TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Preschoolers Activity Trial - a Pilot Randomized Controlled to Increase Physical Activity and Reduce Sedentary Behaviour
Brief Summary: The purpose of this pilot study is to test the efficacy of the physical activity (PA) intervention protocol to increase preschoolers overall PA levels and time spent in moderate to vigorous PA (MVPA) at the day care setting. The PA intervention includes the Healthy Opportunities for Preschoolers manual, a compilation of locomotor, gross motor and movement based activities developed for preschoolers and successfully piloted for feasibility in 3 to 5 year old preschoolers by Drs. Viviene Temple, Justen O'Connor, and Patti-Jean Naylor. As well, the PA intervention includes educational workshops for the day care providers, ongoing biweekly facilitation and troubleshooting sessions with a Master Trainer, and the equipment necessary to implement the program. The study is also evaluating the efficacy of the PA intervention to decrease the amount of time spent in sedentary behaviour at the day care setting.

Secondary objectives include evaluating the effects of the PA intervention on preschool children's anthropometrics, and fundamental and gross motor skills. In addition, the intervention is also assessing the effects of the program on day care provider's attitudes, control beliefs, and self-efficacy toward incorporating PA into the day care curriculum.


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: Change in Nutrition and Physical Activity Policies (Baseline, Year 1, Year 2)
C: Body Mass Index Z-Score (Fall 2005, Spring 2006, Fall 2006, Spring 2007, Fall 2007, Spring 2008)
D: Increase MVPA (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Double-Dummy, Active-controlled, Parallel-group, Multicenter Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Subjects With Acute Coronary Syndrome
Brief Summary: The purpose of this study is to estimate the risk of bleeding with rivaroxaban, compared with acetylsalicylic acid (ASA), in addition to a single antiplatelet/ platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor agent: clopidogrel or ticagrelor), in participants with a recent acute coronary syndrome (ACS: including ST segment elevation myocardial infarction \[STEMI\] and non-ST-segment elevation acute coronary syndrome \[NSTE-ACS\]).


Options:
A: Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (From start of study treatment until follow-up (up to 390 days))
B: Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization (Randomization up to 47 months); Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients (First dosing up to 48 months)
C: Mortality (4 years)
D: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Double-Dummy, Active-controlled, Parallel-group, Multicenter Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Subjects With Acute Coronary Syndrome
Brief Summary: The purpose of this study is to estimate the risk of bleeding with rivaroxaban, compared with acetylsalicylic acid (ASA), in addition to a single antiplatelet/ platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor agent: clopidogrel or ticagrelor), in participants with a recent acute coronary syndrome (ACS: including ST segment elevation myocardial infarction \[STEMI\] and non-ST-segment elevation acute coronary syndrome \[NSTE-ACS\]).


Options:
A: Time to First Adjudicated ISTH MBE or CRNMBE (up to 30 months)
B: Major or clinically relevant non-major bleeding (12 months)
C: Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (From start of study treatment until follow-up (up to 390 days))
D: The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority) (Up to 4 years); The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority) (Up to 4 years); The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety (Up to 4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients
Brief Summary: The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).


Options:
A: Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint (up to 36 months after the last patient was randomized)
B: Small effect of an intervention (immediate after completion of study); Moderate effect of an intervention (immediate after completion of study); Large effect of an intervention (immediate after completion of study)
C: Estimated Annualized Aggregate Relapse Rate (ARR) (Baseline to end of study (Month 24))
D: Adjusted Annualized Relapse Rate (ARR) During the Treatment Period (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients
Brief Summary: The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).


Options:
A: Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS. (1 year and 2 years)
B: Time to First Confirmed Worsening on the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale (Month 12)
C: Adjusted Annualized Relapse Rate Between Baseline and Week 52 (Baseline through Week 52)
D: Adjusted Annualized Relapse Rate (ARR) During the Treatment Period (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Randomized Trial Evaluating the Efficacy of Sarpogrelate on Ischemic Heart Disease After Drug-eluting Stent Implantation in Patients With Diabetes Mellitus or Renal Impairment
Brief Summary: The purpose of the SERENADE trial is to evaluate the safety and efficacy of sarpogrelate in patients with CKD or DM after DES implantation.


Options:
A: late lumen loss measured by quantitative coronary angiography (9 months)
B: Composite of All-cause Mortality and Nonfatal MI (30 days); All-cause Mortality and Nonfatal MI (1 year)
C: Cardiovascular events (five years)
D: Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization (Randomization up to 47 months); Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients (First dosing up to 48 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Family Startup Program. A Randomized Controlled Trial of a Universal Group-based Parenting Support Program
Brief Summary: The aims of this study are to determine whether a group-based parent support program ("Family Startup") can lead to early improved parental sense of competence, family relations, and child development. Evaluation is based on a randomized controlled trial, with half of the participants receiving Family Startup and the other half receiving treatment as usual.


Options:
A: The Parenting Sense of Competence scale (PSOC) (measured when child is 9 months)
B: child behavior (1yr, 2 yr, 3 yr, 4 yr, 5 yr); child social skills (1yr, 2 yr, 3 yr, 4 yr, 5 yr); child cognition (1 yr, 3 yr, 5 yr); child language/communication (2 yr, 4 yr, 5 yr); child attachment (2 yr); child peer relationships (5 yr); child academics (4 yr, 5 yr); parent-child interaction (6 months, 5 yr)
C: Parenting behavior (Measured post-intervention and at 6- and 12-month follow-ups); Child disruptive behaviors (Measured post-intervention and at 6- and 12-month follow-ups)
D: Change in Child Behavior Problems (baseline, first follow-up (up to 2 years))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: ActiveBrains: Effects of an Exercise-based Randomized Controlled Trial on Cognition, Brain Structure and Brain Function in Overweight/Obese Preadolescent Children
Brief Summary: The ActiveBrains project aims to examine whether a 5-months physical exercise program has benefits on cognition and brain, as well as on selected physical and mental health outcomes in preadolescent overweight/obese children.


Options:
A: 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).)
B: Changes in Academic Achievement in Elementary Students (Baseline to 3 Years)
C: 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.)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: ActiveBrains: Effects of an Exercise-based Randomized Controlled Trial on Cognition, Brain Structure and Brain Function in Overweight/Obese Preadolescent Children
Brief Summary: The ActiveBrains project aims to examine whether a 5-months physical exercise program has benefits on cognition and brain, as well as on selected physical and mental health outcomes in preadolescent overweight/obese children.


Options:
A: Metabolic syndrome score (Change during 3 month of intervention compared with change during 3 month control period); Concentration Performance (Change during 3 month of intervention compared with change during 3 month control period)
B: Changes in Academic Achievement in Elementary Students (Baseline to 3 Years)
C: 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).)
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: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial
Brief Summary: Background: Up to 90% of nursing home residents with dementia experience behavioural and psychological symptoms like apathy, agitation, and anxiety. According to analyses of prescription prevalence in Germany, antipsychotic drugs seem to be prescribed as first line treatment of neuropsychiatric symptoms in persons with dementia. A huge number is prescribed for inappropriate reasons and too long without regular review. The use of antipsychotics is associated with adverse events like increased risk of falling, stroke, and mortality. This study aims to investigate whether a person-centered care approach developed in the United Kingdom can be adapted and implemented in German nursing homes. The aim of the investigators trial is to achieve a clinically relevant reduction of the proportion of residents with alt least one antipsychotic drug prescription.

Methods/Design: Cluster-randomised controlled trial comparing an intervention group (two-day initial skill training on person-centred care and on-going training and support programme) with a control group receiving optimised usual care. Both study groups will receive a medication review by an experienced psychiatrist with feedback to the prescribing physician. Overall, 36 nursing homes from East, North and West Germany will be included and randomised. The primary outcome is defined as the proportion of residents receiving at least one antipsychotic medication at 12 months. Secondary outcomes are residents' quality of life, behavioural and psychological symptoms of dementia as well as safety parameters like falls and fall-related medical attention. Cost parameters will be collected and process evaluation will be performed alongside the trial.


Options:
A: Antipsychotic Efficacy (Day 43)
B: Proportion of residents receiving at least one antipsychotic medication after 12 months (12 months)
C: Agitation Behavior Mapping Instrument (ABMI) (10 days of intervention vs. 10 days of baseline)
D: Neuropsychiatric symptoms (9 months); Quality of life (9 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial
Brief Summary: Background: Up to 90% of nursing home residents with dementia experience behavioural and psychological symptoms like apathy, agitation, and anxiety. According to analyses of prescription prevalence in Germany, antipsychotic drugs seem to be prescribed as first line treatment of neuropsychiatric symptoms in persons with dementia. A huge number is prescribed for inappropriate reasons and too long without regular review. The use of antipsychotics is associated with adverse events like increased risk of falling, stroke, and mortality. This study aims to investigate whether a person-centered care approach developed in the United Kingdom can be adapted and implemented in German nursing homes. The aim of the investigators trial is to achieve a clinically relevant reduction of the proportion of residents with alt least one antipsychotic drug prescription.

Methods/Design: Cluster-randomised controlled trial comparing an intervention group (two-day initial skill training on person-centred care and on-going training and support programme) with a control group receiving optimised usual care. Both study groups will receive a medication review by an experienced psychiatrist with feedback to the prescribing physician. Overall, 36 nursing homes from East, North and West Germany will be included and randomised. The primary outcome is defined as the proportion of residents receiving at least one antipsychotic medication at 12 months. Secondary outcomes are residents' quality of life, behavioural and psychological symptoms of dementia as well as safety parameters like falls and fall-related medical attention. Cost parameters will be collected and process evaluation will be performed alongside the trial.


Options:
A: Gait Velocity (Discharge (Average Duration of Hospital Stay is 3 weeks))
B: Body balance. (at 6 weeks)
C: Functional capacity and quality of life (August 2009)
D: Proportion of residents receiving at least one antipsychotic medication after 12 months (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Physical Exercise Intervention Program in Improving Functional Mobility in Older Adults After Hip Fracture in Later Stage Rehabilitation: a Randomized Clinical Trial
Brief Summary: Hip fractures resulting from falls increase substantially with advancing age and less than a half of the elderly that have sustained and survived after the surgery regain their former levels of mobility. There is increasing evidence that rehabilitation interventions involving exercises and extended beyond the sub acute phase or even in a later stage of care have a positive impact on various functional abilities. The purpose of this study is to determine if an exercise program training for people who have suffered a fall-related hip fracture will improve functional mobility when compared with usual care. Randomized controlled trial using blinded assessors and intention-to-treat analysis. We will recruit 82 older adults, 60 years or over who have suffered a hip fracture due to a fall and have or have not completed physiotherapy and/or rehabilitation. These participants will be in a later stage rehabilitation phase (6 months up to 2 years after the fracture). Participants randomized to the Intervention Group (IG) will be submitted to a physical exercise program involving a progressive and challenging balance training and a neuromuscular and functional training of the lower limbs, conducted at home by physiotherapists, once a week, lasting about one hour, in the first, second and third month after randomization and will be oriented to perform exercises, twice a week, through a booklet. Visits to follow up exercises progression will be conducted once a month, from de fourth to the sixth month and each two months until the end of the follow up at the 12th month, summing up 18 sessions. Participants will receive monthly phone calls to increase exercise adherence. The control group will receive usual care. The primary outcome will be mobility-related disability and participants will be assessed in the baseline, at the end of the intervention (3 months), at 6 and 12 months. The participants will receive monthly phone calls to investigate falls and exercise adherence. Adverse effects will be monitored.


Options:
A: Self-efficacy (2, 6, and 12 months post hip fracture); Exercise behavior and activity (2, 6, and 12 months post hip fracture); Subjective reporting of exercise (2, 6, and 12 months post hip fracture)
B: Lower extremity function (Short Physical Performance Battery (SPPB) (Change from baseline will be assessed at 6 and 12 months)
C: Analysis of feasibility (Up to 4 weeks)
D: modified IOWA Level of Assistance Scale (5 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Parallel-group Trial to Investigate the Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention Compared to no Dressings
Brief Summary: The aim of this randomized controlled trial is to test the efficacy of preventive dressings for pressure ulcer prevention.


Options:
A: rate of pressure injury from nasogastric tube (Each participant will be followed for 18 days)
B: Number of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion) (Duration of hospital stay, an average of 12.6 (SD +/-12.7) days)
C: Appearance grade II pressure ulcers (48 months)
D: Rate of any type of pressure ulcer in the sacral area. (On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Overweight Adolescents Physical Activity and Adherence to Healthy Lifestyles: a Randomized Controlled Trial
Brief Summary: Objectives: Aim of this study is to evaluate the effectiveness of Facebook-delivered lifestyle counseling intervention on overweight and obese adolescent's physical activity, BMI and adherence to healthy lifestyles.

Design: A 12-week, randomized controlled trial with three, 24 and 36 month follow-up.

Settings: One of the Northern Finland healthcare districts school health care units.

Participants: all overweight or obese 13-16 years old adolescent and their parents were invited to study.

Methods: Adolescents were stratified by gender, age, and self-reported physical activity and they were randomized into three groups. Two experimental groups, where those both got Facebook-delivered lifestyle counseling and one of the experimental groups got activity monitor which showed the daily activity. One group served as a control group. Parents were allocated to intervention groups according which group their adolescent were randomized.

Outcomes: physical activity,body mass index (BMI) adherence to healthy lifestyles. Baseline measurements have been done and assessment to adherence to healthy lifestyles have been measured. Follow-up measures have been conducted three months after baseline. Adherence to healthy lifestyles measurement follow-up is at 24 and 36 months after intervention.


Options:
A: To investigate the feasibility of replicating a successful hospital based, childhood obesity clinic in primary care using trained primary care staff and undertake a pilot trial. (12 months)
B: weight change over 6 months (Baseline, 6 months); weight change over 12 months (Baseline, 12 months)
C: Percent Change From Baseline Weight (Baseline, 2 years)
D: Change from baseline physical activity at 12 weeks (12 weeks)

Answer: D