TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Daclizumab in Patients With Chronic, Persistent Asthma
Brief Summary: The purpose of the study is to evaluate an investigational medication to treat chronic persistent asthma. The research is being conducted at up to 22 clinical research sites in the US and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site over a 10-month period. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.


Options:
A: Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 28; Day 35); Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 56; Day 63, 84, 105 and 147); Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0 - Infinity]) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Apparent Terminal Elimination Phase Half-Life (t[1/2]el) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Clearance (CL) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Volume of Distribution (Vd) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Observed Serum Drug Concentration for CAT-354 28 Days (C28) After First Dose (Pre-dose on Day 28); Observed Serum Drug Concentration for CAT-354 28 Days (C28) After Second Dose (Pre-dose on Day 56); Observed Serum Concentration for CAT-354 28 Days (C28) After Third Dose (Day 84); Accumulation Ratio (R0) for CAT-354 (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0 and 56; Pre-dose on Day 28; Day 4, 7, 14, 21, 63 and 84)
B: Late asthmatic response (LAR) (Day 92)
C: N/A
D: Annualized Rate of Asthma Exacerbations Over the Treatment Period (up to Week 24) (Baseline (Week 0) up to Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Daclizumab in Patients With Chronic, Persistent Asthma
Brief Summary: The purpose of the study is to evaluate an investigational medication to treat chronic persistent asthma. The research is being conducted at up to 22 clinical research sites in the US and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site over a 10-month period. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.


Options:
A: Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second (Baseline and Week 24); Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months (Baseline to Week 24)
B: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in Full Analysis Set (Baseline (Day 1), Week 16)
C: Percentage of Participants With Asthma Exacerbations at Week 12 (Week 12)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Tial Of Paclitaxel Versus Paclitaxel Plus Bevacizumab (rhuMAb VEGF) As First-Line Therapy For Locally Recurrent or Metastatic Breast Cancer
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. It is not yet known whether paclitaxel works better with or without bevacizumab in treating breast cancer.

PURPOSE: This randomized phase III trial is to see if paclitaxel works better with or without bevacizumab in treating patients who have locally recurrent or metastatic breast cancer.


Options:
A: Number of Eyes Showing Recurrence of Neovascularization Arising From the Retinal Vessels and Requiring Re-treatment (54 weeks postmenstrual age (window of 50 to 70 weeks))
B: N/A
C: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)
D: Progression-Free Survival (Assessed every 3 months for 2 years, then every 6 months for 3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Chiropractic Care, Medication, and Self-Care for Neck Pain
Brief Summary: This study will compare the effectiveness of chiropractic care, medications, and self-care on neck pain, a very common condition. The broad, long-term objective of this study is to identify effective therapies for neck pain sufferers and to increase understanding of neck pain conditions.


Options:
A: N/A
B: Patient-rated neck and back disability (9 months)
C: Patient-rated pain (0-10 scale, 11 box) (short term = 12 weeks; long term = 52 weeks)
D: Manual Examination of the Cervical Spine; Pressure algometry; Thermal stimulation; Perceived effect; HIT-6

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Chiropractic Care, Medication, and Self-Care for Neck Pain
Brief Summary: This study will compare the effectiveness of chiropractic care, medications, and self-care on neck pain, a very common condition. The broad, long-term objective of this study is to identify effective therapies for neck pain sufferers and to increase understanding of neck pain conditions.


Options:
A: N/A
B: Reduction in number of days per month with headache and shoulders pain after 6 months.Proportion of subjects with more than 4 days with headache and shoulder pain at the baseline that will have reduction in pain frequency of more than 50%, after 6 months (6 months)
C: Pain of the neck and shoulders (At week 0 (baseline) and week 20 (follow-up)); Pain in the arm/hand (At week 0 (baseline) and week 20 (follow-up))
D: Pain (Measured 3 months after the accident); Functional activity (Measured 3 months after the accident); Mood (Measured 3 months after the accident)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Chiropractic Care, Medication, and Self-Care for Neck Pain
Brief Summary: This study will compare the effectiveness of chiropractic care, medications, and self-care on neck pain, a very common condition. The broad, long-term objective of this study is to identify effective therapies for neck pain sufferers and to increase understanding of neck pain conditions.


Options:
A: N/A
B: neck/shoulder pain, selfreported (20 weeks)
C: Reduction in number of days per month with headache and shoulders pain after 6 months.Proportion of subjects with more than 4 days with headache and shoulder pain at the baseline that will have reduction in pain frequency of more than 50%, after 6 months (6 months)
D: Neck Pain (Up to 10 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing Effect and Safety in Obese Patients With Type 2 Diabetes
Brief Summary: To assess the effect on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with Type 2 Diabetes


Options:
A: Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52 (52 weeks); Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104 (104 weeks)
B: Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE) (Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up)
C: Change in body weight
D: Change in ambulatory blood pressure (50 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing and Prevention of Weight Regain Effects and Safety in Obese Patients With or Without Comorbidities
Brief Summary: To assess the effects of weight loss and weight maintenance over a period of two years when prescribed with a hypocaloric diet in obese patients with or without comorbidities


Options:
A: Absolute change from baseline in averaged per patient carotid artery intima-media thickness (CIMT) (Month 30)
B: Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim Analysis (Baseline up to Month 42); Time From Randomization to First Occurrence of MACE+ (Baseline up to end of study (Month 56))
C: Percent Weight Change at End of Treatment, Week 108. (From baseline to end of treatment); Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108. (Baseline to End of Treatment)
D: Change in body weight

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The purpose of this study is to determine if natalizumab in combination with AVONEX is safe and effective in delaying progression of individuals diagnosed with relapsing remitting Multiple Sclerosis (MS).


Options:
A: Part 1: Percentage of Participants With Confirmed Progression of Disability in One or More of the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), or 9-Hole Peg Test (9HPT) (Up to 96 weeks (2 years)); Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (218 weeks)
B: Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6 (Baseline, Month 6)
C: Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS. (1 year and 2 years)
D: Adjusted Annualized Relapse Rate (ARR) (Up to 144 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The purpose of this study is to determine if natalizumab in combination with AVONEX is safe and effective in delaying progression of individuals diagnosed with relapsing remitting Multiple Sclerosis (MS).


Options:
A: Adjusted Annualized Relapse Rate Between Baseline and Week 52 (Baseline through Week 52)
B: Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS. (1 year and 2 years)
C: Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain (Week 12 to Week 24)
D: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity (From the first dose of study drug administration up to Week 24); Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) (Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36); Change From Baseline in Vital Signs: Pulse Rate (Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36); Change From Baseline in Vital Signs: Temperature (Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36); Change From Baseline in Electrocardiogram (ECGs) (Baseline, Week 12 and 36); Number of Subjects With Worsened Post Baseline Shift in Immunoglobulin A (IgA), IgG and IgM Levels (Baseline up to Week 36); Number of Subjects With Positive Neutralizing Antibody (NAb) (Baseline, Week 12 and 36)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The purpose of this study is to determine if natalizumab in combination with AVONEX is safe and effective in delaying progression of individuals diagnosed with relapsing remitting Multiple Sclerosis (MS).


Options:
A: Number of Participants With Treatment-emergent Adverse Events (AEs) (Up to 72 weeks); Number of Participants With Abnormalities in Vital Signs (Up to Week 72); Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities (Up to 72 Weeks); Number of Participants With Abnormalities in Blood Chemistry Laboratory Data (Up to 72 Weeks); Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline (Up to 72 weeks)
B: Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS. (1 year and 2 years)
C: Number of Days Until First On-study Relapse (12 months)
D: Adjusted Annualized Relapse Rate (ARR) (Up to 144 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The purpose of this study is to determine if natalizumab in combination with AVONEX is safe and effective in delaying progression of individuals diagnosed with relapsing remitting Multiple Sclerosis (MS).


Options:
A: The primary objectives of this study are to determine whether natalizumab, when compared with placebo, is effective in reducing the rate of clinical relapses at 1 year and, in slowing the progression of disability at 2 years. (1 year and 2 years)
B: Time to First Relapse (Baseline up to 96 weeks)
C: Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS. (1 year and 2 years)
D: Hazard ratio for relapses (During the first and during the second 52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) Treatment (CAT)
Brief Summary: The purpose of this study is to determine the safety and efficacy of clonidine alone or in combination with methylphenidate for children 7-12 years of age with attention-deficit, hyperactivity disorder.


Options:
A: Efficacy outcome was change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T) (at 16 weeks)
B: Attention Deficit / Hyperactivity Disorder Total Sum Score of All 18 ADHD Symptom Items (end of first week, end of second week, end of third week, end of fourth week. Total of 4 weeks.)
C: The primary objective of this study is to evaluate, under controlled conditions, the safety and efficacy of SPD485 (MTS) compared to placebo with reference to CONCERTA®, as determined by the change in the clinician completed ADHD-RS-IV at each visit. (7 weeks)
D: Clinicians Manuals from Russell A. Barkley as Disruptive Behavior Disorders Rating Scale--Parent Form (Form 4), Disruptive Behavior Disorders Rating Scale--Teacher Form (Form 5) and Clinical Interview--Parent Report Form (Form 6) (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) Treatment (CAT)
Brief Summary: The purpose of this study is to determine the safety and efficacy of clonidine alone or in combination with methylphenidate for children 7-12 years of age with attention-deficit, hyperactivity disorder.


Options:
A: Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Combined Attention and Deportment Scores at 10, 11, and 12 Hour (Averaged) Post-dose (Pre-dose to 10, 11, and 12 hours post-dose)
B: Pain Scores on Standardized Experimental Pain Testing (baseline and 1 hour pain measurement)
C: occurrence of treatment-emergent adverse events (Within 6 months)
D: Efficacy outcome was change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T) (at 16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Equivalence Trial of Azithromycin vs. Benzathine Penicillin for the Treatment of Early Syphilis
Brief Summary: The purpose of this study is to determine if azithromycin, a drug approved for treatment of other infections, is as effective for syphilis (a sexually transmitted disease) as the standard treatment. Approximately 600 healthy adults, who are HIV-negative, ages 18 to 55 years of age, with primary, secondary or early latent syphilis, will participate in this research study. Volunteers will be enrolled in 5 U.S. cities and in Madagascar. Participants will be chosen randomly (by chance) to receive 1 of 2 study drugs: benzathine penicillin given (2 shots in the buttocks) or 4 tablets of azithromycin. Subjects who report a history of a penicillin allergy will be given either 2.0 g of oral azithromycin or 100 mg doxycycline taken orally, twice a day for 14 days. Over 2 years, 10 visits will be required. Procedures will include blood samples, physical exams, and swabs of sores.


Options:
A: To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.
B: Cure of syphilis defined as a negative reactive serologic test for syphilis (RPR) titer or greater than or equal to a 4-fold (2 dilution) decrease in RPR titer at 6 months following treatment and resolution of all signs and symptoms of syphilis. (Month 6.)
C: Plasma HIV-1 levels and HIV-1 mucosal shedding (18 weeks)
D: Difference of HIV-1 RNA and DNA shedding assessed by performing cervicovaginal lavage (CVL) HIV viral load, among groups; Difference of HSV-2 DNA shedding among groups

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Carpal Tunnel Syndrome: Diagnosis and Treatment Trial
Brief Summary: The Carpal Tunnel Syndrome Diagnosis and Treatment Trial is project #1 of the Multidisciplinary Clinical Research Center focused on upper extremity pain. It is a randomized trial comparing surgical and nonsurgical treatments for patients with early, mild to moderate carpal tunnel syndrome. In addition the study will evaluate the ability of a new magnetic resonance (MR) technique at predicting who will likely benefit from carpal tunnel syndrome (CTS) surgery.


Options:
A: Changes in the intensity of pain symptoms between baseline and follow-up periods (Baseline and 1, 3, 6 and 12 months after the intervention)
B: Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand (5 to 7 years); Symptom Severity Score (5-7 years)
C: Changes in hand function between baseline and follow-up periods (Baseline and 1, 3, 6 and 12 months after the intervention)
D: Carpal Tunnel Syndrome Assessment Questionnaire- function scale (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of a Wedged Insole for Treatment of Osteoarthritis of the Knee
Brief Summary: This trial will test shoe inserts for the treatment of knee osteoarthritis, the most common form of knee arthritis. Those with disease on the inner (medial) aspect of the knee will be studied.


Options:
A: The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index (3 weeks)
B: Change in knee pain intensity from baseline at 4 weeks (4 weeks)
C: N/A
D: the more small change clinically relevant of the WOMAC indice and/or of pain. (at 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #453 - Homocysteinemia in Kidney and Endstage Renal Disease Study (HOST)
Brief Summary: The primary objective of this study is to test the hypothesis that administration of folate, pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) in high doses to patients with advanced chronic renal failure or end stage renal disease and abnormally high plasma homocysteine levels will lower the homocysteine levels and the death rate compared to patients who receive placebo. The secondary objective is to test the hypothesis that intake of the vitamins compared to placebo decreases the incidence of myocardial infarction, disabling stroke, and amputation of a lower extremity and, in hemodialysis patients, thrombosis of the vascular access.


Options:
A: serum B12 status; serum folate status
B: N/A
C: The composite of cardiovascular death, myocardial infarction (MI) and stroke
D: 1 or more adenomas (For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #453 - Homocysteinemia in Kidney and Endstage Renal Disease Study (HOST)
Brief Summary: The primary objective of this study is to test the hypothesis that administration of folate, pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) in high doses to patients with advanced chronic renal failure or end stage renal disease and abnormally high plasma homocysteine levels will lower the homocysteine levels and the death rate compared to patients who receive placebo. The secondary objective is to test the hypothesis that intake of the vitamins compared to placebo decreases the incidence of myocardial infarction, disabling stroke, and amputation of a lower extremity and, in hemodialysis patients, thrombosis of the vascular access.


Options:
A: Common carotid artery intima media thickness; Brachial artery flow mediated vasodilatation
B: N/A
C: Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes (The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).)
D: The composite of cardiovascular death, myocardial infarction (MI) and stroke

Answer: B