TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Heart Outcomes Prevention Evaluation-3
Brief Summary: Heart disease and stroke are major causes of death and disability worldwide and are largely preventable. Cholesterol and blood pressure are major cardiovascular risk factors. Previous studies have shown that certain drugs can effectively and safely lower cholesterol and blood pressure and prevent heart attacks and strokes. Such studies have been conducted primarily in people who had already sustained a heart attack or a stroke, or in people with high cholesterol and blood pressure levels. However, most heart attacks and strokes occur in people with average ("normal") cholesterol and blood pressure. Therefore, in the HOPE-3 trial the investigators will evaluate whether a cholesterol lowering drug, rosuvastatin, and a combination blood pressure lowering pill, candesartan/hydrochlorothiazide, used alone or together can reduce the risk of heart attacks, stroke and their sequelae in people without known heart disease and at average risk.


Options:
A: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) (time since randomization; follow-up period is 1.5 to 4.4 years); Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) (time since randomization; follow-up period is 1.5 to 4.4 years)
B: Renal Composite Outcomes (Randomization to 5 years)
C: The composite of; Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke. (Biannually); The composite of; cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, heart failure, arterial revascularizations (Biannually)
D: Time to the first occurrence of microalbuminuria defined as excretion of greater than 35 mg albumin/g urine creatinine for women and greater than 25 mg albumin/g urine creatinine for men in morning spot urine (Time to the first occurrence)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Heart Outcomes Prevention Evaluation-3
Brief Summary: Heart disease and stroke are major causes of death and disability worldwide and are largely preventable. Cholesterol and blood pressure are major cardiovascular risk factors. Previous studies have shown that certain drugs can effectively and safely lower cholesterol and blood pressure and prevent heart attacks and strokes. Such studies have been conducted primarily in people who had already sustained a heart attack or a stroke, or in people with high cholesterol and blood pressure levels. However, most heart attacks and strokes occur in people with average ("normal") cholesterol and blood pressure. Therefore, in the HOPE-3 trial the investigators will evaluate whether a cholesterol lowering drug, rosuvastatin, and a combination blood pressure lowering pill, candesartan/hydrochlorothiazide, used alone or together can reduce the risk of heart attacks, stroke and their sequelae in people without known heart disease and at average risk.


Options:
A: Incidence of hypertension, by blood pressure ≥ 140/90 mmHg in individuals without diabetes or ≥ 135/85 mmHg in participants with diabetes. (18 months); Adverse events. (18 months); Development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG (18 months)
B: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)
C: stroke; new or recurrent transient ischemic attack; new or recurrent acute myocardial infarction; new occurrence or exacerbation of heart failure; new occurrence or exacerbation angina pectoris; dissecting aneurysm of the aorta; lower limb arterial obstruction; transition to dialysis; doubling of plasma creatinine (Cr) levels
D: The composite of; Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke. (Biannually); The composite of; cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, heart failure, arterial revascularizations (Biannually)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, 14 Day Repeat Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Extra-pulmonary Pharmacodynamics of Inhaled Doses of GW642444M Formulated With Magnesium Stearate in Healthy Subjects
Brief Summary: GW642444 (the study medicine) is a new experimental medicine for treating asthma and chronic obstructive pulmonary disease (COPD). People with asthma and COPD suffer from breathlessness because the small tubes (bronchioles) that carry air in and out of the lungs become narrow. We hope that the study medicine will work by relaxing the muscles in the airways and help to keep the airways open, and make breathing easier. The study medicine might improve on available treatments by having fewer side-effects, and by working faster and for longer, so that patients could take it once daily, instead of twice daily.

When a medicine is made into a form ready to be given to patients, inactive ingredients are often added. Inactive ingredients might be used to help a medicine work better, to make it easier to produce the medicine, or to make it easier to get an accurate dose of medicine. In this study, the study medicine contains the inactive ingredient magnesium stearate.

We need to check that the study medicine doesn't cause problems when inhaled along with magnesium stearate. So, we're doing this study in healthy people to find out the answers to these questions.

1)Do repeated once-daily doses of the study medicine cause any important side effects when inhaled, along with magnesium stearate, as a fine powder? 2)How much of the study medicine gets into the bloodstream and how long does the body take to get rid of it?


Options:
A: Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 (Baseline and Week 8)
B: Safety：adverse events, vital sign, ECGs, and clinical laboratory test; PK：Cmax, tmax and AUC(0-t)
C: Mean Change From Baseline (BL) in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period (Baseline and Weeks 1-12 (up to Day 84))
D: General safety and tolerability as measured by ECG, blood pressure, pulse rate and blood and urine tests. Repeated measures on Day 1, 7 and 14 (Repeated measures on Day 1, 7 and 14)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Comparative Study on Effects of Immunosuppression on HCV Recurrence After Living Donor Liver Transplantation - Comparison Between Tacrolimus + MMF and Tacrolimus + Steroid
Brief Summary: The aim of this study is to compare immunosuppression protocol of tacrolimus + MMF with that of tacrolimus + steroid for preventing recurrence of hepatitis C after living donor liver transplantation.


Options:
A: Incidence Rate of Composite Efficacy Failure From Randomization to Month 12 (Randomization to Month 12)
B: Estimated Glomerular Filtration Rate (GFR) (month 12)
C: Proportion of patients who can significantly decrease the doses of tacrolimus 1 year after transplantation (as defined by: tacrolimus administered on alternate days, or daily with trough levels below 5 ng/mL. (1 year)
D: Event-free survival time at the end of first year after living liver transplantation. (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Intra-Aortic Balloon Counterpulsation in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock - The Prospective, Randomised IABP SHOCK Trial for Attenuation of Multi-Organ Dysfunction Syndrome
Brief Summary: The role of intra aortic balloon counterpulsation in patients experiencing acute myocardial infarction with shock is not established. We hypothesised that use of such a device would lead to improved outcomes in these patients.


Options:
A: Mortality (30-days)
B: Efficacy: Changes in regional contractility measured as wall-motion score index, proBNP and clinical symptoms. (At 5 days)
C: Length of ICU stay (two weeks)
D: APACHE II SCORE (4 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Intra-Aortic Balloon Counterpulsation in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock - The Prospective, Randomised IABP SHOCK Trial for Attenuation of Multi-Organ Dysfunction Syndrome
Brief Summary: The role of intra aortic balloon counterpulsation in patients experiencing acute myocardial infarction with shock is not established. We hypothesised that use of such a device would lead to improved outcomes in these patients.


Options:
A: APACHE II SCORE (4 days)
B: Major Adverse Cardiac and Cerebrovascular Events (Hospital discharge or 28 days following PCI, whichever occurs sooner)
C: death, myocardial infarction or refractory (up to and including Day 9); major bleeding (Up to Day 9)
D: 30-day mortality (30 day)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Tetracycline (Doxycycline) In Patients With Large Acute Myocardial Infarction TO Prevent Left Ventricular Remodeling. TIPTOP Study
Brief Summary: The aim of the study is to assess the efficacy of an antibiotic treatment with tetracycline (doxycycline) in the early stage of large reperfused acute myocardial infarction (AMI), in preventing left ventricular (LV) remodeling.


Options:
A: Reduction of LV dilation (six months versus baseline LV end-diastolic volume index by 2D-echocardiogram [echo]) more than 50% in the treated group in comparison to the placebo group (6 months)
B: Angiographic restenosis (6 months)
C: Composite consisting of: death regardless of cause; non-fatal AMI or; unstable angina pectoris whichever occurred first
D: biochemical markers of brain ischemia and intraoperative cerebral oxymetry data (September 2010)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Inspiratory Muscle Training on Inspiratory Capacity in Patients
Brief Summary: Hypothesis:benefits of inspiratory muscle strenght training with Respifit S decreases symptoms, disability or handicap of patients affected by COPD. The inspiratory fraction (inspiratory capacity IC/ total lung capacity TLC)may be functionally more representative than other traditional indices.


Options:
A: Recruitment (4 months)
B: 6-Minute Walking Distance (Baseline and 8 weeks follow-up)
C: respiratory muscle strength measurements (baseline and 8 weeks)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Study of Irinotecan Plus 5-fluorouracil Plus Leucovorin and Bevacizumab (FOLFIRI+Avastin) Versus Irinotecan Plus Capecitabine and Bevacizumab (XELIRI+Avastin) as 1st Line Treatment of Locally Advanced or Metastatic Colorectal Cancer
Brief Summary: This phase III study will compare two combinations of irinotecan, Folfiri versus Xeliri, with the addition of Avastin as 1st line treatment of colorectal cancer.


Options:
A: Overall survival (Assessed until 1.5 years after the last patient enrolment)
B: Time To Progression (1 year)
C: Overall Survival: Time From Randomization to Death From Any Cause (within 6.5 years)
D: Overall Survival (OS) (Randomization to Date of Death from Any Cause Up to 39.36 Months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Empiric Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis: A Randomized Controlled Trial in Subjects Co-Infected With Helminths and Leishmania Brasiliensis
Brief Summary: The purpose of this project is to investigate the efficacy of early, empiric anti-helminthic therapy combined with standard pentavalent antimony in the treatment of subjects co-infected with helminths and cutaneous leishmaniasis caused by L. brasiliensis. The study hypothesis is that early intervention with antihelminthic therapy will improve response rates to antimony in subjects with cutaneous leishmaniasis.


Options:
A: Bidirectional measurements will be taken of the subjects' lesions at each visit and will be categorized as active or healed by a dermatologist. (90 days)
B: Prevalence of hookworm in community members (Endline survey conducted, approximately 24 months after starting the intervention)
C: Mean (± standard deviation) weight gain (kg) (from 12 to 24 months of age)
D: CD4 count (every 6 months for 24 months (enrollment and months 6, 12, 18, and 24 )); HIV-1 RNA level (enrollment, 12, and 24 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Empiric Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis: A Randomized Controlled Trial in Subjects Co-Infected With Helminths and Leishmania Brasiliensis
Brief Summary: The purpose of this project is to investigate the efficacy of early, empiric anti-helminthic therapy combined with standard pentavalent antimony in the treatment of subjects co-infected with helminths and cutaneous leishmaniasis caused by L. brasiliensis. The study hypothesis is that early intervention with antihelminthic therapy will improve response rates to antimony in subjects with cutaneous leishmaniasis.


Options:
A: Bidirectional measurements will be taken of the subjects' lesions at each visit and will be categorized as active or healed by a dermatologist. (90 days)
B: Proportion and severity of local adverse events of Anfoleish or Vehicle when applied three or two times per day. (At the end of treatment (Day 28)); Clinical cure rates in two regimens of Anfoleish: Three times a day and Two times a day (Day 90)
C: Effectiveness of meglumine antimoniate treatment (6 years)
D: Complete reepithelization (three months after the beginning of the treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Exercise Training After Percutaneous Coronary Intervention
Brief Summary: The Efector study is an open, randomized and controlled trial assessing the effect of regular exercise training on endothelial function, inflammatory markers, progression of disease, heart rate variability and mental health in patients who have been successfully treated with percutaneous coronary intervention and stent implantation for angina pectoris.


Options:
A: Cardiorespiratory Fitness (Change from Baseline in Cardiorespiratory Fitness at 8 weeks of Cardiac Rehabilitation Home-based Program); Blood tests (Change from Baseline in blood tests at 8 weeks of Cardiac Rehabilitation Home-based Program); Computerized axial tomography (Change from Baseline in Computerized axial tomography at 8 weeks of Cardiac Rehabilitation Home-based Program)
B: Change from baseline aerobic exercise capacity (watts) at 4 months (4 months)
C: Proportion of Patients With Hospital Length of Stay Greater Than 7 Days. (Post-surgery (approximately 9 weeks after baseline))
D: flow mediated dilation, serum concentrations of biomarkers, restenosis-rate/ late luminal loss, heart rate variability in SDNN (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Exercise Training After Percutaneous Coronary Intervention
Brief Summary: The Efector study is an open, randomized and controlled trial assessing the effect of regular exercise training on endothelial function, inflammatory markers, progression of disease, heart rate variability and mental health in patients who have been successfully treated with percutaneous coronary intervention and stent implantation for angina pectoris.


Options:
A: Maximal oxygen consumption (At baseline and after 6 months)
B: cardiovascular mortality; non fatal re-MI; angina requiring hospitalization; urgent revascularization procedures; hospitalization for heart failure; non fatal stroke
C: Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period (0, 12 and 52 weeks)
D: flow mediated dilation, serum concentrations of biomarkers, restenosis-rate/ late luminal loss, heart rate variability in SDNN (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise Diet and Sex Hormones in Postmenopausal Women (NEW)
Brief Summary: RATIONALE: A low-calorie diet and/or exercise program may help lower an overweight or obese postmenopausal woman's risk of developing breast cancer. It is not yet known whether a low-calorie diet and/or exercise program are more effective than no diet or exercise program in lowering an overweight or obese postmenopausal woman's risk of developing breast cancer.

PURPOSE: This randomized clinical trial is studying the effect of a low-calorie diet and/or exercise program on risk factors for developing breast cancer compared with no diet or exercise program in overweight or obese postmenopausal women.


Options:
A: Change in Body Weight (Change from baseline weight to weeks 6, 10, 16, 20, 24.)
B: N/A
C: Serum estrone concentrations as measured by radioimmunoassay (At baseline and 12 months timepoint)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise Diet and Sex Hormones in Postmenopausal Women (NEW)
Brief Summary: RATIONALE: A low-calorie diet and/or exercise program may help lower an overweight or obese postmenopausal woman's risk of developing breast cancer. It is not yet known whether a low-calorie diet and/or exercise program are more effective than no diet or exercise program in lowering an overweight or obese postmenopausal woman's risk of developing breast cancer.

PURPOSE: This randomized clinical trial is studying the effect of a low-calorie diet and/or exercise program on risk factors for developing breast cancer compared with no diet or exercise program in overweight or obese postmenopausal women.


Options:
A: Change in Body Weight (Change from baseline weight to weeks 6, 10, 16, 20, 24.)
B: Weight change (0, 3, 6 months)
C: N/A
D: Serum estrone concentrations as measured by radioimmunoassay (At baseline and 12 months timepoint)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Transfusion Triggers in Cardiac Surgery
Brief Summary: A high proportion of patients having cardiac surgery receive red cell transfusions. Yet, the investigators do not know whether transfusions are beneficial and they may be associated with harm. It is thus important to determine when a transfusion is required. The investigators will conduct a small pilot study at St. Michael's Hospital to address this issue. Patients having cardiac surgery will be allocated to one of two transfusion strategies with endpoints being compliance with the transfusion strategy and clinical outcome. The results of this study will be used to design a large definitive multicentered trial of these two transfusion strategies.


Options:
A: Overall adherence to the transfusion strategies defined as adherence to the transfusion strategies in 90% of patients in more than 90% of their days in hospital. (Day of surgery through to hospital discharge.)
B: FACT-G, FACT-An, Numeric Rating Scale on symptoms of anaemia, Performance status (Before each cylces of chemotherapy in up to six months, and before transfusion, and daily in seven days after transfusion)
C: Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction (Within 30 days of randomization)
D: Mean Post-operative hemoglobin (longitudinal outcome) (Day 0 - 15)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Transfusion Triggers in Cardiac Surgery
Brief Summary: A high proportion of patients having cardiac surgery receive red cell transfusions. Yet, the investigators do not know whether transfusions are beneficial and they may be associated with harm. It is thus important to determine when a transfusion is required. The investigators will conduct a small pilot study at St. Michael's Hospital to address this issue. Patients having cardiac surgery will be allocated to one of two transfusion strategies with endpoints being compliance with the transfusion strategy and clinical outcome. The results of this study will be used to design a large definitive multicentered trial of these two transfusion strategies.


Options:
A: Cost-effectiveness ratio at 30 days (30 days)
B: Timed Up and Go-test (TUG)in seconds. (30 days)
C: Tolerance of low transfusion threshold as assessed by the percentage of participants who crossed over from the low arm to the high arm. (60 days)
D: Overall adherence to the transfusion strategies defined as adherence to the transfusion strategies in 90% of patients in more than 90% of their days in hospital. (Day of surgery through to hospital discharge.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Transfusion Triggers in Cardiac Surgery
Brief Summary: A high proportion of patients having cardiac surgery receive red cell transfusions. Yet, the investigators do not know whether transfusions are beneficial and they may be associated with harm. It is thus important to determine when a transfusion is required. The investigators will conduct a small pilot study at St. Michael's Hospital to address this issue. Patients having cardiac surgery will be allocated to one of two transfusion strategies with endpoints being compliance with the transfusion strategy and clinical outcome. The results of this study will be used to design a large definitive multicentered trial of these two transfusion strategies.


Options:
A: Overall adherence to the transfusion strategies defined as adherence to the transfusion strategies in 90% of patients in more than 90% of their days in hospital. (Day of surgery through to hospital discharge.)
B: To compare mortality between groups 28 day after ICU admission (28 days after ICU admission)
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: 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: Transfusion Triggers in Cardiac Surgery
Brief Summary: A high proportion of patients having cardiac surgery receive red cell transfusions. Yet, the investigators do not know whether transfusions are beneficial and they may be associated with harm. It is thus important to determine when a transfusion is required. The investigators will conduct a small pilot study at St. Michael's Hospital to address this issue. Patients having cardiac surgery will be allocated to one of two transfusion strategies with endpoints being compliance with the transfusion strategy and clinical outcome. The results of this study will be used to design a large definitive multicentered trial of these two transfusion strategies.


Options:
A: Overall adherence to the transfusion strategies defined as adherence to the transfusion strategies in 90% of patients in more than 90% of their days in hospital. (Day of surgery through to hospital discharge.)
B: Core Temperature and blood loss (intraoperative)
C: Composite end-point of mortality and severe complication (30 days)
D: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)

Answer: A