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Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study of orally administered ivosidenib. Participants are required to have a histopathological diagnosis consistent with isocitrate dehydrogenase-1 (IDH1) gene-mutated, locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection. IDH1 mutant status will be determined during pre-screening/screening phase. Participant must have radiographic progression/recurrence of disease according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and have received 0 to 1 prior systemic treatment regimen in the advanced/metastatic setting for conventional chondrosarcoma. The primary endpoint is progression-free survival (PFS) in Grades 1 and 2 participants. Key secondary endpoints are PFS in all randomized participants, overall survival (OS) in Grades 1 and 2 participants, and OS in all randomized participants. Participants who meet enrollment criteria will be randomized 1:1 to receive oral ivosidenib 500mg once daily, or a matching placebo once daily.
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...Location:
- Muhc Glen Site, Montréal, Quebec, Canada
- UNIVERSITY HEALTH NETWORK, Princess Margaret Cancer Centre,, Toronto, Ontario, Canada
- University Health Network, Toronto, Ontario, Canada
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Over 18Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD) clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies that have combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD.
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Alzheimer Disease | Mild Cognitive Impairment | DementiaLocation:
- Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
- Parkwood Institute, London, Ontario, Canada
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55 - 90Idiopathic Pulmonary Fibrosis is a chronic lung disease which causes scarring of the lungs and difficulty in breathing. GSK3915393 is a new medicine, which is being tested in participants with IPF for the first time. The study will assess the safety and effectiveness of GSK3915393 in IPF participants.
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Idiopathic Pulmonary FibrosisLocation:
- GSK Investigational Site, Ajax, Ontario, Canada
- GSK Investigational Site, Saint John's, Newfoundland and Labrador, Canada
- GSK Investigational Site, Hamilton, Ontario, Canada
- GSK Investigational Site, Vancouver, British Columbia, Canada
- GSK Investigational Site, Trois RiviEres, Quebec, Canada
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Over 18Total Knee Replacement (TKR) is an operation to help with the pain and decreased function that happens with end stage arthritis of the knee. This operation has been shown to be very successful at relieving pain and improving patient mobility; however, some studies have shown that up to 20% of TKR recipients are not happy with their knee replacement. All of the reasons why some patients are not pleased with the outcome of surgery are not known, but one of the possible causes is the way the implants are placed, or aligned, during surgery. Most TKRs are aligned in a fashion that the bones in the leg are completely straight after surgery. This is known as mechanically aligning a TKR. A different alignment method known as kinematic alignment respects the natural bow legged or knock kneed alignment of the patient. It is hoped that kinematically aligning a knee replacement will improve how the knee feels to the patient and therefore improve their satisfaction. Another potential factor affecting the outcomes of TKR is obtaining optimal soft tissue balance. The challenge with balancing a TKR is that traditional operative techniques rely on subjective feel of the knee stability during surgery. The balance or tension in the knee can however be objectively measured using specialized intraoperative pressure sensing devices. The purpose of this study is to assess the impact of kinematically aligned TKR on the pressures measured by Verasense during total knee replacements. The study will also determine if differences in the pressure measured during TKR surgery impact patient outcomes after surgery.
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Osteo Arthritis KneeLocation:
- Nova Scotia Health Authority, Halifax, Nova Scotia, Canada
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21 - 80In Canada, depression affects more than 300,000 adults over the age of 60, which costs the healthcare system an estimated $5 billion each year. Late-life depression (LLD) is associated with more deaths, more physical and mental health problems. LLD is hard to treat, as many people will not respond to treatment and many will stop taking antidepressant medication due to negative side-effects. Unfortunately, common non-medication treatments like cognitive behavioral therapy are often inaccessible because of long (6-12 months) wait times and high costs. In a previous study, we found that an 8-week group mindfulness-based cognitive therapy (MBCT) program improved depressive symptoms more than regular LLD treatment (i.e. antidepressants and/or support counseling). Now, a larger scale study is required to compare MBCT to an active control group. Furthermore, research and clinical experience during and post-Covid pandemic has shown that older adults are nowadays far less likely to participate in in-person intervention studies but appreciate and tolerate Zoom delivery of behavioral interventions. This study will compare the effects of MBCT versus an active control group, Health Enhancement Program (HEP), both delivered by Zoom, to see if it improves symptoms of depression in older adults. The study team plans to recruit approximately 100-120 participants in across Canada, who will be randomly assigned to 8-weeks of either MBCT or HEP, delivered by Zoom. The investigators will observe if these treatments improve depression as well as cognition by conducting in-person cognitive assessments. Currently there is a lack of affordable and accessible non-medication treatments for LLD that can be scaled to reach many people. If successful, Mindfulness may be a potential solution, as it is easily given in groups and is well-tolerated by older adults with LLD.
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Older Age; DepressionLocation:
- Douglas Mental Health University Institute, Verdun, Quebec, Canada
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Over 60To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA
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Refractory IPALocation:
- Clinical Research Site 008, Toronto, Ontario, Canada
- Clinical Research Site 110, Toronto, Ontario, Canada
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Over 18The goal of this clinical trial is to learn if administering a high dose stimulant with Contingency Management reduces days of use in adults who use methamphetamine better than the usual treatment provided by the clinic. The main questions the trial aims to answer are: Is a high dose stimulant better than a placebo and usual treatment at helping reduce the number of days they use methamphetamine? Is a high dose stimulant with contingency management better than placebo and usual treatment at helping people reduce the number of days they use methamphetamine? Participants will be placed randomly into one of four groups: 1. Usual treatment and placebo 2. Usual treatment, placebo and contingency management 3. Usual treatment and high dose stimulant 4. Usual treatment, high dose stimulant and contingency management Participation includes the following: 1. Participants will receive medication or placebo weekly for 15 weeks. 2. Participants will attend the clinic for weekly treatment 3. Participants will attend the clinic once every 2 weeks for study visits. Each visit will take about an hour to complete. At these visits, participants will be asked to provide a urine sample and complete questionnaires.
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Addiction | Methamphetamine Abuse | Addiction, Substance | Methamphetamine-dependenceLocation:
- University of Montreal Hospital Research Center, Montréal, Quebec, Canada
- Center for Addiction and Mental Health, Toronto, Ontario, Canada
- Rapid Access Addiction Medicine Clinic, St. Paul's Hospital, Vancouver, British Columbia, Canada
- River Stone Recovery Centre, Fredericton, New Brunswick, Canada
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18 - 55The objective of this study is to evaluate the efficacy of plixorafenib in participants with locally advanced or metastatic solid tumors, or recurrent or progressive primary central nervous system (CNS) tumors harboring BRAF fusions, or in participants with rare solid tumors, melanoma, thyroid, or recurrent primary CNS tumors harboring BRAF V600E mutation. This will be conducted as four open-label subprotocols (F8394-201A; F8394-201B; F8394-201C; F8394-201D) under one master protocol.
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Cancer Harboring BRAF AlterationsLocation:
- Sunny brook Health Sciences Centre- Bayview Campus, Toronto, Ontario, Canada
- Centre Hospitalier Universitaire Sainte-Justine, Montréal, Quebec, Canada
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Over 10The purpose of this study is to find out whether a novel manualized intervention, called Emotion and Symptom-focused Engagement (EASE), that combines psychological support with symptom screening plus triggered referral to early palliative care for symptom control, reduces psychological distress and physical symptom burden in individuals newly diagnosed with acute leukemia. To do this, half of the participants in this study will receive the usual care offered to patients with acute leukemia and half of the participants will receive usual care plus the EASE intervention.
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Acute LeukemiaLocation:
- Odette Cancer Centre, Toronto, Ontario, Canada
- Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
- University Health Network, Toronto, Ontario, Canada
- Kingston Health Sciences Centre, Kingston, Ontario, Canada
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Over 18The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Participants who complete 52-weeks of treatment in the Double-blind Treatment (DBT) period can choose to enroll in the optional Open-label Extension (OLE) period to receive treatment with vixarelimab for another 52 weeks.
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Idiopathic Pulmonary Fibrosis | Systemic Sclerosis With Lung InvolvementLocation:
- Kelowna Allergy and Respiratory Health Clinic, Kelowna, British Columbia, Canada
- Dynamic Drug Advancement Ltd., Ajax, Ontario, Canada
- Dr Anil Dhar Professional Medicine Corporation, Windsor, Ontario, Canada