There are about 28871 clinical studies being (or have been) conducted in Canada. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Main objective: To evaluate the bidirectional relationships between physical exercise and sleep parameters, as a part of multimodal prehabilitation intervention, on pre- and postoperative outcomes in surgical patients with colorectal cancer, in an RCT. Secondary objective: to determine whether the levels of anxiety and depression affect these relationships. Objectives are based on the overarching hypothesis that is sleep and physical activity influence each other through complex, reciprocal interactions including multiple physiological and psychological pathways. To achieve this, providing a multimodal prehabilitation, specifically physical exercise, involved in mental and physical health through different mechanisms, i.e., improving physical functioning and fitness, reducing side effects of cancer treatments, preventing bone loss and weight gain, improving the quality of life and sleep, decreasing symptoms of fatigue and depression. The present is a pilot study aiming to evaluate the bidirectional relationships between sleep and physical exercise, and the preliminary outcome has important implications for informing both clinical and public health practice. Research question: Does a multimodal intervention including physical exercise improve sleep quality and duration compared to standard of care, during the perioperative period? Conversely, does a better sleep quality and duration increases the level of physical exercise during the perioperative period? How the level of anxiety and depression will affect these relationships? If the Prehabilitation program specifically physical exercise will positively affect sleep quality and duration after surgery, in the way to be a protective factor of sleep to not be reduced by up to 55% compared to those receiving standard of care?
Primary Objectives: - Safety run-in: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) - Randomized Phase 3: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in subjects with high-risk SMM Secondary Objectives: Safety run-in - To assess overall response rate (ORR) - To assess duration of response (DOR) - To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR) - To assess time to diagnostic (SLiM CRAB) progression or death - To assess time to first-line treatment for multiple myeloma (MM) - To assess the potential immunogenicity of isatuximab - Impact of abnormal cytogenetic subtype on participant outcome Randomized Phase 3 - Key Secondary Objectives: To compare between the arms - MRD negativity - Sustained MRD negativity - Second progression-free survival (PFS2) - Overall survival Other Secondary Objectives: To evaluate in both arms - CR rate - ORR - DOR - Time to diagnostic (SLiM CRAB) progression - Time to biochemical progression - Time to first-line treatment for MM - Safety and tolerability - Pharmacokinetics (PK) - Potential of isatuximab immunogenicity - Clinical outcome assessments (COAs)
The first line of therapy for cervical dystonia patients is botulinum toxin injections, however injection parameter determination and optimization are challenging for physicians to do. In addition, some patients receiving this treatment long-term experience short duration of relief. Thus, Dysport (Ipsen Biopharmaceuticals), another BoNT-A formulation, may increase the duration of clinical benefit. The objective of this study is to compare the wearing off time of their original BoNT-A formulation (same injection parameters for at least 3 cycles) and the optimized treatment of Dysport (after 2 injection cycles). Ideally, the clinical benefits should last 2.5 - 3 months as injections are administered every 3 months. Conversion to Dysport will be conducted and optimization of Dysport dosing will be done using our sensor-technology assessment. It is unclear whether there are differences in the neurophysiological effects between BoNT-A formulations, such as blocking spinal afferent signals from proprioceptive mechanoreceptors of the injected muscles contributing to CD or the modulation of cortical activity [8]. The underlying pathophysiology of impaired motor control in CD is theorized to be caused by abnormal somatosensory processing that affects proprioceptive and tactile function [8]. By altering the processing of proprioceptive signals from the muscles to the cortical somatosensory-motor areas, proprioceptive perception can be modulated and possibly normalize activity of the somatosensory-motor areas in CD. Thus, it is hypothesized that BoNT-A may indirectly modulate these cortical pathways and Dysport may have a longer modulatory effect to produce a longer lasting clinical response.
This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.
A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.
Anticoagulation and coagulation management during ECMO is a challenge. Bleeding and clotting are major sources of morbidity and mortality. The currently used strategies are of poor evidence. This observational study wants to evaluate the use of automated thromboelastography (TEG 6s) to guide the management of coagulation and anticoagulation in patients supported by ECMO
The purpose of this study is to determine whether the Optimal Acuity Clear-K® Low Vision Aid System provides a safe and effective treatment to improve vision for patients with age-related macular degeneration.
This study is to see if the standard of care subcutaneous injection of bortezomib can safely be administered at home by the patient or caregiver. All tests and assessments are based on standard of care procedures.
Most older people want to stay at home as long as possible. Effective self-management for people losing autonomy depends on reliable monitoring of their mobility, health and safety and active implication in decision-making. New technologies have the potential to provide information about changing patterns that reflect changing care needs. This information could help older adults, caregivers and health professionals to participate in decision-making about housing options when a change in living environment needs to be considered.
The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH).