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To date, patients with Crohn's Disease (CD) and permanent ileostomies have been excluded from clinical trials for new treatments. To allow this patient population to be included in clinical trials, outcome and measurement tools are needed. This study aims to develop a Patient Reported Outcome (PRO) and Endoscopic Index (EI) for patients with Crohn's Disease (CD) and permanent ileostomy. The study will enroll about 50 participants and collect videos of endoscopies that are done as part of standard of care. The videos will be centrally read to identify features that represent a broad range of inflammation and will be used to develop the EI. Participants will also be asked to participate in interviews, to understand the symptoms and impacts that are most important to participants for the development of a PRO.
Conditions:
Crohns DiseaseEmplacement:
- LHSC - University Campus, London, Ontario, Canada
- McMaster University Medical Centre, Hamilton, Ontario, Canada
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Over 18The purpose of this study is to collect data on the performance of the Biodesign® Hernia Graft when used to reinforce soft tissues during ventral hernia repair.
Conditions:
Ventral HerniaEmplacement:
- Queen Elizabeth II Hospital, Halifax, Nova Scotia, Canada
- St. Paul's Hospital, Vancouver, British Columbia, Canada
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Over 18This study will evaluate the safety and efficacy of intravesical administration of EG-70 in the bladder and its effect on bladder tumors in patients with NMIBC. This study study consists of two phases; a Phase 1 dose-escalation to establish safety and recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the treatment is. The Study will include patients with NMIBC with Cis for whom BCG therapy is unresponsive and patients with NMIBC with Cis who are BCG-naïve or inadequately treated.
Conditions:
Superficial Bladder Cancer | Non-muscle Invasive Bladder Cancer With Carcinoma in SituEmplacement:
- McGill University Health Center - Glen site, Montréal, Quebec, Canada
- Nova Scotia Health Authority, Halifax, Nova Scotia, Canada
- McGill University Health Center - Glen site, Montreal, Quebec, Canada
- Prostate Cancer Centre, Calgary, Alberta, Canada
- Vancouver Prostate Centre, Vancouver, British Columbia, Canada
- CHUM Centre Hospitalier de l Universite de Montreal, Montreal, Quebec, Canada
- University Health Network, Princess Margaret Cancer Centre, Toronto, Ontario, Canada
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Over 18The goal of this mixed-methods, single-arm intervention study is to develop and evaluate a new internet-delivered psychotherapy option called Ger-iPST in older adults with symptoms of depression. The overall aim of this project is to improve access to psychotherapy for older adults by developing, adapting and implementing a new internet-based treatment option, Ger-iPST. Towards this aim, our objectives are to: 1. Examine the preliminary effectiveness of Ger-iPST for symptoms of depression. 2. Examine barriers and facilitators to the use of Ger-iPST. Participants will be asked to complete 8 weekly online therapy modules (Ger-iPST) through the Online Psycho Therapy Tool (OPTT); each module takes 45-60 minutes, and an extra 20-30 on weekly homework. Caregivers will be invited to assist participants if required. Homework exercises are submitted through the platform, and a clinician trained in PST l will provide personalized, asynchronous online feedback. Participants will receive a weekly phone call from a research assistant to support any technical issues with completing the online modules. Following completion of the Ger-iPST modules, participants will be interviewed to provide feedback on acceptability and barriers and facilitators to the use of Ger-iPST.
Conditions:
Depression in Old Age | Depression, AnxietyEmplacement:
- Department of Psychiatry, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
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Over 65The investigators propose a real-world study to assess the mechanism of action of long-lasting response to mepolizumab in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) and identify clinically useful predictors of response. Mepolizumab is a monoclonal antibody targeting IL-5 and is approved for use in asthma and CRSwNP. In clinical studies, 12 months of treatment with mepolizumab improved signs and symptoms of CRSwNP and reduced the need for surgery. While several biologic medications targeting facets of the Type 2 mechanism are currently indicated for chronic rhinosinusitis with nasal polyps mepolizumab alone appears capable of modifying the disease's biological behaviour and producing long-standing improvements after the cessation of treatment. In the mepolizumab for CRSwNP regulatory trial (SYNAPSE), a subset of patients experienced dramatic and long-lasting, which is over 48 months after cessation of administration of the investigational medicinal product (IMP) in our experience. This has been partially captured in a follow-on study to the registration trail, which showed that a subset of patients followed for 24 weeks after cessation of biologic therapy (with continued use of mometasone furoate) demonstrated persistent improvements over baseline. However, the mechanism of the long-lasting effect in a subset of patients is not well understood, and it is impossible currently to identify patients who will derive this maximal benefit. The mechanism for the prolonged improvements in CRSwNP seen in certain patients with mepolizumab remains to be established but suggests that effects beyond eosinophil trafficking are implicated. The investigators believe that mepolizumab has IL-5-mediated pleiotropic effects which contribute to disease modification with effects extending beyond eosinophil activation and trafficking. This may include the following primary or secondary effects: i) Improving epithelial barrier function ii) Altering mast cell dynamics iii) Reversing epigenetic modifications iv) Altering the immune response to better clear pathogenic bacteria or viruses.
Conditions:
Chronic Rhinosinusitis With Nasal PolypsEmplacement:
- Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Quebec, Canada
- Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada
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Over 18The proposed study aims to improve the psychosocial health of adolescents living with type 1 diabetes (T1D). The study will generate knowledge and support knowledge mobilization about the effectiveness of a novel model of care for psychosocial health and self-management for adolescents living with type 1 diabetes (T1D). The novel model of care is the recruitment and training if young adult mentors to deliver a behavioural intervention that empowers adolescents with T1D to increase daily physical activity. The study will also advance the development and implementation of this peer mentoring model to improve the psychosocial health of adolescents with T1D.
Conditions:
Type 1 Diabetes | Physical ActivityEmplacement:
- Trillium Health Partners, Mississauga, Ontario, Canada
- the Children's Hospital Research Institute of Manitoba and the University of Manitoba, Winnipeg, Manitoba, Canada
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13 - 17The purpose of this study is: * To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose, * To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine, * To give the opportunity to participants who received only placebo in the RSVOA=ADJ- 006 study, to receive a dose of the RSVPreF3 OA vaccine and collect additional safety information.
Conditions:
Respiratory Syncytial Virus InfectionsEmplacement:
- GSK Investigational Site, Vancouver, British Columbia, Canada
- GSK Investigational Site, Truro, Nova Scotia, Canada
- GSK Investigational Site, Sarnia, Ontario, Canada
- GSK Investigational Site, Pointe-Claire, Quebec, Canada
- GSK Investigational Site, Sherbrooke, Quebec, Canada
- GSK Investigational Site, New Westminster, British Columbia, Canada
- GSK Investigational Site, Victoria, British Columbia, Canada
- GSK Investigational Site, London-Ontario, Ontario, Canada
- GSK Investigational Site, Chicoutimi, Quebec, Canada
- GSK Investigational Site, Saint-Charles-Borromée, Quebec, Canada
- GSK Investigational Site, Surrey, British Columbia, Canada
- GSK Investigational Site, Halifax, Nova Scotia, Canada
- GSK Investigational Site, Ottawa, Ontario, Canada
- GSK Investigational Site, Mirabel, Quebec, Canada
- GSK Investigational Site, Sainte-Foy, Quebec, Canada
- GSK Investigational Site, Edmonton, Alberta, Canada
- GSK Investigational Site, Victoria, British Columbia, Canada
- GSK Investigational Site, Greater Sudbury, Ontario, Canada
- GSK Investigational Site, Toronto, Ontario, Canada
- GSK Investigational Site, Québec, Quebec, Canada
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Over 60An Open-Label Exploratory Study of Fosigotifator in Participants With Vanishing White Matter Disease
Fosigotifator is an investigational drug being researched for the treatment of Vanishing White Matter disease in adult, pediatric and infant participants. This is a 201-week, open-label, multiple cohort study enrolling adults, pediatric and infant participants with Vanishing White Matter disease. Participants will attend regular visits during the course of the study and complete medical assessments, blood tests, questionnaires, and be evaluated for side effects.
Conditions:
Vanishing White Matter DiseaseEmplacement:
- McGill University Health Centre - Glen Site, Montreal, Quebec, Canada
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Over 1The purpose of this study is to describe the natural history and progression of patients diagnosed with PH1, and to characterize the long-term real-world safety and effectiveness of lumasiran.
Conditions:
Primary Hyperoxaluria Type 1Emplacement:
- Clinical Trial Site, Laurier, Quebec, Canada
- Clinical Trial Site, Toronto, Ontario, Canada
- Clinical Trial Site, Hamilton, Ontario, Canada
Sexe:
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AnyResearchers 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:
- The Hospital for Sick Children (SickKids), Toronto, Ontario, Canada
- CHU Sainte-Justine, Montreal, Quebec, Canada
- Alberta Children's Hospital - Nephrology Clinic, Calgary, Alberta, Canada