TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of New Vascular Events in Patients With Brain Infarction or Peripheral Embolism and Thoracic Aortic Plaques ≥ 4 mm in Thickness in the Aortic Arch or Descending Aortic Upstream to the Embolized Artery
Brief Summary: The ARCH is a controlled trial with a sequential design and with a prospective, randomized, open-label, blinded-endpoint (PROBE) methodology. The objective is to compare the efficacy and tolerance (net benefit) of two antithrombotic strategies in patients with atherothrombosis of the aortic arch and a recent (less than 6 months) cerebral or peripheral embolic event.

Hypothesis:

The association of clopidogrel 75 mg/d plus aspirin 75 mg/d is 25% more effective than an oral anticoagulant (target International Normalized Ratio \[INR\] 2 to 3) in preventing brain infarction, brain hemorrhage, myocardial infarction, peripheral embolism, and vascular death.


Options:
A: New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death (every 4 months)
B: percentage of patients with new stroke (ischemic or hemorrhage) (90 days)
C: Number of Participants With a Composite Endpoint of Fatal Stroke, Recurrent Ischemic Stroke, or TIA (180 days)
D: Composite outcome of recurrent ischemic stroke, symptomatic intracerebral hemorrhage, or all-cause mortality (90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease: An Interventional and Methodological Study
Brief Summary: The purpose of this study is to determine whether a combination therapy with angiotensin-converting enzyme (ACE)-inhibitors and angiotensin receptor blockers reduces the arterial stiffness assessed by applantiontonometry more than a single treatment in kidney patients.


Options:
A: N/A
B: change in Six-minutes walk test (After 6 months); Rate of occurrence of worsening renal function (through 2 months); Rates of discontinuation of- or intolerance to the used agent for RAAS inhibition (enalapril/telmisartan) (Through 6 months)
C: N/A
D: pulse wave velocity (aortic and brachial) (0, 8, 16 and 24 weeks after start of intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Prospective, Randomized, Multicenter Phase II Comparative Trial of Thymoglobulin® Versus Simulect® for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients
Brief Summary: A multicenter clinical study comparing event-free survival at 6 months after transplant between Thymoglobulin-treated and Simulect-treated adult kidney transplant patients. Patients received Thymoglobulin or Simulect from Day 0 through Day 4. Day 0 was considered the day of the transplant procedure.

Subjects meeting all inclusion and exclusion criteria were eligible to participate in this study. The treatment assignment was random and not chosen by the subject or their physician.

Subjects were monitored during treatment with Thymoglobulin and during the transplant hospitalization. Additional subject monitoring occurred up to 12 months after transplant.

278 study subjects were enrolled at 28 transplant centers in the United States and Europe.


Options:
A: Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant. (6 months)
B: Time to first BPAR episode or treatment failure (6 months)
C: GFR calculated from the serum creatinine with the Cockcroft-Gault formula at 12 months posttransplantation
D: renal function as measured by serum creatinine at 6 months post-transplant

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Dose Adjustment of Nicotine Replacement Therapies According to Saliva Cotinine Increase Efficacy of These Treatments of Assistance To the Nicotinic Weaning Of the High-Risk Patients?
Brief Summary: Nicotine replacement therapies (NRT) have proven efficacy to help smokers quit. However, their effectiveness is low. This study aims to answer the question: Does the dose adjustment of NRT according the saliva concentration of nicotine's main metabolite: cotinine improve their efficacy compared with the lack of dose adjustment (usual care) in smoking patients with smoking related disease condition.


Options:
A: Self-Reported 7-Day Point-Prevalence Abstinence (Assessed at 52 weeks after target quit day)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
C: 7-Day Point Prevalence Abstinence From Smoking by Intervention (26 weeks after the target quit smoking date); 7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group (26 weeks after the target quit smoking date)
D: sustained smoking abstinence (during the study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Dose Adjustment of Nicotine Replacement Therapies According to Saliva Cotinine Increase Efficacy of These Treatments of Assistance To the Nicotinic Weaning Of the High-Risk Patients?
Brief Summary: Nicotine replacement therapies (NRT) have proven efficacy to help smokers quit. However, their effectiveness is low. This study aims to answer the question: Does the dose adjustment of NRT according the saliva concentration of nicotine's main metabolite: cotinine improve their efficacy compared with the lack of dose adjustment (usual care) in smoking patients with smoking related disease condition.


Options:
A: sustained smoking abstinence (during the study)
B: Cotinine validated quit rates.
C: Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events (During all the study)
D: Biochemically Verified 7-day Point Prevalence Abstinence (End of Treatment (week 24))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Dose Adjustment of Nicotine Replacement Therapies According to Saliva Cotinine Increase Efficacy of These Treatments of Assistance To the Nicotinic Weaning Of the High-Risk Patients?
Brief Summary: Nicotine replacement therapies (NRT) have proven efficacy to help smokers quit. However, their effectiveness is low. This study aims to answer the question: Does the dose adjustment of NRT according the saliva concentration of nicotine's main metabolite: cotinine improve their efficacy compared with the lack of dose adjustment (usual care) in smoking patients with smoking related disease condition.


Options:
A: Participants Abstinent From Cigarettes (Two years)
B: sustained smoking abstinence (during the study)
C: Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement (6 months)
D: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Dose Adjustment of Nicotine Replacement Therapies According to Saliva Cotinine Increase Efficacy of These Treatments of Assistance To the Nicotinic Weaning Of the High-Risk Patients?
Brief Summary: Nicotine replacement therapies (NRT) have proven efficacy to help smokers quit. However, their effectiveness is low. This study aims to answer the question: Does the dose adjustment of NRT according the saliva concentration of nicotine's main metabolite: cotinine improve their efficacy compared with the lack of dose adjustment (usual care) in smoking patients with smoking related disease condition.


Options:
A: The primary measure of results will be the differences in smoking cessation rates between intervention and control groups (12 months after been conducted the intervention)
B: Adherence to COPD guidelines (Twelve months post intervention)
C: sustained smoking abstinence (during the study)
D: Smoking abstinence (one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Dose Adjustment of Nicotine Replacement Therapies According to Saliva Cotinine Increase Efficacy of These Treatments of Assistance To the Nicotinic Weaning Of the High-Risk Patients?
Brief Summary: Nicotine replacement therapies (NRT) have proven efficacy to help smokers quit. However, their effectiveness is low. This study aims to answer the question: Does the dose adjustment of NRT according the saliva concentration of nicotine's main metabolite: cotinine improve their efficacy compared with the lack of dose adjustment (usual care) in smoking patients with smoking related disease condition.


Options:
A: Prevention in relapse (Up to 6 months)
B: The primary outcome will be measured at 5, 10, 22, and 52 weeks after the target quit date and include: CO confirmed continuous abstinence from 5-10 weeks, 5-22 weeks and 5-52 weeks. (5-10 weeks, 5-22 weeks, and 5-52 weeks post target quit date)
C: Seven-day point prevalence smoking abstinence at end of trial (abstinence based on self-reported smoking abstinence verified by CO levels < 10 ppm) (9 weeks)
D: sustained smoking abstinence (during the study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension Phase
Brief Summary: This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.


Options:
A: Hazard ratio for relapses (During the first and during the second 52 weeks)
B: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity (From the first dose of study drug administration up to Week 24); Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) (Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36); Change From Baseline in Vital Signs: Pulse Rate (Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36); Change From Baseline in Vital Signs: Temperature (Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36); Change From Baseline in Electrocardiogram (ECGs) (Baseline, Week 12 and 36); Number of Subjects With Worsened Post Baseline Shift in Immunoglobulin A (IgA), IgG and IgM Levels (Baseline up to Week 36); Number of Subjects With Positive Neutralizing Antibody (NAb) (Baseline, Week 12 and 36)
C: Part 1: Percentage of Participants With Confirmed Progression of Disability in One or More of the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), or 9-Hole Peg Test (9HPT) (Up to 96 weeks (2 years)); Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (218 weeks)
D: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension Phase
Brief Summary: This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.


Options:
A: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))
B: Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6 (Baseline, Month 6)
C: Estimated Annualized Aggregate Relapse Rate (ARR) (Baseline to end of study (Month 24))
D: Change from baseline in Pulmonary function tests (particularly Forced Expiratory Volume at 1 sec (FEV1) at Day 10 (10 days); Safety of FTY720 (10 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension Phase
Brief Summary: This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.


Options:
A: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))
B: Core Treatment Period: Overview of Failures (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled); Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled)
C: Hazard ratio for relapses (During the first and during the second 52 weeks)
D: Proportion of Subjects Relapsed (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension Phase
Brief Summary: This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.


Options:
A: Part A: Number of Participants With Adverse Events (AEs) (Baseline (Week 0) to Week 24); Part B: Rate of Development of New Active Lesions Over 24 Weeks (Baseline (Week 0) to Week 24)
B: Visual Analog Scale (VAS) of Patient Reported Pain: Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and 30 Minutes Post-injection Timepoints (From pre-injection to 30 minutes post injection of the VAS pain scores across the first 21 injections of full dose therapy of a new formulation of rebif and Betaseron)
C: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))
D: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks In Double Blind Period (Week 96)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Supplemental Perioperative Oxygen Reduces the Risk of Surgical Wound Infection: A Randomized, Double-blind Trial
Brief Summary: Supplemental perioperative oxygen has been reported to halve or double the risk of surgical wound infection. We tested the hypothesis that supplemental oxygen reduces infection risk following colorectal surgery. Colorectal surgery patients (n=300) were randomly assigned to 30% or 80% FiO2 intraoperatively and 6 hours postoperatively. Wound infections were diagnosed by blinded investigators using Centers for Disease Control criteria. Baseline patient characteristics, anesthetic management, and potential confounding factors were recorded. Wound infection rates were compared with chi-square analysis. Logistic regression identified the contribution of potential confounding factors. Surgical wound infection occurred in 24.4% of patients receiving 30% oxygen, but only 14.9% of those receiving 80% oxygen (P\<0.039). According to logistic regression, the relative risk of infection in patients given supplemental oxygen was 0.46 (P=0.035). Supplemental inspired oxygen reduced wound infection risk by roughly a factor of two. We thus recommend that supplemental oxygen be provided to patients undergoing colorectal surgery.


Options:
A: Frequency of patients with the composite outcome measure of either a subsequent, new or recurrent, cancer registration or a new histological specimen showing any neoplasm (36-60 months after randomization)
B: Surgical wound infection (30 days)
C: Incisional Surgical Wound Infection (0 to 14 days after surgery)
D: The Primary Endpoint is a Composite of Death and Cardiovascular Events (Clinical and Silent MI, Cardiac Failure, Cardiac Arrest, Pulmonary Embolism, and Stroke) Measured at 30 Days After Surgery. (30 days post op)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Eszopiclone 3 mg as Adjunctive Therapy in Subjects With Insomnia Related to Generalized Anxiety Disorder.
Brief Summary: To determine the safety and efficacy of eszopiclone as adjunctive therapy in the treatment of insomnia in patients with insomnia related to Generalized Anxiety Disorder. All subjects will receive an approved anxiolytic agent and will be randomized to nightly therapy with either eszopiclone or placebo.


Options:
A: mean subjective wake time after sleep onset (WASO) (Week 1)
B: The change from baseline in subjective sleep latency averaged over the double-blind treatment period. (8 weeks)
C: Latency to persistent sleep measured by polysomnography (4 weeks)
D: Overall Incidence of Adverse Events (12 Months (from the 1st dose to the end of study))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Inter-Mountain Project on Antimicrobial Resistance and Therapy (IMPART)
Brief Summary: This is a four-year study, funded by the Center for Disease Control and Prevention, related to antimicrobial resistance in rural communities. The project consists of four components: A) surveillance of antimicrobial resistance, B) promotion of appropriate antimicrobial drug prescribing, C) preliminary assessment of the environmental impact of antimicrobials, and D) the development of new antimicrobial products. Six rural communities in Utah, and six rural communities in Idaho are participating in this study. Component D is being performed by investigators at Harvard University, under the direction of Co-Investigator Roger Inouye.


Options:
A: N/A
B: Proportion of patients reporting a decision for "immediate antibiotics." (After index consultation)
C: Impact on rates of medication errors (1 year)
D: Proportion of visits to primary care clinic associated with antibiotic prescriptions (30 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #546 - A Randomized, Clinical Trial of Vitamin E and Memantine in Alzheimer's Disease (TEAM-AD)
Brief Summary: The purpose of this study is to determine whether alpha-tocopherol, memantine (Namenda), or the combination will significantly delay clinical progression in mild to moderately demented patients with Alzheimer's disease compared to placebo.


Options:
A: Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Mini-Mental State Examination Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Neuropsychiatric Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Caregiver Activity Survey Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline)
B: Depression (Baseline, 6 weeks, 6-, 12-, 48-, and 51 month followups.)
C: Change in Clinical Dementia Rating Scale (CDR) (Change from baseline in CDR at month 9, 18, 27)
D: Prostate cancer (Ongoing); Total cancer (Ongoing); Major cardiovascular events (Ongoing)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #546 - A Randomized, Clinical Trial of Vitamin E and Memantine in Alzheimer's Disease (TEAM-AD)
Brief Summary: The purpose of this study is to determine whether alpha-tocopherol, memantine (Namenda), or the combination will significantly delay clinical progression in mild to moderately demented patients with Alzheimer's disease compared to placebo.


Options:
A: Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Mini-Mental State Examination Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Neuropsychiatric Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Caregiver Activity Survey Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline)
B: Frequency of adverse events (baseline, monthly for 1 year, then 15 and 18 months)
C: The goal is to determine the effects of the vitamin C and vitamin E on surrogate markers of atherosclerosis following an atherogenic meal in type 2 diabetes (2 months)
D: Prostate cancer (Ongoing); Total cancer (Ongoing); Major cardiovascular events (Ongoing)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #546 - A Randomized, Clinical Trial of Vitamin E and Memantine in Alzheimer's Disease (TEAM-AD)
Brief Summary: The purpose of this study is to determine whether alpha-tocopherol, memantine (Namenda), or the combination will significantly delay clinical progression in mild to moderately demented patients with Alzheimer's disease compared to placebo.


Options:
A: Number of Participants With Prostate Cancer (Every six months for 7 to 12 years depending on when the participant was randomized.)
B: The goal is to determine the effects of the vitamin C and vitamin E on surrogate markers of atherosclerosis following an atherogenic meal in type 2 diabetes (2 months)
C: Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Mini-Mental State Examination Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Neuropsychiatric Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Caregiver Activity Survey Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline)
D: cognitive improvement or maintenance of cognitive performance (within 3 months of treatment)

Answer: C