All Clinical Trials

Sleep deprivation is a major problem in military populations. Some major consequences of sleep loss are inability to concentrate, poor work efficiency, and increase in errors during daily tasks. There is some evidence that ketone ester supplements may lessen the adverse effects of sleep restriction. The main purpose of these supplements is to raise your blood concentration of ketones, which are safe, small molecules that appear in the blood during fasting, when following a ketogenic diet, or consuming ketone supplements. The main purpose of this study is to examine if ingesting a ketone ester supplement, twice daily, can improve cognitive and physical performance during short-term sleep restriction. Read Less

The ACHIEVE RCT will measure the effect of the intervention (mHealth app with CGM, provider dashboard, and care team coaching) compared to current standard care (prenatal visits, self-monitored blood glucose, and certified diabetes care and education specialist) on achieving glycemic control (hemoglobin A1c \<6.5% in the third trimester). We hypothesize a 25% absolute increase in the proportion of participants in the intervention group who will meet the target hemoglobin A1c \<6.5% in the third trimester compared to the standard care group Read Less

Suicide is the leading cause of death among YEH and most youth do not access services that may be available to them. Therefore, this study seeks to address this gap in the research literature with the goal to identify an effective intervention that can be readily adopted by communities that serve these youth. We will test the effects of outreach-worker delivered Cognitive Therapy for Suicide Prevention (CTSP)+Services as Usual (SAU) versus SAU alone on suicidal ideation (primary outcome), substance use and depressive symptoms (secondary outcomes) at 3, 6, 9 and 12- months. Read Less

The proposed research is a parallel arm, randomized placebo-controlled clinical trial designed to assess changes in muscle strength, volume, fatigue resistance, and mobility in older adults after daily consumption of 12g of linoleic acid-rich oil. Read Less

This phase I trial tests the safety, side effects, and best dose of anti-glycoprotein-A repetitions predominant (GARP) chimeric antigen receptor (CAR) T cell therapy and how well it works in treating patients with grade III or IV gliomas that have come back after a period of improvement (recurrent). CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein, such as GARP, on the patient's tumor cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain tumors. Giving anti-GARP CAR T cell therapy may be safe, tolerable, and/or effective in treating patients with recurrent grade III or IV gliomas. Read Less

The FORTRESS trial (NG-350A-03) is an open-label, single-arm, and multicentre trial of NG-350A in combination with chemoradiotherapy (CRT) in adult patients with locally advanced rectal cancer (LARC) and at least one risk factor for local or distant recurrence. 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

The goal of this clinical trial is to test and improve an online program for caregivers of young childhood cancer survivors called the Preparing for Life and Academics for Young survivors program (PLAY). The PLAY program was created with a group of caregivers of young children with cancer and healthcare providers. Ultimately, investigators hope to see if the program can improve positive parenting behaviors, reduce caregiver stress, and help get young children ready for school. In the preliminary phase of this clinical trial, investigators are aiming to answer these questions: 1. Are caregivers of childhood cancer survivors willing to participate in the PLAY program and complete assessments before and after the program? 2. Do caregivers of childhood cancer survivors rate the PLAY program as easy to use? 3. Are caregivers of childhood cancer survivors satisfied with the PLAY program? 4. How can the PLAY program be improved in the future? When the child is transitioning to maintenance phase therapies or off cancer treatment, caregivers will be invited to participate and complete surveys when they begin the study as well as a videotaped interaction task with their child. Children will complete brief developmental testing at the beginning of the program. Caregivers will then complete the PLAY Program, which will involve completing 7 weekly or bi-weekly online modules and meeting with a trained coach by videoconference for up to 8 one-hour sessions over three months. Sessions will focus on helping their child get ready for school and help their family adjust and cope with stress. Caregivers will repeat the surveys and videotaped interaction task again three months later, after the PLAY program is completed. They will also be invited to participate in an interview to learn about their experience in the program. Read Less

The goal of this clinical trial is to reduce heavy drinking and enhance medication for opioid use disorder (MOUD) outcomes in individuals receiving MOUD. The main questions it aims to answer are: * Does the brief, digitally-enhanced, virtual psychotherapeutic intervention, called Managing Physical Reactions to Overwhelming Emotions (IMPROVE), impact daily alcohol use and MOUD adherence? * Does the intervention change self-report and physiological responses to intolerance to uncertainty and anxiety sensitivity? Researchers will compare IMPROVE to a control intervention (health education treatment) to see if IMPROVE impacts daily alcohol use and MOUD adherence. Participants will: * Complete a baseline electroencephalography (EEG) and self-report questionnaires. * Complete three one-hour intervention sessions (IMPROVE or control) each one week a part. * Complete a post-intervention EEG and self-report questionnaires. * Complete five ecological momentary assessment (EMA) surveys a day for 21 days. * Complete self-report questionnaires one-month after their last intervention session. Read Less

The objective of the study is to assess 2 different initial incubator humidification protocols for infants \<25 weeks' gestation admitted to the neonatal intensive care unit (NICU). The hypothesis is that a higher starting humidity decreases dehydration and results in no difference in survival or morbidity. Higher (90%) and lower (70%) starting humidity will be compared. Read Less

This clinical trial studies if a bowel management program with a retrograde rectal enema (RRE) for the treatment of low anterior resection syndrome (LARS) in rectal cancer patients is better than medical management alone. Rectal cancer treatment can include a procedure where part of the rectum with cancer is removed and the remaining part of the rectum is reconnected to the colon, this is called a low anterior resection of the rectum. LARS is a common condition that can develop after undergoing a low anterior resection of the rectum. LARS consists of any change in how the body performs defecation, the discharge of feces from the body, after undergoing a resection procedure. Patients with LARS may experience fecal urgency, incontinence, increased frequency, constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Patients may experience individual symptoms of LARS or a combination of them. A bowel management program assists patient's with identifying a specific bowel management regimen that works best for managing symptoms of LARS. A RRE consists of inserting a catheter through the anus into the rectum. The RRE is designed to assist fecal emptying. Medical management of LARS can include the use of fiber, loperamide hydrochloride, or pelvic floor physical therapy. Fiber may help relieve constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Loperamide hydrocholoride may help lessen fecal urgency, incontinence, or increased frequency. Pelvic floor physical therapy may help restore strength in the rectum possibly helping to improve symptoms of LARS. Participating in a bowel management program with a RRE may be more effective in treating LARS than medical management alone. Read Less

This phase I trial tests the safety, side effects and best infusion dose of genetically engineered cells called anti-CD19/CD20/CD22 chimeric antigen receptor (CAR) T-cells following a short course of chemotherapy with cyclophosphamide and fludarabine in treating patients with lymphoid cancers (malignancies) that have come back (recurrent) or do not respond to treatment (refractory). Lymphoid malignancies eligible for this trial are: non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and B-prolymphocytic leukemia (B-PLL). T-cells (a type of white blood cell) form part of the body's immune system. CAR-T is a type of cell therapy that is used with gene-based therapies. CAR T-cells are made by taking a patient's own T-cells and genetically modifying them with a virus so that they are recognized by a group of proteins called CD19/CD20/CD22 which are found on the surface of cancer cells. Anti-CD19/CD20/CD22 CAR T-cells can recognize CD19/CD20/CD22, bind to the cancer cells and kill them. Giving combination chemotherapy helps prepare the body before CAR T-cell therapy. Giving CAR-T after cyclophosphamide and fludarabine may kill more tumor cells. Read Less