TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Predictor for an Additional Benefit of Inhaled Corticosteroid in Patients Treated With Tiotropium for Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: Study purpose is to evaluate if subjects with chronic obstructive pulmonary disease (COPD) are more likely to be responsive to additional inhaled corticosteroids if they have a positive response to hyperosmolar challenge with mannitol than if their response is negative.


Options:
A: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))
B: Change in Lung Function (FEV1) (12 weeks)
C: Standardized Dyspnea Score at Isotime During Exercise (2 Weeks)
D: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT of an Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to "Stay Within the Guidelines" (SUSTAIN)
Brief Summary: The purpose of this study is to test a newly developed outpatient care intervention called SUSTAIN (Systematic Use of Stroke Averting Interventions) for improving delivery of stroke preventive services at Los Angeles County hospitals and to measure the costs of running such an intervention.


Options:
A: Blood Pressure (12 months)
B: Blood Pressure (6 months and 1 year)
C: Increase in Adherence and Control of Stroke Risk Factors (1, 3, 6, 9 and 12 months)
D: Wolf Motor Function Test (WMFT) (Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)); Motor Activity Log (MAL) Score (Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)); Family Caregiver Conflict Scale (FCCS) Score (Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)); Center for Epidemiologic Studies Depression Scale (CES-D) Score (Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT of an Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to "Stay Within the Guidelines" (SUSTAIN)
Brief Summary: The purpose of this study is to test a newly developed outpatient care intervention called SUSTAIN (Systematic Use of Stroke Averting Interventions) for improving delivery of stroke preventive services at Los Angeles County hospitals and to measure the costs of running such an intervention.


Options:
A: Impact of personalized risk information (baseline); Impact of personalized risk information (3 month)
B: Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II) (End of program (6 months))
C: Blood Pressure (12 months)
D: 12-month systolic blood pressure (SBP) change (Baseline, 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT of an Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to "Stay Within the Guidelines" (SUSTAIN)
Brief Summary: The purpose of this study is to test a newly developed outpatient care intervention called SUSTAIN (Systematic Use of Stroke Averting Interventions) for improving delivery of stroke preventive services at Los Angeles County hospitals and to measure the costs of running such an intervention.


Options:
A: Low Density Lipoprotein Value (1 year); Systolic Blood Pressure Value (1 year); Hemoglobin A1C Value (1 year); Pill count of antiplatelet therapy medications (1 year)
B: Difference in physical activity scale for the elderly (24 months)
C: systolic blood pressure (primary vascular risk factor being assessed) (baseline, post-intervention, 6 months, 12 months); diastolic blood pressure (baseline, post-intervention, 6 months, 12 months); waist circumference (baseline, post-intervention, 6 months, 12 months); 12-hour fasting lipid profile (baseline, post-intervention, 6 months, 12 months); 12-hour fasting glucose/hemoglobin A1C (baseline, post-intervention, 6 months, 12 months)
D: Blood Pressure (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT of an Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to "Stay Within the Guidelines" (SUSTAIN)
Brief Summary: The purpose of this study is to test a newly developed outpatient care intervention called SUSTAIN (Systematic Use of Stroke Averting Interventions) for improving delivery of stroke preventive services at Los Angeles County hospitals and to measure the costs of running such an intervention.


Options:
A: Major vascular event consisting of nonfatal stroke, nonfatal major coronary event and vascular death (Up to 6 years from inclusion)
B: Change Between the Value of the SF-36 Physical Function Score at 12 Months Minus Value at Baseline to Measure the Change in Health-related Quality of Life and Function (Baseline (pre-randomization) and 12 months)
C: Blood Pressure (12 months)
D: systolic blood pressure (primary vascular risk factor being assessed) (baseline, post-intervention, 6 months, 12 months); diastolic blood pressure (baseline, post-intervention, 6 months, 12 months); waist circumference (baseline, post-intervention, 6 months, 12 months); 12-hour fasting lipid profile (baseline, post-intervention, 6 months, 12 months); 12-hour fasting glucose/hemoglobin A1C (baseline, post-intervention, 6 months, 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk
Brief Summary: The majority of individuals with alcohol problems remain current smokers, and the negative health consequences of smoking among these individuals are substantial. This study will investigate the impact of smoking cessation interventions initiated during intensive alcohol treatment on processes reflecting risk of alcohol relapse.


Options:
A: Rate of all-cause hospital readmission or death during the 6-month follow-up period. (6 months)
B: Weight (Measured at Month 24)
C: BP at 6 months (6 months)
D: Smoking Abstinence (12 weeks); Smoking Abstinence (2 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk
Brief Summary: The majority of individuals with alcohol problems remain current smokers, and the negative health consequences of smoking among these individuals are substantial. This study will investigate the impact of smoking cessation interventions initiated during intensive alcohol treatment on processes reflecting risk of alcohol relapse.


Options:
A: Smoking Abstinence (12 weeks); Smoking Abstinence (2 weeks)
B: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)
C: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)
D: 6 Month Smoking Abstinence (6 months after smoking quit date); 12 Month Smoking Abstinence (12 months after smoking quit date)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Long-term Dosing of AMG 531 on Bone Marrow Morphology in Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Brief Summary: This study was conducted in conjunction with the 2 phase 3 studies of AMG 531 (20030105 and 20030212) and an open-label extension study (20030213) and compared pretreatment and posttreatment bone marrow samples for the purpose of studying morphologic changes.


Options:
A: Number of Participants With Splenectomy During 52-Week Treatment Period (52 weeks); Number of Participants With Treatment Failure During 52-Week Treatment Period (52 weeks)
B: Percentage of Responders (Baseline; each on-therapy treatment day; Weeks 10, 14, 18, 22, and 26; and Weeks 1, 2, and 4 post-treatment)
C: To evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP as measured by durable platelet response during the last 8 weeks of treatment and other platelet response parameters (Last 8 weeks of treatment)
D: The changes from baseline in bone marrow morphology by subject (Entire duration of the study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Nicotine Substitute Prescribed at Hourly Intake or ad Libitum for Heavy Smokers Willing to Quit: a Randomized Controlled Trial
Brief Summary: Objective: To assess the impact of instructional guidance in the regular use of use nicotine nasal spray (NNS) on the true use of NNS during the first three weeks of smoking cessation for heavy smokers who are willing to quit.

Methods: This randomized, open, controlled trial included 50 patients who were heavy smokers, were willing to quit, and attending an academic outpatient clinic in Western Switzerland. Patients were randomised to instruction on NNS use as "ad libitum" (administration whenever cravings appear; control group) or to use NNS at least every hour when awake (intervention group). Intakes were monitored using an electronic device fixed in the spray unit (MDILogTM) during the first three weeks of use. Self reported abstinence from smoking at six months was confirmed by expired-air carbon monoxide. Using intention-to-treat analysis, random-effect GLS regression was used to calculate the mean difference of daily doses between groups controlling for lack of independence between measures from the same individual.


Options:
A: Prolonged Abstinence (7 weeks, 6 months and 12 months)
B: The daily number of intakes during the first three weeks recorded with an electronic device fixed on the spray unit (microswitch-actuated metered-dose inhaler chronology, MDILog™, model MDC-511, Medtrac, Denver, Colorado). (first 3 weeks)
C: 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (Week 11)
D: Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events (During all the study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Nicotine Substitute Prescribed at Hourly Intake or ad Libitum for Heavy Smokers Willing to Quit: a Randomized Controlled Trial
Brief Summary: Objective: To assess the impact of instructional guidance in the regular use of use nicotine nasal spray (NNS) on the true use of NNS during the first three weeks of smoking cessation for heavy smokers who are willing to quit.

Methods: This randomized, open, controlled trial included 50 patients who were heavy smokers, were willing to quit, and attending an academic outpatient clinic in Western Switzerland. Patients were randomised to instruction on NNS use as "ad libitum" (administration whenever cravings appear; control group) or to use NNS at least every hour when awake (intervention group). Intakes were monitored using an electronic device fixed in the spray unit (MDILogTM) during the first three weeks of use. Self reported abstinence from smoking at six months was confirmed by expired-air carbon monoxide. Using intention-to-treat analysis, random-effect GLS regression was used to calculate the mean difference of daily doses between groups controlling for lack of independence between measures from the same individual.


Options:
A: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (Assessed 26 weeks after the target quit day.)
B: 6 Month Self-reported Abstinence From Smoking (6 months)
C: 6 Month Smoking Abstinence (6 months after smoking quit date); 12 Month Smoking Abstinence (12 months after smoking quit date)
D: The daily number of intakes during the first three weeks recorded with an electronic device fixed on the spray unit (microswitch-actuated metered-dose inhaler chronology, MDILog™, model MDC-511, Medtrac, Denver, Colorado). (first 3 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Nicotine Substitute Prescribed at Hourly Intake or ad Libitum for Heavy Smokers Willing to Quit: a Randomized Controlled Trial
Brief Summary: Objective: To assess the impact of instructional guidance in the regular use of use nicotine nasal spray (NNS) on the true use of NNS during the first three weeks of smoking cessation for heavy smokers who are willing to quit.

Methods: This randomized, open, controlled trial included 50 patients who were heavy smokers, were willing to quit, and attending an academic outpatient clinic in Western Switzerland. Patients were randomised to instruction on NNS use as "ad libitum" (administration whenever cravings appear; control group) or to use NNS at least every hour when awake (intervention group). Intakes were monitored using an electronic device fixed in the spray unit (MDILogTM) during the first three weeks of use. Self reported abstinence from smoking at six months was confirmed by expired-air carbon monoxide. Using intention-to-treat analysis, random-effect GLS regression was used to calculate the mean difference of daily doses between groups controlling for lack of independence between measures from the same individual.


Options:
A: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)
D: The daily number of intakes during the first three weeks recorded with an electronic device fixed on the spray unit (microswitch-actuated metered-dose inhaler chronology, MDILog™, model MDC-511, Medtrac, Denver, Colorado). (first 3 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase II 2 x 2 Factorial Trial of the Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly Paclitaxel Followed by Dose-Dense AC in Hormone Receptor-Poor/HER2-Negative Resectable Breast Cancer
Brief Summary: This randomized phase II trial studies how well paclitaxel with or without carboplatin and/or bevacizumab followed by doxorubicin and cyclophosphamide works in treating patients with breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.


Options:
A: Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is). (At the time of definitive surgical removal, up to 28 weeks); Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is). (At the time of definitive surgical removal, up to 28 weeks)
B: Definition of a biomarker (profile) characterizing "good responders" to dual blockade T and P anti-HER2 blockade that have similar pCR rates as patients treated with identical dual anti-HER2 blockade + taxane backbone (After 12 weeks of therapy)
C: disease-free survival in patients treated with either 6 cycles of Docetaxel / Cyclophosphamide chemotherapy or 4 cycles of EC followed by 4 cycles of Docetaxel as adjuvant treatment (5 years)
D: Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS≤11 (8 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Metabolic and Anti-Inflammatory Effects of Combined Ezetimibe and Simvastin Therapy, as Compared to Simvastatin Alone, in Patients With Chronic Proteinuric Nephropathy
Brief Summary: The purpose of this study is to determine whether, in patients with chronic proteinuric nephropathy and dyslipidemia, ezetimibe-simvastatin combined therapy is more effective than statin alone to achieve the optimum lipid control, and if this translates to an improvement of the markers of vascular damage. Thirty hypertensive patients in stable therapy with RAS inhibitors, with low-density lipoprotein (LDL) cholesterol superior to 100 mg/ml, are treated with three different hypolipidemic regimens: Simvastatin alone (40 mg/day) or ezetimibe/simvastatin combined therapy (10/20 or 10/40 mg/day).


Options:
A: Compare the effects of simvastatin + ezetimibe with those of simvastatin alone, on thrombogenic mechanisms, in patients with diabetes mellitus type 2. (6 weeks, 14-18 weeks, 22-24 weeks)
B: Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes. (Assessed at Week 52, Last observation carried forward (LOCF))
C: To assess whether EZE-statin combined therapy is more effective than statin alone to achieve the optimum lipid control (LDL-cholesterol < 70 mg/dl) in chronic proteinuric nephropathy. (at baseline and every 4 months after therapy start)
D: Relative reduction in circulating osteoprotegerin levels (18 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Metabolic and Anti-Inflammatory Effects of Combined Ezetimibe and Simvastin Therapy, as Compared to Simvastatin Alone, in Patients With Chronic Proteinuric Nephropathy
Brief Summary: The purpose of this study is to determine whether, in patients with chronic proteinuric nephropathy and dyslipidemia, ezetimibe-simvastatin combined therapy is more effective than statin alone to achieve the optimum lipid control, and if this translates to an improvement of the markers of vascular damage. Thirty hypertensive patients in stable therapy with RAS inhibitors, with low-density lipoprotein (LDL) cholesterol superior to 100 mg/ml, are treated with three different hypolipidemic regimens: Simvastatin alone (40 mg/day) or ezetimibe/simvastatin combined therapy (10/20 or 10/40 mg/day).


Options:
A: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) (baseline to 6 weeks)
B: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline and Week 12); Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 (Baseline and Weeks 10 and 12)
C: To assess whether EZE-statin combined therapy is more effective than statin alone to achieve the optimum lipid control (LDL-cholesterol < 70 mg/dl) in chronic proteinuric nephropathy. (at baseline and every 4 months after therapy start)
D: Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events) (Entire follow-up (median = 4.35 years))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: 48-week,Multinational,Randomized,Double-blind,2-parallel Groups,Comparing the Efficacy of Foster for Maintenance and Reliever Versus Fixed-dose Foster for Maintenance Plus Salbutamol as Reliever in Asthmatics >=18 Years of Age
Brief Summary: Double-blind, multinational, multicentre, randomized, 2-arm parallel-group study


Options:
A: Time to first severe asthma exacerbation (At each clinic visit)
B: The primary outcome for comparison across treatment groups was the mean value of morning PEF measured during the last 2 weeks of treatment (weeks 23-24)
C: 'Well-controlled Asthma Week' - a Derived Binary Variable (Yes/No) (Weekly, up to 52 weeks)
D: Change in PD20 histamine

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Sildenafil for Improving Outcomes After Valvular Correction
Brief Summary: The purpose of this study is to evaluate the clinical efficacy of the mid-term treatment with sildenafil in patients with persistent moderate or severe pulmonary hypertension (PH) after a heart valve intervention.


Options:
A: Percent Change in Mean Pulmonary Artery Pressure in the Whole Cohort. (Baseline and 60 minutes after drug administered)
B: Change From Baseline in the Total Distance Walked During 6-Minute Walk Test (6MWT) at Week 12 (Baseline and Week 12)
C: Safety; Standard safety data; Efficacy; 6-Minute Walk Test; BORG Dyspnoea Score; WHO Functional Class; Quality of Life SF-36 and EQ-5D
D: Combined Outcome End-Point: all-cause mortality or hospital admission for heart failure, worsening of World Health Organization (WHO) functional class, or of the patient global assessment score (Six months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Active-Controlled Study of Patients With Cardiovascular Disease and Diabetes Mellitus Not Adequately Controlled With Simvastatin or Atorvastatin: Comparison of Switching to Combination Tablet Ezetimibe/Simvastatin Versus Switching to Rosuvastatin or Doubling the Statin Dose
Brief Summary: The purpose of this study is to determine the efficacy of switching to a combination tablet ezetimibe/simvastatin (10mg/20mg) versus rosuvastatin (10 mg) versus doubling the statin dose in those patients who have cardiovascular disease and diabetes mellitus not adequately controlled on simvastatin 20 mg or atorvastatin 10 mg.


Options:
A: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin). (Baseline and Week 6)
B: Effect of Intensive Lipid Modification Medication Therapy on Progression of Atherosclerosis and Restenosis of Femoral Arteries Measured Using High Resolution Magnetic Resonance Imaging (MRI) to Examine the Femoral Artery for Progression of Atherosclerosis (Measured at baseline and 24 Months)
C: 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)
D: Percent Change From Baseline in LDL-C at Week 52 (Baseline and Week 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Active-Controlled Study of Patients With Cardiovascular Disease and Diabetes Mellitus Not Adequately Controlled With Simvastatin or Atorvastatin: Comparison of Switching to Combination Tablet Ezetimibe/Simvastatin Versus Switching to Rosuvastatin or Doubling the Statin Dose
Brief Summary: The purpose of this study is to determine the efficacy of switching to a combination tablet ezetimibe/simvastatin (10mg/20mg) versus rosuvastatin (10 mg) versus doubling the statin dose in those patients who have cardiovascular disease and diabetes mellitus not adequately controlled on simvastatin 20 mg or atorvastatin 10 mg.


Options:
A: Coronary Heart Disease(CHD)[fatal/non-fatal MI, sudden/cardiac death, angina, revascularization]
B: Thrombin generation (8 weeks)
C: Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities (7days after index surgery)
D: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin). (Baseline and Week 6)

Answer: D