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The objective of this study is to demonstrate the efficacy and response of novel Magnetic Resonance Imaging (MRI)-guided ultrasound stimulated microbubble treatment to enhance radiation effects in humans receiving external beam radiotherapy delivered using a LINAC (linear accelerator) radiation therapy device.
Conditions:
Breast CancerLocation:
- Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
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ALLAges:
Over 18The purpose of the study is to assess the safety and efficacy of inavolisib as a single-agent and in combination with atezolizumab in participants with phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform (PIK3CA)-mutated cancers, including previously treated head and neck squamous cell carcinoma (HNSCC).
Conditions:
PIK3CA-Mutated CancersLocation:
- Jewish General Hospital, Montreal, Quebec, Canada
- Princess Margaret Cancer Center, Toronto, Ontario, Canada
- BC Cancer Vancouver Centre, Vancouver, British Columbia, Canada
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ALLAges:
Over 18A core symptom of body dysmorphic disorder (BDD) is perceptual distortions for appearance, which contributes to poor insight and delusionality, limits engagement in treatment, and puts individuals at risk for relapse. Results from this study will provide a comprehensive mechanistic model of brain, behavioral, and emotional contributors to abnormal perceptual processing, as well as how malleable it is with visual modulation techniques. This will lay the groundwork for next-step translational perceptual retraining approaches.
Conditions:
Body Dysmorphic DisorderLocation:
- Centre for Addiction and Mental Health, Toronto, Ontario, Canada
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ALLAges:
18 - 40A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.
Conditions:
Biliary Tract CancerLocation:
- Research Site, Brampton, Ontario, Canada
- Research Site, Ottawa, Ontario, Canada
- Research Site, Halifax, Nova Scotia, Canada
- Research Site, Mississauga, Ontario, Canada
- Research Site, Montreal, Quebec, Canada
- Research Site, Vancouver, British Columbia, Canada
- Research Site, Kingston, Ontario, Canada
- Research Site, Toronto, Ontario, Canada
- Research Site, Moncton, New Brunswick, Canada
- Research Site, London, Ontario, Canada
- Research Site, Toronto, Ontario, Canada
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ALLAges:
Over 18This is a phase I dose-finding trial of an autologous CD22 targeting chimeric antigen receptor (CAR)-T cell product, called CLIC-2201, for participants with relapsed/refractory B cell malignancies. In the proposed trial, eligible enrolled participants will undergo leukapheresis for autologous T cell collection to enable CLIC-2201 manufacturing, followed by lymphodepletion with cyclophosphamide and fludarabine, then intravenous infusion of the autologous CLIC-2201 product. The trial will use the 3+3 design to escalate or de-escalate the dose level of CLIC-2201 administered. Participants will be monitored for safety and tolerability up to day 365 following CLIC-2201 infusion. The primary objective is to evaluate the safety and tolerability of CLIC-2201 and estimate the maximum tolerated dose (MTD) of CLIC-2201 in B-cell malignancies. The secondary objectives are to evaluate the (i) feasibility; (ii) anti-tumour activity of CLIC-2201; (iii) and characterize the pharmacokinetic (PK) profile of CLIC-2201. Exploratory objectives will include: i) characterizing the cellular and humoral immune responses against CLIC-2201 up to 1 year following infusion of CLIC-2201; (ii) characterizing the phenotype and gene expression profile of CLIC-2201 cells; (iii) evaluating immune and tumour cells at baseline and relapse for biomarkers of response or toxicity; (iv) evaluating serum cytokines, circulating tumour DNA (ctDNA) and B cell aplasia as biomarkers of clinical outcomes; and (v) assessing the quality of life.
Conditions:
Mantle Cell Lymphoma | Diffuse Large B Cell Lymphoma | Non-Hodgkin's Lymphoma | B-Cell...Location:
- Vancouver General Hospital, Vancouver, British Columbia, Canada
- The Hospital for Sick Children, Toronto, Ontario, Canada
- Calgary Cancer Centre, Calgary, Alberta, Canada
- Princess Margaret Cancer Centre, Toronto, Ontario, Canada
- BC Children's Hospital, Vancouver, British Columbia, Canada
- Alberta Children's Hospital, Calgary, Alberta, Canada
- The Ottawa Hospital - General Campus, Ottawa, Ontario, Canada
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ALLAges:
Over 1In Canada, the incidence of esophageal cancer has been increasing over time, while surgical standards for esophageal resections have remained unchanged. Currently, the standard of surgical care for this cancer is Open Transthoracic Esophagectomy (OTE), a highly morbid operation that is associated with a complication rate of 60-80%, and a recovery period of many months. While Minimally Invasive Esophagectomy (MIE) has been developed it has not been adopted because it is highly complex, technically demanding, and has a longer operative time than OTE. With the advent of robotic platforms, Robotic Assisted Minimally Invasive Esophagectomy (RAMIE) has recently emerged as a novel minimally invasive alternative to OTE. RAMIE utilizes the DaVinci Xi robotic surgical platform which offers superior dexterity, 3D-vision, and wristed surgical equipment. To date, case reports and small case series have demonstrated the safety of RAMIE, however it has not been performed yet in Canada, and there has been no randomized trial that has compared RAMIE to OTE. This study proposes to build the infrastructure for introducing RAMIE to Canada, while laying the foundations for a future randomized controlled trial which will compare it to OTE.
Conditions:
Esophageal CancerLocation:
- St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada
Sex:
ALLAges:
Over 18Long-term, multicenter, multinational, observational, registry of patients with gMG that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT) such as eculizumab (Soliris®) and ravulizumab (Ultomiris®).
Conditions:
Generalized Myasthenia GravisLocation:
- Clinical Trial Site, London, Ontario, Canada
- Clinical Trial Site, Brampton, Ontario, Canada
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ALLAges:
Over 18This is a multicenter Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of tildrakizumab in Subjects with Active Psoriatic Arthritis I (INSPIRE 1)
Conditions:
Active Psoriatic ArthritisLocation:
- Sunpharma Site no. 97, Markham, Ontario, Canada
- Sunpharma site 98, Trois-Rivières, Quebec, Canada
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ALLAges:
Over 18This is a global multi-center, long-term follow-up study to assess durability of efficacy, as measured by maintenance of treatment response from the parent study, in participants who participated in a previous bepirovirsen study and achieved a complete or partial response. Eligible participants will be enrolled in this study after completing the end of study (EoS) visit in the respective parent bepirovirsen studies (studies B-Clear \[209668: NCT04449029\], B-Together \[209348: NCT04676724\], B-Fine \[212602: NCT04544956\], B-Well 1 \[202009: NCT05630807\], B-Well 2 \[219288: NCT05630820\], and TH HBV ASO-001 \[217023: NCT05276297\]). Participants will be categorized as Not-on-NA, NA-cessated, or On-NA based on their nucleos(t)ide analogue (NA) status in the parent study. No further treatment with bepirovirsen will be administered in this study.
Conditions:
Hepatitis BLocation:
- GSK Investigational Site, Toronto, Ontario, Canada
- GSK Investigational Site, Victoria, British Columbia, Canada
- GSK Investigational Site, Calgary, Alberta, Canada
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ALLAges:
Over 18The objective of the study is to assess feasibility, and clinical efficacy of a novel Fecal Microbiota Transplantation protocol for the treatment of pediatric small intestinal bacterial overgrowth (SIBO).
Conditions:
Small Intestinal Bacterial OvergrowthLocation:
- McMaster Children's Hospital, Hamilton, Ontario, Canada