TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas
Brief Summary: RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor cells. It is not yet known which radiation therapy regimen combined with chemotherapy with or without surgery is more effective for head and neck cancer.

PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens combined with cisplatin with or without surgery in treating patients who have stage III or stage IV head and neck cancer.


Options:
A: N/A
B: Overall Survival (Percentage of Participants Alive) (From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.)
C: Overall survival after treatment with the test tri-therapy (TPF: docetaxel plus cisplatin and 5-FU) or the control treatment (PF: Cisplatin plus 5-FU) followed by chemoradiotherapy.
D: Overall Survival (3-years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Stop Atherosclerosis in Native Diabetics Study
Brief Summary: Compared to standard treatment goals achieving lower targets for LDL cholesterol (bad cholesterol) and blood pressure in people with diabetes will slow the progression of atherosclerosis as measured by carotid artery thickness, and reduce clinical cardiovascular events such as heart attacks and strokes. This study is a randomized 3-year trial. The primary endpoint will be a combination of various measures of the carotid artery, (which is an easy, non-invasive way to detect cardiovascular disease) and events such as heart attacks and strokes. The study will also look at secondary endpoints such as how well the heart pumps, fat,protein and inflammatory markers in the blood,and kidney function. The study enrolled 549 American Indian men and women with diabetes, \> 40 years of age and is being conducted in four field centers involving Indian Health Service/Tribal primary care facilities in Phoenix/Sacaton, Arizona; Chinle, Arizona; Rapid City/Pine Ridge, South Dakota; and Lawton, Oklahoma, with input from American Indian physicians and community members.


Options:
A: Changing LDL Cholesterol (36 months)
B: Recurrent stroke (five years)
C: Mobility - Measured by Change in Gait Speed (Change from baseline to 36 months)
D: To evaluate changes from baseline in Left Ventricular Mass at 24M (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Stop Atherosclerosis in Native Diabetics Study
Brief Summary: Compared to standard treatment goals achieving lower targets for LDL cholesterol (bad cholesterol) and blood pressure in people with diabetes will slow the progression of atherosclerosis as measured by carotid artery thickness, and reduce clinical cardiovascular events such as heart attacks and strokes. This study is a randomized 3-year trial. The primary endpoint will be a combination of various measures of the carotid artery, (which is an easy, non-invasive way to detect cardiovascular disease) and events such as heart attacks and strokes. The study will also look at secondary endpoints such as how well the heart pumps, fat,protein and inflammatory markers in the blood,and kidney function. The study enrolled 549 American Indian men and women with diabetes, \> 40 years of age and is being conducted in four field centers involving Indian Health Service/Tribal primary care facilities in Phoenix/Sacaton, Arizona; Chinle, Arizona; Rapid City/Pine Ridge, South Dakota; and Lawton, Oklahoma, with input from American Indian physicians and community members.


Options:
A: The primary endpoint is the change in carotid intima-media thickness between groups after 14 months (14 months)
B: Changing LDL Cholesterol (36 months)
C: 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)
D: Percent change in LDL-C

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Stop Atherosclerosis in Native Diabetics Study
Brief Summary: Compared to standard treatment goals achieving lower targets for LDL cholesterol (bad cholesterol) and blood pressure in people with diabetes will slow the progression of atherosclerosis as measured by carotid artery thickness, and reduce clinical cardiovascular events such as heart attacks and strokes. This study is a randomized 3-year trial. The primary endpoint will be a combination of various measures of the carotid artery, (which is an easy, non-invasive way to detect cardiovascular disease) and events such as heart attacks and strokes. The study will also look at secondary endpoints such as how well the heart pumps, fat,protein and inflammatory markers in the blood,and kidney function. The study enrolled 549 American Indian men and women with diabetes, \> 40 years of age and is being conducted in four field centers involving Indian Health Service/Tribal primary care facilities in Phoenix/Sacaton, Arizona; Chinle, Arizona; Rapid City/Pine Ridge, South Dakota; and Lawton, Oklahoma, with input from American Indian physicians and community members.


Options:
A: Major coronary events (sudden cardiac death, fatal and nonfatal myocardial infarction, unstable angina pectoris including hospitalization for ischemic episodes,events of angioplasty/ stenting or coronary artery bypass grafting)
B: Time from randomization to the occurrence of a primary clinical endpoint; i.e. major coronary event or CABG or other coronary revascularization procedure; or unstable angina or resuscitated cardiac arrest or stroke.
C: Changing LDL Cholesterol (36 months)
D: attack number (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Stop Atherosclerosis in Native Diabetics Study
Brief Summary: Compared to standard treatment goals achieving lower targets for LDL cholesterol (bad cholesterol) and blood pressure in people with diabetes will slow the progression of atherosclerosis as measured by carotid artery thickness, and reduce clinical cardiovascular events such as heart attacks and strokes. This study is a randomized 3-year trial. The primary endpoint will be a combination of various measures of the carotid artery, (which is an easy, non-invasive way to detect cardiovascular disease) and events such as heart attacks and strokes. The study will also look at secondary endpoints such as how well the heart pumps, fat,protein and inflammatory markers in the blood,and kidney function. The study enrolled 549 American Indian men and women with diabetes, \> 40 years of age and is being conducted in four field centers involving Indian Health Service/Tribal primary care facilities in Phoenix/Sacaton, Arizona; Chinle, Arizona; Rapid City/Pine Ridge, South Dakota; and Lawton, Oklahoma, with input from American Indian physicians and community members.


Options:
A: Changing LDL Cholesterol (36 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: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
D: First occurrence of death or nonfatal myocardial infarction (MI) or nonfatal stroke

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)
Brief Summary: The purpose of this study is to determine the long-term safety and effectiveness of exercise training for individuals with congestive heart failure (CHF).


Options:
A: Baseline to post intervention (12 weeks) and follow-up (32 weeks) change in Body Composition. (Change from baseline to post intervention (12 weeks) and follow-up (32 weeks))
B: Patient rated physical functioning (at 8 weeks and 24 weeks)
C: Quality of Life
D: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)
Brief Summary: The purpose of this study is to determine the long-term safety and effectiveness of exercise training for individuals with congestive heart failure (CHF).


Options:
A: Peak exercise capacity (16 weeks)
B: Peak oxygen uptake
C: HF-specific quality of life (baseline, midpoint, endpoint, 6mo); functional capacity (baseline and endpoint); Walking Test (baseline, midpoint, endpoint)
D: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)
Brief Summary: The purpose of this study is to determine the long-term safety and effectiveness of exercise training for individuals with congestive heart failure (CHF).


Options:
A: Percentage of Participants With Remission (Score of 12 or Less on Inventory for Depressive Symptomatology- Clinician-rated) (12 weeks)
B: Measured at Week 16 and Months 6 and 12 post-treatment: Post-treatment recovery from MDD; Post-treatment depression scores on the Hamilton Depression Rating Scale
C: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)
D: Hamilton Depression Rating Scale (Measured at 16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)
Brief Summary: The purpose of this study is to determine the long-term safety and effectiveness of exercise training for individuals with congestive heart failure (CHF).


Options:
A: Exercise Capacity (20 weeks)
B: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)
C: Improvement tolerance capacity (4 months and 6 months)
D: Change in Peak VO2 after three months (Baseline and three months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)
Brief Summary: The purpose of this study is to determine the long-term safety and effectiveness of exercise training for individuals with congestive heart failure (CHF).


Options:
A: Mental Stress Induced Elevation in "Double Product" by Math Stress Task (Immediate to 6 months post intervention); Mental Stress Induced Elevation in Double Product by Math Stress Task (3 months post intervention); Mental Stress Induced Elevation in "Double Product" by Anger-recall Task (Immediate to 6 months post intervention)
B: Quality of life (3 -6-12 month); Physical capability (3-6-12 month)
C: Hospital Anxiety and Depression Scale - Depression Scale at Baseline (Baseline); Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up (Six-months follow-up); Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up (Twelve-months follow-up); Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline (Baseline); Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up (Six-months follow-up); Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up (Twelve-months follow-up); Impact of Events Scale-Revised - Total Score at Baseline (Baseline); Impact of Events Scale-Revised - Total Score at 6-months Follow-up (Six-months follow-up); Impact of Events Scale-Revised - Total Score at 12-months Follow-up (Twelve-months follow-up); Impact of Events Scale-Revised - Intrusiveness Scale at Baseline (Baseline); Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up (Six-months follow-up); Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up (Twelve-months follow-up); Impact of Events Scale-Revised - Avoidance Scale at Baseline (Baseline); Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up (Six-months follow-up); Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up (Twelve-months follow-up); Impact of Event Scale-Revised Hyperarousal Scale at Baseline (Baseline); Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up (Six-months follow-up); Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up (Twelve-months follow-up); Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline (Baseline); Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up (Six-months follow-up); Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up (Twelve-months follow-up)
D: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)
Brief Summary: The purpose of this study is to determine the long-term safety and effectiveness of exercise training for individuals with congestive heart failure (CHF).


Options:
A: Possible (neuro)physiological determinants of postcancer fatigue (The measurements will be performed at baseline and comparable measurements will be performed 6 months later (after 6 months cognitive behavior therapy or 6 months waiting list condition))
B: Change in QoL between baseline and postintervention. (12 weeks)
C: Change from baseline in Exercise Levels (Baseline and within 7 days of completing the 12-week intervention)
D: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)
Brief Summary: The purpose of this study is to determine the long-term safety and effectiveness of exercise training for individuals with congestive heart failure (CHF).


Options:
A: CR Program Adherence (6 months)
B: Maximal oxygen consumption (At baseline and after 6 months)
C: Mortality rate (10-year)
D: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)
Brief Summary: The purpose of this study is to determine the long-term safety and effectiveness of exercise training for individuals with congestive heart failure (CHF).


Options:
A: Mortality rate (10-year)
B: Participation in cardiac rehabilitation (4 months)
C: Adherence to cardiac rehabilitation (After 8 weeks of cardiac rehabilitation); Morbidity and mortality (Three or four years after last patient into trial)
D: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Citalopram Augmentation in Older Patients With Schizophrenia
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of citalopram (Celexa) for the treatment of depressive symptoms in middle-aged and elderly patients with schizophrenia.


Options:
A: N/A
B: N/A
C: Scores on Hamilton Depression Rating Scale (8 time points through 6 weeks)
D: Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint] (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this trial is to test the safety, tolerability, and effectiveness of minocycline compared to placebo in patients with amyotrophic lateral sclerosis (ALS).


Options:
A: Survival
B: to evaluate the long-term safety and tolerability of thalidomide; to compare the total number of adverse events (AE), abnormal laboratory tests, and number of patients who completed the study between groups
C: Change in function as detected by the ALS Functional Rating Scale (ALSFRS-R) in patients taking minocycline compared to those taking placebo.
D: Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire (ALSFRS-R) (9 months: Baseline to study termination (January 2009 - October 2009))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Intravenous Epoetin Alfa to Maintenance Treatment With Intravenous RO0503821 in Hemodialysis Patients With Chronic Renal Anemia.
Brief Summary: This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.


Options:
A: Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen (From Baseline (Day -28 to Day 1) to EOIT (Week 19))
B: Occurrence of clinically relevant calcium disturbances (patients are followed for 8 weeks); Occurrence of clinically relevant acid-base disturbances (patients are followed for 8 weeks)
C: The Primary End Point is the Regression of Left Ventricular Hypertrophy (LVH) by Echocardiographic Criteria From Baseline to 1 Year. (Baseline, 6 months, 12 months)
D: Percent change in left ventricular volume index (LVVI) at Week 96.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Multicenter Evaluation of Intravenous Levosimendan Efficacy Versus Placebo in the Short Term Treatment of Decompensated Chronic Heart Failure: the REVIVE II Study.
Brief Summary: The purpose of this study is to evaluate the efficacy of a 24-hour infusion of levosimendan compared with placebo in the treatment of decompensated chronic heart failure.


Options:
A: B-type natriuretic peptide (7 days)
B: Mortality (30-days)
C: All cause mortality at 30 days post randomization
D: A clinical composite classification incorporating a Patient Global Assessment at 6 hours, 24 hours and Day 5, combined with clinical criteria for worsening heart failure through 5 days after the start of the study drug infusion.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis
Brief Summary: This is a multicenter, Phase 3 randomized, placebo-controlled study designed to evaluate adalimumab in children 4 to 17 years old with polyarticular juvenile idiopathic arthritis (JIA) who are either methotrexate (MTX) treated or non-MTX treated.


Options:
A: To demonstrate that a higher proportion of subjects will have an improvement of uveitis on adalimumab versus placebo after 2 months relative to baseline (Final visit could occur at any point up to 78 weeks)
B: Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase (Week 16 to Week 48 (32 weeks))
C: ACR Pedi 75 response (54 weeks from baseline (0))
D: Time to Treatment Failure (From baseline until 48 weeks post-randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: PEG-Intron as Maintenance Therapy vs. an Untreated Control Group in Adult Subjects With Compensated Cirrhosis (METAVIR F4), Secondary to Chronic Hepatitis C, Who Have Failed to Respond to Therapy With Any Alpha Interferon Plus Ribavirin
Brief Summary: The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no treatment for the prevention of disease progression in adult subjects with compensated cirrhosis secondary to chronic hepatitis C, who failed to respond to therapy with an a interferon plus ribavirin.


Options:
A: Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points (1400 days (3.85 years) post randomization); Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies (1400 days (3.85 years) post randomization); Death From Any Cause (1400 days (3.85 years) post randomization); Development of Hepatocellular Carcinoma (HCC) (1400 days (3.85 years) post randomization); Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits (1400 days (3.85 years) post randomization); Variceal Hemorrhage (1400 days (3.85 years) post randomization); Ascites (1400 days (3.85 years) post randomization); Spontaneous Bacterial Peritonitis (1400 days (3.85 years) post randomization); Hepatic Encephalopathy (1400 days (3.85 years) post randomization)
B: Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment (24 weeks after last planned dose of study treatment (up to Week 72))
C: Sustained Virologic Response (SVR) Rate (At Follow-up Week (FW) 24)
D: Time to Observation of the First Clinical Event Experienced by a Subject (Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event)

Answer: D