TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Full Thickness Macular Hole and Internal Limiting Membrane Peeling Study: Randomised Comparison of Macular Hole Surgery With or Without Internal Limiting Membrane Peeling
Brief Summary: A macular hole is a fairly common problem in the retina and is an important cause of loss of central vision. The aim of this study is to determine whether, in patients with a stage 2 or 3 full thickness macular hole (FTMH), peeling a very fine, transparent tissue that covers the surface of the retina, called the internal limiting membrane (ILM) during surgery is superior to non-ILM peeling macular hole surgery. The main outcomes are improvement in vision, achievement of macular hole closure, need for re-operation, health related quality of life (HRQOL) and cost effectiveness.


Options:
A: Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28 (Day 28)
B: Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28. (Day 28)
C: Visual Acuity (ETDRS Letters) (Visual acuity at 12 months)
D: The primary outcome of the study is the mean difference between treatment groups in the Early Treatment Diabetic Retinopathy Study (ETDRS) distance visual acuity score. (6 months post surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-Center Trial on the Effect of Anesthetics on Morbidity and Mortality in Patients Undergoing Major Non-cardiac Surgery
Brief Summary: Volatile anesthetics may provide some protection from myocardial ischemia, an effect called anesthetic preconditioning. In patients undergoing coronary artery bypass surgery, this preconditioning effect resulted in better cardiac performance, faster recovery and lower morbidity and mortality.

The investigators will perform a prospective randomized multi-center study to compare volatile with total intravenous anesthesia in patients at a high cardiac risk who undergo major non-cardiac surgery.


Options:
A: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
B: Ischemia (Holter-electrocardiogram [ECG], troponin T, ECG) (7 days postoperatively)
C: Postoperative delirium rate within 7 days after surgery (7 days after surgery)
D: Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h) (30 days postoperatively)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-Center Trial on the Effect of Anesthetics on Morbidity and Mortality in Patients Undergoing Major Non-cardiac Surgery
Brief Summary: Volatile anesthetics may provide some protection from myocardial ischemia, an effect called anesthetic preconditioning. In patients undergoing coronary artery bypass surgery, this preconditioning effect resulted in better cardiac performance, faster recovery and lower morbidity and mortality.

The investigators will perform a prospective randomized multi-center study to compare volatile with total intravenous anesthesia in patients at a high cardiac risk who undergo major non-cardiac surgery.


Options:
A: quality of life (1 year); functional health (1 year); falls (1 year); cognition (1 year); emotional health (1 year); mental health (1 year); physical health (1 year); pain (1 year); intraoperative awareness (30-90 days); all-cause mortality (1 year); surgical wound infection (1 year); nerve injury (30-90 days); stroke (1 year); delirium (30-90days); Stomach Ulcer (30-90 days); Gastrointestinal Bleed (30-90 days); Pneumonia (1 year); Respiratory Failure (1 year); Respiratory Arrest (1 year); Pulmonary Embolism (1 year); Deep Vein Thrombosis (1 year); Angina (1 year); Atrial Fibrillation (1 year); Congestive Heart Failure (1 year); Cardiac Arrest (1 year); Heart Attack (1 year)
B: For our first objective (i.e., the incidence of major perioperative vascular events) our primary outcome is major vascular events (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, and nonfatal stroke) (30 days post surgery.)
C: Ischemia (Holter-electrocardiogram [ECG], troponin T, ECG) (7 days postoperatively)
D: The change in reactive hyperemia index assessed by EndoPat (The change from 4-24 hours to between day 3 and 5 after surgery); Major adverse cardiovascular events (Within 365 days of surgery); Postoperative non-cardiovascular complications (Within 365 days of surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Feet First: Increasing Activity Without Increasing the Risk of Foot Ulcers in People With Diabetes and Insensate Feet
Brief Summary: The role of weight-bearing physical activity in the development of diabetic foot ulcers remains poorly understood. Regular participation in moderately intense physical activity (e.g. brisk walking ) reduces 8-year cardiovascular mortality in those with diabetes mellitus by over 30%. The American Diabetes Association (ADA) recommends at least 30 minutes of daily moderate intensity activity for people with diabetes. However, the ADA recommends that people with diabetes and insensate feet, which affects up to 40% of those with diabetes, should limit their walking because of concerns that walking could increase the risk of foot ulcers and amputation. Firm evidence is lacking to support these concerns; in fact, while a research fellow I conducted an observational study that showed daily weight-bearing activity may reduce the risk of foot ulceration among people with diabetic foot problems. A controlled clinical trial is needed to study these issues further.

The present study is a randomized controlled trial in 100 older adults with diabetes and insensate feet, 50 of whom will participate in an individually-tailored behavior-change intervention called "Feet First", and 50 of whom will be controls. The intervention is based on the extensively-tested CHAMPS model used by the Robert Wood Johnson Foundation's Active for Life Program. Feet First extends the target population beyond older adults generally to people with insensate feet due to diabetic peripheral neuropathy.

The specific aims of the study are:

* To determine whether Feet First intervention subjects achieve a greater increase in weight-bearing activity than control subjects, and
* To obtain preliminary evidence on intervention subjects' foot outcomes (foot function, foot-related self-care, and risk of foot ulcers), compared to control subjects.


Options:
A: Change in weight-bearing physical activity (steps/day) (Baseline, 3, 6 and 12 months post-enrollment)
B: Change in Intraepidermal Nerve Fiber Density (IENFD) (Baseline, 9 months, and 18 months); Change in Quality of Life (NQOL-DN) Questionnaire Results (Baseline, 9 months, and 18 months)
C: Incremental Shuttle Walk Test (Eight weeks)
D: Change in Patient Quality of Life at Baseline and 8 Months (Baseline and 8 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Group Visits Improve Outcomes of Veterans With Diabetes
Brief Summary: Background: Diabetes is a common, morbid and expensive disease among veterans. Achieving adequate glycemic control and blood pressure control can reduce the devastating complications of diabetes. Because the majority of patients do not achieve adequate control of blood sugar and blood pressure, innovative strategies to improve control are needed. One strategy with great potential for veterans receiving VA care is the group clinic. Group clinics have been developed over the last 5-10 years, and have been shown to improve clinical outcomes and reduce outpatient utilization in geriatric settings. Group medical clinics involve a cohort of 8-20 patients who have 1-2 hour group visits. These clinics are distinguished from traditional group education visits for diabetes by the fact that these visits involve one physician and one or more additional health care professionals, usually a nurse practitioner and/or a pharmacist, and are designed to make management changes for a number of people with the same disease in a short period of time. The effect of group medical clinics on blood sugar, blood pressure, and the cost of diabetes care, is unknown. Objectives: Our primary objectives in this project are to determine the effectiveness and cost-effectiveness of a group visit intervention in improving rates of control of diabetes and high blood pressure in patients with both illnesses.


Options:
A: Patient Activation Measure (PAM) (Every 3 months during the 12-month trial)
B: Hemoglobin A1c (12 months); Systolic Blood Pressure (12 months)
C: Death or non-fatal myocardial infarction (Up to 10 months)
D: HbA1c (Last measurement within 12 months before - and 15 months after nurse participation in the course)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Growing Future Physician Leaders: A Randomized, Controlled Trial of an Educational Intervention in Postgraduate Trainees
Brief Summary: Study objective: The objective of this trial was to determine the effectiveness of a Leadership Development Program (LDP) aimed at 1) establishing basic management knowledge and 2) promoting reflection of leadership skills.

Study design: Randomized, controlled, single-blind trial. Study participants: Senior postgraduate medical and surgical trainees at an urban university health care centre.

Methods: Eligible participants were randomized to either the LDP(intervention group) or to regular postgraduate training (control group). For ethical reasons, all participants assigned to the control group were offered the LDP at the end of the trial. The 1º outcome measure used was a knowledge-based written exam. The sample size was estimated on finding a 20% difference in mean test scores between groups. Participants' reflective capacity and higher order leadership role skills were tested through a personal learning project (PLP, 2º outcome measure).


Options:
A: N/A
B: Change in team cohesion (Change from baseline to 6 months)
C: Supportive leadership behaviour questionnaire for assessing head nurses performance (10 months)
D: Percentage of adherence of opportunities for hand hygiene (march 2008, october 2008, may 2009, november 2009)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Adoptive Cell Therapy Following Non-myeloablate Chemotherapy in Metastatic Melanoma Patients
Brief Summary: Metastatic melanoma is an aggressive and highly malignant cancer. The five-year survival rate of patients with metastatic disease is less than 5% with a median survival of only 6-10 months. Drugs like Dacarbazin (DTIC) as a single agent or in combination with other chemotherapy agents, have a response rate of 15-30%, but the duration of response is usually short, with no impact on survival. Interleukin-2 (IL-2) based immunotherapy has shown more promising results. This form of therapy has a similar response rate with some patients achieving a durable complete response. Recently the National Institute of Health (NIH) reported that by using lympho-depleting chemotherapy, followed by an adoptive transfer of large numbers of anti-tumor specific tumor-infiltrating lymphocytes (TIL), an objective regression was achieved in 51% of patients with metastatic melanoma.

Objectives: To introduce the TIL technology to advanced metastatic melanoma patients in Israel.


Options:
A: To evaluate safety and dose limiting toxicities (DLT) of autologous CD30.CAR-T and establish the recommended Phase dose (Day 0 to 28 for DLT)
B: Event Free Survival (EFS) Per Blinded Central Assessment (From randomization date up to a median follow-up: 24.9 months)
C: Objective Reaction Rates (0 to 180 days)
D: Response rate and toxicity (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Randomized Controlled Trial of Azithromycin or Artesunate Added to Sulphadoxine Pyrimethamine as Therapy for Malaria in Pregnancy
Brief Summary: The purpose of this study is to compare the efficacy and safety of three treatment regimens for the prevention of malaria during pregnancy.


Options:
A: Parasitological failure rates; Parasite clearance time; Fever clearance times; Incidence rate of adverse events
B: Parasitological failure by day 28 (Within 28 days of treatment.)
C: Primary clinical outcome is cure (ACPR as defined by WHO criteria) on Day 42. (42 days)
D: Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitologic Response (ACPR) at Day 28 in the Modified Intent-to-treat (mITT) Population (Day 28); Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population (Day 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Testosterone Replacement on Atherosclerosis Progression in Older Men With Low Testosterone Levels
Brief Summary: As men grow older, their testosterone levels decrease with age. One-third of men, 70 years of age or older, have low testosterone levels. It is known that short-term testosterone replacement is safe, and can increase muscle strength and physical function, but the risks of long-term testosterone replacement in older men with low testosterone levels are incompletely understood.

Atherosclerosis is characterized by thickening of the artery walls, and the narrowing of the blood vessels as cholesterol is deposited in the lining of the arteries. It is the major cause of cardiovascular disease including ischemic heart disease (heart attacks) and stroke. Although, historically, there has been a widespread perception that higher levels of testosterone might increase the risk of atherosclerosis, the evidence from research does not support this. In observational studies, higher testosterone levels have been correlated with more favorable cardiovascular risk factors, and supplementation with testosterone to bring older men into the normal range for healthy younger men appears to improve several cardiovascular risk factors, and may slow the progression of atherosclerosis.

The primary purpose of this study is to look at the effects of testosterone replacement on the progression of atherosclerosis in older men. This study is also being done to find out whether replacement with testosterone in older men with low testosterone levels improves their health-related quality of life.


Options:
A: waist-to-hip ratio (3 years)
B: Change From Baseline in Common Carotid Artery Intima-Media Thickness (IMT) (Baseline and Month 36); Change From Baseline in Coronary Artery Calcium Score (Baseline and Month 36)
C: Body Composition at the End of Each Study Phase (end of each study phase: Day 11 for Phase 1, Day 39 for Phase 2, up to Day 85 for Phase 3)
D: Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF) (Week 0, week 8, week 11, week 14)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Terlipressin as Treatment of Patients With Cirrhosis and Hepatorenal Syndrome. Effect on Survival and Renal Function. Multicenter, Randomized and Prospective Study
Brief Summary: Hepatorenal syndrome is a common complication of cirrhotic patients. The prognosis of patients with HRS is very poor. It have been demonstrated that vasoconstrictors agents (Terlipressin) plus albumin are effective in the reversal of the treatment. However, previous studies are pilot studies and they are not able to give information about an improvement in survival. This comparative randomized study was delineated to test the efficacy of terlipressin on survival.


Options:
A: Treatment Success (Day 14)
B: Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal (within 14 days)
C: Renal function at the beginning and at the end of therapy (two weeks)
D: Survival

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo Controlled, Phase 3, Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Brief Summary: The objectives of this study are to assess the safety and efficacy of treatment with pirfenidone 2403 milligrams per day (mg/d) compared with placebo in patients with idiopathic pulmonary fibrosis (IPF), to assess the safety and efficacy of treatment with pirfenidone 1197 mg/d in patients with idiopathic pulmonary fibrosis and to characterize the pharmacokinetic disposition of pirfenidone in patients with idiopathic pulmonary fibrosis.


Options:
A: Peak VO2 (Before and after 12 weeks of Pulmonary Rehabilitation); 6 min walk test (Before and after 12 weeks of Pulmonary Rehabilitation)
B: Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks (52 weeks)
C: changes in six minute walking distance after 6 months (6 months)
D: Absolute Change in Percent Predicted Forced Vital Capacity (FVC) (From baseline up to 72 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo Controlled, Phase 3, Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Brief Summary: The objectives of this study are to assess the safety and efficacy of treatment with pirfenidone 2403 milligrams per day (mg/d) compared with placebo in patients with idiopathic pulmonary fibrosis (IPF), to assess the safety and efficacy of treatment with pirfenidone 1197 mg/d in patients with idiopathic pulmonary fibrosis and to characterize the pharmacokinetic disposition of pirfenidone in patients with idiopathic pulmonary fibrosis.


Options:
A: Forced Vital Capacity (12 months)
B: Absolute Change in Percent Predicted Forced Vital Capacity (FVC) (From baseline up to 72 weeks)
C: Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value (Measured at study Baseline and Months 3, 6, 12, 15, 18, 21, and 24)
D: Absolute Change in Percent Predicted Forced Vital Capacity(FVC) (Baseline to week 72)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Brief Summary: The purposes of this study are to assess the efficacy of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis (IPF)and to assess the safety of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis.


Options:
A: Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52 (52 weeks)
B: Functional exercise capacity
C: Absolute Change in Percent Predicted Forced Vital Capacity(FVC) (Baseline to week 72)
D: Absolute Change in Percent Predicted Forced Vital Capacity (FVC) (From baseline up to 72 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Brief Summary: The purposes of this study are to assess the efficacy of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis (IPF)and to assess the safety of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis.


Options:
A: Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value (Measured at study Baseline and Months 3, 6, 12, 15, 18, 21, and 24)
B: Forced Vital Capacity (12 months)
C: Overall Change in Forced Vital Capacity (Measured as the estimated change from baseline to Week 60)
D: Absolute Change in Percent Predicted Forced Vital Capacity(FVC) (Baseline to week 72)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Study of Docetaxel and S-1 Versus S-1 in the Treatment of Advanced Gastric Cancer
Brief Summary: The primary objective of this study is to compare median overall survival of the test arm (docetaxel and S-1) to the control arm (S-1 only) in subjects with advanced or recurrent gastric cancer.


Options:
A: Overall Survival (OS) - Percentage of Participants With an Event (Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis); Overall Survival - Time to Event (BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis)
B: Time to Progression (every 8 weeks up to a maximum of 36 months)
C: Number of Participants Experiencing Adverse Events (AEs) (Serious AEs: Up to 90 days after last dose of treatment (Up to 28 months); nonserious AEs: Up to 30 days after last dose of treatment (Up to 26 months) - through final analysis (FA) cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C)); Number of Participants Discontinuing From Study Treatment Due to an AE (Up to last dose of study treatment (Up to approximately 25 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C)); Overall Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Response Rate Based on Blinded Independent Central Radiology (BICR) Review (Cohorts A, B, C, and D) (Every 8 weeks until disease progression (Cohorts A, B, D: Up to ~ 35 months; Cohort C: Up to ~ 28 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, D) & 01 Sep 2015 (Cohort C)); Overall RECIST 1.1 Response Rate Based on BICR Review for Participants in Cohort B2 (Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016)
D: overall survival (median)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Study of Docetaxel and S-1 Versus S-1 in the Treatment of Advanced Gastric Cancer
Brief Summary: The primary objective of this study is to compare median overall survival of the test arm (docetaxel and S-1) to the control arm (S-1 only) in subjects with advanced or recurrent gastric cancer.


Options:
A: response (WHO criteria) (staging every 8 weeks)
B: overall survival (median)
C: 6 Month Progression Free Survival (PFS) (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months)
D: Progression Free Survival (PFS) (22 months)

Answer: B