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The investigators intend to screen for new donors, given that there may a donor effect (PubMed ID: 25857665), with some donors not inducing remission in any patient whilst others inducing remission in 20-40% of cases. It is important to give UC patients participating in RCTs stool that has been demonstrated to be effective in some patients. We therefore propose to conduct an open label study in patients with active UC to ensure new donors are effective at inducing remission in some patients. Patients that have FMT will relapse within 18 months (PubMed ID: 25857665) although further FMT therapy induces remission so it is possible that maintenance FMT will result in long term remission, but this needs evaluation. We will therefore follow UC patients that have responded to FMT long term in this open label study.
Conditions:
Ulcerative Colitis FlareLocation:
- Hamilton Health Sciences / McMaster University, Hamilton, Ontario, Canada
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ALLAges:
Over 18In Canada, 35,000 people are experiencing homelessness on any night. Compared to the general population, people experiencing homelessness (PEH) sleep less and experience increased daytime fatigue. A common sleep disorder and treatable cause of morbidity and low quality of life is sleep apnea. High prevalence of chronic comorbid disorders of sleep apnea in PEH suggest high prevalence of sleep apnea, but the rate of sleep apnea treatment in PEH is very low. Also, in PEH, individual and systemic barriers lead to a high rate of underdiagnosed and untreated sleep apnea. Mortality is higher in PEH than the general population, and sleep apnea remains a potential silent cause of morbidity and low quality of life in PEH. Our goal is to diagnose and treat sleep apnea in people living in shelters and to examine the effect of patient-centered treatment on their quality of life.
Conditions:
Sleep Apnea | Sleep Disorder | Sleep Deprivation | Sleep DisturbanceLocation:
- Fred Victor, Toronto, Ontario, Canada
- Dixon Hall, Toronto, Ontario, Canada
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Over 18Genitourinary Syndrome of Menopause (GSM) due to low estrogen levels affects about half of post-menopausal women and may have a dramatic impact on women's quality of life. Women complain of vaginal dryness, itching, discomfort, malodour, painful intercourse and may have urinary urgency, irritation, bladder/urethral pain and recurring bladder infections. First-line therapies include vaginal moisturizers, lubricants and estrogen (either oral or with vaginal cream/tablets). While these therapies are effective, the ongoing costs and the resistance to the indefinite use of vaginal creams/inserts is a challenge to the continued use of these therapies. Recently, an innovative laser therapy has been used to treat women with GSM. A randomized controlled trial (RCT) to study how effective the laser is to treat women with GSM is planned.
Conditions:
Vulvar Atrophy | Menopausal Urethral AtrophyLocation:
- Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada
Sex:
FEMALEAges:
45 - 70This is a prospective, longitudinal observational study conducted at The Hospital for Sick Children (SickKids). The purpose of this study is to evaluate the ability of MRI to detect changes in lung structure and function in CF patients receiving CFTR-modulator therapy. Participants who meet eligibility criteria and consent to the study will undergo study procedures which include spirometry and body plethysmography (optional), multiple breath washout testing, MRI and measurement of quality of life. The study will consist of three to six study visits for Group 1, 2 and 3: baseline, one month (±1 week) and 6 month (±2 week) and if they re-consent then 3 additional visits of 1 year (±6 months). (2 years (±6 months) and 3 years (±6 months) follow-up. Some participants in Group 2 may transition to Group 3. This study includes three populations of interest: Group 1: 25 healthy volunteers, Group 2: 25 patients with stable CF lung disease , Group 3: 20 patients with CF lung disease anticipated to receive treatment with CFTR-modulator therapy and Group 4: 18 patients with CF who are between 4-8 years old and are starting triple combination modulator therapy using the rapid lung and abdominal imaging methods.
Conditions:
Group 4: 4-8 yo CF Participants Starting Triple Combination Modulator...Location:
- The Hospital for Sick Children, Toronto, Ontario, Canada
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4 - 18Fluid-unresponsive hypotension needing cardiotropic drug treatment is a serious complication in very preterm neonates with suspected late-onset sepsis (LOS; defined as culture positive or negative bloodstream infection or necrotizing enterocolitis occurring \>48 hours of age). In Canada, \~250 very preterm neonates receive cardiotropic drugs for LOS related fluid-unresponsive hypotension every year; of these \~35-40% die. Unlike for adult patients, there is little evidence to inform practice. While several medications are used by clinicians, the most frequently used medications are Dopamine (DA) and Norepinephrine (NE). However, their relative impact on patient outcomes and safety is not known resulting in significant uncertainty and inter- and intra-unit variability in practice. Conducting large randomized trials in this subpopulation can be operationally challenging and expensive. Comparative effectiveness research (CER), is a feasible alternative which can generate high-quality real-world evidence using real-world data, by comparing the impact of different clinical practices. Aim: To conduct an international CER study, using a pragmatic clinical trial design, in conjunction with the existing infrastructure of the Canadian Neonatal Network to identify the optimal management of hypotension in very preterm neonates with suspected LOS. Objective: To compare the relative effectiveness and safety of pharmacologically equivalent dosages of DA versus NE for primary pharmacotherapy for fluid-unresponsive hypotension in preterm infants born ≤ 32 weeks gestational age with suspected LOS. Hypothesis: Primary treatment with NE will be associated with a lower mortality Methods: This CER project will compare management approach at the unit-level allowing inclusion of all eligible patients admitted during the study period. 15 centers in Canada, 4 centers in Ireland, 2 centers in Israel and 6 centers in the United States have agreed to standardize their practice. All eligible patients deemed circulatory insufficient will receive fluid therapy (minimum 10-20 cc/kg). If hypotension remains unresolved: Dopamine Units: start at 5mics/kg/min, increase every 16-30 minutes by 5 mics/kg/min to a maximum dose of 15 mics/kg/min or adequate response Norepinephrine Units: start at 0.05 mics/kg/min, increase every 16-30 minutes by 0.05 mics/kg/min to maximum dose of 0.15/mics/kg/min or adequate response
Conditions:
Late-Onset Neonatal Sepsis | Extreme Prematurity | Neonatal HypotensionLocation:
- St.Boniface Hospital, Winnipeg, Manitoba, Canada
- London Health Sciences Centre, London, Ontario, Canada
- Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
- Montreal Children's Hospital, Montréal, Quebec, Canada
- BC Women's Hospital, Vancouver, British Columbia, Canada
- McMaster Children's Hospital, Hamilton, Ontario, Canada
- Mount Sinai Hospital, Toronto, Ontario, Canada
- Jewish General Hospital, Montréal, Quebec, Canada
- Winnipeg Health Sciences Centre, Winnipeg, Manitoba, Canada
- Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
- Windsor Regional Hospital, Windsor, Ontario, Canada
- Foothill's Medical Centre, Calgary, Alberta, Canada
- IWK Health Centre, Halifax, Nova Scotia, Canada
- Hospital for Sick Children, Toronto, Ontario, Canada
- CHU Sainte- Justine, Montréal, Quebec, Canada
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21 - 32The goal of this clinical trial is to test the effect of granulocyte colony-stimulating factor (G-CSF, A.K.A. Filgrastim) in infertility patients undergoing in vitro fertilization (IVF) treatment. The main question it aims to answer is: Can in vitro fertilization-embryo transfer (IVF-ET) outcomes be improved by supplementing the transfer media with Granulocyte colony-stimulating factor (GCSF)? Participants will undergo their embryo transfer as per the normal clinic protocol but will be randomized to either receive the standard embryo transfer media or the GCSG-supplemented transfer media. Researchers will compare the GCSF and standard transfer media groups to see if clinical outcomes are improved (i.e., implantation rate, pregnancy, clinical pregnancy rate, live birth rate).
Conditions:
Infertility | Infertility Unexplained | Infertility of Uterine Origin |...Location:
- Newlife Fertility Centre, Mississauga, Ontario, Canada
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FEMALEAges:
18 - 38Epirubicin is a common chemotherapy medication used in the treatment of breast cancer. However, chemotherapy dosing is calculated based on people's height and weight, which may not be the most accurate way. The purpose of this study is to see if epirubicin dosing based on people's genetic profiles is better than the usual methods.
Conditions:
Breast NeoplasmsLocation:
- Cross Cancer Institute, Edmonton, Alberta, Canada
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FEMALEAges:
Over 18Falls are a major health concern amongst older adults with cancer, and are often related to decreased physical strength due to effects of cancer and its treatments. Ample evidence demonstrates the benefits of exercise programs incorporating strength and balance training on lower body strength, balance, and fall prevention older adults. However, gaps in research exist within the geriatric oncology context. The purpose of this study is to determine the feasibility and efficacy of a 3-month, remotely delivered exercise program regimen on lower body strength, balance, and falls in older adults with cancer. This observer-blinded, randomized controlled feasibility trial aims to recruit older cancer patients (aged ≥65). Participants in the intervention group will undertake the exercise program 3 times weekly for three months. Data collection will include sociodemographic survey, baseline, end-of-intervention (3-month) assessment, follow-up (6-month) assessment, chart review, and exit survey. Descriptive and inferential statistics will be used to analyze data, following the intention-to-treatment principle. Data generated from this research project will inform design of a subsequent, larger exercise intervention trial. This is an important step to establish the knowledge base regarding provision of exercise interventions as a fall prevention strategy to reduce falls and their negative outcomes in older patients in the community.
Conditions:
NeoplasmsLocation:
- Cross Cancer Institute, Edmonton, Saskatchewan, Canada
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Over 65Patients undergoing transcatheter aortic valve replacement (TAVR) often have concomitant coronary artery disease (CAD) which may adversely affect prognosis. There is uncertainty about the benefits and the optimal timing of revascularization for such patients. There is currently clinical equipoise regarding the management of concomitant CAD in patients undergoing TAVR. Some centers perform routine revascularization with percutaneous coronary intervention (PCI) (either before or after TAVR), while others follow an alternative strategy of medical management. The potential benefits and optimal timing of PCI in these patients are unknown. As TAVR expands to lower risk patients, and potentially becomes the preferred therapy for the majority of patients with severe aortic stenosis, the optimal management of concomitant coronary artery disease will be of increasing importance. The COMPLETE TAVR study will determine whether, on a background of guideline-directed medical therapy, a strategy of complete revascularization involving staged PCI using drug eluting stents to treat all suitable coronary artery lesions is superior to a strategy of medical therapy alone in reducing the composite outcome of Cardiovascular Death, new Myocardial Infarction, Ischemia-driven Revascularization or Hospitalization for Unstable Angina or Heart Failure. The study will be a randomized, multicenter, open-label trial with blinded adjudication of outcomes. Patients will be screened and consented for elective transfemoral TAVR and randomized within 96 hours of successful balloon expandable TAVR. Complete Revascularization: Staged PCI using third generation drug eluting stents to treat all suitable coronary artery lesions in vessels that are at least 2.5 mm in diameter and that are amenable to treatment with PCI and have a ≥70% visual angiographic diameter stenosis. Staged PCI can occur any time from 1 to 45 days post successful transfemoral TAVR. Vs. Medical Therapy Alone: No further revascularization of coronary artery lesions. All patients, regardless of randomized treatment allocation, will receive guideline-directed medical therapy consisting of risk factor modification and use of evidence-based therapies. The COMPLETE TAVR study will help address the current lack of evidence in this area. It will likely impact both the global delivery of health care and the management and clinical outcomes of all patients undergoing TAVR with concomitant CAD.
Conditions:
Coronary Artery Disease | Coronary Stenosis | Aortic StenosisLocation:
- Royal Columbian Hospital, New Westminster, British Columbia, Canada
- Saint Boniface, Winnipeg, Manitoba, Canada
- Ottawa Heart, Ottawa, Ontario, Canada
- Centre Hospitalier de l'Université de Montréal, Montréal, Quebec, Canada
- University of Alberta, Mazankowski Heart Institute, Edmonton, Alberta, Canada
- St. Paul's Hospital, Vancouver, British Columbia, Canada
- Hamilton Health Sciences, Hamilton, Ontario, Canada
- Montréal Heart, Montréal, Quebec, Canada
- Prairie Vascular, Regina, Saskatchewan, Canada
- Vancouver General Hospital, Vancouver, British Columbia, Canada
- New Brunswick Heart, Saint John, New Brunswick, Canada
- Sunnybrook Hospital, Toronto, Ontario, Canada
- Sacré-Coeur, Montréal, Quebec, Canada
- Centre for Cardiovascular Innovation-Centre d'Innovation Cardiovasculaire (CCI-CIC), Vancouver, British Columbia, Canada
- Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada
- St. Michael's Hospital, Toronto, Ontario, Canada
- CIUSSS de l'Estrie-CHUS, Sherbrooke, Quebec, Canada
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AnyPrevious clinical trials in adults with acute respiratory distress syndrome (ARDS) have demonstrated that ventilator management choices can improve Intensive Care Unit (ICU) mortality and shorten time on mechanical ventilation. This study seeks to scale an established Clinical Decision Support (CDS) tool to facilitate dissemination and implementation of evidence-based research in mechanical ventilation of infants and children with pediatric ARDS (PARDS). This will be accomplished by using CDS tools developed and deployed in Children's Hospital Los Angeles (CHLA) which are based on the best available pediatric evidence, and are currently being used in an NHLBI funded single center randomized controlled trial (NCT03266016, PI: Khemani). Without CDS, there is significant variability in ventilator management of PARDS patients both between and within Pediatric ICUs (PICUs), but clinicians are willing to accept CDS recommendations. The CDS tool will be deployed in multiple PICUs, targeting enrollment of up to 180 children with PARDS. Study hypotheses: 1. The CDS tool in will be implementable in nearly all participating sites 2. There will be \> 80% compliance with CDS recommendations and 3. The investigators can implement automatic data capture and entry in many of the ICUs Once feasibility of this CDS tool is demonstrated, a multi-center validation study will be designed, which seeks to determine whether the CDS can result in a significant reduction in length of mechanical ventilation (LMV).
Conditions:
ARDS | Ventilator-Induced Lung Injury | Ventilation Therapy; ComplicationsLocation:
- CHU Sainte-Justine, Montréal, Quebec, Canada