All Clinical Trials in Canada

To determine the feasibility of whether the addition of key prebiotics administered orally can mitigate some of the most problematic side-effects of the most common psychiatric medications - weight gain and metabolic abnormalities caused by some antidepressants, mood stabilizers and antipsychotics. In the initial part of the study, we aim to determine feasibility of the study and evaluate participant compliance. Our clinical trial will encourage the growth of Akkermansia muciniphila (AM) through enteric-coated orally-administered acetate (apple cider vinegar powder in capsules) in 16-to-28 year-old patients who have already experienced weight gain while on stable doses of psychiatric medication, with the hypothesis that the addition of this prebiotic will result in alterations in gut microbiota and measurable weight loss, as well as improvement in metabolic measurements. Primary Objective: * To evaluate feasibility of using acetate in a large-scale clinical trial, including considerations for protocol, study agent, recruitment, retention, adverse events, budget, staff, facility, and patient experience * To estimate effect size of change in AM relative abundance by measuring pre- and post-intervention levels for use in designing future large-scale clinical trials Secondary Objectives: * To determine whether acetate administered orally shows an observable effect on weight gain as a side effect from antidepressants, mood stabilizers, and/or antipsychotics in a sample of participants already on stable doses of at least one of these medications * To determine changes in metabolic syndrome profile, as indicated by blood pressure and high-density lipoprotein. * To conduct preliminary analyses on any possible changes in mood/anxiety symptoms pre- versus post-intervention * To identify and define other potential confounders or effect modifiers of our primary and secondary objectives that should be considered in future study designs Read Less

The objective of this study is to evaluate (1) the effect of a non-restrictive satiating intervention on appetite control, body weight loss and maintenance; and (2) determine whether switching to a non-restrictive satiating intervention following a conventional restrictive intervention can prevent increases in appetite and attenuate body weight regain usually observed after weight loss in men and women living with obesity. This is an 18-month, randomized, controlled, parallel weight loss \[Phase 1 (P1): 6 months\] and maintenance trial \[Phase 2 (P2): 12 months\] with three groups (n=234 men and women): (1) non-restrictive, satiating intervention (P1) followed by a continuation of this intervention (P2); (2) conventional restrictive intervention (-500 kcal/d) (P1) followed by a non-restrictive satiating intervention (P2); (3) control group that follows minimal healthy guidelines (P1) followed by recommended weight maintenance strategies (P2). All groups will be controlled for physical activity and sleep patterns. The non-restrictive satiating intervention will include guidelines and recipes to prepare highly satiating meals that will be low in energy density and glycemic index and high in protein, polyunsaturated fats, vitamins and minerals (e.g. calcium), and certain constituents of spices (e.g. capsaicin). Measurements at baseline (week 0), after P1 and P2 will include the following primary outcomes: appetite control, weight loss and maintenance; and secondary outcomes: body composition, physiological, psycho and neurobehavioural and health-related variables. Follow-ups will be done by a dietitian every 2 weeks during P1 and once a month during P2. Read Less

The aim of this research is to clarify the role of different dairy products including both full-fat and low-fat dairy in maintaining health in adults and children through its effects beyond their well-known contribution of healthy nutrients. The deleterious health consequences of obesity are recognized as a major financial burden to health care systems. Diets rich in fruits and vegetables and that also include dairy products have been suggested to play a role in the control of body weight and other aspects of health including the maintenance of healthy gut bacteria. In contrast, full-fat diets, especially those high in saturated fat, have been linked with negative health effects. Although dairy products represent an important source of saturated fat, it has been proposed that the combination of nutrients and complex food forms of the various dairy products may in fact counteract the negative effects of the fat. Thus, increased consumption of dairy products could very likely provide a partial dietary solution to improved body weight and metabolic health. Therefore, we are investigating the role of both full-fat and low-fat dairy products in their different physical forms (i.e. varying levels of fat that contribute to different textures) on appetite, food intake, control of blood sugar (glucose), body weight, cholesterol levels, and blood pressure in both children and adults. Existing dairy products (milk, cheese, and yogurt) ranging in fat content will be compared for their effects on satiety, food intake, glucose, insulin, satiety hormones, gut bacteria and other metabolic parameters linked to cardiometabolic health in normal weight children and adults, as well as in children and adults living with overweight and obesity. Read Less

Familial hypercholesterolemia (FH) is the most frequent genetic lipoprotein disorder associated with premature CAD. In Canada, the burden of disease is estimated to be approximately 83,500 patients. The goal of this initiative is to create a registry of subjects with FH across Canada. Rare diseases of lipoprotein metabolism are also included. Using a "hub and spoke" model, the registry extends in various communities to link primary care physicians with provincial academic centers. The registry includes clinical, biochemical and demographic information. Specimens (plasma/serum and DNA) are collected for biobanking. The "local" portion of the registry is available for clinicians to manage patient care, and identify relatives for screening and treatment (cascade screening). The Canada-wide registry, which is completely anonymized, will be made available to provide advice to general practitioners and to support collaborative studies in biomedical, clinical, health outcomes and health economics research. The data extracted for the provincial portion of the database will allow administrative database research that will provide important information to key stakeholders and permit allocation of resources. It will also allow a sound and uniform rationale for the use of novel therapeutic agents and provide expert advice to regulatory agencies. At the Canadian level, the database will allow clinicians and researchers to determine the burden of disease and the long-term effects of treatment. Through the creation of a Canada-wide network of academic clinics, integrating lipid specialists, endocrinologists and cardiologists, the Canadian FH registry will lead to significant benefits for FH patients, clinicians and researchers, biopharmaceutical industry and government. Read Less

A new infusion strategy named the 'programmed intermittent bolus' (PIB) technique delivers the hourly dose within minutes compared to the traditional infusion that delivers such dose over an hour. The PIB technique has demonstrated superior patient satisfaction and reduced local anesthetic consumption when utilized for pain control during labour and delivery. However, it is not known if the PIB technique gives any benefits during a continuous nerve block in other settings. The aim of this randomized controlled trial (RCT) is to elucidate if PIB is better than (traditional) continuous infusion for postoperative analgesia in patients receiving a continuous nerve block for total shoulder arthroplasty with respect to pain control. Read Less

Hypothesis: Taurine, in combination with standard iron chelation therapy, is more effective than chelation therapy alone in reducing cardiac iron overload, oxidative stress and cardiac damage in β-Thalassemia. Protocol: Sixty subjects with transfusion dependent β-Thalassemia receiving deferasirox iron chelation therapy will be recruited and randomized in a 1:1 ratio to either (1) placebo and continuation of their iron chelation or (2) a combination of iron chelation plus taurine. Transfusion and safety visits will be scheduled monthly with clinical/biochemical assessment visits every three months. The efficacy of taurine combined with standard chelation therapy will be assessed at baseline and 12 months posttreatment by both cardiac T2\*MRI, and cardiac function. The recruitment period is projected to be 12 months from initiation. Read Less

Ultrasound (US) used for hepatocellular carcinoma (HCC) surveillance suffers from low sensitivity (60-78%) due to fatty liver, obesity, and diffusely nodular appearance in cirrhosis. Once a suspicious malignant lesion is detected at US, guidelines recommend contrast-enhanced US, magnetic resonance imaging (MRI) or computed tomography (CT) scans to confirm suspicion. The investigators' team has developed innovative quantitative US (QUS) techniques that have a high potential to improve tissue characterization in terms of sensitivity and specificity. The investigators hypothesize that advanced QUS providing tumor viscoelasticity assessment, sub-resolution tissue structure characterization and US attenuation in the framework of a machine learning classification model can improve HCC diagnosis compared with standard US. Early detection through systematic US surveillance translates into curative therapy in a higher proportion of patients and into improvements in survival rates. Thus, there is an urgent need to investigate innovative and cost-effective imaging techniques for improving detection and characterization of HCC. The proposed QUS methods are experimental and will be validated in this proof-of-concept clinical study. A major impact of this work, for patients and medical institutions, will be to improve early-stage detection and characterization of HCC, and offer alternatives in patients with negative or inconclusive conventional US. QUS are low-cost, non-invasive and non-irradiating imaging modalities available from a single exam (i.e., no additional imaging session is necessary). Read Less

Contracture which is defined as a limitation of the maximum passive range of motion due to changes in periarticular soft tissue can contributes to severe pain and increased disabilities. Once contracture is present, management options are very limited and mainly includes surgery. This clinic offers cryoneurolysis routinely to spastic patients to manage their severe spasticity, contracture and associated pain. In this observational project, the outcomes after cryoneurolysis in patients with wrist and hand contracture will be studied systematically and with more details to determine any changes in pain and range of motion after this procedure. Read Less

It has been a longstanding teaching in plastic surgery that intra-operative ketorolac use for postoperative pain control increases hematoma and bleeding in breast reduction surgery. However, there is no literature that supports this teaching. Ketorolac is used routinely in free flap reconstruction including breast reconstruction as well as many other surgeries including hand surgery without increased risks of hematoma or bleeding. Ketorolac has been shown to give good postoperative pain control. The object of this study is to look at whether ketorolac increases the rate of hematoma/bleeding in breast reduction. If there is no increased risk of hematoma, then ketorolac can be used safely for postoperative pain control with an increased risk of hematoma/bleeding. Normally, without using ketorolac, the hematoma rates in a breast reduction are 1-2%. Read Less

This study is a single center, random participant selection, data analyst is blinded to patient identifiers, controlled clinical trial. The proposed study is intended to establish safety and efficacy of quantifiable electrical biomarkers for migraine that can be used to confirm a diagnosis in people that have already been screened as positive for migraine using the gold standard participative criteria set out in the International Classification of Headache disorders-3 (ICHD-3) criteria. It is hypothesized that specific brain signals can be used to distinguish between migraine patients with and without aura from normal control and tension- type headache control participants by EEG enhanced with machine learning software. Read Less

Obstructive sleep apnea (OSA) is a sleep related breathing disorder, affecting approximately 10% of adults. Mandibular advancement oral appliances (OAM) are an effective treatment for OSA, however, long term use has shown to lead to changes in teeth positioning and jaw alignment (bite changes), which has resulted in some patients stopping treatment. It is becoming common clinical practice for doctors to prescribe the use of repositioning splints to help reduce the bite changes associated with using OAM. However, this has not been studied in a clinical trial. This study will compare the bite changes between patients using OAM alone against patients using a morning repositioning splint in addition to OAM. Other variables, such as oral health, the size of mandibular advancement, and treatment adherence will also be measured to determine if they have an effect on the bite changes associated with OAM use. By understanding the key the factors that influence the bite changes associated with OAM use and potentially validating a technique to reduce these changes, this study will improve the clinical practice of Dental Sleep Medicine, leading to improved health outcomes for OSA patients. Read Less

The WHEAT International trial is a comparative effectiveness trial exploring whether withholding enteral feeds around the time of blood transfusion in very premature infants (\<30 weeks) will reduce the occurrence of Necrotizing Enterocolitis (NEC). Currently both continued feeding and withholding feeding are approved care practices. The current study will randomize infants from Neonatal Intensive Care Units (NICUs) across Canada and the United Kingdom (UK) into one of the two care approaches (withholding or continued feeds) to determine if any significant outcomes are found. Read Less