TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Vitamin D to Improve Glucose Metabolism and Reduce Inflammation in Obese Adolescents on a Standard Weight Loss Program
Brief Summary: The investigators' project will study the effects of optimizing the vit D status of obese adolescents on markers of glucose metabolism and inflammation.


Options:
A: BMI percentile (6 months)
B: 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)
C: BMI SDS or Z-score (12 months primary/ 18 months secondary outcome)
D: serum 25-hydroxy vitamin D concentrations (baseline, 3, 6 months); serum concentrations of inflammatory markers (Interleukin-6, TNF-alpha, c reactive protein) (baseline and 6 mos); Hemoglobin A1C, serum glucose and insulin concentrations (baseline, 3 and 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of Physical Activity Monitoring and Distance Counselling in an Occupational Health Setting - a Randomised Controlled Trial (CoAct)
Brief Summary: The CoAct study is investigating a novel lifestyle intervention, aimed at the working population, with daily activity monitoring and distance counseling via telephone and secure web messages. The main purpose of this study is to evaluate the effectiveness of lifestyle counseling on the level of physical activity in an occupational health setting. The purposes include also analyzing the potential effects of changes in physical activity on productivity at work and sickness absence, and health care costs.


Options:
A: Physical Activity (One year)
B: Time between emergency call and therapy decision
C: Fasting Insulin (Baseline); 3 Month Fasting Insulin (3 month); 12 Month Fasting Insulin (12 months); Fasting Glucose (Baseline); 3 Month Fasting Glucose (3 months); 12 Month Fasting Glucose (12 Months)
D: The change in mean daytime systolic BP from baseline to the last (12-month) visit on 24-hour ambulatory. (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Monotherapy Versus Dual Therapy for Initial Treatment for Hypertension
Brief Summary: To test whether the current custom of initiating treatment for hypertension with a single drug is less effective in the short-term than initial combination therapy, and results in the eventual need for comparatively more antihypertensive drug therapy.


Options:
A: Blood pressure variation and proportion of use of add-on drugs (18 months); Adverse events (18 months); Development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. (18 monyhs)
B: The rate of decline of glomerular filtration rate (GFR).GFR is measured at baseline,and at 6,12,18,24,30 and 36 months after randomization
C: Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria. (3 years)
D: Change in mean home systolic BP for the group treated initially with monotherapy compared to the group treated initially with combination therapy. (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-term Role of Pioglitazone in Non-Alcoholic Fatty Liver Disease (NAFLD) in Type 2 Diabetes Mellitus (T2DM).
Brief Summary: Obesity and Type 2 diabetes are creating a silent epidemic, Non-alcoholic fatty liver disease, which is a chronic liver disease associated with insulin resistance, impaired glucose intolerance, and hepatic fat accumulation. The thiazolidinedione pioglitazone improves glucose/lipid metabolism and histology in NASH by improving insulin resistance in the liver/peripheral/adipose tissues and reducing subclinical inflammation. The aim of this study is to assess the underlying mechanisms at the clinical and molecular level and the long-term efficacy and safety of pioglitazone in NASH in a multiethnic cohort of subjects (predominantly Hispanics, Caucasians and African-Americans - the most common ethnic groups locally) and examine the response including patients with normal glucose tolerance, impaired glucose tolerance or established type 2 diabetes mellitus (T2DM).


Options:
A: Percent Change From Baseline to Month 12 in Bone Mineral Density in the Total Proximal Femur by Dual-Energy-Ray Absorptiometry (DXA) (Baseline and Month 12.)
B: Change From Baseline in Fasting Body Weight (Week 0, Week 56); Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight. (At Week 56); Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (At 56 weeks); Proportion of Subjects With Onset of Type 2 Diabetes (At 160 weeks)
C: Liver Histology (Using Kleiner et al Criteria, Hepatology 2005) (At 18 months)
D: Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction (Up to 5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion
Brief Summary: The primary aim of this study is to assess the acceptability of home-use mifepristone for termination of pregnancy among women who choose it and their providers. The investigators' secondary aims are to assess rates of follow-up, adherence, efficacy, complications, lost productivity, and to estimate the minimum proportion of women who choose home-use over clinic use of mifepristone.


Options:
A: Proportion of participants who would choose outside of center administration of mifepristone again (1-2 weeks); Proportion of participants who would recommend outside-of-center administration to a friend (1-2 weeks)
B: successful menstrual regulation without the need for a surgical evacuation (14 days)
C: Proportion of women who select home-use of mifepristone (1-2 weeks); Satisfaction with Method (1-2 weeks)
D: Efficacy defined as complete abortion without recourse to surgical abortion. (2 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Levosimendan to Reduce Mortality in High Risk Cardiac Surgery Patients. A Multicentre Randomized Controlled Trial
Brief Summary: Low cardiac output syndrome (LCOs) is a serious complication in critically ill patients or those undergoing major surgery, resulting in multiple organ damage with significant in-hospital and long-term morbidity and mortality, as well as prolonged hospital stay. In this setting the mortality rate is distressingly high despite improvements in intensive care treatment, but survivors have an acceptable quality of life.


Options:
A: APACHE II SCORE (4 days)
B: All-cause mortality in the 180 days following randomization.
C: Mortality (30-days)
D: Efficacy: Changes in regional contractility measured as wall-motion score index, proBNP and clinical symptoms. (At 5 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Levosimendan to Reduce Mortality in High Risk Cardiac Surgery Patients. A Multicentre Randomized Controlled Trial
Brief Summary: Low cardiac output syndrome (LCOs) is a serious complication in critically ill patients or those undergoing major surgery, resulting in multiple organ damage with significant in-hospital and long-term morbidity and mortality, as well as prolonged hospital stay. In this setting the mortality rate is distressingly high despite improvements in intensive care treatment, but survivors have an acceptable quality of life.


Options:
A: Confirmed low cardiac output syndrome (within the 28 days after ICU admission)
B: Number of Dual Efficacy Endpoint Events (30 days); Number of Quad Efficacy Endpoint Events (30 days)
C: blood pressure (up to 5 days)
D: Mortality (30-days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm , Study to Assess Efficacy and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or Placebo Co-Administered With Varenicline (Champix®) as an Aid in Smoking Cessation
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit smoking.


Options:
A: 7-Day Point Prevalence Smoking Abstinence (24 weeks); Continuous Smoking Abstinence (24 weeks)
B: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
C: Number of Participants With Cotinine-confirmed 7-day Point Prevalence Abstinence at the End of Treatment (7 days at end of treatment); Number of Participants Experiencing Treatment-emergent Adverse Events (26 weeks (12 weeks of treatment plus full post-treatment follow-up))
D: Long term abstinence (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm , Study to Assess Efficacy and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or Placebo Co-Administered With Varenicline (Champix®) as an Aid in Smoking Cessation
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit smoking.


Options:
A: To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. (8 weeks)
B: Long term abstinence (one year)
C: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
D: Weight Gain in Treatment Completers (baseline and 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm , Study to Assess Efficacy and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or Placebo Co-Administered With Varenicline (Champix®) as an Aid in Smoking Cessation
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit smoking.


Options:
A: The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26. (26 weeks)
B: Long term abstinence (one year)
C: Seven-day point prevalence and treatment or treatment strategy (At week 6); Main effects of varenicline and nicotine patch + lozenge on smokers who remain on these medications throughout the trial as documented in questionnaires (Up to 12 weeks); Probability of response at week 12 conditional on response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and augmentation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and treatment switching (At 12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after the initial treatment with nicotine patch + lozenge for six weeks (12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after initial treatment with varenicline for six weeks (12 weeks)
D: Weight Gain in Treatment Completers (baseline and 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm , Study to Assess Efficacy and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or Placebo Co-Administered With Varenicline (Champix®) as an Aid in Smoking Cessation
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit smoking.


Options:
A: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
B: Tobacco use (Six-month follow-up)
C: 4-week continuous quit rate (CQR) for Weeks 9-12
D: Long term abstinence (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm , Study to Assess Efficacy and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or Placebo Co-Administered With Varenicline (Champix®) as an Aid in Smoking Cessation
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit smoking.


Options:
A: Long term abstinence (one year)
B: Success rates and safety at week 24 in the varenicline vs placebo. Success rates will be defined as the Continuous Quit Rate since last visit. Maintain abstinence during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. (week 24)
C: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco (Weeks 9 through 12)
D: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm , Study to Assess Efficacy and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or Placebo Co-Administered With Varenicline (Champix®) as an Aid in Smoking Cessation
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit smoking.


Options:
A: Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions. (Last 4 weeks of treatment); Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions (First 3 weeks (pretreatment))
B: Smoking Cessation at 7 days (7-day point prevalence abstinence); Continuous Smoking Abstinence at 6 weeks (6 weeks)
C: Long term abstinence (one year)
D: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm , Study to Assess Efficacy and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or Placebo Co-Administered With Varenicline (Champix®) as an Aid in Smoking Cessation
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit smoking.


Options:
A: Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group (76 weeks)
B: Long term abstinence (one year)
C: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
D: Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day) (12 weeks); Sustained Abstinence at the 12-week Follow up (12 weeks); Number of Days of Varenicline Use (12 weeks); Number of Active Smoking Cessation Activities Used (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm , Study to Assess Efficacy and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or Placebo Co-Administered With Varenicline (Champix®) as an Aid in Smoking Cessation
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit smoking.


Options:
A: Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F).
B: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)
C: Long term abstinence (one year)
D: 7-day Point Prevalence Abstinence From Smoking at 6 Months (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm , Study to Assess Efficacy and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or Placebo Co-Administered With Varenicline (Champix®) as an Aid in Smoking Cessation
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit smoking.


Options:
A: Percent days abstinent of tobacco, alcohol and drugs (Past 90 days)
B: Smoking Abstinence (week 7, week 11 and week 24 after scheduled quit day)
C: Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12. (Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks))
D: Long term abstinence (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm , Study to Assess Efficacy and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or Placebo Co-Administered With Varenicline (Champix®) as an Aid in Smoking Cessation
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit smoking.


Options:
A: Long term abstinence (one year)
B: Smoking Status (at week 48)
C: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)
D: To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Follow-Up of Fully Resected Stage II or III Colorectal Cancer. Phase III Multicentric Prospective Randomised Study
Brief Summary: RATIONALE: Diagnostic procedures, such as ultrasound, x-ray, colonoscopy, CT scan, and CEA assessment, may help monitor a patient's response to surgery. It is not yet known which follow-up regimen is more effective in patients who have undergone surgery for colorectal cancer.

PURPOSE: This randomized phase III trial is comparing two types of follow-up care with or without CEA assessments to see how well they work in patients who have undergone surgery for stage II or stage III colorectal cancer.


Options:
A: The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative (Baseline); The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive (Baseline); The Expanded Prostate Cancer Index (EPIC) - Bowel Health (Baseline); The Expanded Prostate Cancer Index (EPIC) - Sexual Health (Baseline); The Expanded Prostate Cancer Index (EPIC) - General Health (Baseline); The Expanded Prostate Cancer Index (EPIC) - EPIC-26 Mean (Baseline); The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative (5 Months); The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive (5 Months); The Expanded Prostate Cancer Index (EPIC) - Bowel Health (5 Months); The Expanded Prostate Cancer Index (EPIC) - Sexual Health (5 Months); The Expanded Prostate Cancer Index (EPIC) - General Health (5 Months); The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative (12 Months); The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive (12 Months); The Expanded Prostate Cancer Index (EPIC) - Bowel Health (12 Months); The Expanded Prostate Cancer Index (EPIC) - Sexual Health (12 Months); The Expanded Prostate Cancer Index (EPIC) - General Health (12 Months); Confidence in Symptom Self-Management (5 months); Confidence in Symptom Self-Management (12 months)
B: Overall survival rate (5 years)
C: Overall Survival (OS) (5-year OS); Health Related Quality of Life (Yearly assessment over 5 years)
D: Patient satisfaction with follow-up care (up to 60 months after completion of primary treatment); Costs-effectiveness (assessed at 60 months after completion of primary treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Follow-Up of Fully Resected Stage II or III Colorectal Cancer. Phase III Multicentric Prospective Randomised Study
Brief Summary: RATIONALE: Diagnostic procedures, such as ultrasound, x-ray, colonoscopy, CT scan, and CEA assessment, may help monitor a patient's response to surgery. It is not yet known which follow-up regimen is more effective in patients who have undergone surgery for colorectal cancer.

PURPOSE: This randomized phase III trial is comparing two types of follow-up care with or without CEA assessments to see how well they work in patients who have undergone surgery for stage II or stage III colorectal cancer.


Options:
A: Quality of life; EORTC-QLQ-C30 and EQ 5D (2 years)
B: Percentage of patients with a non removable recurrence (at the end of the study)
C: Overall and cancer-specific mortality (5 years)
D: Overall survival rate (5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Randomized, Parallel-group, Multicenter Study of Neoadjuvant Docetaxel(Taxotere®) Plus Cisplatin Plus 5-fluorouracil Versus Neoadjuvant Cisplatin Plus 5-fluorouracil in Patients With Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck
Brief Summary: The Primary Objective is to evaluate the progression-free survival after treatment with docetaxel plus cisplatin plus 5-Fluorouracil (5-FU) (DCF) in comparison with cisplatin plus 5-FU (CF) in patient with locally advanced inoperable SCCHN The Secondary Objective is to evaluate and compare the clinical response rate both before and after radiotherapy, the local symptoms, the duration of response, the time to treatment failure, the survival, the toxicity and the quality of life in the 2 study groups.


Options:
A: Tumor Responses (Baseline and 2 months)
B: Progression-free survival (From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months))
C: Disease free survival (3 years)
D: overall survival (3 years)

Answer: B