TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Practice-Based Nutrition Intervention
Brief Summary: This study aims to test a dietary intervention for diabetes in a medical practice setting, with the aim of developing a model for diabetes care that can be used widely. The investigators hypothesize that a low-fat vegan diet will be effective for management of diabetes and will be feasible in a practice-based setting.


Options:
A: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
B: hemoglobin A1C (diabetes management) (assessment at baseline (0 weeks)); hemoglobin A1C (diabetes management) (assessment at 10 weeks); hemoglobin A1C (diabetes management) (assessment at 20 weeks); hemoglobin A1C (diabetes management) (assessment at one-year follow-up); lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) (assessment at baseline (0 weeks)); lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) (assessment at 10 weeks); lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) (assesment at 20 weeks); lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) (assessment at one-year follow-up); body weight (assessment at baseline (0 weeks)); body weight (assessment at 10 weeks); body weight (assessment at 20 weeks); body weight (assessment at one-year follow-up); indices of renal function (serum creatinine, microalbumin) (assessment at baseline (0 weeks)); indices of renal function (serum creatinine, microalbumin) (assessment at 10 weeks); indices of renal function (serum creatinine, microalbumin) (assessment at 20 weeks); indices of renal function (serum creatinine, microalbumin) (assessment at one-year follow-up)
C: Hemoglobin A1c (22 weeks)
D: total and low-density lipoprotein (LDL) cholesterol; LDL:HDL cholesterol ratio; weight reduction

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomised, Placebo- and Active-controlled, 5 Way, Crossover Trial to Characterise the Pharmacokinetics and Evaluate the Bronchodilator Efficacy and Safety of Once-daily Tiotropium Delivered (Double-blind) From the Respimat Inhaler as Solution for Inhalation (1.25, 2.5, 5 mcg or Placebo) and as Inhalation Powder (18mcg) From the HandiHaler (Open Label) After 4 Week-treatment Periods in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of this study is compare the effect of different doses of tiotropium delivered by the HandiHaler and Respimat device on lung function. Additionally, the study will investigate the pharmacokinetic profile of these different doses. Studying the pharmacokinetic profile shows what happens to the medication in the body over a period of hours and provides information on potential effects of the medication.


Options:
A: Plasma concentration levels over time of biomarkers of oxidative stress, apoptosis, inflammation and platelet aggregation (Within 8hours from baseline)
B: Insomnia (Up to 18 weeks)
C: Change From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT) (10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication); Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL) (Week 48); TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies) (Week 48); COPD Exacerbation Rate, Safety Set (SS) (Combined Studies) (48 weeks)
D: Maximum Plasma Concentration at Steady-state (Cmax,ss) (Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.); Area Under the Curve 0 to 6 Hours at Steady-state (AUC0-6h,ss) (Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Double-blind, Randomized, Active Reference, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of a 10-day Twice Daily Oral Administration of Three Doses of Cadazolid (ACT-179811) in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)
Brief Summary: Cadazolid is a new antibiotic developed for the treatment of Clostridiun difficile associated diarrhea (CDAD), also known as Clostridium Difficile Infection (CDI). The purpose of the study was to evaluate the efficacy and safety of different doses of cadazolid in order to find the dose of cadazolid to be used for further clinical development of the compound in subjects with CDAD.


Options:
A: Number of Participants With a Clinical Response Outcome of Clostridium Difficile Infection Cure at the End of Study Treatment (Baseline (Day 0) through Study Day 19); Number of Participants With a Clinical Response Outcome of Failure or Unable to Evaluate at the End of Study Treatment (Baseline (Day 0) through Study Day 19)
B: The evaluation of the safety of HBT (13 Weeks post HBT); To determine the cure rate without recurrence of CDI at 13 weeks from the last HBT. (13 Weeks post HBT)
C: Clinical cure rate at test-of-cure (Day 13 or 24-72 hours after end of treatment)
D: Number of Participants With Recurrence of Clostridium Difficile Associated Disease (CDAD) (Day 0 to Day 84)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Randomized, Multi-center, Phase III Study to Compare the Safety and Efficacy of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma After Failure of Anti-angiogenic (VEGF-targeted and mTOR Inhibitor) Therapies
Brief Summary: This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients with metastatic renal cell cancer.


Options:
A: progression-free rate (at 48 weeks post-treatment)
B: Progressive Free Survival (PFS) in Patients Who Receive RAD001 Plus Best Supportive Care(BSC) Versus Patients Who Receive Matching Placebo Plus BSC (Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported between date of first patient randomized until 28Feb2008 cut of date.)
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) Per Independent Central Radiology Review (Until disease progression or discontinuation of treatment due to unacceptable toxicity up to 30-Jun-2014 (discontinuation))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-week, Randomized, Open-label, Parallel Group, Multicenter Comparison of Lantus® (Insulin Glargine) Given Once Daily Versus Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Mellitus Aged at Least 6 Years to Less Than 18 Years
Brief Summary: Primary Objective:

6 To assess the efficacy of insulin glargine given once daily (QD) on glycosylated hemoglobin (HbA1c) levels over a period of 24 weeks in children with type 1 diabetes mellitus (T1DM) aged at least 6 years to less than 18 years.

Secondary Objectives:

* To assess the effects of insulin glargine compared to NPH insulin over 24 weeks on:

  * Percentage of patients reaching International Society of Pediatric and Adolescent Diabetes (ISPAD) recommended target of HbA1c \< 7.5%,
  * Fasting blood glucose (FBG),
  * Nocturnal blood glucose (BG),
  * 24-hour blood glucose profile based on 8-point self-monitoring of blood glucose (SMBG) values,
  * Daily total insulin dose and basal insulin dose,
  * Rates of asymptomatic and/or symptomatic, severe, nocturnal and nocturnal symptomatic hypoglycemia.
* To assess the safety and tolerability of insulin glargine versus NPH insulin based on the occurrence of treatment-emergent adverse events (TEAEs).
* To assess anti-insulin and anti-glargine antibody development in both groups.
* To assess insulin glargine pharmacokinetic(PK) for all patients treated with insulin glargine in selected sites with approximately 45% of insulin glargine population to rule out accumulation tendency of insulin glargine after repeated dosing


Options:
A: Insulin Detemir-insulin Aspart Cross-reacting Antibodies (week 0, 52 and 104)
B: N/A
C: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment (Week 0, Week 26); Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes (Week 0 to Week 53 + 7 days follow up); Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes (Week 0 to Week 53 + 7 days follow up); Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) (Week 0 to Week 53 + 7 days of follow up)
D: Absolute change of glycosylated hemoglobin (HbA1c) (from baseline to week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: eRehab: Can Information and Communication Technology (ICT) Enhance Self-management of Cardiovascular Disease?
Brief Summary: Cardiovascular Diseases (CVD) according to the World Health Organization (WHO) are leading causes of death and represent 30% of all global deaths and 48% of the deaths in Europe. Moreover, the current trends predict increase in deaths caused by Cardiovascular Diseases over the next years. Secondary preventive efforts can decrease mortality risk as well as improve health among Cardiovascular Disease patients.

This study suggests an innovative approach in supporting the self-management of Cardiovascular Disease patients after rehabilitation. The implied Randomized Controlled Trial has two arms and aims to investigate the effectiveness of tailoring in an Information and Communication Technology (ICT) based intervention. The tailoring will be based on concepts derived from health psychology theories, and will contribute in their further development. More specifically:

* Aim 1: To assess the needs of CVD rehabilitation patients that can potentially be met through the use of ICT.
* Aim 2: To assess the effects of a tailored Internet-based intervention on maintenance of self-management behaviors after a rehabilitation stay. Hypothesis: The intervention group (tailored) will have higher adherence a) to the Internet-based intervention, and b) to self-management.
* Aim 3: To assess the effect of mobile technology with activity sensors on physical activity. Hypothesis: There will be a relationship between the data collected from activity sensors and the self-reported physical activity levels.


Options:
A: Duration and Intensity of Physical Activity (1 month, 3 months and 12 months after discharge)
B: Physical Fitness (Measured after 12 weeks and after one year); Physical Activity Level (PAL) (measured after 12 weeks and after one year)
C: Effectiveness measured by exercise testing and control of cardiovascular risk factors (During 12 months)
D: functional capacity at 6- and 12-months after CR in pts older than 75 years randomly allocated to Home-Based exercise program or usual care. (6 and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: eRehab: Can Information and Communication Technology (ICT) Enhance Self-management of Cardiovascular Disease?
Brief Summary: Cardiovascular Diseases (CVD) according to the World Health Organization (WHO) are leading causes of death and represent 30% of all global deaths and 48% of the deaths in Europe. Moreover, the current trends predict increase in deaths caused by Cardiovascular Diseases over the next years. Secondary preventive efforts can decrease mortality risk as well as improve health among Cardiovascular Disease patients.

This study suggests an innovative approach in supporting the self-management of Cardiovascular Disease patients after rehabilitation. The implied Randomized Controlled Trial has two arms and aims to investigate the effectiveness of tailoring in an Information and Communication Technology (ICT) based intervention. The tailoring will be based on concepts derived from health psychology theories, and will contribute in their further development. More specifically:

* Aim 1: To assess the needs of CVD rehabilitation patients that can potentially be met through the use of ICT.
* Aim 2: To assess the effects of a tailored Internet-based intervention on maintenance of self-management behaviors after a rehabilitation stay. Hypothesis: The intervention group (tailored) will have higher adherence a) to the Internet-based intervention, and b) to self-management.
* Aim 3: To assess the effect of mobile technology with activity sensors on physical activity. Hypothesis: There will be a relationship between the data collected from activity sensors and the self-reported physical activity levels.


Options:
A: Motivation (12 weeks); Needs Satisfaction (12 weeks)
B: Self-care Maintenance in Patients (3 months from the intervention)
C: Duration and Intensity of Physical Activity (1 month, 3 months and 12 months after discharge)
D: The primary outcome was a composite end-point of a first visit to the emergency department (lasting less than 24 hours), or a first hospital readmission (> 24h) or all-cause death, assessed during the first 6 months of follow-up. (Up to 36 months.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: eRehab: Can Information and Communication Technology (ICT) Enhance Self-management of Cardiovascular Disease?
Brief Summary: Cardiovascular Diseases (CVD) according to the World Health Organization (WHO) are leading causes of death and represent 30% of all global deaths and 48% of the deaths in Europe. Moreover, the current trends predict increase in deaths caused by Cardiovascular Diseases over the next years. Secondary preventive efforts can decrease mortality risk as well as improve health among Cardiovascular Disease patients.

This study suggests an innovative approach in supporting the self-management of Cardiovascular Disease patients after rehabilitation. The implied Randomized Controlled Trial has two arms and aims to investigate the effectiveness of tailoring in an Information and Communication Technology (ICT) based intervention. The tailoring will be based on concepts derived from health psychology theories, and will contribute in their further development. More specifically:

* Aim 1: To assess the needs of CVD rehabilitation patients that can potentially be met through the use of ICT.
* Aim 2: To assess the effects of a tailored Internet-based intervention on maintenance of self-management behaviors after a rehabilitation stay. Hypothesis: The intervention group (tailored) will have higher adherence a) to the Internet-based intervention, and b) to self-management.
* Aim 3: To assess the effect of mobile technology with activity sensors on physical activity. Hypothesis: There will be a relationship between the data collected from activity sensors and the self-reported physical activity levels.


Options:
A: Blood Pressure Control (Baseline, 6 months, 12 months, 18 months); Mean Systolic Blood Pressure (Baseline, 6 months, 12 months, 18 months, 54 months); Mean Diastolic Blood Pressure (Baseline, 6 months, 12 months, 18 months, 54 months)
B: Duration and Intensity of Physical Activity (1 month, 3 months and 12 months after discharge)
C: Weight (Measured at Assessment Visits) and Pain Intensity and Pain Related Disability (NRS-I) (baseline, 3, 6, 9, and 12 months)
D: State-Trait Anger Inventory (STAXI-2) Anger Expression Index (Baseline); State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale (Post-treatment (2 weeks following last treatment session)); State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale (3-month Follow Up); State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale (6-month Follow Up); Novaco Anger Scale (NAS) (Baseline); Novaco Anger Scale (NAS) (Post-treatment (2 weeks following last treatment session)); Novaco Anger Scale (NAS) (3-Month Follow Up); Novaco Anger Scale (NAS) (6-Month Follow Up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: eRehab: Can Information and Communication Technology (ICT) Enhance Self-management of Cardiovascular Disease?
Brief Summary: Cardiovascular Diseases (CVD) according to the World Health Organization (WHO) are leading causes of death and represent 30% of all global deaths and 48% of the deaths in Europe. Moreover, the current trends predict increase in deaths caused by Cardiovascular Diseases over the next years. Secondary preventive efforts can decrease mortality risk as well as improve health among Cardiovascular Disease patients.

This study suggests an innovative approach in supporting the self-management of Cardiovascular Disease patients after rehabilitation. The implied Randomized Controlled Trial has two arms and aims to investigate the effectiveness of tailoring in an Information and Communication Technology (ICT) based intervention. The tailoring will be based on concepts derived from health psychology theories, and will contribute in their further development. More specifically:

* Aim 1: To assess the needs of CVD rehabilitation patients that can potentially be met through the use of ICT.
* Aim 2: To assess the effects of a tailored Internet-based intervention on maintenance of self-management behaviors after a rehabilitation stay. Hypothesis: The intervention group (tailored) will have higher adherence a) to the Internet-based intervention, and b) to self-management.
* Aim 3: To assess the effect of mobile technology with activity sensors on physical activity. Hypothesis: There will be a relationship between the data collected from activity sensors and the self-reported physical activity levels.


Options:
A: Duration and Intensity of Physical Activity (1 month, 3 months and 12 months after discharge)
B: Health related quality of life (12 months); HbA1c change over time (participants with T2DM only) (12 months)
C: Medication Adherence Score (2 months)
D: Change in Chronic Heart Failure Health Status Between Baseline and 12 Months. (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: eRehab: Can Information and Communication Technology (ICT) Enhance Self-management of Cardiovascular Disease?
Brief Summary: Cardiovascular Diseases (CVD) according to the World Health Organization (WHO) are leading causes of death and represent 30% of all global deaths and 48% of the deaths in Europe. Moreover, the current trends predict increase in deaths caused by Cardiovascular Diseases over the next years. Secondary preventive efforts can decrease mortality risk as well as improve health among Cardiovascular Disease patients.

This study suggests an innovative approach in supporting the self-management of Cardiovascular Disease patients after rehabilitation. The implied Randomized Controlled Trial has two arms and aims to investigate the effectiveness of tailoring in an Information and Communication Technology (ICT) based intervention. The tailoring will be based on concepts derived from health psychology theories, and will contribute in their further development. More specifically:

* Aim 1: To assess the needs of CVD rehabilitation patients that can potentially be met through the use of ICT.
* Aim 2: To assess the effects of a tailored Internet-based intervention on maintenance of self-management behaviors after a rehabilitation stay. Hypothesis: The intervention group (tailored) will have higher adherence a) to the Internet-based intervention, and b) to self-management.
* Aim 3: To assess the effect of mobile technology with activity sensors on physical activity. Hypothesis: There will be a relationship between the data collected from activity sensors and the self-reported physical activity levels.


Options:
A: Phase 1: patient who've received interventions based on evidence proportion informed by the indicators (9 months); Phase 2: increase of prescription of evidence based treatment in clinical practice (6 months)
B: cardiovascular mortality; non fatal re-MI; angina requiring hospitalization; urgent revascularization procedures; hospitalization for heart failure; non fatal stroke
C: Duration and Intensity of Physical Activity (1 month, 3 months and 12 months after discharge)
D: Feasibility of subject recruitment; feasibility of delivery of the CHD intervention and surveys in a busy practice setting; feasibility of measuring study outcomes (Measured at the end of the study period (approximately 2 years))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: eRehab: Can Information and Communication Technology (ICT) Enhance Self-management of Cardiovascular Disease?
Brief Summary: Cardiovascular Diseases (CVD) according to the World Health Organization (WHO) are leading causes of death and represent 30% of all global deaths and 48% of the deaths in Europe. Moreover, the current trends predict increase in deaths caused by Cardiovascular Diseases over the next years. Secondary preventive efforts can decrease mortality risk as well as improve health among Cardiovascular Disease patients.

This study suggests an innovative approach in supporting the self-management of Cardiovascular Disease patients after rehabilitation. The implied Randomized Controlled Trial has two arms and aims to investigate the effectiveness of tailoring in an Information and Communication Technology (ICT) based intervention. The tailoring will be based on concepts derived from health psychology theories, and will contribute in their further development. More specifically:

* Aim 1: To assess the needs of CVD rehabilitation patients that can potentially be met through the use of ICT.
* Aim 2: To assess the effects of a tailored Internet-based intervention on maintenance of self-management behaviors after a rehabilitation stay. Hypothesis: The intervention group (tailored) will have higher adherence a) to the Internet-based intervention, and b) to self-management.
* Aim 3: To assess the effect of mobile technology with activity sensors on physical activity. Hypothesis: There will be a relationship between the data collected from activity sensors and the self-reported physical activity levels.


Options:
A: Physical Fitness (Measured after 12 weeks and after one year); Physical Activity Level (PAL) (measured after 12 weeks and after one year)
B: Adherence to cardiac rehabilitation (After 8 weeks of cardiac rehabilitation); Morbidity and mortality (Three or four years after last patient into trial)
C: Duration and Intensity of Physical Activity (1 month, 3 months and 12 months after discharge)
D: CR Program Adherence (6 months)

Answer: C