UAB - Center for Clinical and Translational Science

The goal of this clinical trial is to compare treatment outcomes between an oral medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency urinary incontinence (UUI). Participants will be randomly selected to receive one of the two treatments. The primary outcome measure will be at 3 months, and women will be followed for a total of 12 months. Based on patient expert input, there are 2 primary outcomes: Treatment satisfaction and urinary symptom severity. The study will also have a long-term follow-up component (prospective cohort) including 346 participants from the parent trial to describe treatment continuation, treatment efficacy, patient direct costs and other secondary outcomes up to 5 years after treatment.

Type: Interventional

Start Date: Jun 2023

open study

The UAB Institute for Arts In Medicine (AIM) is currently implementing an expressive emotional writing pilot project for adults with paralysis caused by neurological conditions such as traumatic head or spinal cord injury.

Type: Observational

Start Date: Sep 2020

open study

The purpose of this study is to find out what combination of components, if any, offers the best support for keeping weight off after someone loses weight. Long term weight loss maintenance is a challenge for many people who lose weight. There are many strategies, or components, people may use to avoid regain, but investigators do not know if there is a best, or optimal, combination of such components that can be done without adding a lot of cost or other burdens for people. - The primary goal of this clinical trial is to identify the optimal package that maximizes weight loss maintenance. - The study also wants to understand the reasons why these components may work and if certain components help specific sub-groups of people. Participants will engage in a 16-week Phase 1 Weight Loss Program. Participants who lose 5% or more of their weight during that program will continue to Phase 2 Extended Care and be randomly assigned to 0, 1, 2, 3, or all of four methods of weight loss maintenance. They will use their assigned package for 12 months. Researchers will compare 16 different possible combinations of components and learn which of the 16 packages offers the best support for keeping weight off. The four components participants could be assigned to in Phase 2 are: 1. Reduced Food Variety: Limiting the variety of foods participants eat by having them choose a few high-calorie, low nutrient foods to eat regularly 2. Home-based Resistance Training: Engaging in exercises that build strength from the comfort of the participant's own home 3. Buddy Training and Support: Having a friend or "buddy" get trained to support the participant 4. Acceptance and Commitment (ACT) Workshops: Having participants learn skills to handle tough thoughts and feelings about weight control in a healthy way Participants will have their weight measured and complete surveys 4 times if they complete both Phase 1 and Phase 2. During Phase 1, participants will attend weekly group sessions and be in touch with a study staff member investigators call a Wellness Coach. During Phase 2, participants will stay in touch with their Wellness Coach, use their assigned package, and answer questions about their experience periodically.

Type: Interventional

Start Date: Dec 2025

open study

HVTN 206/HPTN 114 is a randomized, double blind, controlled, phase 2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and neutralization of VRC07-523LS, PGT121.414.LS, and PGDM1400LS broadly neutralizing monoclonal antibodies given intravenously in adult participants without HIV. The hypothesis of the study is that the combination of VRC07-523LS and PGT121.414.LS and PGDM1400LS antibodies when administered via the intravenous (IV) route will be safe and tolerable in adult participants without HIV. The study aims to enroll 200 participants across multiple sites with an estimated total duration of participation of eighteen (18) months.

Type: Interventional

Start Date: Mar 2025

open study

T1D Pregnancy & Me will partner with pregnant participants living with type 1 diabetes (T1D) in the United States to collect real-world data on management of T1D in pregnancy. This is a remote study where participants can complete online surveys and share device data (continuous glucose monitor (CGM) data and insulin data). Through the collection of CGM, insulin, and pregnancy outcome data, the study will provide important information to understand how diabetes is being managed during pregnancy. These data will provide much needed evidence to guide modern management of diabetes during pregnancy with a goal of improving care and outcomes.

Type: Observational

Start Date: Apr 2025

open study

This is a randomized, placebo-controlled, double blinded phase 2 exploratory clinical trial of intravenously administered pooled human immunoglobulin (IVIG) in anti-3-hydroxy-3-methylglutaryl-CoA reductase (HMGCR) immune mediated necrotizing myopathy (IMNM). Planned enrollment is 12 individuals with active anti-HMGCR IMNM meeting inclusion and exclusion criteria. Assuming 20% drop-out, the investigators anticipate 10 participants will complete all study assessments. Enrolled participants will be randomized 1:1 to either IVIG 2g/kg or placebo (0.9% sodium chloride at equivalent volume) at weeks 0, 4, and 8. The primary efficacy and co-primary safety and tolerability endpoints will be assessed at week 12. After the randomized phase of the trial, all participants will be offered to continue on to an open-label extension phase in which participants will receive IVIG at weeks 12, 16, and 20. Participants will then return at week 24 for a final non-infusion visit to reassess safety, tolerability, and efficacy outcome.

Type: Interventional

Start Date: Oct 2025

open study

The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) in patients with active, refractory systemic lupus erythematosus (SLE) or active, refractory lupus nephritis (LN).

Type: Interventional

Start Date: Sep 2024

open study

PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia will demonstrate the benefit of statins for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events.

Type: Interventional

Start Date: Sep 2020

open study

Obese individuals have a higher prevalence of nocturnal hypertension and non-dipping blood pressure (BP). These conditions are associated with an increased risk of cardiovascular (CV) events and death. Natriuretic Peptides (NPs) are hormones produced by the heart which directly regulate BP by causing dilation of blood vessels and by removing sodium and water from the body. NPs have a 24-hour day-night rhythm and this controls the day-night rhythm of BP as well. The NP-BP rhythm relationship is broken down in obese individuals. Obese individuals also have lower circulating NP levels. Lower circulating levels of NPs and elevated renin hormone (a part of the Renin-Angiotensin-Aldosterone System [RAAS]) at nighttime may contribute to the high nocturnal blood pressure in obese individuals which puts them at a higher risk of developing CV events. This current study seeks to determine the biological implications of chronopharmacology for synchronizing NP-RAAS-based blood pressure therapy with the physiological diurnal rhythms to restore the normal diurnal rhythm of blood pressure in obese individuals.

Type: Interventional

Start Date: Feb 2022

open study