TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Breaking Sedentary Time Improve Glucose Regulation in Women With Impaired Glucose Tolerance? A Balanced Incomplete Block Design Study
Brief Summary: The number of people diagnosed with Type 2 diabetes (T2DM) is increasing rapidly and about 2.9 million people in the UK currently have diabetes. There is increasing evidence suggesting that prolonged sedentary time may actually increase the risk of diabetes and other chronic diseases. Importantly, adults can meet public health guidelines on physical activity (150 minutes of moderate activity per week), but if they still sit for prolonged periods, their metabolic health is compromised. Going from sitting to standing and carrying out light-intensity activities (such as casual walking) may reduce diabetes risk. However, no one has investigated the effect of standing and walking on markers of cardio-metabolic markers in individuals with a high risk of T2DM. Therefore, the aim is to find out whether reducing the amount of time people spend sitting and replacing it with standing and light intensity activity (walking) reduces glucose, insulin and triglyceride levels, therefore reducing the risk of diabetes.


Options:
A: Adherence (8 weeks)
B: Physical activity of the lower and upper extremities (6 months)
C: 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)
D: Glucose area under the curve (0 weeks and 2 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Belgian Trial With Azithromycin During Acute COPD Exacerbations
Brief Summary: This project (funded by the IWT-TBM program) will organize a randomized placebo-controlled multicenter intervention trial in 500 COPD patients to study the effectiveness and safety of azithromycin therapy in the acute setting of COPD exacerbations requiring hospital admission. Although long-term use of azithromycin is proven effective to prevent exacerbations, inherent risks outweigh the benefits. By reducing the dose and duration of the azithromycin treatment and by restricting the treatment to acute periods with highest risk for treatment failure, benefits may counterbalance potential side effects, which may result in a new treatment strategy for these acute events.

The present study is designed by the services of respiratory medicine of the Leuven and Ghent University hospitals but will run in total in 17 different large hospitals in Belgium, of which 12 are located in Flanders.


Options:
A: Exacerbation Frequency; Airway Inflammation
B: Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years); Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years)
C: Time to clinical failure (Will be assessed between day 1 (from 1 hour after first drug intake) till day 90 (24 hours after last study drug intake))
D: Overall Survival (Up to 9 years); Progression-free Survival (From the date of enrollment to first progression or death or last contact, if alive and progression free.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Belgian Trial With Azithromycin During Acute COPD Exacerbations
Brief Summary: This project (funded by the IWT-TBM program) will organize a randomized placebo-controlled multicenter intervention trial in 500 COPD patients to study the effectiveness and safety of azithromycin therapy in the acute setting of COPD exacerbations requiring hospital admission. Although long-term use of azithromycin is proven effective to prevent exacerbations, inherent risks outweigh the benefits. By reducing the dose and duration of the azithromycin treatment and by restricting the treatment to acute periods with highest risk for treatment failure, benefits may counterbalance potential side effects, which may result in a new treatment strategy for these acute events.

The present study is designed by the services of respiratory medicine of the Leuven and Ghent University hospitals but will run in total in 17 different large hospitals in Belgium, of which 12 are located in Flanders.


Options:
A: Time to clinical failure (Will be assessed between day 1 (from 1 hour after first drug intake) till day 90 (24 hours after last study drug intake))
B: Occurrence of and time to Pseudomonas aeruginosa pneumonia (daily)
C: Re-hospitalization or Death (6 months)
D: Duration of diarrhea in days (up to 10 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: MEtoclopramide, DExamethasone or Axoli (Palonoseton) for the Prevention of Delayed Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy: the MEDEA-trial
Brief Summary: In this phase III non-inferiority trial, the aim is to evaluate whether metoclopramide and palonosetron prophylactic antemetic treatment are non-inferior to dexamethasone with regard to its efficacy to prevent delayed chemotherapy-induced nausea and vomiting (CINV) induced by non- anthracyclines plus cyclophosphamide (AC) based moderately emetogenic chemotherapy (MEC).


Options:
A: Delayed Phase Complete Response (CR) Rate (24 - 120 Hours)
B: No Emetic Episodes and No Rescue Medication (>24 to 120 hours post chemotherapy)
C: Patient diary recording nausea, emesis, food ingestion, and rescue therapy (From initiating administration of anticancer agents to day 6 (120 hours))
D: efficacy (24 to 160 hours); tolerability (24 to 160 hours); cost-effectiveness (24 to 160 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Centre, Open-Label, Study of Mepolizumab in a Subset of Subjects With a History of Life Threatening/Seriously Debilitating Asthma Who Participated in the MEA115661 Trial
Brief Summary: This is a multi-center, open-label, long-term study of subcutaneously (SC) administered mepolizumab 100mg in addition to standard of care (SOC), in subjects with severe eosinophilic asthma. This study will enroll a subset of subjects from Study MEA115661 who have demonstrated clear benefit from therapy and who without continuation of mepolizumab therapy are individuals at greatest risk of serious deterioration of their health status. In order to target individuals at greatest risk for serious deterioration of their health status, only subjects from the MEA115661 study with a history of life-threatening or seriously debilitating asthma, will be allowed to participate. Subjects meeting all of the eligibility criteria for the study will be offered the opportunity to consent for this study of up to 128 weeks in length (including the Follow-Up Visit). This study will give opportunity to extend the collection of clinical data for long-term use and further assess the sustainability of efficacy in a population likely to experience significant loss of asthma control and the need for higher doses of systemic steroids if returned to SOC only.


Options:
A: Annualized Rate of On-treatment Exacerbations Per Year (Baseline (Week 0) to Week 172); Number of Participants With Any On-treatment Adverse Event (AE) or On-treatment Serious AE (SAE) (Baseline (Week 0) to Week 172)
B: Evaluate the safety and tolerability of MEDI-563 in adults with atopic asthma and evaluate the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies 28 days after completion of dosing in adults with atopic asthma. (Study Day 84 or Day 140 - (dose-driven))
C: Rate of asthma exacerbations during the 52-week placebo-controlled period (weeks 0-52)
D: Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second (Baseline and Week 24); Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months (Baseline to Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pre-Discharge Bundle for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease to Reduce Readmissions and Emergency Department Visits: a Randomized, Controlled Trial.
Brief Summary: Hospital readmissions for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) pose burdens to the healthcare system and patients. The aim of this study was to determine whether a screening and educational tool, administered prior to discharge, would result in a decrease in the rate of hospital readmissions.


Options:
A: Change in the strength of the quadriceps over the 6-week electrostimulation program. (6 to 8 weeks)
B: COPD Assessment Test (CAT) (1 Year)
C: Re-hospitalizations (During the 30days after discharge)
D: 30 day readmission rate (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pre-Discharge Bundle for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease to Reduce Readmissions and Emergency Department Visits: a Randomized, Controlled Trial.
Brief Summary: Hospital readmissions for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) pose burdens to the healthcare system and patients. The aim of this study was to determine whether a screening and educational tool, administered prior to discharge, would result in a decrease in the rate of hospital readmissions.


Options:
A: 30 day readmission rate (30 days)
B: The primary measure of results will be the differences in smoking cessation rates between intervention and control groups (12 months after been conducted the intervention)
C: Smoking abstinence (one year)
D: The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention (5 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pre-Discharge Bundle for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease to Reduce Readmissions and Emergency Department Visits: a Randomized, Controlled Trial.
Brief Summary: Hospital readmissions for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) pose burdens to the healthcare system and patients. The aim of this study was to determine whether a screening and educational tool, administered prior to discharge, would result in a decrease in the rate of hospital readmissions.


Options:
A: Readmission rate (6 month)
B: 30 day readmission rate (30 days)
C: disease-specific health-related quality of life (HRQoL) (two years)
D: CCQ-recovery time in the event of an exacerbation(Health status recovery time) (6-months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Preparing to Run Effective Prevention
Brief Summary: Young people can engage in a variety of negative behaviors-such as drug use, underage drinking, and premarital sex-that exact a high toll on local communities. These activities are often the target of community-based prevention efforts. Getting To Outcomes (GTO) is an approach that includes a toolkit, technical assistance, and training, organized around a 10-step process, that helps communities plan, implement, and evaluate the impact of their programs that attempt to prevent these negative behaviors. This study will examine the degree to which Getting To Outcomes helps Boys and Girls Clubs implement an evidence based drug prevention program.


Options:
A: Number of Participants With Changes in Help Seeking Scores (Baseline and 1-month post intervention)
B: Mean Susceptibility to Vaping Score (Week 3)
C: Point Prevalent Abstinence (PPA) from vaping (1 month); Point Prevalent Abstinence (PPA) from vaping (3 months); Point Prevalent Abstinence (PPA) from vaping (6 months)
D: Drug use (Baseline, 3 months, 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Randomised Controlled Trial of an Internet-based Lifestyle Intervention for People Around Retirement
Brief Summary: The LiveWell research programme aims to develop evidence-based, acceptable and scalable interventions to improve health and wellbeing in the retirement transition.

Life stage transitions involve changes in lifestyle and thus present key opportunities for behaviour change interventions. Our assessment of the literature shows that interventions with people of retirement age can effectively promote components of the Mediterranean diet (Lara et al, BMC Medicine Apr 8;12(1):60: 2014), physical activity (Hobbs et al, BMC Medicine Mar 19;11:75; 2013) and explicit social roles (Heaven et al, Milbank Q. Jun;91(2):222-87: 2013).

This study is a 2-month randomised controlled trial (RCT) with two intervention arms taking place in the North-East of England.

We have developed an internet-based lifestyle programme (Living, Eating, Activity and Planning through retirement (LEAP)) that promotes three key health and social behaviours; 1) healthy eating by adopting a Mediterranean diet, 2) increasing physical activity with the use of a step-counter, and 3) improving social connectedness.

Participants recruited for this study will be allocated in random order with a ratio of 2:1 to the intervention group (LEAP) or to a control group.

This study will evaluate the feasibility and acceptability of the LEAP intervention among people of retirement age and will pilot trial procedures.

In this programme of research we have also defined a suite of outcome measures and identified tools appropriate for capturing the Healthy Ageing Phenotype (HAP) (Lara et al, Maturitas. 2013 Oct;76(2):189-99). We will assess aspects of Cognition, Physical capability, Physiological outcomes, and psycho-social wellbeing. The feasibility and acceptability of these measures has yet to be determined and therefore will be formally assessed in this pilot RCT alongside more proximal outcomes of the intervention modules (i.e. diet, physical activity and social roles).

The hypotheses to be tested in the LiveWell programme are as follows:

* A newly developed internet-based lifestyle programme (Living, Eating, Activity and Planning through retirement (LEAP)) is an acceptable tool for behaviour change among people of peri-retirement age.
* A suite of outcome measures and identified tools appropriate for capturing the Healthy Ageing Phenotype (HAP) is acceptable among people of peri-retirement age.


Options:
A: weight loss (12 weeks)
B: Feasibility and acceptability of intervention (2 months)
C: Step Watch - Physical Activity Minutes (12 weeks between baseline and post-intervention follow up)
D: change in physical activity (4 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet-based Medication Adherence Program for Nicotine Dependence Treatment
Brief Summary: The purpose of this pilot study is to evaluate the acceptability and feasibility of the proposed smoking cessation intervention (called MyMAP or My Mobile Advice Program).


Options:
A: Point Prevalence Abstinence (5 month follow-up)
B: Self-Reported 7-Day Point-Prevalence Abstinence (Assessed at 52 weeks after target quit day)
C: 7-Day Point Prevalence Abstinence From Smoking by Intervention (26 weeks after the target quit smoking date); 7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group (26 weeks after the target quit smoking date)
D: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet-based Medication Adherence Program for Nicotine Dependence Treatment
Brief Summary: The purpose of this pilot study is to evaluate the acceptability and feasibility of the proposed smoking cessation intervention (called MyMAP or My Mobile Advice Program).


Options:
A: Point Prevalence Abstinence (5 month follow-up)
B: 7-day point prevalence abstinence (Measured at Months 3, 6, and 12)
C: Change in smoking status and maintenance in smoking cessation (the outcome measure is studied at 6 and 12 months)
D: Smoking abstinence (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia in Parkinson's Disease Patients (EASE LID Study)
Brief Summary: This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of levodopa induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in the evening, potentially reducing the negative impact of amantadine on sleep. This pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER formulation than can be tolerated with an immediate-release formulation. The once-nightly dosing regimen may also provide enhanced convenience and compliance.

In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.


Options:
A: Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 12 (Baseline to Week 12)
B: Unified Parkinson's Disease Rating Scale (UPDRS) Part III (30 minutes post-dose at week 12)
C: Falls Diary (6-7 Months)
D: Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (six years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Joint Infant and Young Child Nutrition Program in Burkina Faso : Impact Evaluation
Brief Summary: Study title: Joint Infant and young children nutrition program in Burkina Faso: Impact evaluation Hypothesis: The fortification of complementary foods associated with a counseling on feeding practices for infants and young children prevents malnutrition in 6-23 months-old children.

Objective: to assess the effectiveness of a promotional care package in preventing malnutrition among children aged 6-23 months.


Options:
A: gut microbiota composition (Fecal sample after 2 months)
B: Proportion of children with Weight-for-height and/or Height-for-age ZScore <-2 (1 year)
C: Acceptability of iron and folic acid (IFA) syrup (Endline (Up to 5 months)); Acceptability of micronutrient powders (MNP) (Endline (Up to 5 months)); Preference for vitamin supplementation (Endline (Up to 5 months)); Vitamin supplementation compliance (Baseline, Endline (Up to 5 months))
D: Changes in GI microbiome (6 and 9 months of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Brief Summary: maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis


Options:
A: Development and evaluation of the CFAbd-Score (initially named JenAbdomen CF-Score), a CF-specific PROM following FDA recommendations (7 years); Development and evaluation of a diary for assessment and quantification of abdominal symptoms, a CF-specific PROM following FDA recommendations (7)
B: Coefficient of Fat Absorption (CFA) (5 days)
C: Change from open label baseline to end of 6 day double blind treatment period in Coefficient of Fat Absorption (CFA) (Open label baseline, end of 6 day double blind treatment period)
D: Coefficient of Fat Absorption (%) (5 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Translating Telephonic Diabetes Self-management Support to Primary Care Practice: The NYC Care Calls Trial
Brief Summary: The goal of this study is to evaluate the implementation and effectiveness of an intervention to improve diabetes self-management, emotional distress and metabolic control among adults with type 2 diabetes receiving care in primary care practices throughout New York City. The program will be implemented by the New York City Department of Health, through their Primary Care Improvement Project.


Options:
A: Number of Steps Completed in Transplant Process (18-24 months)
B: HbA1c (Change from baseline at 12 months)
C: New advance care planning documentation in the medical record (15 months after study enrollment)
D: Beck Depression Inventory- II (Assessed at every session and at the 1-month follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Healing and Empowering Alaskan Lives Towards Healthy-Hearts Study
Brief Summary: This study aims to identify effective and cost-effective interventions for tobacco use and other risk behaviors for cardiovascular disease among Alaska Native people in rural villages. In a randomized controlled trial, the study will compare interventions using telemedicine to promote the American Heart Association's identified ideal health behaviors (nonsmoking and physical activity) relative to ideal health factors (managing cholesterol and blood pressure).


Options:
A: Point prevalence abstinence at 6 months (6 months after beginning treatment)
B: Smoking Status: 7-day point prevalence abstinence (Assessed at baseline, 3, 6, 12, and 18 months)
C: 7-day point prevalence abstinence (Measured at Months 3, 6, and 12)
D: Physician performance on refering patients that smoke cigarettes to the web intervention (pre-intervention, 6 months, 12 months and 24 months); Of the smokers who are referred to the web intervention, the number who go to the site (preintervention, 6 months, 12 months, 24 months); Point prevalence smoking cessation (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Double-blind, 56 Week Placebo-controlled, Parallel Group, Multicentre, Phase 3 Study to Evaluate the Efficacy and Safety of 2 Doses of Benralizumab in Patients With Moderate to Very Severe COPD With a History of Exacerbations
Brief Summary: The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies


Options:
A: Percentage decrease of sputum eosinophils from baseline (6 months)
B: Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants (Week 1 up to Week 52)
C: Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL (From first IP to week 56)
D: Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) (Day 1 up to 393)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical and Economic Assessment of an Opportunistic Screening Program for Pre-frailty State in Elderly Population.
Brief Summary: The study intervention improves functional capacity and delays frailty status in pre-frail elderly subjects.


Options:
A: Frailty according to L.Fried criteria (questionnaire). (One year); Functional capacity according to Barthel score and Timed up and go test. (One year)
B: rate of falls (12 months); proportion of fallers (12 months)
C: Fall risk management, assessment and management of gate, strength and balance deficits, completion of medication review, including postural hypotension and psychotropic medications as well as the assessment and management of environmental risk factors.
D: number of falls (24 months)

Answer: A