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NCT ID: NCT05417516 Recruiting - Radiotherapy Clinical Trials

A Randomized Trial of Five Fraction Partial Breast Irradiation

Start date: November 20, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine in women with node negative BC ≤3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.

NCT ID: NCT05417347 Recruiting - Obesity Clinical Trials

Full-fat Dairy Products, Body Weight Control and Metabolic Health

Start date: June 19, 2021
Phase: N/A
Study type: Interventional

The aim of this research is to clarify the role of different dairy products including both full-fat and low-fat dairy in maintaining health in adults and children through its effects beyond their well-known contribution of healthy nutrients. The deleterious health consequences of obesity are recognized as a major financial burden to health care systems. Diets rich in fruits and vegetables and that also include dairy products have been suggested to play a role in the control of body weight and other aspects of health including the maintenance of healthy gut bacteria. In contrast, full-fat diets, especially those high in saturated fat, have been linked with negative health effects. Although dairy products represent an important source of saturated fat, it has been proposed that the combination of nutrients and complex food forms of the various dairy products may in fact counteract the negative effects of the fat. Thus, increased consumption of dairy products could very likely provide a partial dietary solution to improved body weight and metabolic health. Therefore, we are investigating the role of both full-fat and low-fat dairy products in their different physical forms (i.e. varying levels of fat that contribute to different textures) on appetite, food intake, control of blood sugar (glucose), body weight, cholesterol levels, and blood pressure in both children and adults. Existing dairy products (milk, cheese, and yogurt) ranging in fat content will be compared for their effects on satiety, food intake, glucose, insulin, satiety hormones, gut bacteria and other metabolic parameters linked to cardiometabolic health in normal weight children and adults, as well as in children and adults living with overweight and obesity.

NCT ID: NCT05416385 Recruiting - Clinical trials for Cardiovascular Diseases

Carotid Intraplaque Neovascularization Combined With Stress Echo

CIRCE
Start date: August 16, 2021
Phase:
Study type: Observational

The root cause of heart attacks and strokes is atherosclerosis, the hardening and thickening of blood vessels due to the presence of "plaque" which is a build-up of fat and cholesterol in the walls of vessels. To diagnose heart disease, patients receive a stress test to find out if they require surgery. Up to 52% of patients receiving an angiogram (surgery) to look at plaque blockages in the heart are found to be normal (no blockage). Patients who are suspected of having heart disease often undergo a stress test, which helps cardiologists decide if the patient has heart disease, but stress tests can give false results. In Ontario alone, 90% are stress tests are found to be normal and patients are sent home with little follow-up. Of these 3-5% (~4,000 patients/year) will have a major cardiovascular event (heart attack, surgery, or death) within 3 years. We need to improve the stress test accuracy to reduce cardiac outcome. We now know that it is not just the total amount of plaque that leads to heart attacks and strokes, but the composition of the plaque that can lead to breakage causing a heart attack. Plaques are soft and fragile, and typically contain fat and small leaky blood vessels within their cores. If we are able to identify patients that have leaky plaques using ultrasound, we may be able to improve the accuracy of stress testing. We propose a study looking at the combination of stress testing (assessing heart function) and neck ultrasound (assessing plaque composition), to identify patients at risk for cardiovascular events (heart attacks and death). We will enrol patients from 6 sites across Canada and follow-them for cardiac outcome for 3 years.

NCT ID: NCT05414058 Recruiting - Clinical trials for Schizophrenia Schizoaffective

Adjunctive Methylphenidate ER in Patients With Schizophrenia to Improve Functional and Cognitive Outcomes

Start date: September 9, 2022
Phase: Phase 2
Study type: Interventional

Two of the major features of schizophrenia spectrum illness, negative and cognitive symptoms, have been associated with poor functional outcome and burden of illness. Given the proposed role of dopaminergic hypoactivity, augmentation with psychostimulants has been postulated as one of the potential treatment options for negative and/or cognitive symptoms of schizophrenia. The major drawback for use of these agents is a potential risk of relapse or worsening of psychosis through direct or indirect dopamine agonism activity and a great deal of caution has been called for use of stimulants in individuals with psychosis. However, preliminary results of earlier studies indicated improvement of negative and cognitive symptoms with off-label use of adjunctive psychostimulants. The present study aims to assess off-label use of adjunct psychostimulants in patients with schizophrenia in a tertiary mental health centre, focusing on efficacy and safety.

NCT ID: NCT05414032 Recruiting - Clinical trials for Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Molecular Residual Disease Interception in Locoregionally-Advanced High Risk HPV+ and HPV- HNSCC

MERIDIAN
Start date: July 12, 2023
Phase: Phase 2
Study type: Interventional

This is a phase II, open-label study to assess the efficacy of AZD2936 in terms of molecular residual disease (MRD) clearance and treatment outcome in patients with MRD after definitive treatment for high risk locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). MRD is defined as ctDNA detection in plasma after definitive treatment. Approximately 200 patients are expected to be enrolled.

NCT ID: NCT05413915 Recruiting - Clinical trials for Chronic Myeloid Leukemia

Asciminib Used in Consolidation With Imatinib vs. Imatinib to Achieve TFR in CP-CML

Start date: June 19, 2023
Phase: Phase 3
Study type: Interventional

The aim of this study is to establish if consolidation of imatinib-treated patients in stable DMR through the addition of asciminib, can lead to superior rates of TFR1, compared to imatinib alone in Chronic Phase-Chronic Myelogenous Leukemia patients.

NCT ID: NCT05413473 Recruiting - Cancer Clinical Trials

Northern Alberta Linac-MR Image-Guided Radiotherapy (Northern LIGHTs-2)

Start date: February 8, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Cancers are often treated with external beam radiotherapy. Current radiotherapy treatments are performed using computed tomography (also known as CT) scans which may not always clearly identify the cancer. In some instances, magnetic resonance imaging (MRI) may be able to better identify cancers. Therefore, efforts are currently underway to use the MRI scans to improve radiotherapy treatments or eventually even use radiotherapy equipment that only uses MRI scans to guide treatments. This new technology that will only use MRI scans to guide treatments is called the Linac-MR (linear accelerator with an MRI). This new Linac-MR is a unique innovation at the Cross Cancer Institute, with theoretical advantages over other Linac-MR machines that are being tested elsewhere in the world. This feasibility study is being done as a first step in clinical development of the Linac-MR, as this new technology has to be tested to see if it is acceptable to both doctors and participants. The purpose of this Phase I/II study is (1) to verify treatment completion as intended and scheduled the oncology team, and (2) to evaluate treatment effects, including any expected or unexpected radiation side effects and cancer response to radiation. This study will allow the researchers at the Cross Cancer Institute to develop this technology further by conducting additional studies to take advantage of MRI scanning on tumor tracking during radiation treatments.

NCT ID: NCT05411562 Recruiting - COVID-19 Clinical Trials

COVID-19 Genomic Sequencing for Nosocomial Outbreak Investigations

NOSO-COVID
Start date: November 9, 2020
Phase:
Study type: Observational

This is a tertiary care hospital-based prospective molecular epidemiology study in Montreal, Canada. When nosocomial transmission was suspected by local infection control teams' investigations, SARS-CoV-2 viral genomic sequencing was performed locally for all putative outbreak cases and contemporary controls. Molecular and conventional epidemiology data were confronted in real time to improve understanding of COVID-19 transmission and reinforce or adapt prevention measures.

NCT ID: NCT05411302 Recruiting - Clinical trials for Major Depressive Disorder

Augmenting Mental Health Support Through a Supportive Text Messaging Program

Text4Support
Start date: October 3, 2022
Phase: N/A
Study type: Interventional

Patients seeking mental health care and those being discharged from psychiatric units frequently express psychological distress. A lack of routine follow-up and tailored support during these critical stages of a patient's journey can weaken the patient's connection to the health care system, resulting in low adherence and dissatisfaction with treatment, and the need for more intensive therapies. These unfavourable outcomes may result in deterioration of the patient's mental health, readmissions, recurrent emergency department (ED) visits, and extended length of stay (LOS). The investigators propose implementing an add-on supportive text messaging service (Text4Support), developed using cognitive-behavioural therapy (CBT) principles to augment mental health support for patients accessing different degrees of psychiatric care in Nova Scotia. The primary objective is to investigate the effectiveness of Text4Support, compared to usual care, in improving clinical mental health outcomes and overall mental wellbeing among participants. Secondary objective is to examine the impact of Text4Support on health services utilization and patient satisfaction. Lastly, investigators will explore Text4Support implementation outcomes. This will be a multicenter, mixed-methods, longitudinal, prospective, parallel, two-arm, rater-blinded randomized controlled trial. Participants will be randomized into two arms: the intervention arm will receive the usual care, plus daily automated supportive text messages from an online application, and the control arm will receive the usual care, which includes the freely accessible Health Authority approved e-mental health services. It is planned to enrol at least 1500 participants. Quantitative data will be analyzed using repeated measures mixed-effects modelling, effect size analysis, and correlational analysis between measures at each time point on an intention-to-treat basis. Qualitative data analysis will be guided by the six-phase thematic analysis framework. The analysis of the implementation outcomes will be guided by the RE-AIM framework. The results of the study will provide important information with respect to a comprehensive evaluation of outcomes of a supportive daily text message program; comparability of a supportive daily text message program compared with care as usual; and the impact of a supportive daily text message program on clinical outcomes, patient satisfaction and health services utilization.

NCT ID: NCT05411094 Recruiting - Clinical trials for Stage III Pancreatic Cancer AJCC v8

Testing the Safety of the Anti-Cancer Drugs Durvalumab and Olaparib During Radiation Therapy for Locally Advanced Unresectable Pancreatic Cancer

Start date: May 22, 2023
Phase: Phase 1
Study type: Interventional

This phase I trial tests the safety and tolerability of olaparib in combination with durvalumab and radiation therapy in patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable). Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. The combination of targeted therapy with olaparib, immunotherapy with durvalumab and radiation therapy may stimulate an anti-tumor immune response and promote tumor control in locally advanced unresectable pancreatic cancer.