TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Differing Levels of Support for Family Mealtimes on Obesity Prevention Among Head Start Preschoolers
Brief Summary: Socioeconomic disparities in early childhood place low-income children at 1.5 to 2 times higher risk for obesity compared to middle- to upper-income children. Obesity interventions have turned toward the promotion of family mealtimes. This study will test the effects of 6 intervention components reflecting differing levels of supports to ultimately reduce childhood obesity prevalence and increase the frequency of healthy family mealtimes and improve dietary quality. The investigators will test 6 intervention components in Phase 1 (Screening Phase), resulting in the implementation and evaluation via a randomized controlled trial of a "final" intervention model in Phase 2 (Confirming Phase). The investigators hypothesize that providing low-income families with effective supports to enhance family capability to plan and implement family mealtimes will lead to improvements in children's adiposity indices, dietary quality and frequency of family meals.


Options:
A: Change in BMIz (Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).)
B: Fruit and vegetable acceptance (post intervention) (The parents filled in the questionnaire after the intervention (4-5 weeks after the onset of the intervention).); Relative fruit and vegetable acceptance (post intervention) (The parents filled in the questionnaire after the intervention (4-5 weeks after the onset of the intervention).)
C: Change in Child BMI-z score (Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2) rather than 4 years as planned); Modified change in BMI z-score (Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2))
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Differing Levels of Support for Family Mealtimes on Obesity Prevention Among Head Start Preschoolers
Brief Summary: Socioeconomic disparities in early childhood place low-income children at 1.5 to 2 times higher risk for obesity compared to middle- to upper-income children. Obesity interventions have turned toward the promotion of family mealtimes. This study will test the effects of 6 intervention components reflecting differing levels of supports to ultimately reduce childhood obesity prevalence and increase the frequency of healthy family mealtimes and improve dietary quality. The investigators will test 6 intervention components in Phase 1 (Screening Phase), resulting in the implementation and evaluation via a randomized controlled trial of a "final" intervention model in Phase 2 (Confirming Phase). The investigators hypothesize that providing low-income families with effective supports to enhance family capability to plan and implement family mealtimes will lead to improvements in children's adiposity indices, dietary quality and frequency of family meals.


Options:
A: Vegetable Flavor Acceptance [Infants' Intake] (6- to 10-month-old weaned infants (3 separate test days )); Taste Liking Ratings of Vegetable Flavors [Mothers]. (Monthly, 0.5 to 4.5 months); Vegetable Flavor Acceptance (Infants' Rate of Feeding) (6- to 10-month-old weaned infants (3 separate test days))
B: Change in BMIz (Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).)
C: To evaluate and compare in overweight children the effectiveness of the following interventions: a parent-centered dietary modification program; a physical activity skill development program; and a parent-centered dietary modification + physical activity skill development program.
D: Vegetable Intake in Preschool Children (1 year 11 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Differing Levels of Support for Family Mealtimes on Obesity Prevention Among Head Start Preschoolers
Brief Summary: Socioeconomic disparities in early childhood place low-income children at 1.5 to 2 times higher risk for obesity compared to middle- to upper-income children. Obesity interventions have turned toward the promotion of family mealtimes. This study will test the effects of 6 intervention components reflecting differing levels of supports to ultimately reduce childhood obesity prevalence and increase the frequency of healthy family mealtimes and improve dietary quality. The investigators will test 6 intervention components in Phase 1 (Screening Phase), resulting in the implementation and evaluation via a randomized controlled trial of a "final" intervention model in Phase 2 (Confirming Phase). The investigators hypothesize that providing low-income families with effective supports to enhance family capability to plan and implement family mealtimes will lead to improvements in children's adiposity indices, dietary quality and frequency of family meals.


Options:
A: Body Mass Index Z-Score (Fall 2005, Spring 2006, Fall 2006, Spring 2007, Fall 2007, Spring 2008)
B: Change in BMIz (Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).)
C: BMI change at 6 month post assessment (Baseline and 6 month post assessment); BMI change at 1 year post assessment (Baseline to 1 year post assessment)
D: Change in Body Mass Index Percentage (BMI%) (Change from Baseline to 12-Month Post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 12-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 15-Week Post intervention); Social Skills (15-Week Post); Academic Performance (15-Week Post); Change in Body Mass Index Percentile (%) (Change from Baseline to 6-Month post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 12-Month Post intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Differing Levels of Support for Family Mealtimes on Obesity Prevention Among Head Start Preschoolers
Brief Summary: Socioeconomic disparities in early childhood place low-income children at 1.5 to 2 times higher risk for obesity compared to middle- to upper-income children. Obesity interventions have turned toward the promotion of family mealtimes. This study will test the effects of 6 intervention components reflecting differing levels of supports to ultimately reduce childhood obesity prevalence and increase the frequency of healthy family mealtimes and improve dietary quality. The investigators will test 6 intervention components in Phase 1 (Screening Phase), resulting in the implementation and evaluation via a randomized controlled trial of a "final" intervention model in Phase 2 (Confirming Phase). The investigators hypothesize that providing low-income families with effective supports to enhance family capability to plan and implement family mealtimes will lead to improvements in children's adiposity indices, dietary quality and frequency of family meals.


Options:
A: Increase physical activity (2010); Increase the intake of fiber (2010); Decrease fat intake (2010); Decrease television and other screen time (2010); Decrease obesity (2010)
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: Change in BMIz (Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).)
D: Food and energy intake (Food weight (grams) and energy (kcal) (Once a week for four weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility and Cost-effectiveness of a Multidisciplinary Home-telehealth Intervention Programme to Reduce Falls Among Elderly Discharged From Hospital: a Randomized Controlled Trial
Brief Summary: Fall incidents are the third cause of chronic disablement in elderly according to the World Health Organization (WHO). Recent meta-analyses shows that a multifactorial falls risk assessment and management programs are effective in all older population studied. However, the application of these programs may not be the same in all National health care setting and, consequently, needs to be evacuated by cost-effectiveness studies before to plan this intervention in regular care. In Italy structured collaboration between hospital staff and primary care is generally lacking and the role of Information and Communication Technologies (ICT) in a fall prevention program at home has never been explored.

This is a two-group randomized controlled trial aiming to evaluate the effect of a home-based intervention program, delivered by a multidisciplinary health team, in preventing falls in elderly. The home tele-management program, previously adopted in our Institute for chronic patients, will be proposed to elderly people affected by chronic diseases at high risk of falling at time of hospital discharge. The program will involve the hospital staff and will be managed thanks to the collaboration between hospital and primary care setting. Patients will be followed at home for 6 months after hospital discharge. A nurse-tutor will be the case manager and telephone support, telemonitoring and tele-exercise will characterize the intervention program. People in the control group will receive the usual care. The main outcome measure of the study will be the percentage of patients sustaining a fall during the 6-months follow-up period. An economic evaluation will be performed from a societal perspective and will involve calculating cost-effectiveness and cost utility ratios.


Options:
A: Falls events (6-months)
B: Reduction of frailty (12 months); Frailty score (continuous variable) (12 months); Measures of frailty components (BMI, fast gait speed test, knee extension, exhaustion score and time spent on physical activities per day). (12 months)
C: fall incidence rate
D: Primary outcomes are number of falls and falls rates as well as number and incidence of injurious falls measured by monthly fall calendars (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Long-Term Treatment of Drug Addiction and Unemployment
Brief Summary: The purpose of this clinical trial is to evaluate the effectiveness and economic benefits of a Wage Supplement Model of arranging long-term exposure to employment-based abstinence reinforcement.


Options:
A: abused drug abstinence measured by observed urine specimen testing weeks 1-52, and bimonthly months 13-18
B: The Percentage of Opiate- and Cocaine-negative Urine Samples (1 year); The Percentage of Participants Who Are Employed (1 year)
C: HIV Viral Load (15 Months)
D: Relapse (Through hospitalization completion, an average of 14 days); Relapse (Through the 8-week period of arm 1 or 2.); Relapse (At 1 month follow-up after Arm 1 or 2); Relapse (At 3 months follow-up after Arm 1 or 2); Relapse (At 6 months follow-up after Arm 1 or 2); Treatment retention (Through hospitalization completion, an average of 14 days); Treatment retention (Through the 8-week period of arm 1 or 2); Treatment retention (At 1 month follow-up after completing Arm 1 or 2); Treatment retention (At 3 months follow-up after completing Arm 1 or 2); Treatment retention (At 6 months follow-up after completing Arm 1 or 2)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation (tDCS)
Brief Summary: This is a two-site study that explores the effects of mirror therapy and transcranial Direct Current Stimulation (tDCS, Soterix ©) in a randomized factorial controlled trial in which patients will be assigned to one of four groups: active tDCS and active MT; sham tDCS and active MT; active tDCS and sham MT (which consists of using a covered mirror for the therapy); and both sham tDCS and sham MT (covered mirror).


Options:
A: Change From Baseline in Visual Analogue Scale (VAS) for Pain Change From Baseline (On a weekly basis: 1) Day 1 (first day of tDCS). 2) Day 8 (after first week with post 5 consecutive sessions of tDCS followed by 2 consecutive days without tDCS). 3) Day 15 (after second week post another 5 sessions of tDCS followed by 2 consecutive days)
B: Changes in the Visual Analog Scale for Phantom Limb Pain (4 weeks)
C: Analgesic efficiency (36 months)
D: Change in pain Scores as measured by the Visual Analog Scale (2 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a School-based Physical Activity Intervention on Math Achievement - A Randomized Controlled Trial
Brief Summary: Background

Increased physical activity can improve cognition and academic skills. However due to economic concerns and increasing focus on standardized testing, PA in schools often receives little attention and physical education is reduced in many countries in favor of spending more time devoted to academic classes. This tendency is not compatible with the increasing evidence for the association between physical activity, fitness, cognitive and academic performance.

Despite increasing evidence for the association between PA, fitness, cognitive and academic performance, very few longitudinal high-quality studies exists examining the effect of physical activity on academic performance (ref.). Furthermore, to the best of our knowledge only two studies have assessed academic outcomes following the integration of physical activity into the classroom with intervention participants scoring significantly higher in test sections compared to controls which makes generalizing from these results challenging.

To promote policy changes that require more physical activity in school, empirical data are needed to study the effects of school-based physical activity programs. Therefore the investigators carried out a cluster randomized controlled trial conducted to examine the effect on math achievement and executive functions of classroom based PA in math.


Options:
A: Academic performance (October 2014 - June 2015 (8 months))
B: Math Skills, as measured by a 45-minute standardized math test specifically designed for this age group by the developer of the Danish national tests (MG) (Hoegrefe Forlag). (Change from Baseline Math Skills at 9 months)
C: Fitness (Day 0, Day 120)
D: Intake of unhealthy foods, unhealthy drinks, healthy foods assessed by a photo-based method (volume) (6 months post baseline); Intake of unhealthy foods, unhealthy drinks, healthy foods assessed by a photo-based method (volume) (18 months post baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Intervention After a Brain Tumor
Brief Summary: This study evaluates the feasibility and utility of two behavioural programs designed to reduce cognitive impairments secondary to brain tumors and/or their treatment. One-third of participants will complete training in either program, with the remaining third a wait-list control group.


Options:
A: Change in cognitive composite score (baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training))
B: Percent Change in Delayed Recall at 4 Months as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) (Baseline and 4 months from start of treatment)
C: The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 8 Weeks. (At 8 weeks)
D: Stroop Test (Change from baseline at 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Brief Summary: The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.


Options:
A: Radiographic Progression-Free Survival (PFS) (Up to 44 months); Overall Survival (OS) (Up to 66 months)
B: Survival (7.5 years after the first inclusion); Survival (9.5 years after the first inclusion)
C: Radiographic Progression-free Survival (rPFS) (Up to 35 months); Overall Survival (OS) (Up to 57 months)
D: Overall Survival (Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Telemedicine in Qualifying Care Transition Between Tertiary and Primary Health Care Among Stable Coronary Artery Disease Patients: a Randomized Non-inferiority Trial
Brief Summary: The purpose of this study is to determine whether the telemedicine use in primary health care is effective in the accompaniment of stable coronary artery disease patients who were discharged from the tertiary health care clinics.


Options:
A: Skindex-16 Change Scores Between Baseline to Month 9 - Composite Score (Baseline to Month 9); Skindex-16 Change Scores Baseline to Month 3 - Composite Score (Baseline to Month 3); Skindex-16 Change Scores Baseline to Month 9 - Symptoms Score (Baseline to Month 9); Skindex-16 Changes Scores Baseline to Month 3 - Symptoms Score (Baseline to Month 3); Skindex-16 Change Scores Between Baseline and Month 9 - Emotions Score (Baseline to Month 9); Skindex-16 Change Scores Between Baseline to Month 3 - Emotions Score (Baseline to Month 3); Skindex-16 Change Scores Between Baseline and Month 9 - Functioning Scores (Baseline to Month 9); Skindex-16 Change Scores Between Baseline and Month 3 - Functioning Score (Baseline to Month 3)
B: Number of participants that stay in Canadian Cardiovascular Society (CCS) Functional Classification of Angina I and II as a measure of safety (within one year after discharge)
C: Change in VR-12 Mental Component Summary Scores (Six months)
D: Delay before expertise by a dermatologist (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Management in Real-life of Patients Hospitalized With Community-acquired Pneumonia in China
Brief Summary: The purpose of this study is to evaluate the disease burden of hospitalized patients with CAP and healthcare-associated pneumonia (HCAP) in real life of China .


Options:
A: Glittre test (up to 9 months)
B: Length of Hospital Stay (End of hospital stay); Time to Clinical Stability (Daily for the duration of the hospital stay); Symptomatic and Functional Recovery Score (14, 30, and 60 days post-admission)
C: Change in adventitious lung sounds (24 hours after hospital presentation (baseline) and 3 weeks after intervention)
D: treatment failure at 72h after initiation of antibiotics (Time from the first dose use of antibiotics to 72 hours); in-hospital treatment failure due to multiple causes (Time from date of admission to discharge up to 1 week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Ventilation Tubes Versus no Ventilation Tubes for Recurrent Acute Otitis Media or Chronic Otitis Media With Effusion in 9 to 36 Month Old Greenlandic Children - a Randomised Clinical Trial
Brief Summary: The prevalence of otitis media among Greenlandic children is one of the highest in the world and twenty per cent of schoolchildren have impaired hearing in the frequencies for normal speech. Yet, there are no national guidelines to ensure prevention and treatment of recurrent acute otitis media and chronic otitis media with effusion and impaired hearing in Greenlandic children. International studies from the developed part of the world have shown that otitis prone children may benefit from tubulation of the tympanic membrane. However, it is unknown if these results can be applied to Greenlandic children.

This PhD project will conduct a randomised controlled trial comparing tubulation of the tympanic membrane, in Greenlandic children aged 9-36 months with recurrent acute otitis media and/or chronic otitis media with effusion, to conservative treatment. The children will be followed for two years. Outcome measures will include number of visits to health clinics, number of tympanic membrane perforations, number of episodes with acute otitis media according to medical records, Quality of life, measured by the validated questionnaires OM6 and Caregiver Impact Questionnaire, number of episodes where per oral or intravenous antibiotics have been administered according to medical records and serious adverse events

The trial will be conducted in collaboration with the Greenlandic health authorities and Copenhagen Trial Unit.

With this trial the investigators hope to decrease the number of episodes with acute otitis media, the number of Greenlandic children with chronic perforations of the tympanic membrane and hearing impairment and increase quality of life.

The results will add important knowledge to the effect of ventilation tube treatment also in an international aspect. There are to date only less than a handful of high quality studies concerning this issue on an international basis. The study will be among the first addressing this problem among populations with high risk of otitis media and is also of interest to other indigenous populations and the developing part of the world.


Options:
A: Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment (6 weeks)
B: Non B type tympanogram (one month)
C: Number of visits to health clinic (Two years after randomisation)
D: - number of acute otitis media; - quality of life issues

Answer: C