TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of an Intervention to Reduce Diary Hours of Sitting Time in Overweight and Obese Patients (SEDESACTIV):Simple Randomized Controlled Trial
Brief Summary: Primary care centres are a key setting to treat people with overweight and moderate obesity. There is growing evidence that sitting for a long time is negatively associated with people's health. Interventions with the aim of reducing daily time of sedentary activities can be an effective strategy to increase daily energy expenditure. To improve the effectiveness of programmes promoting physical activity in primary care we need some clear action protocols that can be easily integrated in the daily routines of primary care professionals.

Objective. The objective of the study is to evaluate the effectiveness of a six-moth primary care intervention to reduce diary hours of sitting time in overweight and obese sedentary patients, as well as to increase their weekly caloric spend.

Methods. The design of the study is a simple randomized controlled trial. Ten primary care centers will be invited to participate and will be randomized into control (CG) and intervention group (IG). Each professional will randomly invite to participate voluntarily moderate obese or overweight patients (BMI: 25-34,9 kg/m2) of both sexes, aged between 25 and 65 years old, who are 6 or more than 6 hours daily sitting. A total of 400 subjects (200 individuals in each group) are needed. In addition, 50 subjects with fibromyalgia will be included in the study to know the feasibility of the intervention among them.

The main dependent variable (sitting times) will be measured with an ActivPAL during first and last intervention week. There will be a follow up after 3, 6 and 12 months of the end of the intervention. Other variables included in the study: number of steps walked, subjective level of physical activity, weight, height, BMI, skinfolds, waist circumference, triglycerides, total cholesterol, (LDL and HDL), glucose, sociodemographic variables, blood pressure and quality of life related to health. A descriptive analysis of all variables and a multivariate analysis to assess differences among intervention and control group will be undertaken. Multivariate analysis will be carried out to assess time changes of dependent variables. All the analysis will be done under the intention to treat principle.


Options:
A: Acceptability and feasibility (3 weeks)
B: Reduced total time spend sitting at work (1 month); Reduced number of prolonged siting periods (>30 min) (1 month); Increased number of breaks from sitting time (1 month)
C: To assess the effectiveness of a 6-month primary care intervention to reduce diary hours of Sitting time in overweight and obese patients, as well as to increase their weekly caloric spend (Baseline-6-9-12 and 18 month)
D: change in physical activity (4 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of an Intervention to Reduce Diary Hours of Sitting Time in Overweight and Obese Patients (SEDESACTIV):Simple Randomized Controlled Trial
Brief Summary: Primary care centres are a key setting to treat people with overweight and moderate obesity. There is growing evidence that sitting for a long time is negatively associated with people's health. Interventions with the aim of reducing daily time of sedentary activities can be an effective strategy to increase daily energy expenditure. To improve the effectiveness of programmes promoting physical activity in primary care we need some clear action protocols that can be easily integrated in the daily routines of primary care professionals.

Objective. The objective of the study is to evaluate the effectiveness of a six-moth primary care intervention to reduce diary hours of sitting time in overweight and obese sedentary patients, as well as to increase their weekly caloric spend.

Methods. The design of the study is a simple randomized controlled trial. Ten primary care centers will be invited to participate and will be randomized into control (CG) and intervention group (IG). Each professional will randomly invite to participate voluntarily moderate obese or overweight patients (BMI: 25-34,9 kg/m2) of both sexes, aged between 25 and 65 years old, who are 6 or more than 6 hours daily sitting. A total of 400 subjects (200 individuals in each group) are needed. In addition, 50 subjects with fibromyalgia will be included in the study to know the feasibility of the intervention among them.

The main dependent variable (sitting times) will be measured with an ActivPAL during first and last intervention week. There will be a follow up after 3, 6 and 12 months of the end of the intervention. Other variables included in the study: number of steps walked, subjective level of physical activity, weight, height, BMI, skinfolds, waist circumference, triglycerides, total cholesterol, (LDL and HDL), glucose, sociodemographic variables, blood pressure and quality of life related to health. A descriptive analysis of all variables and a multivariate analysis to assess differences among intervention and control group will be undertaken. Multivariate analysis will be carried out to assess time changes of dependent variables. All the analysis will be done under the intention to treat principle.


Options:
A: Change in Occupational Physical Activity From Baseline to 16 Weeks (Baseline and 16 weeks)
B: Step Watch - Physical Activity Minutes (12 weeks between baseline and post-intervention follow up)
C: To assess the effectiveness of a 6-month primary care intervention to reduce diary hours of Sitting time in overweight and obese patients, as well as to increase their weekly caloric spend (Baseline-6-9-12 and 18 month)
D: change in physical activity (4 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind Study of the Efficacy and Safety of Alirocumab Added on to Atorvastatin Versus Ezetimibe Added on to Atorvastatin Versus Atorvastatin Dose Increase Versus Switch to Rosuvastatin in Patients Who Are Not Controlled on Atorvastatin
Brief Summary: This is a randomized, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH).


Options:
A: Percent Change From Baseline in Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) Analysis (From Baseline to Week 24); Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum (From Baseline to Week 24)
B: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis (From Baseline to Week 52)
C: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis (From Baseline to Week 24)
D: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind Study of the Efficacy and Safety of Alirocumab Added on to Atorvastatin Versus Ezetimibe Added on to Atorvastatin Versus Atorvastatin Dose Increase Versus Switch to Rosuvastatin in Patients Who Are Not Controlled on Atorvastatin
Brief Summary: This is a randomized, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH).


Options:
A: Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) (Up to approximately 9 years)
B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)
C: Percent Change From Baseline in LDL-C at the Mean of Weeks 22 and 24 (Baseline and weeks 22 and 24); Percent Change From Baseline in LDL-C at Week 24 (Baseline and week 24)
D: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis (From Baseline to Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Rosuvastatin Versus Ezetimibe Added-on to Rosuvastatin Versus Rosuvastatin Dose Increase in Patients Who Are Not Controlled on Rosuvastatin
Brief Summary: To evaluate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab (REGN727/SAR236553) as an add-on therapy to other LMT in patients with hypercholesterolemia at high cardiovascular (CV) risk.


Options:
A: Number of Participants With Adverse Events (From first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months.)
B: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis (From Baseline to Week 24)
C: Percent Change From Baseline in Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) Analysis (From Baseline to Week 24); Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum (From Baseline to Week 24)
D: Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 150 mg Dose Group and Matched Placebo (Baseline, Week 12); Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 0 (Day 1) (Week 0 (Day 1)); Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 2 (Week 2); Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 4 (Week 4); Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 6 (Week 6); Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 8 (Week 8); Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 10 (Week 10)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Rosuvastatin Versus Ezetimibe Added-on to Rosuvastatin Versus Rosuvastatin Dose Increase in Patients Who Are Not Controlled on Rosuvastatin
Brief Summary: To evaluate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab (REGN727/SAR236553) as an add-on therapy to other LMT in patients with hypercholesterolemia at high cardiovascular (CV) risk.


Options:
A: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis (From Baseline to Week 24)
B: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis (From Baseline to Week 52)
C: The primary endpoint in the study is to assess the incidence and severity of treatment-emergent adverse events in hyperlipidemic patients treated with REGN727 or placebo receiving stable doses of atorvastatin. (visit 4 (day 1) to visit 16 (day 148))
D: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent--To-Treat (ITT) Analysis (From Baseline to Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of RAD001/Everolimus in Autism and NeuroPsychological Deficits in Children With Tuberous Sclerosis Complex
Brief Summary: Tuberous sclerosis complex (TSC) is a genetic disease that leads to mental retardation in over 50% of patients, and to learning problems, behavioral problems, autism and epilepsy in up to 90% of patients. The underlying deficit of TSC, loss of inhibition of the mammalian target of rapamycin (mTOR) protein due to dysfunction of the tuberin/hamartin protein complex, can be rescued by everolimus. Everolimus has been registered as treatment for renal cell carcinoma and giant cell astrocytoma (SEGA). Evidence in human and animal studies suggests that mTOR inhibitors improve learning and development in patients with TSC.


Options:
A: Cognitive ability measured by IQ (12 months)
B: Core Phase: European Medicine Agency (EMA): Seizure Frequency Response Rate (Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase)); Core Phase: Food & Drug Administration (FDA): Percentage Change From Baseline in Partial Onset-seizure Frequency (Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase))
C: Rapamycin level (6 months); Complete blood count (6 months); Total cholesterol (6 months); Dermatologic sensitivity at site of application (pain, erythema, edema, pruritis) (6 months)
D: longest diameter of renal angiomyolipomas assessed by MRI scan, toxicity graded by National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (assessments at baseline and 2,6,12 and 24 months); toxicity graded by National Cancer Institute's Common Terminology Criteria for Adverse Events (throughout study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: My MediHealth: A Paradigm for Children-centered Medication Management
Brief Summary: The last mile of the medication use system requires tools to help patients comply with medication administration rules and monitor for side effects. Personal health records (PHR) and emerging user-adopted communication tools promise to change the landscape of medication management. The overarching goal of the MyMediHealth project is to investigate ways in which PHRs and supported applications can improve the safety and quality of medication delivery. Preliminary work in this area by a team of parents, patients and school/clinic health providers created a vision for MyMediHealth, a next-generation medication management system. MyMediHealth was envisioned to allow home-based, school-based, and other caregivers to ensure safe and effective medication delivery. This vision featured just-in-time medication reminders to children with special health care needs, two-way communication to log when doses have been administered or when side effects have occurred, and mechanisms to warn caregivers about side effects and drug interactions. However, much of this work was done using prototypes, storyboards, and vision videos. Recognizing that this vision cannot be carried out without significant changes in processes and policies, the purpose of this proposed study is to evaluate the impact of medication management tools such as MyMediHealth on medication adherence for children with chronic illnesses. Specifically, the investigators hypothesize that compared with usual practice, children using mymedihealth will have improved medication adherence and will report improved (decreased) asthma symptoms.


Options:
A: Pediatric Asthma Quality of Life Questionnaire (PAQLQ) (9 months post camp); Asthma Control Questions (9 months post camp)
B: Change in baseline asthma self efficacy after 3 weeks (participants will be followed for an average of 4 weeks, with this measure collect at the beginning of the period and after 3 weeks of reminders.)
C: Number of Symptom Free Days (Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February))
D: Change in asthma control from baseline at 3 months (3 months); Change in asthma control from baseline at 6 months (6 months); Change in asthma control from baseline at 9 months (9 months); Change in asthma control from baseline at 12 months (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: My MediHealth: A Paradigm for Children-centered Medication Management
Brief Summary: The last mile of the medication use system requires tools to help patients comply with medication administration rules and monitor for side effects. Personal health records (PHR) and emerging user-adopted communication tools promise to change the landscape of medication management. The overarching goal of the MyMediHealth project is to investigate ways in which PHRs and supported applications can improve the safety and quality of medication delivery. Preliminary work in this area by a team of parents, patients and school/clinic health providers created a vision for MyMediHealth, a next-generation medication management system. MyMediHealth was envisioned to allow home-based, school-based, and other caregivers to ensure safe and effective medication delivery. This vision featured just-in-time medication reminders to children with special health care needs, two-way communication to log when doses have been administered or when side effects have occurred, and mechanisms to warn caregivers about side effects and drug interactions. However, much of this work was done using prototypes, storyboards, and vision videos. Recognizing that this vision cannot be carried out without significant changes in processes and policies, the purpose of this proposed study is to evaluate the impact of medication management tools such as MyMediHealth on medication adherence for children with chronic illnesses. Specifically, the investigators hypothesize that compared with usual practice, children using mymedihealth will have improved medication adherence and will report improved (decreased) asthma symptoms.


Options:
A: change in asthma control between baseline and six months as measured by ACQ.24 The ACQ measures clinical goals of asthma management on a scale: 0 (good control) to 6, is responsive to change,24 with a intra-individual minimum important difference (6 months)
B: Asthma Control Test (ACT) (12 month follow-up assessment); Frequency of Urgent Health Utilization (the 12 month study period); 12 Month Rate of Medication Use (Over a 12 month study period); Frequency of Asthma-related Hospitalizations (the 12 month study period)
C: Change in baseline asthma self efficacy after 3 weeks (participants will be followed for an average of 4 weeks, with this measure collect at the beginning of the period and after 3 weeks of reminders.)
D: Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor for Arms; ("Cohort 1: Data on Maintenance Use Supplied to Participant and HCP" and"Cohort 5: no Data Supplied to Participant or HCP") (Month 4 to Month 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: My MediHealth: A Paradigm for Children-centered Medication Management
Brief Summary: The last mile of the medication use system requires tools to help patients comply with medication administration rules and monitor for side effects. Personal health records (PHR) and emerging user-adopted communication tools promise to change the landscape of medication management. The overarching goal of the MyMediHealth project is to investigate ways in which PHRs and supported applications can improve the safety and quality of medication delivery. Preliminary work in this area by a team of parents, patients and school/clinic health providers created a vision for MyMediHealth, a next-generation medication management system. MyMediHealth was envisioned to allow home-based, school-based, and other caregivers to ensure safe and effective medication delivery. This vision featured just-in-time medication reminders to children with special health care needs, two-way communication to log when doses have been administered or when side effects have occurred, and mechanisms to warn caregivers about side effects and drug interactions. However, much of this work was done using prototypes, storyboards, and vision videos. Recognizing that this vision cannot be carried out without significant changes in processes and policies, the purpose of this proposed study is to evaluate the impact of medication management tools such as MyMediHealth on medication adherence for children with chronic illnesses. Specifically, the investigators hypothesize that compared with usual practice, children using mymedihealth will have improved medication adherence and will report improved (decreased) asthma symptoms.


Options:
A: Change in baseline asthma self efficacy after 3 weeks (participants will be followed for an average of 4 weeks, with this measure collect at the beginning of the period and after 3 weeks of reminders.)
B: Adherence to inhaled corticosteroid medication (12 months)
C: medication adherence (1 year)
D: number of subjects who achieved Total asthma Control: Period 2 (Up to Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Dapagliflozin Effect on Cardiovascular Events A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients With Type 2 Diabetes
Brief Summary: This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors.


Options:
A: Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular (CV) Death (Up to 4.6 years)
B: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)
C: Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke (up to 5.2 years); Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure. (up to 5.2 years)
D: Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) (From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Dapagliflozin Effect on Cardiovascular Events A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients With Type 2 Diabetes
Brief Summary: This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors.


Options:
A: Changes in Endothelial Function (FMD - Flow Mediated Dilatation) From Baseline to 12 Weeks (12 weeks)
B: Development of diabetes (Up to 5 years)
C: Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke (up to 5.2 years); Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure. (up to 5.2 years)
D: Change in HbA1c (Week 0, week 30)

Answer: C