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

Fabry Outcome Survey (FOS)

The purpose of this study is to collect data that will increase understanding of Fabry disease history and progression, in treated and untreated patients with Fabry disease. The data from FOS may provide guidance to health-care professionals about disease treatment options.

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

Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis Study 02

This study will evaluate the safety and efficacy of Relamorelin compared to placebo in patients with diabetic gastroparesis. Patients will report daily severity scores of their diabetic gastroparesis symptoms.

A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03

A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for six additional weeks.

A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04

A 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.

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

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 Study Following People With Haemophilia A and B, With or Without Inhibitors, When on Usual Treatment (Explorer™6)

This study will collect data on bleeds and data related to quality of life in people with severe congenital (a disease existing from birth) haemophilia A and B, with or without inhibitors.

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.

Breast Cancer WEight Loss Study (BWEL Study)

This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence).

Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer

This randomized phase II clinical trial studies how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer.

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.

Trial of Preoperative Therapy for Gastric and Esophagogastric Junction Adenocarcinoma (TOPGEAR)

The primary objective of TOPGEAR is to investigate whether the addition of chemoradiotherapy to chemotherapy is superior to chemotherapy alone in the neoadjuvant setting by improving pathological complete response rates in the first instance, and subsequently overall survival, in patients undergoing adequate surgery (D1+ dissection) for resectable gastric cancer.

A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread.

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

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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