TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Compared With Placebo in the Treatment of Older Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Glucose Lowering Therapy
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2 diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen.


Options:
A: ß-cell Function parameter (From the signature of the Informed Consent Form (ICF) up to the end of study); Glucose Homeostasis and glycemic control status (From the signature of the Informed Consent Form (ICF) up to the end of study)
B: Change in HbA1c From Baseline to Week 26 (Day 1 (Baseline) and Week 26)
C: Change in baseline HbA1c after 52 weeks
D: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Compared With Placebo in the Treatment of Older Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Glucose Lowering Therapy
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2 diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen.


Options:
A: Change in low-density lipoprotein cholesterol (52-weeks); Change in glycated hemoglobin (52-weeks)
B: Changes in Endothelial Function (FMD - Flow Mediated Dilatation) From Baseline to 12 Weeks (12 weeks)
C: Time to First Occurrence of Major Adverse Cardiovascular Events (MACE) During Cardiovascular (CV) Follow-up Time Period (Median of 1.65 person years for CV follow-up time period)
D: Change in HbA1c From Baseline to Week 26 (Day 1 (Baseline) and Week 26)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo and Active-Controlled, 4-Arm, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared with sitagliptin and placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (i.e., treatment with a single drug) and have inadequate glycemic (blood sugar) control.


Options:
A: Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment (after 24 weeks of treatment)
B: Incidence of liver inflammation or injury greater than 3 times the upper limit of normal, as monitored by serum alanine aminotransaminase elevation. (At All Visits)
C: Change in HbA1c From Baseline to Week 26 (Main Study) (Day 1 (Baseline) and Week 26); Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy) (Day 1 (Baseline) and Week 26)
D: Change in HbA1c From Baseline to Week 26 (Day 1 (Baseline) and Week 26)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Pioglitazone Therapy
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receving treatment with metformin and pioglitazone and have inadequate glycemic (blood sugar) control.


Options:
A: Change in HbA1c From Baseline to Week 26 (Day 1 (Baseline) and Week 26)
B: Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (week 0, week 52); Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104 (week 0, week 104); Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156 (week 0, week 156)
C: Change in HbA1c From Baseline to Week 52 (Day 1 (Baseline) and Week 52)
D: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26); Change in Glycosylated A1c (HbA1c) at Week 104 (week 0, week 104)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Progressive Resistance Training vs. Relaxation for Breast Cancer Patients During Chemotherapy: A Randomized Controlled Intervention Trial to Evaluate the Biological Mechanisms and Effects of Resistance Training on Fatigue and Quality of Life
Brief Summary: The purpose of this randomized intervention study is to investigate the effects and biological mechanisms of a supervised 12-week progressive resistance training on fatigue and quality of life in breast cancer patients during chemotherapy. To determine the effect of the exercise itself beyond potential psychosocial effects due to attention by trainers or the group support, patients in the control group have a comparable training schedule (i.e. 60 min, twice a week, for 12 weeks) but with relaxation training (Jacobsen method).


Options:
A: Fatigue measured by Fatigue Assessment Questionnaire (FAQ) (change between baseline and week 13 (end of intervention))
B: Change in Functional Assessment of Cancer Therapy summary score (physical, emotional, spiritual, and social QOL) (Baseline to up to 6 months); Program compliance as measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form (Up to 6 months); Program satisfaction measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form (Up to 6 months)
C: Quality of Life
D: Menopausal symptoms (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effective Care Management of Depressed Diabetes Patients
Brief Summary: Evaluation of telephone care management intervention designed to improve outcomes among depressed diabetes patients.


Options:
A: HAMD-17
B: HAM-D17 (Before and after 3 months intervention)
C: Participant HbA1c levels (one year); Participant cardiovascular risk index (one year)
D: Depression Score (6 months); Abstinent From Smoking (6 months); Days Walk Per Week (6 months); Minutes Per Week of Moderate Physical Activity (6 months); Minutes Per Week of Vigorous Physical Activity (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effective Care Management of Depressed Diabetes Patients
Brief Summary: Evaluation of telephone care management intervention designed to improve outcomes among depressed diabetes patients.


Options:
A: Participant HbA1c levels (one year); Participant cardiovascular risk index (one year)
B: This research study may lead to a potentially useful treatment for diabetes management when depression is present. (6 weeks); HbA1c (3-,6-, and 9-months); Depression (3-, 6- and 9-months)
C: Glucose Monitoring Adherence at Acute Outcome (Measured at Month 4); Percent Medication Adherence Via MEMS (month 4); Clinician Rated Depression (MADRS) at the Acute Timepoint (month 4); Depression on the CGI at Acute Outcome (Month 4)
D: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Technology Assisted Intervention for the Treatment and Prevention of Depression
Brief Summary: Investigators are evaluating the use of phone sensor data to estimate behavior, depression and anxiety.


Options:
A: Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain (3 months)
B: Depression, as assessed the Patient Health Questionnaire-9 (Baseline, Weeks 2-6)
C: Maximum Walking Distance (MWD) (Changes from before-assignment (T0 - treadmill and T1 - 6min walk test) to T2 (3 months), and to T3 (six-months)); Pain-free Walking Distance (PFWD) (Changes from before-assignment (T0 - treadmill and T1 - 6min walk test) to T2 (3 months), and to T3 (six-months)); Functional Walking Distance (FWD) (Changes from before-assignment (T0 - treadmill and T1 - 6min walk test) to T2 (3 months), and to T3 (six-months))
D: Change in Six-Minute Walk Performance at 9-month follow-up (change from baseline to month 9)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical Study on the Effect of Remote Ischemic Conditioning on Atrial Fibrillation and Outcome After Coronary Artery Bypass Grafting
Brief Summary: Recent studies indicate that remote ischemic conditioning can protect the heart and other organs during cardiac surgery. The investigators aim to investigate whether such a stimulus can reduce the incidence of atrial fibrillation or other complications following coronary artery bypass surgery.


Options:
A: Mitochondrial respiration (1 hour)
B: cognitive function (preoperative, 1 week and 6 months after surgery)
C: Composite structural and functional neurological outcome (7 days)
D: Post-operative atrial fibrillation (72 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Music-Based Multitask Exercises (Jaques-Dalcroze Eurhythmics) on Gait, Balance and Fall Risk in the Elderly
Brief Summary: The aim of this study is to investigate the effectiveness of a 6-month music-based multitask exercises program (Jaques-Dalcroze eurhythmics) in improving gait and balance, and reducing fall risk in community-dwelling older adults with an increased risk of falling.


Options:
A: Major Mobility Disability, Defined as Incapacity to Walk 400 Meters (Median 2.7 years/Average 2.6 years)
B: Change in gait variability (6 months)
C: Fall incidence, which is measured by monthly fall registration cards
D: Incidence of serious fall-related injuries and of all injurious falls including those leading to more moderate injuries (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Dose-Ranging And Efficacy Study of LY2439821 (An Anti-IL-17 Antibody) In Patients With Moderate-To-Severe Psoriasis
Brief Summary: The primary purpose for this study is to help answer the following research questions

* The safety of ixekizumab (LY2439821) and any side effects that might be associated with it.
* Whether ixekizumab can help participants with Psoriasis.
* How much ixekizumab should be given to participants.


Options:
A: Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index at Week 16 (Baseline to Week 16 (end of phase))
B: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Week 12); Percentage of PASI Improvement From Baseline to 12 Week Endpoint (Baseline to Week 12)
C: Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 (Baseline, Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Week 16); Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Week 52)
D: Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks (12 weeks); Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1 (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Dose-Ranging And Efficacy Study of LY2439821 (An Anti-IL-17 Antibody) In Patients With Moderate-To-Severe Psoriasis
Brief Summary: The primary purpose for this study is to help answer the following research questions

* The safety of ixekizumab (LY2439821) and any side effects that might be associated with it.
* Whether ixekizumab can help participants with Psoriasis.
* How much ixekizumab should be given to participants.


Options:
A: Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B) (Weeks 4, 8 12, and 16 (Period B)); Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B) (Weeks 4, 8, 12, and 16 (Period B)); Percentage of Participants Achieving a PASI75 Response During CP-690,550 Re-Treatment (Period C) Among Those Who Had a Greater Than (>)50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B) (Baseline and Weeks 4, 8, and 16 (Period C)); Percentage of Participants Achieving a PGA Response of Clear or Almost Clear During CP-690,550 Re-treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe During Double-Blind Treatment Withdrawal (Period B) (Baseline and Weeks 4, 8, and 16 (Period C))
B: Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12. (Week 12)
C: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Week 12); Percentage of PASI Improvement From Baseline to 12 Week Endpoint (Baseline to Week 12)
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: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Dose-Ranging And Efficacy Study of LY2439821 (An Anti-IL-17 Antibody) In Patients With Moderate-To-Severe Psoriasis
Brief Summary: The primary purpose for this study is to help answer the following research questions

* The safety of ixekizumab (LY2439821) and any side effects that might be associated with it.
* Whether ixekizumab can help participants with Psoriasis.
* How much ixekizumab should be given to participants.


Options:
A: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Week 12); Percentage of PASI Improvement From Baseline to 12 Week Endpoint (Baseline to Week 12)
B: Long-term Safety and Tolerability of Secukinumab (Week 268)
C: Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R (Week 16 of Period R)
D: The changes in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the carotid artery and ascending aorta in patients randomized to adalimumab as compared to patients randomized to standard non-systemic therapy. (Day -10 to -1, Day 105)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Dose-Ranging And Efficacy Study of LY2439821 (An Anti-IL-17 Antibody) In Patients With Moderate-To-Severe Psoriasis
Brief Summary: The primary purpose for this study is to help answer the following research questions

* The safety of ixekizumab (LY2439821) and any side effects that might be associated with it.
* Whether ixekizumab can help participants with Psoriasis.
* How much ixekizumab should be given to participants.


Options:
A: Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest (From Day 169 to Day 729); Short-term Period: Number of Participants With ACR 20 Response at Day 169 (At Day 169 from Baseline)
B: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) (Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A) (Week 16); Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B) (Week 44)
C: Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12 (Baseline and Week 12)
D: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Week 12); Percentage of PASI Improvement From Baseline to 12 Week Endpoint (Baseline to Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Dose-Ranging And Efficacy Study of LY2439821 (An Anti-IL-17 Antibody) In Patients With Moderate-To-Severe Psoriasis
Brief Summary: The primary purpose for this study is to help answer the following research questions

* The safety of ixekizumab (LY2439821) and any side effects that might be associated with it.
* Whether ixekizumab can help participants with Psoriasis.
* How much ixekizumab should be given to participants.


Options:
A: Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12 (Week 0 to Week 12)
B: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Week 12); Percentage of PASI Improvement From Baseline to 12 Week Endpoint (Baseline to Week 12)
C: Number of Participants Achieving a Greater Than or Equal to 75 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 (Baseline and Week 12)
D: Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Number of Participants With Treatment Emergent Adverse Events (3 months); Pharmacokinetics Parameter : Skin Flux of INCB018424 (Days 8, 15, 22, and 28); Pharmacokinetics Parameter : Bioavailability of INCB018424 (Days 8, 15, 22, and 28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention Project of Cerebrovascular Diseases and Dementia in the District of Ebersberg
Brief Summary: In Western Countries, stroke and dementia are the main causes of long-term disability, dependency, and nursing home admission. Due to demographic trends a continuous increase of patient numbers can be expected.

There is growing evidence that vascular risk factors which are implicated in the etiology of stroke also play important etiologic roles in both vascular dementia and Alzheimer disease. The present project is aimed at the reduction of stroke and dementia by means of a systematic detection and subsequent treatment of vascular risk factors by the family doctor based on established guidelines.


Options:
A: Incidence of long-term care disability (8 years); Incidence of stroke (8 Years)
B: N/A
C: Change in cognitive function at 36 months determined by a composite score (sum of Z-score of 4 tests: FCRST test (free recall + total recall) score, MMSE orientation score, Wais-R score (Digit Substitution Symbol test), and the Category Naming Test score (Baseline, 6, 12, 24, 36 months)
D: First Occurrence of a Severe Cardiovascular Event (up to 11 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Opinion Leaders to Improve Care After COPD or Asthma Emergency Department (ED) Visits.
Brief Summary: This study will enroll patients who present to Emergency Departments (EDs) and have an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD) or asthma at discharged in one Edmonton ED. Patients will all be provided with evidence-based discharge (prednisone and an antibiotic for COPD and prednisone and inhaled corticosteroids for asthma) and will be randomized to receive enhanced education to the primary care provider or standard care. The investigators' goal is to determine if an opinion leaders' advice will improve chronic care in these patients.


Options:
A: Proportion of CAPTURE+ Participants Who Meet a Composite Endpoint for Diagnosis and Management of COPD (Baseline to 12 months)
B: Follow-up with primary care provider (90 days)
C: COPD Assessment Test (CAT) (Baseline and 6 months)
D: The number of ED presentations (1 year after randomization.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients With Type 2 Diabetes
Brief Summary: The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications


Options:
A: Change From Baseline in Hemoglobin A1c (A1C) at Week 24 (Baseline, Week 24)
B: Percentage of Participants With Primary Major Adverse Cardiac Events (MACE) (From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).)
C: 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)
D: HbA1c Change From Baseline at Week 12 (Baseline and Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients With Type 2 Diabetes
Brief Summary: The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications


Options:
A: ß-cell Response Measured by Hyperglycemic Clamp (3-months after medication washout (Month 15)); M/I (3-months after a medication washout)
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: Mean Change From Baseline in Body Weight at Week 20 (Week 0, week 20)
D: Steady State Beta Cell Compensation (24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients With Type 2 Diabetes
Brief Summary: The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications


Options:
A: Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death. (Up to 38.2 months)
B: Change in left ventricular (LV) Mass by Cardiac MRI at 52 weeks (Baseline and 52 weeks)
C: Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) (From randomisation until completion of the planned treatment period, up to 1040 days.)
D: 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)

Answer: D