TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacokinetics and Dynamics in Patients Randomized to Once Daily Awakening and Sedated According to Standardized Algorithm
Brief Summary: Certain methods of sedation increase the duration of respiratory failure. Two strategies, a nursing- implemented sedation algorithm and daily interruption of sedatives, decrease length of mechanical ventilation compared to "conventional care" but have not been compared to each other. The reason certain methods of sedation lead to prolonged respiratory failure is unknown but may be related to altered pharmacokinetics and dynamics that are unique to critically ill patients. Critically ill patients receive substantial doses of sedatives over prolonged periods. The impact of these management strategies on short- and long-term psychiatric complications are unknown. The study seeks to test the central hypothesis that sedation practices impact strongly on outcome of respiratory failure and psychiatric complications. The three specific aims are (1) to compare two sedation strategies (protocol directed sedation and daily interruption of sedatives), (2) to examine the prevalence of psychiatric complications, and (3) to compute the pharmacokinetics of commonly used sedatives and narcotics.

These aims will be achieved by enrolling critically ill patients in a prospective randomized trial comparing the above mentioned sedation strategies, and assessing sedation level as well as delirium throughout the duration of respiratory failure. Sedative plasma levels will be measured, and pharmacokinetics computed. Psychiatric morbidity will be assessed by administration of validated questionnaires.


Options:
A: Time receiving mechanical ventilation, total intensive care and hospital length of stay.
B: Length of mechanical ventilation and ICU stay. Mortality
C: The percentage of time spent within the protocol specified sedation range (Richmond Agitation-Sedation Scale [RASS] range of -2 to +1) (Preinfusion, Treatment period: every 10min for 30min, 1 & 4 hr after infusion starts, every 4 hrs, prior to end of infusion & extubation. Follow-up Period (48hrs): every 10min for 1st 30min after drug discontinuation, 1, 4, 8,12, 24 & 48 hr post infusion)
D: achieving target sedation level (Patients will receive study drug for a maximum of 120 hours (5 days))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Increased Convective Clearance by On-line Hemodiafiltration on All Cause and Cardiovascular Mortality in Chronic Hemodialysis Patients: The Dutch Convective Transport Study (CONTRAST)
Brief Summary: The purpose of this study is to compare the effect of low flux hemodialysis with online hemodiafiltration on all cause mortality and a combination of cardiovascular morbidity and mortality in chronic hemodialysis patients.


Options:
A: all cause mortality (entire follow up (until dead or end of study, 1-7 years))
B: N-balances (20 days)
C: Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death) (Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years)
D: a composite of mortality with the change over 12 months in left ventricular mass (12 months); a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite. (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: International, Multi-center, Prospective, Double Randomized, Open Phase III Study Evaluating Thalidomide/Dexamethasone Versus Melphalan/Prednisone as Induction Therapy and Thalidomide/Interferon-alpha Versus Interferon-alpha as Maintenance Therapy in Newly Diagnosed Patients With Multiple Myeloma
Brief Summary: This is an international multi-center prospective, double randomized, open, controlled phase III study with a phase II entrance phase to compare the therapeutic efficacy of thalidomide plus dexamethasone to conventional melphalan plus prednisone in newly diagnosed myeloma patients.


Options:
A: Progression Free Survival (PFS) (From randomization until disease progression. Median follow-up time was 43 months.)
B: Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC) (From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months.); Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis (From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months)
C: Time to progression; Response rate
D: Number of Patients With Combined Complete Response and Very Good Partial Response (Up to 48 weeks or until disease progression)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The "EXTEND" Study: A Randomized, Double-blind, Parallel-group, Phase III b, Multi-centre Study Evaluating Extended Prophylactic Treatment With Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events in Patients Undergoing Elective Hip Replacement or Hip Fracture Surgery.
Brief Summary: This study is being carried out to study the efficacy and safety of treatment with melagatran injection followed by ximelagatran tablets in preventing blood clots, compared with enoxaparin for a period of 5-6 weeks. A separate visit, independent from the study will be done approximately 6 months after the surgery.


Options:
A: Non-inferiority for the prevention of VTE or VTE related death
B: Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes (Treatment period: up to day 35+/-6)
C: Rate of Adjudicated Venous Thromboembolic Event-related and All-cause Deaths With Onset During the Intended-treatment Period (Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study drug)
D: Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes (Treatment period : up to day 36+/-6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients
Brief Summary: The purpose of this study is to compare a combination asthma drug (Symbicort) with its two components, budesonide and formoterol, taken individually or in combination, and with placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)


Options:
A: Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE) (From the start of study drug up to 52 weeks)
B: Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours Post-dose at Day 168 (Baseline (BL) to Day 168); Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169 (Baseline to Day 169)
C: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
D: Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients
Brief Summary: The purpose of this study is to compare a combination asthma drug (Symbicort) with its two components, budesonide and formoterol, taken individually or in combination, and with placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)


Options:
A: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
B: Inflammation: localisation, numbers and profile of neutrophils, eosinophils, macrophages, and CD8+T cells in bronchial biopsy specimens after 6 months and 2.5 years treatment.
C: Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period
D: Post-study medication FEV1 (1 hour after medication)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients
Brief Summary: The purpose of this study is to compare a combination asthma drug (Symbicort) with its two components, budesonide and formoterol, taken individually or in combination, and with placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)


Options:
A: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
B: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)
C: All cause mortality at 3 years
D: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients
Brief Summary: The purpose of this study is to compare a combination asthma drug (Symbicort) with its two components, budesonide and formoterol, taken individually or in combination, and with placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)


Options:
A: Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12) (End of treatment (Week 12))
B: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
C: Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours Post-dose at Day 168 (Baseline (BL) to Day 168); Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169 (Baseline to Day 169)
D: Rate of moderate/severe exacerbations over a 52 week treatment period.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients
Brief Summary: The purpose of this study is to compare a combination asthma drug (Symbicort) with its two components, budesonide and formoterol, taken individually or in combination, and with placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)


Options:
A: Rate of moderate/severe exacerbations over a 52 week treatment period
B: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
C: Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours (h) Post-dose at Day 168 (Baseline (BL) to Day 168); Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169 (Baseline to Day 169)
D: Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients
Brief Summary: The purpose of this study is to compare a combination asthma drug (Symbicort) with its two components, budesonide and formoterol, taken individually or in combination, and with placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)


Options:
A: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
B: Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours (h) Post-dose at Day 168 (Baseline (BL) to Day 168); Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169 (Baseline to Day 169)
C: Inflammation: localisation, numbers and profile of neutrophils, eosinophils, macrophages, and CD8+T cells in bronchial biopsy specimens after 6 months and 2.5 years treatment.
D: Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date (From the date of randomization until date of death due to any cause (average of 2 study years))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients
Brief Summary: The purpose of this study is to compare a combination asthma drug (Symbicort) with its two components, budesonide and formoterol, taken individually or in combination, and with placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)


Options:
A: Eosinophils in induced sputum (as % of Total Cell Count), change from the start of the exacerbation to the end of 14 days treatment
B: Post-study medication FEV1 (1 hour after medication)
C: All cause mortality at 3 years
D: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients
Brief Summary: The purpose of this study is to compare a combination asthma drug (Symbicort) with its two components, budesonide and formoterol, taken individually or in combination, and with placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)


Options:
A: CRP (4 weeks)
B: Inflammation: localisation, numbers and profile of neutrophils, eosinophils, macrophages, and CD8+T cells in bronchial biopsy specimens after 6 months and 2.5 years treatment.
C: Identifying new patient subtypes and endpoints for COPD (3 years)
D: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy and Safety Study of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid Compared to Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD
Brief Summary: The purpose of this study is to compare Symbicort in a pressurized metered-dose inhaler (pMDI) with formoterol and placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).


Options:
A: Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period
B: Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE) (From the start of study drug up to 52 weeks)
C: Exercise Tolerance Comparison Between QVA149 and Placebo Groups (3 weeks)
D: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks) (1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Day 85); Trough FEV1 Response at Day 85 (12 Weeks) (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h and - 10 mins prior to study drug at Day 85.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy and Safety Study of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid Compared to Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD
Brief Summary: The purpose of this study is to compare Symbicort in a pressurized metered-dose inhaler (pMDI) with formoterol and placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).


Options:
A: All cause mortality at 3 years
B: Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period
C: Post-study medication FEV1 (1 hour after medication)
D: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy and Safety Study of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid Compared to Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD
Brief Summary: The purpose of this study is to compare Symbicort in a pressurized metered-dose inhaler (pMDI) with formoterol and placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).


Options:
A: Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment (after 12 weeks of treatment)
B: Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period
C: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))
D: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy and Safety Study of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid Compared to Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD
Brief Summary: The purpose of this study is to compare Symbicort in a pressurized metered-dose inhaler (pMDI) with formoterol and placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).


Options:
A: Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period
B: Forced Expiratory Volume in 1 Second (FEV1) Pre-dose (Baseline to 12 weeks)
C: AUC(0-6) FEV1 (Area under the curve of change in FEV1 from baseline to 6 hours post dose) (after 12 weeks of treatment)
D: Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period. (64 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy and Safety Study of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid Compared to Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD
Brief Summary: The purpose of this study is to compare Symbicort in a pressurized metered-dose inhaler (pMDI) with formoterol and placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).


Options:
A: Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours Post-dose at Day 168 (Baseline (BL) to Day 168); Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169 (Baseline to Day 169)
B: Pre-dose Forced Expiratory Volume in One Second (FEV1) (Before randomization, 0, 4, 8 and 12 weeks after randomization)
C: Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period
D: Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year (12 months); Rate of Exacerbations Per Subject-year (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy and Safety Study of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid Compared to Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD
Brief Summary: The purpose of this study is to compare Symbicort in a pressurized metered-dose inhaler (pMDI) with formoterol and placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).


Options:
A: All cause mortality at 3 years
B: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
C: Inflammation: localisation, numbers and profile of neutrophils, eosinophils, macrophages, and CD8+T cells in bronchial biopsy specimens after 6 months and 2.5 years treatment.
D: Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Controlled Rosuvastatin Multinational Study in Heart Failure CORONA A Randomized, Double-Blind, Placebo Controlled Phase III Study With Rosuvastatin in Subjects With Chronic Symptomatic Systolic Heart Failure
Brief Summary: The purpose of the study is to investigate if rosuvastatin, added on top of all other medicines prescribed to subjects with symptomatic systolic heart failure, reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction or non-fatal stroke (time to first event)


Options:
A: Endothelial Progenitor Cells (EPCs) Count (Cells/µl) (Postoperative 6th hours)
B: Post operative atrial fibrillation detected on continuous ECG monitoring. (Monitoring will commence soon after surgery and will be continued until the end of post operative day 5); Myocardial injury assessed by Troponin release (Serial blood samples for Troponin assay will be collected at 6, 24, 48 and 120 hours after surgery)
C: to evaluate whether 2 years of treatment with 40 mg rosuvastatin results in regression of coronary artery atheroma burden via the total atheroma volume in the most diseased segment or the percent atheroma volume, as measured by IVUS
D: The primary objective of this study is to determine whether rosuvastatin reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction (MI) or non-fatal stroke (time to first event).

Answer: D