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This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).
Conditions:
Pulmonary HypertensionEmplacement:
- St. Boniface Hospital, Winnipeg, Manitoba, Canada
- London Health Sciences Center, London, Ontario, Canada
Sexe:
ALLÂges:
18 - 85The purpose of this study is to build upon trials done over 30 years ago, which did not include statins, new antiplatelet agents, and newer antihypertensive medications. Since the landmark trials (NASCET, ECST), there have been new developments in medical stroke prevention, which creates a gap in knowledge. The aim of this study is to evaluate that clinical care with Intensive Medical Therapy (IMT) alone, the one year stroke rate in patients with symptomatic carotid stenosis and low risk clinical features will be \<5%.
Conditions:
Ischemic Stroke | Transient Ischemic Attack | Carotid StenosisEmplacement:
- Calgary Health Sciences Center, Calgary, Alberta, Canada
- Western University/London Health Sciences Center, London, Ontario, Canada
- University of Manitoba, Winnipeg, MN, Canada
- University of Alberta, Edmonton, Alberta, Canada
- Northern Ontario School of Medicine, Sudbury, Ontario, Canada
- Vancouver General Hospital, Vancouver, British Columbia, Canada
Sexe:
ALLÂges:
Over 40Given the continued high human immunodeficiency virus (HIV) prevalence rates among gay, bisexual, and other men who have sex with men (MSM) in North American cities, there is a critical need for HIV prevention interventions for MSM in Canada. Social anxiety, or anxiety about being evaluated in interpersonal and performance situations, is a reliable risk factor for condomless anal sex (CAS) among MSM. Social anxiety may also increase substance use in sexual situations, which is another risk factor for HIV among MSM. As such, an empirically-based social anxiety treatment may also reduce HIV risk behaviours among MSM. The present study will provide the first efficacy data for a novel and innovative HIV prevention intervention for MSM. This intervention will build upon empirically supported interventions to reduce HIV risk among MSM and therapies to reduce social anxiety. The investigators propose to test the efficacy of a novel integrated HIV prevention intervention that combines the most empirically supported treatment for social anxiety disorder, cognitive-behavioural therapy, with HIV risk reduction counselling in order to simultaneously treat social anxiety disorder, substance use disorders, and HIV sexual risk behaviour. This study will be a randomized controlled trial comparing the study intervention relative to applied relaxation, a behavioural intervention that is efficacious in treating social anxiety disorder but that does not address substance use problems or HIV sexual risk behaviours. For this trial, 176 participants will be randomized to either 12 sessions of cognitive-behavioural therapy with HIV risk reduction counselling or 12 sessions of applied relaxation. Participants will be eligible for the trial if they are HIV-negative, report clinically significant symptoms of social anxiety disorder, substance use 2 hours before or during sexual activity, and CAS without the use of pre-exposure prophylaxis (PrEP) with a male partner who was not known to be HIV-negative. PrEP is a biomedical prevention approach in which HIV-negative individuals are provided with daily oral antiretroviral medication for the primary prevention of HIV.126 The present intervention, if found to be efficacious, is innovative in that mental health clinicians will be able to not only extend empirically supported therapies tested primarily with heterosexual populations to MSM, but they will also be able to prevent HIV through empirically supported psychotherapy practice.
Conditions:
HIV | Social Anxiety | Sexual RiskEmplacement:
- Toronto Metropolitan University, Toronto, Ontario, Canada
Sexe:
MALEÂges:
Over 18Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients
A double-blind, multi-centre, randomized, placebo-controlled, feasibility pilot trial in the prevention of new onset atrial fibrillation of critically ill patients admitted to an ICU.
Conditions:
Critical Illness | New Onset Atrial FibrillationEmplacement:
- Kingston Health Sciences Centre, Kingston, Ontario, Canada
Sexe:
ALLÂges:
Over 18There are currently no approved medications for the treatment of anxiety in children and youth with neurodevelopmental disorders (NDDs), both common and rare. Sertraline, a selective serotonin reuptake inhibitor, has extensive evidence to support its use in children's and youth with anxiety but not within NDDs. More research is needed to confirm whether or not sertraline could help improve anxiety in children and youth with common and rare neurodevelopmental conditions. This is a pilot study, in which we plan to estimate the effect size of reduction in anxiety of sertraline vs. placebo. across rare and common neurodevelopmental disorders, and determine the best measure(s) to be used as a primary transdiagnostic outcome measure of anxiety, as well as diagnosis specific measures in future, larger-scale clinical trials of anxiety in NDDs.
Conditions:
Anxiety | Autism Spectrum Disorder | Anxiety Disorders | ADHD | Autism | Tourette Syndrome | Tic...Emplacement:
- University of Alberta-Glenrose, Edmonton, Alberta, Canada
- University of Western Ontario, Lawson Health Research Institute, London, Ontario, Canada
- Alberta Children's Hospital - University of Calgary, Calgary, Alberta, Canada
- Queen's University, Kingston, Ontario, Canada
- Dalhousie University - IWK Health Centre, Halifax, Nova Scotia, Canada
- Holland Bloorview Kids Rehabilitation Hospital, Toronto, Ontario, Canada
- McMaster University, Hamilton, Ontario, Canada
- Ste Justine Hospital - Universite de Montreal, Montréal, Quebec, Canada
Sexe:
ALLÂges:
8 - 17The purpose of this post-market study is to describe the long-term safety and performance of Clareon Toric Intraocular Lenses (IOLs).
Conditions:
Corneal Astigmatism | AphakiaEmplacement:
- Uptown Eye Specialists, Concord, Ontario, Canada
- McGill University, Montréal, Quebec, Canada
- Gimbel Eye Centre, Calgary, Alberta, Canada
- Bellevue, Montréal, Quebec, Canada
- Prism Eye Institute, Oakville, Ontario, Canada
- Laurentians Eye Institute, Boisbriand, Quebec, Canada
Sexe:
ALLÂges:
Over 18This is an observational, proof-of-concept, feasibility study where 50 preterm infants with gestational age \< 32+0 weeks will be recruited from the neonatal intensive care unit (NICU) at the Montreal Children's Hospital. The study's primary objective is to describe the relationship between respiratory acoustics and airflow and determine the reliability of a novel respiratory acoustic sensor at detecting breathing sounds in preterm infants. The study's secondary objectives are: 1. To compare transthoracic impedance, respiratory inductive plethysmography and an inertial measurement unit for the detection of respiratory efforts in preterm infants. 2. To evaluate the feasibility and accuracy of a novel, non-invasive method for continuously detecting and differentiating cardiorespiratory events in preterm infants on CPAP by integrating measurements of respiratory effort with respiratory acoustic monitoring.
Conditions:
Apnea of PrematurityEmplacement:
- McGill University Health Center, Montreal, Quebec, Canada
Sexe:
ALLÂges:
Over 72Soft tissue sarcomas (STSs) are malignant tumours that arise in any of the mesodermal tissues in the body including muscles, fibrous tissues, bone and cartilage, adipose tissue, and blood vessels, most frequently in the extremities (40%), trunk and retroperitoneum (40%). Traditionally, the prescription schedule for conventional preoperative RT is a regimen of 50 Gy in fractions of 1.8-2 Gy per day. Concerns regarding this regimen include the delay to definitive surgery and the higher rate of wound complications compared to post-operative radiotherapy. Hypofractionated RT is a prescription schedule in which the total dose of radiation is delivered in larger doses per fraction in fewer fractions allowing the delivery of a higher biologically effective dose (BED) to the tumour than with conventional RT \[7\] during a shorter period of time.
Conditions:
Soft Tissue Sarcoma AdultEmplacement:
- McGill University Health Centre-Cedars Cancer Centre, Montréal, Quebec, Canada
Sexe:
ALLÂges:
Over 18The goal of this randomized clinical trial is to evaluate the effectiveness of SmartMom, a text messaging-based mobile health program for prenatal education. The main questions are to determine if healthy pregnant people receiving SmartMom messages that promote health behaviours in pregnancy versus messages that don't provoke behaviour change have improvement in: 1. knowledge about healthy pregnancy and birth 2. standardized measures of depression, anxiety, and fear of childbirth 3. adoption of positive health behaviours in pregnancy 4. maternal, fetal, and newborn outcomes Participants in the intervention group will receive three evidence-based text messages per week, plus optional supplemental messages on topics relevant to them, throughout pregnancy. The control group will receive general interest messages on pregnancy-related topics that are not promoting behaviour change.
Conditions:
PregnancyEmplacement:
- BC Children's Hospital Research Institute, Vancouver, British Columbia, Canada
Sexe:
FEMALEÂges:
Over 15This is an open-label, multi-center, phase 1b study designed to determine a tolerable dose of CX-5461 administered by IV infusion on Day 1 and Day 8 of a 28-day cycle in patients with selected solid tumours and associated mutations for future Phase II trials. The safety and tolerability of CX-5461, preliminary evidence of antitumor effect and the effect of CX-5461 on the Health-Related Quality of Life (HRQoL) will also be evaluated. The study will also evaluate the predictive value of mutational signatures and explore the significance of dynamic changes in ctDNA levels and plasma DNA methylome profiling in this study's exploratory cohort.
Conditions:
Advanced Solid TumorEmplacement:
- Centre hospitalier de l'Université de Montréal (CHUM), Montréal, Quebec, Canada
- Princess Margaret Cancer Centre, Toronto, Ontario, Canada