TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Exercise on Individuals With Parkinson's Disease
Brief Summary: The goal of this trial is to compare the effect of two different exercise programs on neuro-physiological, motor, functional, and quality-of-life issues in individuals with Parkinson's disease to determine which program is most beneficial.


Options:
A: The equilibrium score (ES) and sensory ratio were measured. The verbal reaction time (VRT) was recorded. (6 weeks)
B: Off Medication UPDRS Part III, Motor Subscale Score (obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
C: Falls rate (6 months post intervention)
D: Parkinson's Disease Quality of Life Questionnaire (PDQL) (8 months); AMC Linear Disability Score (ALDS) (8 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Teleconference Delivered Fatigue Management Program for People With Multiple Sclerosis
Brief Summary: Approximately 60% of individuals with multiple sclerosis (MS) describe fatigue as their most disabling symptom. Energy conservation education involves teaching people with MS different strategies to manage fatigue and reduce its impact on daily life. Despite growing evidence of the effectiveness of face-to-face energy conservation education, not all people with MS are able to access these programs. The purpose of this project is to test the effectiveness and efficacy of a teleconference-delivered energy conservation education program for people with MS. The primary goals of the project are to reduce the impact of fatigue on participants' everyday lives, reduce fatigue severity, and improve quality of life. Secondary goals are to increase self-efficacy for managing fatigue and increase the number of energy conservation strategies used. The study will employ a randomly allocated two group time series design with a wait-list control group, which is one type of randomized control trial. A total of 181 people with MS will be recruited through direct mailing and advertising. The program will be delivered by telephone teleconference by a licensed occupational therapist. Outcome measures will be administered over the telephone by a research assistant before and after the program, at three months and at six months. We hypothesize that: (1) individuals in the immediate intervention group achieve better outcomes than individuals in the wait-list control group; (2) the program leads to significant reductions in fatigue impact and fatigue severity, and improved quality of life; and (3) improvements in the outcomes can be maintained over six months.


Options:
A: Time Per Patient From a Clinical Event to a Clinical Decision in Response to Arrhythmias, Cardiovascular (CV) Disease Progression, and Device Issues (Enrollment to last visit (up to 15 month post-implant))
B: Change in medication adherence (Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months); Change in number of hospitalizations (costs) (Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months)
C: Blood Pressure Control (Baseline, 6 months, 12 months, 18 months); Mean Systolic Blood Pressure (Baseline, 6 months, 12 months, 18 months, 54 months); Mean Diastolic Blood Pressure (Baseline, 6 months, 12 months, 18 months, 54 months)
D: Change From Baseline in Subscale Scores of the Fatigue Impact Scale (baseline, 7 weeks (immediate post-intervention))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of SCE-B on Nocturnal Vasomotor Symptoms in Postmenopausal Women
Brief Summary: This is a multi-center study to evaluate the effects of SCE-B on nocturnal vasomotor symptoms. Study duration will be approximately 16 weeks; this includes a 4-week screening period and approximately 5 scheduled clinic visits. Participants will receive one of two strengths of SCE-B tablets plus matching placebo or placebo only, and will have a physical and gynecological exams that may include transvaginal ultrasound, endometrial biopsy and a pap smear. Participants will be asked to wear a monitoring device for a portion of the study and be asked to complete a daily dairy.


Options:
A: Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes (Baseline to End of Treatment (Week 12))
B: Relief of vaginal symptoms (over 12 months of treatment); Safety: Long-term effect on the endometrium assessed through evaluation of endometrial biopsies. AEs, clinical laboratory data and serum hormone levels
C: Clinical symptoms (after 12 months)
D: Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole (Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease (up to approximately 38 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: OSTPRE-FPS Prevention of Fractures and Falls in Postmenopausal Women With Calcium and Vitamin-D Supplementation - a Randomised Study
Brief Summary: The purpose of this study is to determine the effect of calcium 1000 mg/d and vitamin-D3 800 IU/d divided in two daily doses on the incidence of falls and fractures, bone mineral density and bone metabolism in postmenopausal women 65-71 years of age.


Options:
A: Chang in Disposition Index, a Measure of Beta Cell Function (baseline and 4 months)
B: The primary outcome measure is change in 25OHD with various D2 and D3 dosing regimens. (12 months)
C: fractures (4 years)
D: fractures (3 year follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: OSTPRE-FPS Prevention of Fractures and Falls in Postmenopausal Women With Calcium and Vitamin-D Supplementation - a Randomised Study
Brief Summary: The purpose of this study is to determine the effect of calcium 1000 mg/d and vitamin-D3 800 IU/d divided in two daily doses on the incidence of falls and fractures, bone mineral density and bone metabolism in postmenopausal women 65-71 years of age.


Options:
A: fractures (3 year follow-up)
B: Serum calcium (at each dose change)
C: Body Weight; Body composition; Measures of calcium metabolism; Insulin sensitivity; Muscle strength; Depression score; Blood pressure
D: median time to next exacerbation. (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy Study 1. Phase I Study of Feasibility and Safety.
Brief Summary: This is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous)umbilical cord blood in the first 14 days after birth if the baby is born with signs of brain injury.


Options:
A: Adverse event rates occurring in the pilot study population will be compared between the cord blood cell recipients and historical controls. (during infusions: first 18 postnatal days)
B: Serious adverse event (14 days of life)
C: Neurodevelopmental outcomes (6 months); EEG changes (2-3 weeks); MRI of the brain (3 weeks)
D: Incidence of Any Treatment-emergent Serious Adverse Events (TE-SAEs) (One month post-catheterization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy Study 1. Phase I Study of Feasibility and Safety.
Brief Summary: This is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous)umbilical cord blood in the first 14 days after birth if the baby is born with signs of brain injury.


Options:
A: To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner (Longitudinal database currently funded through 3/31/2030)
B: Number of subjects with Adverse Drug Reaction (at corrected age of 21 months (±3 months))
C: Number of participant with adverse reaction (12 weeks from the day of treatment)
D: Adverse event rates occurring in the pilot study population will be compared between the cord blood cell recipients and historical controls. (during infusions: first 18 postnatal days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)
Brief Summary: The purpose of the study is to evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule.

A five year follow-up visit is being conducted in 2014 to gather information on long term outcomes.


Options:
A: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)
B: Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 (Baseline to Month 24)
C: Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year (Baseline, Year 1)
D: Visual acuity; Central macular thickness

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)
Brief Summary: The purpose of the study is to evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule.

A five year follow-up visit is being conducted in 2014 to gather information on long term outcomes.


Options:
A: visual acuity; central macular thickness
B: Mean Change in Best Corrected Visual Acuity (BCVA) at Month 6 (6 months)
C: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)
D: Visual acuity; Central macular thickness

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)
Brief Summary: The purpose of the study is to evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule.

A five year follow-up visit is being conducted in 2014 to gather information on long term outcomes.


Options:
A: Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) (Baseline and at week 52)
B: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)
C: N/A
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)
Brief Summary: The purpose of the study is to evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule.

A five year follow-up visit is being conducted in 2014 to gather information on long term outcomes.


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: Assessment of Ocular Adverse Events (6 months)
C: N/A
D: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)
Brief Summary: The purpose of the study is to evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule.

A five year follow-up visit is being conducted in 2014 to gather information on long term outcomes.


Options:
A: The difference from baseline in mean Best Corrected Visual Acuity (BCVA) (12 months)
B: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)
C: N/A
D: Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye (Baseline, Month 1 through Month 3)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)
Brief Summary: The purpose of the study is to evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule.

A five year follow-up visit is being conducted in 2014 to gather information on long term outcomes.


Options:
A: N/A
B: Change of visual acuity over time (12 months)
C: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)
Brief Summary: The purpose of the study is to evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule.

A five year follow-up visit is being conducted in 2014 to gather information on long term outcomes.


Options:
A: N/A
B: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)
C: change in best-corrected visual acuity (6 months)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Advancing INSIGHT Methods in General Practice
Brief Summary: Family Physicians, the subjects of this trial are reluctant to initiate insulin in patients with type 2 diabetes due to a lack of familiarity and comfort with this clinical strategy. This study will test the effectiveness of diabetes specialist consultation support, and community pharmacy insulin initiation support on the insulin prescribing behaviour of family physicians across Canada.


Options:
A: Insulin Prescription Rate - the Number of Insulin-eligible Patients Per 12 Months Who Are Prescribed Insulin in Each Family Physician (FP) Practice (12 months)
B: hemoglobin A1c levels (at six months)
C: Percentage of patients who attain 2 or more of the 'ABC' targets (12 months)
D: Hemoglobin A1c (Change from baseline to 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind Safety Comparison of Intravenous Iron Dextran Versus Iron Sucrose in an Adult Non-Hemodialysis Outpatient Population: A Pilot Study
Brief Summary: The purpose of this trial is to compare the safety profile using equal doses of intravenous iron dextran versus iron sucrose. The researchers hypothesize that significantly more patients receiving intravenous iron dextran (using the current intermediate molecular weight product) will have severe adverse outcomes than patients receiving iron sucrose in the adult non-hemodialysis outpatient population. Secondly, since these severe reactions may require additional nursing time and physician interventions that may negate any cost advantage of iron dextran, the researchers hypothesize that iron sucrose will be more cost-effective than iron dextran.


Options:
A: Change in Peak VO2 (mL/kg/min) from baseline to Week 24 (Week 24)
B: Red blood cell (RBC) units transfused (7 days)
C: Incidence of severe adverse drug reactions (ADRs) (Immediate - during infusion)
D: Iron bio-availability (%) from oral iron supplementation (3x 120 mg) (3 days); Serum hepcidin concentrations on the 1st day of iron supplementation (1 day); Iron bio-availability (%) from oral iron supplementation (6x 60 mg) (6 days); Serum hepcidin concentrations on the 2nd day of iron supplementation (2 days); Serum hepcidin concentrations on the 3rd day of iron supplementation (3 days); Serum hepcidin concentrations on the 4th day of iron supplementation (4 days); Serum hepcidin concentrations on the 5th day of iron supplementation (5 days); Serum hepcidin concentrations on the 6th day of iron supplementation (6 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Anti-Nephropathic Effects of Chronic Intermittent Intravenous Insulin Therapy (CIIIT)
Brief Summary: Investigators with the goal of optimizing glycemic and blood pressure control saw type 1 diabetic patients weekly. A control group received 3-4 subcutaneous insulin injections per day; an intravenous insulin pulsed infusion group received, in addition, three one hour infusions in a pulsatile fashion over one eight hour period each week. Patients were followed for 12 months with periodic testing of renal function by repeated blood and urinary analyses; diabetes control by blood testing and diabetes impact measurement score; cardiac and autonomic function by echocardiography, 24 hour electrocardiographic testing; and visual changes with repeated fundus photography. The study hypothesis was that correction of respiratory quotient would correct the defect leading to microvascular complications of diabetes (Type 1).


Options:
A: Change in HbA1c From Baseline to Week 52 (Day 1 (Baseline) and Week 52)
B: Rate of loss of creatinine clearance (18 months)
C: Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) (Baseline , Week 24)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555-18) 1 Mg Bid For Smoking Cessation (Protocol A3051080)
Brief Summary: The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.


Options:
A: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
B: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (Assessed 26 weeks after the target quit day.)
C: 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (Week 11)
D: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555-18) 1 Mg Bid For Smoking Cessation (Protocol A3051080)
Brief Summary: The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.


Options:
A: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
B: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)
C: Tobacco use (Six-month follow-up)
D: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555-18) 1 Mg Bid For Smoking Cessation (Protocol A3051080)
Brief Summary: The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.


Options:
A: Continuous Nicotine Abstinence (8 weeks)
B: Seven-day point prevalence smoking abstinence at end of trial (abstinence based on self-reported smoking abstinence verified by CO levels < 10 ppm) (9 weeks)
C: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
D: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Baseline up to 30 days after last dose of study treatment or up to Week 16); Number of Participants With Psychiatric Adverse Events (Baseline up to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS) (Baseline to Week 12); Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS) (Baseline to Week 24); Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase (Week 1 to Week 12 (Treatment phase)); Number of Participants With Suicidal Behavior or Suicical Ideation ("Yes" Response ) on the Columbia Suicide-Severity Rating Scale (C-SSRS) During the Post Treatment Phase (Week 13 to Week 24 (Post treatment phase)); Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline (Bsl) to Week 12); Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline to Week 24); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1 (Baseline, Week 1); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12 (Baseline, Week 12); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24 (Baseline, Week 24)

Answer: C