TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This evaluation is part of a five country project to evaluate the benefits and costs of the use of two alternatives to food transfers: vouchers and cash (hereafter referred to as "alternative modalities"). The project will generate information on how outcomes such as household food expenditure and dietary diversity, relevant to both beneficiaries and WFP, change following the introduction of these alternative modalities; how benefits and costs of these are, relative to food transfers, distributed across and within households; and what are the critical operational issues that need to be addressed for these alternatives to be successfully implemented. More specifically, the project will answer seven questions:

1. Do households benefit from receipt of the alternative modalities?
2. Are these benefits greater, or less, when transfers are made using alternative modalities compared to food transfers. How does this vary across outcomes (such as nutrition, livelihoods, gender dynamics and intra-household resource allocation) that are of especial interest to WFP?
3. How does the distribution of benefits differ across households when transfers are made using alternative modalities compared to food transfers?
4. How does the distribution of benefits differ within households when transfers are made using alternative modalities compared to food transfers? Do certain household members (women, young children) benefit more from one type of modality? How do these modalities affect decision-making processes within the household?
5. Why are these differences observed? How do the reasons for these differences affect the study's ability to generalize from these evaluations?
6. Does the delivery of alternative modalities cost less than food transfers? What accounts for these cost differences? Are some costs (such as transport) really lower or are they transferred to beneficiaries? Within the household, who bears these additional costs?
7. What is the benefit: cost ratios associated with these different modalities from the perspective of WFP? Is there a conflict between the modality "preferred" by WFP and the modality "preferred" by beneficiaries?

These objectives will be accomplished through household survey data collection among a panel of households before and after transfer of alternative modalities. In addition, select countries will involve the collection of anthropometric, biomarker and cognitive testing.


Options:
A: Sexually Transmitted Infections (18 months); Schooling (12 months/24 months)
B: Food security as measured by the value of food consumption through a household questionnaire (6 months); Dietary diversity as measured by dietary diversity index and food consumption score through a household questionnaire (6 months)
C: Incidence of Diarrhea (2 weeks)
D: Recovery rate in the outpatient therapeutic program (At 6 week)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Battlefield Auricular Acupuncture for Control of Post-partum Pain
Brief Summary: We will conduct a randomized controlled trial to determine whether the addition of battlefield auricular acupuncture to standard of care is effective for control of postpartum pain for mothers in the immediate post-partum period. Post-partum patients (DoD beneficiaries) 18 years or older, regardless of gravida/parity, who plan to have a childbirth in a hospital setting will be offered the opportunity to participate in the study through PCM referrals and posted advertisements. After a minimum of 6 hours post-vaginal delivery or 24 hours post caesarean section subjects will be given treatment according to their randomization group. Subjects will be assessed on pain control, overall satisfaction with pain management, and the amount of pharmacological pain medications used. Safety of measures will also be assessed to include infection rates, syncope, vertigo, and hypotension.


Options:
A: Lowest Pain Level Postoperative (24 hours postoperative); Average Pain Level Postoperative (24 hours postoperative); Worst Pain Level Postoperative (24 hours postoperative)
B: Pain score by visual analogue scale (VAS) on movement at 48 hours postoperatively (48 hours)
C: Number of Subjects Who Achieved 50% Sustained Pain Reduction (12 days)
D: Daily average postoperative pain scores (An average of pain scores at 8:00 am and 4:00 pm, up to 7 days postoperation); Postoperative functional recovery (In the morning of postoperative day 3)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Battlefield Auricular Acupuncture for Control of Post-partum Pain
Brief Summary: We will conduct a randomized controlled trial to determine whether the addition of battlefield auricular acupuncture to standard of care is effective for control of postpartum pain for mothers in the immediate post-partum period. Post-partum patients (DoD beneficiaries) 18 years or older, regardless of gravida/parity, who plan to have a childbirth in a hospital setting will be offered the opportunity to participate in the study through PCM referrals and posted advertisements. After a minimum of 6 hours post-vaginal delivery or 24 hours post caesarean section subjects will be given treatment according to their randomization group. Subjects will be assessed on pain control, overall satisfaction with pain management, and the amount of pharmacological pain medications used. Safety of measures will also be assessed to include infection rates, syncope, vertigo, and hypotension.


Options:
A: Number of Subjects Who Achieved 50% Sustained Pain Reduction (12 days)
B: use of analgesia during hospitalization (24 hours post partum)
C: Patient Reported Average Pain Score (Average score computed from postpartum day 0, postpartum day 1); Number of Patient Using Each Type of Non-narcotic Pain Medications (Number of patients using each type of non-narcotic medication recorded on postpartum day 0 and postpartum day 1); Any Narcotic Pain Medication Use (Any narcotic medication use from postpartum day 0 and postpartum day 1)
D: Reduction in the level of perineal pain (3 days); Reduction in perineal swelling (3 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Treatment Effectiveness of Theta Burst Stimulation and Voluntary Trunk Rotation for Patients With Unilateral Neglect in Stroke
Brief Summary: This is a double blinded, randomized control trial with a pretest-posttest control and interventional group design. The assessor is blinded to all assessments and evaluations. All patients with subacute stroke undergo in-patient or out-patient rehabilitation are screened initially by a series of screening test. Suitable patients are assigned randomly to two groups respectively. Group 1 is the experimental group for Transcranial Magnetic Stimulation (TMS) and trunk rotation; Group 2 is the control group with only trunk rotation training and placebo stimulation.


Options:
A: Unilateral neglect (Change of baseline to 3-week and to follow-up at 6-week); Allocentric and egocentric neglect (Change of baseline to 3-week and to follow-up at 6-week); Functional performance related to unilateral neglect (Change of baseline to 3-week and to follow-up at 6-week)
B: Neglect symptom severity (neuropsychological test performance) (Intra-individual difference of the outcome's change during 3 weeks Intervention versus 3 weeks Control phase, i.e. (T3 on Day 21 - T2 on Day 1) - (T5 on Day 42 - T4 on Day 22)); Neglect-related functional disability (Intra-individual difference of the outcome's change during 3 weeks Intervention versus 3 weeks Control phase, i.e. (T3 on Day 21 - T2 on Day 1) - (T5 on Day 42 - T4 on Day 22))
C: Change from Baseline: behavioral Inattention Test (BIT) (up to 21 days post baseline and up to 90 days follow-up)
D: Change score in Behaviorial Inattention Test (BIT) - Chinese version (Day 0 (Date of initial assessment before treatment), Day 10 (Date after last session of treatment, expected average 3 weeks), 4 weeks follow up after last session of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Severe Steroid Dependent Asthma
Brief Summary: Primary Objective:

To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in participants with severe steroid-dependent asthma.

Secondary Objectives:

* To evaluate the safety and tolerability of dupilumab.
* To evaluate the effect of dupilumab in improving participants-reported outcomes.
* To evaluate dupilumab systemic exposure and the incidence of treatment-emergent antidrug antibodies.


Options:
A: Percentage Reduction From Baseline in Oral Corticosteroids (OCS) Dose at Week 24 While Maintaining Asthma Control (Baseline, Week 24); Supplementary Presentation of Primary Outcome Measure Data: Median Percentage Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control (Baseline, Week 24)
B: Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population (Baseline to Week 52); Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population (Baseline, Week 12)
C: Proportion of Participants With Severe Asthma Exacerbations (from baseline to week 26)
D: Symptom scoring (1 to 3 years of age); Duration in days of each asthmatic episode from randomisation start (1 to 3 years of age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-country cOllaborative Project on the rOle of Diet, FOod-related Behaviour, and Obesity in the Prevention of Depression (MoodFOOD)
Brief Summary: The study examines the feasibility and effectiveness of two different nutritional strategies (multi-nutrient supplement and food-related behavioural change) to prevent depression in high-risk overweight European Union citizens. Interventions will last 12 months. Design is a two-by-two factorial randomized controlled prevention trial with four intervention groups:

1. Control group (daily placebo supplements)
2. Multi-nutrient supplementation group (daily multi-nutrient supplement)
3. Food-related behavioural change group (food-related behavioural activation focusing on improving overall diet + placebo supplements)
4. Multi-nutrient supplementation + food-related behavioural activation group (daily multi-nutrient supplement + food-related behavioural activation focusing on improving overall diet).

Follow-up assessment will be conducted at 3, 6, and 12 months for primary and secondary endpoints, and during intervention for compliance, adverse events and mediating variables.Data will first be analyzed according to the intention-to-treat principle, using (mixed model) analysis of covariance with primary and secondary endpoints, testing for the effects of the two nutritional strategies separately as well as combined.


Options:
A: Cumulative incidence of Major depressive Disorder (12 months)
B: The Primary endpoint will be improvement in a composite score of histological injury as measured by the NASH Activity Score (NAS). (approximately 12 months from enrollment)
C: Sudden cardiac death (12 months)
D: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-country cOllaborative Project on the rOle of Diet, FOod-related Behaviour, and Obesity in the Prevention of Depression (MoodFOOD)
Brief Summary: The study examines the feasibility and effectiveness of two different nutritional strategies (multi-nutrient supplement and food-related behavioural change) to prevent depression in high-risk overweight European Union citizens. Interventions will last 12 months. Design is a two-by-two factorial randomized controlled prevention trial with four intervention groups:

1. Control group (daily placebo supplements)
2. Multi-nutrient supplementation group (daily multi-nutrient supplement)
3. Food-related behavioural change group (food-related behavioural activation focusing on improving overall diet + placebo supplements)
4. Multi-nutrient supplementation + food-related behavioural activation group (daily multi-nutrient supplement + food-related behavioural activation focusing on improving overall diet).

Follow-up assessment will be conducted at 3, 6, and 12 months for primary and secondary endpoints, and during intervention for compliance, adverse events and mediating variables.Data will first be analyzed according to the intention-to-treat principle, using (mixed model) analysis of covariance with primary and secondary endpoints, testing for the effects of the two nutritional strategies separately as well as combined.


Options:
A: Cumulative incidence of Major depressive Disorder (12 months)
B: Percentage of Liver Fat (Baseline and 18 months); Liver Fibrosis Score (Baseline and 18 months); NAFLD Fibrosis Score (Baseline and 18 months)
C: time to clinical relapse (52 weeks)
D: MRI disease activity measured by the number of new T1-enhancing lesions during the six months of treatment.; MRI disease activity measured by the number of new T1-hypo-intensive lesions (black holes) after 24 months of treatment.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-country cOllaborative Project on the rOle of Diet, FOod-related Behaviour, and Obesity in the Prevention of Depression (MoodFOOD)
Brief Summary: The study examines the feasibility and effectiveness of two different nutritional strategies (multi-nutrient supplement and food-related behavioural change) to prevent depression in high-risk overweight European Union citizens. Interventions will last 12 months. Design is a two-by-two factorial randomized controlled prevention trial with four intervention groups:

1. Control group (daily placebo supplements)
2. Multi-nutrient supplementation group (daily multi-nutrient supplement)
3. Food-related behavioural change group (food-related behavioural activation focusing on improving overall diet + placebo supplements)
4. Multi-nutrient supplementation + food-related behavioural activation group (daily multi-nutrient supplement + food-related behavioural activation focusing on improving overall diet).

Follow-up assessment will be conducted at 3, 6, and 12 months for primary and secondary endpoints, and during intervention for compliance, adverse events and mediating variables.Data will first be analyzed according to the intention-to-treat principle, using (mixed model) analysis of covariance with primary and secondary endpoints, testing for the effects of the two nutritional strategies separately as well as combined.


Options:
A: Changes from baseline in global cognitive composite score (2 years); Changes from baseline in macular degeneration (2 years)
B: Surgical Arm: Proportion of study SVGs which are totally occluded on cardiac CT angiography at 1-year post-CABG and death due to CV or unknown causes. (1 year post-operative); Pharmacological Arm: Proportion of patients with ≥1 graft (saphenous or arterial) totally (100%) occluded on cardiac CT angiography at 1-year post-CABG and death due to CV or unknown causes, comparing the fish-oil to placebo groups. (1-year post-operative)
C: Inflammatory Response (1 year)
D: Cumulative incidence of Major depressive Disorder (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Subject-blind, Investigator-blind, Placebo-controlled, Single-dose, Dose-escalating Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of UCB4940 in Patients With Mild to Moderate Psoriasis
Brief Summary: To evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis.


Options:
A: Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects prematurely discontinuing due to a Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks)
B: Proportion of patients in remission defined by disease specific composite scores Study part A (30 weeks); Sustained disease control throughout the study period without disease worsening defined by disease specific composite scores Study part B (52 weeks)
C: Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) (Week 0 and Week 16)
D: Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) (Week 12); Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) (Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Subject-blind, Investigator-blind, Placebo-controlled, Single-dose, Dose-escalating Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of UCB4940 in Patients With Mild to Moderate Psoriasis
Brief Summary: To evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis.


Options:
A: Number of Participants Achieving a Greater Than or Equal to 75 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 (Baseline and Week 12)
B: Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score (Week 16)
C: Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) (Week 12); Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) (Week 12)
D: Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects prematurely discontinuing due to a Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Subject-blind, Investigator-blind, Placebo-controlled, Single-dose, Dose-escalating Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of UCB4940 in Patients With Mild to Moderate Psoriasis
Brief Summary: To evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis.


Options:
A: 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)
B: Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 (Week 12); Participants With IGA Mod 2011 0 or 1 at Week 12 (Week 12)
C: Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects prematurely discontinuing due to a Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks)
D: Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24 (Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Subject-blind, Investigator-blind, Placebo-controlled, Single-dose, Dose-escalating Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of UCB4940 in Patients With Mild to Moderate Psoriasis
Brief Summary: To evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis.


Options:
A: Percentage of Participants With a PASI 75 Response at Week 12 (Baseline and week 12)
B: PASI 75 (16 weeks); Physician Global Assessment, PGA (16 weeks)
C: Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. (Baseline to week 16)
D: Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects prematurely discontinuing due to a Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled Trial Evaluating Methods to Use Physical Activity to Improve Outcomes After Acute Coronary Syndrome
Brief Summary: This study will use a randomized, controlled trial to test the effectiveness of a home-based physical activity program using wearable devices and financial incentives. All participants in will establish a baseline step count during the first two weeks and then proceed to a 16-week intervention period and 8-week follow-up period.


Options:
A: Change in Mean Daily Steps (Baseline and end of Maintenance Period at Week 16)
B: Cardiorespiratory Fitness (Change from Baseline in Cardiorespiratory Fitness at 8 weeks of Cardiac Rehabilitation Home-based Program); Blood tests (Change from Baseline in blood tests at 8 weeks of Cardiac Rehabilitation Home-based Program); Computerized axial tomography (Change from Baseline in Computerized axial tomography at 8 weeks of Cardiac Rehabilitation Home-based Program)
C: Maximal oxygen consumption (At baseline and after 6 months)
D: Autonomic Function (Change from Baseline in Autonomic Function at 8 weeks of Cardiac Rehabilitation Program)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled Trial Evaluating Methods to Use Physical Activity to Improve Outcomes After Acute Coronary Syndrome
Brief Summary: This study will use a randomized, controlled trial to test the effectiveness of a home-based physical activity program using wearable devices and financial incentives. All participants in will establish a baseline step count during the first two weeks and then proceed to a 16-week intervention period and 8-week follow-up period.


Options:
A: Cardiopulmonary function (Measured at Week 8)
B: Physical Fitness (Measured after 12 weeks and after one year); Physical Activity Level (PAL) (measured after 12 weeks and after one year)
C: Change in Mean Daily Steps (Baseline and end of Maintenance Period at Week 16)
D: Participation in cardiac rehabilitation (4 months)

Answer: C