TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Ranibizumab for Edema of the Macula in Diabetes: a Phase 2 Study ( The Read-2 Study)
Brief Summary: This study is being done to see if the investigational drug Ranibizumab (RBZ) given by injection into the eye, is safe and effective to use in people with diabetic macular edema (DME). The investigators want to compare RBZ to laser treatment which is the current standard way to treat DME.

RBZ blocks a growth factor that is thought to be involved in the formation of abnormal blood vessels that cause loss of vision in patients with DME.


Options:
A: 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])
B: 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])
C: Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year (Baseline, Year 1)
D: Mean Change in Best Corrected Visual Acuity (BCVA) at Month 6 (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Can a Novel Treatment Using "Mandometer®" Technology Improve Weight Loss in a Childhood Obesity Clinic?
Brief Summary: We run a successful clinic in Bristol for children with severe obesity who already demonstrate many features to suggest they are at increased risk of early diabetes and heart disease. However, we have found that young children respond better to simple interventions than do adolescents. We have used a new treatment regimen "Mandometer®" to help our most difficult adolescent cases lose weight. We would like to do a study to see if all adolescents might improve weight loss using this technology compared to what we routinely offer


Options:
A: exercise adherence (Longitudinal and following the 16-week intervention)
B: BMI z-score (2 years)
C: BMI SDS or Z-score (12 months primary/ 18 months secondary outcome)
D: Change in Body Mass Index (z-BMI) in Adolescents (Baseline to 2 months); Change in Body Mass Index (z-BMI) in Adolescents (Baseline to 4 months); Change in Body Mass Index (z-BMI) in Adolescents (Baseline to 6-month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cluster Randomized Trial On Cardiovascular Risk Factor Management: Caduet Versus Usual Care In Subjects With Hypertension And Additional Cardiovascular Risk Factors In Clinical Practice
Brief Summary: To investigate whether a Caduet based treatment strategy might result in greater reduction in total cardiovascular risk as compared to usual care in subjects with hypertension and additional risk factors.


Options:
A: Proportion of patients receiving AAS, an ACE inhibitor and a statin among those without contraindications to any of these drugs Adherence to treatment measured by: Morinsky-Green test and Pill accountability. (18 months); Adherence to treatment measured by the Morisky-Green questionnaire (18 months); Treatment adherence measured by: Morisky-Green test: (Good adherence score 16-20) at 1 and 9 months. (18 months); Treatment adherence measured by: Pill counts at 1-4-9 months. (Good adherence 80-110% PC) (18 months)
B: Major Cardiovascular Events (5 years)
C: Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP). (baseline to 12 weeks)
D: Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12 (Baseline, Month 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cluster Randomized Trial On Cardiovascular Risk Factor Management: Caduet Versus Usual Care In Subjects With Hypertension And Additional Cardiovascular Risk Factors In Clinical Practice
Brief Summary: To investigate whether a Caduet based treatment strategy might result in greater reduction in total cardiovascular risk as compared to usual care in subjects with hypertension and additional risk factors.


Options:
A: Reduction in blood Pressure (12 weeks); reduction in Heart Rate (12 weeks); modify lipids (12 weeks)
B: Proportion of patients receiving AAS, an ACE inhibitor and a statin among those without contraindications to any of these drugs Adherence to treatment measured by: Morinsky-Green test and Pill accountability. (18 months); Adherence to treatment measured by the Morisky-Green questionnaire (18 months); Treatment adherence measured by: Morisky-Green test: (Good adherence score 16-20) at 1 and 9 months. (18 months); Treatment adherence measured by: Pill counts at 1-4-9 months. (Good adherence 80-110% PC) (18 months)
C: Trough Seated Diastolic Blood Pressure (DBP) Control (End of study (34 weeks or last value on treatment))
D: Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12 (Baseline, Month 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Study of Bevacizumab With Abraxane in Patients With Recurrent, Platinum-Resistant Primary Epithelial Ovarian or Primary Peritoneal Carcinoma
Brief Summary: The purpose of this study is to evaluate the effectiveness and tolerability of the combination of bevacizumab and Abraxane in the treatment of women with epithelial ovarian cancer or peritoneal cancer. The study will also evaluate how the patient's quality of life is during their treatment.


Options:
A: Overall Objective Response (1 year after end inclusion)
B: Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) (Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.)
C: 6-month Progression-Free Rate (6 months after initiation of study treatment)
D: Overall Survival (OS) (From randomization until the date of first documented progression or date of deaths from any cause, whichever came first, assessed up to 30 months (based on cutoff date: 19 September 2018).); Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Tinzaparin Sodium on Cardio-vascular OUtcomes and on Blood Lipids in Diabetic Patients on Chronic HEmodialysis: A Long-term, Prospective Study (The "Tinzaparin COULD HELP" Study).
Brief Summary: Low molecular weight heparin (LMWH) provides a safe and effective alternative to UFH for hemodialysis anticoagulation. While unfractionated (UF) heparin has been implicated in hyper-lipidemia, the effect of LMWHs on the lipid profile in non-diabetic patients on chronic hemodialysis remains controversial. The effect of LMWH in diabetic patients, a high risk group for developing hyper-lipidemia and cardio-vascular disease, has not been studied.

The study intends to examine the long-term effects of the replacement of UFH by LMWH (tinzaparin sodium) on cardio-vascular outcomes and on lipoprotein profiles in a large group of diabetic patients stable on HD.


Options:
A: the composite event rate in death (any cause), myocardial infarction and stroke
B: Levels of osteoprotegerin after administration of UFH or LMWH used as anticoagulant therapy for hemodialysis (during and after dialysis sessions)
C: Ischemic stroke or systemic embolism (efficacy) (Up to 72 months); Intracranial bleeding (including hemorrhagic stroke) and fatal bleeding (safety) (Up to 72 months)
D: Prothrombin time (Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis); Activated partial thromboplastin time (Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis); Anti-Xa level (Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis; 24 hours after administration of LMWH); Dialyser urea and creatinine clearances (At 15 mins after starting hemodialysis and 15 mins before the end of hemodialysis); Dialyser thrombus score (At the end of hemodialysis (8th hour))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 17-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Of Pregabalin For The Treatment Of Chronic Central Neuropathic Pain After Spinal Cord Injury
Brief Summary: The purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury compared to placebo (pill that contains no active medicine). This study will also evaluate the safety of pregabalin in this patient population.


Options:
A: Composite of Safety and Effectiveness (3 months)
B: Duration Adjusted Average Change (DAAC) of Mean Pain Score (Baseline, Week 16)
C: Change From Baseline to Study Endpoint in Mean Weekly Pain Scores (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Number of Responders (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Change From Baseline at Week 1 in Mean Weekly Pain Scores (From baseline to Week 1); Change From Baseline at Week 2 in Mean Weekly Pain Scores (From baseline to Week 2); Change From Baseline at Week 3 in Mean Weekly Pain Scores (From baseline to Week 3); Change From Baseline at Week 4 in Mean Weekly Pain Scores (From baseline to Week 4); Change From Baseline at Week 5 in Mean Weekly Pain Scores (From baseline to Week 5); Change From Baseline at Week 6 in Mean Weekly Pain Scores (From baseline to Week 6); Change From Baseline at Week 7 in Mean Weekly Pain Scores (From baseline to Week 7); Change From Baseline at Week 8 in Mean Weekly Pain Scores (From baseline to Week 8); Change From Baseline at Week 9 in Mean Weekly Pain Scores (From baseline to Week 9); Change From Baseline at Week 10 in Mean Weekly Pain Scores (From baseline to Week 10); Change From Baseline at Week 11 in Mean Weekly Pain Scores (From baseline to Week 11); Change From Baseline at Week 12 in Mean Weekly Pain Scores (From baseline to Week 12); Change From Baseline at Week 13 in Mean Weekly Pain Scores (From baseline to Week 13)
D: Percentage of Participants Who Have a >= 30% Reduction (Improvement) in the Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score From Baseline to the Last Assessment (Day 0, Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 17-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Of Pregabalin For The Treatment Of Chronic Central Neuropathic Pain After Spinal Cord Injury
Brief Summary: The purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury compared to placebo (pill that contains no active medicine). This study will also evaluate the safety of pregabalin in this patient population.


Options:
A: Total pain intensity as measured by numeric rating scale 0-10 points. (Median of ratings from last week of each treatment period)
B: Duration Adjusted Average Change (DAAC) of Mean Pain Score (Baseline, Week 16)
C: Daily Pain Rating Scale (DPRS)- Mean Pain Score (ITT Population) (Endpoint- Week 8 or Early Discontinuation)
D: Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data (Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder A Prospective, Randomized Migration and Bone Density Study
Brief Summary: The purpose of this study is to determine whether there is a difference between the result of treatment of shoulder osteoarthritis with two different shoulder prostheses.


Options:
A: Difference in Glenoid Component Placement (Inclination and Version) (Two weeks post surgery); Difference in Glenoid Component Placement (AP and SP). (Two weeks post surgery)
B: disease specific quality of life comparing the 2 groups at 2 years using several shoulder function rating scales.; the Western Ontario Osteoarthritis of the Shoulder Index (WOOS); the Constant Score; American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment form.; Short Form-12
C: Postoperative External Range of Motion (ROM) (2 years); Postoperative Internal Range of Motion (ROM) (2 years)
D: Migration of resurfacing prostheses (five years); Bone density around the prosthesis (five years); Pain (five years); Activities of Daily Living (ADL) (five years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial to Assess the Utility of Empirical Anti-Arrhythmic Drug Therapy to Prevent Atrial Arrhythmia During the 6 Weeks Following Pulmonary Vein Isolation to Treat Paroxysmal Atrial Fibrillation
Brief Summary: The purpose of this study is to examine the overall effectiveness of anti-arrhythmic medicines (to control heart rhythm) prescribed after an ablation procedure for atrial fibrillation.


Options:
A: The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF) (The evaluation time frame for the THERMOCOOL catheter subjects is 91-361 days (12 months) post procedure; for Antiarrhythmic Drug Therapy subjects the time frame is 15-285 days (9 months) post procedure.); The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events (Within 7 Days of Ablation Procedure)
B: Time to first recurrence of electrocardiographically documented, symptomatic AF or atrial flutter/tachycardia between 3 and 12 months post ablation in the absence of antiarrhythmic drug therapy. (Between 3 and 12 months post ablation)
C: Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion. (1-year follow-up)
D: Composite Endpoint: Atrial Arrhythmias Lasting >24 Hrs or Requiring Antiarrhythmic Drug Therapy; Need for Cardioversion/Repeat Ablation During the Study Period; Adverse Outcome/Intolerance of Antiarrhythmic Agent Requiring Cessation or Change of Drug (6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation in Substance Abuse Treatment Patients: A Feasibility Study
Brief Summary: The purpose of this study is to compare the effects of self-help materials for smoking cessation and self-help materials for smoking cessation plus prize-based contingency management (CM), in which prize incentives are available for breath and saliva samples that indicate smoking abstinence, in substance abuse treatment patients who want to quit smoking.


Options:
A: Expired Carbon Monoxide (Baseline and treatment phases, 2-mont and 6-month follow up.)
B: Continuous smoking abstinence since target quit date until last visit before delivery. (Last 6 months of pregnancy)
C: Biologically confirmed tobacco cessation (6 months)
D: Percent negative CO readings; Percent negative cotinine readings; Longest period of continuous abstinence

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Trial of Neoadjuvant Therapy in Patients With Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC With or Without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR With Each of the Regimens
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy and bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known which chemotherapy regimen is more effective with or without bevacizumab in treating breast cancer.

PURPOSE: This randomized phase III trial is studying six different chemotherapy regimens to compare how well they work with or without bevacizumab in treating women with stage I, stage II, or stage IIIA breast cancer that can be removed by surgery.


Options:
A: Percentage of Participants With Disease Progression or Death (Maintenance Phase Data Cutoff October 4, 2013) (Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years); Progression Free Survival (Maintenance Phase Data Cutoff October 4, 2013) (Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years)
B: Pathologic Complete Response (pCR) of the Primary Tumor in the Breast (Time of surgery, on average 6 or 13 months)
C: Overall Survival (OS) (From date of randomization until date of death from any cause, assessed up to data cutoff date of 12 Mar 2012, or up to approximately 6 years); Progression Free Survival (PFS) (From date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date of 12 Mar 2012 or up to approximately 6 years)
D: Overall Survival (From date of randomization until death from any cause)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Duloxetine 60 to 120 mg Versus Placebo in the Treatment of Patients With Osteoarthritis Knee Pain
Brief Summary: The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.


Options:
A: Change From Baseline in the Weekly Mean of the 24-Hour Average Pain Score at 8 Weeks (Baseline, 8 weeks (blinded endpoint))
B: McGill Pain Questionnaire - Short Form (Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.); PamSys Actigraph Data (48 hours after visit 3); Pain Anxiety Symptoms Scale (PASS) (Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.); Pain Disability Index (PDI) (Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.); Center for Epidemiological Studies Depression Scale CESD-10 (CES-D 10) (Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.); Pain Visual Analogue Scale (Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.)
C: Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary (Over 13 Weeks)
D: Brain Regional Gray Matter Density (2 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating a Low-Literacy Discharge Medication Education Tool
Brief Summary: Recent studies have demonstrated that patients sub-optimally understand hospital discharge medication instructions Health literacy has been shown to be an important factor in patient understanding of medical information , and following medication instructions.

The primary aim of this project is to test the efficacy of a low-literacy discharge medication education tool on medication adherence, and patient knowledge and understanding of inpatient discharge medications, in a low-income population with low health literacy levels. This evaluation is a prospective trial with patients randomly assigned to either receiving this tool or receiving the current standard of care. Given the complexity of the discharge medication regimen for the conditions of congestive heart failure (CHF) and coronary artery disease (CAD), and the proven effectiveness of these medications in the post discharge period, this trial will focus on the subpopulation of patients hospitalized with these two conditions.


Options:
A: Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes. (minimum of 1 year)
B: Self-Reported Medication Adherence (2 & 4 weeks post discharge)
C: The proportion of time that nursing home residents receiving warfarin have their international normalized ratios (INRs) within the target therapeutic range (one year); The time to next INR measurement after an out-of-range INR. (one year); Rates of adverse events (bleeds and thromboembolic events) (one year)
D: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)

Answer: B