TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Health Promotion and Fitness for Younger and Older Adults With SMI
Brief Summary: The goal of this project, which has not changed, is to improve the health and fitness of persons with serious mental illness (SMI) using an innovative model: In SHAPE Lifestyles. Participants are randomly assigned to the In SHAPE program or Health Club Membership and Education only.

The three specific aims of this study are to:

1. To compare the treatment groups with respect to improvement in physical fitness outcomes, including: (a) health behaviors (engagement in exercise and diet changes); and (b) indicators of physical fitness.
2. To compare the treatment groups with respect to improvements in mental health outcomes, including negative symptoms, depression, and self-efficacy.
3. To explore differences in the treatment groups with respect to psychosocial functioning, health status, and acute service use, and the effects of selected demographic, clinical, and health behavior variables on primary outcomes.


Options:
A: BMI (11 months)
B: Change in Weight (Baseline, 3-, 6-, 9-, 12-, and 18-months)
C: Weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8 (10 weeks)
D: First Occurrence of a Severe Cardiovascular Event (up to 11 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Health Care Hotspotting: A Randomized Controlled Trial
Brief Summary: This trial investigates the value created by the highly innovative Camden Coalition of Healthcare Providers' Care Management Program: Link2Care. The program targets "super-utilizers" of the health care system - specifically adults with 2 or more hospitalizations in the last six months 2 or more chronic conditions, and 5 or more outpatient medications - with intensive case management services. In particular, a team of nurses, social workers, community health workers and health coaches, supported by real-time data of healthcare utilization, perform home visits, accompany patients to doctor visits, and help patients enroll in social-service programs. This approach aims to improve the self-sufficiency of patients in navigating the healthcare and social-service systems and has the potential to reduce healthcare costs and improve patient health.


Options:
A: Readmissions (30 days); Admissions (180 days); Emergency Department Visits (180 days); Composite Endpoint, Admissions or Emergency Department Visits (180 days)
B: Any Hospital Readmission (180-day from indexed hospital discharge)
C: Proportion of patients adherent to medication at 1 month after discharge as assessed by the Morisky Medication Adherence Scale - 8 items (1 month)
D: Time to composite all-cause readmissions/emergency department (ED) visits/death at 3 months (Within 3 months of hospital discharge); Time to composite all-cause readmissions/emergency department (ED) visits/death at 30 days (Within 30 days of hospital discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Open-label Study to Compare the Clinical Outcomes and Magnesium Serum Concentrations Obtained in the Treatment of Severe Preeclampsia With a Repeat Bolus Intravenous Magnesium Sulfate Regimen Administered With the Springfusor Infusion Pump to a Continuous Intravenous Magnesium Sulfate Regimen
Brief Summary: The trial will test the equivalence of a repeat bolus protocol of magnesium sulfate administered by the Springfusor® controlled pump to a continuous intravenous regimen. The goal of this pharmacokinetic study is to assess the pharmacological equivalence of the serum magnesium sulfate concentrations obtained in the treatment of severe preeclampsia with the continuous intravenous and Springfusor repeat bolus regimens. The study will also document the clinical outcomes, efficacy and acceptability of each treatment for patients and staff.


Options:
A: completed course of treatment (24 hours postpartum)
B: Magnesium concentration (00:00, 00:20; 00:40; 1:20; 2:20; 3:00; 4:40; 5:20; 6:00; 6:20; 7:00; 8:00; 9:40; 10:00; 10:40; 12:00)
C: Time of magnesium sulfate therapy (minutes); Blood pressure; Maternal symptoms (headaches, blurred vision, chest pain, shortness of breath)
D: Eclampsia (24 hours postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Protocol and Design of a Randomized Controlled Study on Attention Training in First Year After Acquired Brain Injury
Brief Summary: Background: To study intensive targeted cognitive rehabilitation of attention in the acute (\<4 months) and subacute rehabilitation phases (4 -12 months) after acquired brain injury and to evaluate the effects on function, activity and participation (return to work).

Design: prospective, randomised, controlled study. Methods: 120 consecutive patients with stroke or traumatic brain injury are randomised to 20 hours of intensive attention training by Attention Process Training or by standard, activity based training. Progress is evaluated by Statistical Process Control and by pre and post measurement of functional and activity levels. Return to work is also evaluated in the post-acute phase. Primary endpoints are the changes in the attention measure, Paced Auditory Serial Addition Test and changes in work ability. Secondary endpoints include measurement of cognitive functions, activity and work return. There are 3, 6 and 12-month follow ups focussing on health economics.

Discussion: The study will provide information on rehabilitation of attention in the early phases after acquired brain injury (ABI); effects on function, activity and return to work. Further, the application of Statistical Process Control might enable closer investigation of the cognitive changes after acquired brain injury and demonstrate the usefulness of process measures in rehabilitation.


Options:
A: Change from baseline in the Montreal Cognitive Assessment (Baseline, End (4-6 weeks) and 8-weeks follow-up)
B: Paced auditory Serial Attention Test (PASAT) (change from baseline after each 3 treatment sessions, change from baseline after 20 hours of training, change from baseline after 6 months and change from baseline after 1 year); Work Ability Index (WAI) (change from baseline after 20 hours of training, change from baseline after 3 months and change from baseline after 1 year)
C: Frontal Assessment Battery (3 months)
D: Change in Rivermead Mobility index (Baseline, 6 months, 9 months); Change in Timed Up and Go Test (Baseline, 6 months, 9 months); Change in Modified Patient Specific Functional Scale (Baseline, 6 months, 9 months); Change in Physical Activity Diary (Baseline, 6 months, 9 months); Change in Physical activity - 7-day accelerometry (Baseline, 6 months, 9 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Stress Management Intervention for High Risk Children With Asthma
Brief Summary: The purpose of the proposed study is to conduct a randomized controlled pilot trial of a school-based stress management and coping skills training program among a sample of economically disadvantaged urban 8- to 12-year-old school children with physician-confirmed asthma. The investigators aim (1) to establish feasibility of this approach by recruiting from different schools and (2) to learn whether individuals assigned to receive the intervention show improvements in psychological function, decreases in lung inflammation, and related improvements in asthma health when compared with disease severity-matched peers who receive education-only or standard care.


Options:
A: Night Wakenings Due to Asthma (To assess change, this measure will be taken: (1) prior to starting the trial (baseline); (2) within two weeks of completing the last module (immediate post-test); and (3) one month after completing their last module (1-month follow-up).)
B: Product Evaluation (Once per module (One Evaluation per week for seven weeks))
C: Pulmonary functioning (FEV-1, FVC) (Measured at study entry and Months 7 (post treatment) and 12); Hospital and emergency department utilization (for asthma exacerbation) (Measured at study entry and Months 7 (post treatment) and 12)
D: Proportion of Eligible Children who Participate in Study (End of enrollment: estimated 2 years after beginning active enrollment.); Participant Drop-out Rates (After final outcome measures are collected: up to 2 1/2 years from beginning of active enrollment.); Session Completion Rates (After final participant has completed study: estimated 2 1/2 years after beginning active enrollement.); Program Satisfaction Survey (End of Study Participation: up to 5 months from initial enrollment.); Barriers to offering the Intervention in Selected Schools (End of enrollment: estimated 2 years after beginning active enrollment.); Child Depression Inventory (Pre and Post Intervention: baseline, up to 4 months later.); State-Trait Anxiety Inventory for Children (Pre and Post Intervention: baseline, up to 4 months later.); Perceived Stress Scale (Pre and post intervention: baseline, up to 4 months later.); Pediatric Asthma Quality of Life Questionnaire (Pre and Post Intervention: baseline, up to 4 months later.); Asthma Self-Management Scale (Pre and Post Intervention: baseline, up to 4 months later.); KIDCOPE (Pre and Post Intervention: baseline, up to 4 months later.); Measure of Current Status (MOCS - Adapted) (Pre and Post Intervention: baseline, up to 4 months later.); Change in Asthma Health from Baseline (Pre to post-intervention: baseline, up to 4 months later.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Longitudinal Outcomes in Pediatric rTMS and CIT
Brief Summary: Track behavioral and qualitative longitudinal outcomes in children with hemiparesis who previously participated in a randomized, controlled trial (RCT) of intensive therapy combined with repetitive Transcranial Magnetic Stimulation (rTMS)


Options:
A: TMS Symptom Checklist (Adminstered at testing session, 2-4 years after intervention.)
B: Hamilton Rating Scale for Depression (HRSD) (1 year post-treatment)
C: Reduction in depression (Hamilton Depression Rating Scale)at 12 months following stroke. (12 months following stroke)
D: Treatment response (Week 4 after tenth day of tDCS)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Longitudinal Outcomes in Pediatric rTMS and CIT
Brief Summary: Track behavioral and qualitative longitudinal outcomes in children with hemiparesis who previously participated in a randomized, controlled trial (RCT) of intensive therapy combined with repetitive Transcranial Magnetic Stimulation (rTMS)


Options:
A: Treatment response (Week 4 after tenth day of tDCS)
B: Occurrence rate of depression (3 months)
C: TMS Symptom Checklist (Adminstered at testing session, 2-4 years after intervention.)
D: Progression in the Fugl-Meyer Motor Scale (M3 (3 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study of an Internet-based Cognitive Behavioral Therapy Program for Sexuality and Intimacy Problems in Women Treated for Breast Cancer.
Brief Summary: The purpose of this study is to evaluate the efficacy and cost-effectiveness of an internet-based cognitive behavioural therapy program in alleviating problems with intimacy and sexuality in women treated for breast cancer.


Options:
A: Physical Function (14 months)
B: Overall mood (Up to 6 months)
C: To evaluate the efficacy of a multicomponent biobehavioral psychosocial telephone counseling (PTC) intervention for cervical cancer survivors, compared to usual care (10 years)
D: Sexuality problems (Baseline); Intimacy problems. (Baseline); Sexuality problems (T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group)); Sexuality problems (T2: 20-24 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group)); Sexuality problems (T3: 3 months after T2 (intervention group)); Intimacy problems. (T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group)); Intimacy problems. (T2: 20-24 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group)); Intimacy problems. (T3: 3 months after T2 (intervention group)); Sexuality problems (T4: 6 months after T3 (intervention group)); Intimacy problems (T4: 6 months after T3 (intervention group))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study of an Internet-based Cognitive Behavioral Therapy Program for Sexuality and Intimacy Problems in Women Treated for Breast Cancer.
Brief Summary: The purpose of this study is to evaluate the efficacy and cost-effectiveness of an internet-based cognitive behavioural therapy program in alleviating problems with intimacy and sexuality in women treated for breast cancer.


Options:
A: Menopausal symptoms (6 months)
B: Sexuality problems (Baseline); Intimacy problems. (Baseline); Sexuality problems (T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group)); Sexuality problems (T2: 20-24 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group)); Sexuality problems (T3: 3 months after T2 (intervention group)); Intimacy problems. (T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group)); Intimacy problems. (T2: 20-24 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group)); Intimacy problems. (T3: 3 months after T2 (intervention group)); Sexuality problems (T4: 6 months after T3 (intervention group)); Intimacy problems (T4: 6 months after T3 (intervention group))
C: Fatigue as measured by the Brief Fatigue Inventory (prior to beginning of treatment and after treatment ends. Up to an average of 44 weeks.)
D: Physical activity questionnaire (International Physical Activity Questionnaire) (Baseline and 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial Examining the Effectiveness of Mobile-Based Asthma Action Plans vs. Paper Asthma Action Plans
Brief Summary: The purpose of this study is to see if using a mobile phone application asthma action plan will help improve asthma management.


Options:
A: Appropriate use of asthma controller medications (Measured at Year 1); Number of asthma symptom days (Measured at Year 1)
B: Change in Asthma Control Test Scores (Baseline and Six months)
C: Medication Adherence (12 months)
D: Change from Baseline in adherence rate to entire treatment period (From baseline to end of participation (up to 3 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared With Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years With Asthma
Brief Summary: The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to \<12 Years with Asthma during 12 weeks.


Options:
A: Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis (up to 52 weeks); Annual Severe Asthma Exacerbation Rate - Superiority Analysis (up to 52 weeks)
B: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Week 12)
C: Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms (26 weeks, or 7 days after the last treatment dose, whichever occurred later)
D: Change From Baseline to Week 12 in 1h Post-dose FEV1 (Week 0 (baseline), Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A LARGE-SCALE CLUSTER RANDOMIZED TRIAL TO DETERMINE THE EFFECTS OF SODIUM REDUCTION ON STROKE: THE CHINA SALT SUBSTITUTE AND STROKE STUDY (SSaSS)
Brief Summary: The study is a large scale cluster randomised trial to evaluate the effects of sodium reduction based upon the use of salt substitute on the risk of stroke defined as the occurrence of stroke and stroke deaths. The corresponding null hypothesis that will be tested is that sodium reduction will have no effect upon stroke risk. The secondary objectives are to determine effects of sodium reduction on major vascular events and total mortality.


Options:
A: Systolic Blood Pressure (three months)
B: Absolute difference between systolic blood pressure values determined with an oscillometric cuff device and an iPhone 4s (Delta mmHg) (1 day)
C: Change in Baseline Mean Systolic Blood Pressure (mmHg) at 6 months ((Baseline compared to 6 months after start of intervention))
D: Stroke (5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A LARGE-SCALE CLUSTER RANDOMIZED TRIAL TO DETERMINE THE EFFECTS OF SODIUM REDUCTION ON STROKE: THE CHINA SALT SUBSTITUTE AND STROKE STUDY (SSaSS)
Brief Summary: The study is a large scale cluster randomised trial to evaluate the effects of sodium reduction based upon the use of salt substitute on the risk of stroke defined as the occurrence of stroke and stroke deaths. The corresponding null hypothesis that will be tested is that sodium reduction will have no effect upon stroke risk. The secondary objectives are to determine effects of sodium reduction on major vascular events and total mortality.


Options:
A: Change in 24-hour urinary creatinine clearance from baseline to final follow-up, measured from 24-hour urinary collection and corresponding serum creatinine measurement at randomisation and final visit. (24 months)
B: Stroke (5 years)
C: feasibility of intensive sodium management (12 months)
D: Quality of life (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects With Chronic Hepatitis C Virus Infection and Chronic Kidney Disease
Brief Summary: This study will evaluate the safety and efficacy of combination treatment with grazoprevir (MK-5172) + elbasvir (MK-8742) for cirrhotic and non-cirrhotic participants with chronic Genotype 1 (GT1) hepatitis C virus (HCV) infection and chronic kidney disease (CKD). The primary study hypothesis is that the proportion of HCV GT1-infected CKD participants within the Immediate Treatment and Intensive Pharmacokinetics (PK) groups achieving a sustained viral response 12 weeks after the end of all study treatment (SVR12) will be \>45%.


Options:
A: Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) (Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)); Number of Participants Experiencing an Adverse Event (AE) During the Initial Treatment and 14-day Follow-up Periods (Up to Week 14); Number of Participants Discontinuing Study Drug Due to AEs During the Initial Treatment Period (Up to Week 12)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) (12 weeks after the last actual dose of study drug)
C: There is no specific primary outcome measure but we indicated below (see Description) a list of potential outcome measures according to the objectives. (From recruitment to the end of the cohort, with a minimum of one medical visit per year (the duration of follow-up is 7-8 years))
D: Sustained Virologic Response (SVR)Rate (1.5 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects With Chronic Hepatitis C Virus Infection and Chronic Kidney Disease
Brief Summary: This study will evaluate the safety and efficacy of combination treatment with grazoprevir (MK-5172) + elbasvir (MK-8742) for cirrhotic and non-cirrhotic participants with chronic Genotype 1 (GT1) hepatitis C virus (HCV) infection and chronic kidney disease (CKD). The primary study hypothesis is that the proportion of HCV GT1-infected CKD participants within the Immediate Treatment and Intensive Pharmacokinetics (PK) groups achieving a sustained viral response 12 weeks after the end of all study treatment (SVR12) will be \>45%.


Options:
A: Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) (Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)); Number of Participants Experiencing an Adverse Event (AE) During the Initial Treatment and 14-day Follow-up Periods (Up to Week 14); Number of Participants Discontinuing Study Drug Due to AEs During the Initial Treatment Period (Up to Week 12)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (12 weeks after the last actual dose of active study drug)
C: Percentage of Participants Achieving RVR (Week 4); Number of Participants Experiencing an Adverse Event (AE) (Up to Day 42); Number of Participants Discontinuing From Study Therapy Due to AEs (Day 1 to Day 28)
D: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug (Up to 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects With Chronic Hepatitis C Virus Infection and Chronic Kidney Disease
Brief Summary: This study will evaluate the safety and efficacy of combination treatment with grazoprevir (MK-5172) + elbasvir (MK-8742) for cirrhotic and non-cirrhotic participants with chronic Genotype 1 (GT1) hepatitis C virus (HCV) infection and chronic kidney disease (CKD). The primary study hypothesis is that the proportion of HCV GT1-infected CKD participants within the Immediate Treatment and Intensive Pharmacokinetics (PK) groups achieving a sustained viral response 12 weeks after the end of all study treatment (SVR12) will be \>45%.


Options:
A: Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2 (Follow-up Week 24); Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3 (Follow-up Week 24)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) (Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)); Number of Participants Experiencing an Adverse Event (AE) During the Initial Treatment and 14-day Follow-up Periods (Up to Week 14); Number of Participants Discontinuing Study Drug Due to AEs During the Initial Treatment Period (Up to Week 12)
C: Proportion of treated subjects in each of the naive arms with sustained virologic response (SVR12) (Post treatment 12 week)
D: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12) (Week 24 (12 weeks after the end of treatment)); Percentage of Participants Experiencing at Least One Adverse Event (Up to Week 14 (14 days after the Blinded Treatment was completed)); Percentage of Participants Discontinued From Study Treatment Because of an Adverse Event (Up to Week 12 (end of Blinded Treatment))

Answer: B