TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Safety and Immunogenicity of GSK Biologicals' HPV Vaccine 580299 When Administered in Healthy Females Aged 9 - 25 Years Using an Alternative Schedule and an Alternative Dosing as Compared to the Standard Schedule and Dosing
Brief Summary: Human Papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. GlaxoSmithKline (GSK) Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers. In previous trials this vaccine has been found to be efficacious in the prevention of incident and persistent HPV-16/18 infections and associated cytological abnormalities and cervical dysplasia. In this partially-blind study, GSK Biologicals will evaluate the safety and immunogenicity of the HPV vaccine using an alternative schedule and an alternative dosing when administered in healthy young females aged 9 to 25 years, as compared to the standard HPV vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following a protocol amendment.


Options:
A: Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies (One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).); Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms (Within 7 days (Day 0-6) after vaccination.); Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms (Within 7 days (Day 0-6) after vaccination.)
B: Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7.
C: Number of Subjects With Injection Site Adverse Experiences (Days 1-5 following any vaccination visit)
D: Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens (One month after the third dose (at Month 7))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Effectiveness and Cost-effectiveness of a Monitoring System for Patients With COPD and Asthma With Persistent Obstruction in Primary Care; a Multicentre Randomised Nested Clinical Trial
Brief Summary: The purpose of this study is to determine the clinical effectiveness and cost-effectiveness of a written expert advice for GPs on additional diagnostic, treatment, and referral of patients based on half-yearly monitoring routines for patients with COPD or ashtma with a persistent obstruction in primary care based on a multicentre randomised nested clinical trial


Options:
A: Characterize COPD Disease Severity in Clinical Practice (2 years); Characterize COPD Disease Activity in Clinical Practice (2 years)
B: Change in Respiratory Specific Health Related Quality of life (HRQoL) (3 months)
C: Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge (6 months post-discharge from hospitalization following COPD exacerbation)
D: Disease-specific health related quality of life assessed with the Chronic Respiratory Questionnaire (CRQ-SR) (At baseline, after one year follow-up, and after two years follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Effectiveness and Cost-effectiveness of a Monitoring System for Patients With COPD and Asthma With Persistent Obstruction in Primary Care; a Multicentre Randomised Nested Clinical Trial
Brief Summary: The purpose of this study is to determine the clinical effectiveness and cost-effectiveness of a written expert advice for GPs on additional diagnostic, treatment, and referral of patients based on half-yearly monitoring routines for patients with COPD or ashtma with a persistent obstruction in primary care based on a multicentre randomised nested clinical trial


Options:
A: The two primary outcomes are disease-specific quality of life assessed with the St. George's Respiratory Questionnaire (SGRQ) and the total number of exacerbations
B: Chronic Respiratory Disease Questionnaire (6, 12, and 18 months); 6-minute walk (6, 12, and 18 months)
C: Disease-specific health related quality of life assessed with the Chronic Respiratory Questionnaire (CRQ-SR) (At baseline, after one year follow-up, and after two years follow-up)
D: Health-Related quality of life (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study
Brief Summary: Diabetic retinopathy (DR) is an eye disease that can occur in people with diabetes and can cause poor vision or blindness. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study is examining the effect of various treatments on cardiovascular disease in people with diabetes. This current study will examine the effects of the ACCORD treatments on the progression of DR in people participating in the ACCORD study.


Options:
A: Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy (Measured at Year 4)
B: Percentage of Participants Who Improved by ≥2 Steps From Baseline in the Diabetic Retinopathy Disease Severity Scale (DRSS) Score at Week 24 in the Combined 2Q16 and 2Q8 Groups (At Week 24); Percentage of Participants With a ≥ 2-step Change at Week 52 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline (At Week 52)
C: Mean Change in Visual Acuity From Baseline (2-years)
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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study
Brief Summary: Diabetic retinopathy (DR) is an eye disease that can occur in people with diabetes and can cause poor vision or blindness. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study is examining the effect of various treatments on cardiovascular disease in people with diabetes. This current study will examine the effects of the ACCORD treatments on the progression of DR in people participating in the ACCORD study.


Options:
A: To recruit 285 type 1 DM Pts without HTN, diabetic nephropathy, or microalbuminuria into a 5-year study to determine the effect of inhibition RAS with either losartan or enalapril. (5 year); To obtain two percutaneous renal biopsies from each patient, five years apart. (5 year)
B: Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale. (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
C: Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy (Measured at Year 4)
D: BP measurement (Measured at 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study
Brief Summary: Diabetic retinopathy (DR) is an eye disease that can occur in people with diabetes and can cause poor vision or blindness. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study is examining the effect of various treatments on cardiovascular disease in people with diabetes. This current study will examine the effects of the ACCORD treatments on the progression of DR in people participating in the ACCORD study.


Options:
A: 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)
B: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)
C: Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy (Measured at Year 4)
D: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study
Brief Summary: Diabetic retinopathy (DR) is an eye disease that can occur in people with diabetes and can cause poor vision or blindness. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study is examining the effect of various treatments on cardiovascular disease in people with diabetes. This current study will examine the effects of the ACCORD treatments on the progression of DR in people participating in the ACCORD study.


Options:
A: Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy (Measured at Year 4)
B: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF] (From Baseline to Week 24)
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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study
Brief Summary: Diabetic retinopathy (DR) is an eye disease that can occur in people with diabetes and can cause poor vision or blindness. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study is examining the effect of various treatments on cardiovascular disease in people with diabetes. This current study will examine the effects of the ACCORD treatments on the progression of DR in people participating in the ACCORD study.


Options:
A: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
B: Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy (Measured at Year 4)
C: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
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: Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study
Brief Summary: Diabetic retinopathy (DR) is an eye disease that can occur in people with diabetes and can cause poor vision or blindness. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study is examining the effect of various treatments on cardiovascular disease in people with diabetes. This current study will examine the effects of the ACCORD treatments on the progression of DR in people participating in the ACCORD study.


Options:
A: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
B: 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)
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: Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy (Measured at Year 4)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient-Centered Online Disease Management Using a Personal Health Record System
Brief Summary: Diabetes is a major, growing, and costly chronic disease in the U.S., and implementation of recommended diabetes care remains poor, not merely suboptimal, and varied for a sizable proportion of Americans with diabetes. To further reduce the treatment and adherence gaps in diabetes care, the researchers propose to evaluate a Customized, Continuous Care Management (CCCM) program that actively supports a partnership between the patient and his/her multidisciplinary care management (CM) team using an online disease management (ODM) system, which is integrated with a comprehensive electronic health record (EHR) system that includes a personal health record and secure patient-clinician messaging capabilities. The CCCM program builds upon CM strategies proven effective in past studies and creates an ODM system that is built upon and fully integrated with a leading, commercially available EHR product - providing a blueprint for instituting customized, continuous care management for many different chronic conditions in a range of ambulatory care settings.


Options:
A: Hemoglobin A1C (Baseline, 6 months and 12 months)
B: Glycosylated Hemoglobin (HbA1c): (baseline and at the end of 12 months post index date)
C: Hemoglobin A1c (6 and 12 months)
D: Hemoglobin A1c (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient-Centered Online Disease Management Using a Personal Health Record System
Brief Summary: Diabetes is a major, growing, and costly chronic disease in the U.S., and implementation of recommended diabetes care remains poor, not merely suboptimal, and varied for a sizable proportion of Americans with diabetes. To further reduce the treatment and adherence gaps in diabetes care, the researchers propose to evaluate a Customized, Continuous Care Management (CCCM) program that actively supports a partnership between the patient and his/her multidisciplinary care management (CM) team using an online disease management (ODM) system, which is integrated with a comprehensive electronic health record (EHR) system that includes a personal health record and secure patient-clinician messaging capabilities. The CCCM program builds upon CM strategies proven effective in past studies and creates an ODM system that is built upon and fully integrated with a leading, commercially available EHR product - providing a blueprint for instituting customized, continuous care management for many different chronic conditions in a range of ambulatory care settings.


Options:
A: Systolic blood pressure (9 months); Diastolic blood pressure (9 months)
B: Comparison of change in diabetes quality of care between intervention and usual care group. (6 months follow-up)
C: The primary study endpoint is 10-year risk of non-fatal acute myocardial infarction or coronary heart disease death as estimated by the Framingham risk equation (12 months)
D: Hemoglobin A1C (Baseline, 6 months and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients
Brief Summary: The purpose of this study is to determine whether a painless and noninvasive procedure called transcranial direct current stimulation (tDCS) combined with a method of physical therapy called constraint-induced movement therapy improves motor function in patients with chronic stroke. Research in healthy subjects has shown that when tDCS is combined with motor learning tasks, there is an increase in learning as compared to motor learning tasks only. The tDCS procedure sessions will be compared to sham (fake) procedure sessions, which is also called placebo stimulation. This study is double blind, which means neither the subjects nor researchers analyzing motor function will know if participants are receiving real tDCS stimulation or placebo. Only the person performing the procedure will know which one participants are receiving. Only by comparing the tDCS procedure to a sham (placebo) procedure can we understand if the tDCS actually improves motor function.

We hypothesize that tDCS will enhance the effects of constraint-induced movement therapy on motor recovery in chronic stroke patients.


Options:
A: Change in Rivermead Mobility index (Baseline, 6 months, 9 months); Change in Timed Up and Go Test (Baseline, 6 months, 9 months); Change in Modified Patient Specific Functional Scale (Baseline, 6 months, 9 months); Change in Physical Activity Diary (Baseline, 6 months, 9 months); Change in Physical activity - 7-day accelerometry (Baseline, 6 months, 9 months)
B: Jebsen-Taylor Hand Function Test (Baseline, Treatment days 1,5,10, Follow Up); Motor Activity Log Rating Scale (Baseline, Treatment Days 1,5,10 and Follow Up); Beck Depression Inventory (Baseline, Treatment days 1,5,10 and Follow up); Visual Analogue Scale for Anxiety (Baseline, Treatment days 1,5,10 and Follow Up)
C: Safety of the intervention as assessed by frequency of adverse events (2 weeks)
D: Change from baseline in Upper Extremity Fugl Meyer Assessment (Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients
Brief Summary: The purpose of this study is to determine whether a painless and noninvasive procedure called transcranial direct current stimulation (tDCS) combined with a method of physical therapy called constraint-induced movement therapy improves motor function in patients with chronic stroke. Research in healthy subjects has shown that when tDCS is combined with motor learning tasks, there is an increase in learning as compared to motor learning tasks only. The tDCS procedure sessions will be compared to sham (fake) procedure sessions, which is also called placebo stimulation. This study is double blind, which means neither the subjects nor researchers analyzing motor function will know if participants are receiving real tDCS stimulation or placebo. Only the person performing the procedure will know which one participants are receiving. Only by comparing the tDCS procedure to a sham (placebo) procedure can we understand if the tDCS actually improves motor function.

We hypothesize that tDCS will enhance the effects of constraint-induced movement therapy on motor recovery in chronic stroke patients.


Options:
A: Fugl Meyer Assessment (Upper extremity) of motor recovery following stroke (assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.)
B: Jebsen-Taylor Hand Function Test (Baseline, Treatment days 1,5,10, Follow Up); Motor Activity Log Rating Scale (Baseline, Treatment Days 1,5,10 and Follow Up); Beck Depression Inventory (Baseline, Treatment days 1,5,10 and Follow up); Visual Analogue Scale for Anxiety (Baseline, Treatment days 1,5,10 and Follow Up)
C: Fugl-Meyer Upper Extremity (A week prior to treatment beginning)
D: Motor Skill Retention (Day 9)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A DANish Randomized, Controlled, Multicenter Study to Assess the Efficacy of Implantable Cardioverter Defibrillator in Patients With Non-ischemic Systolic Heart Failure on Mortality. The DANISH Study
Brief Summary: The primary objective of this study is to determine the efficacy of ICD therapy compared with control on the endpoint of death from any cause in patients with heart failure of non-ischemic oetiology.


Options:
A: Sudden and/or arrhythmic cardiac death or resuscitated ventricular fibrillation. (Median follow-up estimated to be 10.7 years)
B: All cause mortality (5 years)
C: Primary outcome is a composite of all cause total mortality and hospitalization for CHF (Study end)
D: Percentage of Patients Worsened for Clinical Composite Response (12 Months)

Answer: B