TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Varenicline in Methadone-Stabilized Cocaine Users
Brief Summary: Cocaine addiction continues to be an important public health problem in the US with a significant cost to the individual and society. Among substance abusers, cocaine use has been recognized as a significant problem especially in methadone-maintenance patients. In several studies, rates of cocaine use have been reported to range from 30 to over 60 percent of those in methadone maintenance programs (Condelli et al. 1991; Hunt et al. 1984; Kidorf and Stitzer 1993; Kosten et al. 1988). In these patients, cocaine use seems to be a predictor of poor clinical outcome (Hartel et al. 1995; Kosten et al. 1987a). The development of effective pharmacotherapies for cocaine use disorders, especially in the opioid-dependent population is of great importance. Unfortunately, such effective pharmacotherapies do not exist.

1. To determine the safety and tolerability of varenicline in cocaine-using methadone-stabilized subjects.
2. To determine if varenicline is efficacious in reducing cocaine-use in methadone-stabilized subjects.


Options:
A: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)
B: 4-week continuous quit rate (CQR) for Weeks 9-12
C: Primary Patient Acceptability A: Rate of Patient Wanting Provider to Use QA-DDS (Immediately Post-Consultation up to 1 week); Primary Patient Acceptability B: Rate of Patient Wanting to Use QA-DDS Patient Portal (1-Month Follow-Up); Primary Patient Feasibility A: Rate of Patient Completion of 1-Month Follow-Up Survey (1-Month Follow-Up)
D: Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits (Period between 8-week and 11-week visits post target Quit Day)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Varenicline in Methadone-Stabilized Cocaine Users
Brief Summary: Cocaine addiction continues to be an important public health problem in the US with a significant cost to the individual and society. Among substance abusers, cocaine use has been recognized as a significant problem especially in methadone-maintenance patients. In several studies, rates of cocaine use have been reported to range from 30 to over 60 percent of those in methadone maintenance programs (Condelli et al. 1991; Hunt et al. 1984; Kidorf and Stitzer 1993; Kosten et al. 1988). In these patients, cocaine use seems to be a predictor of poor clinical outcome (Hartel et al. 1995; Kosten et al. 1987a). The development of effective pharmacotherapies for cocaine use disorders, especially in the opioid-dependent population is of great importance. Unfortunately, such effective pharmacotherapies do not exist.

1. To determine the safety and tolerability of varenicline in cocaine-using methadone-stabilized subjects.
2. To determine if varenicline is efficacious in reducing cocaine-use in methadone-stabilized subjects.


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: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)
C: Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 (12 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 (24 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 (52 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 (64 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 (104 weeks following treatment initiation)
D: 7-Day Point Prevalence Smoking Abstinence (24 weeks); Continuous Smoking Abstinence (24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study is to evaluate acute and long-term safety and effectiveness of Left atrial appendage occlusion (LAA)with the AtriCure LAA Occlusion System. This device will be applied in patients with atrial fibrillation (AF), paroxysmal, persistent and permanent, undergoing cardiac surgery with a concomitant Maze/Ablation procedure.


Options:
A: Rate of Device Related Serious Adverse Events (Discharge/30 days Post Procedure); Percent of Patients With Complete Occlusion of the Left Atrial Appendage. (3 Months Post Procedure)
B: Safety - Device related complications (30 days); Efficacy - Occlusion of the LAA (6 months)
C: At 3rd, 6th and 12th month's follow-up, to evaluate the rhythm status by ECG and 24-hour Holter and cardiac hemodynamic status by transthoracic echocardiography (1 year)
D: The primary outcome endpoint was the presence of SR at 12 months

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia or Progressive Keratoconus
Brief Summary: Prospective, randomized, single site study to determine the safety and effectiveness of performing corneal collagen cross-linking (CCCL)using riboflavin and UVA light in eyes with corneal ectasia or progressive keratoconus.


Options:
A: Mean Change From Baseline in Maximum Keratometry (Kmax) (baseline,12 months)
B: Mean Change From Baseline in Maximum Keratometry (Kmax) (baseline,12 months)
C: Change in keratometry (3 Months)
D: Best corrected visual acuity (at six months after surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study Comparing the Safty Anf Efficacy of Ranibizumab (Lucentis®) to Sham in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO
Brief Summary: A prospective multicenter study comparing patients with CRVO amd secondary macular edema treated with ranibizumab versus sham. Safety and efficacy will be evaluated. Patients will be randomized in a 1:1 ratio to one of the two arms. 32 patients, 6 months follow up. There will be monthly visits with injection the first three months and subsequently new injection if present edema.


Options:
A: Progression-Free Survival (Assessed every 3 months for 2 years, then every 6 months for 3 years)
B: N/A
C: The primary efficacy outcome measure is the mean change from baseline in BCVA score (6 months)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study Comparing the Safty Anf Efficacy of Ranibizumab (Lucentis®) to Sham in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO
Brief Summary: A prospective multicenter study comparing patients with CRVO amd secondary macular edema treated with ranibizumab versus sham. Safety and efficacy will be evaluated. Patients will be randomized in a 1:1 ratio to one of the two arms. 32 patients, 6 months follow up. There will be monthly visits with injection the first three months and subsequently new injection if present edema.


Options:
A: The primary efficacy outcome measure is the mean change from baseline in BCVA score (6 months)
B: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months (Baseline and 6 months)
C: The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit (Change from baseline to 12 months)
D: Proportion of eyes with an improvement of more than 15 letters (approximately > 3 lines of visual acuity gain) after one year as compared to baseline

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center, Phase II Study to Determine the Efficacy, Tolerability and Safety of Low and High Non-overlapping Dose Ranges of BL-1020 Compared to Placebo and Risperidone
Brief Summary: This is a prospective, six-week, randomized, double blind, placebo-controlled, multi-center study in patients with schizophrenia who are experiencing an acute exacerbation of psychosis.


Options:
A: Number Who Discontinued Medication Within First 6 Study Months (Measured at Six Months)
B: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia (Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks))
C: To assess the impact of switching subjects from an existing antipsychotic to risperidone long acting on healthcare resource utilization. This will be evaluated by assessing:; Direct cost of care; Frequency and duration of institutional care; Discharge; Relapse
D: to evaluate the safety and tolerability of two dose ranges (6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-week Treatment, Multi-center, Randomized, Double-blind, Double- Dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control
Brief Summary: This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.


Options:
A: Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84 (Baseline and Day 84)
B: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)
C: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Week 12)
D: Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-week Treatment, Multi-center, Randomized, Double-blind, Double- Dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control
Brief Summary: This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.


Options:
A: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
B: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Week 12)
C: Forced Expiratory Volume in 1 second measured at 2 h post dosing following 24 weeks treatment
D: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-week Treatment, Multi-center, Randomized, Double-blind, Double- Dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control
Brief Summary: This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.


Options:
A: Forced Expiratory Volume in 1 second measured at 2 h post dosing following 24 weeks treatment
B: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Week 12)
C: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))
D: Trough FEV1 (L) at 28 Weeks on Treatment (28 weeks); Trough FEV1 (L) at 12 Weeks on Treatment (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-week Treatment, Multi-center, Randomized, Double-blind, Double- Dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control
Brief Summary: This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.


Options:
A: The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo (Up to 52 weeks); The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo (Up to 52 weeks); The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo (Up to 52 weeks); The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo (Up to 52 weeks); Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52 (Weeks 12, 26, 36, 44 and 52); Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52 (Weeks 12, 26, 36, 44 and 52)
B: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85) (End of treatment (Week 12 + 1 day, Day 85))
C: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Week 12)
D: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-week Treatment, Multi-center, Randomized, Double-blind, Double- Dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control
Brief Summary: This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.


Options:
A: Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment (after 12 weeks of treatment)
B: Time-normalized Area Under the Change From Study Baseline Curve for Forced Expiratory Volume in One Second (FEV1) Over 24 Hours (nAUC0-24B) (24 hours following two weeks of dosing.)
C: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Week 12)
D: 24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment (23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 15 of each treatment period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Antipyretics for Preventing Recurrences of Febrile Seizures
Brief Summary: We wanted to find out if the early use of antipyretics is capable in preventing recurrences of febrile seizures. When a child has had his/her first febrile seizure, the parents were instructed to give him/her antipyretic medication every time when the child had a new episode of fever during two years.


Options:
A: recurrence of febrile seizure (two years)
B: Length of Seizure After Study Medication Administration (24 hours)
C: Cessation of all clinical seizure activity within 10 min of drug administration (10 min)
D: whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Prospective Randomized Comparison of Depot Octreotide Plus Interferon Alpha Versus Depot Octreotide Plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients
Brief Summary: This randomized phase III trial studies octreotide acetate and recombinant interferon alfa-2b to see how well it works compared to octreotide acetate and bevacizumab in treating patients with high-risk neuroendocrine tumors that have spread to other places in the body (metastatic) or spread from where it started to nearby tissue or lymph nodes (locally advanced). Octreotide acetate and recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of cancer. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving octreotide acetate together with recombinant interferon alfa-2b is more effective than giving octreotide acetate together with bevacizumab in treating patients with neuroendocrine tumor.


Options:
A: Disease Control Rate (DCR) After 6 Months (6 months)
B: Progression Free Survival (PFS) (9 months after the last patient enrolled)
C: Central Review-based Progression-Free Survival (Up to 3 years)
D: Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review (Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Simplified Detection of Dynamic Hyperinflation Using Metronome Paced Hyperventilation and the Effect of Tiotropium in Patients With COPD
Brief Summary: We will detect dynamic hyperinflation (DH) in 40 COPD (chronic obstructive pulmonary disease) patients with moderately severe disease using metronome paced hyperventilation (MPH) with inspiratory capacity as the primary end point. Hypothesis: Is tiotropium capable of lung volume protecting inspiratory capacity from MPH induced DH vs placebo in a randomized crossover double blinded study.


Options:
A: Trough FEV1 response (after 12 weeks)
B: Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years); Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years)
C: Bronchodilator Response:Peak FEV1(L)(Forced Expiratory Volume in One Second)- (30 days); Bronchodilator Response:Peak FRC (L) (Functional Residual Capacity) (30 days); Bronchodilator Response: Peak FVC (L) (Forced Vital Capacity)- Tiotropium and Placebo (30 days); Bronchodilator Response: Peak IC (L) - (Inspiratory Capacity) - Tiotropium Versus Placebo (30 days); Bronchodilator Response: Peak FRC/TLC Percentage (Functional Residual Capacity(L)/Total Lung Capacity(L) - Tiotropium or Placebo (30 days); Bronchodilator Response: Peak TLC (L) (Total Lung Capacity)- Tiotropium or Placebo (30 days); Bronchodilator Response: Trough FEV1 (L)- (Forced Expiratory Volume) Tiotropium Versus Placebo (30 days); Bronchodilator Response: Trough FRC (L)- Tiotropium Versus Placebo (30 days); Bronchodilator Response: Trough FVC (L)- (Forced Vital Capacity) Tiotropium Versus Placebo (30 days); Bronchodilator Response: Trough IC (L) Inspiratory Capacity - Tiotropium Versus Placebo (30 days); Bronchodilator Response: Trough FRC/TLC (Functional Residual Capacity/Total Lung Capacity)- Tiotropium Versus Placebo (30 days); Bronchodilator Response: Trough TLC (L) (Total Lung Capacity)- Tiotropium Versus Placebo (30 days); IC (Inspiratory Capacity L)and Metronome Paced Hyperventilation-induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo and Baseline (baseline and 30 days (+2h) post dose); TLC (L) Before and After Metronome Paced Hyperventilation Induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo (one hour before intervention & 2 hrs. after after 30 days)
D: Change from baseline in trough FEV1 (Forced expiratory volume in one second) (after 12 weeks); Change from baseline in FEV1 2 hours post inhalation (after 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Rehabilitation for Patients Living With an ICD
Brief Summary: The purpose of this study is to describe the effect and meaning of an outpatient-nursing programme including physical activity for patients with implantable cardioverter defibrillators (ICD).

Hypothesis: The outpatient nursing programme will increase the perceived health and quality of life; improve the management of life from a patient perspective; reduce fear of exercise and increase physical capability and reduce the number of treatment-demanding arrhythmias.


Options:
A: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)
B: Hospital Anxiety and Depression Scale - Depression Scale at Baseline (Baseline); Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up (Six-months follow-up); Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up (Twelve-months follow-up); Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline (Baseline); Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up (Six-months follow-up); Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up (Twelve-months follow-up); Impact of Events Scale-Revised - Total Score at Baseline (Baseline); Impact of Events Scale-Revised - Total Score at 6-months Follow-up (Six-months follow-up); Impact of Events Scale-Revised - Total Score at 12-months Follow-up (Twelve-months follow-up); Impact of Events Scale-Revised - Intrusiveness Scale at Baseline (Baseline); Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up (Six-months follow-up); Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up (Twelve-months follow-up); Impact of Events Scale-Revised - Avoidance Scale at Baseline (Baseline); Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up (Six-months follow-up); Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up (Twelve-months follow-up); Impact of Event Scale-Revised Hyperarousal Scale at Baseline (Baseline); Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up (Six-months follow-up); Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up (Twelve-months follow-up); Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline (Baseline); Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up (Six-months follow-up); Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up (Twelve-months follow-up)
C: Quality of life (3 -6-12 month); Physical capability (3-6-12 month)
D: Cardiopulmonary function (Measured at Week 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Rehabilitation for Patients Living With an ICD
Brief Summary: The purpose of this study is to describe the effect and meaning of an outpatient-nursing programme including physical activity for patients with implantable cardioverter defibrillators (ICD).

Hypothesis: The outpatient nursing programme will increase the perceived health and quality of life; improve the management of life from a patient perspective; reduce fear of exercise and increase physical capability and reduce the number of treatment-demanding arrhythmias.


Options:
A: length of sickness absence (6 months after randomization)
B: Change in Sickness leave 1 year after inclusion (At 12 months after baseline)
C: Quality of life (3 -6-12 month); Physical capability (3-6-12 month)
D: N/A

Answer: C