TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy
Brief Summary: The purpose of this study is to evaluate the role, the safety and the effectiveness of Intravitreal Bevacizumab injections as an adjunct to vitrectomy in the management of severe proliferative diabetic retinopathy.


Options:
A: Treatment or "Failure" Defined as Vitrectomy (within 112 days of randomization); Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) (Baseline to 16 weeks)
B: N/A
C: E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) (24 weeks)
D: The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR (3 months after last surgery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy
Brief Summary: The purpose of this study is to evaluate the role, the safety and the effectiveness of Intravitreal Bevacizumab injections as an adjunct to vitrectomy in the management of severe proliferative diabetic retinopathy.


Options:
A: N/A
B: Fluorescein leakage area of active new vessels (FLA) (48 weeks)
C: Treatment or "Failure" Defined as Vitrectomy (within 112 days of randomization); Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) (Baseline to 16 weeks)
D: Regression of neovascularization (12-month treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy
Brief Summary: The purpose of this study is to evaluate the role, the safety and the effectiveness of Intravitreal Bevacizumab injections as an adjunct to vitrectomy in the management of severe proliferative diabetic retinopathy.


Options:
A: Treatment or "Failure" Defined as Vitrectomy (within 112 days of randomization); Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) (Baseline to 16 weeks)
B: N/A
C: The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR (3 months after last surgery)
D: amount of intraoperative intra-ocular bleeding (three weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy
Brief Summary: The purpose of this study is to evaluate the role, the safety and the effectiveness of Intravitreal Bevacizumab injections as an adjunct to vitrectomy in the management of severe proliferative diabetic retinopathy.


Options:
A: Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 (Baseline to Month 24)
B: N/A
C: Treatment or "Failure" Defined as Vitrectomy (within 112 days of randomization); Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) (Baseline to 16 weeks)
D: Pain recorded using a Visual Analog Scale (15 minutes after the procedure)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized,Double-Blind,Placebo-Controlled,Ascending,Single-Dose Study of the Safety,Tolerability and Bioeffect of Intravenously Administered REGN727 in Healthy Volunteers
Brief Summary: This study will test the safety and tolerability (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in healthy subjects. The study drug and placebo will be administered by intravenous (I.V) infusion at one clinic visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs(blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.


Options:
A: Effects on HDL-C and Triglycerides after 12 weeks; Safety after 12 weeks
B: The incidence of treatment-emergent adverse events in subjects treated with REGN727 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 106 (106 days)
C: The primary endpoint in the study is the incidence of treatment-emergent adverse events in subjects treated with REGN727 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 106. (106 days)
D: The primary endpoint in the study is to assess the incidence and severity of treatment-emergent adverse events in hyperlipidemic patients treated with REGN727 or placebo receiving stable doses of atorvastatin. (visit 4 (day 1) to visit 16 (day 148))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized,Double-Blind,Placebo-Controlled,Ascending,Single-Dose Study of the Safety,Tolerability and Bioeffect of Intravenously Administered REGN727 in Healthy Volunteers
Brief Summary: This study will test the safety and tolerability (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in healthy subjects. The study drug and placebo will be administered by intravenous (I.V) infusion at one clinic visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs(blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.


Options:
A: The primary endpoint in the study is the incidence of treatment-emergent adverse events in subjects treated with REGN727 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 106. (106 days)
B: Number of Participants With Adverse Events (From first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months.)
C: Percentage of Participants Who Experienced Adverse Events (AEs) (Up to 10 weeks after last study drug administration (maximum of 86 weeks))
D: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis (From Baseline to Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized,Double-Blind,Placebo-Controlled,Ascending,Single-Dose Study of the Safety,Tolerability and Bioeffect of Intravenously Administered REGN727 in Healthy Volunteers
Brief Summary: This study will test the safety and tolerability (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in healthy subjects. The study drug and placebo will be administered by intravenous (I.V) infusion at one clinic visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs(blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.


Options:
A: The primary endpoint in the study is the incidence of treatment-emergent adverse events in subjects treated with REGN727 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 106. (106 days)
B: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent--To-Treat (ITT) Analysis (From Baseline to Week 24)
C: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis (From Baseline to Week 52)
D: Percent Change From Baseline in LDL-C at the Mean of Weeks 22 and 24 (Baseline and weeks 22 and 24); Percent Change From Baseline in LDL-C at Week 24 (Baseline and week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Toolkit to Improve Cardiovascular Disease Screening and Treatment for People With Type 2 Diabetes
Brief Summary: Diabetes is a common and serious chronic disease. However, there is a large gap between the level of care that people should receive (based on research and guidelines) and the level of care they actually receive. With the release of their 2008 Clinical Practice Guidelines, the Canadian Diabetes Association has a strategy to improve heart disease screening and treatment for people with diabetes. This study will evaluate whether the strategy works. The focus of the strategy was to give all family physicians in Canada a Toolkit in June 2009 to help them delivery better care for their diabetic patients. In Ontario, only half of doctors received this Toolkit. We will compare the quality of care received by diabetic patients whose doctors received this Toolkit versus those who doctors did not.


Options:
A: Change from baseline in HbAlc level; percentage of subjects reaching or maintaining the risk target (represented by a combination of LBGI<=2.5 together with HBGI<=5). (Visit 5 (52 weeks after Visit 1 +/- 2 weeks).)
B: HbA1c (18 months)
C: Medication regimen knowledge (One year)
D: Patient is receiving a statin (July 2009 to April 2010)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Toolkit to Improve Cardiovascular Disease Screening and Treatment for People With Type 2 Diabetes
Brief Summary: Diabetes is a common and serious chronic disease. However, there is a large gap between the level of care that people should receive (based on research and guidelines) and the level of care they actually receive. With the release of their 2008 Clinical Practice Guidelines, the Canadian Diabetes Association has a strategy to improve heart disease screening and treatment for people with diabetes. This study will evaluate whether the strategy works. The focus of the strategy was to give all family physicians in Canada a Toolkit in June 2009 to help them delivery better care for their diabetic patients. In Ontario, only half of doctors received this Toolkit. We will compare the quality of care received by diabetic patients whose doctors received this Toolkit versus those who doctors did not.


Options:
A: Completion of dilated eye examination (12-months following intervention)
B: % of patients reaching goal HbA1C (<7) (2 years after enrollment); % of patients with BP goal (<130/80) (Two years after enrollment); % of patients with LDL at goal (<100) (2 years after enrollment); % of patients at goal for all three parameters (HbA1C <7, BP <130/80, LDL <100) (2 years after enrollment)
C: Patient is receiving a statin (July 2009 to April 2010)
D: change in number of care goals met (one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Innovative Tools to Improve Colorectal Cancer Screening Rates in Manitoba
Brief Summary: The primary purpose of the study is to investigate the efficacy and effectiveness of a community-based nurse managed telephone support line (Provincial Health Contact Center; PHCC) and Colorectal Cancer Information and Screening Website in supporting Primary Care Providers (PCP) from Winnipeg, Manitoba (Canada) in their efforts to improve colorectal cancer (CRC) screening Fecal Occult Blood Test (FOBT) compliance in average risk men and women 50-74 years of age. Secondary outcomes of the study involve documenting and investigating common patient questions and comments about CRC and the FOBT during their PHCC communication(s)/Website visits as well as procuring feedback from PCP and patients related to their experiences with the study protocol (PCP), FOBT (patients) and PHCC/website (patients).


Options:
A: Fecal Occult Blood Test (FOBT) completion rate (4 months)
B: Adherence to the decision to use or not to use statins
C: Decisional quality (knowledge, decisional conflict, and satisfaction) (Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter)
D: The primary outcome involves evaluation of the decision process leading to decision quality as assessed by the Decisional Conflict Scale (DCS). The DCS is a validated scale that has been used in more than 30 PtDA studies across different decisions. (1 Day)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomised, Multicenter Study to Investigate the Efficacy of Two Dosages of Propionyl-L-Carnitine Colon Release Tablets in Patients Affected by Ulcerative Colitis Under Oral Stable Treatment
Brief Summary: The purpose of this study is to determine whether Propionyl-L-carnitine administration may ameliorate the illness in patients affected by mild to moderate ulcerative colitis already in treatment with one of the standard treatments (corticosteroids excluded).


Options:
A: Disease Activity Index score (baseline, week 4)
B: To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis. (Day 3 (after colonoscopy and CCE-2))
C: Rate of clinical remission
D: Change in Mayo score at Day 57 compared with Screening (Day 57)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to determine whether a High Intensity exercise intervention can elicit cardiovascular disease protection in adolescents.


Options:
A: Change in BMI Percentile (baseline and 12 months)
B: To improve blood lipid profiles and lower levels of plasma inflammatory markers.
C: Percent Body Fat (Baseline and One year)
D: Effectiveness of a nutrition advice programme in exclusive breastfeeding. (1 year); Effectiveness of a nutrition advice programme in dietary intake (1 year); Effectiveness of a nutrition advice programme in dietary intake (4 years); Effectiveness of a nutrition advice programme in dietary intake (8 years); Effectiveness of a nutrition advice programme in dietary intake (12 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Recurrence of All Inner-city Strokes Through Education
Brief Summary: The purpose of this study is to evaluate if a peer-led stroke recurrence prevention intervention, versus usual care, will help reduce risk factors for recurrent strokes among adults in Harlem.


Options:
A: Stroke Specific Health Related Quality of Life (6 months for (SSQoL) and 3 months for Perceived Energy Subdomain); Self-Efficacy to Manage Stroke Symptoms (6 months)
B: Difference in physical activity scale for the elderly (24 months)
C: Blood Pressure (6 months post enrollment into trial); LDL Cholesterol (6 months post enrollment into trial); Use of Anti-thrombotic Medication (6 months post enrollment into trial)
D: Change in Systolic Blood Pressure (baseline and 6 months); Change in HDL Level (baseline and 6 months); Change in LDL Level (baseline and 6 months); Change in Triglyceride Level (baseline and 6 months); Change in HbA1c Level (baseline and 6 months); Change in Glycaemia Level (baseline and 6 months); Change in BMI Value (baseline and 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Recurrence of All Inner-city Strokes Through Education
Brief Summary: The purpose of this study is to evaluate if a peer-led stroke recurrence prevention intervention, versus usual care, will help reduce risk factors for recurrent strokes among adults in Harlem.


Options:
A: Blood Pressure (12 months)
B: Blood Pressure (6 months post enrollment into trial); LDL Cholesterol (6 months post enrollment into trial); Use of Anti-thrombotic Medication (6 months post enrollment into trial)
C: Changes from baseline in body weight. (Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).)
D: The proportion of high-risk individuals that have been assessed for cardiovascular risk (12 months after intevention); The proportion of individuals with correct knowledge about the effects of behavioural determinants of the risk of cardiovascular disease (12 months from intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Recurrence of All Inner-city Strokes Through Education
Brief Summary: The purpose of this study is to evaluate if a peer-led stroke recurrence prevention intervention, versus usual care, will help reduce risk factors for recurrent strokes among adults in Harlem.


Options:
A: Blood Pressure (12 months)
B: Blood Pressure (6 months post enrollment into trial); LDL Cholesterol (6 months post enrollment into trial); Use of Anti-thrombotic Medication (6 months post enrollment into trial)
C: systolic blood pressure (primary vascular risk factor being assessed) (baseline, post-intervention, 6 months, 12 months); diastolic blood pressure (baseline, post-intervention, 6 months, 12 months); waist circumference (baseline, post-intervention, 6 months, 12 months); 12-hour fasting lipid profile (baseline, post-intervention, 6 months, 12 months); 12-hour fasting glucose/hemoglobin A1C (baseline, post-intervention, 6 months, 12 months)
D: Major vascular event consisting of nonfatal stroke, nonfatal major coronary event and vascular death (Up to 6 years from inclusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Recurrence of All Inner-city Strokes Through Education
Brief Summary: The purpose of this study is to evaluate if a peer-led stroke recurrence prevention intervention, versus usual care, will help reduce risk factors for recurrent strokes among adults in Harlem.


Options:
A: Targeted risk and protective factors, substance use, delinquency, violence (Baseline through thirteen-year follow-up (age 23)); CTC coalition functioning, prevention system transformation, evidence-based program (EBP) implementation (Baseline through eight-year follow-up (age 18))
B: Weight loss. (1 year); HgbA1c (1 year)
C: Blood Pressure (6 months post enrollment into trial); LDL Cholesterol (6 months post enrollment into trial); Use of Anti-thrombotic Medication (6 months post enrollment into trial)
D: Reach (RE-AIM Framework) (up to 12 months); Effectiveness (RE-AIM Framework) (up to 24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Evaluation of Vitagel for Reduction in Blood Loss and Pain Following Unilateral Total Knee Arthroplasty
Brief Summary: Vitagel® is an FDA approved class III medical device. It is a surgical hemostat, which has been shown to control bleeding during orthopaedic, cardiac, hepatic, and general surgical procedures. The product is a thrombin/collagen suspension which works in combination with the patient's own plasma to form a fibrin/collagen clot.

The present prospective, randomized controlled trial is designed to evaluate the efficacy of Vitagel® for reducing blood loss and pain in patients managed with unilateral total knee arthroplasty (TKA). It is hypothesized that the use of Vitagel® may lead to less blood filled knees, and thus to a greater improvement in postoperative pain scores when compared to the control group. The two arms of the study will include:

1. experimental group in which Vitagel® is used unilateral TKA
2. control group representing our current standard of care (no Vitagel®)

A comparison of the functional and clinical results between these two groups will be conducted using several outcome measures including the KOOS, SF-12 version2 and pain scores through the previously IRB approved OrthoMidas registry. The primary variable of interest is blood loss, based on hemoglobin drop during the postoperative hospital stay. Of secondary interest will be; 1) pain levels in the PACU, 2) pain scores for all postoperative days, 3) average pain for the entire hospital stay, 4) length of stay, 5) patient satisfaction at discharge, 4 weeks postoperative, and 12 weeks postoperative, and 6) functional scores at 4 and 12 weeks postoperative.


Options:
A: Blood loss in postoperative drainage. (Blood loss in 24 hours postoperative drainage)
B: The volume of postoperative blood loss in the drain (48 hours after the operation); Changes from baseline hemoglobin concentrations (48 hours after the operation); unit of blood transfusion (48 hours after the operation)
C: Total blood loss after operation (From the operation to the postoperative day 3 or 4); Decrease of hemoglobin level after operation (From the operation to the postoperative day 14)
D: Number of Patients Managed With Blood Transfusion (daily during hospital stay (an expected average of 4 days))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: B-LONG: An Open-Label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant, Long-acting Coagulation Factor IX Fc Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia B
Brief Summary: The primary objectives of the study were: to evaluate the safety and tolerability of rFIXFc; to evaluate the efficacy of rFIXFc in all treatment arms; to evaluate the effectiveness of prophylaxis over on-demand (episodic) therapy by comparing the annualized number of bleeding episodes between participants receiving rFIXFc on each prevention (prophylaxis) regimen and participants receiving rFIXFc on an episodic regimen. The secondary objectives of the study were: to evaluate and assess the pharmacokinetic (PK) parameter estimates of rFIXFc and rFIX (BeneFIX®) at baseline in the Sequential PK subgroup as well as rFIXFc at Week 26 (±1 week); to evaluate participants' response to treatment; to evaluate rFIXFc consumption.


Options:
A: Change in Frequency of Spontaneous Bleeding Events Between On-demand and Prophylaxis Treatments (Annualized) (Up to 26 weeks for on-demand regimen, and between 1 and 17 months for prophylaxis regimen.); Number of Subjects Developing Inhibitors Against Factor IX (FIX) (Up to 27.7 months (maximum))
B: N/A
C: Annualized Bleeding Rate (ABR) (9 months)
D: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (up to 52 weeks ± 1 week); Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) (up to 52 weeks + 30 days ± 1 week); Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs) During the Surgical / Rehabilitation Period (up to 52 weeks + 30 days ± 1 week); Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) During the Surgical / Rehabilitation Period (up to 52 weeks + 30 days ± 1 week); Incidence Rate of FIX Inhibitor Development (up to 52 weeks ± 1 week); Annualized Bleeding Rate (up to 52 weeks ± 1 week (efficacy period as defined in description)); Comparison of Annualized Bleeding Rates (up to 52 weeks ± 1 week (efficacy period as defined in description))

Answer: D