All Clinical Trials in Canada

Athletes in low energy availability (LEA) are at increased risk of developing the Relative Energy Deficiency in Sports (RED-S) syndrome (Mountjoy et al., 2018). LEA is a mismatch between dietary energy intake and exercise energy expenditure, leaving inadequate energy to support physiological functions, and the RED-S syndrome increases the risk of impaired health and performance (Drew et al., 2018, Sesbreno et al., 2022a, under review; Sesbreno et al., 2022b, in preparation; \& VanHeest et al., 2014). Although athletes with eating disorders are at high risk, many more may be vulnerable due to uninformed practices for weight loss and/or failure to match energy intake to energy demands for exercise (Wells et al., 2020). Despite efforts to better detect athletes in LEA/RED-S;there is no research on the effectiveness of dietary interventions to influence energy intake in international elite/world-class athletes tomitigate risk of LEA (De Souza et al., 2021; Elliott-Sale et al., 2018; Heikura et al., 2021; Melin et al., 2014; Stellingwerf et al., 2021;Stenqvist et al., 2021 \& Rogers et al., 2021). Therefore, it is important to investigate dietary interventions to influence eating habits to improve energy availability in elite athletes. Energy deficit associated with LEA in elite athletes may be accompanied by insufficient carbohydrate intake for training demands (Burke et al., 2011; Heikura et al., 2017; Sesbreno et al., 2021). Unfortunately, there is a paucity of information on the influence of sport nutrition education interventions on dietary intake in elite international (tier 4) and world-class (tier 5) athletes (McKay et al., 2022). However, recent findings suggest an association between nutrition knowledge and energy/carbohydrate availability in young female endurance athletes (Kettunen et al., 2021). This finding may offer a cost effective approach to lower the risk of LEA since education programs have shown to improve nutrition knowledge in athletes (Tam et al., 2019). However, an increase in nutrition knowledge may not always lead to a parallel increase in energy/carbohydrate intake (Heikkila et al., 2019). Indeed, the influence of nutrition education programs on improving dietary intake in athletes is reportedly equivocal (Boidin et al., 2021). However, the differences in intervention design with lack of guidelines on standardized and/or validated methods to assess sport nutrition knowledge and eating habits in elite athletes have made comparisons difficult for generalized interpretation. Fortunately, the new arrival of the Platform to Evaluate Athlete Knowledge of Sports Nutrition Questionnaire (PEAK-NQ) and the Athlete Diet Index (ADI) offer validated methods for assessing sport nutrition knowledge and eating habits in elite athletes (Capling et al., 2021 and Tam et al., 2021). Nevertheless, it is also important to appreciate that nutrition knowledge is not the sole influencing factors to athletes' dietary habits; and recognizing additional factors affecting athletes' decisions around nutrition is critical. A multitude of factors influence food choices in elite athletes (Thurecht et al., 2019). It ranges from sensory appeal, emotional influences, influence of others, weight control, performance among others (Thurecht et al, 2020). Interestingly, a moderate intercorrelation between nutritional attributes of the food and weight control, performance as well as food values and beliefs were reported (Thurecht et al., 2021). In fact, restraint eating behaviour have been associated with LEA, body weight and physique morphology (Jurov et al., 2021; Sesbreno et al., 2021; Sesbreno et al., 2022c in preparation; Sesbreno et al., 2022d, in preparation \& Viner et al., 2015). Clearly, multiple factors influence dietary habits, and therefore, it is important to consider how education interventions are developed to influence dietary outcomes in elite athletes. The Capability, Opportunity, Motivation - Behaviour (COM-B) model describes the importance of influencing 3-sources of behaviour to consistently alter habits (Michie et al., 2011). This was reiterated by sport nutritionists who characterized enablers and barriers to nutrition adherence in high performance sports (Bentley et al., 2019). In a case study, dietary interventions that targeted all 3-source behaviours was associated with improvements in dietary intake, including energy availability as an elite rugby player prepared for his 1st professional season (Costello et al., 2018). Therefore, a sport nutrition education program that accounts for all source behaviours may be necessary to improve eating habits intake to lower the risk of LEA/RED-S in elite international and world-class athletes during the competitive season. Overall Aim: Investigate whether elite athletes' nutrition knowledge and dietary intake can improve through an education intervention to lower the risk of low energy availability. Read Less

People who report subjective memory complaints have a greater risk of developing dementia. Memory issues may be an early warning sign of dysfunctional cerebral glucose metabolism and cerebral blood flow. Interventions that can restore cerebral metabolism and enhance cerebral blood flow may protect against conversion to dementia. Exogenous ketone supplements have been shown rapidly improves brain network function in young adults. Further, infusion studies demonstrate that ketone bodies enhance cerebral blood flow in cognitively normal adults. Whether acute ketone monoester supplementation can improve brain function in adults with subjective memory complaints is currently unknown. This study will investigate the effects of a single ketone monoester dose on resting-state functional connectivity in the default mode network and resting cerebral blood flow in adults with subjective memory complaints. Read Less

Parkinson's disease (PD) has been classically regarded as a "movement disorder", so earlier work has focused on treating motor symptoms only. As PD patients now have longer life expectancy, the relatively slowly progressing cognitive deficits (compared to their motor deficits) have become one of the major challenges. Approximately 80% of PD patients eventually become demented. Therefore cognitive dysfunction is one of the most significant factors affecting the quality of life of patients with PD. While dementia in Parkinson's disease is routinely treated by cholinesterase inhibitors (e.g., donepezil and rivastigmine), their efficacy on mild cognitive impairment found in non-demented PD is questionable. Alternative approaches have been proposed including transcranial direct current stimulation (tDCS) but no consensus has been reached. This can be attributed mainly to: (1) imprecise knowledge of the underlying functional circuitry mediating this disease manifestation and (2) inter-individual variability. Here, the investigators will utilize a novel personalized network analysis approach to elucidate on the underlying mechanisms of the effect of tDCS on cognitive dysfunction in non-demented PD patients. It has been well documented that the caudate nucleus plays an important role in cognitive dysfunction found in PD. In the investigators' preliminary resting-state functional magnetic resonance imaging (fMRI) study, they have shown that the connectivity of the right caudate nucleus is correlated to cognitive status of PD patients measured by the Montreal Cognitive Assessment (MoCA). The investigators hypothesize that tDCS on the left and/or right dorsolateral prefrontal cortex may restore the functional connectivity of the right caudate nucleus which may in turn improve patients' cognitive performance. Read Less

The purpose of this study is to characterize and compare the molecular gene expression profile in endobronchial biopsies and cells recovered in bronchial washings from study subjects who have asthma of varying disease severity and who are on maintenance inhaled corticosteroid (ICS) treatment, with that for healthy control subjects. These studies will produce transcriptomic profiles of gene expression associated with asthma disease severity. The investigators will also culture epithelial cells from study participant endobronchial brushings, including those with asthma of varying disease severity and healthy control subjects, to examine differences in the response to corticosteroids (CS) in vitro. These studies will test whether intrinsic differences exist between the responses to ICS in each group. 60 participants will be recruited with 15 of each mild, moderate and severe asthma as defined by the Global Initiative for Asthma (GINA) guidelines, as well as 15 healthy controls. Participants will undergo an initial visit to obtain informed consent, bloodwork and to assess asthma control using the Asthma Control Questionnaire (ACQ); if \>1.5, ICS dose will be increased, as per GINA strategy, for a 2 week 'stabilization' phase. Repeat ACQ, spirometry and sputum induction will be performed at visit 2. Bronchoscopy will be performed at visit 3, 2-4 weeks after visit 2. Mucosal biopsies, bronchial brushings and bronchial washings will be performed and processed as per our prior methods. Mucosal biopsies will be homogenized and processed for RNA, or fixed for later sectioning and histological examination. Biopsy RNA will be assessed for quality and subjected to RNA-sequencing of all human genes (mRNA-seq). Bronchial washing cells will be collected for differential cell counting and mRNA-seq analysis. Bronchial epithelial cells (BECs) from the brushings will be cultured. BECs treated with CS and inflammatory cytokines will allow comparative assessment of BEC responses. Read Less

The PERSON-JIA Trial is a cluster-randomized trial testing the use of Shared Decision Making (SDM) with families for treatment of children with arthritis. The intervention is a discussion between physicians and families at the time of diagnosis that uses computer-generated personalized outcome reports generated by previously developed prediction algorithms. By using information provided by thousands of families, the investigators have developed a way of providing answers to common questions asked by patients and their families at diagnosis. We will test whether a structured discussion and shared decision between families and doctors (guided by the patient's personal report) will improve the tailoring of treatment to the child and control of their disease. The personal report is called the PERSON-JIA report and presents the child's expected disease severity, the likelihood the child will be arthritis free by age 18 and the chance treatments will be effective and/or have side effects. This way, answers to these questions can be shared by physicians and families to weigh potential benefits and harms according to family values and preferences. The investigators expect that using the personalized report in a frank and thoughtful discussion will help physicians and families make better decisions about managing the child's disease. This in turn will result in better disease control, greater family engagement and satisfaction with care and better-tailored treatment. If so, this will be a ground-breaking way of using information provided by families and doctors to improve the care provided to and the outcomes of children with arthritis in Canada. Read Less

This study aims to develop a new measure which can accurately assess social connection for people with dementia living in long-term care homes. The Social Connection in Long-term Care home residents (SONNET) study will use interviews and focus groups with people affected by dementia and long-term care residents to establish what aspects of social connection are important for people living in care homes. These findings and a review of other studies and measures will be used to develop a new measure or measures of social connection which will then be tested in a study based in care homes in Canada and the UK. Read Less

Police officers are exposed to hazardous, disturbing events that impose stress and long-term trauma. Upwards of 15-26% of public safety personnel (PSP) report one or more mental health symptoms. Accumulated stress and posttraumatic stress injuries (PTSI) result in chronic physical and mental health disorders including anxiety, depression, substance abuse, and cardiovascular disease. PTSI are related to reduced occupational performance, absenteeism, and risky behaviour, with implications for both police and public safety. Recent empirical evidence and government reports highlight a mental health and suicide crisis among various PSP sectors in Canada. Prior research forms an urgent call for evidence-based programs that build resilience and wellness capacity to prevent PTSI symptoms before they manifest as severe, chronic, diagnosable disorders. The current study addresses the limited effectiveness issues associated with existing interventions for PTSI among PSP and also considers sex and gender as central determinants of health. Advances in physiology and neuroscience demonstrate that resilience is maintained by the healthy functioning of psychophysiological systems within the body. Objective biological measures have shown that chronic stress and trauma disrupt both psychological and physiological functioning, eroding resilience and reducing wellness capacity. Traditional interventions to build resilience among PSP have not adequately addressed the physiological underpinnings that lead to mental and physical health conditions, as well as burnout and fatigue following trauma. Together with previous empirical research lead by the NPA, the current proposal addresses this gap in PSP intervention research by employing Autonomic Modulation Training (AMT), a biological approach to building resilience and wellness capacity among PSP exposed to PTSI. Prior research shows that core AMT techniques effectively reduce psychophysiological stress and mental health symptoms in clinical and non-clinical populations. Further, research has shown that AMT techniques improve police health and occupational performance when completed during scenario-based, in-person training. The aim of the proposed study is to test if a web-based delivery of AMT for police officers can build resilience and wellness capacity, and reduce symptoms of PTSI with similar effectiveness as in-person training. An additional novel scientific contribution of the current proposal includes an examination of sex and gender in baseline biological presentation of PTSI among police, and in response to a resilience building intervention. Read Less

Osteoarthritis (OA) is disease in which the joint breaks down, causing pain. The decision to surgically replace the knee, a procedure called total knee arthroplasty (TKA), depends on x-ray results as well as pain and dysfunction. Despite TKA resulting in good outcomes for most patients, between 1 in 10 and 1 in 5 patients remain in significant pain - i.e., are 'TKA non-responders'. Two pain conditions - myofascial pain syndrome (MPS) and central sensitization - frequently coexist with signs of OA and may contribute to a TKA non-responder profile. MPS, caused by knots within skeletal muscle, can contribute to an OA patient's pain and dysfunction. In central sensitization, faulty pain sensing leads to increased pain sensitivity. However, there is currently no established process to identify these sources of pain and potential associated TKA non-responder risk. Our research aims conduct a pilot study to examine the impact of pain diagnosis tools to help orthopedic surgeons identify potential TKA nonresponders. This new approach may increase healthcare efficiency (reduce TKA waitlist and length of hospital stay), and help patients receive the right care at the right time. Read Less

The purpose of this study is to evaluate the effect of a 1-month, peer-led eHealth training program (TEAM Wheels) on satisfaction with activity participation and related rehabilitation outcomes among individuals transitioning to manual wheelchair use, compared with current wheelchair training practice. The primary objectives include: 1. Measuring the effect of TEAM Wheels on satisfaction with participation in important activities of life compared to current practice; 2. Measuring retention of participation benefits at 6-months post treatment. Secondary Objectives relate to additional rehabilitation Outcomes and include: 1. Comparing the effect of TEAM Wheels to current practice on wheelchair skills capacity and performance; wheelchair-specific self-efficacy; health-related quality of life; and objective measurement of wheelchair mobility. 2. Measuring retention of rehabilitation outcome benefits at 6-months post treatment. Read Less

Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Theta burst stimulation (TBS) is a very promising new treatment for major depression that allows a 15-fold reduction in duration of daily sessions. However, no large scale naturalistic study has assessed the superiority of bilateral TBS in comparison with unilateral left TBS. In fact, no TBS study thus far has included both unipolar and bipolar depression, or other psychiatric comorbidities such as anxiety. Maintenance has yet to be studied with TBS, along with an effective maintenance protocol to prevent relapse. Our study aims to explore and address these gaps. Read Less

Emergent experimental and anecdotal evidence has indicated that critically ill COVID-19 patients demonstrate two patient sub-types (called phenotypes). In one group the disease progresses slowly and patients have a low potential of developing mild respiratory failure, but in the other group, an exaggerated immune response (hyper-inflammation/cytokine storm) may be linked to the onset of precipitous respiratory failure, termed acute respiratory distress syndrome. This syndrome is responsible for a large portion of COVID-19 associated mortality. Thus, determining links between hyper-inflammation and acute respiratory distress syndrome in COVID-19 patients is of immediate importance. Blood samples will undergo a number of analyses to help us to understand as much as possible about COVID-19. We will also study any differences in physiologic and cytokine levels before and after patients are treated with immunomodulatory therapies as part of clinical care in COVID-19 patients. Read Less

Forensic patients often display cognitive deficits, particularly in the domain of executive functions, that represent a challenge to forensic rehabilitation. One empirically-validated method to train executive functions is cognitive remediation, which consists of cognitive exercises combined with coaching. This trial investigates whether cognitive remediation can improve cognitive, functional, and clinical outcomes in forensic inpatients. Read Less