TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Single Dose, Four Way Cross-over Study to Assess the Systemic Exposure, Systemic Pharmacodynamics and Safety and Tolerability of FluticasoneFuroate, Umeclidinium and Vilanterol Following Single Inhaled Doses of Umeclidinium/Vilanterol Blend + Fluticasone Furoate, Umeclidinium + Vilanterol, Fluticasone Furoate + Vilanterol and Fluticasone Furoate + Umeclidinium in Healthy Subjects
Brief Summary: This is a double-blind, single dose (four inhalations), four-way cross over study in healthy subjects that will assess the systemic pharmacokinetics (PK) and systemic pharmacodynamics (PD) of Fluticasone Furoate, (FF), Umeclidinium, (UMEC) and Vilanterol (VI). Study drug will be delivered through a novel single-step activation dry powder inhaler (NDPI) which has a two strip configuration. The NDPI will be configured with different combinations of each compound and also a new blend of UMEC/VI inhalation powder within a single strip of the NDPI device. Study drug will be administered through the inhaled route to healthy subjects in single doses (four inhalations). Each subject will receive treatment in a randomized order Treatment A FF (400 microgram \[µg\]) and UMEC (500 µg)/VI (100 µg), Treatment B UMEC (500 µg) and VI (100 µg), Treatment C FF (400 µg) and VI (100 µg) and Treatment D FF (400 µg) and UMEC (500 µg) over four treatment periods. Each treatment period will be separated by a washout of 7 to 21 days. After the four treatment periods, a follow up visit will take place 7 to 21 days following the final dose of study medication and the maximum duration a subject will be involved in the study is eighteen weeks.

Pharmacokinetics will be assessed by the measurement of plasma and urine concentrations of FF, UMEC and VI. Safety and PD will be monitored using blood glucose, serum potassium, heart rate, 12-lead ECGs and clinical laboratory tests. Plasma samples for PK will be collected throughout the study, urine, blood glucose, serum potassium, heart rate, 12-lead ECGs and clinical laboratory tests will be assessed on Day 1 only. AEs will be assessed throughout the study.


Options:
A: Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 169 (Baseline and Day 169)
B: Identifying new patient subtypes and endpoints for COPD (3 years)
C: AUC and Cmax, for each of the treatment groups FF/UMEC/VI, UMEC/VI and FF/VI (3 days of each treatment period.)
D: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85 (Day 85)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: MEA115666: A Multi-centre, Open-label, Long Term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in the MEA112997 Trial
Brief Summary: This is a multi-centre, open-label long term safety study of 100 milligrams (mg) mepolizumab administered subcutaneously (SC) in addition to standard of care in subjects who participated in the MEA112997 study. At each clinic visit, adverse events will be assessed and exacerbations will also be reviewed.


Options:
A: Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL (Immediately following the first administration of study drug through Study Week 48.)
B: Number of Participants Who Experienced On-treatment Adverse Events (AE) and On-treatment Serious Adverse Events (SAE) (Baseline (Week 0) to Week 240)
C: To understand the mechanisms driving eosinophilia and disease pathogenesis in patients with a wide range of eosinophilic disorders (Ongoing assessment)
D: Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second (Baseline and Week 24); Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months (Baseline to Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure (PHARM-CHF): A Randomized Controlled Trial
Brief Summary: The aim of the study is to investigate whether a continuous interdisciplinary intervention improves medication adherence (primary efficacy endpoint) and leads to a reduction of hospitalizations and mortality (primary safety endpoint) in elderly patients with chronic heart failure. The intervention, consisting of regular contacts with the local pharmacy and weekly dosing aids, aims to improve medication adherence and management.


Options:
A: Changes in decisional conflict (baseline and 3 month post intervention)
B: Hemoglobin A1c (Change in Baseline in HbA1c at 6 Months)
C: Medication Adherence (12 months); Days Lost Due to Unplanned Cardiovascular Hospitalizations or Death of Any Cause (12 months)
D: Appropriate medicine adherence (During entire study period (24 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: RandomizEd Trial of reVascularizAtion With Solitaire FR® Device Versus Best mediCal Therapy in the Treatment of Acute Stroke Due to anTerior Circulation Large Vessel Occlusion Presenting Within 8 Hours of Symptom Onset
Brief Summary: To evaluate the hypothesis that mechanical embolectomy with the Solitaire FR device is superior to medical management alone in achieving favorable outcome in the distribution of the modified Rankin Scale scores at 90 days in subjects presenting with acute large vessel ischemic stroke \< 8 hours from symptom onset.


Options:
A: clinical (efficacy): favorable modified Rankin Score (less than or equal to 2) (3 months); Rate of symptomatic intracranial hemorrhage (24 hours)
B: Distribution of the modified Rankin Scale scores (shift analysis) (90 days)
C: Between-group comparison of the distribution of the modified Rankin Scale scores (shift analysis) (90 days after enrollment)
D: Good Functional Outcome as Defined by a Modified Rankin Score of 0-2 (90 days); Incidence of All Serious Adverse Events (90 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: RandomizEd Trial of reVascularizAtion With Solitaire FR® Device Versus Best mediCal Therapy in the Treatment of Acute Stroke Due to anTerior Circulation Large Vessel Occlusion Presenting Within 8 Hours of Symptom Onset
Brief Summary: To evaluate the hypothesis that mechanical embolectomy with the Solitaire FR device is superior to medical management alone in achieving favorable outcome in the distribution of the modified Rankin Scale scores at 90 days in subjects presenting with acute large vessel ischemic stroke \< 8 hours from symptom onset.


Options:
A: Between-group comparison of the distribution of the modified Rankin Scale scores (shift analysis) (90 days after enrollment)
B: Feasibility of enrolling 12 subjects with major vessel occlusion within 1 year and random 1:1 assignment to treatment with IV (N=6) and IA (N=6) IA Activase using the following criteria: Time to clinical and radiological assessments (3 years); Time to IA Activase treatment (3 years); Preliminary safety assessment: 24 hour symptomatic ICH (3 years); Resources utilized and risk-benefit of IA Activase treatment. (3 years)
C: modified Rankin scale (mRS) 0-1 (favourable outcome) at Day 90 (at day 90)
D: The Modified Rankin Scale Score (at 90 days post-stroke)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Meibum lipids are modified in patients with MGD, resulting in tear instability, evaporative dry eye, and eyelid inflammation. These changes add to corneal damages and exacerbate ocular symptoms, which are all associated with the constant release of inflammatory mediators. To our knowledge, there has been no study on tear cytokine levels in MGD patients treated with topical loteprednol etabonate. The investigators, thus, evaluated both inflammatory tear cytokine levels and corresponding clinical outcomes for analyzing the efficacy of topical loteprednol etabonate in moderate and severe MGD. The aim of this research was to determine the concentration of inflammatory tear cytokines in patients with MGD and to compare the changes in tear cytokine levels between topical loteprednol etabonate and warm compress treatment group and warm compress only treatment group.


Options:
A: Changes of inflammatory cytokines in the tears of moderate and severe MGD (1 second before using topical loteprednol etabonate, after 1 month, and after 2 months of using topical loteprednol etabonate)
B: Conjunctival hyperemia (5 minutes)
C: Bulbar Conjunctival Hyperemia (Visit 6 (Day 29)); Ocular Discomfort (Visit 6 (Day 29))
D: Ocular Surface Disease Questionnnaire Results; Lissamine green staining; Fluorescein Staining; Schirmer testing

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD)
Brief Summary: Improved methods are needed to monitor patients with inflammatory bowel disease. Telemedicine has shown promise in patients with other chronic diseases; pilot testing in our patients with inflammatory bowel disease demonstrated that the technology was feasible and improved clinical outcomes.

The telemedicine system for patients with inflammatory bowel disease (Tele-IBD) should improve outcomes for patients, improve access to care in areas with limited resources, and decrease health care costs.


Options:
A: Changes in the paediatric IBD-specific health-related quality of life (QOL) scores. (6 monthly over 2 years)
B: Clinical Remission (6 months); Clinical Remission (6 months)
C: Outpatient hospital visits (1 year); Satisfaction (1 year)
D: Harvey Bradshaw Index (12 months); Inflammatory Bowel Disease Questionnaire (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD)
Brief Summary: Improved methods are needed to monitor patients with inflammatory bowel disease. Telemedicine has shown promise in patients with other chronic diseases; pilot testing in our patients with inflammatory bowel disease demonstrated that the technology was feasible and improved clinical outcomes.

The telemedicine system for patients with inflammatory bowel disease (Tele-IBD) should improve outcomes for patients, improve access to care in areas with limited resources, and decrease health care costs.


Options:
A: Overall length of stay (1 year); Percentage of patients undergoing colectomy (1 year)
B: The St Mark's faecal incontinence score (0-24 scale) (At 6 months from recruitment)
C: Harvey Bradshaw Index (12 months); Inflammatory Bowel Disease Questionnaire (12 months)
D: Outpatient hospital visits (1 year); Satisfaction (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Open-label, Crossover Clinical Trial to Assess the Effects of Indacaterol 150 µg d.o. Compared to Tiotropium Bromide 5 µg d.o. on Dyspnea, Dynamic Pulmonary Hyperinflation and Exercise Tolerance in Patients With Moderate COPD
Brief Summary: Exercise intolerance is a major complain of patients with chronic obstructive pulmonary disease (COPD). Dynamic hyperinflation has been recognized as an important limiting factor responsible for the appearance of intolerable dyspnea during exercise. Regular treatment with long-acting bronchodilators promotes a more sustained reduction of hyperinflation and consequent symptom relief and increase in the patient's ability to overcome physical demands of daily life. Tiotropium bromide (TIO) is a new generation, long-acting anticholinergic bronchodilator that significantly improves lung function, reduces symptoms and improves exercise tolerance in patients with advanced COPD. Indacaterol is a new ultra-long duration (\>24 h) β2-agonist, which promotes sustained dilation of the bronchi with a once-daily administration. Compared to tiotropium, indacaterol provides evidence that is as effective as tiotropium for bronchodilation, as well as other clinical outcomes such as dyspnea and state of health. However, comparative effects of indacaterol versus tiotropium with regard to outcomes in tolerance, dyspnea and dynamic lung hyperinflation during exercise is scarce. We hypothesized that indacaterol and TIO are not different in terms of exercise tolerance and its determinants (dynamic hyperinflation and dyspnea).


Options:
A: Exercise tolerance (3 weeks)
B: Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12) (End of treatment (Week 12))
C: FEV1 AUC 0-12 on Day 7 (Day 7)
D: Peak Forced Expiratory Volume in One Second (FEV1) at Week 24 (At Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of HX575 Epoetin Alfa vs. US Licensed Epoetin Alfa (Epogen®/Procrit®) in the Treatment of Anemia Associated With Chronic Kidney Disease
Brief Summary: The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to generate data supporting that the efficacy and safety under treatment with HX575 and Epogen®/Procrit® are comparable.


Options:
A: TSAT (transferrin saturation), serum albumin, serum ferritin, serum transferrin, serum C reactive protein (after randomization at month 1, 2, 3, 6, 12)
B: Time to All Cause Death or First Hospitalization for Worsening Heart Failure (From randomization to the end of study; maximum time on study was 73 months)
C: Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period (Baseline, Week 29 to Week 36)
D: Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28) (Week -4 to Day1 and Week 21-28); Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (Week 21-28) (Week -4 to Day1 and Week 21-28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility of Using the Inverness Lateral Flow Urine LAM Test for Diagnosis of Tuberculosis in HIV-Positive TB Suspects in Cape Town, South Africa
Brief Summary: The purpose of this study is to evaluate the accuracy, diagnostic yield, operational performance, and time to diagnosis of a novel lateral-flow urine LAM test in detecting tuberculosis in HIV-infected adults.

A secondary study objective is to evaluate the accuracy and diagnostic yield of the Cepheid Xpert MTB/Rif test in detecting tuberculosis in the blood of HIV-infected adults.


Options:
A: Sensitivity of the lateral-flow urine LAM assay (LF-LAM) (One year); Failure rate of the lateral-flow urine LAM assay (One year); Inter-reader variability of the lateral-flow urine LAM assay (One year); Specificity of the lateral-flow urine LAM assay (LF-LAM) (One year)
B: Sensitivity of the lateral-flow urine LAM assay (LF-LAM) (One year); Failure rate of the lateral-flow urine LAM assay (One year); Inter-reader variability of the lateral-flow urine LAM assay (One year); Specificity of the lateral-flow urine LAM assay (LF-LAM) (One year)
C: To compare the characteristics of subjects with relapsed tuberculosis verses the characteristics of subjects that do not experience relapse disease (Over course of the study)
D: All-cause mortality (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility of Using the Inverness Lateral Flow Urine LAM Test for Diagnosis of Tuberculosis in HIV-Positive TB Suspects in Cape Town, South Africa
Brief Summary: The purpose of this study is to evaluate the accuracy, diagnostic yield, operational performance, and time to diagnosis of a novel lateral-flow urine LAM test in detecting tuberculosis in HIV-infected adults.

A secondary study objective is to evaluate the accuracy and diagnostic yield of the Cepheid Xpert MTB/Rif test in detecting tuberculosis in the blood of HIV-infected adults.


Options:
A: To compare the characteristics of subjects with relapsed tuberculosis verses the characteristics of subjects that do not experience relapse disease (Over course of the study)
B: Sensitivity of the lateral-flow urine LAM assay (LF-LAM) (One year); Failure rate of the lateral-flow urine LAM assay (One year); Inter-reader variability of the lateral-flow urine LAM assay (One year); Specificity of the lateral-flow urine LAM assay (LF-LAM) (One year)
C: All-cause mortality (8 weeks)
D: All-cause Mortality (6 months post-HAART initiation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility of Using the Inverness Lateral Flow Urine LAM Test for Diagnosis of Tuberculosis in HIV-Positive TB Suspects in Cape Town, South Africa
Brief Summary: The purpose of this study is to evaluate the accuracy, diagnostic yield, operational performance, and time to diagnosis of a novel lateral-flow urine LAM test in detecting tuberculosis in HIV-infected adults.

A secondary study objective is to evaluate the accuracy and diagnostic yield of the Cepheid Xpert MTB/Rif test in detecting tuberculosis in the blood of HIV-infected adults.


Options:
A: Rates of TB treatment initiation (48 hours)
B: Sensitivity and specificity (10 months)
C: Sensitivity of the lateral-flow urine LAM assay (LF-LAM) (One year); Failure rate of the lateral-flow urine LAM assay (One year); Inter-reader variability of the lateral-flow urine LAM assay (One year); Specificity of the lateral-flow urine LAM assay (LF-LAM) (One year)
D: Sensitivity of the lateral-flow urine LAM assay (LF-LAM) (One year); Failure rate of the lateral-flow urine LAM assay (One year); Inter-reader variability of the lateral-flow urine LAM assay (One year); Specificity of the lateral-flow urine LAM assay (LF-LAM) (One year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multi-National, Multi-Center, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal Insert in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
Brief Summary: A study to evaluate the safety and efficacy of an FAI insert for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye.


Options:
A: Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit (36 months)
B: Evaluation of the effectiveness of a subconjunctival injection of triamcinolone on reducing the central macular thickness versus an intravitreal implant of dexamethasone between patient selection and 2 months after treatment (At 2 months after treatment)
C: Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis (24 months)
D: Recurrence of uveitis before and after implantation. (34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multi-National, Multi-Center, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal Insert in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
Brief Summary: A study to evaluate the safety and efficacy of an FAI insert for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye.


Options:
A: Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero (Week 8)
B: Evaluation of the effectiveness of a subconjunctival injection of triamcinolone on reducing the central macular thickness versus an intravitreal implant of dexamethasone between patient selection and 2 months after treatment (At 2 months after treatment)
C: Recurrence of uveitis before and after implantation. (34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation)
D: Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit (36 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Varenicline Associated With Intensive Counselling Versus Placebo of Varenicline Associated With Intensive Counselling on Smoking Cessation at the Acute Phase of an Exacerbation of Chronic Obstructive Pulmonary Disease (COPD). A Multicenter Randomized Double-blind Trial
Brief Summary: Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the bronchi with an increasing prevalence. By 2020, the mortality related to COPD is expected to become the 3rd leading death worldwide. COPD is caused by smoking in approximately 90 % of the cases. Nevertheless, COPD remains under-diagnosed and more than half of patients remain active smokers. Brittany is the second region of France facing an abnormal high death rate related to COPD. Smoking cessation is the most effective therapeutic approach to reduce the evolution of the disease, the frequency of the exacerbations and the the mortality. Besides, smoking cessation is associated with a reduced risk of cardiovascular events and cancer. Given the COPD patients' strong addiction, smoking cessation is not easily obtained in such population. Furthermore, smoking cessation has been underestimated in several studies. Most of these studies evaluated various methods of smoking cessation in COPD patients performed after an exacerbation, which has a hospitalization related mortality of approximately 10%. Thus, there is an urgent need to find effective pharmacotherapies to help COPD patients to cease smoking. Varenicline, a partial agonist at a4ß2 nicotinic acetylcholine receptors is reported to be one of the most effective pharmacotherapies for smoking cessation. However, it has never been evaluated at the acute phase of an exacerbation of COPD requiring hospitalization.


Options:
A: Continuous abstinence Weeks 13 -24.
B: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: To demonstrate an increase in smoking abstinence rate (12 months)
D: Summarization of safety data in smokers treated with either varenicline or placebo.

Answer: C