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NCT ID: NCT05548127 Recruiting - Breast Cancer Clinical Trials

TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A)

Start date: February 23, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called ARV-471) when given together with other medicines for the potential treatment of advanced or metastatic breast cancer. This study is seeking participants who have breast cancer that: - is advanced, may have spread to other organs (metastatic) and cannot be fully treated by surgery or radiation therapy - is sensitive to hormonal therapy (it is called estrogen receptor positive); and - is no longer responding to previous treatments This study is divided into separate sub-studies. For Sub-Study A: All participants will receive ARV-471 and a medicine called abemaciclib. ARV-471 will be given by mouth, at home, 1 time a day. Abemaciclib will be given by mouth, at home, 2 times a day. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective. Participants will continue to take ARV-471 and abemaciclib until their cancer is no longer responding, or side effects become too severe. They will have visits at the study clinic about every 4 weeks.

NCT ID: NCT05547620 Recruiting - Orthostatic Tremor Clinical Trials

Modulating Cerebellar Activity With Low-intensity Focused Ultrasound Stimulation for Primary Orthostatic Tremor

LIFUS-POT
Start date: March 8, 2021
Phase: N/A
Study type: Interventional

Primary orthostatic tremor (POT) is a rare movement disorder that is manifested through high frequency tremor of weight bearing limbs. This is often accompanied by a debilitating sensation of falling. POT has been linked to abnormal activity of the cerebellum, a structure deep within the brain. However, established non-invasive brain stimulation techniques can only modulate brain activity and plasticity in superficial brain areas with low spatial resolution. This limits their efficacy when targeting the cerebellum. In contrast, low intensity focused ultrasound (LIFUS) is a novel non-invasive brain stimulation technique that permits stimulation with high spatial focality and can reach greater depth compared other methods. Therefore, LIFUS is well suited to modulate cerebellar activity and has the potential to be a superior technique for the management of POT. This study will investigate the effectiveness of MRI-guided bilateral cerebellar LIFUS stimulation for the treatment of POT and evaluate the underlying changes in brain circuits caused by the stimulation. Comparisons between symptoms and connectivity of brain circuits pre- and post-stimulation will be conducted to assess the effects of cerebellar LIFUS. The effects of real stimulation will also be compared to sham stimulation. This study is the first to apply LIFUS for neuromodulation in POT and will be critical in developing therapeutic LIFUS protocols.

NCT ID: NCT05547217 Recruiting - Stroke Clinical Trials

Gamification of Neurorehabilitation-centric Hand Exercises Post Stroke or Brain Injury

Start date: September 19, 2022
Phase: N/A
Study type: Interventional

Stroke is the leading cause of adult disability worldwide. Often, severe neurological deficits occur after a stroke and roughly 70% of all stroke survivors have some form of hand function disability. To improve the lives of those with hand function disability, IRegained Inc. has created the MyHandTM System. The MyHandTM System is a smart-mechatronic device programmed with proprietary hand function training regiments (protocols) based on deep research in neuroplasticity. It provides a highly unique and targeted approach to hand function rehabilitation with the help of the aforementioned protocols delivered with gamified training techniques. The gamified format of the protocols allows for better patient engagement, thus allowing for more effective and efficient therapy. Individuals who have sustained a stroke 5 months or earlier (considered to be chronic stroke survivors) will be eligible to participate in this study. Participants will undergo a 2-hour training session, 2-3 days per week, over 12 weeks, for a total of 30 sessions. Hand function therapy will be administered in a specific and gamified manner to enhance rehabilitation of the hand and provide participants with greater opportunity to regain hand function over the course of the study. The goal of this research project is to understand how a gamified approach to hand function rehabilitation impacts engagement and motivation. This understanding will directly translate into the development of more efficient and effective modes of therapy.

NCT ID: NCT05546359 Recruiting - Clinical trials for Nausea and Vomiting, Postoperative

Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients

Start date: January 18, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Randomized, double-blind, pediatric trial of amisulpride for prophylaxis of post operative nausea and vomiting

NCT ID: NCT05546281 Recruiting - Type 1 Diabetes Clinical Trials

Study of the Characteristics of Orthorexia Nervosa in the Population Living With Type 1 Diabetes

Santal-DT1
Start date: October 1, 2022
Phase:
Study type: Observational

In the general population, the excessive and constant desire to control one's diet and body has become increasingly problematic. Indeed, the demand for control over one's diet and body is now an unspoken social prescription that can lead in some cases to eating disorders. In patients with type 1 diabetes (T1D), these concerns are even more central, as they are accentuated by the very nature of the treatment of the disease (dietary modification, insulin compensation according to food intake, etc.). Studies on adolescents with T1D show that the prevalence of eating disorders would be present in at least 1 in 5 patients. Among these disorders, orthorexia is of particular interest. Indeed, orthorexia was defined in 1997 by Steven Bratman as a rigid eating behavior based on the avoidance of foods considered qualitatively unhealthy. More precisely, orthorexia is characterized by a constant preoccupation with one's diet and persistent nutritional (or health) beliefs that take precedence over food pleasure. It has been estimated that the prevalence of orthorexia in patients living with T1D may be as high as 80%. We are currently conducting a study on the mechanisms of orthorexia in the general population of Quebec (the results of phase 1 of this study are being analyzed). We now wish to conduct the same study in a population with T1D, which has a higher prevalence of people with orthorexia nervosa. The main objective of this study is to investigate the characteristics of orthorexia nervosa (obsessions and fixations on healthy eating) in the Quebec population with T1D from the BETTER Registry.

NCT ID: NCT05546268 Recruiting - Prostate Cancer Clinical Trials

Study of Oral MRT-2359 in Selected Cancer Patients

Start date: October 12, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This Phase 1/2, open-label, multicenter study is conducted in patients with previously treated selected solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), high-grade neuroendocrine cancer of any primary site, diffuse large B-cell lymphoma (DLBCL), and tumors with L-MYC or N-MYC amplification. Patients receive escalating doses of a GSPT1 molecular glue degrader MRT-2359 to determine safety, tolerability, maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of MRT-2359. Once the MTD and/or RP2D is identified, additional patients enroll to Phase 2 study, which includes molecular biomarkers stratification or selection, namely expression or amplification of L-MYC and N-MYC genes, hormone receptor positive (HR)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer and prostate cancer.

NCT ID: NCT05545839 Recruiting - Autoimmune Diseases Clinical Trials

Transition to Adulthood Through Coaching and Empowerment in Rheumatology

TRACER
Start date: October 17, 2022
Phase: N/A
Study type: Interventional

TRACER is a study aiming to investigate the feasibility of transition coaching sessions for patients moving from paediatric to adult rheumatology care.

NCT ID: NCT05544929 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers

Start date: October 26, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the safety and tolerability of KFA115 and KFA115 in combination with pembrolizumab in patients with select advanced cancers, and to identify the maximum tolerated dose and/or recommended dose.

NCT ID: NCT05543941 Recruiting - Knee Osteoarthritis Clinical Trials

Evaluating XPERIENCE™ Advanced Surgical Irrigation

XPERIENCE
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

A prospective, multi-center, double-arm, parallel, interventional, randomized, controlled clinical trial to assess the rate of periprosthetic joint infection (PJI) in patients undergoing primary total knee arthroplasty (TKA), total hip arthroplasty (THA) or hip resurfacing (HR) with XPERIENCE™ (XP) Advanced Surgical Irrigation versus dilute Betadine (DB).

NCT ID: NCT05543720 Recruiting - Hypertension Clinical Trials

Evaluation of Nurse-led Integrated Care of Complex Patients Facilitated By Telemonitoring: The SMaRT Study

Start date: October 17, 2022
Phase: N/A
Study type: Interventional

In Canada, 3 out of 4 Canadians aged 65 and older have at least one chronic condition, while 1 in 4 seniors reported having three or more. Caring for complex patients who usually have multiple chronic conditions (MCC) is one of the biggest challenges facing our healthcare system. For patients, the lack of coordination and continuity of care as they transfer between healthcare settings and healthcare providers (HCPs) often results in a higher risk of readmission, suboptimal and fragmented care plans, delays in required medical intervention, inadequate self-care, and confusion on whom they should contact when they have questions. For the patient's care team, they often have no indication how patients are doing between clinic visits unless the patient can provide a log of their home measurements (e.g., blood pressure). Therefore, they are unable to detect and intervene if their patient's health is worsening between visits. In order to address this increasing need to bridge the current gap in clinical management and self-care of complex patients during their transition from healthcare settings to home care, our team aims to design, implement and evaluate the SMaRT (Safe, Managed, and Responsive Transitions) Clinic, a nurse-led integrated care model facilitated by telemonitoring (TM). Specifically, the SMaRT Clinics aim to meaningfully introduce a nurse (or nurse practitioner) role to improve clinical coordination across patient care teams and reinforce proper self-care education through the use of telemonitoring. This project will be conducted in two phases across four years; Phase I: Design and Development, and Phase II: Implementation and Effectiveness Evaluation. Phase II research activities include enrolling 350 patients with complex chronic conditions in the SMaRT clinics across four study sites. The implementation and effectiveness of the SMaRT clinics will be evaluated through a mix of semi-structured interviews, ethnographic observation, patient questionnaires, and analyses of health utilization outcomes using propensity-matched controls from the ICES provincial database.