers provide an excellent opportunity to build healthy dietary and physical activity lifestyle habits and avoid the rapid weight gain that leads to health disparities. Building on a statewide survey among childcare centers and a pilot evaluation of an environmental intervention, this 3-cell randomized trial evaluates the impact of a staff-led wellness intervention and a staff-led and family-focused intervention, against a control condition.


Options:
A: BMI z-score (via measured weight and height) of preschooler (~2 years post baseline)
B: Change of BMI Z-score for preschoolers (Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up)
C: Change in Observed Child Dietary Intake (8 Months); Change in Measured Child Physical Activity in Child Care (8 months); Change in Observed Child Dietary Intake (12 Months); Change in Measured Child Physical Activity in Child Care (12 Months)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Strengthening Intrapartum and Immediate Newborn Care to Reduce Morbidity and Mortality of Preterm Infants in Health Facilities in Migori County, Kenya and Busoga Region, Uganda: an Implementation Science RCT
Brief Summary: The purpose of this study is to determine whether a combination of evidence-based strategies can improve intrapartum and newborn care in facilities to reduce mortality among preterm infants. This will be a cluster randomized implementation science study across 23 facilities in Eastern Uganda and Western Kenya. Selected interventions will be supported in facilities to measure impact during the study period. These interventions are: a) data strengthening and data use activities; b) implementation of a modified WHO Safe Childbirth Checklist with an emphasis on preterm labor and preterm babies; c) simulation-based provider training and mentoring on key existing evidence-based practices to improve newborn outcomes; d) support of Quality Improvement (QI) cycles to identify and resolve facility-specific issues and bottlenecks. A two-stage design will be used where all study facilities will receive some aspects of the intervention initially, namely data strengthening and the modified checklist. Subsequently, the remaining interventions (QI cycles and simulation training of providers) will be rolled out to a randomly selected half of the facilities in the first stage. At a second stage, the remaining half of the facilities will receive the remaining interventions.


Options:
A: all-cause neonatal mortality among preterms/low birth weight newborns (28-days after facility-based delivery)
B: Knowledge test by written test as multiple-choice questions (MCQ). (The participants will get a knowledge test at the training day they will participate in. Ten training days will be conducted in a 3 months period)
C: Perinatal mortality (12 months)
D: The primary outcome was the proportion of deliveries at greater than or equal to 20 weeks gestation in which one or more adverse maternal and/or neonatal outcomes occurred (Adverse Outcome Index).

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Three Endourological Procedures for the Management of Renal Calculi Regarding Acute Kidney Injury: a Prospective Randomized 3-arm Study.
Brief Summary: The main aim of the study is to investigate and compare the possible acute effect of standard PCNL, mini-PCNL and RIRS on renal function. Secondary aims are to investigate the efficacy (stone-free rate), safety (complication rate, long-term kidney function) and other parameters (operation, fluoroscopy and hospitalization time) concerning the 3 endourological operations (PCNL, mini- PCNL, RIRS) for the treatment of renal calculi.


Options:
A: The change in urine NGAL/Cr value (2 hours preoperative and 2 hours postoperatively)
B: Analgesic demand (Postoperative 24 hours); Stone clearance (3 months)
C: Number of patients stone free SFR 4 (1 month from treatment)
D: SFR (3 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Three Endourological Procedures for the Management of Renal Calculi Regarding Acute Kidney Injury: a Prospective Randomized 3-arm Study.
Brief Summary: The main aim of the study is to investigate and compare the possible acute effect of standard PCNL, mini-PCNL and RIRS on renal function. Secondary aims are to investigate the efficacy (stone-free rate), safety (complication rate, long-term kidney function) and other parameters (operation, fluoroscopy and hospitalization time) concerning the 3 endourological operations (PCNL, mini- PCNL, RIRS) for the treatment of renal calculi.


Options:
A: The change in urine NGAL/Cr value (2 hours preoperative and 2 hours postoperatively)
B: To assess the value of tranexamic acid (12 months)
C: Stone free rate (SFR) (The primary endpoint was the SFR at 3-months after surgery.)
D: Analgesic demand (Postoperative 24 hours); Stone clearance (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Three Endourological Procedures for the Management of Renal Calculi Regarding Acute Kidney Injury: a Prospective Randomized 3-arm Study.
Brief Summary: The main aim of the study is to investigate and compare the possible acute effect of standard PCNL, mini-PCNL and RIRS on renal function. Secondary aims are to investigate the efficacy (stone-free rate), safety (complication rate, long-term kidney function) and other parameters (operation, fluoroscopy and hospitalization time) concerning the 3 endourological operations (PCNL, mini- PCNL, RIRS) for the treatment of renal calculi.


Options:
A: The change in urine NGAL/Cr value (2 hours preoperative and 2 hours postoperatively)
B: The primary outcome is death from haemorrhage (within 5 days of randomisation)
C: To assess the value of tranexamic acid (12 months)
D: SFR (3 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Open-label Multi-center Study of Ruxolitinib vs. Best Available Therapy in Patients With Corticosteroid-refractory Chronic Graft vs Host Disease After Allogeneic Stem Cell Transplantation (REACH3)
Brief Summary: The purpose of this study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).


Options:
A: Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit (Cycle 7 Day 1 (each cycle was comprised of 4 weeks))
B: comparison of cumulative incidence of chronic GvHD (limited or extensive) after allogeneic SCT from HLA-identical siblings with or without anti-T-lymphocyte-globulin at 2 years after transplantation (2 years after transplantation)
C: Incidence of Epstein-Barr virus(EBV) viremia (1 year)
D: Incidence of acute GVHD, and chronic GVHD (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Empagliflozin in Post-Transplantation Diabetes Mellitus
Brief Summary: RELEVANCE:

Up to 50% of patients without previously known disorders of glucose metabolism develop posttransplantation diabetes mellitus (PTDM) after renal transplantation, which is associated with cardiovascular events. Although PTDM is triggered by immunosuppressive agents (calcineurin inhibitors, glucocorticoids), there is consensus against switching patients from potent tacrolimus to the less diabetogenic cyclosporin. Full-blown PTDM must therefore be treated aggressively. Empagliflozin inhibits sodium-glucose cotransporter 2 in the proximal tubule of the kidney and dramatically reduced cardiovascular risk in type 2 diabetics in a recent randomized trial. Especially in diabetics with impaired renal function, empagliflozin was safe, well tolerated, and effective against hyperglycemia and against high blood pressure. Data on SGLT2 inhibition after transplantation are completely lacking. Therefore, the potential antidiabetic of choice is currently withheld from the vulnerable PTDM population.

METHODS, STUDY DESIGN:

Prospective, single-center, non-inferiority study. Inclusion criteria: PTDM (antidiabetic therapy ≥6 months, based on prior 2-h BG ≥200 mg/dL, fasting BG ≥125 mg/dL (2 times) or HbA1c ≥6.5%); stable renal allograft function \>6 months; eGFR ≥30 mL/min/1.73m2. Most important exclusion criteria: type 1 and 2 diabetes; insulin demand \>40 IU/day; HbA1c \>8.5%. After study inclusion, patients will record 4 weeks of 4-times daily BG measurements before undergoing an OGTT, lab work and urine analysis (including ketones, urinary culture). Empagliflozin (10 mg) will be started and insulin discontinued within 3 days. Patients will be asked to perform urinary dipstick tests at home (i.e. ketones), and to continue recording BG. Study visits at 2 and 4 weeks (second OGTT + lab work (as above)). If control over hyperglycemia is insufficient, insulin therapy will be added back, otherwise study patients remain on empagliflozin monotherapy for 1 year. Statistics will include the paired t-test.


Options:
A: Concentration of glucagon during fasting glycemia and during hyperglycemic conditions measured in picomoles per liter (4 weeks)
B: Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) (from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days))
C: Incidence of Poor Graft Function After Kidney Transplant (7 days after transplant)
D: OGTT-derived 2-hour blood glucose level (4 weeks after start of Empagliflozin treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Culturally Competent Behavioral Intervention for Diabetes Risk Reduction
Brief Summary: This pragmatic randomized clinical trial will assess the efficacy, cost, and sustainability of a culturally tailored weight-loss program targeting obese Hispanic women with pre-diabetes or T2D. The intervention will be integrated into patient care at a Federally Qualified Health Center serving over 30,000 low-income patients, and will be delivered by trained clinic staff, with minimal support from research staff. After the effectiveness clinical trial, two cohorts of clinic patients will receive the intervention in a sustainability test.


Options:
A: Mammogram receipt (1 week)
B: Gain in phosphorus knowledge as assessed by the chronic kidney disease Knowledge Assessment Tool (CKDKAT) of nutrition. (4 to 8 weeks post intial questionnaire/survey); Compliance with dietary phosphorous will be measured by serum phosphorous level. (4 to 8 weeks after initial questionnaire/survey appointment); Compliance with dietary phosphorous will be measured by serum calcium level (4 to 8 weeks after initial questionaire/survey appointment); Compliance with dietary phosphorous will be measured by para thyroid hormone (PTH) level (4 to 8 weeks after initial questionnaire/survey appointment); Compliance with dietary phosphorous will be measured by serum calcium phosphorus product. (4 to 8 weeks after initial questionnaire/survey appointment); Compliance with dietary phosphorus intake will be measured by using 24 hour recall diary. (4 to 8 weeks after initial questionnaire/survey appointment)
C: Weight in Kilograms (Baseline, 6, 12, and 18 months); Waist Circumference in Centimeters (Baseline, 6, 12, and 18 months)
D: Number of participants linked to medical service for dementia measured by medical record verification (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: imPact Of a mindfuLness-based Intervention on Quality of Life and reduCtion of Burnout Symptoms in policE Officers - the POLICE Study
Brief Summary: The physical, emotional, economic and social damage of stress in the police corporation indicates an urgent call for preventive programs to approach stress reduction, burnout symptoms and promotion of quality of life and well-being.

The aim of the POLICE study is to evaluate the effectiveness of a Mindfulness-based intervention (MBI), compare to a waiting list (WL), in promoting quality of life and mental health in police officers.


Options:
A: Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks (Baseline and after 4, 8 weeks later)
B: Change from baseline quality of Life (8 weeks and 6 months); Change from baseline burnout symptoms (8 weeks and 6 months)
C: Change in Aggression (baseline, post-intervention (week 8), 3-month followup, 6-month followup)
D: Changes in PTSD symptoms(PCL) (Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat); Probable PTSD diagnosis(CAPS) (Four months after combat)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Value of Eye Movement Desensitization Reprocessing in the Treatment of Tinnitus
Brief Summary: A prospective, randomized, controlled, clinical trial with blind evaluator that uses TRT and EMDR as a treatment for tinnitus.


Options:
A: Tinnitus Functional Index (TFI) (Change will be assessed at 3 test moments during the trial: before the start of therapy (T0), after 3 months (10 treatment sessions) (T1) and 3 months after the last therapy session (T2). The change will be assessed at every test moment.)
B: Generic Quality of Life as measured with the Health Utilities Index Mark 3 (HUI3) (At baseline and 3, 8 and 12 months follow-up)
C: Change in tinnitus complaints as measured by the German version of the Tinnitus Questionnaire (TQ)(Baseline versus week 9) (Baseline to Week 9)
D: The Tinnitus Functional Index (Assessed at baseline and 8 weeks post-intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Psychological Intervention for Suicide Applied to Patents With Psychosis: the CARMS Trial (Cognitive Approaches to Combatting Suicidality)
Brief Summary: This is a randomised controlled trial which investigates the effectiveness of CARMS (Cognitive AppRoaches to coMbatting Suicidality) therapy in reducing suicidal thoughts and how well CARMS works in practice within the NHS. The trial will compare two groups of people with psychosis who are using NHS mental health services. One group will carry on with their usual treatment. The other group will be offered 24 weekly sessions of CARMS therapy, plus their usual treatment.


Options:
A: suicidal act frequency (12 months)
B: Change from Baseline Adult Suicide Ideation Questionnaire score at 6 and 12 months (Baseline, 6 month and 12 month follow up)
C: The primary clinical endpoint is the duration (in days) of a suicide reattempt-free follow-up period (12 months)
D: MHS heavy use (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Psychological Intervention for Suicide Applied to Patents With Psychosis: the CARMS Trial (Cognitive Approaches to Combatting Suicidality)
Brief Summary: This is a randomised controlled trial which investigates the effectiveness of CARMS (Cognitive AppRoaches to coMbatting Suicidality) therapy in reducing suicidal thoughts and how well CARMS works in practice within the NHS. The trial will compare two groups of people with psychosis who are using NHS mental health services. One group will carry on with their usual treatment. The other group will be offered 24 weekly sessions of CARMS therapy, plus their usual treatment.


Options:
A: 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)
B: Acceptability of the intervention assessed by the number of therapy sessions completed by participants in the intervention arm. (2 years); Incidence of Treatment-Emergent Adverse Events as assessed by the adverse experiences in psychotherapy self-reported measure (2 years); Feasibility of the intervention assessed by the number of assessments completed by participants in the intervention arm (2 years)
C: Change from Baseline Adult Suicide Ideation Questionnaire score at 6 and 12 months (Baseline, 6 month and 12 month follow up)
D: Client Satisfaction Questionnaire (Immediately following Brief Intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Psychological Intervention for Suicide Applied to Patents With Psychosis: the CARMS Trial (Cognitive Approaches to Combatting Suicidality)
Brief Summary: This is a randomised controlled trial which investigates the effectiveness of CARMS (Cognitive AppRoaches to coMbatting Suicidality) therapy in reducing suicidal thoughts and how well CARMS works in practice within the NHS. The trial will compare two groups of people with psychosis who are using NHS mental health services. One group will carry on with their usual treatment. The other group will be offered 24 weekly sessions of CARMS therapy, plus their usual treatment.


Options:
A: Change from Baseline Adult Suicide Ideation Questionnaire score at 6 and 12 months (Baseline, 6 month and 12 month follow up)
B: Clinical Global Impression (CGI) (Day 0); Suicide Intent Scale (Day 0); Montgomery-Asberg depression rating scale (Day 0)
C: Social Processing (Cyberball) fMRI Task: fMRI Responses (Pre-treatment (baseline) and post-treatment (up to 2 weeks)); Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior (One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)); Self Injurious Thoughts and Behaviors Inventory Part 1 (Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)); Ecological Momentary Assessment (EMA): NSSI Urges and Behavior (One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)); Self Injurious Thoughts and Behaviors Inventory Part 2 (pre-treatment (baseline) and post-treatment (up to 2 weeks)); Self Injurious Thoughts and Behaviors Inventory Part 3 (Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)); Self Injurious Thoughts and Behaviors Inventory Part 4 (Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline))
D: Suicide Events (Measured after 6 months of treatment)

Answer: A