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NCT ID: NCT03534817 Suspended - Clinical trials for Myocardial Infarction

Early Versus Standard Access Cardiac Rehabilitation to Counter Ventricular Remodeling Post-MI (EVADE)

EVADE
Start date: January 8, 2018
Phase: N/A
Study type: Interventional

BACKGROUND: Cardiac rehabilitation (CR) is an outpatient chronic disease management program delivering secondary prevention, which is proven to reduce morbidity and mortality. The Canadian Cardiovascular Society Access to Care working group recommends patients access CR "preferably" within 2-7 days following percutaneous intervention for myocardial infarction (MI), but that 30-60 days is "acceptable". Despite these benchmarks, in practice patients access CR up to 90 days post-treatment in Canada. This is disconcerting given the detrimental impacts of delayed access to CR. These include ventricular remodeling (i.e., ventricular enlargement and reduced pump function), lower CR use, less post-CR exercise, among others. Accordingly, EVADE will be the first randomized controlled trial (RCT) to test the effects of early access CR (1-week post-discharge to first CR visit) compared to standard access CR (7-weeks post-discharge to first CR visit) in ameliorating these concerns. AIMS & HYPOTHESIS: The primary aim is to compare ventricular remodeling as defined by the change in end-systolic volume at 1-year in participants randomized to early versus standard access CR. The secondary aims are: (1) to compare post-CR exercise adherence by accelerometry, exercise capacity by 6-minute walk test distance, and health-related quality of life (HRQL) at 1-year in participants randomized to early versus standard access CR; (2) to compare CR program session attendance in participants randomized to early versus standard access CR; and (3) to assess biomarkers of ventricular remodeling in participants randomized to early versus standard access CR. The final aims are to explore more immediate health benefits associated with early versus standard access CR. Accordingly, at 6 months following hospital discharge the investigators will measure end-systolic volume, exercise adherence, exercise capacity, biomarkers of ventricular remodeling, and HRQL. The investigators will also explore hospitalization for any cause of death at 1 year in order to inform future research. The overall hypothesis is that early access CR will be associated with less ventricular remodeling, increased CR attendance and post-CR exercise adherence, increased exercise capacity, and greater HRQL. DESIGN: EVADE will be a two-centre, 2 parallel-arm, single-blinded RCT. Participants will be recruited through coronary care units following treatment for MI from the Royal University Hospital in Saskatoon, Saskatchewan and the University of Alberta Hospital in Edmonton. The University of Alberta Research Electronic Data Capture (REDCap) online database will randomize (1:1) participants (allocation concealed). A total of 60 participants will be enrolled: 30 participants will each be allocated to early access and standard access CR. IMPACT: In the first prospective multicentre trial of its kind, EVADE will test an innovative post-MI rehabilitation strategy that has the potential to demonstrate the superior benefits of early access CR for attenuating ventricular remodeling, and increasing CR attendance, post-CR exercise adherence, exercise capacity, and HRQL. The results from EVADE would encourage the Canadian CR community to consider early access CR to further enhance readily available and existing CR programs. The knowledge gained from EVADE will inform clinical decision-making practices, influence future CR guidelines and policy, and will contribute to the ongoing goal of improving efficiency and effectiveness of the Canadian health care system.

NCT ID: NCT03484143 Suspended - Alzheimer Disease Clinical Trials

Neuro RX Gamma - Pivotal Phase

Start date: June 26, 2019
Phase: N/A
Study type: Interventional

The active Neuro RX Gamma device uses non-invasive near-infrared energy delivered to the brain with the intention to improve cognitive functioning and quality of life in patients with moderate to severe Alzheimer's Disease. Treatment will occur at home-based treatment sessions with the device.

NCT ID: NCT03444948 Suspended - Clinical trials for Pancreatic Ductal Adenocarcinoma

A Clinical Study of EUS-RFA for Inoperable Pancreatic Ductal Adenocarcinoma

EUS-RFA
Start date: February 14, 2019
Phase: N/A
Study type: Interventional

To assess if endoscopic ultrasound-guided radiofrequency ablation application in patients with inoperable pancreatic cancer confers survival benefit when compared to patients receiving standard medical care.

NCT ID: NCT03439358 Suspended - Anesthesia Clinical Trials

Magnesium for Shivering in Epidural Lidocaine Deliveries

Mag-SHIELD
Start date: June 11, 2018
Phase: N/A
Study type: Interventional

Magnesium has been shown to decrease the shivering experienced from neuraxial anesthesia. This study aims to investigate whether magnesium decreases the shivering experienced in parturients undergoing labor epidural anesthesia for Cesarean delivery.

NCT ID: NCT03406052 Suspended - Clinical trials for Disorder, Major Depressive

Smartphone-enabled Health Coaching Intervention for Youth Diagnosed With Major Depressive Disorders

Start date: January 19, 2018
Phase: N/A
Study type: Interventional

Randomized controlled trial (RCT) comparing youth diagnosed with major depressive disorder treated with online mindfulness-based cognitive behavioural therapy vs. standard psychiatric care (as wait-list controls). Eligible subjects will be recruited from the wait-lists of the Centre for Addiction and Mental Health. N = 168 subjects will consist of youth from First Nations background (18-30 yrs) and youth from all other ethnic backgrounds stratified to two intervention groups and two wait-list control groups consisting of 50% First Nations youth and 50% youth of all other ethnic backgrounds.

NCT ID: NCT03229850 Suspended - Diabetes Mellitus Clinical Trials

Dynamics of Insulin Absorption in Subclinical Lipohypertrophy Using the Euglycemic Clamp Technique

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

This study will use the euglycemic clamp technique to evaluate insulin absorption when insulin is administered subcutaneously in an area of subclinical lipohypertrophy vs an area of normal tissue.

NCT ID: NCT03218475 Suspended - Clinical trials for Head and Neck Cancer

MRG FU With Radiotherapy for Palliation of H&N Cancer

Start date: July 28, 2016
Phase: N/A
Study type: Interventional

Head and neck cancer is the sixth most common form of malignancy world-wide. Surgery, chemotherapy and radiation are associated with a high burden of side effects; tumour recurrence within the neck continues to be a major cause of treatment failure. To our knowledge, this research is the first clinical study in human subjects to utilize magnetic resonance guided focused ultrasound to treat cancer of the neck. The goal is to evaluate the safety and technical feasibility of this therapy in order to guide future clinical applications such as ablation, radiosensitization or drug delivery that could ultimately improve clinical outcomes. A total of 10 patients will be treated with MR guided focused ultrasound.

NCT ID: NCT03188393 Suspended - Clinical trials for Stage IIIA Breast Cancer

Assessing the Accuracy of Tumor Biopsies After Chemotherapy to Determine if Patients Can Avoid Breast Surgery

Start date: April 13, 2017
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well biopsy of breast after chemotherapy works in predicting pathologic response in patients with stage II-IIIA breast cancer undergoing breast conserving surgery. Tumor tissue collected from biopsy before surgery may help to check if chemotherapy destroyed the breast cancer cells and may be compared to the tumor removed during surgery to check if they are the same.

NCT ID: NCT03150693 Suspended - Clinical trials for B Acute Lymphoblastic Leukemia

Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia

Start date: June 1, 2017
Phase: Phase 3
Study type: Interventional

This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.

NCT ID: NCT03142958 Suspended - Clinical trials for Rheumatoid Arthritis

Clinical Evaluation of Integra® Cadenceā„¢ Total Ankle System in Primary Ankle Joint Replacement (CADENCE)

Cadence
Start date: August 24, 2017
Phase: N/A
Study type: Interventional

A post market, prospective, non-randomized, multi-center, open-label,clinical study using survivorship as the reference performance goal to study the safety and efficacy of the Cadence Total Ankle System (TAS) when used for primary ankle arthroplasty.