TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Activity, Gait, and Efficacy (AGE II): Functional Limitations and Quality of Life
Brief Summary: The purpose of this study is to test the effectiveness of a DVD-delivered, home-based, six-month physical activity intervention for older adults.

A comparative effectiveness study of the FlexToBa DVD exercise program will be conducted in 2014.


Options:
A: Physical activity level
B: Absolute level of physical activity: (Assessed at baseline, 6, 12 and 24-month follow-up as kcals/wk expenditure based on survey self-report, validated against activity monitor data in a random sub-sample.); Maintenance of physical activity (Physical activity level relative to baseline assessed at all follow-ups 6, 12, 24 months.)
C: Functional performance, balance and reduced self-reported upper and lower body functional limitations in sedentary, older adults' physical activity. (Baseline, 6-month, 12-month follow-up)
D: Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps (Baseline, 3, and 9 months); Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day) (Baseline, 3 and 9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a/2b Study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotypes 1 and 4 Chronic Hepatitis C Infection
Brief Summary: The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).


Options:
A: Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12) (Follow-up Week 12)
B: The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) (Week 36 or Week 60)
C: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12), Treatment-naive, Noncirrhotic Participants (Posttreatment Week 12); Percentage of Participants With Sustained Virologic Response at 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event (Up to 12 weeks)
D: Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs (12 weeks after first dose); Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA (Week 4); Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA (Week 12); Phase 2b only: Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA (at follow-up Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a/2b Study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotypes 1 and 4 Chronic Hepatitis C Infection
Brief Summary: The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).


Options:
A: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (12 weeks after the last actual dose of study drug)
B: Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs (12 weeks after first dose); Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA (Week 4); Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA (Week 12); Phase 2b only: Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA (at follow-up Week 24)
C: Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d. (Up to 72 weeks); Number of Participants Experiencing an Adverse Event (AE) (Up to 73 weeks); Number of Participants Discontinuing From Study Treatment Due to AEs (Up to 48 weeks)
D: The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24) (Week 72)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma (TIVO-1)
Brief Summary: This is an open-label, randomized, controlled, multi-national, multi-center, parallel-arm trial comparing tivozanib to sorafenib in subjects with advanced RCC. The study is designed to compare the PFS, OS, ORR, DR, safety and tolerability, and kidney specific symptoms/health outcome measurements of tivozanib and sorafenib.


Options:
A: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.)
B: Objective Response Rate (ORR) - Percentage of Participants With Objective Response (Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.)
C: Progression-free Survival (PFS) (From randomization until the earliest date of disease progression or date of death from any cause, assessed up to approximately 39 months)
D: Progression-free Survival (PFS) of Subjects With Advanced Renal Cell Cancer (RCC) Randomized to Treatment With Tivozanib or Sorafenib (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cluster Randomized Controlled Trial of a Treatment Algorithm for the Management of Crohn's Disease
Brief Summary: Assess if the implementation of a treatment algorithm will improve the management of Crohn's disease (CD) in comparison to usual care based gastroenterology practices.


Options:
A: Proportion of patients in remission at the end of the 24 month followup period. Remission is defined as a HBS< or = 4 without use of steroids for the treatment of CD. the primary analysis will be performed at the level of the practice. (24 months)
B: Occurrence of disease worsening (52 weeks)
C: Percentage of Participants With Corticosteriod-free Clinical Remission (Week 26)
D: co-primary efficacy end points (2 ans)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cluster Randomized Controlled Trial of a Treatment Algorithm for the Management of Crohn's Disease
Brief Summary: Assess if the implementation of a treatment algorithm will improve the management of Crohn's disease (CD) in comparison to usual care based gastroenterology practices.


Options:
A: Proportion of patients in remission at the end of the 24 month followup period. Remission is defined as a HBS< or = 4 without use of steroids for the treatment of CD. the primary analysis will be performed at the level of the practice. (24 months)
B: Endoscopic recurrence of disease (18 months)
C: Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment (Week 52 of double-blind treatment)
D: The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4 (4 Weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cluster Randomized Controlled Trial of a Treatment Algorithm for the Management of Crohn's Disease
Brief Summary: Assess if the implementation of a treatment algorithm will improve the management of Crohn's disease (CD) in comparison to usual care based gastroenterology practices.


Options:
A: remission without corticosteroids and without surgical resection (month 6 and 12 after inclusion)
B: Proportion of patients in remission at the end of the 24 month followup period. Remission is defined as a HBS< or = 4 without use of steroids for the treatment of CD. the primary analysis will be performed at the level of the practice. (24 months)
C: Proportion of patients in remission defined by disease specific composite scores Study part A (30 weeks); Sustained disease control throughout the study period without disease worsening defined by disease specific composite scores Study part B (52 weeks)
D: The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6 (at Week 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Shared Decision-Making for Elderly Depressed Primary Care Patients
Brief Summary: Shared decision-making (SDM), in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The proposed study will evaluate the impact of a brief SDM nursing intervention among elderly, depressed primary care patient subjects in comparison to physician recommended Usual Care. The focus of the SDM intervention is to empower depressed patients and help them arrive at a treatment decision that can be successfully carried out.


Options:
A: SCL-20 depression (baseline, 3, 6 12, 18 month follow-ups)
B: Number of Participants Who Adhered to Physician Recommended Treatment (12 weeks)
C: The proportion of residents whose preferences and needs, together with the related actions to meet them, are known, documented and satisfied in their 'life-and-care plans'. (6 months after the SDM interview)
D: Shared Decision-Making Coding System (Change in collaborative decision-making behaviors from baseline (month 0) to post-intervention (month 2)); Shared Decision-Making Coding System (Change in collaborative decision-making behaviors from baseline (month 0) to follow-up at 3-months post-intervention (month 5))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-week, Multicentre, Randomised, Double-blind, Age-stratified, Placebo Controlled, Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin 10 mg Once Daily in Pts With T2DM, CV Disease and Hypertension Who Exhibit Inadequate Glycaemic Control on Usual Care
Brief Summary: This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight and blood pressure, when added to patients existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes, cardiovascular disease and hypertension.


Options:
A: Adjusted Mean Change in HbA1c Levels (Baseline to Week 24); Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit (Baseline to week 24)
B: Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke (Randomization (day 0) up to 2.9 years)
C: Change of global myocardial function from baseline to 6 months of follow-up. (Recruitment period: 4,5 years. Follow-up assessment: 1 year. Analyses and reporting: 6 months. Overall duration: 6 years.)
D: Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke. (From randomisation to individual end of observation, up to 4.6 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Sustained Impact of Hypertonic Saline on Mucociliary Clearance in Young Children With Cystic Fibrosis
Brief Summary: Previous work demonstrated that inhaled hypertonic saline (HS) reduces exacerbation frequency and improves lung function in adults with cystic fibrosis (CF). It is unclear, however, whether HS will benefit young patients suffering from CF. The investigators propose to further support the concept that HS can benefit children with mild CF lung disease by performing a relatively short, placebo controlled study of HS in 5-12 year olds, using lung function and mucociliary clearance as key outcome measures.


Options:
A: Number of Participants Eligible to be Assessed for Sub-study Enrollment (2-week run-in period)
B: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
C: Change in Mucociliary Clearance Rate (Baseline versus after completion of 4 week treatment period)
D: Change in FEV1 (in liters) from baseline (At the end of the 14 day treatment period); Adverse events such as gastrointestinal complaints, wheezing, hepatitis or shortness of breath (70 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Topical Rapamycin Therapy to Alleviate Cutaneous Manifestations of Tuberous Sclerosis Complex and Neurofibromatosis 1
Brief Summary: This study is a prospective, randomized, double-blind, placebo-controlled evaluation of the safety of a topically applied formulation of rapamycin to cutaneous fibromatous lesions in subjects with Tuberous Sclerosis Complex (TSC) and Neurofibromatosis I (NF1). Subjects will apply either a Polyvinylidene fluoride (PVDF) coating (Skincerity) containing rapamycin or the PVDF coating alone nightly to fibromatous lesions for a duration of six months.

The primary goal of this study is to evaluate the safety of the topical product in patients with TSC and NF1. The secondary goal of this study is to evaluate the effectiveness of the topical product for treatment of cutaneous fibromatous lesions.


Options:
A: Objective Response Rate (On treatment, patients were evaluated radiologically for response to therapy up to 52 weeks.)
B: Number With Observed Adverse Side Effects (During the entire study)
C: Improvements in angiofibroma (12 weeks)
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Topical Rapamycin Therapy to Alleviate Cutaneous Manifestations of Tuberous Sclerosis Complex and Neurofibromatosis 1
Brief Summary: This study is a prospective, randomized, double-blind, placebo-controlled evaluation of the safety of a topically applied formulation of rapamycin to cutaneous fibromatous lesions in subjects with Tuberous Sclerosis Complex (TSC) and Neurofibromatosis I (NF1). Subjects will apply either a Polyvinylidene fluoride (PVDF) coating (Skincerity) containing rapamycin or the PVDF coating alone nightly to fibromatous lesions for a duration of six months.

The primary goal of this study is to evaluate the safety of the topical product in patients with TSC and NF1. The secondary goal of this study is to evaluate the effectiveness of the topical product for treatment of cutaneous fibromatous lesions.


Options:
A: Objective Response Rate (On treatment, patients were evaluated radiologically for response to therapy up to 52 weeks.)
B: Volume of Angiomyolipomata
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: Number With Observed Adverse Side Effects (During the entire study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Depression Interventions After Acute Coronary Syndrome (CODIACS)
Brief Summary: Patients will be consented and screened within 2 to 6 months of the index ACS. Patients who have elevated depression (BDI\>=15 or BDI\>=10 assessed twice over two week period) and who continue to meet all of the trial's eligibility criteria will be consented. Through informed consent, both arms of the trial will be described with equipoise as to these approaches to postACS depression care. Patients who consent to randomization will be enrolled in the treatment trial.

The intervention phase will be 6 months, and hence the final outcome assessments will be performed approximately 9 months after the index ACS. Interim measures of depression will be obtained at 2 and 4 months post-enrollment. Major adverse cardiac events and all-cause mortality will also be ascertained at 6 months post-enrollment. Quality assurance by an independent medical event adjudication committee using prospective guidelines will be employed.


Options:
A: Re-hospitalization and death rates (Measured at Month 12); Total hospitalizations (Measured at Month 12); HF-specific quality of life (Measured at Months 6 and 12)
B: Admission to hospital for recurrent CHD event (8 years)
C: Depressive Symptom Reduction (Change from depression at baseline to depression at 6-months); Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services) (6 months after randomization)
D: Levels of proinflammatory cytokines (IL-1 and IL-6) (at baseline and after 8 weeks (at the completion of the intervention)); The soluble receptor for IL-6 (sIL-6) (at baseline and after 8 weeks (at the completion of the intervention)); Inflammatory markers c-reactive protein (CRP and sICAM-1) (at baseline and after 8 weeks (at the completion of the intervention))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Depression Interventions After Acute Coronary Syndrome (CODIACS)
Brief Summary: Patients will be consented and screened within 2 to 6 months of the index ACS. Patients who have elevated depression (BDI\>=15 or BDI\>=10 assessed twice over two week period) and who continue to meet all of the trial's eligibility criteria will be consented. Through informed consent, both arms of the trial will be described with equipoise as to these approaches to postACS depression care. Patients who consent to randomization will be enrolled in the treatment trial.

The intervention phase will be 6 months, and hence the final outcome assessments will be performed approximately 9 months after the index ACS. Interim measures of depression will be obtained at 2 and 4 months post-enrollment. Major adverse cardiac events and all-cause mortality will also be ascertained at 6 months post-enrollment. Quality assurance by an independent medical event adjudication committee using prospective guidelines will be employed.


Options:
A: Acceptability (From the completion of the manual till 4 months)
B: The cumulative incidence of new cardiological events and the occurrence of new medical pathologies (5 years)
C: Depressive Symptom Reduction (Change from depression at baseline to depression at 6-months); Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services) (6 months after randomization)
D: Score on the Hamilton Depression Rating Scale-17 item (24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled, Open-label, Parallel-group, Multi-center Study to Compare the Effect of Intrathecal Baclofen Therapy Versus Best Medical Treatment on Severe Spasticity in Post-stroke Patients After 6 Months Active Treatment
Brief Summary: To demonstrate that Intrathecal Baclofen (ITB) Therapy, compared to Best Medical Treatment (BMT), has superior efficacy in the treatment of severe spasticity in adult post-stroke patients with generalized spastic hypertonia who have not reached their therapy goal with other treatment interventions assessed by a decrease in the average Ashworth Scale (AS) score in the lower extremities.


Options:
A: Occurrence (yes or no) of agitation-related adverse events (at the end of treatment (22 days max))
B: Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6 (Baseline and month 6)
C: alcohol consumption (12 weeks)
D: Total alcohol abstinence; cumulative abstinence duration (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Falls in Community-dwelling Older Adults by a Standardized Assessment of Fall Risks in the General Practitioner Setting and Through Implementation of a Network for Effective Individual Reduction on Fall Risks.
Brief Summary: The primary aim of this two-year project for falls prevention is to reduce number of falls and fall incidence in community-dwelling people of 65 years and older in the setting of general practitioners. In addition a reduction of fall-related injuries, reduction of fall-related risk factors and preservation of Quality of Life is to be achieved.

A second goal of this study is the implementation of standardized assessment for fall risk factors as well as building up a network between instructors for fall prevention exercise and general practitioners.


Options:
A: Change from baseline in Geriatric Depression Scale (GDS) (Pre-treatment, posttreatment (expected average of 9 months after protreatment), 6- and 12-months follow-up)
B: Change in PTSD Checklist (PCL-5) (Baseline, Post-treatment (8-12 weeks after baseline), 3-months post-treatment, 6-months post-treatment)
C: Primary outcomes are number of falls and falls rates as well as number and incidence of injurious falls measured by monthly fall calendars (24 months)
D: PTSD Checklist (PCL) (Baseline and 6 weeks, 12 weeks, and 18 weeks post randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Falls in Community-dwelling Older Adults by a Standardized Assessment of Fall Risks in the General Practitioner Setting and Through Implementation of a Network for Effective Individual Reduction on Fall Risks.
Brief Summary: The primary aim of this two-year project for falls prevention is to reduce number of falls and fall incidence in community-dwelling people of 65 years and older in the setting of general practitioners. In addition a reduction of fall-related injuries, reduction of fall-related risk factors and preservation of Quality of Life is to be achieved.

A second goal of this study is the implementation of standardized assessment for fall risk factors as well as building up a network between instructors for fall prevention exercise and general practitioners.


Options:
A: rate of falls (12 months); proportion of fallers (12 months)
B: Number of falls and injurious falls in 12 months
C: The number of fallers who have fallen at least once during the 9-month study period (9 months)
D: Primary outcomes are number of falls and falls rates as well as number and incidence of injurious falls measured by monthly fall calendars (24 months)

Answer: D