TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Philani Mobile Video Intervention for Exclusive Breastfeeding (MOVIE) Study: a Cluster-randomized Controlled Trial of a Mobile Video Entertainment-education Intervention to Promote Exclusive Breastfeeding in South Africa
Brief Summary: This cluster-randomized controlled trial seeks to evaluate the impact of a mobile video intervention for exclusive breastfeeding (MOVIE) on the infant feeding practices of mothers living in under-resourced communities in the Western Cape, South Africa. The trial will compare infant feeding practices in two groups of participants, enrolled in the Philani Mentor-Mother Outreach Program, a home-visiting program focused on community-based health promotion through peer-to-peer counseling. The participants in the intervention arm will receive the Philani Intervention Model (PIM), a perinatal health promotion intervention, together with the additional mobile, video intervention for exclusive breastfeeding. The participants in the control arm will receive only the standard PIM. Participants will be exposed to either the intervention or the control condition during pregnancy and the first five months after delivery. The central hypothesis in this trial is that, when compared with the control group, infant feeding practices in the intervention group will be significantly better aligned with current World Health Organization recommendations, after exposure to the Philani MOVIE intervention. The primary outcomes in this study are short-term exclusive breastfeeding, in the first month of life, and long-term exclusive breastfeeding, in the fifth month of life, (based on maternal 24-hour recall). Secondary outcomes include other infant feeding practices, such as early initiation of breastfeeding, any breastfeeding in the first month and in the fifth month of life, bottle-feeding, early introduction of complementary foods in the first month and in the fifth month of life and maternal knowledge in the first month and the fifth month post delivery.


Options:
A: Short-term Exclusive Breastfeeding (24-hour recall) (Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week); Long-term Exclusive Breastfeeding (24-hour recall) (Measured at 5 months post-delivery via tablet based survey AND independent verification phone survey within one week)
B: Contraceptive knowledge score (1 year)
C: Contraceptive uptake (10 weeks postpartum; 24 weeks postpartum); Facility Delivery (Postpartum); Exclusive Breastfeeding (24 weeks postpartum)
D: Skilled delivery attendance (From inclusion to 42 days after delivery. Asssessed at delivery and confirmed 42 days after delivery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: SPIDER: A Structured Process Informed by Data, Evidence and Research - A Research and Quality Improvement Collaboration Supporting Practices in Improving Care for Complex Elderly Patients
Brief Summary: Elders living with multiple chronic conditions often take many drugs (polypharmacy); some of the drugs may not benefit them or may be harmful. The Canadian Institute for Health Information has reported that about one-quarter of Canadian seniors are prescribed ten or more different drugs each year. Polypharmacy can result in poorer health, reduced quality of life and high healthcare costs. Choosing Wisely Canada and the Canadian Deprescribing Network have suggested wiser uses for the following four Potentially Inappropriate Prescriptions (PIPs): drugs that reduce stomach acid; reduce anxiety and induce sleep; treat agitation; and treat type 2 diabetes but have a high risk of low blood sugar. To improve care for elderly patients living with polypharmacy, we propose SPIDER: a Structured Process Informed by Data, Evidence and Research. Using quality improvement (QI) and supported by Electronic Medical Record (EMR) data, SPIDER will invite family doctors, nurses, pharmacists and front desk staff to participate in Learning Collaboratives and learn from each other. The practice teams will work with a QI Coach to identify areas to improve, develop strategies and implement changes tailored to the local practice context. The objective of this study is to determine whether SPIDER will reduce PIPs for patients 65 years or older who are on ten or more different drugs. The study will also explore patient experience and provider satisfaction with SPIDER and assess the cost of running SPIDER. The study will first be tested for feasibility in Toronto, Edmonton and Montreal. Findings will then guide a Randomized Controlled Trial (RCT) in Calgary, Winnipeg, Ottawa, Montreal and Halifax where practices enrolled in the SPIDER intervention will be compared with those in usual care.


Options:
A: N/A
B: Adverse Drug Events within 30 days post-discharge (ascertained via telephone interviewer and adjudicated via clinician reviewers) (Interview performed 30-35 days post-discharge.)
C: Number of Potentially Inappropriate Prescriptions (PIPs). (12 months)
D: Emergency medical visits (12 months after hospital discharge)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Prebiotic Supplementation and Exercise on Inflammatory Markers, Vascular Function, Cognition, and Mental Well-being in Pre-Dialysis Kidney Patients
Brief Summary: The study is primarily designed to examine the effect of 16 weeks of prebiotic supplementation (resistant starch)and moderate intensity aerobic training on markers of inflammation in stage 3-4 patients with chronic kidney disease.


Options:
A: inflammatory adipokine- Progranulin (PGRN) (8 week); cytokine receptor -soluble tumor necrosis factor receptor 1 (sTNFR1), (8 week); serum levels of Neutrophil gelatinase-associated lipocalin (NGAL) (8 week); cystatin C (Cys- C) (8 week)
B: Change in hs CRP (baseline and after 16 weeks); Change in TNF alpha (Baseline and at week 16); Change in IL6 (Baseline and at week 16); Change in IL10 (Baseline and at week 16); Change in MCP1 (Baseline and at week 16)
C: Plasma level of p-cresol sulfate (8 weeks)
D: Change from baseline of the microbial gut populations (5 months); Change from baseline of the microbial inflammatory uremic toxins (5 months); Change from baseline of the markers of cardiovascular diseases (5 months); Change from baseline of the markers of intestinal barrier permeability (5 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Interactive Video Game-based Exercise on Balance of Persons With Parkinson's Disease
Brief Summary: This study assessed the effects of interactive video game-based exercise (IVGB) on balance in persons with Parkinson's disease . Twenty-four patients were randomly allocated to two groups (12 participants per group). Group A underwent IVGB training for the first 6 weeks, with no exercise in the subsequent 6 weeks. Group B had no exercise for the first 6 weeks and then received IVGB training in the subsequent 6 weeks. Both subjective and objective measures were used to determine whether IVGB exercise improves balance function.


Options:
A: Number of Participants With Treatment-Emergent Adverse Events [Safety & Tolerability] (8 weeks)
B: Change of Berg Balance Scale (BBS) (15 minutes/session; measured at weeks 0, 6, and 12 of the experiment)
C: Balance (3 time points)
D: Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias (90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Low-dose Atropine Eye Drops to Reduce Progression of Myopia in Children: a Multi-centre Placebo Controlled Randomised Trial in the United Kingdom
Brief Summary: Short-sightedness, also called myopia, makes objects in the distance, such as the television, look blurred. This is caused by the eye growing too long, something that usually happens while children are also getting taller. People with myopia can see better with glasses or contact lenses, but this doesn't stop their eyes continuing to become more short-sighted. The CHAMP UK study is investigating a type of eye drop called atropine that might help to stop myopia getting worse as children get older.


Options:
A: N/A
B: Spherical equivalent refraction determined by cycloplegic autorefraction
C: Spherical equivalent refractive error (i.e. myopia severity) (Baseline - 24-months)
D: Changes in axial length in 2 years (Every 6 months for a period of 2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Cardiovascular Rehabilitation on the Quality of Life of Adolescents and Young Adults With Congenital Heart Disease: A Randomized Controlled Multicentre Trial
Brief Summary: The investigators aim to measure the impact of a rehabilitation program in congenital cardiology in terms of health related quality of life. The orginality of the rehabilitation program consists in its design : initial hospitalizationfor a short period of time (5 days) at the rehabilitation center, followed by 11 weeks of rehabilitation at home under the supervision of a specialized sports trainer.


Options:
A: Moderate to Vigorous Physical Activity (MVPA) (From baseline to follow-up (approximately 22 weeks).)
B: Quality of life score (PedsQL, 24 items), range score from 0 to 100, higher score indicating better quality of life. (follow up of patients over 12 months)
C: Cardiac disease knowledge (12 months)
D: Consent rate (1 year); Enrolment rate (1 year); Adherence rate (1 year); Completion rate (1 year); Attrition rate (1 year); Acceptability questionnaire (Investigator-generated satisfaction questionnaire) (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Medication Adherence in Adolescents Who Had a Liver Transplant
Brief Summary: The study's aim is to test a tailored telemetric intervention to reduce rejection incidence by improving medication adherence in a group of adolescent liver transplant recipients identified as nonadherent by a marker (the Medication Level Variability Index, MLVI).


Options:
A: Kidney recipients'knowledge level (7-8 weeks post kidney transplantation); Kidney recipients'knowledge level (6 months post kidney transplantation)
B: Incidence of Rejection (2 Years)
C: Self-reported Medication Adherence From Baseline to 6 Months. (6 months post conversion)
D: The primary objective of this study is to compare tacrolimus formulations (Envarsus XR® versus twice a day tacrolimus) based on the difference in mean Calcineurin Inhibitor-Related Symptoms (CIRS) severity score. (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Effectiveness Trial of Transoral Head and Neck Surgery Followed by Adjuvant Radio(Chemo)Therapy Versus Primary Radiochemotherapy for Oropharyngeal Cancer
Brief Summary: Comparative Effectiveness Trial of Transoral Head and Neck Surgery followed by adjuvant Radio(chemo)therapy versus primary Radiochemotherapy for Oropharyngeal Cancer


Options:
A: Spinal accessary nerve function (2 years)
B: Recurrence-free survival (5 years)
C: Time to local or locoregional failure or death from any cause (Defined as time from randomization up to 36 month)
D: blood loss (intraoperative)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Multiple Doses of Orally Administered EDP-938 Against Respiratory Syncytial Virus Infection in the Virus Challenge Model.
Brief Summary: A randomised, Phase 2a, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-938 in healthy subjects infected with RSV-A Memphis 37b. This study is designed to compare the antiviral effect of EDP-938 compared to a placebo control in the respiratory syncytial virus challenge model.


Options:
A: Safety and tolerability assessed through diaries for local and systemic tolerability and with follow up for occurrence of any adverse event (7 days post each dose / 57 days post prime)
B: Number of Subjects With Solicited Local Symptoms (During the 7-day (Days 0-6) post-vaccination period); Number of Subjects With Solicited General Symptoms (During the 7-day (Days 0-6) post-vaccination period); Number of Subjects With Unsolicited Adverse Events (AEs) (During the 30-Day (Days 0-29) post-vaccination period); Number of Subjects With Serious Adverse Events (SAEs) (From vaccination at Day 0, up to Day 30 post-vaccination); Titres of RSV-A Neutralizing Antibodies (At Day 0 pre-vaccination); Titres of RSV-A Neutralizing Antibodies (At Day 30 post-vaccination)
C: Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load (Twice daily on Day 2 through Day 11 and once on Day 12)
D: Secondary infection with influenza of the household members who are healthy at the start of the study

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age
Brief Summary: This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-445, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF) subjects 6 through 11 years of age with F/F and F/MF genotypes.


Options:
A: Pharmacokinetic parameters of lumacaftor and ivacaftor, including Cmax, AUC0-tlast, and AUC0-∞ (up to 5 days)
B: Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Baseline up to Week 100)
C: Part A: Maximum Observed Plasma Concentration (Cmax) of ELX, TEZ, and IVA (Part A: Day 15); Part A: Observed Pre-dose Plasma Concentration (Ctrough) of ELX, TEZ, and IVA (Part A: Day 15); Part A: Area Under the Concentration Versus Time Curve From 0 to 24 Hours (AUC0-24h) of ELX, TEZ, and IVA (Part A: Day 15); Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Part B: Day 1 Through Safety Follow-up Visit (up to Week 28))
D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline, Week 16 and 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age
Brief Summary: This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-445, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF) subjects 6 through 11 years of age with F/F and F/MF genotypes.


Options:
A: Part A: Maximum Observed Plasma Concentration (Cmax) of ELX, TEZ, and IVA (Part A: Day 15); Part A: Observed Pre-dose Plasma Concentration (Ctrough) of ELX, TEZ, and IVA (Part A: Day 15); Part A: Area Under the Concentration Versus Time Curve From 0 to 24 Hours (AUC0-24h) of ELX, TEZ, and IVA (Part A: Day 15); Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Part B: Day 1 Through Safety Follow-up Visit (up to Week 28))
B: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (From Day 1 up to 28 Days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100))
C: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Week 4 and Week 8 (Baseline, Week 4 and Week 8 of each treatment period)
D: Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in treatment period up to safety follow-up (up to 28 days)); Parts D, E and F: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)); Part D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part E: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part F: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Brief Intervention for Co-occurring Pain and Distress in Primary Care
Brief Summary: The purpose of this research study is to investigate potential benefits of a behavioral intervention for co-occurring chronic pain and distress that is delivered in a primary care clinic.


Options:
A: Percent of Participants Who Develop Major Depression and Anxiety Disorders (One year); General Health Questionnaire (GHQ) Scores (One year)
B: Number of significantly improved child and maternal outcomes (2 Years)
C: Brief Pain Inventory (5 weeks post-baseline); Hospital Anxiety and Depression Scale (5 weeks post-baseline)
D: Child disruptive behavior (baseline, 8 weeks, 16 weeks, 6 months); Child impairment (baseline, 8 weeks, 16 weeks, 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Recovering Together: Building Resiliency in Dyads of Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Caregivers
Brief Summary: The investigators will compare a dyadic intervention (Recovering Together) with an attention placebo educational control in dyads of patients with acute neurological illnesses and their caregivers at risk for chronic emotional distress. The primary aim of this study is to determine the feasibility, credibility, and satisfaction with Recovering Together. The second aim is to show proof of concept for sustained improvement in emotional distress, post traumatic stress (PTS), resiliency and interpersonal communication outcomes in patients and caregivers.


Options:
A: General Health Questionnaire-12 (GHQ-12) continuous total score (4 months post randomisation); Depression Intensity Scale Circles (DISCS) continuous total score (4 months post randomisation); General Health Questionnaire-12 (GHQ-12) continuous total score (10 months post randomisation); Depression Intensity Scale Circles (DISCS) continuous total score (10 months post randomisation)
B: Feasibility of recruitment (ability to recruit dyads) (Baseline); Feasibility of intervention delivery (ability to deliver intervention to dyads) (Feasibility of program delivery will be measured at 6 weeks); Credibility and expectancy questionnaire (Baseline); Client Satisfaction Questionnaire (post intervention (6 weeks after baseline))
C: Hamilton Rating Scale for Depression (HRSD) (1 year post-treatment)
D: Efficacy (90 day after stroke); Safety (90 day after stroke)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Desmopressin for Reversal of Antiplatelet Drugs in Stroke Due to Haemorrhage (DASH)
Brief Summary: Haemorrhagic stroke, an emergency caused by bleeding in the brain, often leads to death or long-term disability. A quarter of these patients are taking blood-thinning drugs (antiplatelet drugs, such as aspirin) because they are at risk of a heart attack or ischaemic stroke. Patients taking these drugs are more likely to die or be disabled if they have a haemorrhagic stroke. At present, there is no effective treatment for reversing their effects. Desmopressin is a drug which may reverse the effects of antiplatelet drugs and stop bleeding. The investigators would like to run a large randomised trial to see if Desmopressin can reduce the number of people who die or are disabled after haemorrhagic stroke.


Options:
A: ICH growth by 24±3 hours as defined by either 33% or 6 ml increase from baseline, adjusted for baseline ICH volume. (24+/-3 hours)
B: Number of Study Subjects With Life-threatening Thromboembolic Complications (through day 4 after completion of study drug administration); Number of Subjects With Hematoma Growth Among Spot Sign Positive Subjects at 24 Hours. (From baseline to 24 hours); The Sensitivity of the Spot Sign for Predicting Hematoma Growth (Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours.); The Specificity of the Spot Sign for Predicting Hematoma Growth (Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours.)
C: Modified Rankin Scale (mRS) (180 days)
D: Number of eligible patients who received allocated treatment (90 days); Rate of eligible patients randomised (18 months); Proportion of eligible patients and randomised (18 months); Proportion of participants followed up at 90 days (90 days); Proportion of patients with full outcome data available, and reasons for non-availability (90 days); Proportion of eligible patients approached (18 months); Adherence to intervention (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized Study of Adjuvant Versus NeoAdjuvant Pembrolizumab (MK-3475) for Clinically Detectable Stage III-IV High-Risk Melanoma
Brief Summary: This phase II trial studies how pembrolizumab works before and after surgery in treating patients with stage III-IV high-risk melanoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab before and after surgery may work better compared to after surgery alone in treating melanoma.


Options:
A: Percent of patients who actually become resectable and are resected (Following 18 weeks of combined treatment)
B: The proportion of viable melanoma tissue, compared to baseline, in dissected lymph node and / or in-transit tumour tissue after 12 weeks of neoadjuvant treatment. (12 weeks)
C: Progression-free Survival (Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months))
D: Two-Year Event-Free Survival Rate (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized Study of Adjuvant Versus NeoAdjuvant Pembrolizumab (MK-3475) for Clinically Detectable Stage III-IV High-Risk Melanoma
Brief Summary: This phase II trial studies how pembrolizumab works before and after surgery in treating patients with stage III-IV high-risk melanoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab before and after surgery may work better compared to after surgery alone in treating melanoma.


Options:
A: Two-Year Event-Free Survival Rate (2 years)
B: Major Pathologic Response (MPR) (54 weeks)
C: Progression-free Survival (Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months))
D: Overall Survival (OS) (From the date of randomization until date of death due to any cause (up to approximately 6 years))

Answer: A