TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Relapse to Opioid Addiction Using Depot Naltrexone
Brief Summary: The aim of this project is to conduct a multi-site effectiveness study to determine whether the addition of a monthly injection of depot naltrexone to treatment as usual (TAU) will significantly improve outcome in parolees and probationers with a history of opioid addiction compared to TAU alone. Participants will be randomized to either treatment as usual in community programs or monthly injections of depot naltrexone for six months with treatment as usual in community programs. The effectiveness of depot naltrexone has never been studied in opioid dependent parolees. all parolee subjects will be evaluated at baseline, while in treatment, and at 6, 12 and 18 month post entry time points. The primary study outcomes are retention in treatment, drug use, re-arrests, psychosocial and medical/psychiatric functioning, and economic costs and benefit costs of naltrexone.


Options:
A: Abstinence (3 month follow up); Abstinence (6 month follow up); Abstinence (9 month follow up); Abstinence (12 month follow up); Abstinence (18 month follow up); Abstinence (24 month follow up); Cocaine Urine Toxicology (3 month follow up); Cocaine Urine Toxicology (6 month follow up); Cocaine Urine Toxicology (9 month follow up); Cocaine Urine Toxicology (12 month follow up); Cocaine Urine Toxicology (18 month follow up); Cocaine Urine Toxicology (24 month follow up); Comparison Across Groups in Societal Costs (24 months); Net Saving/Spending Comparisons Across Groups From Provider Perspective (24 months); Net Comparisons of Savings and Spendings Across Groups From Societal Perspective (24 months); Percent Days Cocaine Use (3 months (approximately study days 1 - 90)); Percent Days Cocaine Use (6 months (approproximately study days 91 - 180)); Percent Days Cocaine Use (9 months (approximately study days 181 - 270)); Percent Days Cocaine Use (12 months (approximately study days 271 - 365)); Percent Days Cocaine Use (18 months (approximately study days 366 - 546)); Percent Days Cocaine Use (24 months (approximately study days 547 - 730)); Percent Days Abstinent (3 months (approximately study days 1 - 90)); Percent Days Abstinent (6 months (approximately study days 91 - 180)); Percent Days Abstinent (9 months (approximately study days 181 - 270)); Percent Days Abstinent (12 months (approximately study days 271 - 365)); Percent Days Abstinent (18 months (approximately days 366 - 546)); Percent Days Abstinent (24 months (approximately study days 547 - 730))
B: Three consecutive weeks of negative urine tests (benzoyl ecgonine) for cocaine use (no slips allowed). (These must be the last three weeks (7,8,9) of the trial.)
C: Service Cascade: % Referred to Substance Use Treatment (120 weeks); Staff Perception: Value of Evidenced Based Substance Use Treatment (120 weeks)
D: Relapse (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Relapse to Opioid Addiction Using Depot Naltrexone
Brief Summary: The aim of this project is to conduct a multi-site effectiveness study to determine whether the addition of a monthly injection of depot naltrexone to treatment as usual (TAU) will significantly improve outcome in parolees and probationers with a history of opioid addiction compared to TAU alone. Participants will be randomized to either treatment as usual in community programs or monthly injections of depot naltrexone for six months with treatment as usual in community programs. The effectiveness of depot naltrexone has never been studied in opioid dependent parolees. all parolee subjects will be evaluated at baseline, while in treatment, and at 6, 12 and 18 month post entry time points. The primary study outcomes are retention in treatment, drug use, re-arrests, psychosocial and medical/psychiatric functioning, and economic costs and benefit costs of naltrexone.


Options:
A: Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL (Baseline to month 6 post release)
B: Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month (6 months)
C: Relapse (6 months)
D: Change From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks (Baseline-25 weeks); Change From Baseline in Treatment Adherence Score as Measured at 25 Weeks (Baseline-25 weeks); Change From Baseline in Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 25 Weeks (Baseline-25 weeks); Change From Baseline in Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 25 Weeks (Baseline-25 weeks); Change From Baseline in Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 25 Weeks (Baseline-25 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Liraglutide on Long-term Weight Maintenance and Additional Weight Loss Induced by a 4 to 12 Week Low Calorie Diet in Obese Subjects; A 56 Week Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Trial With a 12 Week Follow-up Period
Brief Summary: This trial is conducted in North America. The aim of this clinical trial is to evaluate the potential of liraglutide to maintain long term weight loss in obese non-diabetic subjects, as well as in overweight subjects who have medical problems such as hypertension (high blood pressure) or dyslipidaemia (an abnormal amount of lipids in the blood).

Trial has following trial periods: A 12-week run-in period (from week -12 to week 0) followed by a 56-week main trial period (weeks 0-56) and a 12-week follow-up period (weeks 56-68).


Options:
A: ß-cell Response Measured by Hyperglycemic Clamp (3-months after medication washout (Month 15)); Insulin Sensitivity, M/I (3-months after a medication washout)
B: Mean Percentage Change in Fasting Body Weight From Baseline (Week 0, week 56); Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0 (Week 0, week 56); Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0 (Week 0, week 56)
C: Change in area under the 0-2 hour prandial glucose curve at 12 weeks
D: Inflammatory Biomarker 1: Plasma hsCRP Concentration (2 months); Inflammatory Biomarker 2: Plasma IL-6 Concentration (2 months); Inflammatory Biomarker 3: Serum D-dimer Concentration (2 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind, Randomized, Placebo Controlled, Study for Assessment of Dietary Flaxseed on Improving Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease
Brief Summary: This Clinical Trial is being conducted to study how patients with peripheral arterial disease (a condition in which the blood vessels of the extremities are affected) respond to a dietary regimen of flaxseed. The purpose of the study is to examine whether or not dietary flaxseed have any effect on improving symptoms of cardiovascular disease. Additionally, the effects of dietary flaxseed on exercise tolerance will be assessed.


Options:
A: Development of Advanced AMD in People at Moderate to High Risk for Progression. (5 years of follow-up)
B: Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm) (one year)
C: Changes from baseline in global cognitive composite score (2 years); Changes from baseline in macular degeneration (2 years)
D: Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind, Randomized, Placebo Controlled, Study for Assessment of Dietary Flaxseed on Improving Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease
Brief Summary: This Clinical Trial is being conducted to study how patients with peripheral arterial disease (a condition in which the blood vessels of the extremities are affected) respond to a dietary regimen of flaxseed. The purpose of the study is to examine whether or not dietary flaxseed have any effect on improving symptoms of cardiovascular disease. Additionally, the effects of dietary flaxseed on exercise tolerance will be assessed.


Options:
A: Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm) (one year)
B: Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions (1 year)
C: Survival free of atrial fibrillation (12 months)
D: Death, all-cause (Up to 7 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind, Randomized, Placebo Controlled, Study for Assessment of Dietary Flaxseed on Improving Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease
Brief Summary: This Clinical Trial is being conducted to study how patients with peripheral arterial disease (a condition in which the blood vessels of the extremities are affected) respond to a dietary regimen of flaxseed. The purpose of the study is to examine whether or not dietary flaxseed have any effect on improving symptoms of cardiovascular disease. Additionally, the effects of dietary flaxseed on exercise tolerance will be assessed.


Options:
A: Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality
B: Atrial tachycardia and atrial fibrillation burden (18 months)
C: Weight loss (1 year)
D: Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind, Randomized, Placebo Controlled, Study for Assessment of Dietary Flaxseed on Improving Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease
Brief Summary: This Clinical Trial is being conducted to study how patients with peripheral arterial disease (a condition in which the blood vessels of the extremities are affected) respond to a dietary regimen of flaxseed. The purpose of the study is to examine whether or not dietary flaxseed have any effect on improving symptoms of cardiovascular disease. Additionally, the effects of dietary flaxseed on exercise tolerance will be assessed.


Options:
A: Death, all-cause (Up to 7 years)
B: Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions (1 year)
C: The Primary endpoint will be improvement in a composite score of histological injury as measured by the NASH Activity Score (NAS). (approximately 12 months from enrollment)
D: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind, Randomized, Placebo Controlled, Study for Assessment of Dietary Flaxseed on Improving Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease
Brief Summary: This Clinical Trial is being conducted to study how patients with peripheral arterial disease (a condition in which the blood vessels of the extremities are affected) respond to a dietary regimen of flaxseed. The purpose of the study is to examine whether or not dietary flaxseed have any effect on improving symptoms of cardiovascular disease. Additionally, the effects of dietary flaxseed on exercise tolerance will be assessed.


Options:
A: Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm) (one year)
B: The primary endpoint is change in coronary noncalcified plaque volume. (Baseline and 30 months)
C: MRI disease activity measured by the number of new T1-enhancing lesions during the six months of treatment.; MRI disease activity measured by the number of new T1-hypo-intensive lesions (black holes) after 24 months of treatment.
D: Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 48 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL (5 mcg [2 Actuations of 2.5 mcg] and 10 mcg [2 Actuations of 5 mcg]) Delivered by the Respimat® Inhaler, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (COPD).

The safety of BI 1744 CL inhalation solution delivered through the Respimat inhaler will also be compared to placebo.


Options:
A: Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks (Baseline and Weeks 2 to 52)
B: Time to All-Cause Mortality (Up to 3 years); Time to First COPD Exacerbation (Up to 3 years)
C: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks (1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24); Trough FEV1 Response at Week 24 (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.); Mahler Transitional Dyspnea Index Focal Score at 24 Weeks (Baseline, Week 24); Mahler Transitional Dyspnea Index Focal Score at 24 Weeks for Combined Analysis (Baseline, Week 24)
D: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks) (1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Day 85); Trough FEV1 Response at Day 85 (12 Weeks) (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h and - 10 mins prior to study drug at Day 85.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Randomized, Double-Blind, Ascending Multiple-Dose Study of the Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Chronic Hepatitis C Infection
Brief Summary: The purpose of this study is to investigate the safety, tolerability, and antiviral activity of ANA598 in patients with genotype-1 chronic hepatitis C infection.


Options:
A: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event (Up to 24 weeks)
B: Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period (Baseline to Week 12 plus 30 days)
C: The safety and tolerability of ascending multiple oral doses of ANA598 administered for 3 days to adult patients with chronic HCV infection and compensated liver disease; (10 days); The antiviral activity of ANA598, assessed by changes in serum HCV RNA levels (10 days)
D: The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) (Week 36 or Week 60)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Randomized, Double-Blind, Ascending Multiple-Dose Study of the Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Chronic Hepatitis C Infection
Brief Summary: The purpose of this study is to investigate the safety, tolerability, and antiviral activity of ANA598 in patients with genotype-1 chronic hepatitis C infection.


Options:
A: The safety and tolerability of ascending multiple oral doses of ANA598 administered for 3 days to adult patients with chronic HCV infection and compensated liver disease; (10 days); The antiviral activity of ANA598, assessed by changes in serum HCV RNA levels (10 days)
B: Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 (A Weeks 4 and 12)
C: Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir. (Baseline and 4 weeks)
D: Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients) (Baseline and up to 4 weeks); Occurrence of Adverse Events (AEs) During BI201335 + Washout Period (from day 1 and up to 4 weeks + 4 days washout); Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period (from day 1 and up to 4 weeks + 4 days washout); Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time (Baseline and up to 4 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Double Blind Clinical Study of Effectiveness and Safety of Vero Cell-Derived, Trivalent, Seasonal Influenza Vaccine in Adults Aged 50 Years and Older
Brief Summary: The purpose of this study is to demonstrate the effectiveness (seroprotection and seroconversion as measured by the hemagglutination inhibition \[HI\] assay) of an investigational Vero cell-derived, trivalent, seasonal influenza vaccine in adults 50 years of age and older. Subjects will be randomized in a double-blind fashion to receive a single intramuscular injection of either the investigational vaccine or a licensed egg-derived seasonal influenza vaccine. Blood will be drawn from all subjects for a determination of HI antibody titers on Days 0 and 21, body temperature and injection site reactions will be monitored daily for 7 days. In addition, subjects will be monitored for adverse events and rises in body temperature until Day 21 and again until Day 180.


Options:
A: Seroconversion at Day 21 after vaccination (21 days)
B: Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years (Pre-vaccination (Day 0) and day 21 post-vaccination); Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years (Pre-vaccination (Day 0) and Day 21 post-vaccination); Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years (Pre-vaccination (Day 0) and 21 days post-vaccination); Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years (Pre-vaccination (Day 0) and 21 days post-vaccination); Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years (Pre-vaccination (Day 0) and 21 days post-vaccination); Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years (Pre-vaccination (Day 0) and 21 days post-vaccination); Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years (Days 0 to 7 post-vaccination); Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years (Days 0 to 7 post-vaccination)
C: the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay (21 days after each vaccination)
D: To provide information concerning the immunogenicity of an inactivated, split-virion influenza vaccine (21 Days pot-vaccination)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The aim of this study is to compare laparoscopic versus open approach on the surgical treatment of mid and low-lying rectal cancer, both performed by the same surgical team with experience in open colorectal surgery and advanced laparoscopic surgery, assessing preoperative and anatomopathological results and long-term outcome.


Options:
A: Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay (1 month)
B: locoregional recurrence rate (3 years post operatively)
C: Primary endpoint is cancer free survival at three years.
D: Disease free survival (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 48 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL (5 mcg [2 Actuations of 2.5 mcg] and 10 mcg [2 Actuations of 5 mcg]) Delivered by the Respimat® Inhaler, in Patients With Chronic Obstructive Pulmonary Disease (COPD
Brief Summary: This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (COPD).


Options:
A: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks) (1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Day 85); Trough FEV1 Response at Day 85 (12 Weeks) (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h and - 10 mins prior to study drug at Day 85.)
B: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)
C: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Treatment Day 85 (Visit 8) (Baseline (BL) and Day 85)
D: Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo (Baseline and 6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients
Brief Summary: The purpose of this study is to determine whether nepafenac is safe and effective for reducing the incidence of macular edema following cataract surgery in diabetic retinopathy patients.


Options:
A: Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery (3 Months)
B: N/A
C: The incidence of CME was evaluated by retinal foveal thickness on optical coherence tomography (OCT) (After 1 week, 4 weeks, 12 weeks after surgery)
D: Percentage of patients who develop macular edema within 90 days following cataract surgery (Time to event)

Answer: A