TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Parallel Group 8-week Study to Evaluate the Efficacy and Safety of Chewable Montelukast When Initiated at the Start of the School Year in Pediatric Patients With Chronic Asthma
Brief Summary: This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.


Options:
A: Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants (8 Week treatment period initiated at the beginning of a school year)
B: Mean maximum symptom days per 2 weeks, as assessed by questionnaire (At Visits 3 and 8)
C: Maximum Number of Asthma Symptom Days (Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.)
D: Daily asthma symptom score

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Parallel Group 8-week Study to Evaluate the Efficacy and Safety of Chewable Montelukast When Initiated at the Start of the School Year in Pediatric Patients With Chronic Asthma
Brief Summary: This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.


Options:
A: FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1
B: Maximum Post-exercise Percent (%) Fall in FEV1 (4 weeks (Weeks 0 to 4 or Weeks 6 to 10))
C: Daily asthma symptom score
D: Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants (8 Week treatment period initiated at the beginning of a school year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dyspnea Self-Management: Internet or Face-to-Face
Brief Summary: Chronic obstructive pulmonary disease, including emphysema and chronic bronchitis, is the fourth most common cause of death and the second leading cause of disability in the United States. COPD is estimated to be responsible for more than 13.4 million physician visits and 13% of hospitalizations nationally. These hospitalizations are usually caused by acute exacerbations characterized by an increase in symptoms including dyspnea or shortness of breath (SOB), cough, wheezing, and sputum production. The significant disability for people with COPD is primarily due to the symptom of dyspnea (shortness of breath) that affects an individual's quality of life more than does the physiological impairment. Despite optimal medical and pharmacological therapy, most people with COPD continue to suffer from chronic and progressive dyspnea and other symptoms of cough and fatigue.

We have previously shown that an individualized face-to-face dyspnea self-management program was effective in improving dyspnea with activities of daily living (ADL), physical functioning, and self-efficacy for managing dyspnea. Using an experimental longitudinal design, the i-DSMP will be compared to the Face-to-Face Dyspnea Self-Management Program (f-DSMP) and to an Attention Control (AC) intervention


Options:
A: Dyspnea with ADL (3, 6, and 12 months); Exercise and functional performance (3, 6, and 12 months); Exercise adherence (3, 6, and 12 months); Acute COPD exacerbations (3, 6, and 12 months)
B: Change in level of objectively measured physical activity (7 Days at baseline, 7 days at 3- and 12- months after baseline)
C: Change in HADS-A score from baseline to three months follow-up (Three months)
D: Number of unscheduled hospital days (up to 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Dyspnea Self-Management: Internet or Face-to-Face
Brief Summary: Chronic obstructive pulmonary disease, including emphysema and chronic bronchitis, is the fourth most common cause of death and the second leading cause of disability in the United States. COPD is estimated to be responsible for more than 13.4 million physician visits and 13% of hospitalizations nationally. These hospitalizations are usually caused by acute exacerbations characterized by an increase in symptoms including dyspnea or shortness of breath (SOB), cough, wheezing, and sputum production. The significant disability for people with COPD is primarily due to the symptom of dyspnea (shortness of breath) that affects an individual's quality of life more than does the physiological impairment. Despite optimal medical and pharmacological therapy, most people with COPD continue to suffer from chronic and progressive dyspnea and other symptoms of cough and fatigue.

We have previously shown that an individualized face-to-face dyspnea self-management program was effective in improving dyspnea with activities of daily living (ADL), physical functioning, and self-efficacy for managing dyspnea. Using an experimental longitudinal design, the i-DSMP will be compared to the Face-to-Face Dyspnea Self-Management Program (f-DSMP) and to an Attention Control (AC) intervention


Options:
A: 6 minute walk test (measured at week 8)
B: The dyspnea of the chronic respiratory questionnaire (CRQ) at 12 months is the primary outcome variable. (The data collection was terminated in January 2007 and publication was done December 2008)
C: Dyspnea with ADL (3, 6, and 12 months); Exercise and functional performance (3, 6, and 12 months); Exercise adherence (3, 6, and 12 months); Acute COPD exacerbations (3, 6, and 12 months)
D: Quality of Life of chronic obstructive pulmonary disease patients after a 1-year téléherabilitaion versus standard care program, after an initial short-term pulmonary rehabilitation program (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Dyspnea Self-Management: Internet or Face-to-Face
Brief Summary: Chronic obstructive pulmonary disease, including emphysema and chronic bronchitis, is the fourth most common cause of death and the second leading cause of disability in the United States. COPD is estimated to be responsible for more than 13.4 million physician visits and 13% of hospitalizations nationally. These hospitalizations are usually caused by acute exacerbations characterized by an increase in symptoms including dyspnea or shortness of breath (SOB), cough, wheezing, and sputum production. The significant disability for people with COPD is primarily due to the symptom of dyspnea (shortness of breath) that affects an individual's quality of life more than does the physiological impairment. Despite optimal medical and pharmacological therapy, most people with COPD continue to suffer from chronic and progressive dyspnea and other symptoms of cough and fatigue.

We have previously shown that an individualized face-to-face dyspnea self-management program was effective in improving dyspnea with activities of daily living (ADL), physical functioning, and self-efficacy for managing dyspnea. Using an experimental longitudinal design, the i-DSMP will be compared to the Face-to-Face Dyspnea Self-Management Program (f-DSMP) and to an Attention Control (AC) intervention


Options:
A: Disease-specific health related quality of life assessed with the Chronic Respiratory Questionnaire (CRQ-SR) (At baseline, after one year follow-up, and after two years follow-up)
B: 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)
C: Dyspnea with ADL (3, 6, and 12 months); Exercise and functional performance (3, 6, and 12 months); Exercise adherence (3, 6, and 12 months); Acute COPD exacerbations (3, 6, and 12 months)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Dyspnea Self-Management: Internet or Face-to-Face
Brief Summary: Chronic obstructive pulmonary disease, including emphysema and chronic bronchitis, is the fourth most common cause of death and the second leading cause of disability in the United States. COPD is estimated to be responsible for more than 13.4 million physician visits and 13% of hospitalizations nationally. These hospitalizations are usually caused by acute exacerbations characterized by an increase in symptoms including dyspnea or shortness of breath (SOB), cough, wheezing, and sputum production. The significant disability for people with COPD is primarily due to the symptom of dyspnea (shortness of breath) that affects an individual's quality of life more than does the physiological impairment. Despite optimal medical and pharmacological therapy, most people with COPD continue to suffer from chronic and progressive dyspnea and other symptoms of cough and fatigue.

We have previously shown that an individualized face-to-face dyspnea self-management program was effective in improving dyspnea with activities of daily living (ADL), physical functioning, and self-efficacy for managing dyspnea. Using an experimental longitudinal design, the i-DSMP will be compared to the Face-to-Face Dyspnea Self-Management Program (f-DSMP) and to an Attention Control (AC) intervention


Options:
A: Dyspnea with ADL (3, 6, and 12 months); Exercise and functional performance (3, 6, and 12 months); Exercise adherence (3, 6, and 12 months); Acute COPD exacerbations (3, 6, and 12 months)
B: Self-Reported Respiratory-Specific Quality of Life (four months from randomization); Self-Reported Respiratory-Specific Quality of Life (twelve months from randomization)
C: Dyspnea; Exercise adherence and performance; Pulmonary exacerbations
D: Exercise behavior (3 & 6 Months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing the Quality of Life and Independence of Persons Disabled by Severe Mental Illness Through Supported Employment
Brief Summary: The primary aim of the study was to determine the effectiveness of a form of supported employment, Individual Placement and Support (IPS) compared to existing good quality rehabilitation and vocational services for people with psychotic illnesses in terms of 'open' employment outcomes (in the competitive labour market), and to examine its relative effectiveness in the context of different European welfare systems and labour markets. The primary hypothesis was that IPS patients would be more likely to obtain open employment than control service patients. Secondary hypotheses were that they would be in open employment for longer than the control patients, and that they would not spend more time in hospital.


Options:
A: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)
B: Hours in competitive employment or education (Measured at 18 month)
C: Psychotic Symptoms (two years)
D: sucessful employment for one day in the open labour market

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: IATROREF III: a Multifaceted Program for Improving Quality of Care in Critically Ill Patients
Brief Summary: Medical errors that affect patient safety have generated huge concern since the publication of "To Err Is Human" 6 years ago \[1\]. Given the complexity of management in the intensive care unit (ICU) and the nature of human activities, critically ill patients are exposed to adverse events (AEs) induced by medical errors. A large number of studies have focused on AEs and medical errors in ICUs \[2-6\], one of their main goals being to identify strategies for preventing AEs and thereby improving patient outcomes. Choosing the best AE to serve as an indicator for the risk of medical error is challenging. In 2005, our group conducted a systematic literature review and presented the results to 30 national experts with clinical backgrounds in internal, emergency, and intensive care medicine. Using the Delphi technique, these experts selected 14 AEs that had the following characteristics: high frequency, easy and reproducible definition, association with morbidity and mortality, and ease of reporting without fear of punishment (Iatroref I study) (ref abstract). These AEs were used in a French multicenter study (75 ICUs) for a weeklong incidence evaluation (Iatroref II study) (ref abstract). Preliminary evaluation of the results allowed us to choose the following AEs for the current Iatroref III study: error in insulin administration, error in anticoagulant administration, error in anticoagulant prescription, unplanned extubation, and unplanned removal of central venous catheter. Evidence suggests that guidelines alone without reinforcing strategies may be insufficient to change provider behavior and that the most effective interventions may be multifaceted rather than single-component strategies (\[7\]). This study will test a composite intervention program. The objectives of the study are to determine whether the introduction of a composite intervention program decreases the predefined AEs.

Study hypothesis: The intervention program will decrease the incidence of the predefined AEs.


Options:
A: 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)
B: functional gain as measured by motor FIM score (One year post team training intervention)
C: decreased of occured of iatrogenic event in ICU (one month)
D: Primary Process Outcome: A composite score counting the number of appropriate processes achieved for patients within appropriate time-frames, including laboratory testing, blood pressure measurements and active prescriptions (24 months); Primary Disease-Related Outcomes: mean BP and mean LDL level. (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Teen Sexual Behavior: A Clinic-Based Approach
Brief Summary: This study will evaluate the effectiveness of a parent-based intervention in reducing sexual risk behavior in high-risk Latino and African-American adolescents.


Options:
A: HIV incidence
B: N/A
C: rates of STIs (Baseline, 6 and 12 months); computer-assisted survey results (baseline, 1 week, 3, 6, & 12 months); - score on self-report of frequency of risky sexual and substance use behaviors (baseline, 1 week, 3, 6, & 12 months)
D: Incidence of vaginal sexual intercourse measured (Measured at Months 3 and 12 post-treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient-Centered Disease Management for Heart Failure Trial
Brief Summary: The purpose of this study is to evaluate a patient-centered disease management intervention for VA patients with heart failure.


Options:
A: Change in VO2peak (day1); Change in VO2peak (month 2 + 14 days); Change in VO2peak (month 4 + 14 days)
B: Change in dietary and physical activity behavior (self-report) (Baseline to 8 weeks later)
C: Change in Chronic Heart Failure Health Status Between Baseline and 12 Months. (12 months)
D: functional capacity at 6- and 12-months after CR in pts older than 75 years randomly allocated to Home-Based exercise program or usual care. (6 and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient-Centered Disease Management for Heart Failure Trial
Brief Summary: The purpose of this study is to evaluate a patient-centered disease management intervention for VA patients with heart failure.


Options:
A: Health related quality of life (12 months); HbA1c change over time (participants with T2DM only) (12 months)
B: Medication Adherence (3 Months)
C: Change in Chronic Heart Failure Health Status Between Baseline and 12 Months. (12 months)
D: Brain Natriuretic Peptide values (Baseline, 6 months); Self-care practices measured through Self-Care of Heart Failure Index scores and interviews (baseline, 6 months); Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews (baseline, 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient-Centered Disease Management for Heart Failure Trial
Brief Summary: The purpose of this study is to evaluate a patient-centered disease management intervention for VA patients with heart failure.


Options:
A: Performance of non-technical skills of the teams. (1 year)
B: Change in Chronic Heart Failure Health Status Between Baseline and 12 Months. (12 months)
C: functional gain as measured by motor FIM score (One year post team training intervention)
D: Adherence of occupational therapists to the COTiD program (one year (baseline, T1, and T2)); Community occupational therapy use according to the COTiD program (one year); Costs of the implementation strategies (October 2009 - December 2011)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of the Long-term Clinical Effects of Raising HDL Cholesterol With Extended Release Niacin/Laropiprant
Brief Summary: The primary aim is to assess the effects of raising HDL cholesterol (the good type) with extended release niacin/laropiprant 2g (previously known as MK-0524A) versus matching placebo on the risk of heart attack or coronary death, stroke, or the need for arterial bypass procedures (revascularisation) in people with a history of circulatory problems. The secondary aim is to assess the effects of extended release niacin/laropiprant 2g daily on heart attack, coronary death, stroke, and revascularisation separately and to assess the effects on mortality both overall and in various categories of causes of death, and of the effects on major cardiovascular events in people with a history of different diseases at the beginning of the study.


Options:
A: Major Vascular Event (During scheduled treatment period (median duration 3.9 years))
B: Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) (Up to approximately 9 years)
C: Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.
D: Triglycerides (Measured at 24 weeks); Non-HDL-C (Measured at 24 weeks); HDL-C (Measured at 24 weeks); Total Cholesterol (Measured at 24 weeks); Total Cholesterol : HDL-C Ratio (Measured at 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A National, Open-Label, Multicenter, Randomized, Comparative Phase III Study of Induction Treatment With VBMCP-VBAD/Velcade Versus Thalidomide / Dexamethasone Versus Velcade / Thalidomide / Dexamethasone Followed by High Dose Intensive Therapy With Autologous Hemopoietic Stem Cell Support and Maintenance Treatment With Interferon-a Versus Thalidomide Versus Thalidomide / Velcade in Untreated Patients With Multiple Myeloma Less Than 65 Yrs Old
Brief Summary: The primary objective is to compare safety and efficacy of three induction treatments: VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide / Dexamethasone. The second one is to evaluate the ability of stem cell mobilization after the treatments in order to do an autologous transplant. Otherwise this study wants to compare the safety and efficacy of the maintenance treatments: Interferón a-2b versus Thalidomide versus Thalidomide/Velcade.


Options:
A: Number of Patients With Overall Response (Complete Response + Partial Response) (Over 4 cycles (prior to the addition of dexamethasone))
B: Number of Patients With Combined Complete Response and Very Good Partial Response (Up to 48 weeks or until disease progression)
C: The primary objective is to compare safety and efficacy of three induction treatments: VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide / Dexamethasone. (2 years)
D: To compare the CR rate (with negative or positive immunofixation) obtained with VAD or the Velcade®/dexamethasone combination used as induction treatment in patients up to the age of 65 with newly diagnosed MM, at the end of this induction treatment

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to compare the efficacy of Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg BID to Combivent® Inhalation Aerosol \[2 inhalations from metered dose inhaler (MDI)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate QID\], and to Compare the preference/compliance of BID nebulization to QID use of MDI


Options:
A: The percentage of selected patients receiving anti-tabacco counseling recorded by the GPs in the labeled patients' medical records. (1 year)
B: Lung function after 2 weeks of treatment
C: Overall Discrepancy Rate (4-week Treatment Period); Overall Quartile Discrepancy Rate (4-week Treatment Period); Overall Discrepancy Size (4-week Treatment Period); End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population) (4-week Treatment Period)
D: Readmission rate (6 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluierung Eines Therapiemodells Der Autologen Knochenmark-Transplantation Bei Herzerkrankungen Mit Besonderem Schwerpunkt Der Prüfung Verschiedener Progenitorzellen
Brief Summary: Cell transplantation for treatment of heart failure is a novel field of translational research that offers the perspective of developing curative approaches by regenerating or "rejuvenating" lost and/or diseased myocardium and inducing growth of new blood vessels. Based on the safety and preliminary efficacy testing in previous trials, a stringent efficacy testing will be performed in this study. Sixty patients who had myocardial infarction in the past and now need bypass surgery for ongoing coronary artery disease will undergo either bypass surgery and placebo treatment or bypass surgery and injection of CD133 bone marrow cells directly in the heart muscle. The study will be fully blinded, i.e. neither the patient nor the surgeon knows what substance is injected (placebo or cell product). Patients will be followed for 6 months and various heart function measurements will be performed.


Options:
A: N/A
B: Safety of Autologous-bone-marrow Injections (up to 2 weeks post-procedure, 3 months and 6 months)
C: Improvements in left ventricular function (6 and 12 months)
D: Left ventricular ejection fraction at rest, measured six months postoperatively, measured by MRI

Answer: D