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Growing evidence has supported rapid and robust antidepressant effects with subanesthetic doses of intravenous (IV) ketamine for treatment resistant depression (TRD). However, no completed or ongoing randomized control trials (RCTs) have evaluated the effects of repeated doses of IV ketamine for a homogenous sample of patients with treatment-resistant bipolar disorder (TRBD). The primary research goal is to determine the acute antidepressant efficacy, safety and tolerability of four repeated sub-anesthetic doses of IV ketamine in moderate to severe TRBD. Secondary aims include evaluating effects of IV ketamine on suicidal ideations, quality of life, function and duration of effects. Herein, a two-site (University Health Network and Ontario Shores Centre for Mental Health Sciences), phase II, double-blinded, midazolam-controlled, two-week RCT evaluating the efficacy, safety and tolerability of four flexibly-dosed adjunctive ketamine infusions (0.5-0.75mg/kg infused over 40 minutes) for acute treatment of moderate to severe TRBD (type I \& II) is proposed. The primary outcome will be Montgomery-Åsberg Depression Rating Scale (MADRS) scores, determining the between group difference in change from baseline to day 14, using analysis of covariance (ANCOVA), with 14-day MADRS as the outcome and baseline MADRS and stratification variables (sex, bipolar type) as covariates. Secondary outcomes include evaluating response and remission rates, safety, tolerability (including treatment-emergent mania), and effects on suicidality, anxiety, quality of life, function and the duration of effects (to day 28).
Conditions:
Bipolar Disorder | Bipolar I Disorder | Bipolar Depression | Bipolar II DisorderEmplacement:
- Toronto General Hospital, Toronto, Ontario, Canada
- Toronto Western Hospital, Toronto, Ontario, Canada
- Ontario Shores Centre for Mental Health Sciences, Whitby, Ontario, Canada
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21 - 65The causes of neurodegenerative dementias such as Frontotemporal Dementia, Lewy Body Disease and Alzheimer's disease are still largely unknown. While the contribution of some genetic mutations and polymorphisms is associated with autosomal dominant patterns of inheritance of these dementias, in many cases, the specific causative mutation in these families is not yet identified. Further, in many patients, polygenic risk is thought to give rise to pathophysiologic changes, but which specific genes affect risk are largely yet unknown. By examining genotypes in patients that present to our Cognitive Neurology and Alzheimer's Research Clinic with suspected or confirmed neurodegenerative dementia, or have a history of a familial dementia, we aim to help identify and characterize genetic mutations or polymorphisms that give rise to neurodegenerative diseases.
Conditions:
Alzheimer Dementia (AD) | Dementia, Frontotemporal | Lewy Body Dementia (LBD)Emplacement:
- Parkwood Institute, London, Ontario, Canada
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Over 18Loss of skeletal muscle mass (atrophy) and strength in the lower limb are consequences of elective knee surgery as result of prolonged disuse from limb immobilization and impaired mobility, as well as pathophysiological trauma. The highest rates of skeletal muscle mass and strength loss occur during the 2-week post-surgery period, considered the early phase of outpatient recovery. Alternative to resistance exercise and pharmacology, nutritional intervention represents one strategy to combat skeletal muscle disuse atrophy. Essential amino acids (EAA) and omega-3 fatty acids are known to independently potentiate rates of skeletal muscle protein synthesis and attenuate skeletal muscle atrophy in humans. However, the combined actions these nutritional strategies on skeletal muscle have not been explored in a pathophysiological context, such as surgery. With the ultimate goal to test the efficacy of the combined nutritional strategy to attenuate skeletal muscle disuse atrophy in the future, the aim of this present pilot study is to explore the feasibility of recruitment and retention of anterior cruciate ligament reconstruction (ACLR) outpatients from a single centre across 18 months for a 6-week nutritional intervention. Participants will consume either an intervention of omega-3 fatty acids and EAAs, or a placebo control of safflower oil and non-essential amino acids (NEAA), for 4 weeks before and 2 weeks after elective ACLR surgery. Furthermore, this pilot will characterize secondary outcomes of skeletal muscle mass, strength, and power, and integrated rates of muscle protein synthesis, as well as report participant adherence to protocols and incidence of adverse events.
Conditions:
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION | Muscular AtrophyEmplacement:
- Queen's University, Kingston, Ontario, Canada
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Over 18The goal of this prospective, randomized trial is to explore the link between cardiovascular disease and mortality in individuals with severe and persistent mental illness (SPMI). The main question it aims to answer is: Is a primary prevention cardiac rehabilitation intervention feasible and effective at reducing cardiovascular risk in people with a primary psychotic disorder or bipolar disorder?" Participants will undergo a multi-component primary prevention intervention program. Researchers will compare with a control group to see if cardiovascular risk reduction is attained.
Conditions:
Cardiovascular Prevention | Mental Illness PersistentEmplacement:
- Jewish General Hospital/Lady Davis Institute, Montréal, Quebec, Canada
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30 - 59Mechanical ventilation can lead to diaphragm and lung injury. During mechanical ventilation, the diaphragm could be completely rested or it could be overworked, either of which may cause diaphragm injury. Mechanical stress and strain applied by mechanical ventilation or by the patient's own respiratory muscles can also cause injury to the lungs. Diaphragm and lung injury are associated with increased morbidity and mortality. Throughflow is a novel system that can reduce dead space without the need to increase the tidal ventilation, reducing the ventilatory demands and respiratory drive.
Conditions:
Respiratory Insufficiency | Lung Injury | Diaphragm InjuryEmplacement:
- University Health Network, Toronto, Ontario, Canada
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Over 18The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).
Conditions:
Non-small Cell Lung CancerEmplacement:
- Research Site, Hamilton, Ontario, Canada
- Research Site, Sydney, Nova Scotia, Canada
- Research Site, Montreal, Quebec, Canada
- Research Site, Saint John, New Brunswick, Canada
- Research Site, Montréal, Quebec, Canada
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Over 18The iCOSMO study investigates the feasibility and beneficial effects of an intervention combining sensation, motor and cognition to improve arm and hand function after chronic stroke.
Conditions:
Stroke | Cerebrovascular Accident | CVAEmplacement:
- Toronto Rehabilitation Institute, Toronto, Ontario, Canada
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Over 18Traditional postoperative care has been challenged recently to improve and speedup recovery (including the return of bowel function) such that patients can be discharged to home more quickly. This approach includes earlier mobilization of the patient, and introducing solid food sooner. Additionally, there is evidence in adults to suggest that "sham feeding" by chewing gum may also speed up bowel recovery so the patient may tolerate a solid diet earlier. The aim of this study is to determine if gum chewing can enhance bowel recovery in children who undergo abdominal surgery.
Conditions:
Flatus | Bowel IleusEmplacement:
- Children's Hospital of Winnipeg/Manitoba, Winnipeg, Manitoba, Canada
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4 - 17Stereotactic radiosurgery (SRS) is a commonly used treatment for brain tumors. It is a one-day (or in some cases two day), out-patient procedure during which a high dose of radiation is delivered to small spots in the brain while excluding the surrounding normal brain. Whole brain radiation therapy with hippocampal avoidance (HA-WBRT) is when radiation therapy is given to the whole brain, while trying to decrease the amount of radiation that is delivered to the area of the hippocampus. The hippocampus is a brain structure that is important for memory. Memantine is a drug that is given to help relieve symptoms that can be caused by WBRT, including problems with memory and other mental symptoms. Health Canada, the regulatory body that oversees the use of drugs in Canada, has not approved the sale or use of memantine in combination with WBRT to treat this kind of cancer, although they have allowed its use in this study.
Conditions:
Brain MetastasesEmplacement:
- Tom Baker Cancer Centre, Calgary, Alberta, Canada
- Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
- CHUM - Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
- Centre Hospitalier Universitaire de Sherbrooke-Fleurimont, Sherbrooke, Quebec, Canada
- QEII Health Sciences Centre/Nova Scotia Health Authority, Halifax, Nova Scotia, Canada
- CSSS Champlain-Charles Le Moyne, Greenfield Park, Quebec, Canada
- CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ), Quebec City, Quebec, Canada
- Cross Cancer Institute, Edmonton, Alberta, Canada
- London Regional Cancer Program, London, Ontario, Canada
- The Research Institute of the McGill University Health Centre (MUHC), Montreal, Quebec, Canada
- BCCA-Vancouver Cancer Centre, Vancouver, British Columbia, Canada
- University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
- Jewish General Hospital, Montreal, Quebec, Canada
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Over 18This treatment trial evaluates the addition of an anti-tumor necrosis factor-alpha drug, certolizumab, to usual treatment (a heparin agent and low-dose aspirin) in pregnant women with antiphospholipid syndrome (APS) and repeatedly positive tests for lupus anticoagulant (LAC) to determine if this regimen will improve pregnancy outcomes. All enrolled patients will receive certolizumab, and pregnancy outcomes will be compared to those of women with APS and repeatedly positive tests for LAC enrolled in a previous study by the investigators.
Conditions:
Pregnancy Complications | High Risk Pregnancy | Antiphospholipid Syndrome in Pregnancy | Lupus Anticoagulant DisorderEmplacement:
- TRIO Advancing Reproductive Care, Toronto, Ontario, Canada