Tuscaloosa

Researchers are evaluating whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

Researchers are evaluating the effectiveness of a long-acting injectable form of buprenorphine compared to the daily sublingual under the tongue buprenorphine in treating Veterans with moderate to severe opioid use disorder OUD. This open-label, randomized controlled trial aims to see which treatment better retains Veterans in opioid therapy and helps sustain opioid abstinence. The study also examines secondary outcomes such as substance use, overdose incidents, infectious disease testing, psychiatric symptoms, housing status, dental health, and cost-effectiveness. Participants are Veterans aged 18 and older diagnosed with moderate to severe OUD and beginning a new treatment episode. After an induction period on daily sublingual buprenorphine, participants are randomly assigned to receive either a 28-day supply of daily sublingual buprenorphine or a monthly injectable buprenorphine shot administered in the clinic. Doses for the injectable form target 300mg, with a 100mg option for those who cannot tolerate the higher dose. Study visits occur weekly during the first month, then every two weeks until week 52, including medication management. Throughout the 52-week active phase, participants report opioid use and provide urine samples every two weeks to evaluate abstinence and treatment retention. Additional assessments include HIV, Hepatitis B and C testing, psychiatric questionnaires, risk behavior evaluations, and dental health surveys. After the active phase, participants are followed passively using medical records for up to 10 years to monitor long-term outcomes. The study expects to recruit 952 Veterans over 7 years across multiple VA Medical Centers.

Researchers are studying the effectiveness and safety of eloralintide in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 trial aims to understand how eloralintide affects body weight and related health measures over a long period. The study includes a main phase and an extension phase for those with prediabetes to evaluate ongoing effects. Participants are randomly assigned to receive one of four doses of eloralintide or a placebo, all given by subcutaneous injection once weekly. The main phase lasts about 75 weeks, and participants with prediabetes may continue in an extension phase for an additional two years. This structure allows researchers to assess both short-term and longer-term outcomes. During the study, participants will have regular visits to measure body weight, body fat, waist size, blood pressure, blood markers like triglycerides and insulin, and quality of life questionnaires. Safety and treatment effects are monitored throughout. The main outcome is the percent change in body weight from the start to week 64, with follow-up continuing up to week 191 for some. Overall participation can last up to several years depending on the participants health status.

Researchers are evaluating the safety and effectiveness of AlloNK, a non-genetically modified allogeneic natural killer NK cell therapy derived from cord blood, combined with rituximab, in people with relapsing forms of B-cell dependent rheumatologic diseases. These diseases include refractory rheumatoid arthritis, Sjgrens disease, idiopathic inflammatory myopathies, and systemic sclerosis. This open-label Phase 2a study aims to explore treatment options for patients whose conditions have not responded well to previous therapies. Participants receive AlloNK after a conditioning regimen, followed by rituximab. AlloNK is an off-the-shelf, cryopreserved NK cell therapy given in combination with rituximab. The treatment period lasts up to 104 weeks, during which participants are monitored for safety and clinical response. The study includes one treatment group receiving this combination therapy. Throughout the study, participants undergo regular assessments to evaluate safety from enrollment until the end of treatment at Week 104. Researchers measure disease-specific outcomes at Week 52, including disease activity scores for rheumatoid arthritis, Sjgrens disease activity indices, improvement scores for inflammatory myopathies, and response indices for systemic sclerosis. The study involves clinical evaluations, laboratory tests including inflammatory markers, and joint assessments to monitor treatment effects and safety over the extended period.

Hearing loss is a significant public health issue linked to emotional and cognitive challenges as well as physical health problems like diabetes. Access to hearing healthcare professionals such as audiologists is limited, especially in rural areas with older and lower-income populations. The 2022 FDA rule allowing adults with mild-to-moderate hearing loss to purchase over-the-counter hearing aids OTC HAs without medical clearance opens new possibilities for care, but rural pharmacies currently lack established guidelines for providing these devices. This study evaluates a stepped-wedge educational training program for pharmacy technicians in rural Alabama and Mississippi to support adults with hearing loss by providing basic hearing healthcare related to OTC HAs. The training includes four sequential steps no training control, online modules, online discussions, and practical experience assisting adults with bilateral mild-to-moderate hearing loss, including hearing screening and device setup. Pharmacy technicians knowledge and skills will be assessed before and after each training step. Participants will include pharmacy technicians undergoing the training and adults with hearing loss receiving care from trained technicians. Various surveys and questionnaires will be used to measure training satisfaction, confidence, hearing aid use, and hearing handicap impact. The study aims to create a collaborative model between audiologists and pharmacists to improve hearing healthcare access in rural communities. The study duration for training is 16 weeks, with outcome measures collected during and after this period.

Researchers are evaluating two different therapies aimed at improving emotion regulation in autistic adolescents and young adults. The study compares a widely used treatment for non-autistic groups, called The Unified Protocol UP, with a program designed specifically for autistic individuals, called The Emotion Awareness and Skills Enhancement Program EASE. Both therapies target mental health challenges like depression, irritability, and anxiety, which are important issues identified by patients and caregivers. This trial is conducted in partnership with community clinics in Pennsylvania and Alabama to support real-world application. The trial includes two treatment groups one receiving the EASE program and the other receiving the UP therapy. EASE is a 16-session mindfulness-based program focusing on awareness of emotional arousal, distress tolerance, helpful thoughts, and self-compassion. Each session lasts 45 to 60 minutes and is delivered one-on-one, with caregiver involvement encouraged. UP consists of 16 cognitive behavioral therapy sessions, also lasting about 45 to 60 minutes each, focusing on recognizing emotions and developing coping strategies. Each community clinic involved is randomly assigned to provide either EASE or UP. Participants will attend sessions over about 16 to 20 weeks, with assessments at the start, midpoint, end of treatment, and three months after treatment ends. Researchers will measure emotion regulation, mental health symptoms, quality of life, mindfulness, self-compassion, and therapeutic alliance using various questionnaires and scales. The study also evaluates how acceptable and feasible each therapy is for providers and clients. The total participation includes these treatment and follow-up periods, with ongoing monitoring of provider confidence over four years.

Researchers are conducting a comparative effectiveness trial involving 1,572 pregnant individuals diagnosed with gestational diabetes mellitus GDM who require medication to control their blood sugar. The trial aims to find out if oral metformin is not worse than injectable insulin in reducing negative pregnancy outcomes. It also evaluates the safety for both mothers and their children, as well as patient-reported experiences including barriers and facilitators of using metformin compared to insulin. Participants and their children will be followed up to two years after delivery. Participants will be randomly assigned to one of two treatment groups oral metformin or injectable insulin. Metformin may be given as immediate- or extended-release tablets, with doses increased up to a daily maximum of 2,500 mg, and insulin may be added if blood sugar control is inadequate. Insulin treatment follows clinical dosing standards with up to four daily injections of basal and prandial types, including rapid-, intermediate-, and long-acting formulations. Participants remain on metformin even if insulin is added. The trial will track outcomes from pregnancy through delivery and up to two years postpartum. During the study, participants will have regular assessments for maternal and child health, including monitoring blood sugar control, pregnancy complications, delivery outcomes, and child growth measurements at two years old. Patient questionnaires about treatment satisfaction and acceptability will be collected at six weeks and two years postpartum. The main outcomes measured are a composite of adverse neonatal events and child body mass index at two years. The study also includes long-term follow-up to evaluate maternal and child safety and health effects related to the treatments.

This research aims to evaluate an Interactive Digital PrEP Toolkit designed to help cisgender women in Alabama and Mississippi learn about and access pre-exposure prophylaxis PrEP, a medication that prevents HIV infection. The study focuses on addressing barriers such as limited PrEP awareness, low HIV risk perception, and challenges in client-provider communication, especially in rural southeastern U.S. regions where PrEP use among women remains low. Participants will use the Digital PrEP Toolkit on a tablet during a clinic visit, which includes educational content tailored to women and information about various PrEP options, such as daily pills and injections. After using the Toolkit, participants receive a Personalized HIV Prevention Summary and discuss PrEP options with healthcare staff. Those interested can schedule a PrEP clinic appointment. Follow-up includes phone interviews at 3 months and medical record reviews at 3 and 6 months to assess PrEP uptake and persistence. Participants will be involved in a 30-minute enrollment visit including consent and baseline assessments, use of the Digital PrEP Toolkit, and follow-up interviews. Researchers will evaluate feasibility by measuring Toolkit completion rates and time, acceptability through satisfaction surveys, and preliminary efficacy by tracking PrEP initiation and knowledge changes. Medical records will be reviewed up to 6 months post-enrollment to monitor ongoing PrEP use, with total study participation lasting up to 18 months.

Researchers are exploring the effects of Sudarshan Kriya Yoga SKY, a type of breath-based meditation, on the well-being of university students. This pilot study will involve 56 undergraduate and graduate students who will be randomly assigned to either a SKY breathwork group or a control group practicing general yoga without breathwork. The study aims to evaluate recruitment success, participant retention, adherence, and potential benefits in areas such as stress, anxiety, resilience, social connection, and cognitive focus. The research is intended to lay groundwork for larger future studies and provide early insights on SKYs role in student wellness. The SKY group will participate in a three-day in-person retreat followed by weekly virtual meditation sessions and independent home practice over eight weeks. The control group will receive pre-recorded yoga videos to practice at least three times per week and occasional check-ins. Both groups will be monitored throughout the study to compare adherence and experience with their assigned activities. Participants will complete validated mental health and wellness questionnaires, including measures of perceived stress, anxiety, physical activity, resilience, and social connectedness before and after the eight-week program. Data will be analyzed for all enrolled participants regardless of completion. The study includes monitoring of physical activity levels and aims to assess the feasibility and low-risk nature of SKY breath meditation for improving student well-being.

Researchers are evaluating the impact 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 aims to improve how older adults who have survived cancer manage daily activities, mental well-being, and memory after chemotherapy. The study also seeks to understand how such care affects the quality of life for both cancer survivors and their caregivers. Participants are assigned to one of two groups based on their practice site. One group receives routine follow-up care from their doctors over three visits within six months. The other group takes part in a one-hour GEM consultation discussing geriatric assessment results and recommendations, attends survivorship health education sessions twice weekly for four weeks, and participates in a daily walking and resistance exercise program called EXCAP. Both survivors and their caregivers are involved in these activities. Throughout the study, participants complete patient-reported assessments on physical and cognitive function, objective tests like a 6-minute walk and cognitive exams, and questionnaires about satisfaction with care and coordination. Caregiver distress and quality of life are also measured. Follow-up continues for six months after the interventions to monitor outcomes and gather data on the effects of the GEM-S approach.