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The study is a single-center parallel group randomized controlled trial comparing the administration of a presacral nerve block using 20mL of local ropivacaine 5.0mg/ml versus 20mL of normal saline (sham block) on post-operative pain following total laparoscopic hysterectomy.
Conditions:
Post-operative PainEmplacement:
- Mount Sinai Hospital, Toronto, Ontario, Canada
Sexe:
FEMALEÂges:
Over 18The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with Head and Neck Squamous Cell Carcinoma (HNSCC)
Conditions:
Neoplasms, Head and NeckEmplacement:
- GSK Investigational Site, Montreal, Quebec, Canada
- GSK Investigational Site, Hamilton, Ontario, Canada
- GSK Investigational Site, Toronto, Ontario, Canada
Sexe:
ALLÂges:
Over 18Lung cancer is the leading cause of annual cancer deaths globally, more than breast, prostate, and colon cancers combined. The staging of chest lymph nodes (LNs) is a crucial step in the lung cancer diagnostic pathway because it aids in treatment decisions - whether a patient is a candidate for lung resection, chemotherapy, radiation, or multimodal treatments. Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) is the current standard for chest nodal staging for non-small cell lung cancer (NSCLC), and guidelines mandate that Systematic Sampling (SS) of at least 3 chest LN stations be routinely performed for accurate staging. Unfortunately, EBUS-TBNA yields inaccurate results in 40% of patients, leading to misinformed treatment decisions. This proportion is much higher in patients with Triple Normal LNs \[LNs that appear normal on computed tomography (CT) scans, positron emission tomography (PET) scans, and EBUS\], which have been found to have a \> 93% chance of being truly benign. This is because EBUS-TBNA is based on ultrasound, whose success highly depends on the skill of the person performing it (operator). When the operator makes an error, the entire procedure is jeopardized. This causes downstream delays in treatment due to repeated testing and ill-informed treatment decisions. Over the past decade, the investigator has been conducting a series of research studies and trials: the development and validation of the Canada Lymph Node Score (CLNS) - a surgeon-derived semi-quantitative measure of LN malignancy; an Artificial Intelligence (AI)-based version of the CLNS to predict malignancy; and a fully autonomous AI that learned to predict malignancy directly from ultrasound images, to introduce AI to the decision-making pathway in NSCLC. This resulted in the creation of an AI-powered software to predict malignancy in mediastinal LNs of patients with lung cancer. The software is currently housed in cloud storage and its applications are latent - which means that LN images must be uploaded to the software, and results are received at a future time. In its current form, the software is not ready for clinical application due to this latency. In this project, the investigator aims to build a point-of-care device which will house the software (NodeAI) and deliver real-time results to the surgeon, and this device will be tested in a clinical trial.
Conditions:
Lung Cancer | Non Small Cell Lung CancerEmplacement:
- St. Joseph's Healthcare Hamilton / McMaster University, Hamilton, Ontario, Canada
Sexe:
ALLÂges:
Over 18The goal of this patient preference randomized controlled trial is to investigate the efficacy of Talking for Change (TFC), an intervention for the secondary prevention of child sexual abuse and exploitation (CSA) perpetration. Blinded clinical raters will evaluate the primary endpoint-reductions in dynamic risk factors for sexual offending against children-and clients will provide self-reports to evaluate a second primary outcome-reductions in sexual contact with children, accessing online child sexual exploitation material (CSEM), and desire for sexual contact with children. Researchers will compare the following groups: (1) those receiving 20 weeks of the experimental TFC group psychotherapy; (2) those receiving 20 weeks of a control group psychotherapy targeting mental health and stress more broadly; and (3) those receiving no treatment.
Conditions:
Program Evaluation | Pedophilia | Child Sexual Abuse | Paraphilias and Paraphilic Disorders | Prevention...Emplacement:
- Centre for Addiction and Mental Health, Toronto, Ontario, Canada
Sexe:
MALEÂges:
Over 18Currently, the optimal treatment regimen for elderly Glioblastoma (GBM) patients with poor performance status (PS) is unknown. Based on data for elderly GBM patients and the limited data for patients with poor PS, hypofractionated RT or a short course of Temozolomide (TMZ) may provide survival benefit without the added toxicity and inconvenience of a more protracted treatment regimen. In particular, treatment with RT or TMZ monotherapy on the basis of methylated O6 - methyl guanine - DNA methyltransferase (MGMT) promoter methylation status, followed by the alternative therapy at progression, may provide a safe and effective treatment regimen for patients with poor PS. The hypothesis of this trial is that in elderly GBM patients with poor performance status (age ≥ 65 years and KPS 50-70), a biomarker-guided approach to therapy results in non-inferior overall survival compared to combined TMZ/RT. Specifically, biomarker-guided therapy will consist of TMZ monotherapy for patients with a methylated MGMT promoter, and hypofractionated RT (40 Gy in 15 fractions) for patients with a non-methylated MGMT promoter. It is hypothesized that biomarker-guided therapy will result in non-inferior progression-free survival, reduced toxicity and increased cost-effectiveness compared to combined chemoradiotherapy. Primary objective: • To compare overall survival of standard vs biomarker-guided therapy in elderly and frail patients with newly diagnosed GBM. Secondary objective: * To evaluate progression-free survival following treatment in both arms. * To evaluate adverse events according to CTCAE criteria in both arms. * To evaluate health-related quality-of-life as assessed by MoCA and EORTC QLQ-C30/QLQ-BN20 questionnaires in both arms. * To evaluate cost-effectiveness of standard vs biomarker-guided therapy Methods: Patients will be randomized to two treatment groups in a 1:1 ratio. Standard Arm: TMZ with concurrent RT (combined modality arm) Patients will receive 15 days of TMZ daily with concurrent RT. TMZ will be delivered at a dose of 75 mg/m2, given daily with RT. TMZ will be administered 1 hour before each session of RT. After a 4-week break, patients will receive six cycles of adjuvant TMZ according to the standard 5-day schedule (days 1-5) every 28 days, up to 6 cycles as tolerated by the patient. The dose will be 150 mg/m2 for the first cycle and increased to 200 mg/m2 beginning with the second cycle, so long as there are no hematologic adverse events, intractable nausea or fatigue. Investigational Arm: Biomarker based treatment MGMT (+): TMZ monotherapy Patients will receive TMZ at a dose of 75 mg/m2 daily for 15 days on weekdays (Monday through Friday). This will be followed by six cycles of TMZ according to the standard 5-day schedule (days 1-5) every 28 days. The dose will be 150 mg/m2 for the first cycle and increased to 200 mg/m2 beginning with the second cycle, so long as there are no hematologic adverse events. Dose will be determined using the body surface area (BSA) calculation. MGMT methylation (-): No TMZ will be given. Participants will receive radiation treatment with 40Gy / 15 fractions over a period of 21 days (3 weeks). Upon treatment completion, participants will be followed by every 3 months for 2 years and every 6 months for years 3-5. Response and progression will be evaluated using the new international criteria proposed by the Response Assessment in Neuro-Oncology working group (RANO).
Conditions:
Glioblastoma MultiformeEmplacement:
- Tom Baker Cancer Centre, Calgary, Alberta, Canada
- Cross Cancer Institute, Edmonton, Alberta, Canada
Sexe:
MALEÂges:
Over 65ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.
Conditions:
AMD | Wet Age-related Macular Degeneration | wetAMD | CNV | nAMD | wAMDEmplacement:
- Calgary Retina Consultants, Calgary, Alberta, Canada
- Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- Toronto Retina Institute, North York, Ontario, Canada
- University of British Columbia - Eye Care Centre, Vancouver General Hospital, Vancouver, British Columbia, Canada
- Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
- Alberta Retina Consultants, Edmonton, Alberta, Canada
- Retina Centre of Ottawa, Ottawa, Ontario, Canada
- Calgary Retina Consultants /ID# 258997, Calgary, Alberta, Canada
- Vitreous Retina Macula Specialists of Toronto /ID# 258299, Etobicoke, Ontario, Canada
- Sunnybrook Health Sciences Centre /ID# 270690, Toronto, Ontario, Canada
- Retina Surgical Associates /ID# 270958, New Westminster, British Columbia, Canada
- Retina Centre of Ottawa /ID# 259659, Ottawa, Ontario, Canada
- University of British Columbia - Eye Care Centre, Vancouver General Hospital /ID# 266014, Vancouver, British Columbia, Canada
- Toronto Retina Institute /ID# 265602, Toronto, Ontario, Canada
- Alberta Retina Consultants /ID# 265599, Edmonton, Alberta, Canada
- Ottawa Hospital Research Institute /ID# 258998, Ottawa, Ontario, Canada
- Duplicate_CHU de Quebec-Universite Laval /ID# 258996, Québec, Quebec, Canada
Sexe:
ALLÂges:
50 - 89Endometriosis is a chronic incurable disease where endometrial-like tissue grows outside of the uterus, and causes symptoms such as debilitating menstrual pain, pain during intercourse, infertility, constipation, and bloating, which hurts their quality of life. Endometriosis is estimated to affect approximately 10% of women. Despite this, there's currently not enough research on this disease; in Canada it takes on average 5.4 years to get a diagnosis (from when symptoms start), and once diagnosed, women often have to go through a trial-and-error process to find a treatment that can manage their symptoms. Misunderstanding symptoms and struggling with patient-provider communication both contribute to these delays in diagnosis and finding the best treatment. Mobile health applications have been a promising new tool to self-track symptoms and treatments. There are several apps currently available on the market for logging chronic pain, menstrual cycles, and fertility. However, no apps exist specifically for endometriosis that look at the whole spectrum of symptoms, including pain, quality of life, and especially ease of patient-provider communication. The elleFA app is a new, personal endometriosis and health tracking app designed to improve patient-physician dialogue through more direct, efficient, and impactful communication, as patients navigate their condition. This single-arm interventional study aims to test the feasibility of implementing the new elleFA app in a clinical setting for 6 months in pre-menopausal women 18 years and older with endometriosis, and the app's impact on patient experience. Participants will download the elleFA app on their smartphone and will be asked to complete two questionnaires through the app every month for 6 months. Participants can choose to also optionally track their daily symptoms, lifestyle, and treatments, through weekly symptom log summaries through the app. The main study finding will be be patient adherence to using the app over a 6 month study period. Other findings will include user-reported satisfaction with the elleFA app, and the impact of elleFA app use on patient experience communicating with their healthcare team.
Conditions:
EndometriosisEmplacement:
- McGill University Health Center, Montreal, Quebec, Canada
Sexe:
FEMALEÂges:
Over 18Neuroendocrine tumours (NETs) are rare, slow growing, and diagnosis is often delayed with advanced metastases at presentation. In select patient populations, radioisotope therapy with Lutetium-177 (Lu-DOTA-TATE) has been shown to be a safe and effective palliative therapy, and has been widely used by research groups in Europe. A brand of Lu-DOTA-TATE (Lutathera(R)) is approved for the treatment of gastroenteropancreatic NETs in Europe, the U.S., and more recently in Canada. While Lutathera(R) is approved in Canada, it is not publicly funded in Alberta. Lu-DOTA-TATE has been used at the Cross Cancer Institute to treat more than 300 patients with NETs since August, 2010. Our Lu-DOTA-TATE treatment was initially given under Health Canada's Special Access Programme (SAP), with each individual treatment requiring separate approval. In 2014, Health Canada requested we conduct a clinical trial with Lu-DOTA-TATE instead. The purpose of this study is to: 1) assess the efficacy of Lu-DOTA-TATE treatment in patients with somatostatin receptor positive tumours; 2) assess the safety of Lu-DOTA-TATE; 3) assess the effect of Lu-DOTA-TATE on Quality of Life and survival.
Conditions:
Carcinoma, NeuroendocrineEmplacement:
- Cross Cancer Institute, Edmonton, Alberta, Canada
Sexe:
ALLÂges:
14 - 90The investigators are studying whether treatment with a proton pump inhibitor called omeprazole reduces gastrointestinal bleeding in older adults taking blood thinners for a blood clot (venous thromboembolism). The purpose of this study, a pilot study or a feasibility study, is to test the study plan and determine whether enough participants will join a larger study and accept the study procedures.
Conditions:
Venous Thromboembolism | Blood Clot | Gastro Intestinal BleedingEmplacement:
- The Ottawa Hospital, Ottawa, Ontario, Canada
- University Health Network - Toronto General, Toronto, Ontario, Canada
- Niagara Health System - St. Catharines Site, St. Catharines, Ontario, Canada
Sexe:
ALLÂges:
Over 65This is a pilot trial to discover the feasibility of recruiting 50 pts over the course of 12 months. The trial is testing the efficacy of using cold-stored vs. room temperature stored (current standard of care) platelets to treat bleeding in persons with hematological disorders and thrombocytopenia.
Conditions:
Hematologic MalignancyEmplacement:
- The Ottawa Hospital - General Campus, Ottawa, Ontario, Canada