TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of Laser Photocoagulation for Diabetic Macular Edema
Brief Summary: This pilot study will compare the use of current laser treatment for diabetic macular edema with a similar laser treatment that is milder in intensity, but more extensive.


Options:
A: CSME needing Photocoagulation (24 months)
B: Change in the central subfield of the ETDRS grid measured by OCT. (1 Year)
C: Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12 (Baseline through the end of study (Month 12)); Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 24 Month Extension Study (Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]); Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 24 Month Extension Study (Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months])
D: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12 (Baseline through the end of study (Month 12)); Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye at Month 12 (Baseline through the end of study (Month 12))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Open-label, Parallel-group, Phase 3 Trial of Subcutaneous Azacitidine Plus Best Supportive Care Versus Conventional Care Regimens Plus Best Supportive Care for the Treatment of Myelodysplastic Syndromes (MDS)
Brief Summary: The purpose of this study is to determine whether patients with high-risk myelodysplastic syndromes (MDS) treated with azacitidine have improved survival compared to conventional care treatments. The study will also assess the effect of treatments on response, duration of response, and transformation to acute myeloid leukemia (AML). The study will continue for 12 months following last patient enrolled.

See study AZA PH GL 2003 CL 001 E for information about the extension to this study.


Options:
A: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period (up to 20 weeks))
B: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period through interim follow-up visit (up to 16 weeks))
C: Kaplan-Meier Estimates for Median Time to Death From Any Cause (Day 1 (randomization) to 42 months); Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause (Day 1 (randomization) to 42 months); Number of Participants Who Died (42 months)
D: Participants Who Achieved Red Blood Cell (RBC) -Transfusion Independence (Up to 2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Adjuvant Zoledronic Acid Reduce Recurrence in Patients With High Risk Localized Breast Cancer?
Brief Summary: RATIONALE: Zoledronate may delay or prevent the formation of bone metastases. It is not yet known whether chemotherapy and/or hormone therapy are more effective with or without zoledronate in preventing cancer recurrence and bone metastases in women with breast cancer.

PURPOSE: This randomized phase III trial is studying giving chemotherapy and/or hormone therapy together with zoledronate to see how well they work compared to chemotherapy and/or hormone therapy alone in preventing cancer recurrence and bone metastases in women with stage II or stage III breast cancer.


Options:
A: sCTX values (baseline, 1 week post treatment, week 4, week 8, week 12)
B: Disease-free survival as assessed annually for 10 years
C: Increase in apoptotic index between diagnostic core biopsy and repeat core biopsy taken on day 5 (Repeat biopsy on day 5 (+/- day 21))
D: Time to First Clinical Fracture (From randomization until the primary analysis cut-off date of 26 March 2014; maximum time on main study at the cut-off was 87 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Trial Of Interferon Alfa-2B Or Interferon Alfa-2B Plus Bevacizumab In Patients With Advanced Renal Carcinoma
Brief Summary: RATIONALE: Biological therapies, such as interferon alfa-2b, may interfere with the growth of tumor cells. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known whether interferon alfa-2b is more effective with or without bevacizumab in treating advanced renal cell carcinoma (kidney cancer).

PURPOSE: This randomized phase III trial is studying interferon alfa-2b and bevacizumab to see how well they work compared to interferon alfa-2b alone in treating patients with advanced renal cell carcinoma.


Options:
A: Progression Free Survival First-Line (PFS 1-L) (based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to 35 months)
B: Progression-free Survival (Randomization until progression (up to 2 years))
C: Overall Survival (5 years)
D: Progression Free Survival (PFS) (From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node
Brief Summary: RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection.

PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases.


Options:
A: N/A
B: Axillary recurrence rate (from randomization)
C: 5-year Disease-Free Survival (5-year estimate reported after a median follow-up of 60 months)
D: Morbidity - Number of Participants With Residual Shoulder Abduction Deficit (Before and after surgery (within 30 days of randomization)); Morbidity - Number of Participants With Residual Arm Volume Difference (before and after surgery (within 30 days of randomization)); Morbidity - Number of Participants With Residual Arm Numbness (before and after surgery (within 30 days of randomization)); Morbidity - Number of Participants With Residual Arm Tingling (before and after surgery (within 30 days of randomization)); Overall Survival (8 years); Disease-free Survival as Measured by Breast Cancer Recurrence, Any Second Primary Cancer, and Death From Any Cause in Patients Without a Prior Event. (8 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of the Effects of Titrated Oral Tolvaptan Tablets in Patients With Hyponatremia
Brief Summary: This study's purpose is to determine whether tolvaptan can safely and effectively return the body's balance of sodium and water toward normal, and to characterize and quantify the potential clinical benefits of this treatment.


Options:
A: Change in Serum Sodium From Baseline to 6 Hours (48 hours)
B: Number and time of recurrences of therapeutic paracenteses (up to 12 weeks)
C: The average daily area under the curve of change from baseline in serum sodium level up to Day 4 within the double-blind on therapy period. and/or; The average daily area under the curve of change from baseline in serum sodium level up to Day 30 within
D: Incidence of overcorrection rate at any given period (up to 48 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Silent Cerebral Infarct Transfusion Multi-Center Clinical Trial
Brief Summary: The goal of this study is to determine the effectiveness of blood transfusion therapy for prevention of silent cerebral infarct (stroke) in children with sickle cell anemia.


Options:
A: Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side (Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).)
B: N/A
C: Maximum Time-Averaged Mean velocity (TAMV) on TCD exam (18 months)
D: Recurrence of an Infarct, Defined as a Stroke or a New or Enlarged Silent Cerebral Infarct (From study entry to study exit)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Silent Cerebral Infarct Transfusion Multi-Center Clinical Trial
Brief Summary: The goal of this study is to determine the effectiveness of blood transfusion therapy for prevention of silent cerebral infarct (stroke) in children with sickle cell anemia.


Options:
A: N/A
B: Number of Vaso-Occlusive Crisis (VOC) Events Per Participant Per Year (Rate of VOC) (Randomization through 24 Months)
C: Recurrence of an Infarct, Defined as a Stroke or a New or Enlarged Silent Cerebral Infarct (From study entry to study exit)
D: Acute Chest Syndrome (Chest x-rays (CXR) were ordered for trial eligibility, as a result of clinical indications, or at discharge or 72 hours if no prior CXR.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Silent Cerebral Infarct Transfusion Multi-Center Clinical Trial
Brief Summary: The goal of this study is to determine the effectiveness of blood transfusion therapy for prevention of silent cerebral infarct (stroke) in children with sickle cell anemia.


Options:
A: Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)); Liver Iron Content (LIC) Change-from-baseline (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months))
B: Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side (Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).)
C: Recurrence of an Infarct, Defined as a Stroke or a New or Enlarged Silent Cerebral Infarct (From study entry to study exit)
D: Treatment Differences of the Change in Qualitative Splenic Function From Baseline (Before initiation of treatment and at 2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Silent Cerebral Infarct Transfusion Multi-Center Clinical Trial
Brief Summary: The goal of this study is to determine the effectiveness of blood transfusion therapy for prevention of silent cerebral infarct (stroke) in children with sickle cell anemia.


Options:
A: Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)); Liver Iron Content (LIC) Change-from-baseline (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months))
B: N/A
C: Recurrence of an Infarct, Defined as a Stroke or a New or Enlarged Silent Cerebral Infarct (From study entry to study exit)
D: Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side (Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Silent Cerebral Infarct Transfusion Multi-Center Clinical Trial
Brief Summary: The goal of this study is to determine the effectiveness of blood transfusion therapy for prevention of silent cerebral infarct (stroke) in children with sickle cell anemia.


Options:
A: Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side (Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).)
B: N/A
C: Cerebral vasculopathy (1 year)
D: Recurrence of an Infarct, Defined as a Stroke or a New or Enlarged Silent Cerebral Infarct (From study entry to study exit)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Silent Cerebral Infarct Transfusion Multi-Center Clinical Trial
Brief Summary: The goal of this study is to determine the effectiveness of blood transfusion therapy for prevention of silent cerebral infarct (stroke) in children with sickle cell anemia.


Options:
A: Treatment Differences of the Change in Qualitative Splenic Function From Baseline (Before initiation of treatment and at 2 years)
B: Acute Chest Syndrome (Chest x-rays (CXR) were ordered for trial eligibility, as a result of clinical indications, or at discharge or 72 hours if no prior CXR.)
C: Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side (Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).)
D: Recurrence of an Infarct, Defined as a Stroke or a New or Enlarged Silent Cerebral Infarct (From study entry to study exit)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Silent Cerebral Infarct Transfusion Multi-Center Clinical Trial
Brief Summary: The goal of this study is to determine the effectiveness of blood transfusion therapy for prevention of silent cerebral infarct (stroke) in children with sickle cell anemia.


Options:
A: N/A
B: Recurrence of an Infarct, Defined as a Stroke or a New or Enlarged Silent Cerebral Infarct (From study entry to study exit)
C: Conversion to Abnormal Maximum TAMV (30 months)
D: Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side (Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Three Fixed Doses (100 Mg, 200 Mg, Or 400 Mg) Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder
Brief Summary: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo.


Options:
A: N/A
B: Competitive employment or education (24 months)
C: Sick leave data (One year)
D: Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12 (At Baseline and Week 12.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Diabetes Therapy to Improve BMI and Lung Function in CF
Brief Summary: To recruit 150 adult patients with cystic fibrosis related diabetes (CFRD) without fasting hyperglycemia for a multi-center, twelve month, placebo-controlled intervention trial testing the ability of insulin or repaglinide to improve body mass index (BMI) and stabilize pulmonary function in cystic fibrosis (CF).


Options:
A: Change in glycemia at 2h of -1.5 mmol/L (baseline and week 13)
B: The primary objective of this research is to determine whether treatment with either insulin or an oral diabetes agent that increases endogenous insulin secretion will improve BMI and pulmonary function in cystic fibrosis patients who have diabetes (12 months)
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: HbA1c (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Diabetes Therapy to Improve BMI and Lung Function in CF
Brief Summary: To recruit 150 adult patients with cystic fibrosis related diabetes (CFRD) without fasting hyperglycemia for a multi-center, twelve month, placebo-controlled intervention trial testing the ability of insulin or repaglinide to improve body mass index (BMI) and stabilize pulmonary function in cystic fibrosis (CF).


Options:
A: HbA1c (2 years)
B: Measure Change in Weight in Adults With Cystic Fibrosis (CF) Related Wasting Following Growth Hormone (GH) Therapy (14 months)
C: Feasibility (patient perspective) (Week 0 (baseline)); Feasibility (clinician perspective) (Week 8); Acceptability (patient perspective 1 of 2) (Week 8); Acceptability (patient perspective 2 of 2) (Week 8); Satisfaction (patient perspective 1 of 2) (Week 8); Satisfaction (patient perspective 2 of 2) (Week 8)
D: The primary objective of this research is to determine whether treatment with either insulin or an oral diabetes agent that increases endogenous insulin secretion will improve BMI and pulmonary function in cystic fibrosis patients who have diabetes (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Overweight Using Novel Dietary Strategies (Pounds Lost)
Brief Summary: The purpose of this study is to test the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition: moderate in fat (40 percent energy) with two different protein levels (15 percent and 25 percent), and low in fat (20 percent energy), also with 15 percent and 25 percent protein levels. The study is only accepting participants in the Boston, Massachusetts or Baton Rouge, Louisiana area. For further enrollment information in Boston or Baton Rouge, see Eligibility Criteria or Design Narrative.


Options:
A: Laboratory findings and body composition (2 years)
B: N/A
C: Body weight reduction (Month 6)
D: Change in body weight (measured at Year 2)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Overweight Using Novel Dietary Strategies (Pounds Lost)
Brief Summary: The purpose of this study is to test the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition: moderate in fat (40 percent energy) with two different protein levels (15 percent and 25 percent), and low in fat (20 percent energy), also with 15 percent and 25 percent protein levels. The study is only accepting participants in the Boston, Massachusetts or Baton Rouge, Louisiana area. For further enrollment information in Boston or Baton Rouge, see Eligibility Criteria or Design Narrative.


Options:
A: body weight in kilograms as measured by a calibrated scale (0,1,2,3,4,5,and 6 months)
B: Change in body weight (measured at Year 2)
C: The primary objective will be to compare the effects of the two different diet recommendations with respect to the one-year change in body weight.
D: Non-alcoholic Fatty Liver Disease Ultrasonography Score (Six months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Overweight Using Novel Dietary Strategies (Pounds Lost)
Brief Summary: The purpose of this study is to test the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition: moderate in fat (40 percent energy) with two different protein levels (15 percent and 25 percent), and low in fat (20 percent energy), also with 15 percent and 25 percent protein levels. The study is only accepting participants in the Boston, Massachusetts or Baton Rouge, Louisiana area. For further enrollment information in Boston or Baton Rouge, see Eligibility Criteria or Design Narrative.


Options:
A: Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group (12 months); Predicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group (12 Months); Predicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group (12 months); Predicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group (12 Months); Predicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group (12 Months); Predicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group (12 Months)
B: Change in body weight (measured at Year 2)
C: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))
D: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Overweight Using Novel Dietary Strategies (Pounds Lost)
Brief Summary: The purpose of this study is to test the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition: moderate in fat (40 percent energy) with two different protein levels (15 percent and 25 percent), and low in fat (20 percent energy), also with 15 percent and 25 percent protein levels. The study is only accepting participants in the Boston, Massachusetts or Baton Rouge, Louisiana area. For further enrollment information in Boston or Baton Rouge, see Eligibility Criteria or Design Narrative.


Options:
A: Change in body weight (measured at Year 2)
B: All-cause mortality (from enrollment to 1252 deaths in R2 arm); All cause mortality or hospitalizations for any reason (from enrollment to 1252 deaths)
C: cardiovascular deaths and hospitalization for cardiovascular causes (5 years)
D: Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions (1 year)

Answer: A