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This study aims to evaluate the efficacy and safety of crovalimab in pediatric participants with aHUS.
Conditions:
Atypical Hemolytic Uremic SyndromeEmplacement:
- CHU Sainte-Justine, Montreal, Quebec, Canada
- British Columbia Children's Hospital, Vancouver, British Columbia, Canada
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28 - 17PANTHER-GI Pilot Study will assess the feasibility of a full-scale multicentre cohort management study evaluating the safety of a standardized strategy for resuming direct oral anticoagulants (DOACs) after major DOAC-related gastrointestinal (GI) bleeding among patients at moderate to high risk of re-bleeding and thrombosis. A parallel registry will assess whether eligible patients who are not enrolled in the PANTHER-GI Pilot Study are systematically different than enrolled patients and to explore barriers to enrolment.
Conditions:
Anticoagulant-induced Bleeding | Gastrointestinal BleedingEmplacement:
- Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- Alberta Health Services - Peter Lougheed Center Endoscopy Unit, Calgary, Alberta, Canada
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Over 18The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab together with ustekinumab in adults with moderate to severe Crohn's Disease, and the effect of treatment with vedolizumab alone, after the dual targeted treatment. The study is conducted in two parts. In Part A, participants will receive the dual targeted treatment (vedolizumab together with either adalimumab or ustekinumab). In part B, participants will receive vedolizumab only. Part B will include participants who responded to the treatment in Part A. Each participant will be followed up for at least 26 weeks after the last dose of treatment.
Conditions:
Crohn's DiseaseEmplacement:
- London Health Sciences Centre, London, Ontario, Canada
- ABP Research Services Corp., Oakville, Ontario, Canada
- Covenant Health, Edmonton, Alberta, Canada
- Toronto Immune and Digestive Health Institute Inc. (TIDHI), North York, Ontario, Canada
- McGill University Health Centre Montreal General Hospital, Montreal, Quebec, Canada
- West GTA Endoscopy Inc., Mississauga, Ontario, Canada
- Taunton Surgical Centre, Oshawa, Ontario, Canada
- Viable Clinical Research - North Bay, North Bay, Ontario, Canada
- Toronto Digestive Disease Associates (TDDA) Specialty Research, Vaughan, Ontario, Canada
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18 - 65Through a triple-blinded randomized control trial, the primary purpose of this pilot study is to assess the efficacy of administering peri-operative contralateral corticosteroid injection in patients undergoing TKA. The secondary outcome was to assess the effect of contralateral corticosteroid injection on pain and functional outcomes of patients undergoing TKA.
Conditions:
Total Knee Anthroplasty | Bilateral Knee Osteoarthritis | Osteoarthritis (OA) of the Knee | Osteoarthritis(primary)Emplacement:
- St. Michael's Hospital, Toronto, Ontario, Canada
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Over 18This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation. Data collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewed publications, education materials, regulatory submissions, and/or product development.
Conditions:
Avascular Necrosis | Post-traumatic Arthrosis of Other Joints, Shoulder Region | Rotator Cuff Tear...Emplacement:
- Roth McFarlane Hand and Upper Limb Centre, London, Ontario, Canada
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Over 18Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine. The kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and/or proteinuria. These include "angiotensin-converting enzyme inhibitors" (ACEI) and "angiotensin receptor blockers" (ARB). Both ACEI and ARB can help improve kidney function by reducing the activity of the renin-angiotensin-aldosterone system (RAAS). The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can impair the ability of the kidneys to work properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system. The study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB. So, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function. The main purpose of this study is to learn how safe the treatment is when used of finerenone in addition to an ACEI or ARB in long-term. To see how safe the treatment is, the study team will collect information on medical problems which are also known as "treatment emergent adverse events" (TEAEs). And they will also collect levels of an electrolyte called potassium in the blood by taking blood samples, and measure blood pressure during the study. The secondary purpose of this study is to learn how well long-term use of finerenone can reduce the amount of protein in the participants' urine and benefit kidney function when taken with standard of care. To see how the treatment works, the study team will collect participants' urine samples to assess urinary albumin-to-creatinine ratio (UACR) and urinary protein-to-creatinine ratio (UPCR), which are important assessments for calculating the level of protein in the urine. Researchers will also collect blood samples to analyze serum creatinine and calculate estimated glomerular filtration rate (eGFR). A significant decline in eGFR indicates worsening kidney function. The study will include participants who had previously participated in FIONA study (NCT05196035). The participants will be aged from 1 year up to 18 years. The participants will be in the study for approximately 19 months. They will take study treatment for up to 18 months and will be follow up for 1 month. During this period, at least 12 visits are planned for patients who newly start finerenone, and at least 8 visits for patients who already received finerenone. In the visit, the study team will: * have their blood pressure, heart rate, temperature, height and weight measured * have blood and urine samples taken * have physical examinations * have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart) * answer questions about their medication and whether they have any adverse events, or have their parents or guardian's answer * answer questions about how they are feeling, or have their parents or guardian's answer * answer question about how they like the study medication, or have their parents or guardian's answer The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The doctors will check the participants' health about 30 days after the participants take their last treatment.
Conditions:
Chronic Kidney Disease | Children | ProteinuriaEmplacement:
- CHU Sainte-Justine, Montreal, Quebec, Canada
- The Hospital for Sick Children (SickKids), Toronto, Ontario, Canada
- Alberta Children's Hospital, University of Calgary, Calgary, Alberta, Canada
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1 - 18Osteoarthritis of the knee is a common problem that is increasing in prevalence as the population ages. In a knee with osteoarthritis, there is variable damage to the articular cartilage and underlying bone that can cause varying degrees of pain. When pain is bothersome, osteoarthritis is treated to improve functional abilities. One of the most recognized and used treatments is intra-articular cortisone injection. Cortisone is a powerful anti-inflammatory drug that is used to reduce pain. Unfortunately, cortisone can have significant side effects, even when injected locally. The frequency and intensity of these side effects depend largely on the total dose injected. The main side effects include increased blood sugar levels, increased blood pressure and a temporary decrease in the secretion of the stress hormone, cortisol. In the long term, a decrease in articular cartilage thickness in the injected join and overall bone density reduction is also reported. Despite many years of routine use, the smallest effective dose of cortisone injected into the knee joint is unknown. The main objective of the study is to determine the impact on pain and function of different doses of cortisone injected into the knee. The cortisone chosen for this study is triamcinolone acetonide (TA).
Conditions:
Primary GonarthrosisEmplacement:
- Centre Hospitalier Universitaire de Montréal - Hôtel-Dieu, Montréal, Quebec, Canada
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Over 50Comparing Centre-based, Remotely Supervised, and Self-administered STS Tests in Individuals With CRD
Despite evidence on the psychometric properties of sit-to-stand (STS) tests in chronic respiratory disease (CRD) populations, most studies have been conducted face-to-face. Given the recent emphasis on virtual pulmonary rehabilitation (VPR), there is a need to identify reliable and valid exercise tests that can be delivered in home-based settings, either supervised remotely or self-administered by patients. A repeated-measures crossover design will be used to test the home-based administration of STS tests. The 30-second STS (30-s STS) and 1-minute STS (1-min STS) tests will be randomly administered across three test conditions (centre-based, remotely supervised, and self-administered). Data will summarize the feasibility of remotely supervised and self-administered STS tests and compare the performances of centre-based tests with remotely supervised and self-administered versions of STS tests in patients with CRD.
Conditions:
Chronic Lung DiseaseEmplacement:
- West Park Healthcare Centre, Toronto, Ontario, Canada
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Over 18This is a parallel-group, Phase 2, randomized, double-blind, placebo-controlled, 2-arm study for the treatment of asthma. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig compared with placebo in male and female participants (aged 18 to 80 years, inclusive) with asthma, who are not currently eligible for biologic treatments. Study details include: * The study duration will be approximately 64 weeks for participants not transitioning into the LTS study and approximately 60 weeks for participants transitioning into the LTS study. * The investigational treatment duration will be up to approximately 52 weeks. * The number of visits will be 18.
Conditions:
AsthmaEmplacement:
- Investigational Site Number : 1240012, North Vancouver, British Columbia, Canada
- Investigational Site Number : 1240011, Kelowna, British Columbia, Canada
- Investigational Site Number : 1240003, Guelph, Ontario, Canada
- Investigational Site Number : 1240002, Sherbrooke, Quebec, Canada
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18 - 80This study will test how well a new medicine called concizumab works for participants who have haemophilia A or B with or without inhibitors. The purpose is to show that concizumab can prevent bleeds and is safe to use. Participants will have to inject the study medicine every day under the skin with a pen-injector. The study will last for at least 2 years and up to about 4 years. The length of time the participant will be in the study depends on if the study medicine will be available for purchase in their country.
Conditions:
Haemophilia A and B With and Without InhibitorsEmplacement:
- McMaster Children's Hospital, Hamilton, Ontario, Canada
- BC Children's Hospital, Vancouver, British Columbia, Canada