Ongoing Clinical Trials

ongoing clinical trials

We are currently participating in a number of clinical trial studies, in the following areas:

Cardiology
Genetics
Endocrinology
Respiratory
Oncology/Hematology
Rheumatology
Orthopedics
Other

 

Cardiology

More Response on Cardiac Resynchronization Therapy With MultiPoint Pacing (MORE-CRT MPP)
The purpose of this clinical investigation is to assess the impact of the Multi Point Pacing (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac Resynchronization Therapy (CRT) after six months.
Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome (AEGIS-II)

This is a phase III, multi-centre, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events [MACE – cardiovascular (CV) death, myocardial infarction (MI), and stroke] in subjects with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), including those managed with percutaneous coronary intervention (PCI) or medically managed.

Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency (HEART-FID)

The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo, in the treatment of participants in heart failure with iron deficiency and with a reduced ejection fraction.

Confirm Rx SMART Registry

The purpose of the Confirm Rx SMART Registry is to collect real world data to assess the safety and performance of the Confirm Rx Insertable Cardiac Monitor (ICM) and system over a 12 month period. A sub-set of subjects enrolled in the Confirm Rx SMART Registry will meet the Post Market Clinical Follow-Up (PMCF) requirement for CE mark.

DETERMINE-preserved – Dapagliflozin Effect on Exercise Capacity Using a 6-minute Walk Test in Patients With Heart Failure With Preserved Ejection Fraction

An international, multi-centre, Parallel-group, randomized, double-blind, placebo-controlled, phase III study evaluating the effect of Dapagliflozin on exercise capacity in Heart Failure Patients with Preserved Ejection Fraction (HFpEF)

Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides In patients With diabetes (PROMINENT)

The primary objective of the study is to determine whether pemafibrate administered twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of:

  • nonfatal Myocardial Infarction (MI)
  • nonfatal ischemic stroke
  • hospitalization for unstable angina requiring unplanned coronary revascularization; or
  • Cardio Vascular (CV) death.
Cardiac Sarcoidosis Randomized Trial (CHASM-CS-RCT)

Prospective randomized controlled trial comparing low dose Prednisone/Methotrexate combination to standard dose Prednisone in patients diagnosed with acute active clinically manifest cardiac sarcoidosis and not yet treated.

Remote Patient Management for Cardiac Implantable Electronic Devices (RPM-CIED)

This is a pilot study to assess barriers, evaluate and implement a patient oriented CIED management model incorporating advanced technological innovation to promote a paradigm shift to patient-centered care involving remote CIED monitoring and programming.


Genetics

cfDNA in Hereditary And High-Risk Malignancies (CHARM)

The goal of this study is to develop an effective, sensitive blood test that can detect early tumours in patients with known or suspected hereditary cancer syndromes (HCS). If this new blood test is accurate, it could be used to screen patients for cancer and allow for earlier cancer detection.

The study will also use questionnaires and interviews to understand how patients feel about incorporating these tests into routine medical care, and the perceptions of the medical value of test results.

Canadian Fabry Disease Initiative (CFDI) National Registry (CFDI-NR)

The Canadian Fabry Disease Initiative National Registry (CFDI-NR) is an observational, voluntary registry designed to collect outcomes data on Fabry disease from people living in Canada.

Fabry Disease Registry

The Fabry Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Fabry disease, irrespective of treatment status.


Endocrinology

A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease (FLOW)

The researchers are doing this study to see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type two diabetes.


Respiratory

Frontier 4

This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis.

Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD) (SPARTA)

This is a multi-centre, randomized, placebo-controlled, double-blind clinical study to assess the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156 weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of efficacy.

Undiagnosed COPD and Asthma Population Study (UCAP)

Previous population health studies suggest that up to 10 per cent of Canadian adults have undiagnosed asthma or COPD. These people are currently undiagnosed and untreated, even though they may have significant respiratory symptoms. Our study will use targeted case-finding to find people with undiagnosed asthma and COPD in Canadian communities.


Oncology/Hematology

A Phase 4, single-arm, open-label clinical study of pembrolizumab (MK-3475) to evaluate the efficacy and safety of MK-3475 plus carboplatin and paclitaxel as first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma (KEYNOTE-B10).

The goal of this study is to evaluate the efficacy and safety of pembrolizumab combined with carboplatin and paclitaxel as first line treatment in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). No statistical hypothesis will be tested in this study.

 

A Randomized Phase III Trial of MRI Surveillance with or without Prophylactic Cranial Irradiation (PCI) in Small-Cell Lung Cancer

This phase III trial studies magnetic resonance imaging (MRI) surveillance and prophylactic cranial irradiation (PCI) to see how well they work compared to MRI surveillance alone in treating patients with small cell lung cancer. MRI scans are used to monitor the possible spread of the cancer with an MRI machine over time. PCI is radiation therapy that is delivered to the brain in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients’ lifespan. Monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) may be at least as good as the combination of PCI with MRI scans.

 

A Phase 3, Randomized, Open Label, Controlled, Multicenter Study of Zandelisib (ME 401) in Combination with Rituximab Versus Standard Immunochemotherapy in Patients with Relapsed Indolent Non-Hodgkin’s Lymphoma (iNHL) – The COASTAL Study

This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.

 

CANadian multi-arm multi-stage randomized controlled trial assessing front line treatment in serous or p53 mutant endometrial cancer (CAN-STAMP)

This a phase II and III study whose purpose is to compare how long various treatment regimens can keep the cancer from worsening or coming back in people with serous or p53 abnormal endometrial cancer.

Immune Tolerance Induction in Haemophilia A Patients Using Wilate or Nuwiq
An uncontrolled, multi-centre, non-interventional study with a prospective and a retrospective cohort, to evaluate the efficacy of Wilate or Nuwiq in achieving complete or partial immune tolerance induction (ITI) success in severe and moderate haemophilia A patients with inhibitors.
Metformin in Patients Initiating ADT as Prevention and Intervention of Metabolic Syndrome (PRIME)

This is a multi-centre, double-blind, randomized phase III trial comparing metformin to placebo in patients with advanced prostate cancer starting intermittent androgen deprivation therapy.

De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma (EVADER)

The purpose of this study is to find out whether radiotherapy to some of the lymph node areas can be safely omitted to decrease side effects without increasing the risk of the tumour coming back.


Orthopedics

Fixation In-situ vs Removal for Midfoot Lisfranc Injuries (FIRM)
The aim of this study is to directly compare patient-reported and radiographic outcomes, in order to provide robust evidence for optimal post-operative treatment regimens regarding implant removal or retention for operatively treated Lisfranc injuries.
Study Comparing Surgical Treatment Versus Non-surgical Treatment of Ulnar Fractures
The purpose of this study is to determine if surgery using a plate and screws to fix a forearm fracture (ulnar shaft) will improve functional outcome compared to non-operative treatment out to 1 year of follow-up.
Periprosthetic Distal Femur Fracture

Our multicentre orthopaedic study group is conducting this study to compare two standard, but different treatments for periprosthetic distal femur fractures.

Operative and Nonoperative Treatment of Humeral Shaft Fractures

The purpose of this research study is to compare two different ways of treating a broken arm (fractured humerus) using either, the nonoperative approach or the operative, open reduction and internal fixation (ORIF).


Rheumatology

Golimumab for Adherence in Rheumatoid Arthritis

The purpose of this study is to determine if non-adherence to Rheumatoid Arthritis (RA) drugs in participants treated with biologic disease modifying anti-rheumatic drugs (DMARDs) is associated with a greater incidence of disease in clinical practice.

The study will describe the baseline, characteristics of Canadian RA patients initiating tofacitinib in clinical practice and subsequently assessing disease activity, patient reported outcomes, and persistence of response.

Other

PERC Health Canada COVID-19

A Multi-Center Evaluation of Buccal Swabs with the Abbott ID NOWTM COVID-19 for Point-of-Care Detection SARS-CoV-2 in Pediatric Emergency Departments

MAPP Mental Health Care

The investigators will determine, in an 8-site, hybrid Type 1 cluster randomized effectiveness implementation trial, if an acute mental health care bundle, compared to standard care, improves wellbeing at 30 days in children and youth seeking emergency department care for mental health and substance use concerns.

The IMAGINE-SPOR CIHR Chronic Disease Network (IMAGINE)

The IMAGINE Cohort Study will identify and recruit a cohort of 8000 patients with IBS, IBD and healthy controls (2000 of each) who will be assessed in terms of their psychological status, dietary intake, gut microbiome, metabolomic and inflammatory markers and genotype, health-related quality of life, and health-care resource use and associated costs.

ACCESS HD: Comparing Catheters to Fistulas in Elderly Patients Starting Hemodialysis (ACCESS HD)

This pilot randomized controlled trial (RCT) is multi-centre, parallel-arm and open label. It will test the feasibility and safety of randomizing elderly patients with end-stage kidney failure starting hemodialysis with a tunneled/non-tunneled catheter.

The Rick Hansen Spinal Cord Injury Registry (RHSCIR)

This is a national patient registry collecting data on traumatic spinal cord injuries to understand how spinal cord injury affects a person and his/her whole life. As information builds up in the registry, researchers and other health care professionals use this information to decide how to best help people with a spinal cord injury.

Health Research Innovation Team in Multiple Sclerosis (HITMS) Newfoundland

HITMS is a unique partnership between researchers and clinicians at Eastern Health and Memorial University. The goal is to collect data on overall health, disease symptoms, neuro-immune and blood profiles, and physical and cognitive performance among people living with Multiple Sclerosis in Newfoundland and Labrador.

PROTEOMICS – “Pilot study evaluating plasma proteomics as a potential cancer biomarker”

A study testing a new type of blood test for blood protein oncomarkers (proteins in the blood that may indicate cancer) specifically for breast and ovarian cancer.  It is our hope the test may help us detect cancers at a very early stage.

Surgical Staple Removal by Parents for Children with Minor Lacerations: A Proof of Concept Study

The study aims to explore the feasibility and acceptability of training parents/guardians to remove their child’s surgical staples at home, obviating a return visit to an HCP.

 

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Last updated: 2022-08-17