TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Understanding the Impact of School-Based Physical Activity Programs
Brief Summary: The central hypothesis of the Fueling Learning Through Exercise (FLEX) study is two innovative school-based physical activity programs (a walking/running program and a classroom activity break program) will increase school-time and total daily minutes children engage in moderate-to-vigorous physical activity, relative to controls, and that children who attend schools with these PA programs will demonstrate improved cognitive functioning, academic achievement, and attendance, relative to controls.


Options:
A: Event-related brain potentials (Change from baseline, 36-40 weeks); Task Performance (Change from baseline, 36-40 weeks); Academic Achievement (Change from baseline, 36-40 weeks)
B: Anterior hippocampal volume (change) (5mins, Baseline/pre-intervention (July - September 2017) and after 1 year (July - September 2018))
C: Change from baseline in weekly time in moderate-to-vigorous physical activity at 4 months (baseline and after 4-months of intervention); Change from baseline in the daily time using TV/computer/video games at 4 months (baseline and after 4-months of intervention)
D: School-time and total daily MVPA (5 months and 1.5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Understanding the Impact of School-Based Physical Activity Programs
Brief Summary: The central hypothesis of the Fueling Learning Through Exercise (FLEX) study is two innovative school-based physical activity programs (a walking/running program and a classroom activity break program) will increase school-time and total daily minutes children engage in moderate-to-vigorous physical activity, relative to controls, and that children who attend schools with these PA programs will demonstrate improved cognitive functioning, academic achievement, and attendance, relative to controls.


Options:
A: Event-related brain potentials (Change from baseline, 36-40 weeks); Task Performance (Change from baseline, 36-40 weeks); Academic Achievement (Change from baseline, 36-40 weeks)
B: Change in BMI From Baseline to 12 Months Follow up. (Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions.)
C: School-time and total daily MVPA (5 months and 1.5 years)
D: BMI and aerobic fitness (1 schoolyear)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Understanding the Impact of School-Based Physical Activity Programs
Brief Summary: The central hypothesis of the Fueling Learning Through Exercise (FLEX) study is two innovative school-based physical activity programs (a walking/running program and a classroom activity break program) will increase school-time and total daily minutes children engage in moderate-to-vigorous physical activity, relative to controls, and that children who attend schools with these PA programs will demonstrate improved cognitive functioning, academic achievement, and attendance, relative to controls.


Options:
A: School-time and total daily MVPA (5 months and 1.5 years)
B: Changes in Brain function and structure using magnetic resonance imaging (MRI) (20 days during baselines and Post-evaluations (after intervention).); Brain and cognitive functioning assessment by electroencephalogram (EEG) (20 days during baselines and Post-evaluations (after intervention).); Cognitive performance (DKEFS test battery) (20 days during baselines and Post-evaluations (after intervention).); Academic achievement (20 days during baselines and Post-evaluations (after intervention).)
C: N/A
D: Our outcome measure was reduction of screen time (4 waves of data)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Understanding the Impact of School-Based Physical Activity Programs
Brief Summary: The central hypothesis of the Fueling Learning Through Exercise (FLEX) study is two innovative school-based physical activity programs (a walking/running program and a classroom activity break program) will increase school-time and total daily minutes children engage in moderate-to-vigorous physical activity, relative to controls, and that children who attend schools with these PA programs will demonstrate improved cognitive functioning, academic achievement, and attendance, relative to controls.


Options:
A: School-time and total daily MVPA (5 months and 1.5 years)
B: Change in fruits and vegetables and dairy products (Before and after the intervention (0 and 6 wk))
C: Improved dietary quality (Baseline- 24 months); Increased physical activity (Baseline- 24 months)
D: Body mass index (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Interactive Binocular Treatment (I-BiT) for the Management of Anisometropic, Strabismic and Mixed Amblyopia in Children Aged 3.5 - 12 Years
Brief Summary: Around one child in fifty has a lazy eye (termed amblyopia) where the eye is structurally normal but the vision fails to develop correctly. Around half of these children also have a squint (strabismus) where each eye has a different direction of gaze. This condition is the commonest cause of visual impairment in one eye in children.

This is a randomised control trial of wearing glasses alone (which will result in some visual improvement, termed refractive adaptation) and wearing glasses combined with using I-BiT Plus.

The hypothesis is that using I-BiT Plus will result in an improved visual outcome.


Options:
A: The change of visual acuity from baseline to week six post randomisation visit between the two arms in each group. (6 weeks)
B: Visual acuity improvement
C: Change from baseline in visual acuity (6 weeks)
D: Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks (24 weeks); Mean (SD) of Amblyopic Eye Visual Acuity at 24 Weeks (24 weeks); Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks (Baseline to 24 weeks); Mean Change in Amblyopic Eye Visual Acuity From Baseline to 24 Weeks (Baseline to 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Criteria for Hospitalization or Outpatient Management of Patients With Pulmonary Embolism, Hestia Rule Versus Simplified PESI Score : an Open-label Controlled Randomized International Trial (HOME-PE)
Brief Summary: Several studies have demonstrated the possibility of outpatient management or early discharge for certain patients presenting acute pulmonary embolism (PE), providing a suitable structure is in place.

The approach featured in the most recent guidelines on acute PE of the European Society of Cardiology, refers to an all-cause mortality risk assessment using the Pulmonary Embolism Severity Index (PESI) score or the simplified PESI score (sPESI). The sPESI takes into account demographics (age), patient history (cancer, cardiac or respiratory disease), and clinical data (systolic blood pressure, heart rate, oxygen saturation). Outpatient care is offered to low-risk patients, providing that all the conditions pertaining to start anticoagulant treatment and follow-up at home are met.

An alternative approach based on a list of simple criteria has been developed as the one used in HESTIA study. The main criteria included in the HESTIA rule consist of absence of the following: hemodynamic instability, need for oxygen therapy, high-risk of hemorrhage, renal or liver failure, or other medical or social conditions requiring hospitalization.

The investigators hereby propose comparing these two approaches in an open-label, controlled randomized international trial with blinded adjudication of endpoints.

The main objective is to demonstrate, in normotensive PE patients, that a strategy based on the HESTIA rule compared to a strategy based on the simplified PESI score is at least as safe as regards the 30-day-rate of adverse events (recurrent VTE, major bleeding or death).

The major secondary objectives are to demonstrate, in normotensive PE patients, that a strategy based on the HESTIA rule compared to a strategy based on the simplified PESI score is more effective :

* As regards the rate of patients eventually managed as outpatients.
* As regards the rate of patients, in theory, eligible for outpatient care,


Options:
A: Rate of home discharge from the emergency department following treatment for pulmonary embolism (8 months post-implementation compared to 8 months pre-implementation)
B: Recurrent, symptomatic venous thromboembolism (deep vein thrombosis or pulmonary embolism) (within 3 months of randomization)
C: Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group
D: The rate of the composite of recurrent VTE, major bleeding and all cause death at 30 days (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Everolimus or Pembrolizumab Versus Sunitinib Alone in First-Line Treatment of Subjects With Advanced Renal Cell Carcinoma (CLEAR)
Brief Summary: The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by independent imaging review \[IIR\] using Response Evaluation Criteria in Solid Tumors \[RECIST 1.1\]) as first-line treatment in participants with advanced renal cell carcinoma (RCC).


Options:
A: Progression-free survival (PFS) rate 1 year (12 months)
B: ORR evaluation according to molecular groups (ccRCC1 to 4) and assigned treatment (54 months)
C: Progression Free Survival (PFS) (Measured form start of treatment up to 3 years)
D: Progression-free Survival (PFS) by Independent Imaging Review (IIR) (From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to data cutoff date 28 Aug 2020 (up to approximately 46 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Everolimus or Pembrolizumab Versus Sunitinib Alone in First-Line Treatment of Subjects With Advanced Renal Cell Carcinoma (CLEAR)
Brief Summary: The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by independent imaging review \[IIR\] using Response Evaluation Criteria in Solid Tumors \[RECIST 1.1\]) as first-line treatment in participants with advanced renal cell carcinoma (RCC).


Options:
A: Progression-Free Survival (PFS) (From initiation of treatment up to follow-up period (up to 3 years))
B: Percentage of Participants With Disease Progression as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death From Any Cause in Programmed Death-Ligand 1 (PD-L1)-Selected Population (Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)); Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 in PD-L1-Selected Population (Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)); Percentage of Participants Who Died of Any Cause in ITT Population (Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)); Overall Survival (OS) in ITT Population (Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months))
C: Progression-free Survival (PFS) by Independent Imaging Review (IIR) (From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to data cutoff date 28 Aug 2020 (up to approximately 46 months))
D: Overall survival (OS) (128 of events in max. 72 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluate the Value of Telehomecare for Diabetes
Brief Summary: This is a mixed methods study that evaluates the effectiveness of the BlueStar app and its implementation in 3 hospital/health system sites across Ontario. The 6 month study includes 300 participants that are randomized to an immediate treatment group or a delayed intervention group. The primary outcomes include changes in HbA1c and patient reported outcomes and experience measures. Qualitative interviews with various stakeholders will explore issues relating to successful implementation.


Options:
A: Glucose control (HbA1c levels) (Baseline, 3 months and 6 months)
B: HbA1c (6 months)
C: Comparison of HbA1c mean between the 3 groups (at 6 months)
D: Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: What is the Best Sexual Intercourse Strategy for Couples Actively Trying to Conceive?
Brief Summary: This study will asses the effectiveness of two strategies for timed intercourse in couples actively trying to conceive


Options:
A: Time to Pregnancy (Up to one year.)
B: Cortisol Measurement (Twice monthly)
C: Change in sexual functioning over the course of one year (T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later])
D: Unintended Pregnancies (1, 3, 6, and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Two Different Flaps Associated With Connective Tissue Graft in the Treatment of Gingival Recession: A Randomized Clinical Trial
Brief Summary: The aim of this study was to compare clinical, esthetic and patient-centered outcomes of coronally advanced tunnel (TUN) and coronally advanced flap (CAF) both associated with connective tissue graft (CTG) in the treatment of gingival recession.


Options:
A: Percentage of Defect Coverage (6 months)
B: percentage of root coverage (6 month)
C: Percentage of root coverage (6 months)
D: Recession Reduction (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact Of A Training Program And Organization On The Management Of Stroke In The Acute Phase (AVC-II)
Brief Summary: Acute stroke management represents a true medical emergency that requires prompt diagnosis and urgent treatment. In a previous exhaustive cohort study conducted in the Rhône region, France (AVC69) (Porthault et al. 2013) the investigators observed that only a small percentage of patients could access to thrombolysis in time. In this cohort of 1306 patients treated in one of the emergency department of the Rhone region for a suspected stroke, 84% of patients reached hospital through an emergency department instead of going directly to a stroke unit. Among those patients, only 2% were finally thrombolysed. A significant part of patients arrived in the emergency department too late to be thrombolysed. However, among the subset of ischemic stroke patients who reach emergency department less than 3 hours after symptoms onset, and who had no clinical or radiological exclusion criteria for thrombolysis, only 15 % were thrombolysed. The hypothesis was that an intervention designed to improve ED professional's knowledge and skills and to develop together efficient clinical pathway would decrease door-to imaging time and consequently door-to needle time and eventually improve overall thrombolysis rate.

The investigators have conducted a cluster randomized controlled stepped wedge trial. All adult patients with suspected stroke arriving in one of the participating ED were included in the study along five successive four-month periods. The program featured: development of written materials (booklets) and video (film), and one day session of standardized training for trainers, at least one nurse and one physician of all EDs, with formal presentation to improve knowledge, and simulation to improve skills for using the "FAST" tool (nurses) and the "NIHSS" score (ED physicians). Additionally, a clinical pathway was developed to adapt general evidence based guidelines to the local organization. The primary outcome is the door-to imaging time.


Options:
A: Pneumonia (Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.)
B: percentage of all-or-none measure of evidence-based performance measures in acute ischemic stroke patients without contraindications (participants will be followed for the duration of hospital stay, an expected average of 2 weeks); a composite measure score of performance measures (participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
C: Difference in the percentage of patients who Door-to-Needle Time≤60min (Up to 24 hours)
D: Admission - brain imaging time (Hour 24); Admission- arrival at stroke unit time (Hour 24); Brain imaging time - arrival at stroke unit time (Hour 24); Admission period - thrombolysis time (door-to-needle time) (Hour 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors (NOURISH-T)
Brief Summary: This purpose of this pilot study is to investigate the feasibility of and optimal time post cancer treatment to offer caregivers a new health behavior change intervention (NOURISH-T), as well as assess its preliminary efficacy on specific child health behaviors. The study will also explore whether caregivers NOURISH-T exhibit more improvements than caregivers in EUC (standard care).


Options:
A: Food and energy intake (Food weight (grams) and energy (kcal) (Once a week for four weeks)
B: 1 Year change in insulin resistance via HOMA-IR (Change during first year); 2 year change in insulin resistance via HOMA-IR (Change during 2 years)
C: Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE (6 weeks)
D: Provision of flesh-food or vitamin A-rich food (Change from baseline to 5 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors (NOURISH-T)
Brief Summary: This purpose of this pilot study is to investigate the feasibility of and optimal time post cancer treatment to offer caregivers a new health behavior change intervention (NOURISH-T), as well as assess its preliminary efficacy on specific child health behaviors. The study will also explore whether caregivers NOURISH-T exhibit more improvements than caregivers in EUC (standard care).


Options:
A: Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE (6 weeks)
B: Food and energy intake (Food weight (grams) and energy (kcal) (Once a week for four weeks)
C: 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)
D: Change of BMI Z-score for preschoolers (Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors (NOURISH-T)
Brief Summary: This purpose of this pilot study is to investigate the feasibility of and optimal time post cancer treatment to offer caregivers a new health behavior change intervention (NOURISH-T), as well as assess its preliminary efficacy on specific child health behaviors. The study will also explore whether caregivers NOURISH-T exhibit more improvements than caregivers in EUC (standard care).


Options:
A: Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE (6 weeks)
B: body mass index (three years)
C: Intake of vegetables and fruit (One month)
D: fasting blood glucose (Baseline to 10 months postpartum); weight (body mass index) (Baseline to 10 months postpartum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Cognitive rehabilitation is defined as a systematic functionally oriented intervention of therapeutic cognitive activities based on the assessment and understanding of patient's brain behavior deficits. This project focuses on restoring cognitive functions in order to understand the underlying deficits in the patient's brain by developing integrated cognitive rehabilitation scenarios in virtual reality that combine memory, attention and problem solving training with context specific motor movements.


Options:
A: Change in Digit Span Forward WAIS-IV from baseline to end of treatment and to follow-up (Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)); Change in Corsi block tapping test from baseline to end of treatment and to follow-up (Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)); Change in Trail Making Test, Part A from baseline to end of treatment and to follow-up (Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)); Change in Rey Auditory Verbal Learning Test from baseline to end of treatment and to follow-up (Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)); Change in Digit Span Backward WAIS-IV from baseline to end of treatment and to follow-up (Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)); Change in Corsi block-tapping test reversed from baseline to end of treatment and to follow-up (Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)); Change in Frontal Assessment Battery from baseline to end of treatment and to follow-up (Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)); Change in Trail Making Test, Part B from baseline to end of treatment and to follow-up (Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)); Change in Digit Symbol Coding in WAIS-IV from baseline to end of treatment and to follow-up (Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)); Change in Star Cancellation test from baseline to end of treatment and to follow-up (Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up))
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: Improvement of patient's hemispatial neglect scores (60 days)
D: Change in Behavioural Inattention Test (BIT) (6 months post intervention)

Answer: A