All Clinical Trials

Silent brain infarctions (SBIs) are a manifestation of covert cerebrovascular disease, without obvious clinical deficit, noted very often in patients presenting with a new stroke or new transient ischemic attack. SBIs are linked to a significant increase in risk for subsequent stroke and cognitive decline. However, no biomarker is currently available that can predict the recurrence of these subclinical lesions. Coated-platelets are a measure of platelet procoagulant potential significantly increased in patients with ischemic stroke or transient ischemic attack compared to unaffected controls. Higher coated-platelet levels are strongly associated with both the presence and number of SBIs. Among medications approved for preventing stroke recurrence, we identified clopidogrel as a pharmacological agent leading to a decrease in coated-platelet levels. In this project, we plan to evaluate if clopidogrel can decrease the rate of occurrence of new silent brain infarctions. The result will enhance the investigators understanding of the relationship between platelets and silent brain infarcts, leading to improved health care delivery and also potential targets for novel preventive pharmacological interventions. Read Less

Examine the effects of deutetrabenazine on functional speech and gait impairment Read Less

This clinical feasibility study is to evaluate the performance of the Omega-Cuff in the treatment of acid reflux for up to 15 patients with a 1-year follow-up period. The Omega-shaped nitinol device is placed on top of the esophageal sphincter muscle just above the stomach in a laparoscopic surgical procedure without altering anatomy. In animal studies, the device safely increased the pressure on the sphincter, meaning it increased resistance to acid reflux, but did not interfere with normal food swallowing, meaning food went down to the stomach normally and smoothly. The device is intended to augment the function of the weak sphincter in minimizing acid reflux but allows easy swallowing of food in GERD patients. The clinical feasibility study is to see how well this device functions in patients and to assess its safety profile. This is a permanent implant that will last the lifetime of the patient. The device will not interfere with patients who may need diagnostic MRI scans. The device can be safely removed if needed. Read Less

The research study is being conducted to test the safety and effectiveness of the experimental drug mosunetuzumab (Cohort 1) or obinutuzumab and glofitamab (Cohort 2) when given after CAR (genetically modified) T cells. The study is for patients who have already received a CAR T-cell infusion. Some patients who join the study will receive mosunetuzumab, other patients later in the study may receive a different experimental drug (glofitamab, in combination with obinutuzumab). Read Less

In this project, after systematically developing electronic nicotine delivery systems (ENDS) pictorial health warning labels (HWLs), a proven clinical lab model will be used to examine and test their effect when these are placed on the ENDS device on a variety of subjective (e.g. satisfaction, harm perception, nicotine dependence, intention to quit) and objective outcomes (e.g. plasma nicotine, puff topography) in young adults. Read Less

This is an open-label, single arm, single center, non-randomized feasibility study of the Muse MRgFUS System in subjects with breast cancer. Subjects will undergo partial ablation of half (≤50%) of one of their tumors (if multifocal or multicentric disease) followed by surgical resection per standard of care. The partial tumor ablation design will ensure that no information is lost that would impact the subject's standard of clinical care. Because current care often includes testing on the tumor, retaining a portion of viable tumor is advised by the clinical team. To ensure viable tissue confirmation, patients will be enrolled in two cohorts as described in the protocol. The investigators will use imaging correlation, histological evaluation, and subject reported outcomes to assess the safety, tolerability, and efficacy of the Muse MRgFUS System. This proposed study will adhere to the guidelines of subjects receiving a timely tumor resection after diagnosis. All subjects will undergo the definitive procedure of surgical resection per standard of care. Surgical resection cannot be delayed as a result of the ablation and should occur within 6 weeks after the decision to proceed with surgical resection. In cases where a surgery may occur outside of the 6 week window, prior approval from the external DSMC should be obtained. While MRgFUS ablation is designed to be a breast-conserving technique, the investigators will enroll patients that are undergoing any surgical resection, including both lumpectomy or mastectomy. Both surgical procedures will allow assessment of the defined primary, secondary and exploratory objectives. Read Less

This is a Phase II study of the combination of All-Trans Retinonic Acid (ATRA) and PD-1 inhibition (Retifanlimab) in patient with recurrent IDH-mutant glioma. The Sponsor-Investigator hypothesizes that the proposed regimen will be safe and stimulate a robust anti-tumor immune response. Read Less

Many Veterans experience chronic pain, with back pain the most commonly reported condition. The Veterans Health Administration (VHA) is moving from reliance on medications to an approach in which non-medication interventions, including complementary and integrative health treatments, are now a first line of care. Acupressure, a Traditional Chinese Medicine technique derived from acupuncture, is emerging as a potentially effective approach for treating several chronic pain conditions and could prove beneficial in helping Veterans manage their chronic low back pain. This study will determine the effectiveness of self-administered acupressure to treat chronic low back pain. 300 Veterans will be invited to participate in the study. All participants will be asked to attend an introduction to acupressure class and complete a survey when they join the study and again at 6 weeks and 10 weeks. The survey measures assess important outcomes, such as how pain interferes with daily function, as well as other areas that can be affected by pain such as fatigue and sleep quality. After completing the first survey, half of the participants will receive a tablet computer with an app that shows them how to self-administer acupressure for low back pain and will be asked to do daily acupressure sessions for the next 6 weeks. The other half of the participants will receive the tablet computer with the app approximately 10 weeks after completing the final survey based assessment. The investigators anticipate that outcomes will be improved after 6 weeks of acupressure practice, and these improvements will persist for the following 4 weeks. Read Less

To determine the efficacy of a multicomponent adherence intervention among participants with early-stage breast cancer on endocrine therapy and at least one oral cardiovascular disease (CVD) medication on adherence to endocrine therapy and to CVD medication at 24 weeks assessed by self-report using the Domains of Subjective Extent (DOSE)-Nonadherence questionnaire and also by pharmacy fill data assessed in the electronic health record (EHR). Read Less

Young Latina women face significant barriers to sexual health and healthcare access, particularly in emerging Latino states like Alabama. The goals of the proposed study are to develop and examine the feasibility of an innovative, scalable mHealth, "safe space" intervention for Young Latina Women (YLW) in Alabama (AL) and to stimulate the conduct of behavioral research at the University of Alabama. This work is consistent with the National Institute of Nursing Research's goals of "Enhancing wellness by understanding the physical, behavioral, cultural and environmental influences on health status and developing culturally tailored interventions to prevent illness and promote health" and "Using innovative technologies to develop novel interventions that deliver personalized care and real-time health information to patients, families and healthcare providers". Read Less

This is a Phase 1/2A study of GV20-0251 being developed for the treatment of participants with advanced solid tumors, who are refractory to approved therapies or other standard of care. Read Less

This phase II trial evaluates how well transarterial chemoembolization (TACE) works for treating patients with non-small cell lung cancer or lung metastases. TACE is a minimally invasive procedure that involves injecting chemotherapy directly into an artery that supplies blood to tumors, and then blocking off the blood supply to the tumors. Mitomycin (chemotherapy), Lipiodol (drug carrier), and Embospheres (small plastic beads that block off the artery) are injected into the tumor-feeding artery. This traps the chemotherapy inside the tumor and also cuts off the tumor\'s blood supply. As a result, the tumor is exposed to a high dose of chemotherapy, and is also deprived of nutrients and oxygen. TACE can be effective at controlling or stopping the growth of lung tumors. Read Less