Alabama Paid Clinical Trials

The purpose of this study is to pilot and assess the feasibility of implementing an artificial intelligence-assisted individualized lifestyle modification intervention for glycemic control in rural populations, which can be delivered even with regular landline phone service. This study will provide us with the knowledge to plan a well-powered optimization trial in the future to develop an optimal (low-cost) intervention package that can be delivered in a sustainable manner to the rural portions of America. Read Less

The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin [AZI] + ethambutol [ETH]) compared to the ELC (empty liposome control) + background regimen on participant-reported respiratory symptoms at Month 13. Read Less

This trial is a Phase II randomized, double-blind, placebo controlled multi-site study to evaluate the safety and efficacy of early sirolimus to prevent or delay seizure onset in TSC infants. This study is supported by research funding from the Office of Orphan Products Division (OOPD) of the US Food and Drug Administration (FDA). Read Less

The overall goal of this 5-year Mentored Research Scientist Development K01-Award is to support Henna Budhwani, PhD, MPH to become an independent implementation science investigator in the field of HIV prevention. The proposed project seeks to address the HIV crisis in Alabama, where rates of undiagnosed HIV in black young men who have sex with men (YMSM, 18-29 years) exceed 20%. This project will adapt and test a behavioral intervention to promote HIV rapid testing in the community, deliver culturally appropriate prevention education, offer sociostructural support, and refer eligible participants for pre-exposure prophylaxis (PrEP). Four training objectives are proposed that are in lockstep with three specific aims. Read Less

Sickle Cell Disease (SCD) is a rare disease occurring in an estimated 100,000 individuals, often poor and underserved, in the US. Silent and overt strokes contribute significantly to morbidity in adults with SCD, resulting in functional impairment, challenges with school and job performance, and premature death. Five NIH-funded randomized controlled trials have identified therapies to prevent silent and overt strokes in children with SCD, including monthly blood transfusion therapy (for preventing initial and recurrent strokes) and hydroxyurea (for preventing initial strokes). Despite the observation that at least 99% of children with SCD in high-income countries reach adulthood, and approximately 60% of adults will experience one or more strokes (~50% with silent strokes and ~10% with overt strokes), no stroke trials have established therapeutic approaches for adults with SCD. For adults with SCD, inadequate evidence-based guidelines exist for secondary stroke prevention strategies. Applying stroke prevention strategies in children may not be effective for stroke prevention in adults with SCD, particularly given the high rate of co-morbidities. Identifying subgroups of adults with SCD and higher incidence coupled with the contribution of established stroke risk factors in the general population (smoking, diabetes, obesity, renal disease) will provide the requisite data required for the first-ever phase III clinical trials focused on secondary stroke prevention in adults. Read Less

The purpose of this study is to study the treatment of urgency urinary incontinence (UUI), specifically among women 70 years and older, by comparing reduced versus standard dose of onabotulinumtoxinA (BTX; trade name BOTOX(c)) injection in the bladder. Read Less

This is a multi-center, open-label, first-in-human Phase 1 study evaluating the anti-programmed death receptor 1 (anti-PD-1) antibody dostarlimab (also known as TSR-042) n participants with advanced solid tumors who have limited available treatment options. The study will be conducted in 2 parts with Part 1 consisting of safety evaluation, pharmacokinetics (PK), and pharmacodynamics (PDy) of escalating doses of dostarlimab. Dose escalation will be based on ascending weight-based dose levels (DLs) of dostarlimab and will continue until the maximum tolerated dose (MTD) is reached or may be stopped at any dose level up to the highest dose of 20 milligrams per kilograms (mg/kg) based on emerging safety and PK/PDy data. Part 2 will be conducted in two subparts, Part 2A (fixed-dose safety evaluation cohorts) and Part 2B (expansion cohorts). Part 2A of the study will evaluate the safety and tolerability of dostarlimab at fixed doses of 500 mg administered every 3 weeks (Q3W) and 1000 mg administered every 6 weeks (Q6W). Part 2B of the study will examine the safety and clinical activity of dostarlimab in cohorts of participants with specific types of advanced solid tumors. Read Less

African American adults in the United States have the highest prevalence rate of high blood pressure (hypertension) and heart failure in the world. African Americans with treatment resistant hypertension have higher levels of the enzyme - xanthine oxidase compared to Caucasians. This trial will test if administration of the xanthine oxidase inhibitor - Allopurinol (commonly used in the treatment of gout), given over a period of 8 weeks, will improve heart function, exercise ability and quality of life in African American Veterans with resistant hypertension. Read Less

This is a randomized, double-blind, placebo controlled, multicenter study to compare the efficacy and safety of L-citrulline versus placebo in patients undergoing surgery for congenital heart defects. Eligible patients undergoing repair of a large unrestrictive ventricular septal defect (VSD), a partial or complete atrioventricular septal defect (AVSD), or an ostium primum atrial septal defect (primum ASD) will be eligible for enrollment. Read Less

The purpose of this study is to determine if playing a virtual reality walking game can help improve neuropathic pain in adults with chronic spinal cord injury. Read Less

The human subject research is a randomized, controlled training trial that tests the effectiveness of three Virtual Reality-based Intelligent Orientation and Mobility Specialists (VR-IOMSs) in teaching orientation and mobility (O&M) task skills to low vision patients. It will be conducted on two sites, University of Alabama at Birmingham (UAB) and Alabama Institute for Deaf and Blind (AIDB). The same protocol will be used on both sites. UAB will be the sIRB for the trial. Three O&M tasks will be studied, timing to cross a signalized street using the near lane parallel traffic surge skill, timing to cross an uncontrolled street using the traffic gap judgment skill and learning outdoor numbering system. A VR-IOMS will be develop for each task. The training does not involve research subjects walking into street traffic. Low vision subjects who have difficulties with these O&M tasks due to their impaired vision will be randomized into three groups, learning the task from a VR-IOMS (experimental group), from a human Certified Orientation & Mobility Specialist (COMS) in real streets (active control group) and not learning the task but spending the same amount of time watching low vision education videos (placebo group). All subjects will be evaluated by COMSs in real streets around the two study sites before training (pre-training), within 3 days after the completion of training (post-training) and 3 months after the completion of training (follow up). Their ability to perform the O&M tasks will be assess quantitatively using objective methods. COMSs who conduct these evaluations will be blinded for subject training assignment. The primary outcome measure is the training effect, the difference in task performance between the pre-training and post-training real street evaluations. The training effects of the 3 groups will be compared to determine the training effectiveness of the VR-IOMS relative to human COMS. Secondary outcome measures include the retainment of the training effect. Objective assessment of the VR-IOMS training process and trainee subjective evaluation of the VR-IOMS training will also be analyzed. Read Less

The main aims of the study are to check the side effects and effectiveness of Dexlansoprazole in healing erosive esophagitis (EE) side effects and effectiveness of Dexlansoprazole in maintaining healed EE in children. Participants will take Dexlansoprazole by mouth. Read Less