TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Active-controlled, Parallel Group, Stratified, Multi-center, 12-Week Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™ 250/10ug Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI) With the Administration of Fluticasone (250ug Twice Daily) Alone in SkyePharma HFA pMDI and Flovent® HFA pMDI in Adolescent and Adult Patients With Moderate to Severe Asthma
Brief Summary: The medications being used in this study are individually approved by the Food and Drug Administration (FDA). The medication under investigation is a combination of two medications in one inhaler. The purpose of this study is to determine how well your asthma is controlled when taking one of the three treatment.


Options:
A: Change From Baseline in Evening (Post Meridiem [PM]) Forced Expiratory Volume in One Second (FEV1) Using Intent-to-Treat (ITT) Population (Baseline and Week 24); Change From Baseline in PM FEV1 Using Per Protocol (PP) Population (Baseline and Week 24)
B: To demonstrate the efficacy in terms of the Formoterol fumarate component of SKP FlutiForm HFA pMDI (250/10ug) compared to SKP Fluticasone HFA pMDI (250ug), on the change in FEV1 from morning pre-dose at Baseline (Week 0) to 2 hours post-dose at Week 12. (Week 0 and 12 visits)
C: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Trough FEV1 Response Determined After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984). (48 weeks)
D: Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period (Day 1 to Week 26 of the Treatment Period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: ACTIVE Dialysis - A Multicentre, Unblinded, Randomised, Controlled Trial to Assess Quality of Life, Clinical Outcomes and Cost Utility for Extended vs Standard Duration of Dialysis in Patients With End Stage Kidney Disease.
Brief Summary: This study will assess clinical outcomes of extended weekly hours of haemodialysis (\>= 24 hours per week) compared with standard hours of haemodialysis (\<=18 hours/week) in people with ESKD.


Options:
A: Sleep onset latency < 15 minutes; sleep efficiency > 85%; Normalized melatonin rhythm. Dim Light Melatonin Onset (DLMO) 21:00-23:00 hour
B: Bedtime (Mean Bedtimes over 21 days for each period)
C: The primary end-point for this study is the difference in the change in quality of life between the two groups from randomisation to the 12 month follow-up as measured by the EQ-5D instrument. (12 months from randomisation)
D: IRLS severity scale (24 and 48 wks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel Group Study Evaluating the Efficacy and Safety of Co-Administration of a Triple Combination Therapy of Olmesartan Medoxomil, Amlodipine Besylate and Hydrochlorothiazide in Subjects With Hypertension
Brief Summary: To determine the effectiveness of four different strength combinations of three approved anti-hypertension therapies (olmesartan medoxomil, amlodipine, and hydrochlorothiazide) for lowering blood pressure.


Options:
A: The rate of decline of glomerular filtration rate (GFR).GFR is measured at baseline,and at 6,12,18,24,30 and 36 months after randomization
B: Composite cardiovascular events including fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, admission due to heart failure, coronary intervention and sudden cardiac death (At least 3 years of mean follow up period)
C: Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP). (baseline to 12 weeks)
D: Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event (For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel Group Study Evaluating the Efficacy and Safety of Co-Administration of a Triple Combination Therapy of Olmesartan Medoxomil, Amlodipine Besylate and Hydrochlorothiazide in Subjects With Hypertension
Brief Summary: To determine the effectiveness of four different strength combinations of three approved anti-hypertension therapies (olmesartan medoxomil, amlodipine, and hydrochlorothiazide) for lowering blood pressure.


Options:
A: Reduction of the Estimated 10-year Total Cardiovascular Risk Score (Six months)
B: Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12 (Baseline, Month 12)
C: Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP). (baseline to 12 weeks)
D: Major Cardiovascular Events (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel Group Study Evaluating the Efficacy and Safety of Co-Administration of a Triple Combination Therapy of Olmesartan Medoxomil, Amlodipine Besylate and Hydrochlorothiazide in Subjects With Hypertension
Brief Summary: To determine the effectiveness of four different strength combinations of three approved anti-hypertension therapies (olmesartan medoxomil, amlodipine, and hydrochlorothiazide) for lowering blood pressure.


Options:
A: The rate of decline of glomerular filtration rate (GFR).GFR is measured at baseline,and at 6,12,18,24,30 and 36 months after randomization
B: A composite of fatal and non-fatal cardiovascular events: Cerebrovascular events (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, stroke of undetermined etiology and transient ischemic attack) (36 Months); Coronary events (sudden death, myocardial infarction, angina pectoris, asymptomatic myocardial ischemia) (36 Months); Heart failure (36 Months); Vascular events (aortic aneurysm, aortic dissection, and arteriosclerotic diseases) (36 Months); Diabetic complications (nephropathy, retinopathy and neuropathy) (36 Months); Renal dysfunction (doubling of serum creatinine, end stage renal diseases) (36 Months); All cause mortality (36 Months)
C: Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event (For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]))
D: Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP). (baseline to 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Messages to Increase Eye Examination Behavior
Brief Summary: The purpose of this project is to test two different types of health messages, one that is developed for a specific group (targeted) and the other that is more personalized to individuals (tailored), to see which is better at changing how often people have their eyes examined. We hypothesize that people who get the tailored messages will be more likely to get a dilated eye exam than people who receive the targeted messages.


Options:
A: Pt. 1 Dilated Fundus Exam (DFE) (6-month follow-up assessment)
B: The proportion of subjects who fail to attend at least one outpatient adult endocrinology visit during the second year after transition to adult diabetes care. (30 months)
C: doctor-confirmed dilated eye examination (3 and 6 months)
D: Proportion of Participants that Receive Annual Eye Exam (Baseline; Change from Baseline at 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years (number of follow-up exams depends on number of years enrolled in the study))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prednisone, Azathioprine, and N-acetylcysteine: A Study That Evaluates Response in IPF
Brief Summary: Idiopathic pulmonary fibrosis (IPF) is a long-term lung disease that affects an individual's ability to breathe. In this randomized, double-blind, placebo-controlled trial, we assigned patients with idiopathic pulmonary fibrosis who had mild-to-moderate lung-function impairment to one of three groups - receiving a combination of prednisone, azathioprine, and NAC (combination therapy), NAC alone, or placebo - in a 1:1:1 ratio.


Options:
A: Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52 (52 weeks)
B: Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value (Measured at study Baseline and Months 3, 6, 12, 15, 18, 21, and 24)
C: Absolute Change in Percent Predicted Forced Vital Capacity (FVC) (From baseline up to 72 weeks)
D: Overall Change in Forced Vital Capacity (Measured as the estimated change from baseline to Week 60)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Sitagliptin Plus Granulocyte-colony Stimulating Factor in Patients Suffering From Acute Myocardial Infarction
Brief Summary: Trial design:

This Phase III, investigator-driven, randomised, placebo-controlled efficacy and safety study will compare the effects of Sitagliptin in combination with granulocyte-colony stimulating factor (Lenograstim, G-CSF) on the improvement of myocardial function in patients undergoing routine percutaneous coronary revascularisation for acute myocardial infarction (time from onset of infarction to intervention 2 to 24 hours). The primary objective of this study is to compare between a treatment of G-CSF plus Sitagliptin, (G-CSF/Sitagliptin treatment group, n=87) versus Placebo (control treatment group, n=87) in change of global myocardial function from baseline to 6 months of follow-up.


Options:
A: Change in left ventricular (LV) Mass by Cardiac MRI at 52 weeks (Baseline and 52 weeks)
B: Confirmed Clinical Neuropathy (CCN) (18 Months)
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: Primary Efficacy Outcome MACE Events (Time to first event. Information collected during study period (anticipated to be up to 7.5 years).); Primary Safety Outcome MACE Events (Time to first event. Information collected during study period (anticipated to be up to 7.5 years).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical and Genomic Responses to Open Heart Surgery: A Randomized Controlled Trial of the Effects of Remote Ischemic Preconditioning
Brief Summary: This study will be the first large scale randomized study of remote ischemic preconditioning (RIPC) ever performed and will define the role of this novel therapy as a clinical tool. This study will also be the first to define preoperative gene expression profiles associated with poor postoperative outcomes in a control (SHAM) population of children undergoing cardiac surgery. Finally, the role of RIPC in modifying these gene expression profiles will be examined. Therefore, mechanistic insight into the proven ability of RIPC to improve markers of tissue injury, and the expected improvement in clinically relevant endpoints, will be examined.


Options:
A: troponin level (within the 1 day after operation)
B: Impact of RIPC on length of hospital stay. (Assessed through post-operative hospitalization.)
C: Exercise performance - VO2, exercise time, exercise workload, anaerobic threshold (1 week)
D: Myocardial injury after PCI. (24 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II-III Randomized Trial Pemetrexed-Cisplatin Chemotherapy With or Without Bevacizumab (Avastin), 15 mg/kg, for Malignant Pleural Mesothelioma (MPM)
Brief Summary: Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of MPM will improve overall survival and quality of life beyond that achieved with chemotherapy alone.


Options:
A: % of patients with controled disease (responder and stable patients) at 6 months (3-month)
B: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0) in Participants With Solid Tumors (Parts A and A1) (Up to 28 days in Cycle 1); Number of Participants Who Experienced an Adverse Event (AE) (Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018)); Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Integrated Radiology and Oncology (IRO): Melanoma Participants (Parts B Plus D) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)); ORR According to RECIST 1.1 as Assessed by Independent Review Committee (IRC): Non-Small Cell Lung Cancer (NSCLC) Participants (Parts C Plus F) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015))
C: Effects on Overall Survival (Minimum follow-up is 24 months after randomisation.)
D: Survival (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II-III Randomized Trial Pemetrexed-Cisplatin Chemotherapy With or Without Bevacizumab (Avastin), 15 mg/kg, for Malignant Pleural Mesothelioma (MPM)
Brief Summary: Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of MPM will improve overall survival and quality of life beyond that achieved with chemotherapy alone.


Options:
A: Feasibility in terms of 90-day progression-free survival
B: % of patients with controled disease (responder and stable patients) at 6 months (3-month)
C: To determine the objective response (Weeks 24)
D: Complete macroscopic resection (part 1) (After surgery (15 weeks after trial registration)); Loco-regional relapse-free survival (part 2) (From surgery until the first occurrence of loco-regional relapse)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery
Brief Summary: The primary purpose of this study is to determine the best blood level to begin transfusing red blood cells in individuals undergoing cardiac surgery.

The secondary aim is to determine the impact of red cell transfusion on health-related quality of life following surgery.


Options:
A: Recruitment: screening (One year); Recruitment: consent (One year); Recruitment: enrolment (One year)
B: Incidence of death or major neurodevelopmental impairment (24 months of age corrected for prematurity)
C: A Composite of In-hospital Postoperative Morbidity and Mortality (After surgery until hosptal discharge)
D: To compare mortality between groups 28 day after ICU admission (28 days after ICU admission)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery
Brief Summary: The primary purpose of this study is to determine the best blood level to begin transfusing red blood cells in individuals undergoing cardiac surgery.

The secondary aim is to determine the impact of red cell transfusion on health-related quality of life following surgery.


Options:
A: A Composite of In-hospital Postoperative Morbidity and Mortality (After surgery until hosptal discharge)
B: Postoperative Functional mobility; Restricting factors for functional mobility
C: Randomization Rate (12 months)
D: Occurrence of a composite endpoint (90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery
Brief Summary: The primary purpose of this study is to determine the best blood level to begin transfusing red blood cells in individuals undergoing cardiac surgery.

The secondary aim is to determine the impact of red cell transfusion on health-related quality of life following surgery.


Options:
A: A Composite of In-hospital Postoperative Morbidity and Mortality (After surgery until hosptal discharge)
B: In-hospital death (In-hospital); Recurrent myocardial infarction (MI) (In-hospital); New or worsening heart failure (In-hospital)
C: Total Number of Units Transfused (From randomization until discharge from admission for delivery, an average of 2-3 days)
D: Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction (Within 30 days of randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12 Week Randomized, Double-blind, Double-Dummy, Placebo-controlled Trial of Symbicort TM (160/4.5mcg) Versus Its Mono-Products (Budesonide and Formoterol) in Children (at Least 6years of Age) and Adults With Asthma-SPRUCE 80/4.5
Brief Summary: The purpose of this study is to compare Symbicort with its monocomponents budesonide and formoterol in the treatment of asthma in children and adults


Options:
A: The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. (The last 12 weeks of each 14-week treatment period)
B: Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period (Baseline and Week 24); Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 24 (Baseline and Week 24)
C: Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) (Up to 27 weeks); Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation (Up to 26 weeks)
D: 12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation (FEV1: before start of tretment and at 2 and 12 weeks after start of treatment. Withdrawals: throughout the treatment period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52 wk Randomized, Doubleblind, Single Dummy, Parallel Group Multicenter Phase 3 Study Comparing the Long Term Safety of Symbicort pMDI 4x160/4.5mcg Bid to SymbicortpMDI 2x160/4.5mcg Bid & Budesonide HFA pMDI 4x160mcg Bid in Adult and Adolescent Subjects With Asthma
Brief Summary: The purpose of this study is to compare the long term safety of Symbicort with budesonide alone, in adolescents and adults with asthma.


Options:
A: Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments. (7 assessments within 12 month treatment period)
B: Standardized Baseline-Adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time Zero to 12 Hours Postdose (FEV1 AUEC0-12h) at Week 12 (Day 1 (predose, baseline), Week 12 and was performed at the following times relative to the administration of study drug (±5 minutes): 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, and 12 hours); Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 1 (predose, baseline), Week 12)
C: Trough Forced Expiratory Volume in One Second (Trough FEV1) at Week 26 (26 weeks)
D: Pre-dose FEV1 (Forced Expiratory Volume in the first second) (Week 26); Reduction of moderate and severe asthma exacerbations rate (Week 0 to Week 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12 Week, Randomized, Double-blind, Double-dummy, Placebo-controlled Trial of Symbicort TM (160/4.5mcg) Versus Its Mono-products (Budesonide and Formoterol) in Adolescents (at Least 12 Years of Age) and Adults With Asthma - SPRUCE 160/4.5
Brief Summary: The purpose of this study is to compare Symbicort with budesonide alone and with formoterol alone in the treatment of asthma in adolescents and adults


Options:
A: 12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation (FEV1: before start of tretment and at 2 and 12 weeks after start of treatment. Withdrawals: throughout the treatment period)
B: FEV1, (Forced expiratory volume in the 1st second).
C: Pre-dose morning PEF (End of treatment)
D: Change in Forced Expiratory Volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy (Week 0 and 12 visits)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Test Treat Strategy to Prevent Ulcerative Colitis Relapse
Brief Summary: The proposed study will test whether increasing Lialda dose can reduce fecal calprotectin (FCP) levels, a marker of intestinal inflammation that is highly predictive of the risk of relapse among patients with quiescent ulcerative colitis. Sixty patients with FCP levels \<50µg/g stool will be observed for 48 weeks. All patients will have FCP concentration measured using a commercially available assay at enrollment, 6 weeks and 12 weeks. All patients with persistently elevated FCP will receive one or both of the following interventions: change in the mesalamine formulation to Lialda and/or increase in the dose of Lialda. Reduction in FCP levels below 50µg/g stool 6 weeks after randomization will be the primary outcome. The proportion of patients achieving this outcome will be compared between groups using Fisher's exact test. All randomized patients as well as those who were excluded from the randomized trial because of a low FCP concentration at baseline will be followed to week 48 to determine the rate of clinical relapse.


Options:
A: Fecal Calprotectin Level <50µg/g (6 weeks after randomization)
B: Rate of non-emergence of bloody stool (Week 48)
C: Treatment emergent adverse events (Throughout the study period of approximately 2 year, 4 months)
D: Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI) (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Antidepressant Augmentation With Lamotrigine in Patients With Treatment-Resistant Depression
Brief Summary: This study reports a clinical trial evaluating lamotrigine safety and efficacy as an antidepressant augmentation agent in treatment resistant depression, therefore adding more empirical evidence to the limited number of studies on the use of lamotrigine.


Options:
A: Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period (Baseline (Week 8)); Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in the Double-Blind Period (Baseline (Week 8) to Week 16)
B: Time to premature discontinuation
C: MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate (12 weeks)
D: Montgomery and Asberg Scale for Depression (8 weeks)

Answer: D