TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The AMADEUS Trial, A Multicenter, Randomized, Open-label, Assessor Blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Idraparinux (SR34006) With Adjusted-dose Oral Vitamin-K Antagonists in the Prevention of Thromboembolic Events in Patients With Atrial Fibrillation
Brief Summary: This trial will include patients who have a heart condition called atrial fibrillation. Atrial fibrillation is an abnormal rhythm (irregular beat) in the heart. Patients with atrial fibrillation have an increased chance for a blood clot to form in the heart and move to other blood vessels in the body and cause obstruction. This obstruction may damage tissue. For example, a blood clot plugging a vessel in the brain could cause a stroke. Therefore, patients with atrial fibrillation may be given anticoagulant (blood-thinning) tablets such as warfarin or acenocoumarol.

The purpose of this study is to compare the safety and effectiveness of a new injectable anticoagulant drug that is administered once weekly, SR34006 with warfarin or acenocoumarol tablets.

Assignment to either SR34006 Injection or vitamin K antagonist (warfarin or acenocoumarol) tablets will be purely by chance and will be known by both patients and their doctors.


Options:
A: Composite of all strokes and non-CNS systemic embolism.
B: Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47 (Baseline to Day 47)
C: Primary Outcome based upon intent to treat: Composite outcome of (28 days); Ultrasound or venogram confirmed deep vein thrombosis. (28 days); Lung scan, pulmonary angiogram or CTA confirmed pulmonary embolus. (28 days); Death due to TED (28 days)
D: major bleeding (up to 48 hours from last injection)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The AMADEUS Trial, A Multicenter, Randomized, Open-label, Assessor Blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Idraparinux (SR34006) With Adjusted-dose Oral Vitamin-K Antagonists in the Prevention of Thromboembolic Events in Patients With Atrial Fibrillation
Brief Summary: This trial will include patients who have a heart condition called atrial fibrillation. Atrial fibrillation is an abnormal rhythm (irregular beat) in the heart. Patients with atrial fibrillation have an increased chance for a blood clot to form in the heart and move to other blood vessels in the body and cause obstruction. This obstruction may damage tissue. For example, a blood clot plugging a vessel in the brain could cause a stroke. Therefore, patients with atrial fibrillation may be given anticoagulant (blood-thinning) tablets such as warfarin or acenocoumarol.

The purpose of this study is to compare the safety and effectiveness of a new injectable anticoagulant drug that is administered once weekly, SR34006 with warfarin or acenocoumarol tablets.

Assignment to either SR34006 Injection or vitamin K antagonist (warfarin or acenocoumarol) tablets will be purely by chance and will be known by both patients and their doctors.


Options:
A: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)
B: Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period (First administration until 31-38 days)
C: Bleeding Events (36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)); Creatinine (12 weeks according to protocol.(baseline to week 12 visit)); Alanine Aminotransferase (ALAT) (36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)); Bilirubin (36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit))
D: Composite of all strokes and non-CNS systemic embolism.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The AMADEUS Trial, A Multicenter, Randomized, Open-label, Assessor Blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Idraparinux (SR34006) With Adjusted-dose Oral Vitamin-K Antagonists in the Prevention of Thromboembolic Events in Patients With Atrial Fibrillation
Brief Summary: This trial will include patients who have a heart condition called atrial fibrillation. Atrial fibrillation is an abnormal rhythm (irregular beat) in the heart. Patients with atrial fibrillation have an increased chance for a blood clot to form in the heart and move to other blood vessels in the body and cause obstruction. This obstruction may damage tissue. For example, a blood clot plugging a vessel in the brain could cause a stroke. Therefore, patients with atrial fibrillation may be given anticoagulant (blood-thinning) tablets such as warfarin or acenocoumarol.

The purpose of this study is to compare the safety and effectiveness of a new injectable anticoagulant drug that is administered once weekly, SR34006 with warfarin or acenocoumarol tablets.

Assignment to either SR34006 Injection or vitamin K antagonist (warfarin or acenocoumarol) tablets will be purely by chance and will be known by both patients and their doctors.


Options:
A: The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority) (Up to 4 years); The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority) (Up to 4 years); The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety (Up to 4 years)
B: Composite of all strokes and non-CNS systemic embolism.
C: Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period (Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy))
D: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clustered Trial for Improving Perinatal Care in Uruguay/Argentina
Brief Summary: Many obstetrical interventions used in Latin America, as in other parts of the world, have been shown to be ineffective or harmful, while effective interventions remain underutilized. This study will develop and evaluate an intervention intended to implement two evidence-based practices among birth attendants in Latin America, the selective use of episiotomies and active management of the third stage of labor.


Options:
A: Cardiac Medication Use (3 and 12 months)
B: Episiotomies; Oxytocin use in third stage of labor
C: Composite measure representing improvement in cholesterol-related secondary prevention consisting of (1) provision of a statin sample (2) provision of a statin prescription or (3) dosage increase of a statin within the first 6 months post-angiogram.
D: Bone mineral density (BMD) testing rates

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clustered Trial for Improving Perinatal Care in Uruguay/Argentina
Brief Summary: Many obstetrical interventions used in Latin America, as in other parts of the world, have been shown to be ineffective or harmful, while effective interventions remain underutilized. This study will develop and evaluate an intervention intended to implement two evidence-based practices among birth attendants in Latin America, the selective use of episiotomies and active management of the third stage of labor.


Options:
A: The outcome measure will be rate of patients falls per 1000 patient days (1/2009-6/2009)
B: Episiotomies; Oxytocin use in third stage of labor
C: Changes in a set of predefined quality indicators measuring appropriateness of prescriptions for elderly out-patients (1 year)
D: The primary outcome is the proportion of TB cases identified in primary care. The study is powered to detect a 20% increase (from 55% to 75%) in the detection of new cases of TB in primary care with 80% power at the 5% significance level.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clustered Trial for Improving Perinatal Care in Uruguay/Argentina
Brief Summary: Many obstetrical interventions used in Latin America, as in other parts of the world, have been shown to be ineffective or harmful, while effective interventions remain underutilized. This study will develop and evaluate an intervention intended to implement two evidence-based practices among birth attendants in Latin America, the selective use of episiotomies and active management of the third stage of labor.


Options:
A: Change From Baseline Antibiotic Consumption at 18 Months, in Primary Care (up to 18 months); Antibiotic Monthly Sales Data and Quality Indicators Monthly Prescribing Rates. (May 2012- September 2014)
B: General practitioners'adherence to treatment recommendations (3-6 months after end of intervention)
C: Proportion of febrile patients receiving treatment as recommended in clinical guidelines for uncomplicated malaria (As patients exit the health facility)
D: Episiotomies; Oxytocin use in third stage of labor

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Clustered Trial for Improving Perinatal Care in Uruguay/Argentina
Brief Summary: Many obstetrical interventions used in Latin America, as in other parts of the world, have been shown to be ineffective or harmful, while effective interventions remain underutilized. This study will develop and evaluate an intervention intended to implement two evidence-based practices among birth attendants in Latin America, the selective use of episiotomies and active management of the third stage of labor.


Options:
A: The following dependant variables were measured in this study;; Diabetes medical error in the 12 months post-intervention, Glycated hemoglobin (A1c) values and A1c test rates in the 12 months post-intervention, and; LDL-cholesterol levels and test rates in the 12 months post-intervention.
B: EFFECT AMI Composite Quality Indicator in the year after report cards published (April 1, 2004 - March 31, 2005); EFFECT CHF Composite Quality Indicator in the year after report cards published (April 1, 2004 - March 31, 2005)
C: Proportion of patients treated appropriately with respect to lipid-lowering therapy within four months after lipid testing (Measured at 2 years); Rate of appropriate treatment among patients with high blood pressure (Measured at 2 years)
D: Episiotomies; Oxytocin use in third stage of labor

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Clustered Trial for Improving Perinatal Care in Uruguay/Argentina
Brief Summary: Many obstetrical interventions used in Latin America, as in other parts of the world, have been shown to be ineffective or harmful, while effective interventions remain underutilized. This study will develop and evaluate an intervention intended to implement two evidence-based practices among birth attendants in Latin America, the selective use of episiotomies and active management of the third stage of labor.


Options:
A: Episiotomies; Oxytocin use in third stage of labor
B: The Primary Outcome is a Composite of the Following Three Clinical Outcomes: 1) Severe PPH Defined as Blood Loss ≥1000 ml or; 2) Postpartum Laparotomy for Bleeding or; 3) Postpartum Maternal Death From Bleeding. Please See Below for Further Details. (Postpartum until discharge from the health facility (up to 42 days))
C: Percentage of participants with AMI, coronary artery bypass graft, PCI or IVD, and who had documentation of used of aspirin or another antithrombotic during the measurement period. (Quarterly for 4 years); Percentage of participants with diagnosis of hypertension and whose blood pressure was adequately controlled (<140/90 mmHg) during the measurement period. (Quarterly for 4 years); Percentage of participants considered at high risk of cardiovascular events who were prescribed or were on a statin therapy during the measurement period. (Quarterly for 4 years); Percentage of participants who were screened for tobacco use and received cessation counseling intervention if identified as a tobacco user. (Quarterly for 4 years)
D: Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage (Baseline, Midline (6 months), Endline (12 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clustered Trial for Improving Perinatal Care in Uruguay/Argentina
Brief Summary: Many obstetrical interventions used in Latin America, as in other parts of the world, have been shown to be ineffective or harmful, while effective interventions remain underutilized. This study will develop and evaluate an intervention intended to implement two evidence-based practices among birth attendants in Latin America, the selective use of episiotomies and active management of the third stage of labor.


Options:
A: Episiotomies; Oxytocin use in third stage of labor
B: Cumulative Incidence of ART Initiation 14 Days After Clinical Eligibility in Treatment Eligible HIV-infected Patients (14 days)
C: glycemic control (All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians); lipid control (All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians)
D: The proportion of patients starting bisphosphonate treatment within 6 months of fracture (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clustered Trial for Improving Perinatal Care in Uruguay/Argentina
Brief Summary: Many obstetrical interventions used in Latin America, as in other parts of the world, have been shown to be ineffective or harmful, while effective interventions remain underutilized. This study will develop and evaluate an intervention intended to implement two evidence-based practices among birth attendants in Latin America, the selective use of episiotomies and active management of the third stage of labor.


Options:
A: The primary outcome is the proportion of TB cases identified in primary care. The study is powered to detect a 20% increase (from 55% to 75%) in the detection of new cases of TB in primary care with 80% power at the 5% significance level.
B: Changes in a set of predefined quality indicators measuring appropriateness of prescriptions for elderly out-patients (1 year)
C: Episiotomies; Oxytocin use in third stage of labor
D: The percentage of selected patients receiving anti-tabacco counseling recorded by the GPs in the labeled patients' medical records. (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clustered Trial for Improving Perinatal Care in Uruguay/Argentina
Brief Summary: Many obstetrical interventions used in Latin America, as in other parts of the world, have been shown to be ineffective or harmful, while effective interventions remain underutilized. This study will develop and evaluate an intervention intended to implement two evidence-based practices among birth attendants in Latin America, the selective use of episiotomies and active management of the third stage of labor.


Options:
A: The primary outcome measure will be the "improvement" of prescribing for efficacious therapies in patients with a chronic cardiovascular disease within six months of the intervention.
B: Episiotomies; Oxytocin use in third stage of labor
C: glycemic control (All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians); lipid control (All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians)
D: Composite measure representing improvement in cholesterol-related secondary prevention consisting of (1) provision of a statin sample (2) provision of a statin prescription or (3) dosage increase of a statin within the first 6 months post-angiogram.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS)
Brief Summary: The purpose of this study is to compare liberal red blood cell transfusion therapy with restrictive red blood cell transfusion therapy in surgical patients with cardiovascular disease or risk factors.


Options:
A: Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups. (60 days following randomisation)
B: Hemoglobin difference (14 days)
C: Timed Up and Go-test (TUG)in seconds. (30 days)
D: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS)
Brief Summary: The purpose of this study is to compare liberal red blood cell transfusion therapy with restrictive red blood cell transfusion therapy in surgical patients with cardiovascular disease or risk factors.


Options:
A: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
B: The incidence of explicit recall of events during the surgical and anesthetic periods. (Three years)
C: Prevalence of delirium at two weeks after admission; Activities of Daily Living (ADL) functional improvement two weeks after admission; Full ADL functional recovery to pre-illness status three months after post-acute admission
D: Incidence of Residual Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry (At PACU entry on Day 1)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS)
Brief Summary: The purpose of this study is to compare liberal red blood cell transfusion therapy with restrictive red blood cell transfusion therapy in surgical patients with cardiovascular disease or risk factors.


Options:
A: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
B: Postoperative Functional mobility; Restricting factors for functional mobility
C: The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS. (Through post-operative day 7, hospital discharge, or death, whichever occurs first)
D: Composite score of any one of the following: (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit (Up to hospital discharge or postoperative day 28 (whichever occurs first))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS)
Brief Summary: The purpose of this study is to compare liberal red blood cell transfusion therapy with restrictive red blood cell transfusion therapy in surgical patients with cardiovascular disease or risk factors.


Options:
A: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
B: postoperative delirium (2 MONTHS)
C: Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Enrollment (Enrollment was assessed after enrollment was completed.); Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Adherence (To be evaluated at the conclusion of the study. Adherence was assessed in 3 separate periods: pre hospital, in hospital, and post discharge (typically at the 4 week follow up clinic visit).)
D: Delirium (5 days); Subsyndromal delirium (5 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS)
Brief Summary: The purpose of this study is to compare liberal red blood cell transfusion therapy with restrictive red blood cell transfusion therapy in surgical patients with cardiovascular disease or risk factors.


Options:
A: Multiple Organ Failure (MOF) (Variable until 24h on ICU at the end of the IMP-administration)
B: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
C: Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects. (From administration of Haemocomplettan® P until 24 hours later)
D: Incidense of transfusion with allogenic blood products (During hospital stay or until 6 weeks postintervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS)
Brief Summary: The purpose of this study is to compare liberal red blood cell transfusion therapy with restrictive red blood cell transfusion therapy in surgical patients with cardiovascular disease or risk factors.


Options:
A: Hemoglobin difference (14 days)
B: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
C: Postoperative Functional mobility; Restricting factors for functional mobility
D: Occurrence of a composite endpoint (90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS)
Brief Summary: The purpose of this study is to compare liberal red blood cell transfusion therapy with restrictive red blood cell transfusion therapy in surgical patients with cardiovascular disease or risk factors.


Options:
A: Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups. (60 days following randomisation)
B: The primary purpose of this study is to compare clinical outcomes after cardiac surgery in patients submitted to different strategies of red blood cell transfusion (30 days after surgery)
C: Postoperative Functional mobility; Restricting factors for functional mobility
D: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS)
Brief Summary: The purpose of this study is to compare liberal red blood cell transfusion therapy with restrictive red blood cell transfusion therapy in surgical patients with cardiovascular disease or risk factors.


Options:
A: Adherence to the study protocol (up to 28 days)
B: Quality of Life (QOL)/Function based on the FACT-BMT scale (3 years)
C: Hemoglobin Concentration (In-hospital up to 30 days post randomization); Red Blood Cell Transfusion (In-hospital up to 30 days post randomization)
D: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)

Answer: D