TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation (CAF Trial)
Brief Summary: Patients will be screened at Intermountain Medical Center and at Intermountain-affiliated anticoagulation clinics in the Salt Lake City region. Patients with non-valvular atrial fibrillation will be considered for study. After written informed consent is obtained, subjects who meet eligibility criteria will be randomized 1:1 to 2 treatment arms: Group 1: Dabigatran etexilate (150 mg BID if CrCL \> 30 mL/min, or 75 mg BID if CrCL \> 15 to 30 mL/min or per USPI; and Group 2: Warfarin (Dose-adjusted (INR 2.0 - 3.0). Assessment of kidney function every 6 months will be done for Group 1. Standard warfarin follow-up and education, based upon system criteria, will be done for Group 2. All subjects will be followed for 24 months, and will be assessed at 1-week, then 3-, 6-, 12-, 18- and 24-months post-anticoagulation visits as well as other visits deem necessary for clinical care. All subjects will undergo protocol-specified laboratory tests and will complete 6 standard, validated questionnaires at each follow-up visit following the week 1 visit, except at the 3-month visit when only one questionnaire will be administered. To determine brain volume and characteristic changes representative of micro-bleeding, the first 10 subjects in each treatment group who are willing and able to undergo the procedure will participate in a MRI sub-study. The cranial MRI will be done at baseline and at 24-months post-anticoagulation on this sub-group.


Options:
A: Feasibility of Phase III Trial (36 months (24 Months Recruitment + 12 months Follow Up))
B: The primary endpoint is death from any cause or incident, dementia or persistent physical disability. (every 6 months)
C: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) (time since randomization; follow-up period is 1.5 to 4.4 years); Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) (time since randomization; follow-up period is 1.5 to 4.4 years)
D: Incident dementia determined by a formal diagnosis of dementia by a neurologist (24 months); Moderate decline in cognitive function based on results of the Alzheimer's Disease Assessment Scale and the Disability Assessment for Dementia. (24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR Mutation
Brief Summary: This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, crossover study that will evaluate the efficacy of LUM/IVA in subjects with CF 12 years of age and older who have at least one A455E mutation.


Options:
A: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 8 (Study Baseline, Through Week 8)
B: Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24 (Baseline, Through Week 24)
C: Absolute Change From Baseline in Percent-predicted Forced Expiratory Volume in One Second (ppFEV1) at Week 48 (From Baseline to Week 48)
D: Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in treatment period up to safety follow-up (up to 28 days)); Parts D, E and F: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)); Part D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part E: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part F: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Control Study to Determine the Efficacy and Safety of Combining Hemospray With Medical Standard of Care Treatment in the Management of Acute Variceal Bleeding in Cirrhotic Patients.
Brief Summary: INTRODUCTION Acute variceal bleeding (AVB) is a severe complication of portal hypertension in patients with liver cirrhosis. The primary therapy includes the administration of vasoactive drugs, antibiotics and endoscopic therapy; preferably esophageal banding ligation (EBL) and/or cyanoacrylate injection when bleeding occurs from gastric varices.

In this context, the idea is to assess "Hemospray" (Cook Medical, Winston-Salem, NC) as an initial therapy in patients with massive bleeding as a temporary "bridge" until definitive treatment could be instituted.

The data generated from the pilot study performed between Erasme hospital, ULB and TBRI , Cairo showed that adding Hemospray as early as possible in the management steps could increase the bleeding control rate up to 95 % at 24 hours.

OBJECTIVE The primary efficacy objective of this study is to assess the efficacy of Hemospray in combination with standard of care (SOC) medical treatment compared to the efficacy of SOC in the Control Arm in patient with acute variceal bleeding in cirrhotic patient.

The primary safety objective of this study is to evaluate the safety of Hemospray when used in combination with SOC compared to SOC in the Control Arm.

1.1. Secondary:

* To evaluate the effect of timing of Hemospray treatment on the outcomes of bleeding patients
* To evaluate the adverse effects on both therapeutic regimens (SAEs and clinically significant AEs).


Options:
A: Haemostasis (24 hours)
B: Number of sessions to complete variceal obliteration (1 year)
C: Survival (10 years)
D: Combined: bleeding + absence of severe adverse events + survival (15 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Vagus Nerve Stimulation for Pediatric Intractable Epilepsy (VNS-PIE)
Brief Summary: Children with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 2 arms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.


Options:
A: Bioequivalence for generic 1 compared to generic 2 (18 months)
B: Percent Change From Baseline in Weekly Primary Generalized Tonic-clonic (PGTC) Seizure Frequency During the Entire Double-Blind Treatment Phase (Baseline through end of Double-Blind Treatment Phase (up to Week 19))
C: Changes in seizure frequency (12 weeks of stimulation)
D: Bioequivalence for generic 1 compared to generic 2 (18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vagus Nerve Stimulation for Pediatric Intractable Epilepsy (VNS-PIE)
Brief Summary: Children with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 2 arms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.


Options:
A: Estimate the Effect Size Associated With Objective Measures and Patient Self-reports of Clinical Outcomes Including Seizure Frequency, Seizure Severity, Seizure Duration, Seizure Intensity, and Post-ictal Duration. (Up to 18 Month Visit-End of Study)
B: frequency of epileptic seizures (Change from baseline at 8, 16, 24 weeks respectively in frequency of epileptic seizures)
C: Changes in seizure frequency (12 weeks of stimulation)
D: Summary of Seizures Reported by Investigators and Triple Review (Epilepsy Monitoring Unit Stay); Observed Sensitivity Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting (Epilepsy Monitoring Unit (EMU) Stay); Modeled Sensitivity Based on Heart Rate Increase Associated With Seizures by SDA Setting Post-Processed Through Bench-top Device Simulant (Epilepsy Monitoring Unit (EMU) Stay); Potential False Positives Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting (Epilepsy Monitoring Unit (EMU) Stay)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Team-Based Delivery of Care in Outpatient Settings: An Experimental Investigation
Brief Summary: Through this research we intend to evaluate whether a team-based care delivery approach using daily huddles is effective in improving caregiver and patient outcomes in primary care setting. This approach is expected to not only lead to effective primary care delivery outcomes, but also result in greater team morale, reduced burnout, and a higher rate of innovation.


Options:
A: Change in team cohesion (Change from baseline to 6 months)
B: Implementation Leadership (12 months); Full Range Leadership (12 months)
C: Institutional delivery (Up to six months)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Double-dummy, Active-controlled, 3-period Complete Cross-over Study to Assess the Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma
Brief Summary: The purpose of this study is to assess peak FEV1 of two doses of QVM149 compared to a fixed-dose combination of salmeterol/fluticasone (50/500μg b.i.d.) and to characterize the respective 24 hour bronchodilator effect profiles in patients with asthma. Data from this study will complement lung function data obtained in the pivotal QVM149 phase 3 program by assessing the bronchodilatory effect of QVM149 at multiple time-points over an entire dosing interval of 24 hours.


Options:
A: Peak FEV1 (L) Defined as the Highest Bronchodilatory Effect on FEV1 During a Period of 5 Min to 4 h After the Last Evening Dose of Each Treatment Period (3 weeks)
B: Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24 (24 Weeks); Rate of severe asthma exacerbations (Up to 52 Weeks)
C: Change from baseline in Forced expiratory volume in 1 second (FEV1), obtained through espirometry. (12 weeks)
D: Change from baseline to end of treatment in post-dose peripheral airway resistance [R(5Hz)-R(20Hz)]. (Baseline and 3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)
Brief Summary: Kawasaki disease (KD) is a self-limited illness that affects the heart blood vessels (coronary arteries) of infants and children and is now the most common cause of acquired heart disease in children. A mixture of proteins from human blood (Intravenous immunoglobulin, IVIG) is a treatment that reduces the rate of the major complication of the disease: a bulging of the wall of the coronary arteries called an aneurysm. However, 10-20% of children are resistant to this treatment and the fever returns. These children have the highest rates of aneurysm formation and thus should be treated aggressively. Unfortunately, there are no guidelines for the best secondary treatment for these resistant patients because the problem has never been adequately studied. Most physicians choose either a second infusion of IVIG or an engineered antibody called infliximab that inactivates a molecule that promotes inflammation. This trial will randomize (assign by chance like the flip of a coin) IVIG-resistant patients to receive either a second IVIG infusion or infliximab and the response to treatment will be compared to learn which treatment stops the fever the fastest. In addition, parents and caregivers will provide observations about their child's response to the different treatments.


Options:
A: Number of Participants With Cessation of Fever Within 24h of Initiation of Study Treatment With no Fever Recurrence Within Next 7 Days. (7 days)
B: Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration (Up to 48hours)
C: Percentage of coronary artery lesions(CAL) at one month of illness (at one month of illness)
D: Duration of fever subsided to normal after initial IVIG finished (36 hours after IVIG finished); incidence of coronary artery lesions(CAL) after IVIG finished (start from IVIG finished, ended by the end of 2 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Extracorporeal CPR for Refractory Out-of-Hospital Cardiac Arrest (EROCA)
Brief Summary: In the U.S. alone, over 300,000 people per year have sudden out-of-hospital cardiac arrest (OHCA), and less than 1 out of 10 survive. The current standard practice for treating OHCA is to perform cardiopulmonary resuscitation (CPR) and Advanced Cardiovascular Life Support (ACLS) at the scene until either the heart is restarted or resuscitation efforts are considered hopeless and discontinued. An alternative strategy for those with refractory OHCA is expedited transport with ongoing mechanical CPR to an Emergency Department capable of performing extracorporeal cardiopulmonary resuscitation (ECPR). The purpose of study is to test if this strategy is feasible and beneficial.


Options:
A: Emergency Department Arrivals Under 30 Minutes (Measured within one hour cardiac arrest onset); ECPR Initiations Under 30 Minutes (Measured within 2 hours of cardiac arrest onset)
B: Feasibility of telephone interview (At completion of telephone interview, expected average of 6 months)
C: All cause mortality (90 days after randomisation)
D: Development of ARDS (28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Amonocenter, Prospective, Randomized Clinical Trial to Investigate the Removal Time of Urinary Catheter After Laparoscopic Anterior Resection of the Rectum.
Brief Summary: Traditionally these catheters are retained for 7 days, because a higher incidence of urinary retention is related to early removal of the urinary catheter. However, recently Enhanced Recovery After Surgery presents that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief，but there is no clear data on the incidence of urine retention.Longer retaining time of urethral catheter would induce the urinary tract infection while early removal of urethral catheter is considered to develop acute retention of urine due to lack of sensation when the bladder is full. Taking the comfort and mobility for faster rehabilitation of patients into account, the investigators aim at obtain the optimal removal time of urinary catheter after after laparoscopic anterior resection of the rectum


Options:
A: rate of recatheterization (12 months)
B: Hospital stay (4 weeks)
C: all cause mortality (one year)
D: Post-operative urinary retention requiring re-catheterisation (1 day following urethral catheter removal)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Placebo-controlled Trial Evaluating the Effect of Melatonin on Sleep Quality in Patients With Dementia
Brief Summary: Introduction: Patients with dementia may suffer from poor sleep quality. Disturbance in the metabolism melatonin may have a role in the pathogenesis of sleep-wake cycle alterations in dementia.

Objective: To evaluate the efficacy of low dose exogenous melatonin in improving sleep quality.

Design: A single-center randomized, double-blinded, placebo-controlled study carried out on outpatients with dementia and sleep alterations.

Participants: The investigators calculated a 40 individuals aged 65 years or over with a diagnosis of mild-moderate dementia (Clinical Dementia Rating 1-2).

Intervention: Patients were randomized to receive either 5 mg of melatonin or placebo every night for 8 weeks.

Measurements: The primary outcome was sleep quality according to the Pittsburgh Sleep Quality Index (PSQI).


Options:
A: Pittsburgh Sleep Quality Index (8 weeks)
B: Change from baseline to Week 24 in the standard 11-item total score from the 13-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog). (Week 4, 12, and 24)
C: Sleep Efficiency (Post-intervention, up to 3 weeks); Sleep Minutes (post-intervention, up to 3 weeks)
D: Change From Baseline in Nighttime Total Sleep Time (Baseline, 14 days follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Placebo-controlled Trial Evaluating the Effect of Melatonin on Sleep Quality in Patients With Dementia
Brief Summary: Introduction: Patients with dementia may suffer from poor sleep quality. Disturbance in the metabolism melatonin may have a role in the pathogenesis of sleep-wake cycle alterations in dementia.

Objective: To evaluate the efficacy of low dose exogenous melatonin in improving sleep quality.

Design: A single-center randomized, double-blinded, placebo-controlled study carried out on outpatients with dementia and sleep alterations.

Participants: The investigators calculated a 40 individuals aged 65 years or over with a diagnosis of mild-moderate dementia (Clinical Dementia Rating 1-2).

Intervention: Patients were randomized to receive either 5 mg of melatonin or placebo every night for 8 weeks.

Measurements: The primary outcome was sleep quality according to the Pittsburgh Sleep Quality Index (PSQI).


Options:
A: Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1 (Baseline and Month 1); Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3 (Baseline and Month 3); Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1 (Baseline and Month 1); Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3 (Baseline and Month 3); Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1 (Baseline and Month 1); Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3 (Baseline and Month 3); Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1 (Baseline and Month 1); Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3 (Baseline and Month 3); Number of Participants With an Adverse Event (AE) During 3-Month DB TRT Phase (Up to 3 months); Number of Participants Who Discontinued Study Drug Due to an AE Occurring During 3-Month DB TRT Phase (Up to 3 months)
B: Change in the Cornell Scale for Depression in Dementia (CSDD) (Week -2, week 0, week 6 and week 13)
C: Change from Baseline in Nighttime Total Sleep Time (Baseline, 14 days follow-up)
D: Pittsburgh Sleep Quality Index (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab, to Demonstrate Efficacy After Twelve Weeks of Treatment and to Assess Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis With or Without Psoriatic Arthritis Comorbidity
Brief Summary: The purpose of this study was to determine if secukinumab is effective and safe in the treatment of plaque type psoriasis


Options:
A: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 (Week 16); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 (Week 16)
B: Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation) (Week 12); Investigator's Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation) (Week 12)
C: PASI 75 Response After 12 Weeks of Treatment (12 weeks); IGA Mod 2011 0 or 1 Response After 12 Weeks of Treatment (12 weeks)
D: Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12 (Week 12); Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab, to Demonstrate Efficacy After Twelve Weeks of Treatment and to Assess Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis With or Without Psoriatic Arthritis Comorbidity
Brief Summary: The purpose of this study was to determine if secukinumab is effective and safe in the treatment of plaque type psoriasis


Options:
A: Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 (Baseline, Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Week 16); Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Week 52)
B: Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 (Week 16)
C: Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation) (Week 12); Investigator's Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation) (Week 12)
D: Change in Vascular Inflammation (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Total Cholesterol (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Cholesterol Efflux (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Low Density Lipoprotein Particle Total (Baseline - Week 12); Change in Cardiometabolic Biomarkers: High Density Lipoprotein Particle Total (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Insulin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Adiponectin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Leptin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log C-reactive Protein (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Tumor Necrosis Factor-alpha (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Interleukin 6 (Baseline - Week 12); Change in Cardiometabolic Biomarkers: GlycA (Baseline - Week 12)

Answer: C