TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Modulation of Lung Injury Complicating Lung Resection
Brief Summary: The purpose of this study is to determine whether N-acetylcysteine given intravenously 1 day pre-operatively is effective in preventing inflammation in the lungs, as measured by tests on blood, breath and lung specimens, in patients undergoing surgery to remove a portion of lung.


Options:
A: Post-operative Plasma IL-6 (Post operative, 24 hours)
B: Ventilator free-days (28 days)
C: Number of ventilator-free days (measured at Day 28)
D: 28 days mortality (28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Increasing QUITPLAN Helpline Utilization in Surgical Patients
Brief Summary: Elective surgery represents a teachable moment to deliver tobacco interventions. The overall goal of this proposal is to increase the utilization of the QUITPLANSM Helpline by surgical patients who smoke. Two specific aims will be pursued using a multidisciplinary research team. In the first aim, we will develop a practice-based intervention to promote QUITPLANSM Helpline utilization by surgical patients (Specific Aim 1A) using a combination of key informant interviews (approximately 30 subjects), and focus groups (approximately 25 subjects) then develop methods to educate providers in its implementation (Specific Aim 1B) and test their effectiveness in approximately 20 providers. In the second aim, we will perform a randomized clinical trial of this intervention in 300 patients scheduled for elective surgery, with the primary outcome being utilization of the QUITPLANSM Helpline (Specific Aim 2). Subjects will be randomized to receive either the intervention developed in Specific Aim 1, or a brief control intervention.


Options:
A: Quit line re-enrollment (At 6 months)
B: Smoking Cue Reactivity on Quit Day (4-weeks)
C: Smoking cessation (14 months post baseline)
D: Completion of one quitline counseling session (Three months postoepratively)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Subjects With Active Ulcerative Colitis
Brief Summary: The purpose of this study is to determine the safety and tolerability of the MDX-1100 regimen in subjects with active Ulcerative colitis(UC) and determine the response rate at day 57 in patients administered MDX-1100.


Options:
A: Number of Participants in Clinical Response Through Week 54 (Induction Baseline, Week 0 through Week 54)
B: Proportion of the subjects with clinical remission (defined as Mayo score ≤ 2 points with no individual subscore > 1 point) of BMS-936557 with that of the placebo (End of Induction [Week 11, Induction Period-78 (IP-78)])
C: Change in Mayo score at Day 57 compared with Screening (Day 57)
D: Induction Period (IP); Number of Participants With Clinical Response (Per Mayo Score) at Week 12: IP Cohort 1 (IP1C) (Week 12 (Day IP-85)); Maintenance Period (MP); Number of Participants With Clinical Response (Per Mayo Score) at Month 12 (Month 12 (Day MP-365)); Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation (Day OL-1 through the end of the OL); OL; Number of Participants With AEs of Special Interest (Day OL-1 through Day OL-729); OL; Number of Participants With Physical Examination Findings (Day OL-1 through Day OL-729); OL; Number of Participants With Marked Hematology Laboratory Abnormalities (Day OL-1 through Day OL-729); OL; Number of Participants With Liver and Kidney Function and Electrolyte Laboratory Abnormalities (Day OL-1 through Day OL-729); OL; Number of Participants With Chemistry and Urinalysis Laboratory Abnormalities (Day OL-1 through Day OL-729)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Subjects With Active Ulcerative Colitis
Brief Summary: The purpose of this study is to determine the safety and tolerability of the MDX-1100 regimen in subjects with active Ulcerative colitis(UC) and determine the response rate at day 57 in patients administered MDX-1100.


Options:
A: Rate of clinical remission
B: To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis. (Day 3 (after colonoscopy and CCE-2))
C: Change in Mayo score at Day 57 compared with Screening (Day 57)
D: Disease Activity Index score (baseline, week 4)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Multi-Center, Double-Blind, Single and Double Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus
Brief Summary: The purpose of thie study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab (LymphoStat-B™)in subjects with SLE.


Options:
A: To evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab in subjects with SLE. (Days 0-105)
B: Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24. (Baseline, 24 weeks); Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index) (0 to 52 weeks)
C: Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) (Approximately up to 13 years); Adverse Event (AE) Rates by System Organ Class (SOC) During the Study (Approximately up to 13 years); SAE Rates by System Organ Class (SOC) During the Study (Approximately up to 13 years); Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Erythrocytes at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Hematocrit at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Hemoglobin at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Albumin and Protein at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in BUN/Creatinine at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points (Baseline and approximately up to 13 years)
D: Percentage of Participants With a State of Disease Control at Week 52 (Week 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Orally Administered 220 mg Dabigatran Etexilate Capsules (110 mg Administered on the Day of Surgery Followed by 220 mg Once Daily) Compared to Subcutaneous 40 mg Enoxaparin Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Arthroplasty Surgery. (RE-NOVATE II)
Brief Summary: The primary objective of the trial is to demonstrate non-inferiority of 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily. Safety and efficacy will be compared between the treatment groups.


Options:
A: Percentage of Patients With Any Adverse Event (AE) (From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days))
B: Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1 (Week 1); Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2 (Week 2); Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4 (Week 4); Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12 (Week 12)
C: Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period (28-35 days)
D: Number of Participants With First Event of Ischemic/Unspecified Stroke, Hemorrhagic Stroke, or Systemic Embolism (SE) During the Intended Treatment Period (Time to first event in "Intended Treatment Period": started on day of randomization, ended at efficacy cut-off date (date target number of primary efficacy events [448] was expected to have occurred; set to 30-Jan-2011, prior to unblinding).); Rate of Adjudicated Stroke or Systemic Embolism (SE) During the Intended Treatment Period ("Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Orally Administered 220 mg Dabigatran Etexilate Capsules (110 mg Administered on the Day of Surgery Followed by 220 mg Once Daily) Compared to Subcutaneous 40 mg Enoxaparin Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Arthroplasty Surgery. (RE-NOVATE II)
Brief Summary: The primary objective of the trial is to demonstrate non-inferiority of 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily. Safety and efficacy will be compared between the treatment groups.


Options:
A: Thromboembolism occuring between day 7-35 ;; Major bleeding occuring between day 7-35 ;; LMWH induced thrombopenia; All cause mortality
B: Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes (Treatment period : up to day 36+/-6)
C: Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period (28-35 days)
D: Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period (First administration until 31-38 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of 3 Months Daily Treatment With Selective Serotonin Reuptake Inhibitor (SSRI, Fluoxetine) on Motor Rehabilitation After Ischemic Stroke. FLAME Trial
Brief Summary: Recovery from stroke is a major process and, except for acute intravenous thrombolysis, no treatment able to enhance recovery has yet been validated. Some drugs may have a positive effect when combined with physical rehabilitation. Previous studies have shown a potential effect of catecholaminergic drugs on cerebral plasticity of stroke patients. In 2001, our group has demonstrated in a small group of stroke patients (n=8) that a single dose of fluoxetine (Selective Serotonin Reuptake Inhibitor - SSRI) improved motor performance and modulated cerebral plasticity. We conducted a phase IIb prospective, double-blind, randomized, placebo controlled study to assess the effect of a daily treatment with fluoxetin (20 mg) on motor performance in patients with mild to severe motor deficit after ischemic stroke.


Options:
A: Progression in the Fugl-Meyer Motor Scale (M3 (3 months))
B: Efficacy (90 day after stroke); Safety (90 day after stroke)
C: Functional status, measured with the modified Rankin scale. (6 months)
D: Number of Participants With Adverse Events (After Day 1 of rTMS treatment); Number of Participants With Adverse Events (After Day 2 of rTMS treatment); Number of Participants With Adverse Events (After Day 3 of rTMS treatment); Number of Participants With Adverse Events (After Day 4 of rTMS treatment); Number of Participants With Adverse Events (3 months following neurostimulation); Number of Participants With Adverse Events (6 months following neurostimulation); Number of Participants With Adverse Events (12 months following neurostimulation); Depressive Symptoms as Rated by the Hamilton Depression Rating Scale (Depressive symptoms will be quantified before the rTMS stimulation protocol); Depressive Symptoms as Rated by the Hamilton Depression Rating Scale (Depressive symptoms will be quantified immediately after the 4 days of rTMS stimulation.); Depressive Symptoms as Rated by the Hamilton Depression Rating Scale (Depressive symptoms will be quantified 3 months after completion of the rTMS stimulation protocol.); Depressive Symptoms as Rated by the Hamilton Depression Rating Scale (Depressive symptoms will be quantified 6 months after completion of the rTMS stimulation protocol.); Depressive Symptoms as Rated by the Hamilton Depression Rating Scale (Depressive symptoms will be quantified 12 months after completion of the rTMS stimulation protocol.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of 3 Months Daily Treatment With Selective Serotonin Reuptake Inhibitor (SSRI, Fluoxetine) on Motor Rehabilitation After Ischemic Stroke. FLAME Trial
Brief Summary: Recovery from stroke is a major process and, except for acute intravenous thrombolysis, no treatment able to enhance recovery has yet been validated. Some drugs may have a positive effect when combined with physical rehabilitation. Previous studies have shown a potential effect of catecholaminergic drugs on cerebral plasticity of stroke patients. In 2001, our group has demonstrated in a small group of stroke patients (n=8) that a single dose of fluoxetine (Selective Serotonin Reuptake Inhibitor - SSRI) improved motor performance and modulated cerebral plasticity. We conducted a phase IIb prospective, double-blind, randomized, placebo controlled study to assess the effect of a daily treatment with fluoxetin (20 mg) on motor performance in patients with mild to severe motor deficit after ischemic stroke.


Options:
A: Peak treadmill speed (4 weeks)
B: Occurrence rate of depression (3 months)
C: Incidence of depressive disorders in the study population (Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18)
D: Progression in the Fugl-Meyer Motor Scale (M3 (3 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of 3 Months Daily Treatment With Selective Serotonin Reuptake Inhibitor (SSRI, Fluoxetine) on Motor Rehabilitation After Ischemic Stroke. FLAME Trial
Brief Summary: Recovery from stroke is a major process and, except for acute intravenous thrombolysis, no treatment able to enhance recovery has yet been validated. Some drugs may have a positive effect when combined with physical rehabilitation. Previous studies have shown a potential effect of catecholaminergic drugs on cerebral plasticity of stroke patients. In 2001, our group has demonstrated in a small group of stroke patients (n=8) that a single dose of fluoxetine (Selective Serotonin Reuptake Inhibitor - SSRI) improved motor performance and modulated cerebral plasticity. We conducted a phase IIb prospective, double-blind, randomized, placebo controlled study to assess the effect of a daily treatment with fluoxetin (20 mg) on motor performance in patients with mild to severe motor deficit after ischemic stroke.


Options:
A: Treatment response (Week 4 after tenth day of tDCS)
B: Reduction in depression (Hamilton Depression Rating Scale)at 12 months following stroke. (12 months following stroke)
C: Progression in the Fugl-Meyer Motor Scale (M3 (3 months))
D: General Health Questionnaire (GHQ 28) (T2 (6 months poststroke))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of 3 Months Daily Treatment With Selective Serotonin Reuptake Inhibitor (SSRI, Fluoxetine) on Motor Rehabilitation After Ischemic Stroke. FLAME Trial
Brief Summary: Recovery from stroke is a major process and, except for acute intravenous thrombolysis, no treatment able to enhance recovery has yet been validated. Some drugs may have a positive effect when combined with physical rehabilitation. Previous studies have shown a potential effect of catecholaminergic drugs on cerebral plasticity of stroke patients. In 2001, our group has demonstrated in a small group of stroke patients (n=8) that a single dose of fluoxetine (Selective Serotonin Reuptake Inhibitor - SSRI) improved motor performance and modulated cerebral plasticity. We conducted a phase IIb prospective, double-blind, randomized, placebo controlled study to assess the effect of a daily treatment with fluoxetin (20 mg) on motor performance in patients with mild to severe motor deficit after ischemic stroke.


Options:
A: Vascular death, Transient Ischemic Attack (TIA)/stroke and myocardial infarction (combined) (6 months); Functional status at 6-months (6 months)
B: Occurrence rate of depression (3 months)
C: Incidence of depressive disorders in the study population (Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18)
D: Progression in the Fugl-Meyer Motor Scale (M3 (3 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Initialization of Methadone in Primary Care; a Randomized Intervention Research for Preventing HCV Transmission Practices. ANRS Methaville
Brief Summary: The rapid scale up of opioid substitution treatment (OST) for drug users mainly achieved through the possibility of prescribing buprenorphine in primary care has been successful in reducing HIV prevalence among drug users but still inadequate for reducing the spread of HCV. To date, methadone in France can only be initialised in drug centres but GPs can prescribe methadone after stabilisation of dosages.

This study was born as an answer to a request from the French Minister of Health that supports the initialisation of methadone in primary care in order to improve coverage by OST (now 70%) in drug users.


Options:
A: Relapse (6 months)
B: prevalence of non-users of street opioid after one year of treatment will be compared between arms. (one year)
C: Discussion-opportunity about risk of partner abuse during physician-patient medical encounter (audiotaped data); Detection of partner abuse during physician-patient medical encounter (audio taped data)
D: Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Initialization of Methadone in Primary Care; a Randomized Intervention Research for Preventing HCV Transmission Practices. ANRS Methaville
Brief Summary: The rapid scale up of opioid substitution treatment (OST) for drug users mainly achieved through the possibility of prescribing buprenorphine in primary care has been successful in reducing HIV prevalence among drug users but still inadequate for reducing the spread of HCV. To date, methadone in France can only be initialised in drug centres but GPs can prescribe methadone after stabilisation of dosages.

This study was born as an answer to a request from the French Minister of Health that supports the initialisation of methadone in primary care in order to improve coverage by OST (now 70%) in drug users.


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: Opioid positive drug tests (4 and 12 months post-baseline)
C: 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))
D: prevalence of non-users of street opioid after one year of treatment will be compared between arms. (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Initialization of Methadone in Primary Care; a Randomized Intervention Research for Preventing HCV Transmission Practices. ANRS Methaville
Brief Summary: The rapid scale up of opioid substitution treatment (OST) for drug users mainly achieved through the possibility of prescribing buprenorphine in primary care has been successful in reducing HIV prevalence among drug users but still inadequate for reducing the spread of HCV. To date, methadone in France can only be initialised in drug centres but GPs can prescribe methadone after stabilisation of dosages.

This study was born as an answer to a request from the French Minister of Health that supports the initialisation of methadone in primary care in order to improve coverage by OST (now 70%) in drug users.


Options:
A: prevalence of non-users of street opioid after one year of treatment will be compared between arms. (one year)
B: Hepatitis C seroconversion
C: 1. decrease in the number and proportion of times participants practiced vaginal or anal sex without a condom.; 2. decrease in the overall number of persons participants shared syringes or injection equipment with.; 3. decrease in the number and proportion of injections done with a syringe previously used by another person.; 4. decrease in the number and proportion of times participant used another person's equipment to prepare or divide drugs before injecting.
D: Opiate abstinence

Answer: A