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NCT ID: NCT03937206 Completed - Healthy Clinical Trials

Evaluation of the Pharmacokinetics, Safety and Effects of NutriterraTM in Healthy Adults

Start date: May 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The blood lipid profile plays a role in health and disease states and is affected by many genetic and lifestyle factors. On the more extreme side, hyperlipidemia (a condition characterized by hypertriglyceridemia, hypercholesteremia, or both) is a risk factor for coronary heart disease (CHD) 1. CHD is the most common form of cardiovascular disease (CVD); it is characterized by arterial obstructions or blockages, and is a leading cause of heart attacks and strokes 2. Specifically, blood lipids including triglycerides (TG), total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C), and the ratio of TC: high density lipoprotein (HDL) cholesterol, are key modifiable risk factors for CHD. Hyperlipidemia is thought to be caused or promoted by sedentary lifestyle, obesity, or uncontrolled type 2 diabetes 2. Therefore, lifestyle factors, like the modification of dietary lipids to maintain a healthy blood lipid profile are warranted. There are many beneficial effects of omega-3 fatty acids in terms of cardiovascular disease and the nervous system in general, as well as emerging research on DHA supplementation in acute brain and spinal cord injury. Demand for dietary omega-3's, either through increased fish consumption or through DHA supplementation, is expected to increase, particularly as the baby boomer population adds to the ranks of senior citizens concerned about and/or susceptible to health issues such as dementia and Alzheimer's Disease. Availability of EPA and DHA in circulation is an important parameter in understanding biologic properties of fatty acids. The purpose of this study is to evaluate the pharmacokinetic characteristics of ascending doses of NutriterraTM, as measured by plasma levels of total EPA, DHA, DPA and ALA under fed conditions. In addition, after a two-week (minimum) washout period, subjects will take product for 16 weeks to evaluate effects on cardiovascular markers as a measure of efficacy.

NCT ID: NCT03935698 Completed - Dyspareunia Clinical Trials

Physiotherapy Treatment in Women With Dyspareunia Following Gynecological Cancer: a Pilot Study

Start date: September 8, 2016
Phase: N/A
Study type: Interventional

Gynecological cancers represent more than half of female cancers. It has been clearly established that cancer survivors suffer from important health issues such as pain during sexual intercourse (dyspareunia) and sexual dysfunctions which sorely impact their quality of life. Although it affects more than 63% of cancer survivors, the available treatments remain limited and poorly studied. Cancer survivors are thus confronted with these health issues as well as relationship difficulties and psychological consequences, with limited treatment avenues. Addressing pelvic floor muscle dysfunctions and loss of vaginal elasticity, pelvic floor physiotherapy was shown to be effective in reducing or even alleviating dyspareunia and improving sexual function. Until now, no study investigated this treatment in gynecological cancer survivors with dyspareunia. Therefore, there is a need to examine pelvic floor physiotherapy to determine whether or not gynecological cancer survivors with dyspareunia could benefit from this treatment. The objectives of this single-arm mixed-method study are to evaluate the acceptability and feasibility of a physiotherapy treatment in gynecological cancer survivors suffering from dyspareunia and to explore treatment effects. This single-arm study using mixed methods will involve three data collections (pre- and post-treatment assessments). These assessments will be carried out by physiotherapists. Participants will receive physiotherapy treatment weekly in individual 60-minute sessions for 12 weeks. Thirty-one gynecological cancer survivors with vulvovaginal pain during sexual intercourse for at least 3 months will be recruited. The results of this study will bring new information regarding physiotherapy treatment for this population in preparation for a definitive randomized controlled trial.

NCT ID: NCT03935360 Completed - Clinical trials for Lower Gastrointestinal Bleeding

Oakland-Jairath Score Validation

Start date: November 25, 2019
Phase:
Study type: Observational

Lower gastrointestinal bleeding (LGIB) is a common presentation in the Emergency Room. It can deteriorate into severe adverse event. However some are discharged before these events occur. The Oakland-Jairath score was developed to help determine which patients can be safely discharged and which should be admitted from the ER to the hospital. The score did well in its development, but now needs to be externally validated by other independent cohorts. The limitations of the first study will be addressed in our study. The goal of this study is to perform the first prospective, multi-centered, external validation of the Oakland-Jairath risk score on an independent and diverse population who present to the emergency room with LGIB.

NCT ID: NCT03934853 Completed - Partial Edentulism Clinical Trials

Study to Confirm Accuracy and Safety of the Inliant Surgical Navigation System

Start date: May 29, 2018
Phase: N/A
Study type: Interventional

A confirmatory dual-clinic, non-randomized study of the Inliant device to aid in dental implant placement in humans. The hypothesis is that using the Inliant Surgical Navigation System ("Inliant") will provide a high degree of accuracy in multiple dimensions relative to the ideal implant position as determined in the planning stage, and will not result in any adverse outcomes related to use of the device. Five clinicians (Investigators) of various clinical backgrounds and experience will use the Inliant device, a licensed, medical device in Canada, to place a dental implant in a total of twenty (20) subjects.

NCT ID: NCT03931941 Completed - Infection Clinical Trials

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)

CD3-OLS
Start date: July 30, 2019
Phase: Phase 3
Study type: Interventional

This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.

NCT ID: NCT03931382 Completed - Virtual Reality Clinical Trials

Evaluating Virtual Reality as an Adjunct in Procedural Preparation for Magnetic Resonance Imaging

VR MRI
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

This pilot project aims to establish evidence to investigate whether a virtual reality intervention can be implemented to reduce anxiety and efficiently prepare children for non-sedated MRI assessments. The study consists of comparing the current modes of delivery though a mock behavioural assessment and inquiry into the acceptability and utility of the intervention components, including potential barriers to adherence or behavioural change that could have unintended consequences.

NCT ID: NCT03930732 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation

BOREAS
Start date: April 15, 2019
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate-or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by - Annualized rate of acute moderate and severe COPD exacerbation (AECOPD) Secondary Objectives: To evaluate the effect of dupilumab administered every 2 weeks on - Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo - Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ) - Pre-bronchodilator FEV1 over 52 weeks compared to placebo - Lung function assessments - Moderate and severe COPD exacerbations - To evaluate safety and tolerability - To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies (ADA)

NCT ID: NCT03929471 Completed - Fluid Overload Clinical Trials

Target Weight Correction and Vascular Stiffness in Hemodialysis Patients

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Title of the study: Target weight correction and vascular stiffness in hemodialysis patients Study design: Randomized clinical trial in the study centre at two locations Applied medical device: 1. Body Composition Monitor' (BCM, Fresenius) to measure fluid volume overload. 2. Arteriograph 24 (Tensiomed, Budapest, Hungry) to assess vascular stiffness before, during and after the intervention. Study hypothesis: A protocolized adjustment of target weight guided by bio-impedance spectroscopy will improve fluid status, systolic and diastolic blood pressure, and reduce the arterial wall stiffness without increasing the prevalence of intradialytic hypotension. Aim of the study: 1. To demonstrate improvement in fluid status by a target weight correction protocol which applies BCM measurements. 2. To demonstrate that better fluid volume control is associated with a) improvement in vascular health as assessed by pulse wave velocity and augmentation index and b) reduction in antihypertensive medications use. 3. To show that this approach does not lead to more episodes with intradialytic hypotension. The number of patients: 70 patients

NCT ID: NCT03928132 Completed - Clinical trials for Health Knowledge, Attitudes, Practice

Integrating Sex and Gender Into CPD for Depression/Diabetes

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

People with type 2 diabetes are twice as likely to experience depression as nondiabetic individuals, and depression in turn increases the risk of diabetes. Clinical care for patients for either condition usually fails to consider the impact of sex and gender on tests, diagnosis and treatment, and evidence on these impacts is limited. The investigators aim to assess the impact of a continuing professional education activity (CPD) on diabetes and depression that includes considerations of sex and gender on the clinical behaviours of French-speaking healthcare professionals in Canada. In a non-randomised controlled trial, the investigators are assessing the impacts of two CPD activities on depression and diabetes, one that includes considerations of sex and gender, and an identical one that omits sex and gender considerations, on French-speaking healthcare professionals' self-reported clinical behaviors regarding sex and gender considerations post-intervention and at 3 months. Data collection will occur in three distinct locations in Canada. Project development, data collection and analysis and dissemination of results will all integrate considerations of sex and gender. The process of creating a CPD activity that integrates considerations of sex and gender could be scaled up to other CPD activities in other clinical subjects and in other minority languages.

NCT ID: NCT03928093 Completed - Pain, Neuropathic Clinical Trials

Pregabalin Treatment for RDEB Pain and Itch

Start date: August 7, 2019
Phase: Phase 3
Study type: Interventional

Recessive dystrophic epidermolysis bullosa (RDEB) patients' quality of life is severely affected by neuropathic pain and itch, which have recently been demonstrated to be secondary to skin small fiber neuropathy. To date, there is no evidence on what the best agent is to control these symptoms. Based on the anecdotal data and safety profile, the investigators believe that pregabalin is a therapeutic agent that will be effective and safe in this population. The investigators propose to conduct a blinded study, using pregabalin versus placebo in which each patient serves as its own control (cross-over design). This is a feasibility study that will provide preliminary data on efficacy and safety of pregabalin in RDEB patients with neuropathic pain and itch and gather much needed data (dosage, titration schedule, outcome measures, etc) to inform the design of a larger cohort, controlled, multicenter trial.