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NCT ID: NCT06391697 Not yet recruiting - Amputation Clinical Trials

Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial Amputees

TTeOPRA+MB
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The e-OPRA Implant System, is a further development of the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System. The e-OPRA Implant system is an implant system for direct skeletal anchorage of amputation prostheses. The added feature in the e-OPRA Implant system, is a bidirectional interface into the human body that allows permanent and reliable communication using implanted electrodes. These electrodes will provide long-term stable bioelectric signals for an improved control of the prosthetic limb. The Magnetic Bead Tracking System, which will be implanted and used in combination with the e-OPRA Implant system, is an investigational device that consists of pairs of magnetic beads, and a set of magnetic field sensors that measure and track the length of muscles and the speed at which they move in real-time. When the beads are implanted in muscle in the residual limb of an amputee, the muscle length signal is communicated to an investigational, robotic ankle-foot prosthesis. The purpose of the study is to evaluate the feasibility of a transtibial amputee with the e-OPRA Implant System and Magnetic Bead Tracking System exhibiting full neural control over a neuro-mechanical prosthetic system. A maximum of seven subjects will be enrolled. Each subject will undergo one or more surgeries where the e-OPRA Implant System and Magnetic Bead Tracking System will be implanted. The subjects will participate in follow-up sessions the last of which occurs approximately 24 months after the surgery. This is a prospective, non-randomized, uncontrolled study.

NCT ID: NCT06391099 Not yet recruiting - Clinical trials for Metastatic Renal Cell Carcinoma

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

Start date: May 31, 2024
Phase: N/A
Study type: Interventional

This phase I trial studies how well a ketogenic dietary intervention works to improve response to immunotherapy in patients with melanoma and kidney cancer that has spread from where it first started (primary site) to other places in the body (metastatic). A ketogenic diet (KD) means eating fewer carbohydrates and more fats. The purpose is to use ketones (normal breakdown from fat) instead of glucose (sugar) as an energy source. Researchers want to see whether a ketogenic diet can improve tumor response in patients receiving immune checkpoint inhibitors (ICI). ICI are newer treatment options that help the immune system better fight some cancers. Following a KD may improve tumor response in patients with metastatic melanoma and metastatic kidney cancer treated with ICI.

NCT ID: NCT06391073 Not yet recruiting - Hypertension Clinical Trials

Reach Out 2: Emergency Department-Initiated Hypertension Mobile Health Intervention Connecting Multiple Health Systems

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Emergency department visits provide an opportunity to identify people with undiagnosed, untreated, or uncontrolled high blood pressure. In Reach Out, we will test whether a mobile health intervention yields a greater reduction in blood pressure than usual care among individuals identified with high blood pressure during a safety-net emergency department visit. Subsequently, we will estimate the reduction in heart attack, stroke, and dementia if Reach Out were implemented across all U.S. safety-net emergency departments.

NCT ID: NCT06391034 Not yet recruiting - Prostate Cancer Clinical Trials

Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer

Start date: June 1, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase 2 clinical study of hyperpolarized (HP) 13C-pyruvate (13C), 15N-urea (13C,15N) metabolic MR imaging in prostate cancer patients who are undergoing or have received radiation therapy for prostate cancer.

NCT ID: NCT06390956 Not yet recruiting - Clinical trials for Marginal Zone Lymphoma

Pirtobrutinib With Rituximab for the Treatment of Newly Diagnosed Marginal Zone Lymphoma

Start date: May 1, 2024
Phase: Phase 2
Study type: Interventional

This phase II trial tests how well pirtobrutinib in combination with rituximab works in treating patients with marginal zone lymphoma (MZL). Pirtobrutinib is a BTK inhibitor. It works by blocking the action of the protein that signals tumor cells to multiply. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving pirtobrutinib in combination with rituximab may be an effective treatment for MZL.

NCT ID: NCT06390930 Not yet recruiting - Multiple Sclerosis Clinical Trials

Effects of Acute Intermittent Hypoxia on Neuroplasticity in MS

Start date: July 2024
Phase: N/A
Study type: Interventional

This study seeks to explore changes in the neural pathways and arm function following a breathing intervention in the multiple sclerosis (MS) population. The breathing intervention, known as Acute Intermittent Hypoxia (AIH), involves breathing brief bouts of low levels of oxygen. Research has found AIH to be a safe and effective intervention resulting in increased ankle strength in people with MS. Here, the study examines arm and hand function before and after AIH. In order to better understand the brain and spinal cord response to AIH, the investigators will measure muscle response, and signals sent from the brain to the arm muscles before and after AIH.

NCT ID: NCT06390397 Not yet recruiting - Obesity, Childhood Clinical Trials

Brighter Bites & University of Texas Physicians Produce Rx Extension: Evaluating the Effectiveness of a Prospective Clinical Nutrition Study With Produce Prescriptions

Start date: April 22, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to clinically evaluate the effectiveness of an at-home delivery produce prescription in improving weight status and obesity-related health outcomes and to examine the impacts of the program on child dietary behavioral outcomes (child fruit and vegetable intake, junk food consumption, and eating at any type of restaurant), and parent feeding practices (preparing foods from scratch, use of nutrition facts labels to make purchasing decisions, and eating meals with their referent child).

NCT ID: NCT06390345 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention

FOCuSEd
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

We will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with COPD and OSA. We will include eligible participants receiving primary care at one of five Department of Veterans Affairs (VA) medical centers and their community-based outpatient clinics. We will randomize patients in a 1:1 ratio to the multi-component intervention or "enhanced" usual care, stratifying by age (≥65 vs. < 65) and site. Participants randomized to the intervention will receive an integrated, telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation. At the end of 3 months, we will offer to enter a recommendation for weight management medications on behalf of eligible intervention participants. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach. For participants randomized to the "enhanced" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs. Follow-up will occur at virtual visits at 3 and 12 months. Our primary effectiveness outcome at 1-year is quality of life measured by the SF-12 Physical Component Summary Score. Secondary effectiveness outcomes will include other measures of quality of life (including sleep related impairment), sleep disturbance, disease severity (COPD exacerbations and respiratory event index for OSA), depression, social support, weight loss and cardiovascular risk. In addition to assessing effectiveness, we will also conduct a concurrent implementation process evaluation using the RE-AIM framework.

NCT ID: NCT06390319 Not yet recruiting - T-cell Lymphoma Clinical Trials

Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)

Start date: July 2024
Phase: Phase 2
Study type: Interventional

This is a clinical trial testing whether the addition of one of two chemotherapy agents, dasatinib or venetoclax, can improve outcomes for children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia and lymphoma or mixed phenotype acute leukemia. Primary Objective - To evaluate if the end of induction MRD-negative rate is higher in patients with T-ALL treated with dasatinib compared to similar patients treated with 4-drug induction on AALL1231. - To evaluate if the end of induction MRD-negative rate is higher in patients with ETP or near-ETP ALL treated with venetoclax compared to similar patients treated with 4-drug induction on AALL1231. Secondary Objectives - To assess the event free and overall survival of patients treated with this therapy. - To compare grade 4 toxicities, event-free survival (EFS) and overall survival (OS) of patients treated with this therapy in induction and reinduction to toxicities of similar patients treated on TOT17.

NCT ID: NCT06390267 Not yet recruiting - Clinical trials for Cognitive Performance

Effect of Transcutaneous Auricular Neurostimulation on Cognitive Performance in a Laboratory Model of Acute Stress Reaction

ASR
Start date: August 2024
Phase: N/A
Study type: Interventional

The objective of this study is to test the effects of transcutaneous auricular neurostimulation (tAN) in treating or preventing performance degradation after an acute stressor.