Tuscaloosa

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are evaluating two forms of buprenorphine treatment for Veterans with moderate to severe opioid use disorder (OUD). This Phase 4, open-label, randomized controlled trial aims to compare a 28-day injectable subcutaneous buprenorphine formulation at a target dose of 300 mg with the standard daily sublingual buprenorphine dose ranging from 4 to 32 mg. The study will recruit 952 Veterans over seven years and follow them actively for 52 weeks, with additional passive follow-up via medical records for up to 10 years. The study also explores secondary outcomes including other substance use, overdose incidents, infections like HIV and hepatitis, incarceration, quality of life, mental health symptoms, housing, dental health, and cost-effectiveness. Participants will begin induction on daily sublingual buprenorphine using standard guidelines to reach a target dose between 4 and 32 mg within 45 days. After reaching this dose, participants are randomly assigned to either continue daily sublingual buprenorphine with naloxone, prescribed in 28-day take-home supplies, or receive monthly injectable buprenorphine administered in the clinic. Both treatment groups have visits at weeks 1, 2, 3, and 4 post-randomization, then every two weeks until week 52, with medication management provided at each visit. During the study, participants will provide self-reports of opioid abstinence and undergo urine drug screenings every two weeks. Medication adherence and retention in treatment are tracked approximately every four weeks. After the active 52-week period, participants will be followed passively through electronic medical records for up to 10 years to monitor long-term outcomes. This comprehensive approach aims to assess the effectiveness and safety of these treatments for opioid use disorder in Veterans.

Researchers are evaluating the safety and effectiveness of eloralintide, a drug given by injection, in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 study includes both a main phase and an extension phase to understand the drug's impact on body weight and overall health in this population. The study aims to compare eloralintide with a placebo to see how well it works in reducing weight. Participants will receive either eloralintide or a placebo, both administered under the skin once a week. The main study phase will last about 75 weeks, during which participants will be regularly monitored. Those participants who have prediabetes will have the option to continue into an extension phase lasting an additional 2 years to further assess long-term effects. During the study, participants will have their body weight measured at the start and throughout the trial, with the primary outcome being the percent change in body weight at week 64 compared to baseline. Researchers will also monitor safety and any side effects. Participants will be asked about their weight history and health conditions, and they must maintain stable body weight before joining. The total involvement time for most participants will be about 75 weeks, with longer follow-up for some.

Researchers are studying the safety and effectiveness of AlloNK, a non-genetically modified natural killer (NK) cell therapy derived from cord blood, combined with rituximab. This open-label Phase 2a trial focuses on adults with relapsing forms of B-cell dependent rheumatologic diseases, including refractory rheumatoid arthritis, Sjf6gren's disease, idiopathic inflammatory myopathies, and systemic sclerosis. The goal is to evaluate how this combination treatment works in these difficult-to-treat conditions. Participants receive AlloNK following a conditioning regimen along with rituximab. AlloNK is an off-the-shelf, cryopreserved NK cell therapy given to support the immune response. The study does not mention a placebo group, and all participants receive this combination treatment. The trial monitors participants for up to 104 weeks to assess safety and treatment effects. Throughout the study, participants undergo regular assessments including clinical evaluations, laboratory tests, and disease activity measurements specific to their condition. Researchers will monitor safety from enrollment until the end of treatment at week 104. The study aims to better understand the treatment's impact on disease symptoms and progression over this two-year period.

Hearing loss significantly impacts emotional well-being, cognition, and physical health, including conditions like diabetes. Many rural areas in the US, especially in Alabama and Mississippi, have limited access to audiologists and hearing healthcare, with populations that tend to be older and have lower income and education levels. The 2022 FDA rule allows adults with perceived mild-to-moderate hearing loss to buy over-the-counter hearing aids (OTC HAs) without medical approval, potentially improving access, but rural pharmacies currently lack guidelines for providing these devices effectively. This research evaluates a stepped-wedge educational training program for pharmacy technicians in rural Alabama and Mississippi to develop their skills in assisting adults with OTC hearing aids. The training progresses from no training to online modules, interactive discussions, and practical experience with adults who have bilateral hearing loss. Pharmacy technicians complete quizzes and surveys before and after each training step to assess learning. Participants include pharmacy technicians and adults with mild-to-moderate hearing loss living in rural areas. The study measures knowledge improvement through pre- and post-training quizzes and confidence in skills over 16 weeks. Adults receiving care from trained technicians will report satisfaction and initial performance with OTC hearing aids. The study aims to establish a sustainable collaboration model between audiologists and pharmacists to improve hearing healthcare access in rural communities.

Researchers are comparing two different interventions aimed at improving emotion regulation in autistic adolescents and young adults. The study addresses the challenge that few clinicians are able or willing to provide mental health services tailored for autistic people. The goal is to see if the autism-specific Emotion Awareness and Skills Enhancement Program (EASE) is more effective than a widely used intervention called the Unified Protocol (UP), both of which have been shown to improve mental health outcomes such as depression, irritability, and anxiety. This clinical trial partners with community clinics in Pennsylvania and Alabama to deliver the interventions. Participants will receive either EASE or UP depending on the clinic they join, as clinics are randomly assigned to one of the two treatments. EASE is a 16-session, mindfulness-based program designed specifically for autistic individuals to support emotion regulation, with sessions lasting 45 minutes to an hour and involving caregivers as part of the care team. UP is a flexible cognitive behavioral therapy approach with mindfulness elements, also delivered over 16 sessions of 45 to 60 minutes each, and tailored to different developmental levels. During the study, researchers will evaluate emotion regulation changes using the Emotion Dysregulation Inventory at several points: before treatment, halfway through (after 8 sessions), at the end (after 16 sessions), and three months later. They will also assess the acceptability, appropriateness, and feasibility of the interventions after the first client completes treatment, and measure provider confidence at baseline and after four years. Participants will be involved in completing questionnaires and assessments throughout these periods, with the study focusing on both treatment effectiveness and practical implementation in community settings.

Researchers are evaluating the comparative effectiveness of oral metformin versus injectable insulin in treating gestational diabetes mellitus (GDM) among pregnant individuals. This phase 4 randomized controlled trial aims to determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes such as large-for-gestational-age birthweight, hypoglycemia, hyperbilirubinemia, and death. The study also assesses the safety of both treatments for mothers and their children, and explores patient-reported experiences including challenges and supports for using these medications. Participants will be randomly assigned to receive either oral metformin tablets or injectable insulin to manage their GDM. The trial will recruit 1,572 pregnant individuals from 20 U.S. sites who require medication for glucose control. Treatment will continue from randomization, which occurs between 20 and 33 weeks of pregnancy, through delivery. Both groups will be followed postpartum, with maternal and child monitoring extending to two years after birth to evaluate long-term outcomes. During the study, participants and their children will undergo regular assessments including monitoring for neonatal complications, maternal health outcomes, and child growth measures such as body mass index at 2 years. Researchers will also collect patient-reported outcomes at 6 weeks and 2 years postpartum, and analyze factors influencing treatment use. The total participation lasts from pregnancy through a two-year postpartum follow-up to capture comprehensive safety and effectiveness data.

Researchers are exploring whether Sudarshan Kriya Yoga (SKY), a breath-based meditation, can help improve well-being among university students. This pilot study will enroll 56 undergraduate and graduate students to compare SKY breath meditation with general yoga without breathwork over eight weeks. The study focuses on how feasible SKY is for students, assessing recruitment, retention, and adherence, while also measuring effects on physical activity, stress, anxiety, resilience, social connectedness, and focus. Participants assigned to the SKY group will start with a three-day in-person retreat, followed by weekly virtual sessions and independent home practice. The control group will receive pre-recorded yoga videos to practice yoga three times weekly on their own, with occasional check-ins. Both groups engage in their respective programs over the eight-week period. All participants will complete validated mental health and wellness questionnaires before and after the study period to evaluate changes. Researchers will analyze all enrolled participants' data regardless of completion. The study monitors stress levels using the perceived stress scale at eight weeks and aims to provide early insights into SKY's potential benefits for student mental health and resilience, supporting future larger studies.

Researchers are evaluating a new intervention for children aged 6 to 11 who have elevated callous-unemotional (CU) traits, which are linked to serious behavioral problems and poor outcomes despite current treatments. The study aims to improve facial affect sensitivity (FAS), specifically the ability to recognize distress emotions like fear and sadness, which is often impaired in these children. By targeting this sensitivity, the intervention hopes to reduce CU traits and their negative impact on child socialization and behavior. The study involves two main phases. In the first phase (R61), a novel computerized program called Facial Affect Sensitivity Training (FAST) is tested in a randomized controlled trial with 84 children to see if it can improve distress facial emotion recognition and eye gaze patterns. The second phase (R33) will replicate these findings with a new group to assess the feasibility and preliminary effectiveness of FAST compared to an active control task focusing on implicit eye gaze training. FAST uses real-time feedback and incentives to help children improve their recognition of emotional expressions. During the study, children will be assessed at the start, after 5 weeks of intervention, and again at a 3-month follow-up. Evaluations include facial emotion recognition tests, eye gaze tracking, and measures of callous-unemotional traits. These assessments occur about every two weeks during the intervention period. The researchers will monitor changes in emotional recognition accuracy, eye gaze behavior, brain activity related to emotion processing, and CU traits to understand the intervention's impact and safety over time.

Researchers are evaluating the effect of geriatric evaluation and management combined with survivorship health education (GEM-S) compared to usual care on physical function in older cancer survivors. This phase III trial focuses on survivors aged 65 and older who have completed or will complete curative treatment for solid tumors or lymphoma within the last 6 months. The study aims to determine if GEM-S can improve physical abilities, mental well-being, and memory, as well as understand its impact on the quality of life for both patients and their caregivers. Participants are assigned based on their practice site to one of two groups. One group receives routine survivorship follow-up care through three visits over six months. The other group undergoes a one-hour GEM consultation discussing geriatric assessment results and recommendations, participates in survivorship health education sessions twice weekly for four weeks, and engages in the Exercise for Cancer Patients (EXCAP) program involving daily walking and resistance exercises. After the intervention, all participants are followed up at six months. During the study, participants complete various assessments including patient-reported physical function, cognitive function, and objective physical and cognitive tests. Researchers also evaluate survivor satisfaction with care, care coordination, referral completion, and caregiver outcomes such as distress and quality of life. Questionnaires and other measures support monitoring of these outcomes up to six months, providing comprehensive data on the intervention's effects.