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NCT ID: NCT03234790 Completed - Experimental Clinical Trials

Human Study to Develop a Signature of Occupational Diesel Exhaust Exposure

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

Strong scientific understanding of how emissions from diesel engines impact the lungs could improve policies and regulations protecting workers exposed to diesel exhaust. Accordingly, we are recruiting healthy volunteers who are non-smokers to participate in our study. Volunteers sit in a room for four hours and breathe either clean filtered air or air that contains pollution at various concentrations similar to occupational settings such as bus and ferry terminals where diesel engines are used. A respirologist assesses the volunteer's lung health and clinical samples are taken. We are equipped with advanced molecular biology tools to measure different molecules and compare samples from our volunteer subjects following exposure to clean air or diesel exhaust. Our research aim is to find a simple, clinically relevant strategy that can be used to measure the impact of diesel exhaust on workers' lung health. This knowledge will empower regulators, companies, and ultimately workers to better manage their health risks. Our research aims to provide specific data to help regulators to make informed decisions about the risks of diesel exhaust exposure.

NCT ID: NCT03234777 Completed - Pediatric ALL Clinical Trials

Evaluating a Knowledge Translation Tool for Parents

Start date: November 30, 2017
Phase: N/A
Study type: Interventional

Diarrhea and vomiting in children is a common reason to visit the emergency department. There has been a lot of research on how best to treat children with diarrhea and vomiting who visit the emergency department; however, the care children receive varies by healthcare provider and across hospitals. Additionally, there are things parents can do at home to help manage childhood diarrhea and vomiting and potentially avoid a trip to the emergency department. This shows an urgent need for knowledge translation, that is, efforts to align research knowledge and healthcare practice. Actively involving parents in healthcare decisions has the potential to bridge this gap; however, there is little research on the best ways to communicate complex health information to parents of sick kids. In 2013, a national needs assessment was conducted with parents seeking care for their kids in general emergency departments (trekk.ca). This survey showed that 39% of parents looked for information about their child's health prior to coming to the emergency department and that 44% of these parents looked for this information on the internet. This means that the development and evaluation of digital tools to give parents timely and effective child health information has the potential to reduce unnecessary emergency department visits, empower parents in health decision-making, and ultimately improve child health outcomes. In this project, parents will be actively involved in the evaluation of a digital tool, a whiteboard animation video, designed to communicate the best research evidence on the treatment and management of vomiting and diarrhea in children. In this pilot trial, parents in two emergency departments will be randomized to view the video or a sham video, and then provide quantitative and qualitative data on the potential effectiveness of the video, the perceived benefit and value of the knowledge translation intervention for pediatric vomiting and diarrhea, the feasibility of using iPads and an electronic data collection platform to conduct research with this population, the time required to complete data collection, and parents' willingness to participate in future, similar research.

NCT ID: NCT03234049 Completed - Trauma Clinical Trials

The Use of a Pediatric Trauma Checklist to Improve Clinical Performance in a Simulated Trauma Resuscitation

Start date: November 2016
Phase: N/A
Study type: Interventional

The use of a pre-arrival and pre-departure trauma checklist to optimize care has not yet been studied. The Alberta Children's Hospital (ACH) Trauma Checklist was developed by the ACH Resuscitation Council with input from the ACH Trauma Program. The purpose of this study is to determine if the introduction of the ACH Trauma Checklist as a cognitive aid, coupled with an educational session, will improve clinical performance in a simulated environment. The investigators plan to conduct a pilot, randomized control trial assessing the impact of the ACH trauma checklist on time to critical interventions on a simulated pediatric patient by multidisciplinary teams. The investigators hypothesize that teams who use a trauma checklist as a cognitive aid will have faster initiation of key clinical interventions within a simulated pediatric trauma resuscitation. Improvements in performance in a simulated environment with this tool may translate to similar results in the clinical setting.

NCT ID: NCT03233841 Completed - Clinical trials for Ceramidase Deficiency

Farber Disease Natural History Study

Start date: November 22, 2017
Phase:
Study type: Observational

The primary objective of this study is to establish the natural history of Farber disease (acid ceramidase deficiency) through the collection and analysis of retrospective and prospective data on patients diagnosed with Farber disease. All patients diagnosed with Farber disease are eligible, including both those who have and have not undergone hematopoietic stem cell transplantation (HSCT). Additionally, data and records from deceased patients will provide valuable retrospective data for this study. The secondary objective of the study is to establish a set of clinical data, laboratory data (biomarkers), and functional data potentially useful for: - Assessing the efficacy of HSCT and the efficacy of potential future therapies (for example with RVT-801, recombinant human acid ceramidase) in Farber disease - Characterizing changes in symptoms of patients over time - Characterizing distinct groups (phenotypes) within the patient population - Documenting the disease histories of individual patients to serve as intra-subject control data for those who may enroll in any future clinical studies with therapies for Farber disease The exploratory objectives of the study are: - To explore the relationship between patient disease activity or phenotype and specific ceramide levels or specific immunologic markers (cytokines/chemokines) in blood - To evaluate a standardized tool, the Farber Disease Natural History Instrument (FDNI), to be used for the collection of patient history information, data from clinical, laboratory, genetic, and functional studies, and data from review of medical records

NCT ID: NCT03233750 Completed - Clinical trials for Stress, Psychological

Simulation-Based Stress Inoculation Training

Start date: September 15, 2017
Phase: N/A
Study type: Interventional

Previous research has shown that health professionals can experience stress responses during high acuity events such as trauma resuscitations. These stress responses can lead to impaired clinical performance. The goal of this proposed project is to adapt Stress Inoculation Training (SIT) to the healthcare setting. Stress Inoculation Training is a cognitive-behavioural approach to stress management that has proven effective in reducing stress and improving performance in domains outside of healthcare. Thirty-two emergency medicine residents will be randomly divided into two groups. The SIT group will receive the simulation-based stress inoculation training. We will measure the effectiveness of the training by looking at reduction of stress levels and improvements in clinical performance in a pre-intervention and a post-intervention simulated trauma scenario. The control group will be exposed to the same simulation scenarios and pre/post intervention scenarios as the SIT group, but will not receive the stress inoculation training.

NCT ID: NCT03233529 Completed - Dermatitis, Atopic Clinical Trials

Crisaborole Ointment 2% Skin Biomarker Biopsy Study in Atopic Dermatitis

Start date: July 31, 2017
Phase: Phase 2
Study type: Interventional

This study is being conducted to characterize the mechanism of action of crisaborole ointment 2%, by evaluation of efficacy and changes in key skin biomarkers in atopic dermatitis (AD) lesions treated with crisaborole ointment 2% over vehicle, in subjects with mild to moderate AD. Two identified AD skin lesions for each subject will be treated for the first 15 days, one with crisaborole ointment 2% and one with vehicle, in a blinded manner, and biopsies for biomarker analysis will be performed on the lesions. Following completion of the blinded treatment period, subjects will start the 28 day open label period during which all AD affected skin lesions will be treated with crisaborole ointment 2% twice daily.

NCT ID: NCT03233178 Completed - NAFLD Clinical Trials

Measurement of Alanine Aminotransaminase (ALT) Following Initiation of Antidiabetic Agents in Patients With Type 2 Diabetes in a Real-world Clinical Setting: a Retrospective Cohort Study

ALT
Start date: January 2017
Phase: N/A
Study type: Observational

The primary objective of this study is to investigate the change in Alanine Aminotransaminase (ALT) in patients with Type 2 Diabetes Mellitus (T2DM) initiating Sodium Glucose Cotransporter 2 (SGLT2) inhibitors, liraglutide, or sitagliptin, compared to a control group of patients who did not initiate a new antihyperglycemic therapy. The hypothesis is that patients using Sodium Glucose Cotransporter 2 inhibitors (SGLT2i) will achieve a greater reduction in ALT compared to the control group.

NCT ID: NCT03232996 Completed - Parkinson Disease Clinical Trials

Evaluation of a Computer Game Based Rehabilitation System for Assessment and Treatment of Balance and Gait Impairments in Individuals With Parkinson's Disease.

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

Examining the feasibility and acceptability of the computer game based rehabilitation system for improving balance, gait and executive function in individuals with PD. This will involve a pilot case series intervention study of individuals with PD will be conducted.

NCT ID: NCT03232944 Completed - Heart Failure Clinical Trials

Personalized CRT - MPP Post Approval Study

Start date: July 5, 2017
Phase:
Study type: Observational [Patient Registry]

The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release. This evaluation is based on the Clinical Composite Score which summarizes the proportions and frequencies of CRT non-responder patients who are "improved", "unchanged" or "worsened" after receiving MPP therapy. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the MPP feature and is integrated within the Product Surveillance Registry (PSR).

NCT ID: NCT03232073 Completed - Multiple Sclerosis Clinical Trials

Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis

OPTIMUM-LT
Start date: July 5, 2017
Phase: Phase 3
Study type: Interventional

The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS). The AC-058B303 study is the long-term extension for the core study AC-058B301. The purpose of this long term extension of the core study AC-058B301 is to characterize the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with RMS.