All Clinical Trials

This phase I trial tests the safety, side effects, and best dose of SNDX-5613 and gilteritinib for treating patients with acute myeloid leukemia that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) and has a mutation in the FLT3 gene along with either a mutation in the NMP1 gene or a type of mutation called a rearrangement in the MLL gene. SNDX-5613 is in a class of medications called menin inhibitors. It works by blocking the action of mutated MLL and NMP1 proteins that signal cancer cells to multiply. Gilteritinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of mutated FLT3 proteins that signal cancer cells to multiply. Giving SNDX-5613 with gilteritinib may be safe, tolerable and/or effective in treating patients with relapsed/refractory FLT3 mutated acute myeloid leukemia. Read Less

The purpose of this study is to investigate whether protocolized vasopressor use for patients with normal blood pressure undergoing rapid sequence intubation improves hemodynamic parameters and mitigates adverse events. The hypothesis is that use of vasopressors during Rapid Sequence Intubation will prevent substantial decreases in blood pressure when compared to normal intravenous fluids. Read Less

A phenome-wide association study (PheWAS) identified an association between a variant in the human gene for the N2A subunit of the N-methyl-D-aspartate (NMDA) receptor, GRIN2A, and Systemic Lupus Erythematosus (SLE). A single nucleotide polymorphism (SNP) in this gene encodes for increased NMDA receptor activity. Based on the potential function of the associated SNP and published literature, alterations in SNP function signaling may underlie a cluster of symptoms. The objective of this study is to evaluate the safety, tolerability and efficacy of memantine, an NMDA receptor antagonist, in a precise patient subset with SLE. Participants will complete a full 14-week clinical trial, receiving either memantine or a placebo. Participants' blood will be drawn to test for various antibodies as well as organ function. Patients' urine will also be collected to assess organ function and pregnancy for females at a number of specific time points. The overall goal is to develop a safe and inexpensive therapeutic approach to reduce debilitating cognitive symptoms in a precisely selected SLE sub-population. Read Less

This clinical trial studies the side effects of stereotactic radiosurgery and how well it works with or without vertebroplasty, separation surgery, or immunotherapy in patients with cancer that is radiation resistant and has spread to the spine (spinal metastases). Spinal metastases are rapidly progressive, have poor prognosis, are extremely difficult to treat, and can effect patient quality of life and overall health. Immunotherapy is a type of standard of care therapy to boost or restore the ability of the immune system to fight cancer. Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. A vertebroplasty is a procedure used to repair a bone in the spine that has a break caused by cancer, osteoporosis, or trauma. The purpose of this trial is to test different combinations of immunotherapy, stereotactic radiosurgery, and surgery to improve overall survival and quality of life in patients with spinal metastases. Read Less

The overall purpose of this study is to evaluate the efficacy of an intervention designed to prevent nurse suicide. This randomized controlled trial will test the modified Interactive Screening Program (mISP) alone and the mISP combined with a program called MINDBODYSTRONG. The mISP is a method of screening to detect clinicians at moderate to high risk for suicide and referring them for treatment through an encrypted anonymous on-line platform. MINDBODYSTRONG© is an adaptation of a well-tested cognitive-behavioral skills building intervention (also known as COPE in the literature) that provides a cognitive-behavior theory-based approach to decrease depression, anxiety and suicidal ideation and improve healthy lifestyle beliefs and behaviors in at-risk populations. MINDBODYSTRONG© will involve eight self-paced computerized sessions designed specifically for nurses and clinicians. Nurses will be recruited nationally through the professional nursing organizations and health systems. Read Less

The standard treatment for participants whose cancer has returned after breast conserving surgery is radiation given twice daily (separated by at least 6 hours) for a total of 30 treatments. The purpose of this study is to find out if giving radiation once a day for 15 treatments after repeat breast conserving surgery works as well as giving it the standard way. Read Less

The innovative MPBA+F begins with peer-to-peer mentoring followed by structured parental/family support for long-term reinforcement of PA behaviors. Building and reinforcing skills, MPBA+F mitigates resource stressors and strengthens protective factors by providing culturally appropriate knowledge and skills to improve the sustainability of physical activity at home without the use of exercise equipment. By strengthening social support through peer and friendship networks and family-based support, MPBA+F responds to the unique needs of rural Appalachians in a culturally responsive way. This study targets physical activity among children with overweight, obesity, or extreme obesity because rural Appalachian communities identify sedentary activity as a key contributor to the high rates of obesity and diabetes risk among youth. Read Less

This phase I trial is to find out the possible side effects of pembrolizumab and radiation therapy before and during surgery in treating patients with head and neck squamous cell cancer that remains despite treatment (persistent) or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, 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 or protons to kill tumor cells and shrink tumors. Giving pembrolizumab and radiation therapy before and during surgery may kill more tumor cells. Read Less

The purpose of this study is to determine if the Fractionated Laser Resurfacing (FLR) procedure can protect one forearm/wrist from precancerous actinic keratosis (AKs) as well as prevent skin cancer in older subjects with active AKs. This study builds on a similar study ongoing at the Dayton Veterans Administration dermatology clinic. This study is also testing if a photograph of the skin can be used to predict where the AKs and an skin cancers will form. Read Less

This is an investigator initiated, prospective study to demonstrate the safety and feasibility of implantation of the V-Wave Interatrial Shunt System (herein called the "V-Wave Shunt" in patients immediately following percutaneous mitral valve repair using the MitraClip system. Read Less

The purpose of this study is to test the safety and feasibility of recording brain activity within and around high-grade glioma tumors at the time of surgery. A small biopsy will be taken at the sites of the recordings. Read Less

The primary objective of this study is to tailor and test implementation strategies to support the adoption of two upper extremity motor outcome measures for stroke: the Fugl-Meyer Assessment and the Action Research Arm Test. The study's interdisciplinary team will address this objective through the following specific aims: (a) Tailor a package of implementation strategies (referred to as I-STROM-Implementation STRategies for Outcome Measurement) to promote outcome measure use across the care continuum, (b) Determine the effectiveness of I-STROM on outcome measure adoption and (c) Evaluate the appropriateness, acceptability, and feasibility of I-STROM in rehabilitation settings across the country. The mixed-methods study design is informed by implementation science methodologies, and the tailoring of I-STROM will be guided by input from stakeholders, including occupational therapy practitioners and administrators. The investigators will collect robust quantitative and qualitative data by means of retrospective chart reviews, electronic surveys, and stakeholder focus groups. This study, "Strategies to Promote the Implementation of Outcome Measures in Stroke Rehabilitation," will address core barriers to outcome measure use through a package of implementation strategies, thus laying the groundwork for I-STROM scale-up in health systems nationwide. Read Less