TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Mentorship to Promote Cardiac Rehabilitation Enrollment: A Randomized Controlled Trial
Brief Summary: The current study is a randomized controlled trial, being conducted at two hospitals in Toronto, Ontario, Canada, involving the randomization of cardiac inpatients into an intervention group, in which they will receive mentorship from a volunteer cardiac rehabilitation peer mentor, and a control group, in which they will receive usual care. Patients in both groups will be tracked to determine if they are referred to cardiac rehabilitation and if they enroll in cardiac rehabilitation. We hypothesize that compared to cardiac inpatients who receive usual care, those cardiac inpatients who receive cardiac rehabilitation peer mentorship will be more likely to be referred to and enroll in cardiac rehabilitation.


Options:
A: Cardiac Rehabilitation Enrollment (12 weeks after patient is discharged from hospital)
B: exercise capacity as reported in total time on the exercise test using the BRUCE protocol (16 months)
C: Change from baseline aerobic exercise capacity (watts) at 4 months (4 months)
D: Adherence to cardiac rehabilitation (After 8 weeks of cardiac rehabilitation); Morbidity and mortality (Three or four years after last patient into trial)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mentorship to Promote Cardiac Rehabilitation Enrollment: A Randomized Controlled Trial
Brief Summary: The current study is a randomized controlled trial, being conducted at two hospitals in Toronto, Ontario, Canada, involving the randomization of cardiac inpatients into an intervention group, in which they will receive mentorship from a volunteer cardiac rehabilitation peer mentor, and a control group, in which they will receive usual care. Patients in both groups will be tracked to determine if they are referred to cardiac rehabilitation and if they enroll in cardiac rehabilitation. We hypothesize that compared to cardiac inpatients who receive usual care, those cardiac inpatients who receive cardiac rehabilitation peer mentorship will be more likely to be referred to and enroll in cardiac rehabilitation.


Options:
A: Change in muscle strength (Newton, N) (Change from baseline muscle strength at 12 weeks follow-up)
B: Change of maximal oxygen uptake during exercise, measured in ml/kg/min (3 months)
C: Quality of Life questionnaire (one day)
D: Cardiac Rehabilitation Enrollment (12 weeks after patient is discharged from hospital)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Interventionnal and Randomized Study Measuring Virtual Reality Cue Exposure for the Relapse Prevention of Tobacco Consumption Versus Cognitive and Behavioral Approaches Therapy
Brief Summary: The therapeutic efficacy of virtual reality has been validated for the treatment of various mental disorders ,smoking behavior is the first preventable cause of death in developed countries However, after a successful withdrawal, a high relapse rate (between 40 and 70%)has been observed, which emphasize the urgent need to implement new strategies. Virtual reality cue exposure for the relapse of tobacco consumption


Options:
A: Participant smoking status. (6 and 12 month follow-up)
B: The primary endpoint will be 6M of abstinence measured 18M after enrollment. (18M)
C: smoking, self-report (6 months follow-up)
D: evaluate the abstinence of tobacco consumption (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Interventionnal and Randomized Study Measuring Virtual Reality Cue Exposure for the Relapse Prevention of Tobacco Consumption Versus Cognitive and Behavioral Approaches Therapy
Brief Summary: The therapeutic efficacy of virtual reality has been validated for the treatment of various mental disorders ,smoking behavior is the first preventable cause of death in developed countries However, after a successful withdrawal, a high relapse rate (between 40 and 70%)has been observed, which emphasize the urgent need to implement new strategies. Virtual reality cue exposure for the relapse of tobacco consumption


Options:
A: evaluate the abstinence of tobacco consumption (12 months)
B: N/A
C: Alcohol consumption (12 weeks); Time to lapse (12 weeks); amount of alcohol consumption (12 weeks)
D: Expired Carbon Monoxide (Baseline and treatment phases, 2-mont and 6-month follow up.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Interventionnal and Randomized Study Measuring Virtual Reality Cue Exposure for the Relapse Prevention of Tobacco Consumption Versus Cognitive and Behavioral Approaches Therapy
Brief Summary: The therapeutic efficacy of virtual reality has been validated for the treatment of various mental disorders ,smoking behavior is the first preventable cause of death in developed countries However, after a successful withdrawal, a high relapse rate (between 40 and 70%)has been observed, which emphasize the urgent need to implement new strategies. Virtual reality cue exposure for the relapse of tobacco consumption


Options:
A: Smoking abstinence assessed by self-reported and biochemically verified by salivary cotinine (6 months)
B: evaluate the abstinence of tobacco consumption (12 months)
C: The primary endpoint will be 6M of abstinence measured 18M after enrollment. (18M)
D: Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group (76 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Treatment With the Monoclonal C5 Antibody Eculizumab in Pediatric Patients Affected by Shiga-toxin Related Hemolytic and Uremic Syndrome: A Phase III Prospective Randomized Controlled Therapeutic Trial Versus Placebo
Brief Summary: The investigators aim to perform the first controlled randomized prospective study using ECZ in pediatric STEC-HUS. This is of great interest as there is still no efficient specific therapy in that potentially devastating disease.

Furthermore, published data concerning the use of ECZ in STEC-HUS are controversial, reflecting statistical bias in retrospective or uncontrolled studies, thus emphasizing the need for prospective studies.


Options:
A: Number of children enrolled in the study protocol (at the end of the 24 month study recruiting period)
B: Incidence of HUS development (4 weeks)
C: the duration in days of extrarenal epuration (From the inclusion date and assessed up to 13 months)
D: Time to death or serious extrarenal events (60 days); Time to dialysis (60 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Aerobic High Intensity Training on Symptoms, Cognition, Cortical Structure, Substance Use and Metabolic Indices in Patients With Schizophrenia Spectrum Disorder
Brief Summary: Physical health problems are common in schizophrenia with a two- to three-fold increased morbidity and mortality rate, resulting in a 20 years reduction in life expectancy. A genetic vulnerability for developing cardiovascular disease has been documented in these patients, and many lifestyle factors also negatively influence physical health. Patients with schizophrenia are likely to smoke, are physically inactive and overweight, suffer from malnutrition due to unhealthy diet, and have reduced cardiorespiratory fitness. Moreover, these patients have increased risk of developing diabetes mellitus type II and metabolic syndrome. These aspects demonstrate the need for multi-disciplinary treatments of patients with schizophrenia and underline the need for addressing their physical health.

Poor physical fitness seems to be associated with exacerbated negative symptoms and increased cognitive dysfunction in patients with schizophrenia. However, evidence on physical activity and its consequences in schizophrenia is scarce. In this randomized controlled trial we investigate the effects of high intensity training in outpatients with schizophrenia on psychotic symptoms and well-being, cognition and cortical structure, tobacco smoking and substance use, in addition to metabolic indices.


Options:
A: Change from Baseline in Cognitive Function after 12 Weeks and 28 Weeks (Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment)
B: Work Activity (6 month and 12 month)
C: Cognitive Performance, as measured by a neuropsychological battery (Measured at Baseline, Week 8, and 6 Month Follow-Up)
D: Cognitive Function Measured by MCCB Composite Score (4-6 month period); Cognitive Function as Measured by the University of California, San Diego, Performance-Based Skills Assessment-Brief (UPSA-B) Scale (4-6 month period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of the Ketogenic Diet in the Treatment of Epilepsy in Children Under the Age of Two Years
Brief Summary: Epilepsy, a condition where individuals are prone to recurrent epileptic seizures, is the most common chronic neurological disorder in children. Epilepsy onset is most common in the first two years of life and is associated with poor prognosis for seizure control and neurodevelopmental outcome.

The ketogenic diet (KD) is a medically supervised diet that is high in fat and restricted in carbohydrates and protein. KD therapy has shown to be an effective treatment for seizures in children with epilepsy older than two. Associated benefits include: a reduced requirement for routine and emergency antiepileptic drugs (AED) and fewer seizure related hospital admissions. Although reports suggest that KD therapy improves seizures in younger children there is no high quality trial data that demonstrates effectiveness and safety in this age group. The KD is resource intensive, requiring dietetic and physician time; data is required to justify expansion of services to cater for the apparent need.

The investigators therefore propose a prospective multicentre randomised trial to investigate the effectiveness and safety of the KD in children with epilepsy under the age of 2, who have failed to respond to two or more AEDs. Children will be randomly assigned to either receive the KD or further AEDs. The allocated treatment will be started after a 2week baseline period, and it's effectiveness assessed after 8 weeks. Seizure diaries will be used to record seizures and related events, a questionnaire will be used to assess diet tolerance; also growth and blood biochemistry will be monitored.

The information obtained from this study is necessary to optimise choices in epilepsy treatment, aiming to improve outcomes and thus determine whether and when the KD should should be used.


Options:
A: Change in seizure frequency (3 months)
B: seizure outcome 3months after dietary therapy. (3 months)
C: Number of seizures (6 - 8 weeks)
D: Reduction in seizure frequency at 3 months in the two groups: the modified Atkins diet group, and the control group. (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Clinical Trial of Myopia Control in Schoolchildren Using the Multi-segment (MS) Lens
Brief Summary: The purpose of this study is to determine if the Multiple-Segment (MS) spectacle lens can slow myopia progression in Hong Kong schoolchildren.

MS lens is also called Defocus Incorporated Multiple Segments (DIMS) spectacle lens


Options:
A: Changes in axial length in 2 years (Every 6 months for a period of 2 years)
B: Global Self-Worth Scale from the Self-Perception Profile for Children (3 years)
C: Wearer retention (% wearing at 1 month), vision (logMAR), visual function (0-100), quality of life (0-100) (a 1-month period of spectacle wear)
D: Cycloplegic Refraction Change in SER (Baseline and 2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Telehealth Intervention to Promote Chronic Disease Management After Stroke: A Pilot Randomized Controlled Study
Brief Summary: The purpose of this study is to examine the efficacy of a lifestyle modification telehealth program on health-related behaviours in community-dwelling individuals living with stroke.


Options:
A: Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II) (End of program (6 months))
B: Major vascular event consisting of nonfatal stroke, nonfatal major coronary event and vascular death (Up to 6 years from inclusion)
C: Change in Systolic Blood Pressure (baseline and 6 months); Change in HDL Level (baseline and 6 months); Change in LDL Level (baseline and 6 months); Change in Triglyceride Level (baseline and 6 months); Change in HbA1c Level (baseline and 6 months); Change in Glycaemia Level (baseline and 6 months); Change in BMI Value (baseline and 6 months)
D: Blood Pressure (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Telehealth Intervention to Promote Chronic Disease Management After Stroke: A Pilot Randomized Controlled Study
Brief Summary: The purpose of this study is to examine the efficacy of a lifestyle modification telehealth program on health-related behaviours in community-dwelling individuals living with stroke.


Options:
A: Change in walking activity from admission to discharge from rehabilitation (Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks)); Change in control of walking (Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks))
B: Changes in MVPA (Moderate-to-Vigorous Physical Activity) bouts of participants from baseline to months 6 and 12 (Baseline, 6 and 12 months)
C: Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II) (End of program (6 months))
D: Jette Late Life Functional and Disability Instrument (LLFDI) (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Telehealth Intervention to Promote Chronic Disease Management After Stroke: A Pilot Randomized Controlled Study
Brief Summary: The purpose of this study is to examine the efficacy of a lifestyle modification telehealth program on health-related behaviours in community-dwelling individuals living with stroke.


Options:
A: Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II) (End of program (6 months))
B: Blood Pressure (12 months)
C: systolic blood pressure (primary vascular risk factor being assessed) (baseline, post-intervention, 6 months, 12 months); diastolic blood pressure (baseline, post-intervention, 6 months, 12 months); waist circumference (baseline, post-intervention, 6 months, 12 months); 12-hour fasting lipid profile (baseline, post-intervention, 6 months, 12 months); 12-hour fasting glucose/hemoglobin A1C (baseline, post-intervention, 6 months, 12 months)
D: Sodium intake (12 months); Fruit/vegetable intake (12 months); Physical activity (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Social Media Intervention for Young Adult Smokers
Brief Summary: This randomized clinical trial will test the efficacy of a Facebook intervention based on the Transtheoretical Model (Prochaska and DiClemente) and US Public Health Service Clinical Practice Guidelines with young adults who smoke cigarettes who are age 18 to 25 (N=480).


Options:
A: Abstinence for 7 consecutive days and 24 hours at 1, 3, and 6 months
B: Smoking abstinence (1, 3, 6 and 12 month follow-ups)
C: 7-day point prevalence abstinence at 3 months (3 months post baseline); 7-day point prevalence abstinence at 6 months (6 months post baseline); 7-day point prevalence abstinence at 12 months (12 months post baseline)
D: Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Social Media Intervention for Young Adult Smokers
Brief Summary: This randomized clinical trial will test the efficacy of a Facebook intervention based on the Transtheoretical Model (Prochaska and DiClemente) and US Public Health Service Clinical Practice Guidelines with young adults who smoke cigarettes who are age 18 to 25 (N=480).


Options:
A: Smoking abstinence (Six months post-treatment)
B: Smoking cessation (Change in smoking status from baseline at 6 months)
C: Point prevalence abstinence at 6 months (6 months after beginning treatment)
D: 7-day point prevalence abstinence at 3 months (3 months post baseline); 7-day point prevalence abstinence at 6 months (6 months post baseline); 7-day point prevalence abstinence at 12 months (12 months post baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Social Media Intervention for Young Adult Smokers
Brief Summary: This randomized clinical trial will test the efficacy of a Facebook intervention based on the Transtheoretical Model (Prochaska and DiClemente) and US Public Health Service Clinical Practice Guidelines with young adults who smoke cigarettes who are age 18 to 25 (N=480).


Options:
A: Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months (index visit and 6 months)
B: HIV Viral Suppression (12 months)
C: 7-day point prevalence abstinence at 3 months (3 months post baseline); 7-day point prevalence abstinence at 6 months (6 months post baseline); 7-day point prevalence abstinence at 12 months (12 months post baseline)
D: Proportion of the Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure (Baseline period (August-November 2007)); Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure (Final intervention period (April-July 2009)); Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure (After the washout period (May-August 2011)); Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications (Baseline period (August-November 2007)); Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications (Final intervention period (April-July 2009)); Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications (After the washout period (May-August 2011))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
Brief Summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis.


Options:
A: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16 (Week 16); Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16 (Week 16)
B: The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1) (Week 16); The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75) (Baseline and Week 16)
C: Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment (12 weeks); Participants With IGA Mod 2011 0 or 1 After 12 Weeks of Treatment (12 weeks)
D: Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 (Week 12, as compared to Week 0 (baseline))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
Brief Summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis.


Options:
A: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16 (Week 16); Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16 (Week 16)
B: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) (Week 16)
C: Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24 (Week 24)
D: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 (Week 16); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 (Week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
Brief Summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis.


Options:
A: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16 (Week 16); Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16 (Week 16)
B: Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline (Baseline to Week 16)
C: Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 (Week 12, as compared to Week 0 (baseline))
D: Proportion of subjects with clinical response relative to Baseline PASI score (Week 12, Week 40 and Week 60)

Answer: A