TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Determination of the Optimal Prophylactic Platelet Dose Strategy to Prevent Bleeding in Thrombocytopenic Patients (A TMH CTN Study)
Brief Summary: The primary objective of this study is to compare the three study arms of lower, medium, and higher dose platelet therapy with respect to the percentage of patients experiencing at least one episode of Grade 2 or higher bleeding as determined by the Platelet Dose Trial Bleeding Scale (Grade 2 bleeding corresponds to bleeding that is moderate, but not severe enough to warrant red blood cell transfusion).

There are a number of secondary endpoints related to platelet transfusions, hemostasis, and other concerns. The four most important secondary endpoints will compare the three study arms with respect to the following outcomes: 1) platelet utilization rates (total number of platelets transfused x 10 \^11); 2) number of platelet transfusion events (frequency of transfusions); a transfusion event would be defined as each separate platelet transfusion issued by the study site's transfusion service; 3) highest category of bleeding during time of study (Platelet Dose Trial Bleeding Scale Grades less than or equal to 1, 2, 3, or 4 by arm); and 4) bleeding severity based on number of days with bleeding (total days of bleeding and bleeding/thrombocytopenic day), intensity of bleeding, and number of sites with bleeding (if such a severity score has been validated and published by the time the study is completed).


Options:
A: Safety and tolerability parameters including non-hematological laboratory Grade 3/Grade 4 toxicities, change in bone marrow blast counts from baseline and adverse events reporting. (Approximately 46 months)
B: Part A: Number of Participants With Adverse Events (Treatment period (4 weeks) plus treatment extension (1 year)); Part B: Number of Participants With Adverse Events (Treatment period (8 weeks) plus treatment extension (1 year))
C: Maximum Tolerated Dose (MTD) of Eltrombopag (1.5 years)
D: At Least One Day With Grade 2 or Higher Bleeding (From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Determination of the Optimal Prophylactic Platelet Dose Strategy to Prevent Bleeding in Thrombocytopenic Patients (A TMH CTN Study)
Brief Summary: The primary objective of this study is to compare the three study arms of lower, medium, and higher dose platelet therapy with respect to the percentage of patients experiencing at least one episode of Grade 2 or higher bleeding as determined by the Platelet Dose Trial Bleeding Scale (Grade 2 bleeding corresponds to bleeding that is moderate, but not severe enough to warrant red blood cell transfusion).

There are a number of secondary endpoints related to platelet transfusions, hemostasis, and other concerns. The four most important secondary endpoints will compare the three study arms with respect to the following outcomes: 1) platelet utilization rates (total number of platelets transfused x 10 \^11); 2) number of platelet transfusion events (frequency of transfusions); a transfusion event would be defined as each separate platelet transfusion issued by the study site's transfusion service; 3) highest category of bleeding during time of study (Platelet Dose Trial Bleeding Scale Grades less than or equal to 1, 2, 3, or 4 by arm); and 4) bleeding severity based on number of days with bleeding (total days of bleeding and bleeding/thrombocytopenic day), intensity of bleeding, and number of sites with bleeding (if such a severity score has been validated and published by the time the study is completed).


Options:
A: Daily hemostatic assessments will be conducted to determine presence of WHO Grade 2 bleeding or greater.
B: Bleeding within 24 hours after cvc application; other complications within the first 24 hours
C: At Least One Day With Grade 2 or Higher Bleeding (From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first))
D: reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy) (2010)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease (COPD) in General Practice. A Randomized Controlled Trial Comparing Regular Practice Nurse Review, Self-management Education and Usual Care
Brief Summary: In this randomized controlled trial, three contemporary modes for chronic obstructive pulmonary disease (COPD) management in Dutch general practices are compared for costs and effects:

* usual general practitioner (GP) care (at patient's initiative);
* regular practice nurse review; and
* integrated self-management education.

All three interventions are based on existing guidelines, materials, and field experiences.


Options:
A: Hospitalization or Emergency Department Visit for COPD (1 yr); Hospitalization or ED Visit for COPD (Mean Cumulative Frequency) (1 yr)
B: Improvement tolerance capacity (4 months and 6 months)
C: The primary endpoint will be change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ). (14 Months)
D: disease-specific health-related quality of life (HRQoL) (two years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease (COPD) in General Practice. A Randomized Controlled Trial Comparing Regular Practice Nurse Review, Self-management Education and Usual Care
Brief Summary: In this randomized controlled trial, three contemporary modes for chronic obstructive pulmonary disease (COPD) management in Dutch general practices are compared for costs and effects:

* usual general practitioner (GP) care (at patient's initiative);
* regular practice nurse review; and
* integrated self-management education.

All three interventions are based on existing guidelines, materials, and field experiences.


Options:
A: Number of hospital admissions for exacerbations of COPD
B: disease-specific health-related quality of life (HRQoL) (two years)
C: Hospitalization-free Survival - Time to Event (From randomization until date of first hospitalization for COPD, assessed up to 26 months); Hazard Ratio for First COPD Hospitalization (26 months)
D: Dyspnea; Exercise adherence and performance; Pulmonary exacerbations

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease (COPD) in General Practice. A Randomized Controlled Trial Comparing Regular Practice Nurse Review, Self-management Education and Usual Care
Brief Summary: In this randomized controlled trial, three contemporary modes for chronic obstructive pulmonary disease (COPD) management in Dutch general practices are compared for costs and effects:

* usual general practitioner (GP) care (at patient's initiative);
* regular practice nurse review; and
* integrated self-management education.

All three interventions are based on existing guidelines, materials, and field experiences.


Options:
A: Re-hospitalizations (During the 30days after discharge)
B: disease-specific health-related quality of life (HRQoL) (two years)
C: Self-management and Activation (6 Months)
D: Health-Related quality of life (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease (COPD) in General Practice. A Randomized Controlled Trial Comparing Regular Practice Nurse Review, Self-management Education and Usual Care
Brief Summary: In this randomized controlled trial, three contemporary modes for chronic obstructive pulmonary disease (COPD) management in Dutch general practices are compared for costs and effects:

* usual general practitioner (GP) care (at patient's initiative);
* regular practice nurse review; and
* integrated self-management education.

All three interventions are based on existing guidelines, materials, and field experiences.


Options:
A: Hospitalization-free Survival - Time to Event (From randomization until date of first hospitalization for COPD, assessed up to 26 months); Hazard Ratio for First COPD Hospitalization (26 months)
B: Hospitalization or Emergency Department Visit for COPD (1 yr); Hospitalization or ED Visit for COPD (Mean Cumulative Frequency) (1 yr)
C: CCQ-recovery time in the event of an exacerbation(Health status recovery time) (6-months)
D: disease-specific health-related quality of life (HRQoL) (two years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease (COPD) in General Practice. A Randomized Controlled Trial Comparing Regular Practice Nurse Review, Self-management Education and Usual Care
Brief Summary: In this randomized controlled trial, three contemporary modes for chronic obstructive pulmonary disease (COPD) management in Dutch general practices are compared for costs and effects:

* usual general practitioner (GP) care (at patient's initiative);
* regular practice nurse review; and
* integrated self-management education.

All three interventions are based on existing guidelines, materials, and field experiences.


Options:
A: Evaluation of effects (T1: Initial evaluation; T2: after three months; T3: one year after T1)
B: disease-specific health-related quality of life (HRQoL) (two years)
C: Physical activity (Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)); Physical activity (Change between T1 and T2: 3 months follow up)
D: The combined number of hospital admissions and ED visits for a COPD exacerbation (6-month follow-up period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease (COPD) in General Practice. A Randomized Controlled Trial Comparing Regular Practice Nurse Review, Self-management Education and Usual Care
Brief Summary: In this randomized controlled trial, three contemporary modes for chronic obstructive pulmonary disease (COPD) management in Dutch general practices are compared for costs and effects:

* usual general practitioner (GP) care (at patient's initiative);
* regular practice nurse review; and
* integrated self-management education.

All three interventions are based on existing guidelines, materials, and field experiences.


Options:
A: CCQ-recovery time in the event of an exacerbation(Health status recovery time) (6-months)
B: disease-specific health-related quality of life (HRQoL) (two years)
C: The combined number of hospital admissions and ED visits for a COPD exacerbation (6-month follow-up period)
D: Quality of Care (36 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Relapses in PR3-ANCA-associated Vasculitis, a Tailored Approach
Brief Summary: Treatment of patients with PR3-ANCA-associated vasculitis consists of two phases: remission induction with highly effective, but also relatively toxic, drugs and, secondly, after remission is achieved, maintenance therapy with less toxic drugs. Currently, remission-maintenance therapy with azathioprine is stopped after approximately 18 months. However, the optimal duration of azathioprine maintenance therapy is unknown.

The investigators have found that patients with PR3-ANCA-associated vasculitis who remain cytoplasmic anti-neutrophil cytoplasmic autoantibody (C-ANCA) positive after induction of remission have an increased risk to experience relapse of disease. Therefore they will test whether relapse risk in these patients can be reduced by extending maintenance therapy at the cost of acceptable therapy related toxicity. After induction of stable remission, ANCA will be measured by immunofluorescence (IIF). C-ANCA positive patients will be randomized for either standard therapy with azathioprine (until 18 months after diagnosis), or longterm azathioprine maintenance therapy (until 48 months after diagnosis).


Options:
A: Renal recovery (Three months)
B: Disease free period, time from remission to relapse or study end.
C: disease free survival (four years after diagnosis)
D: Proportion of patients with CMV reactivation and time to CMV reactivation (Over 12 month period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Take Control of Your Blood Pressure (TCYB)
Brief Summary: The purpose of this study is to improve adherence to blood pressure (BP) monitoring and medication compliance in individuals with high BP.


Options:
A: Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy (Measured at Year 4)
B: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
C: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
D: BP measurement (Measured at 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Novel Antihypertensive Goal Of hYpertension With diAbetes - Hypertensive Events and ARb Treatment (NAGOYA-HEART) Study
Brief Summary: Various guidelines recommended angiotensin converting enzyme (ACE) inhibitors or angiotensin Ⅱ receptor-1 blockers (ARBs) for hypertensive patients with diabetes on the basis of the cardiac- and reno-protective effects of these drugs. However, these recommendations could not be extrapolated to Japanese patients, because Japan has been known as a country with a low incidence of coronary artery disease and a high incidence of cerebrovascular disease. Furthermore, calcium channel blockers (CCBs) also were protective against renal function as well as ACE inhibitors in Japanese diabetic hypertensive patients. This study will test whether ARBs or CCBs are superior in treating Japanese diabetic hypertensive patients.


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: Change from baseline diastolic blood pressure after 8 weeks; Change from baseline systolic blood pressure after 8 weeks

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Novel Antihypertensive Goal Of hYpertension With diAbetes - Hypertensive Events and ARb Treatment (NAGOYA-HEART) Study
Brief Summary: Various guidelines recommended angiotensin converting enzyme (ACE) inhibitors or angiotensin Ⅱ receptor-1 blockers (ARBs) for hypertensive patients with diabetes on the basis of the cardiac- and reno-protective effects of these drugs. However, these recommendations could not be extrapolated to Japanese patients, because Japan has been known as a country with a low incidence of coronary artery disease and a high incidence of cerebrovascular disease. Furthermore, calcium channel blockers (CCBs) also were protective against renal function as well as ACE inhibitors in Japanese diabetic hypertensive patients. This study will test whether ARBs or CCBs are superior in treating Japanese diabetic hypertensive patients.


Options:
A: 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.]))
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: N/A
D: Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP). (baseline to 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Stress Response and Smoking Cessation in Depressed Youth
Brief Summary: Little is known about the best ways to help young people stop smoking. Bupropion (a medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers. The purpose of this study is to determine if bupropion is also effective in treating smokers between the ages of 12 and 25 years old. This study also compares the effectiveness of bupropion used as a supplement to behavioral treatment versus behavioral treatment used alone. In addition, the study evaluates whether hormonal response to stress measured prior to the start of treatment predicts whether individuals respond well to treatment with medication.


Options:
A: Survival abstinence rate with maintenance treatment (48 weeks after start of treatment)
B: Smoking Behavior (Nine weeks)
C: Smoking Abstinence (12 months)
D: Smoking Abstinence (week 7, week 11 and week 24 after scheduled quit day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Stress Response and Smoking Cessation in Depressed Youth
Brief Summary: Little is known about the best ways to help young people stop smoking. Bupropion (a medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers. The purpose of this study is to determine if bupropion is also effective in treating smokers between the ages of 12 and 25 years old. This study also compares the effectiveness of bupropion used as a supplement to behavioral treatment versus behavioral treatment used alone. In addition, the study evaluates whether hormonal response to stress measured prior to the start of treatment predicts whether individuals respond well to treatment with medication.


Options:
A: Smoking Behavior (Nine weeks)
B: to assess the continuous abstinence from tobacco smoking at every visit during the last four weeks of treatment through direct inquiry of patients; exhaled carbon monoxide testing; and plasma cotinine measurements
C: Smoking Behavior (2)
D: Smoking Abstinence (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Stress Response and Smoking Cessation in Depressed Youth
Brief Summary: Little is known about the best ways to help young people stop smoking. Bupropion (a medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers. The purpose of this study is to determine if bupropion is also effective in treating smokers between the ages of 12 and 25 years old. This study also compares the effectiveness of bupropion used as a supplement to behavioral treatment versus behavioral treatment used alone. In addition, the study evaluates whether hormonal response to stress measured prior to the start of treatment predicts whether individuals respond well to treatment with medication.


Options:
A: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)
B: To assess the continuous abstinence from tobacco smoking at every visit during the last 4 weeks of treatment period, i.e. from week 4 to week 7, through direct inquiry of patients, exhaled carbon monoxide (CO) testing, and plasma cotinine measurements
C: Smoking Behavior (Nine weeks)
D: Point prevalence of smoking cessation (those who have quitted smoking and have not smoked in the past week prior to the assessment date). (52 weeks after starting the treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Stress Response and Smoking Cessation in Depressed Youth
Brief Summary: Little is known about the best ways to help young people stop smoking. Bupropion (a medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers. The purpose of this study is to determine if bupropion is also effective in treating smokers between the ages of 12 and 25 years old. This study also compares the effectiveness of bupropion used as a supplement to behavioral treatment versus behavioral treatment used alone. In addition, the study evaluates whether hormonal response to stress measured prior to the start of treatment predicts whether individuals respond well to treatment with medication.


Options:
A: Smoking Behavior (Nine weeks)
B: 52-Week Point-Prevalence Abstinence (Assessed 52 weeks after quit date)
C: Biochemically/pharmacologically-confirmed 12-month continuous abstinence as evidenced by self-reports of nonsmoking status in all interviews (i.e., at 3, 6, and 12 months) (12 months)
D: Smoking Abstinence - Serum/Urine Measurements (Week 12); Smoking Abstinence - Number of Cigarettes Smoked (Week 12); Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Stress Response and Smoking Cessation in Depressed Youth
Brief Summary: Little is known about the best ways to help young people stop smoking. Bupropion (a medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers. The purpose of this study is to determine if bupropion is also effective in treating smokers between the ages of 12 and 25 years old. This study also compares the effectiveness of bupropion used as a supplement to behavioral treatment versus behavioral treatment used alone. In addition, the study evaluates whether hormonal response to stress measured prior to the start of treatment predicts whether individuals respond well to treatment with medication.


Options:
A: Continuous Abstinence Rate (CAR) From Week 9 Through Week 12 (Week 9 through Week 12)
B: Smoking Behavior (Nine weeks)
C: Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 (12 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 (24 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 (52 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 (64 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 (104 weeks following treatment initiation)
D: Days of abstinence following the programmed lapse (7 days)

Answer: B