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NCT ID: NCT03627169 Completed - Clinical trials for Obstructive Sleep Apnea

PSG Validation of MATRx Plus AHI

Start date: July 25, 2017
Phase:
Study type: Observational

Obstructive sleep apnea (OSA) is a common disease that carries significant risks for cardiovascular disease, mortality, and economic costs. Almost thirty years ago, initial population studies found the prevalence of OSA to be five to nine percent of the adult population. Excess body weight is a risk factor for the development of OSA, and the recent rise in prevalence of obesity has led to revised estimates of OSA prevalence, now at seventeen per cent of the adult population. OSA is poorly recognized clinically; 85% of apneics remain undiagnosed and untreated. Currently, the diagnosis of OSA commonly relies on an overnight, in-hospital polysomnogram (PSG). Due to the extensive attachments to the body surface required in a PSG, it has developed a negative impression. Any effective solution to the public health challenges posed by sleep apnea will have to consider the need for less cumbersome and off-putting methods. Zephyr Sleep Technologies has developed a device that has been approved for use in Canada. The MATRx plus device functions as both a Level III sleep recorder (records respiratory airflow, respiratory effort, pulse rate, and arterial oxygen saturation) as well as a home-based system to select patients for oral appliance therapy. The American Academy of Sleep Medicine (AASM) recommends the use of apnea-hypopnea index (AHI) for the diagnosis and categorization of OSA severity. The Level III function of the MATRx plus device is approved for use in Canada with two autoscoring methods: oxygen desaturation index, ODI and apnea-hypopnea index, AHI, but requires further validation of AHI for clearance by the US Food and Drug Administration (FDA). The proposed research will validate the AHI autoscoring function of the MATRs plus Level III home sleep recorder by comparing it to data recorded in a PSG, which is considered to be the gold standard for sleep testing. Though the effectiveness of the AHI autoscoring algorithm has been previously established, it has not been validated against PSG data. Additionally, other parameters such as snoring will be examined in order to develop scoring algorithms for other facets of sleep disordered breathing.

NCT ID: NCT03627143 Completed - Atrial Fibrillation Clinical Trials

Decreasing Hospital Admissions From the ED for AAFF

RAFF-3
Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Acute atrial fibrillation and flutter (AAFF) is characterized by rapid heart rates with onset less than seven days. It's the most common type of palpitation treated in the Emergency Department (ED). Some Canadian ED's will discharge 95% of AAFF patients whereas others admit up to 40%. With hospital and ED crowding, discharge is the most optimal, effective and safe strategy. Our aim is to improve the care and reduce the length of stay (LOS) of ED AAFF patients, while decreasing unnecessary hospitalizations. First, the investigators must understand the local barriers. In the previous study, the investigators conducted interviews of emergency physicians, cardiologists and AAFF patients. In Project 1b, the investigators created the CAEP ED AAFF Guidelines Checklist to assist physicians to manage AAFF more efficiently and safely. The Guidelines are comprised of two algorithms and four sets of checklists for ED assessment and management. They have been endorsed by CAEP and are published in CJEM. The investigators are now planning Project 2 in which the investigators will conduct a cluster [group] randomized trial at 11 Canadian EDs and enroll 1,300 patients over thirteen months. The investigators are not randomizing individual patients or doctors; instead the investigators are randomizing the start date of individual hospitals. Our goal is to introduce the new Guidelines into these hospitals to improve the care of AAFF patients. The investigators hope to improve AAFF management, leading to a significant decrease in hospital admissions and ED LOS. Central to our plans will be engagement of our two patient partners. Our behaviorally optimized intervention will be developed using state-of-the-art implementation science approaches informed by the results of Project 1a. The investigators will also undertake within-project and end-of-project knowledge translation and implementation (KTI) strategies to facilitate scale up and roll out of our program to ED departments in small, medium, and large hospitals across Canada (future Project 3). Ultimately the investigators expect to improve ED practices and decrease AAFF admissions and LOS, without increasing visits.

NCT ID: NCT03626688 Recruiting - Hypertension Clinical Trials

A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients

Start date: August 30, 2018
Phase: Phase 3
Study type: Interventional

Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.

NCT ID: NCT03626545 Terminated - Non-Small-Cell Lung Clinical Trials

Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy

CANOPY-2
Start date: January 23, 2019
Phase: Phase 3
Study type: Interventional

This study was designed to evaluate the role of canakinumab in combination with docetaxel in subjects with advanced non-small cell lung cancer (NSCLC) previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy.

NCT ID: NCT03626311 Completed - Clinical trials for Systemic Lupus Erythematosus (SLE)

Omega-3 Replacement With Krill Oil in Disease Management of SLE

ORKIDS
Start date: October 23, 2018
Phase: N/A
Study type: Interventional

A randomized, double-blind controlled, multicenter study in SLE patients given AKBM-3031or placebo for 24 weeks (randomized period) and followed by an open label extension (OLE) treatment with AKBM-3031 for the next 24 weeks. Patients will be maintained on stable doses of background medications, except for glucocorticoids. Decreases in doses of glucocorticoids will be encouraged during the first 20 weeks of both the randomized and open label extension portions of the trial. Stable doses of glucocorticoids and other background medications are required during weeks 20-22 and 44-48.If indicated by the PI, brief increases in corticosteroids are permitted during the first 20 weeks of both the blinded and open label extension portion of the trial. The increase in prednisone (or equivalent) dose is limited to 2X the back-ground level to a maximum of20 mg/day for a maximum of 1 week (7 days) or to a single administration of intravenous methylprednisolone or equivalent at a maximum dose of 500mg. Stable doses of glucocorticoids and other background medications are required during weeks 20-22 and 44-48

NCT ID: NCT03626181 Recruiting - Clinical trials for Depressive Disorder, Treatment-Resistant

Biomarkers of Theta Burst Stimulation in Major Depressive Disorder

Start date: July 6, 2018
Phase: N/A
Study type: Interventional

This study investigates the brain-based biomarkers of treatment response to accelerated theta burst stimulation (aTBS) in patients with Major Depressive Disorder resistant to pharmacological treatment(MDD) in an open label design.

NCT ID: NCT03626155 Completed - Clinical trials for Type 2 Diabetes Mellitus

Does Exercise Timing Affect Glucose Levels in People With Diabetes?

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

It is not clear if there is an optimal time for exercise to improve blood glucose profiles in people with type 2 diabetes. The goal of this study is to compare post meal and 24-hour glucose levels in 4 different conditions: i-seated control, ii-fasted state exercise, iii-30 minutes post meal exercise, and iv- 3-4-hour post meal exercise. The primary outcome of this study is glucose control assessed over 24 hours using continuous glucose monitoring.

NCT ID: NCT03626038 Recruiting - Clinical trials for Rheumatoid Arthritis

Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System

Start date: June 19, 2018
Phase: N/A
Study type: Interventional

This study is a multicenter, prospective, non-randomized, non-controlled post-market clinical follow-up study. The primary objective of this study is to confirm the safety and performance of the A.L.P.S. Proximal Humerus Plating System applied in proximal humerus fracture treatment.

NCT ID: NCT03626012 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB078 in Adults With C9ORF72-Associated Amyotrophic Lateral Sclerosis

Start date: September 10, 2018
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of BIIB078 in adults with C9ORF72-Amyotrophic Lateral Sclerosis (ALS). The secondary objectives of this study are to evaluate the pharmacokinetic profile of BIIB078 and to evaluate the effects of BIIB078 on clinical function. As the first-in-human study, the study enrolls a small number of participants in each cohort. Every participant in a cohort is treated with the same dose or placebo. The study is designed to evaluate and confirm the safety of each dose before enrolling and exposing new participants to a higher dose in the next cohort.

NCT ID: NCT03625271 Recruiting - Depression Clinical Trials

The Canadian Armed Forces PEER Study

PEERCanada
Start date: June 16, 2016
Phase: N/A
Study type: Interventional

This is a prospective, single-blinded, randomized, multicenter study to evaluate the utility, safety, and efficacy of using PEER Interactive - an EEG-based technology - to inform the prescription of medications to participants with a primary diagnosis of a depressive disorder, with or without comorbidity of non-psychotic behavioral disorders, versus treatment as usual.