Clinical trials: open to volunteers, sponsored by University Health Network, Toronto
Respiratory Insufficiency, Extracorporeal Membrane Oxygenation Complication
Platform of Randomized Adaptive Clinical Trials in Critical Illness
PRACTICAL is a randomized multifactorial adaptive platform trial for acute hypoxemic respiratory failure (AHRF). This platform trial will evaluate novel interventions for patients with AHRF across a range of severity states…
- Conditions
- Respiratory Insufficiency, Extracorporeal Membrane Oxygenation Complication, Mechanical Ventilation Pressure High
- Trial name
- PRACTICAL (NCT05440851)
- Testing
- Ultra-Protective Ventilation Facilitated by Extracorporeal Support, Lung-Protective Ventilation (LPV), Driving Pressure-Limited Ventilation (DPL)
- Where
- 103 sites in United States, Australia and 8 more
- Volunteers
- 6,250 people
- Sponsor
- University Health Network, Toronto
Autoimmune Hepatitis
Belimumab in Autoimmune Hepatitis
Background: Autoimmune hepatitis (AIH) is a rare chronic and lifelong liver disease. Untreated, disease progresses to end-stage cirrhosis and the focus of therapy is with immunosuppression.
- Trial name
- BELief (NCT06381453)
- Testing
- Belimumab Auto-Injector [Benlysta]
- Where
- 6 sites in Canada
- Volunteers
- 48 people
- Sponsor
- University Health Network, Toronto
Extubation
EXtubation Related Complications - the EXTUBE Study (EXTUBE)
EXTUBE is an international, multicentre, prospective cohort study evaluating the incidence, risk factors, and outcomes of extubation-related complications and describing clinical practices related to extubation after general…
- Trial name
- EXTUBE (NCT06442930)
- Where
- 35 sites in United States, Australia and 7 more
- Volunteers
- 3,000 people
- Sponsor
- University Health Network, Toronto
Long COVID, Post COVID-19 Condition
Effect of Hi-OxSR for the Treatment of Post COVID Condition
The RECLAIM study platform will be used to explore whether the use of the Hi-OxSR device improves the symptoms of post covid cognitive dysfunction.
- Conditions
- Long COVID, Post COVID-19 Condition, Post Acute Sequelae of COVID-19
- Trial name
- RECLAIM-HiOxSR (NCT06928506)
- Testing
- Hi-OxSR device, Hi-Ox device
- Where
- 3 sites in Canada
- Volunteers
- 120 people
- Sponsor
- University Health Network, Toronto
Hypogonadism, Prostate Cancer
Clinical Trial to Observe the Effects of Tamoxifen on Testosterone Recovery in Medically Castrated Prostate Cancer Patients
Androgen deprivation therapy (ADT) is a cornerstone therapy in the treatment of curable prostate cancer (PCa). However, ADT often leads to a protracted testosterone recovery period in most men or absence of complete recovery in…
- Trial name
- REVIVE (NCT07535905)
- Testing
- Tamoxifen
- Where
- Canada
- Volunteers
- 96 people
- Sponsor
- University Health Network, Toronto
Triple-Negative Breast Cancer (TNBC)
Enhancing ICB Efficacy Through IL-1 Inhibition in TNBC
This study is a phase I/II open-label randomized clinical trial to examine whether administration of isunakinra (EBI-005), a modified recombinant IL1 receptor antagonist, can sensitize human TNBC to the PD1…
- Trial name
- NCT07698106
- Testing
- Group 1-Isunakinra
- Volunteers
- 60 people
- Sponsor
- University Health Network, Toronto
Head and Neck Squamous Cell Carcinoma (HNSCC)
Optimizing Response to Immunotherapy With Online Adaptive Pulsed Radiotherapy in Incurable Head and Neck Cancers
The ORION study will evaluate a novel treatment approach for patients with recurrent, metastatic, oligometastatic, or locoregionally incurable head and neck squamous cell carcinoma (HNSCC).
- Trial name
- ORION (NCT07888816)
- Testing
- Pulsed Adaptive Radiotherapy Combined with Pembrolizumab with or without chemotherapy
- Where
- Canada
- Volunteers
- 48 people
- Sponsor
- University Health Network, Toronto
Prostate Cancer Recurrent, Prostate Cancer
Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era
This is an interventional, single-centre, single-arm, non-randomized, prospective, feasibility trial investigating salvage MR-guided High-Dose-Rate brachytherapy for prostate bed recurrence after postoperative radiotherapy.
- Trial name
- SHAPE-PSMA (NCT06508567)
- Testing
- High Dose Rate Brachytherapy
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- University Health Network, Toronto
Prostate Adenocarcinoma, Iliac Nodal Disease
Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response
This prospective, single-arm feasibility study will include patients with prostate cancer that have controlled local disease diagnosed with oligorecurrent para-aortic nodal disease and/or common iliac nodal disease detected by…
- Conditions
- Prostate Adenocarcinoma, Iliac Nodal Disease, Para-aortic Lymph Node Metastasis, Para-aortic Nodal Disease
- Trial name
- EASY (NCT06831032)
- Testing
- Adaptive radiotherapy using SBRT
- Where
- Canada
- Volunteers
- 26 people
- Sponsor
- University Health Network, Toronto
Palliative Cancer
Prophylaxis for Emetogenic radioTherapy With Akynzeo
This phase II, prospective study evaluates whether prophylactic treatment with Akynzeo can reduce nausea and vomiting in patients receiving palliative radiotherapy in which the gastrointestinal GI tract is within the radiation…
- Trial name
- PRÊT (NCT07882966)
- Testing
- Akynzeo
- Where
- Canada
- Volunteers
- 188 people
- Sponsor
- University Health Network, Toronto
Head and Neck Cancer
SALI-10 Probiotic to Reduce Osteoradionecrosis and Dental Toxicity Following Radiation Therapy for Head and Neck Cancer
This Phase III randomized controlled trial will evaluate whether long-term use of the oral probiotic Streptococcus salivarius strain SALI-10 (SALI-10) can reduce the risk of radiation-related major adverse dental events (MADE) in…
- Trial name
- DIAMOND (NCT07883005)
- Testing
- Standard of Care (SOC), Experimental drug
- Where
- Canada
- Volunteers
- 288 people
- Sponsor
- University Health Network, Toronto
Advanced Cancer, Stage IV Solid Tumor Cancer
Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Patients With Advanced Cancer: A Randomized Controlled Trial
Phase II randomized controlled trial, followed by an open-label extension phase. In the main study, participants will receive either a single high or low dose of psilocybin in the context of Psilocybin-assisted Existential…
- Conditions
- Advanced Cancer, Stage IV Solid Tumor Cancer, Stage IV Sarcoma of Bone, Stage IV Lymphoma
- Trial name
- PEARL RCT (NCT07820033)
- Testing
- Psilocybin (high dose), Psilocybin (low dose), PEARL Therapy
- Where
- Canada
- Volunteers
- 46 people
- Sponsor
- University Health Network, Toronto
Hypertrophic Cardiomyopathy
Echocardiographic Perspectives on Transient Mitral Regurgitation After Septal Myectomy
Mitral regurgitation (MR) following septal myectomy for hypertrophic obstructive cardiomyopathy may persist despite relief of systolic anterior motion and left ventricular outflow tract obstruction.
- Trial name
- TMRSM_R (NCT07831811)
- Volunteers
- 150 people
- Sponsor
- University Health Network, Toronto
Breast Cancer, HER2-positive Breast Cancer
Kadcyla And Neratinib for Interception of HER2+ Breast Cancer With Molecular Residual Disease
This is a Phase 2 study for patients with resected Stage I-III HER2+ breast cancer with detected molecular residual disease (MRD+) following standard neoadjuvant and locoregional therapy delivered with curative intent.
- Trial name
- NCT05388149
- Testing
- Neratinib
- Where
- Canada
- Volunteers
- 15 people
- Sponsor
- University Health Network, Toronto
Cutaneous Melanoma, Melanoma Stage IV
Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma
Clear-Me is a biomarker-driven phase II study that tests whether the combination anti- lymphocyte-activation gene-3 (LAG3)/anti-programmed cell death protein 1(PD-1) inhibition Bristol-Myers Squibb (BMS986213) is superior to…
- Conditions
- Cutaneous Melanoma, Melanoma Stage IV, Mucosal Melanoma
- Trial name
- ClearMe (NCT06319196)
- Testing
- Opdualag, Nivolumab
- Where
- Canada
- Volunteers
- 54 people
- Sponsor
- University Health Network, Toronto
Autonomic Dysfunction
Cervicothoracic Sympathetic Block Evaluation for Post COVID Condition
Post-COVID Condition (PCC) affects roughly 2.1 million Canadians, carrying an annual economic burden of CAD $7.8-50.6 billion. It presents across multiple organ systems with symptoms including fatigue, brain fog, palpitations…
- Trial name
- CeASE (NCT07468604)
- Testing
- 5 mL of 0.25% bupivacaine with epinephrine (1:200,000)
- Where
- 2 sites in Canada
- Volunteers
- 78 people
- Sponsor
- University Health Network, Toronto
Post-Operative Prostate Cancer
Comparing Moderately and Ultra Hypofractionated Radiation Treatments for Post-operative Prostate Cancer
This is a multi-institution, randomized, non-inferiority Phase II trial comparing external beam radiotherapy delivered as 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily with…
- Trial name
- AMPORA (NCT06409910)
- Testing
- Radiotherapy
- Where
- 3 sites in Canada
- Volunteers
- 204 people
- Sponsor
- University Health Network, Toronto
Hereditary Cancer Syndrome
CfDNA in Hereditary And High-risk Malignancies 2
The goal of this study is to understand the performance of an experimental blood test that aims to detect early tumors in patients with hereditary cancer syndromes.
- Trial name
- CHARM2 (NCT06726642)
- Testing
- Cell-free DNA analysis
- Where
- 8 sites in Canada
- Volunteers
- 1,000 people
- Sponsor
- University Health Network, Toronto
Bladder Cancer, Bladder Urothelial Carcinoma
Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)
Upper tract urothelial cancer (UTUC) is cancer in the lining of the kidney or ureter (the tube that drains the kidney). This type of cancer is rare and as a result, there are only a few studies that have looked at it.
- Trial name
- NAUTICAL (NCT04574960)
- Testing
- Gemcitabine, Cisplatin, Carboplatin
- Where
- 2 sites in Canada
- Volunteers
- 14 people
- Sponsor
- University Health Network, Toronto
Chronic Low Back Pain (CLBP), Nociplastic Pain
PRT for Chronic Low Back Pain
The goal of this clinical trial is to learn whether Pain Reprocessing Therapy (PRT) is a feasible and acceptable treatment to complete for working-age adults (ages 18-65) with chronic low back pain.
- Trial name
- NCT07696741
- Testing
- Pain Reprocessing Therapy, Monitoring and Education
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- University Health Network, Toronto