TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Hope Soap Study: a Randomized Controlled Trial of a Hand-washing Intervention Among Children in South Africa
Brief Summary: The Hope Soap Study is a randomised-control pilot study of a hand-washing intervention in which children in treatment households received a bi-monthly delivery of HOPE SOAP©, a colourful, translucent bar of soap with a toy embedded in its centre.


Options:
A: Change in target behaviour: zinc use (six weeks post-intervention); Change in target behaviour: correct ORS preparation (six weeks post-intervention); Change in target behaviour: Exclusive breastfeeding (six weeks post-intervention); Change in target behaviour: Handwashing with soap (six weeks post-intervention)
B: diarrhea longitudinal prevalence
C: Diarrhea in Children Under 5 (one year after the intervention)
D: Direct observation of hand washing prior to eating a snack (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION
Brief Summary: This study is a follow up study for subjects with Ulcerative Colitis (UC) in stable remission designed to evaluate flexible dosing of CP-690,550.


Options:
A: Percentage of Participants With Remission at Week 8 (Week 8)
B: Percentage of Participants With Clinical Response (Week 8)
C: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 (Month 3); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 (Month 3)
D: Number of Participants With Remission Based on Modified Mayo Score at Month 6 (Month 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Adding Psychosocial Stimulation for Children of Lactating Mothers Enroled to Receive Unconditional Cash Transfer (UCT) and Health Education Awareness Programme on Children's Cognition and Behaviour in Rural Bangladesh
Brief Summary: Burden: In developing countries, an estimated 219 million children do not reach their maximum potentiality because of poverty and associated risk factors. More than half of the Bangladeshi children \<5 years are at risk for developmental delay due to poverty and sub-optimal home stimulation. Sometimes poor people become poorer due to catastrophic expenditure on health care and fall into the vicious cycle of poverty

Knowledge gap: Although, there is evidence that conditional cash transfer helps develop poor people' health and nutritional status, little is known about the effect of unconditional cash transfer and health education (HE) programmes along with psychosocial stimulation on children' cognition and behaviour.

Relevance: The study will bring an opportunity to evaluate the effect of transferring unconditional cash and health education programme along with psychosocial stimulation to poor families under safetynet programme of Bangladesh Govt. in rural areas. The study will also document direct and indirect cost to measure cost effectiveness that will help in decision making to implement the project if it shows benefits to children's development.

Primary Hypothesis (if any):

* Unconditional cash transfer (UCT) and health education (HE) programme will improve child's cognitive, motor and language development and behaviour compared to no intervention group.
* Adding psychosocial stimulation to an unconditional cash transfer (UCT) and health education (HE) programme will will have an additive effect on Childs's cognitive, motor and language development and behaviour compared to the control groups

Secondary Hypothesis:

Additionally the intervention will

* be cost effective,
* reduce mothers' depressive symptoms and improve their self esteem
* improve children's growth and household food security status
* reduce domestic violence
* Health seeking behaviour and health care expenditure

Long-term goal: our ultimate goal is to find a suitable infrastructure to take to scale early child development activities for the whole country.

Methods: It is a Cluster Randomized Controlled Trial with three-arms (i) UCT+HE+Psychosocial stimulation (ii) UCT+HE and iii) Comparison group.


Options:
A: Parenting practices (One month and six months post-intervention)
B: depression (On completion of intervention and six months post-intervention)
C: HIV sero-incidence (24 months post-baseline)
D: Child development composite score (Change children's cognition, language and motor as composite score after one year intervention); Children's behavior and composite score (Change children's behaviour after one year intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof of Concept Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects With Bladder Pain Syndrome/Interstitial Cystitis
Brief Summary: The purpose of this study is to investigate efficacy, safety and tolerability of ASP6294 in female participants with Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC). This study will also investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of ASP6294 in female participants with BPS/IC.


Options:
A: Number of Responders Defined as Having at Least a 30% Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint (Baseline to Week 24)
B: Change From Baseline in the Average Daily Bladder Pain Score (e-Diary) (Baseline to Week 6)
C: Change From Baseline in Mean Average Daily Pain Score at Week 8 (Baseline, Week 8)
D: Change from Baseline in Average Mean Daily Pain (MDP) Score at Week 12 (Baseline and Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Salad Bars and Students' Fruit and Vegetable Consumption: A Group-randomized Trial With Objective Assessments
Brief Summary: The investigators propose an efficacy study (i.e., do salad bars work under controlled conditions in naturalistic settings) to test whether introducing salad bars in elementary, middle, and high schools that have never had salad bars affects students' FV consumption and waste during lunch. A cluster randomized controlled trial will test new salad bars against controls for 6 wks, with/without an additional 4-wk marketing phase .


Options:
A: Change in grams of fruit and vegetables consumed (Baseline (prior to randomization allocation of installation of salad bars), Time 2 (6 weeks after randomization), and Time 3 (10 weeks after randomization))
B: fasting blood glucose (Baseline to 10 months postpartum); weight (body mass index) (Baseline to 10 months postpartum)
C: Body fat (At the end of the intervention and at a six month follow-up)
D: 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.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Salad Bars and Students' Fruit and Vegetable Consumption: A Group-randomized Trial With Objective Assessments
Brief Summary: The investigators propose an efficacy study (i.e., do salad bars work under controlled conditions in naturalistic settings) to test whether introducing salad bars in elementary, middle, and high schools that have never had salad bars affects students' FV consumption and waste during lunch. A cluster randomized controlled trial will test new salad bars against controls for 6 wks, with/without an additional 4-wk marketing phase .


Options:
A: Maintenance of a Child's Body Mass Index as a result of the intervention (up to two years)
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 Percentage of Children Meeting Physical Activity Policy (Spring of Year 1, Year 2, and Year 3)
D: Change in grams of fruit and vegetables consumed (Baseline (prior to randomization allocation of installation of salad bars), Time 2 (6 weeks after randomization), and Time 3 (10 weeks after randomization))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Person-centered Follow up and Health Promotion Program After Revascularization for Intermittent Claudication
Brief Summary: The overall aim of the study is to evaluate a nurse-led intervention (person-centered follow up and health promotion) program in comparison to standard follow up for patients treated with surgical or endovascular revascularization of Intermittent Claudication.


Options:
A: Adherence to medication (One year after surgical or endovascular treatment for Intermittent Claudication)
B: Change From Baseline in Peak Walking Time (PWT) at Day 180 (Baseline, Day 180)
C: Improvement in peak walking time at 26 weeks (26 Weeks)
D: The effect on pulse wave velocity (PWV) (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Exercise for Education ('Fit to Study')
Brief Summary: Neuroscience evidence suggests that physical exercise can influence brain function and structure, both immediately and in the long-term. The 'Fit to Study' project is a randomised controlled trial to test the effects on academic performance (as well as fitness, wellbeing and cognitive function) of a teacher-training intervention designed to optimise the content of PE for brain and cognitive function during secondary school (Year 8) Physical Education (PE) lessons. The project aims to rigorously test the impact of this intervention in 100 state-funded secondary schools.


Options:
A: Mathematical attainment: as measured using the level 13 Progress in Maths test (provided at GL assessment) at the end of the school year (June 2018). (1 hour: Last month of the study (June 2018).)
B: Intake of unhealthy foods, unhealthy drinks, healthy foods assessed by a photo-based method (volume) (6 months post baseline); Intake of unhealthy foods, unhealthy drinks, healthy foods assessed by a photo-based method (volume) (18 months post baseline)
C: Math Skills, as measured by a 45-minute standardized math test specifically designed for this age group by the developer of the Danish national tests (MG) (Hoegrefe Forlag). (Change from Baseline Math Skills at 9 months)
D: Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to 3-year and 6-year intervention for children. (3-year, and 6-year changes from baseline of questionnaire scoring for children); Cardiovascular health markers (blood pressure, height, weight, waist circumference and triceps and subscapular skinfold thickness) of children from baseline to 3-year and 6-year intervention. (3-year, and 6-year changes from baseline on cardiovascular health markers of children)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single Arm, Open-label, Multi-centre, Phase I/II Study Evaluating the Safety and Clinical Activity of AUTO3, a CAR T Cell Treatment Targeting CD19 and CD22 With Anti PD1 Antibody in Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma
Brief Summary: The purpose of this study is to test the safety and efficacy of AUTO3, a CAR T cell treatment targeting CD19 and CD22 followed by limited duration of anti-PD1 antibody in patients with DLBCL


Options:
A: Phase I Escalation - Safety (incidence of Grade 3-5 toxicities) and identification of recommended Phase II dose and schedule. (Within 75 days of AUTO3 infusion); Phase I Expansion - Safety (incidence of Grade 3-5 toxicities) in the outpatient / ambulatory care setting (Within 75 days of AUTO3 infusion); Phase II - Overall response rate as per Lugano criteria (Up to 2 years)
B: Dose-limiting toxicity (DLT) (28 days)
C: To assess the safety of allogeneic anti-CD19 CAR (4-5 weeks after first dose)
D: Treatment-related adverse events (AEs) (2 years); Dose-limiting toxicities of JWCAR029 (28 days after JWCAR029 infusion); Objective response rate (ORR) (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Does the Use of Liposomal Bupivacaine Decrease Narcotic Requirements in Geriatric Hip Fractures? A Randomized, Double Blinded Control Trial
Brief Summary: This is a prospective, randomized study looking at the effect that a long-acting local anesthetic has on pain control in patients having surgery for hip fractures. The investigators are conducting the study to see if that reduces the amount of pain medicine needed after surgery, and if it reduces other medical complications after surgery.


Options:
A: Acute complications during insertion of regional anesthesia (at the day of insertion, day zero)
B: Pain scores at rest (45 minutes after the injection)
C: Opiate Requirements (72 hours)
D: Consumption of opioids

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Use of Contact Aspiration and the Stent Retriever Technique Versus Stent Retriever Alone for Recanalisation in Acute Cerebral Infarction: the Randomized ASTER2 Study
Brief Summary: Mechanical thrombectomy (MT) with a stent retriever (SR) device is now the standard intervention in ischemic stroke with large vessel occlusion. Favorable outcome is strongly associated with the successful reperfusion status. New device of MT such as contact aspiration seems promising to increase reperfusion status and clinical outcome.

The main hypothesis is to show the superiority of combining the use of contact aspiration with a stent retriever compared to a stent retriever alone in treatment of acute stroke due to proximal arterial occlusion.

The primary endpoint is the rate of perfect reperfusion score at the end of the endovascular procedure.


Options:
A: 90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS). (90 days)
B: Perfect reperfusion rate (24 hours)
C: Complete recanalization percentage (Immediately after the revascularization procedure is completed)
D: favorable clinical response (day 30)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Accelerating Newborn Survival in Ghana Through a Low-dose, High-frequency Health Worker Training Approach
Brief Summary: This study assesses the effect of a low-dose, high-frequency training approach on long-term evidence-based skill retention among skilled birth attendants and impact on adverse birth outcomes at hospitals in Ghana.


Options:
A: institutional twenty-four hour newborn mortality rate (1 day); institutional intrapartum stillbirth rate (1 day)
B: Perinatal mortality (12 months)
C: 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)
D: increase the proportion of institutional deliveries in intervention vs. control clusters (Up to 15 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Accelerating Newborn Survival in Ghana Through a Low-dose, High-frequency Health Worker Training Approach
Brief Summary: This study assesses the effect of a low-dose, high-frequency training approach on long-term evidence-based skill retention among skilled birth attendants and impact on adverse birth outcomes at hospitals in Ghana.


Options:
A: 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)
B: Neonatal mortality (7 days)
C: Composite of either >28 week / >1000 gram stillbirth or 7 day neonatal mortality rate (7 days post delivery)
D: institutional twenty-four hour newborn mortality rate (1 day); institutional intrapartum stillbirth rate (1 day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial to Identify the Effect and the Working Mechanisms of MyPlan 2.0, a Self-regulation-based e- and mHealth Intervention Targeting Physical Activity and Sedentary Behaviour, in Adults With Type 2 Diabetes.
Brief Summary: The aim of this study is to investigate whether and how 'MyPlan 2.0' helps adults with type 2 diabetes to be more physically active or less sedentary. Two groups will be created, an intervention group and a waiting-list control group.


Options:
A: Functional performance, balance and reduced self-reported upper and lower body functional limitations in sedentary, older adults' physical activity. (Baseline, 6-month, 12-month follow-up)
B: Self reported physical activity (after 3 month); Self reported physical activity (After 6 month)
C: Change in Physical Activity From Baseline to 12 Weeks (12 weeks)
D: Change in objective total, light and moderate-to-vigorous physical activity (PA) (Pretest, posttest (6 weeks) and follow-up (6 months)); Change in objective sedentary behaviour (Pretest, posttest (6 weeks) and follow-up (6 months)); Change in self-reported total, light and moderate-to-vigorous physical activity (PA) (Pretest, posttest (6 weeks) and follow-up (6 months)); Change in self-reported sedentary behaviour (Pretest, posttest (6 weeks) and follow-up (6 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing the Benefits of Functional Recovery Between the Early Mobilization and Early Conventional Intervention After Stroke for the Patients With Mild to Moderate Hemorrhagic Stroke
Brief Summary: This study aims to examine the outcomes of early mobilization and early intervention within 24-72 hours after the onset of hemorrhagic stroke in patients admitted to an intensive care unit within 24 hours after stroke. The patients after hemorrhagic stroke who undergo early intervention only will be compared with those who also receive early mobilization in order to determine if the early mobilization intervention results in earlier or more effective recovery of postural stability, activities of daily living function, or motor capacity.

The participants will be randomly assigned to the following two groups: (1) the early mobilization (+early rehabilitation) group and (2) the early rehabilitation group.The measurement parameters will be collected before the intervention (basic parameters), two weeks after the stroke, four weeks after the stroke and three months after the stroke. SPSS (version 17.0) will be used to carry out repeated measures analysis of variance (repeated ANOVA) to compare the differences between the groups at different time points (including basic values and follow-up values). For statistical significance, Bonferroni correction will be applied for the post-hoc analysis of the groups.


Options:
A: Adherence (8 weeks)
B: Reach (Follow-up (week 16)); Retention (Follow-up (week 16)); Satisfaction with program (Post-intervention (week 9))
C: the score-change of the Functional Independence Measure (FIM) assessment for daily living function (baseline, 2-week, 4-week and three months after stroke)
D: Change in Rivermead Mobility index (Baseline, 6 months, 9 months); Change in Timed Up and Go Test (Baseline, 6 months, 9 months); Change in Modified Patient Specific Functional Scale (Baseline, 6 months, 9 months); Change in Physical Activity Diary (Baseline, 6 months, 9 months); Change in Physical activity - 7-day accelerometry (Baseline, 6 months, 9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing the Benefits of Functional Recovery Between the Early Mobilization and Early Conventional Intervention After Stroke for the Patients With Mild to Moderate Hemorrhagic Stroke
Brief Summary: This study aims to examine the outcomes of early mobilization and early intervention within 24-72 hours after the onset of hemorrhagic stroke in patients admitted to an intensive care unit within 24 hours after stroke. The patients after hemorrhagic stroke who undergo early intervention only will be compared with those who also receive early mobilization in order to determine if the early mobilization intervention results in earlier or more effective recovery of postural stability, activities of daily living function, or motor capacity.

The participants will be randomly assigned to the following two groups: (1) the early mobilization (+early rehabilitation) group and (2) the early rehabilitation group.The measurement parameters will be collected before the intervention (basic parameters), two weeks after the stroke, four weeks after the stroke and three months after the stroke. SPSS (version 17.0) will be used to carry out repeated measures analysis of variance (repeated ANOVA) to compare the differences between the groups at different time points (including basic values and follow-up values). For statistical significance, Bonferroni correction will be applied for the post-hoc analysis of the groups.


Options:
A: Fugl-Meyer Upper Extremity (FM-UE) (from baseline to day 3 post-training)
B: Motor Skill Retention (Day 9)
C: Change of motor function (0 week and 1 week)
D: the score-change of the Functional Independence Measure (FIM) assessment for daily living function (baseline, 2-week, 4-week and three months after stroke)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Venous Ulcer: Endovenous Radiofrequency Treatment of Insufficient Perforating and Saphenous Veins Versus Multilayer Compression Bandaging - Randomized Controlled Clinical Trial
Brief Summary: The aim of this study is to analyze the effect of intravenous therapy with radiofrequency for superficial and perforating venous insufficiency versus compression therapy with multilayer banding in patients with active venous ulcer. This is a controlled, randomized prospective clinical trial. People with venous ulcers and primary venous insufficiency in superficial and perforating venous system will be studied. Participants will be divided into two experimental groups: compression therapy alone, and compression therapy associated with superficial and perforating venous system ablation. Clinical aspects, improvement in patients' quality of life and interventions cost-effectiveness will be analyzed. Patients will be followed for 12 months after ulcer healing.


Options:
A: Generic Quality of life - Short Form-36 (1 week, 6 weeks, 3 months, 1 year, 2 years)
B: Ulcer Healing - 12 w (12 weeks); Ulcer Healing - 24 w (24 weeks)
C: Intra-procedural Pain (Up to end of intervention); Technical Efficacy assessed by successful procedure defined as complete occlusion of the target vein segment. (At 1 year)
D: Complete Closure of the Target Vein at 5 years after index treatment in the VeClose study (NCT01807585). (5 years)

Answer: B