TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Practical Application, Acceptability and Effectiveness of a Portfolio Diet in Reducing Serum Cholesterol
Brief Summary: The purpose of this trial is to re-evaluate the potential role of diet in modulating cardiovascular risk factors. If potent lipid-lowering effects through novel dietary interventions can be demonstrated, then diet may again be seen as providing an alternative to drug therapy in the primary prevention of cardiovascular disease.

Aims:

* To determine the percentage of lipid clinic attendees interested in making a serious dietary change.
* To determine the extent to which a self selected dietary portfolio combining viscous fiber foods (oat \& barley β-glucan, psyllium, etc.), soy and vegetable protein foods (soy milk, soy meat analogues and almonds) and plant sterols (sterol margarine) in the same diet be significantly more effective in reducing LDL-cholesterol and other markers of cardiovascular disease risk than conventional dietary advice.
* To determine whether this effect can be maximized by more frequent follow-up, and what, if any, would be the relationship between dietary compliance and reduction in LDL-C.


Options:
A: Hemoglobin A1c (22 weeks)
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: Primary Outcome Measures Described Below (December 2011)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Practical Application, Acceptability and Effectiveness of a Portfolio Diet in Reducing Serum Cholesterol
Brief Summary: The purpose of this trial is to re-evaluate the potential role of diet in modulating cardiovascular risk factors. If potent lipid-lowering effects through novel dietary interventions can be demonstrated, then diet may again be seen as providing an alternative to drug therapy in the primary prevention of cardiovascular disease.

Aims:

* To determine the percentage of lipid clinic attendees interested in making a serious dietary change.
* To determine the extent to which a self selected dietary portfolio combining viscous fiber foods (oat \& barley β-glucan, psyllium, etc.), soy and vegetable protein foods (soy milk, soy meat analogues and almonds) and plant sterols (sterol margarine) in the same diet be significantly more effective in reducing LDL-cholesterol and other markers of cardiovascular disease risk than conventional dietary advice.
* To determine whether this effect can be maximized by more frequent follow-up, and what, if any, would be the relationship between dietary compliance and reduction in LDL-C.


Options:
A: Primary Outcome Measures Described Below (December 2011)
B: Change in Daily Servings of Fruits and Vegetables (Baseline and 6 months)
C: improvement in insulin resistance measured by HOMA index (6 months)
D: Nutrition Behavior and Knowledge, measured by Likert scale (Change from baseline at three months, and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Practical Application, Acceptability and Effectiveness of a Portfolio Diet in Reducing Serum Cholesterol
Brief Summary: The purpose of this trial is to re-evaluate the potential role of diet in modulating cardiovascular risk factors. If potent lipid-lowering effects through novel dietary interventions can be demonstrated, then diet may again be seen as providing an alternative to drug therapy in the primary prevention of cardiovascular disease.

Aims:

* To determine the percentage of lipid clinic attendees interested in making a serious dietary change.
* To determine the extent to which a self selected dietary portfolio combining viscous fiber foods (oat \& barley β-glucan, psyllium, etc.), soy and vegetable protein foods (soy milk, soy meat analogues and almonds) and plant sterols (sterol margarine) in the same diet be significantly more effective in reducing LDL-cholesterol and other markers of cardiovascular disease risk than conventional dietary advice.
* To determine whether this effect can be maximized by more frequent follow-up, and what, if any, would be the relationship between dietary compliance and reduction in LDL-C.


Options:
A: Change in Fat Mass at 12 Weeks (Value at 12 weeks minus value at baseline)
B: Primary Outcome Measures Described Below (December 2011)
C: weight loss (12 weeks)
D: Oxidized LDL (After 4 and 6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Double-blind, Randomized, Phase IV Clinical Trial Comparing the Safety, Tolerability and Efficacy of Levetiracetam Versus Lamotrigine and Carbamazepine in the Oral Antiepileptic Therapy of Newly Diagnosed Elderly Patients With Focal Epilepsy.
Brief Summary: In this clinical trial patients with newly diagnosed focal epilepsy aged 60 years or older receive three different antiepileptic drugs in a double-blind, randomized design over a period of 58 weeks. All drugs are licensed for the treatment of epilepsy. The primary endpoint of this study will be retention rate at 58-weeks, since it reflects both efficacy and tolerability.


Options:
A: 58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment (58 weeks)
B: N/A
C: Assessment and comparative analysis of initial and follow-up Neuropsychological evaluation in both treated groups. (Levetiracetam and Carbamazepine) (52 weeks)
D: The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase) (From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Double-blind, Randomized, Phase IV Clinical Trial Comparing the Safety, Tolerability and Efficacy of Levetiracetam Versus Lamotrigine and Carbamazepine in the Oral Antiepileptic Therapy of Newly Diagnosed Elderly Patients With Focal Epilepsy.
Brief Summary: In this clinical trial patients with newly diagnosed focal epilepsy aged 60 years or older receive three different antiepileptic drugs in a double-blind, randomized design over a period of 58 weeks. All drugs are licensed for the treatment of epilepsy. The primary endpoint of this study will be retention rate at 58-weeks, since it reflects both efficacy and tolerability.


Options:
A: Rate of seizure-free patients (in the first 6 weeks of the trial)
B: Assessment and comparative analysis of initial and follow-up Neuropsychological evaluation in both treated groups. (Levetiracetam and Carbamazepine) (52 weeks)
C: Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety (Visit 1 to End of Study (approximately 52 weeks))
D: 58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment (58 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Double-blind, Randomized, Phase IV Clinical Trial Comparing the Safety, Tolerability and Efficacy of Levetiracetam Versus Lamotrigine and Carbamazepine in the Oral Antiepileptic Therapy of Newly Diagnosed Elderly Patients With Focal Epilepsy.
Brief Summary: In this clinical trial patients with newly diagnosed focal epilepsy aged 60 years or older receive three different antiepileptic drugs in a double-blind, randomized design over a period of 58 weeks. All drugs are licensed for the treatment of epilepsy. The primary endpoint of this study will be retention rate at 58-weeks, since it reflects both efficacy and tolerability.


Options:
A: Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance Phase (Week 31 through Week 109)
B: N/A
C: 58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment (58 weeks)
D: Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety (Visit 1 to End of Study (approximately 52 weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Low Glycemic Index Diets on Glucose Control in Non-Insulin Dependent Diabetics
Brief Summary: Large observational studies have shown cereal fiber to protect from diabetes and heart disease. Despite the success of acarbose, an α-glucosidase hydrolase inhibitor, which lowers the glycemic index of foods containing starch, sucrose and maltodextrins, the use of diets containing low glycemic index foods still remains to be established. We will therefore provide otherwise healthy individuals with type 2 diabetes intensive counseling on food selection either to improve glucose control using high cereal fiber dietary strategies or low glycemic index foods. Studies will last 6 months with bloods taken for HbA1c, glucose and blood lipids. If the study shows a benefit for either or both diets then use of high fiber and/or low glycemic index foods in the diet may provide another potential way to improve glucose control and lower cholesterol levels in non-insulin dependent diabetes.


Options:
A: Body Composition (Week 6 and 12 - End of diet period 1 and 2)
B: Changes in faecal bacteria population (Changes in faecal bacteria populations upon consumption of the test and control cereals . Faecal samples were collected and analysed at 0, 42, 56, 112, 140 days)
C: Change in Hemoglobin A1c (6 months); Change in Fasting Glucose (6 months)
D: change from baseline in Hb1Ac concentration Hematology index detection Hematology index detection Hematology index detection Hematology index detection Hematology index detection (baseline, 30 days, 6 months and 1 year); changes from baseline in insulin resistance Hematology index detection Hematology index detection Hematology index detection Hematology index detection Hematology index detection (baseline, 30 days, 6 months and 1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Low Glycemic Index Diets on Glucose Control in Non-Insulin Dependent Diabetics
Brief Summary: Large observational studies have shown cereal fiber to protect from diabetes and heart disease. Despite the success of acarbose, an α-glucosidase hydrolase inhibitor, which lowers the glycemic index of foods containing starch, sucrose and maltodextrins, the use of diets containing low glycemic index foods still remains to be established. We will therefore provide otherwise healthy individuals with type 2 diabetes intensive counseling on food selection either to improve glucose control using high cereal fiber dietary strategies or low glycemic index foods. Studies will last 6 months with bloods taken for HbA1c, glucose and blood lipids. If the study shows a benefit for either or both diets then use of high fiber and/or low glycemic index foods in the diet may provide another potential way to improve glucose control and lower cholesterol levels in non-insulin dependent diabetes.


Options:
A: For adults: body weight loss maintenance (6 Month)
B: plaque volume (1, 3 years)
C: Change in Hemoglobin A1c (6 months); Change in Fasting Glucose (6 months)
D: weight loss at 12 weeks; Fat loss at 12 weeks; Lean mass change at 12 weeks

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: LEVP2006-1 CHANGE 2 Trial (C1-Inhibitor in Hereditary Angioedema Nanofiltration Generation Evaluating Efficacy): Open-Label Safety/Efficacy Repeat Exposure Study of C1INH-nf (Human) in the Treatment of Acute HAE Attacks
Brief Summary: The study objective was to evaluate the safety and efficacy of repeat use of C1INH-nf for the treatment of acute HAE attacks.


Options:
A: Number of Hereditary Angioedema (HAE) Attacks Treated With C1INH-nf (Duration of the study (2.5 years)); Percent of HAE Attacks With Substantial Relief of the Defining Symptom (Within 4 hours after initial treatment)
B: Part 1: The Rate of Investigator-confirmed HAE Attacks During Dosing in the Entire 24-week Treatment Period (Day 1 to Day 168) (24 weeks); Part 2 & 3: To Evaluate the Long-term Safety and Tolerability of Berotralstat 110 and 150 mg in Subjects With HAE (Part 2: 24 weeks (Days 169 to 337). Part 3: 48 weeks (Days 338 to 674).)
C: Frequency of All HAE Attacks (Duration of the study)
D: Normalized Number of Angioedema Attacks During the Treatment Period (From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Rheumatoid Arthritis With Roxithromycin
Brief Summary: The purpose of this study is to evaluate the clinical efficacy, safety, and tolerability of roxithromycin in patients with rheumatoid arthritis.


Options:
A: Symptom scoring (1 to 3 years of age); Duration in days of each asthmatic episode from randomisation start (1 to 3 years of age)
B: Occurrence of and time to Pseudomonas aeruginosa pneumonia (daily)
C: The primary efficacy variable was the percentage of patients who had a 20 percent improvement according to American College of Rheumatology (ACR) criteria (an ACR 20 response) at six months.
D: degree of food stasis (when endoscopy is performed.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Comparison of Continuous Positive Airway Pressure (CPAP) With Standard Treatment in Out-of-hospital Patients With Acute Cardiogenic Pulmonary Edema.
Brief Summary: Evaluate efficacy and safety of CPAP in a randomised standard treatment controlled study, in out-of-hospital patients with acute cardiogenic pulmonary edema.


Options:
A: Treatment success after the one hour study period, defined as all of respiratory rate less than 25 bpm, oxygen saturation greater than 90 %. (One hour)
B: Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most) (During the first 3 hours of recruitment); Time Required for Mask Placement (at the initiation of NPPV)
C: The rate of Acute Myocardial Infarction
D: Composite criteria includes during the first 48 hours : death, tracheal intubation and mechanical ventilation rates, persistence of inclusion criteria for respiratory distress and shock until H2, reappearance of inclusion criteria after H2. (48 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis: Comparison of Infusion Every 6 Weeks Versus Infusion on Demand
Brief Summary: Continuous treatment with the anti-tumor necrosis factor alpha monoclonal antibody infliximab is efficacious in ankylosing spondylitis (AS), whereas treatment discontinuation results in disease relapse, with variable delay. Objective of this study was to compare efficacy between a continuous treatment with infliximab, and a treatment adapted to symptoms recurrence. Addition of methotrexate (MTX)to infliximab was also tested.


Options:
A: Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 20. (12 weeks)
B: The primary end point was the proportion of patients with a 20% improvement response according to the ASAS criteria, at week 54.
C: Number of Subjects With a Reduction in Signs and Symptoms as Measured by Assessments of Ankylosing Spondylitis (ASAS) 20 Response at Week 12 (Week 12); Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score (Baseline and Week 104)
D: Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20) (16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of 17 Alpha-Hydroxyprogesterone Caproate for Prevention of Preterm Birth in Nulliparous Women With a Short Cervix
Brief Summary: The purpose of this study is to see if giving progesterone medication to pregnant women, who have never delivered a baby after 19 weeks of pregnancy and who have a short cervix, lowers the risk of early delivery and improves the health of their baby.


Options:
A: Weeks Gestation at Birth Among Patients Receiving the Active Drug. (Through delivery, until discharge up to 40 weeks gestation)
B: Spontaneous delivery before 34 completed weeks (238 days) of gestation.
C: Number of Participants Delivering Before 37 Weeks Gestation (Delivery before 37 weeks gestation)
D: Frequency of delivery <=32 weeks (18 weeks gestation through delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2, Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System (STS) as an Aid for Smoking Cessation.
Brief Summary: The purpose of this study is designed to examine the effects of Selegiline Transdermal System and behavioral intervention in smoking cessation as compared to behavioral intervention alone.


Options:
A: 4-week continuous quit rate (CQR) for Weeks 9-12
B: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)
C: Quit Rate (Study weeks 6 through 9)
D: 7 Day Point Prevalence of Cigarette Abstinence (6-month follow up); 7 Day Point Prevalence of Cigarette Abstinence (Week 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2, Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System (STS) as an Aid for Smoking Cessation.
Brief Summary: The purpose of this study is designed to examine the effects of Selegiline Transdermal System and behavioral intervention in smoking cessation as compared to behavioral intervention alone.


Options:
A: 7 day point prevalence of cigarette abstinence; measured at Week 13 and on a weekly basis (Weekly, and 13 weeks after beginning study medication (Week 13).)
B: Days of abstinence following the programmed lapse (7 days)
C: Smoking Abstinence (12 months)
D: Quit Rate (Study weeks 6 through 9)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2, Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System (STS) as an Aid for Smoking Cessation.
Brief Summary: The purpose of this study is designed to examine the effects of Selegiline Transdermal System and behavioral intervention in smoking cessation as compared to behavioral intervention alone.


Options:
A: Will bupropion reduce relapse to smoking compared to placebo (52 weeks and 76 weeks)
B: Quit Rate (Study weeks 6 through 9)
C: 7 Day Point Prevalence of Cigarette Abstinence (6-month follow up); 7 Day Point Prevalence of Cigarette Abstinence (Week 8)
D: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2, Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System (STS) as an Aid for Smoking Cessation.
Brief Summary: The purpose of this study is designed to examine the effects of Selegiline Transdermal System and behavioral intervention in smoking cessation as compared to behavioral intervention alone.


Options:
A: 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment. (At the end of treatment (12 weeks))
B: Quit Rate (Study weeks 6 through 9)
C: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
D: Biochemically verified 7 day point prevalence abstinence from smoking.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2, Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System (STS) as an Aid for Smoking Cessation.
Brief Summary: The purpose of this study is designed to examine the effects of Selegiline Transdermal System and behavioral intervention in smoking cessation as compared to behavioral intervention alone.


Options:
A: Quit Rate (Study weeks 6 through 9)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: The primary outcome is self-reported consecutive quit at 3 and 12 months following intervention. (3 and 12 month); Secondary outcomes are reduction in use, number of quit attempts at 3 and 12 months, and increases in readiness to quit. (3 and 12 months)
D: Determine the efficacy of combined therapy (VRN+nicotine patches) versus monotherapy (VRN+placebo patches) in smoking cessation assessed as continuous abstinence rate (CAR) from week 2 to week 12. (Participants will be followed for the duration of treatment, 12 weeks.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Telemedicine-Based Collaborative Care to Reduce Rural Disparities
Brief Summary: Across the country, Community Health Centers are participating in the Health Disparities Collaboratives sponsored by the Health Services Resources and Services Administration (HRSA). The Health Disparities Collaboratives integrate three complementary conceptual frameworks: 1) the Institute for Healthcare Improvement's (IHI) Breakthrough Series Model; 2) the Improvement Model (i.e., Plan-Do-Study-Act cycles); and 3) Wagner's Chronic Care Model. The Chronic Care model uses patient self-management, delivery system re-design, decision support, and clinical information systems to maximize the effectiveness of interactions between prepared proactive care teams and informed activated patients with chronic illnesses such as diabetes, asthma, and depression. The Chronic Care model for depression, also known as Collaborative Care, involves primary care providers working with a depression care team comprising non-physicians (e.g., nurses, pharmacists) and mental health specialists (e.g., psychiatrists). Practice-based collaborative care involves primary care providers working with an on-site depression care team. In contrast, telemedicine-based collaborative care involves primary care providers working with an off-site depression care team using telemedicine technologies. The purpose of this research project is to compare the effectiveness and cost effectiveness of practice-based and telemedicine-based collaborative care in Community Health Centers (without on-site mental health specialists) implementing the Health Disparities Collaborative for depression.


Options:
A: Adherence to Antidepressant Medication (At 3 and 6 months)
B: Percentage of Participants With Depression Treatment Response (6 months)
C: To compare processes and outcomes between CHC patients receiving practice-based collaborative care to CHC patients receiving telemedicine-based collaborative care (OUTREACH intervention). (6, 12, 18 months after baseline)
D: Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment (12 months); Depression Care: Treatment Response (Baseline and 12 months); Depression Care: Depression Remission (Baseline and 12 months); Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months (From Baseline to 12 months)

Answer: C