All Clinical Trials

The goal of this project is to identify neonates who are predisposed to Necrotizing Enterocolitis (NEC). the investigators will determine the effectiveness of non-invasive measures as well as biochemical markers to identify neonates early in the disease process. Thus, the investigators aim to identify infants with NEC prior to the onset of symptoms to institute or test treatments in the long term to prevent the progression of the disease in these infants. Read Less

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. Read Less

This clinical trial tests the impact of the The Ohio State University Connecting Underrepresented Populations to Clinical Trials (CUSP2CT) project on clinical trial referrals and enrollment in racial/ethnic minorities. Progress in cancer prevention, detection and treatment can only be made by identifying and validating new and improved methods, compounds and modalities in clinical trials. Unfortunately, participation in clinical trials is not equal across all racial and ethnic groups, limiting progress against cancer in all population groups and further widening the disparity gap. To change this picture, concerted effort needs to be directed both at the communities at risk for being left out of trials and the systems that cause the disparities at all levels involved in accrual to clinical trials. The CUSP2CT project may have the potential to increase referral and accrual of racial/ethnic minorities to prevention/control and treatment trials. Read Less

This phase II study evaluates how well pemigatinib works for the treatment of adult patients with pancreatic cancer that has spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or has spread from where it first started to other places in the body (metastatic) and that have abnormal changes (alterations) in the fibroblast growth factor receptor (FGFR) gene. FGFR genes are genes that, when altered, can lead to and promote the growth of cancer in patients. Researchers want to test if using pemigatinib can block the function of these abnormal FGFR genes and prevent the tumor from growing and whether treatment can help improve overall quality of life. Read Less

This clinical trial studies how well new adhesive-based sensors that stick to the skin (transcutaneous) work in detecting cancer-related long-term arm swelling (lymphedema). For many patients, lymphedema s painful, unsightly, and weakening. The early signs of lymphedema are hard to see, and sometimes it is only diagnosed by hospital equipment at larger centers. Treating lymphedema early is usually more successful than trying to treat in later stages. The adhesive-based sensors used in this study work by using techniques called photoplethysmography (PPG) and bioimpedance (BI). PPG is an optical technique that can be used to detect blood volume changes in tissue. BI evaluates how tissue responds to an externally applied electrical current. This study may assist researchers in distinguishing participants with lymphedema in comparison to participants without lymphedema, and develop a way for patients to check for lymphedema at home. Read Less

The goal of this study is to determine whether an intervention to support caregivers in engaging with their children while using educational media together can improve children's early literacy skills, compared to an aligned shared book reading intervention and to no intervention. Given that early literacy skills predict children's later academic learning, this home intervention, which aims to shape the communication patterns surrounding a common, family-friendly activity, has the potential to positively influence the trajectory of low income children's academic success. The investigators propose that amedia based activity will reduce barriers and increase adherence therefore increasing literacy skills over time. Read Less

A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection. Read Less

This phase Ib/II trial tests the best dose of axatilimab and effectiveness of axatilimab with or without azacitidine for the treatment of patients with advanced phase myeloproliferative neoplasms (MPN), myeloproliferative neoplasm/myelodysplastic syndrome (MPN/MDS) overlap or high risk chronic myelomonocytic leukemia (CMML). Axatilimab is an antibody that is cloned from a single white blood cell that is known to be able to recognize cancer cells and block a protein on the surface of the white blood cells that may be involved in cancer cell growth. By blocking the proteins, this may slow or halt the growth of the cancer. Azacitidine is in a class of medications called antimetabolites. It works by stopping or slowing the growth of cancer cells. Giving axatilimab with or without azacitidine may be safe and effective in treating patients with advanced phase MPN, MPN/MDS overlap or high risk CMML. 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

Nearly 60% of college students use alcohol and 30% binge drink monthly. This is alarming given that heavy alcohol use is linked to serious detrimental outcomes. Despite various prevention and intervention strategies, heavy alcohol use has remained relatively stable over the past decade. Individual differences in stress response connote risk for alcohol use disorder. Anxiety sensitivity (AS) and intolerance of uncertainty (IU) are two key cognitive vulnerabilities that can hinder resilience by amplifying stress responses and promoting maladaptive coping strategies, such as alcohol use. Effective stress management is a cornerstone of resilience. The Intervention for Managing Psychological Responding to Overwhelming Emotions (IMPROVE) targets AS and IU, key barriers to resilience, by modifying cognitive processes that amplify stress and negative affect. In this study, undergraduate students who engage in heavy drinking behaviors and experience elevated anxiety symptoms will be randomized to IMPROVE or a control health promotion intervention (N=20 per arm). All participants will complete daily ecological momentary assessments (EMA) delivered to participants' mobile phones to capture real-world alcohol use before, during, and after the intervention. The investigators will evaluate the feasibility and acceptability of IMPROVE (Aim 1). The investigators will also include a multimodal battery of self-report and objective lab-based measures of AS and IU involving startle eyeblink potentiation and event-related potentials via electromyography (EMG) and electroencephalography (EEG). This will allow the investigators to examine whether IMPROVE changes IU and AS, and to assess if changes in these targets are associated with changes in alcohol use (Aim 2). Read Less

Crisis Response Planning is an efficacious, one-session intervention that increases positive affect, decreases negative affect and psychiatric hospitalizations, and reduces suicide attempts by 76% among Servicemembers. Crisis Response Planning is hypothesized to reduce suicidality by identifying a variety of personalized strategies that are designed to strengthen and/or promote emotion regulation processes.Research in nonmilitary samples suggests the effectiveness of emotion regulation strategies varies across situations. The applicability of these findings to suicidality among Servicemembers is unknown. Improved understanding of what strategies work under which circumstances and for whom will significantly advance our ability to prevent suicide among Servicemembers. Hypotheses include: 1. Use of self-management strategies, thinking about reasons for living, and seeking social support at time t will be associated with significant reductions in suicidal ideation at time t+1. 2. Use of distraction, reappraisal, and interpersonal emotion regulation strategies at time t will be associated with significant reductions in suicidal ideation at time t+1. 3. Affect intensity and social context will significantly moderate the time-lagged effects of Crisis Response Planning and emotion regulation strategy use on suicidal ideation. 4. Distinct profiles of demographic (e.g., gender, age), historical (e.g., prior suicide attempts), and psychological characteristics (e.g., emotion dysregulation, symptom severity) will predict who experiences a decrease in suicidal ideation following the use of Crisis Response Planning and emotion regulation strategies. 5. (Exploratory): Individuals who utilize their Crisis Response Planning more frequently and perceive Crisis Response Planning as more effective will be more likely to engage in mental health treatment at follow-up. Read Less

This clinical trial compares the use of oral nicotine pouches to nicotine replacement therapy, consisting of nicotine patches and lozenges, to reduce cigarette use in smokers living in rural Appalachia. The lung and oral cancers that plague Appalachia are fueled by cigarette smoking. Oral nicotine pouches which contain nicotine but no tobacco leaf, present a new opportunity to reduce cancer risk among Appalachian adults who smoke. Oral nicotine pouches and nicotine replacement therapy may work well to reduce cigarette use for smokers in rural Appalachia. Read Less