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Background \& Rationale: Breast cancer (BC) is the most commonly diagnosed malignancy in women worldwide (2.1 million diagnoses in 2018, 25% of new cancer cases). In Canada, early stage BC mortality rates have decreased by 48% over the past 30 years as a result of advances in prevention, detection, and treatment. However, competing risks for mortality from non-cancer causes have emerged, where cardiovascular disease (CVD) is now a leading cause of death for BC survivors. The direct toxic effects of BC treatment on the heart (cardiotoxicity) are well characterized by the investigators and many others, as a contributor to elevated cardiovascular risk. However, BC treatment and the associated lifestyle changes (i.e. physical inactivity, poor diet quality, stress) are increasingly recognized to also strongly affect metabolism negatively manifesting as insulin resistance, dyslipidemia and adipose tissue (fat) accumulation. These adverse metabolic changes are strongly linked to CVD risk and represent a currently underappreciated contributor to the elevated CVD risk among BC survivors. Preliminary data and recent publications demonstrate that regional fat accumulation occurs during BC treatment and that the fat burden in key locations is associated with poor cardiorespiratory health. A trigger of these adverse metabolic and inflammatory effects is excess fat specifically within ectopic fat (viscera, intermuscular, or hepatic) regions. In 2019, a member of the study team found that the volume of visceral and intermuscular but not subcutaneous fat at BC diagnosis were linearly associated with CVD events within 6 years, even among those with normal BMI and after adjustment for pre-existing CVD risk factors and for BC treatment type. Using MRI, investigators found that \~1 year after chemotherapy, BC survivors had significantly larger depots of visceral fat (49% larger) and thigh intermuscular fat (41% larger) compared to age and sex-matched controls, despite similar BMI and subcutaneous fat volumes in the two groups. Investigators also showed that the fat fraction within the thigh muscle and visceral fat volumes independently explained \~50% of the variation in cardiorespiratory fitness (measured by peak VO2). In particular, peak VO2 is one of the most powerful predictors of all-cause and CVD mortality and health care costs, and is the most consistently reported negative sequelae after treatment for BC. Unfortunately, there are no known therapies to recover long-term myocardial damage (i.e. cell death, fibrosis) from cancer therapies. There are several reasons to target fat as a therapeutic target in BC patients: 1) The study team have compelling preliminary data showing accelerated formation of ectopic fat during BC treatment. 2) Investigator's recent data showed that high fat content in key fat pools was associated with reduced peak VO2. 3) The burden of fat and the associated metabolic abnormalities are dynamic and malleable, and thus highly treatable. Research Question \& Objectives: The primary purpose of this study is to evaluate the effect of a behavioural intervention involving supported time-restricted eating (TRE), diet quality improvements, and reduced sedentary time versus usual cancer and nutrition care in BC patients receiving chemotherapy treatment on ectopic fat, cardiometabolic profile, and chemotherapy outcomes. The investigators hypothesize that the intervention will attenuate the growth of ectopic fat during chemotherapy and reduce chemotherapy symptoms.
Conditions:
Cardiovascular Diseases | Cardiovascular Morbidity | Metabolic DiseaseLocation:
- University of Alberta, Edmonton, Alberta, Canada
- University of Toronto, Toronto, Ontario, Canada
Sex:
FEMALEAges:
Over 18Due to the recent resurgence of infectious syphilis in Canada and the changing epidemiology of the disease to involve heterosexuals and females of child bearing age leading to a record number of congenital syphilis cases and stillbirths, the demand of a rapid test such as POCT that can be used at the place and time that front-line public health workers meet the at risk population is getting louder. Indeed during a number of federal, provincial and territorial meetings on the control of syphilis outbreaks in Canada, requests for POCT to detect syphilis infections have repeatedly come up. However, before a POCT can be widely used, research to find out if it is accurate and reliable is necessary. This study is designed to test the performance of the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POCT) (MedMira Inc., Halifax, Nova Scotia) in an urban clinic (Sexual Health Clinic) in Ottawa, Ontario, Canada and compare its performance in parallel with the usual testing method (the gold standard, i.e. conventional syphilis serology testing).
Conditions:
SyphilisLocation:
- Sexual Health Clinic, Ottawa, Ontario, Canada
Sex:
ALLAges:
Over 16This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal or persistent atrial fibrillation (AF).
Conditions:
Persistent Atrial Fibrillation | Paroxysmal Atrial FibrillationLocation:
- McGill University Health Centre, Montréal, Quebec, Canada
- St.Paul's Hospital, Vancouver, British Columbia, Canada
Sex:
ALLAges:
18 - 80The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.
Conditions:
Mitral Valve RegurgitationLocation:
- Toronto General Hospital, Toronto, Ontario, Canada
- St. Michael's Hospital, Toronto, Ontario, Canada
- Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
- Ottawa Heart Institute, Ottawa, Ontario, Canada
- Institut de Cardiologie de Montreal (Montreal Heart Inst.), Montréal, Quebec, Canada
Sex:
ALLAges:
Over 18Children with disabilities often access rehabilitation services to improve their abilities to participate in everyday activities. Goal-directed therapy is considered an important therapeutic strategy to achieve outcomes that are meaningful to families. Not a lot is known about the effects of goal setting on rehabilitation outcomes. Strategies to help children participate in the goal-setting process are rarely used in clinical practice. The aim of this project is to test the effects of a child-focussed goal setting approach, Enhancing Child Engagement in Goal Setting (ENGAGE), on therapy outcomes. Service use and the cost vs. benefits of the ENGAGE approach compared to usual practice will also be examined. Children with neurodevelopmental disabilities aged 5-12 years old (n=96) who access paediatric rehabilitation services at six rehabilitation sites will participate. Therapists (n=24) at participating sites in Alberta, Canada will be randomized into 1) the ENGAGE intervention group or 2) the usual therapy practice control group. Children will participate in the ENGAGE approach to goal setting or usual practice based on the allocation of their therapist. This study will determine if the ENGAGE approach to goal setting affects child goal performance, satisfaction with goal performance, functional abilities, participation, and parent and child quality of life. The investigators will also evaluate differences in parent and child quality of life in relation to parent costs (e.g., absenteeism, presenteeism, travel costs) and compare amount of therapy time between the two groups to see which approach is more cost-effective and efficient. After the study, children, parents and therapists will be asked to discuss aspects that influenced effective implementation of the ENGAGE approach. This study could provide evidence to improve meaningful child and family outcomes in paediatric rehabilitation and improve efficiency of paediatric rehabilitation services.
Conditions:
Cerebral Palsy | Autism Spectrum Disorder | Neurodevelopmental DisordersLocation:
- Renfrew Educational Services, Calgary, Alberta, Canada
- Children's Rehabilitation Services, Alberta Health Services, Grande Prairie, Alberta, Canada
- Centre for Autism Services Alberta, Edmonton, Alberta, Canada
- Society for Treatment of Autism, Calgary, Alberta, Canada
- Children's Rehabilitation Services, Alberta Health Services, Red Deer, Alberta, Canada
- Children's Rehabilitation Services, Alberta Health Services, Camrose, Alberta, Canada
Sex:
ALLAges:
5 - 12This clinical trial aims to determine the optimal timing for administering a Transversus Abdominis Plane (TAP) block in bariatric surgery, specifically investigating whether initiating TAP blocks at the beginning of surgery is more beneficial than at the end, which is the current practice. The study targets obese patients undergoing bariatric surgery, with a focus on reducing postoperative pain and opioid use. Key outcomes include recovery duration, pain levels, opioid consumption, and respiratory function. Successful results could establish early TAP block initiation as a standard practice, offering faster recovery, decreased opioid reliance, and reduced healthcare costs.
Conditions:
Pain, Postoperative | Opioid UseLocation:
- St. Joseph's Healthcare Hamilton - Charlton Campus, Hamilton, Ontario, Canada
Sex:
ALLAges:
Over 18Individuals receiving dialysis are at risk of heart failure and heart related death. There is an urgent need for treatments that reduce the risk of these problems in patients that require dialysis. Spironolactone is a pill used to prevent heart failure and related deaths in patients that do not require dialysis. It works by blocking a hormone (aldosterone) in your body that causes high blood pressure and can damage the heart. Although spironolactone is very effective in patients that do not require dialysis, we do not know if spironolactone is effective in dialysis patients. Our research will help determine if spironolactone reduces heart failure and heart related deaths in dialysis patients. The purpose of this study is to determine if spironolactone reduces death or hospitalization for heart failure and is well tolerated in patients that require dialysis.
Conditions:
Endstage Renal DiseaseLocation:
- University of Alberta, Edmonton, Alberta, Canada
- Penticton Regional Hospital, Penticton, British Columbia, Canada
- Queens University at Kingston General Hospital, Division of Nephrology, Kingston, Ontario, Canada
- St. Michael's Hospital, Toronto, Ontario, Canada
- Hopital du Sacre-Coeur de Montreal, Montreal, Quebec, Canada
- Foothills Hospital, Calgary, Alberta, Canada
- St. Pauls Hospital, Vancouver, British Colombia, Canada
- St. Joseph's Healthcare, Hamilton, Ontario, Canada
- Health Sciences North Research Institute, Sudbury, Ontario, Canada
- CIUSSS Hopital Maisonneuve- Rosemont, Montreal, Quebec, Canada
- CHU de Quebec L'Hotel-Dieu de Quebec, Québec, Quebec, Canada
- Royal Inland Hospital, Kamloops, British Colombia, Canada
- Queen Elizabeth II Health Science Centre, Halifax, Nova Scotia, Canada
- Victoria Hospital, London, Ontario, Canada
- St. Josephs, Toronto, Toronto, Ontario, Canada
- The Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada
- Kelowna General Hospital, Kelowna, British Colombia, Canada
- Cape Breton Regional Hospital, Sydney, Nova Scotia, Canada
- Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- Humber River Health, Toronto, Ontario, Canada
- Centre Hospitalier de l'Universite de Montreal (CHUM), Montréal, Quebec, Canada
Sex:
ALLAges:
Over 18Patients with recurrent Glioblastoma (GBM) are commonly presented to surgeons, along with the question of whether or not to re-resect the recurrence. There is no Level 1 evidence to support a role for repeat surgery in this context, but a multitude of observational research suggests that repeat surgery may improve quality survival. Unfortunately, these studies all suffer from selection bias. The goal of this study is to provide a care trial context to help neurosurgeons manage patients presenting with recurrent GBM, with no additional risks, tests, or interventions than what they would normally encounter in routine care. Secondary goals include a test of the hypothesis that repeat resection can improve median overall survival, and that it can increase the number of days of survival outside of a hospital/nursing/palliative care facility.
Conditions:
Recurrent Glioblastoma | Glioblastoma - CategoryLocation:
- University of Alberta Division of Neurosurgery, Edmonton, Alberta, Canada
Sex:
ALLAges:
Over 18This phase 2 study will include patients suffering from type 2 diabetes mellitus and will first study their response to enteric coated aspirin at a dose of 80 mg per day for a 7-day period. Participants with an incomplete platelet inhibition after exposure to EC aspirin at doses of 80 mg once daily will be randomized to a random order of 3 different ASA regimens: EC ASA 162 mg once daily, EC ASA 81 mg twice daily and chewable ASA 40 mg twice daily. The aims are to determine the feasibility of a larger scale trial, and to determine the regimen associated with the lowest proportion of non-responders after randomization. Platelet function will be assessed at baseline and at day 7 of each arms of the study.
Conditions:
Diabetes Mellitus, Type 2 | Type 2 Diabetes | Aspirin | Platelet Aggregation | Platelet Aggregation InhibitorsLocation:
- Montreal Heart Institute, Montréal, Quebec, Canada
Sex:
ALLAges:
Over 18Children with disabilities often access rehabilitation services to improve their abilities to participate in everyday activities. Goal-directed therapy is considered an important therapeutic strategy to achieve outcomes that are meaningful to families. Not a lot is known about the effects of goal setting on rehabilitation outcomes. Strategies to help children participate in the goal-setting process are rarely used in clinical practice. The aim of this project is to test the effects of a child-focussed goal-setting approach, Enhancing Child Engagement in Goal Setting (ENGAGE), on therapy outcomes. The investigators are also interested in service use and the cost vs. benefits of the ENGAGE approach compared to usual practice. Children with neurodevelopmental disabilities aged 5-12 years old (n=96) who access paediatric rehabilitation services at six rehabilitation sites will participate. Therapists (n=24) at participating sites will be randomized into 1) the ENGAGE intervention group or 2) the usual therapy practice control group. Children will participate in the ENGAGE approach to goal setting or usual practice based on the allocation of their therapist. The investigators will determine if the ENGAGE approach to goal setting affects child goal performance, satisfaction with goal performance, functional abilities, participation, and parent and child quality of life. The investigators will also evaluate differences in parent and child quality of life in relation to parent costs (e.g., absenteeism, presenteeism, travel costs) and compare amount of therapy time between the two groups to see which approach is more cost-effective and efficient. The investigators will also ask children, parents, therapists, and managers to discuss aspects that influenced effective implementation of the ENGAGE approach. This study could provide evidence to improve meaningful child and family outcomes in paediatric rehabilitation and improve the efficiency of paediatric rehabilitation services.
Conditions:
Neurodevelopmental DisordersLocation:
- University of Alberta, Edmonton, Alberta, Canada