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NCT ID: NCT03568916 Completed - Atrial Fibrillation Clinical Trials

Direct Oral Anticoagulants in Patients With Atrial Fibrillation (DOACs vs DOACs)

Start date: November 2016
Phase:
Study type: Observational

The purpose of this study is to assess safety and effectiveness of direct oral anticoagulants (DOACs) for stroke prevention in patients with non-valvular atrial fibrillation (AF). The comparison of DOACs between themselves is of interest. The investigators will carry out separate population-based, matched cohort studies, using health administrative databases in nine jurisdictions in Canada, the UK and the US. New users of DOACs for stroke prevention in non-valvular AF will be eligible to enter the cohorts. Follow-up will continue until a hospitalization or emergency department visit for a stroke. The results from the separate sites will be combined by meta-analysis to provide an overall assessment of the safety and effectiveness of the different anticoagulation regimens in stroke prevention in AF. The investigators hypothesize that different DOACs will have similar safety and effectiveness profiles.

NCT ID: NCT03568162 Completed - Clinical trials for Moderate to Severe Atopic Dermatitis

Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis

Start date: May 31, 2018
Phase: Phase 2
Study type: Interventional

Phase 2b, randomized, double-blinded, placebo-controlled dose range finding study to evaluate the efficacy, safety and tolerability of ISB 830 in adults with moderate to severe atopic dermatitis. The study will be conducted in 2 Parts, with dosing Groups 1-4 comprising Part 1, and dosing Groups 5-6 comprising Part 2. All subjects will receive open-label ISB 830 after a 16 week blinded treatment period.

NCT ID: NCT03567941 Completed - Healthy Clinical Trials

To Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen

Start date: December 29, 2017
Phase: Phase 1
Study type: Interventional

Evaluation of abuse potential in recreational abusers of Hydrocodone Bitartrate and Acetaminophen versus NORCO®.

NCT ID: NCT03567395 Completed - Poor Quality Sleep Clinical Trials

Honey to Improve Sleep Quality: a Feasibility Study

Start date: April 18, 2018
Phase: N/A
Study type: Interventional

Inadequate sleep quality and duration may result in adverse health outcomes and poorer quality of life. Despite the availability of behavior modification and pharmaceuticals to aid sleep optimization and quality approximately 50% men and women continue to experience difficulty falling asleep or staying asleep. Individuals with sleep disorders may find adherence to such interventions difficult to maintain (e.g. behavior modification) or the therapies may pose a risk (e.g. dependence on pharmaceuticals). A need exists for alternative therapeutic interventions, particularly those that are simple and cost effective. Observational and anecdotal data supports honey as a functional food to promote better sleep. As an initial step towards developing an evidence base for honey for improvement of sleep quality the investigators propose to conduct a preliminary open-label proof-of-principle study to assess the feasibility (primary outcome) and potential effectiveness (secondary outcome) of honey in improving sleep quality before embarking upon a full-scale pivotal clinical trial. The study data will confirm safety of honey use in a population of poor sleepers and to identify where improvements in study design are necessary in planning of a larger clinical trial.

NCT ID: NCT03567200 Completed - Physical Activity Clinical Trials

Girls United on the Move: A Unique Integrated Physical Activity and Psychosocial Program for At-risk Adolescent Girls

GUM
Start date: January 10, 2018
Phase: N/A
Study type: Interventional

The purpose of this project is to evaluate the effectiveness of a 9-week psycho-social and physical activity program aimed at improving body image, physical self-perceptions, and self-compassion for at-risk adolescent girls. In collaboration with the Elizabeth Fry Society, the GUM program will be delivered to at-risk adolescent girls within the Okanagan Region. Information will be gathered concerning program content and delivery, as well as insights into the participants' experiences with the program. These results will provide much needed information about whether programs integrating psychological, social, and physical components of health are beneficial for this population.

NCT ID: NCT03567096 Completed - Heart Failure Clinical Trials

LV Only MPP With SyncAV

Start date: October 9, 2018
Phase: N/A
Study type: Interventional

The objective of this clinical investigation is to evaluate the clinical benefits of left ventricle (LV) only pacing combined with automatic adjustment of AV timing (SyncAV) in patients receiving cardiac resynchronization therapy (CRT) after 6 months of therapy. This clinical investigation is a prospective, two-arm, randomized 1:1, multicenter feasibility study designed to evaluate the effectiveness of LV only with multipoint pacing (MPP) and SyncAV compared to bi-ventricular pacing with MPP and SyncAV. The clinical investigation will be conducted at approximately 7 centers in Europe and Canada. Approximately 120 subjects will be enrolled in the study. No site may enroll more than 33% of the total subjects. Data will be collected at enrollment, CRT implant procedure, hospital pre-discharge, one and 6 months post implant. Enrollment data collection will include demographics, cardiovascular history, medication, echocardiography measurements and quality of life questionnaire. CRT implant procedure data collection will include implanted system information and lead location. The electrical conduction recording procedure will include surface ECG and device IEGM recordings during various pacing configurations at implant or up to 45 days post implant. In patients who consent to invasive measurements (expected target of at least 80 patients), a hemodynamic recording procedure will include invasive hemodynamic measurements during various pacing configurations which may take place during device implant or up to 45 days post implant. Hospital pre-discharge data collection will take place within 3 days after the CRT implant, electrical conduction recordings visit or hemodynamic recordings visit and will include system information, surface ECG, and device IEGMs. In a subset of patients from selected centers that have access to this technology (expected 20 patients), non-invasive electrical activation data will be collected with body surface mapping within 45 days of the implant procedure. Patients will be randomized 1:1 to receive either biventricular pacing with multipoint pacing (MPP) or LV-only pacing with MPP at the one-month (± 15 days) visit. The 6-month (± 15 days) post randomization follow up visit will include surface ECG, IEGMs, echocardiographic parameters and quality of life questionnaire. Subjects participating in this clinical investigation will follow the hospital center standard of care from implant to 6 month follow up. The expected duration of enrollment is 1.5 year. The total duration of the clinical investigation is expected to be 2 years.

NCT ID: NCT03567057 Completed - Multiple Sclerosis Clinical Trials

A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment

Start date: July 18, 2018
Phase: Phase 3
Study type: Interventional

This study assessed the long-term safety and tolerability of ADS-5102 in subjects with MS and walking impairment who had completed the double-blind, placebo-controlled study of ADS-5102 in subjects with MS (ADS-AMT-301).

NCT ID: NCT03567031 Completed - Anesthesia, General Clinical Trials

Impact of CO2 on Cerebral Blood Flow in Infants Less Than 6 Months During General Anaesthesia

Start date: November 27, 2017
Phase: N/A
Study type: Interventional

The study aims at assessing cerebral blood flow variations following expired CO2 variations in anaesthetized infants less than 6 months, during a routine general anesthesia.

NCT ID: NCT03566238 Completed - PFIC2 Clinical Trials

This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2

PEDFIC 1
Start date: May 16, 2018
Phase: Phase 3
Study type: Interventional

Double blind, randomized, placebo controlled, Phase 3 study to investigate the efficacy and safety of low doses and high doses of A4250 compared to placebo in children with progressive familial intrahepatic cholestasis (PFIC) types 1 and 2.

NCT ID: NCT03565900 Completed - Clinical trials for Pneumococcal Infections

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM)

Start date: September 12, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to 1) evaluate the safety and tolerability, and immunogenicity of blinded V114 and Prevnar 13™ within each vaccination group, and 2) evaluate the safety and tolerability, and immunogenicity of PNEUMOVAX™23 (administered as open label, 12 months after allogeneic hematopoietic stem cell transplant [allo-HSCT] in participants who do not develop chronic graft-versus-host disease [GVHD]).