All Clinical Trials

The purpose of this study is to test the safety and effectiveness of using brodalumab in patients who develop side effects from cancer immune therapy. Immune-related side effects are due to activation of the immune system in patients who previously received immunotherapy and the goal of this study is to help better control these side effects. Brodalumab is often used to treat patients with autoimmune diseases (diseases where the immune system is activated against normal organs) and safe doses and treatment schedules have been determined in these patients. Immune-related side effects appear to closely mirror these autoimmune conditions. Brodalumab has not been approved by the United States Food and Drug Administration (FDA) for use in immunotherapy side effects but it has been approved for treatment of autoimmune conditions. Read Less

The central hypothesis of this research study is that perioperative administration of the proton pump inhibitor (PPI) pantoprazole could reduce the development of acute kidney injury (AKI) following cardiac surgery by activation molecular pathways for kidney protection. The investigators propose a single-center, randomized, controlled, single-blinded trial to determine whether perioperative intravenous administration of pantoprazole will reduce the incidence of AKI, some molecules that can be detected the urine, and major adverse kidney events (MAKE) at day 30 postoperatively, compared to famotidine after cardiac surgery. The specific aims of the study will be achieved by randomizing a group of 400 patients to receive pantoprazole (study) or famotidine (control) for 3 days perioperatively. Our study population will include any adult patients (aged over 18 years) scheduled for cardiac surgery requiring a cardiopulmonary bypass machine. Read Less

The goal of this pilot clinical trial is to find out how well low dose naltrexone works for people with pain due to spinal cord injury. The main questions it aims to answer are: will low dose naltrexone reduce pain, and increase the quality of life for people with central neuropathic pain due to spinal cord injury. Hypothesis 1: LDN will decrease the severity of CNP in adult patients with SCI as measured by the Neuropathic Pain Scale (NPS) Hypothesis 2: LDN will improve quality of life of patients with SCI as measured by various validated clinical tools There is no comparison group. This study is being completed to give investigators more information for how to best run a larger clinical trial. Participants will be asked to take an oral dose of 4.5mg of naltrexone, daily, for 12 weeks. Read Less

Master protocol: The main goal of this master clinical study is to evaluate the efficacy and safety of multiple novel combination therapies in participants with head and neck squamous cell carcinoma (HNSCC) in various substudies. Read Less

This study will validate the experimental method and chamber facility at the Duke Center for Hyperbaric Medicine \& Environmental Physiology and test team capabilities to support NASA decompression sickness (DCS) studies. This project is related to development of protocols for extravehicular activity (EVA, "spacewalks") to minimize the risk of decompression sickness. Duke will perform four test days, collecting and recording data each day. Each test day will involve 3 volunteer subjects ages 18-50 years, who will breathe 100% oxygen for 6 hours. This will be followed by 6 hours in the hypobaric chamber at 1/3 atmosphere, during which subjects will perform various tasks, including arm and leg exercises, and undergo ultrasound testing to detect vascular bubbles. End-points will include bubble scores, and decompression sickness (DCS). If subjects develop DCS symptoms they will immediately be recompressed to ambient pressure and be assessed and treated. Read Less

The goal of this pilot randomized controlled trial is to test the feasibility, acceptability, and preliminary signal of effect of a combined school- and home-based sleep promotion program for young children prior to the kindergarten transition. Read Less

Deaf older adults 60 years and older are enrolled into an 8-week exercise program delivered in American Sign Language. The class meets twice a week, with handout and video homework. Outcome measures are self-reported balance confidence, lower extremity strength, walking and agility, and standing balance. In addition, attendance and keeping up with exercises at home will be tracked. Read Less

This is a randomized, double-blind, placebo-controlled study of B07, administered daily by subcutaneous (SC) injection, in up to 100 patients with newly diagnosed metastatic colorectal cancer. This study will evaluate different doses of B07 on weight, body composition and BMI in patients with sub-optimal BMIs (18 to ≤ 29 kg/m2). Treatment will begin on the same day as the start of cancer chemotherapy and continue during the first 28 days of cytotoxic therapy with a goal of preserving muscle and fat mass, relative to placebo control. Read Less

A multicenter study will be conducted to assess the role of the AI/ML technologies of Origin Medical EXAM ASSISTANT (OMEA) in interpreting first-trimester fetal ultrasound examinations (11 weeks 0 days - 13 weeks 6 days). The performance of the AI-based system will be compared against the ground truth provided by an independent reading panel of maternal-fetal medicine physicians. Read Less

The goals of this randomized controlled trial are 1) to test the efficacy of an app-based program in reducing physician burnout vs. no app (control) in 100 physicians; 2) to explore the role of an online live training to augment outcomes and develop an ongoing and sustainable support community with a subsample of physicians. Read Less

The overall objective of this project is to advance understanding of the causes of normal weight obesity (NWO) in men, namely the hormone profile and related potential mediating mechanisms, and the efficacy of different modes of exercise to restore body composition and cardiometabolic health in this population. Read Less

This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis. Read Less