UAB - Center for Clinical and Translational Science

Mobility refers to a person's purposeful movement through the environment from one place to another and can be conceptualized as a continuum from bed bound (immobility) on one extreme to making excursions to distant locations on the other extreme. Primary open-angle glaucoma (POAG) is a chronic, progressive optic neuropathy that can lead to gradual loss of vision in the peripheral field and central vision. Older adults with POAG have an increased risk for motor vehicle collisions and falls. Moreover, existing studies suggest that patients with POAG exhibit more postural sway while standing as measured by a balance platform and also tend to walk more slowly than those who are normally sighted and free of ocular disease. While these disturbances likely influence mobility, there has been little research directly assessing the impact of POAG on mobility. This study will assess the impact of POAG on life space (one aspect of mobility) and will determine whether difficulties with life space are associated with difficulties experienced under conditions of dim lighting.

Type: Observational

Start Date: Jun 2019

open study

The purpose of this study is to assess the safety and tolerability of two 5-day infusion cycles of IV gallium in adult patients with CF who are infected with NTM. Funding Source - FDA Office of Orphan Products Development (OOPD)

Type: Interventional

Start Date: Jun 2021

open study

In this exploratory study we explore the use of Shear Wave Elastography to differentiate between Acute Kidney Injury after vascular surgery and among the healthy population.

Type: Interventional

Start Date: Jan 2020

open study

This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined with 5-fluorouracil, irinotecan (FOLFIRI) and bevacizumab for untreated advanced/metastatic CRC. The study will use an Accelerated titration BOIN design in Phase I to determine the recommended RP2D of ProAgio with FOLFIRI + bevacizumab. The trial will estimate the RP2D of ProAgio when combined with FOLFIRI + bevacizumab, starting from 2 dose levels lower than the estimated RP2D of ProAgio alone. Accelerated titration BOIN design will enroll patients with the 4 combination dose levels. Subjects will be selected based on following criteria: previously untreated advanced/metastatic CRC, ECOG performance status (0-1), and adequate organ functions. Subjects with recent surgeries, history of recent thromboembolic events or significant cardiovascular disease will be excluded. Once the MTD and RP2D of ProAgio with FOLFIRI have been identified, an expansion cohort of 12 subjects with advanced/metastatic CRC will begin. The purpose of the expansion cohort is to confirm the safety of the regimen and provide preliminary data on the activity of ProAgio + FOLFIRI + bevacizumab.

Type: Interventional

Start Date: Jul 2025

open study

The United States is facing unprecedented rates of drug overdose deaths, profoundly impacting millions of families who are left to navigate their grief. Those bereaved by overdose experience a unique form of grief characterized by feelings of guilt, shame, and blame, which can worsen their suffering and deter them from seeking help. Individuals coping with overdose loss often endure more severe health consequences compared to those grieving non-drug related deaths, including prolonged grief disorder, substance use disorders, PTSD, depression, and suicidal thoughts. Moreover, bereaved individuals, particularly those with a history of substance use, may engage in risky behaviors as a means of coping, further exacerbating the risk of overdose and mortality within this vulnerable population. Peer grief support interventions have emerged as a promising approach to assist those experiencing such losses. To combat these outcomes, we are collaborating with Peer Community Support Partners (PSCP) in a novel practice-research partnership to implement the RIVER peer grief support model. Though RIVER has shown success in community settings, it has yet to be rigorously evaluated. In a three-aim approach, this study aims to assess the effectiveness of the RIVER model while also enhancing and engaging grievers with support resources via medical examiner offices (MEOs), which routinely contact families during death investigations. This research represents a pivotal advancement in addressing the needs of the overlooked bereaved community, aligning with the NIH's Helping to End Addiction Long-term (HEAL) initiative to develop effective strategies against the opioid crisis. Together, community engagement and rigorous research efforts aim to enhance support for those affected by the tragedy of drug overdose.

Type: Interventional

Start Date: Jun 2025

open study

The sponsor of this study, Owlet Baby Care, Inc., is comparing the accuracy of their pulse oximeter Sensor with the measurements of oxygen levels in newborns who are already being monitored with arterial blood samples. A minimum of 20, but up to 100 participants will be enrolled in a hospital environment and need to weigh 1500 grams or more. The purpose of the testing is to gather information on pulse oximeter readings taken by the Owlet OSS 3.0 Sensor and compare the readings to blood gas samples drawn by the medical staff. This will determine if the Owlet Sensor is accurate in newborns up to an age of 28 days after actual or expected delivery date. The Owlet OSS 3.0 is the Sensor component within the Owlet Dream Sock, an over the counter, noninvasive pulse oximeter which is currently FDA cleared in infants 1-18 months and between 6 and 30lbs, meant to be used in the home environment. The Owlet Sock is a fabric wrap that secures the Sensor to a baby's foot. The Sensor estimates the baby's SpO2, pulse rate, and measures movement level, and transmits the wearer's readings to the paired Base Station via low energy BlueTooth energy.

Type: Interventional

Start Date: Aug 2025

open study

This is a multi-center randomized, sham-controlled clinical trial to determine the effectiveness of an air cleaner intervention aimed at improving indoor air quality on reducing COPD exacerbation risk and improving quality of life, functional status, rescue medication use.

Type: Interventional

Start Date: May 2024

open study

This clinical trial aims to compare and evaluate the clinical outcomes between two distinct treatment sequences: free gingival graft surgery preceding guided bone regeneration and guided bone regeneration followed by free gingival graft.

Type: Interventional

Start Date: Aug 2024

open study

This is a phase Ib/II, dose escalation and dose expansion study of valemetostat (DS-3201) with atezolizumab and bevacizumab in patients advanced Hepatocellular carcinoma (HCC) who did not receive prior systemic therapy for advanced HCC.

Type: Interventional

Start Date: Jul 2025

open study

The LIGHT PAD Trial is a Phase II multi-centered randomized clinical trial to collect preliminary data to test whether daily far red light treatment of the lower extremities in people with PAD improves six-minute walk distance, lower extremity perfusion, and ischemia-related damage in gastrocnemius muscle at four-month follow-up, compared to a sham control. Participants will complete 10 minutes of twice daily home treatment with either far red light or a sham light for four months.

Type: Interventional

Start Date: Feb 2024

open study

Periodontitis is a bacterial inflammatory disease and antibiotic use is being empirically used as part of its treatment. However, a clinical practice guideline on periodontal treatment adjuncts published in 2015 identified weak evidence on the use of systemic antibiotics and large heterogeneity across small scale studies, suggesting that larger pragmatic clinical trials would benefit clinical decision making. This will be a prospective, randomized, placebo-controlled trial, stratified by practice and practitioner. The study will investigate the effectiveness of adjunctive antibiotics as adjunct to scaling and root planing (SRP) compared to SRP with placebo for the treatment of generalized stage II-III, grades A-C periodontitis in patient participants from National Dental PBRN practices. Periodontal data will be collected at baseline, re-evaluation (6 weeks), and final (4-12 months) study visits. Changes in periodontal clinical and patient-reported outcomes will be assessed to determine the effectiveness of SRP plus adjunctive systemic Amoxicillin / Metronidazole antibiotics (AMXM) versus SRP with Placebo.

Type: Interventional

Start Date: Apr 2024

open study

The purpose of the study is to evaluate the impact on older adults' wellbeing of participating in a 10-week conversation about arts and culture with an international university student whose native language is not English.

Type: Observational

Start Date: Oct 2023

open study

This is a single site, randomized exercise trial with individuals at least 50 years of age living with HIV who experience suboptimal cognition. The overall goals of this proposal are to determine whether 16 weeks of structured high-intensity interval training (HIIT) can overcome vascular and cognitive impairments (Aim 1) to a greater extent than continuous moderate exercise. Additionally, investigator will seek to identify barriers to engagement in exercise and the participants' perceptions of the study and exercise interventions (Aim 2). This study will enroll 60 participants in Birmingham, Alabama. Data collection will occur at each visit, with baseline data collected at the initial visit with a 3-month follow-up occurring following completion of the intervention.

Type: Interventional

Start Date: Feb 2024

open study

This study will expand the types of pediatric cancers being evaluated for response to cabozantinib. The current COG study is restricted to Ewing sarcoma, osteosarcoma, rhabdomyosarcoma, Wilms tumor, and a handful of uncommon tumors. The proposed study will extend this evaluation to tumors that have been shown to either express known targets of cabozantinib or with preclinical evidence of efficacy, including specifically neuroblastomas. These tumors have high morbidity and mortality, particularly in the relapse setting, and few or no proven therapeutic options. As such, evaluation of cabozantinib in these studies is warranted. The study hypothesizes that use of cabozantinib in patients with ultra-high-risk pediatric solid tumors with minimal disease burden, as defined in the inclusion criteria below, can prevent and/or slow recurrent tumor formation in pediatric solid tumors and thereby significantly extend the period of disease control and/or induce a durable cure.

Type: Interventional

Start Date: Jul 2022

open study

X-NOVA3 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adult participants diagnosed with Major Depressive Disorder (MDD)

Type: Interventional

Start Date: Jul 2025

open study

The goal of this Phase 2b clinical trial is to see if nebulized phage (BX004) can treat chronic Pseudomonas aeruginosa (PsA) lung infection in CF subjects. The primary goal is to see if 8 weeks of twice daily BX004 can reduce the amount of PsA in the sputum compared to placebo (on top of background CF therapy).

Type: Interventional

Start Date: Jul 2025

open study

There are 3 aims of this study. In Aim 1 community patient partners will be enrolled to help guide the research being performed in all of the aims. Investigators will also administer a survey that will help determine factors associated with surgical preparedness. In Aim 2 investigators will develop an intervention to increase surgical preparedness using Human Centered Design Methods. Aim 3 will pilot test the intervention using mixed methods to determine feasibility and implementation outcomes.

Type: Interventional

Start Date: Nov 2024

open study

The purpose of this study is to help providers develop an interdisciplinary treatment pathway for functional neurological disorder (FND) at University of Alabama at Birmingham (UAB), and will involve psychiatry, speech therapy, physical therapy, and occupational therapy. The study will also help providers to evaluate the treatment pathway and publish results regarding the process and outcomes.

Type: Observational [Patient Registry]

Start Date: Jul 2025

open study

The TSC Biosample Repository collects and stores samples of blood, DNA, and tissues that scientists can request to use in their research. The samples we collect are all linked to clinical data in the TSC Natural History Database. The TSC Natural History Database captures clinical data to document the impact of the disease on a person's health over his or her lifetime. This data may be collected retrospectively or prospectively.

Type: Observational [Patient Registry]

Start Date: Jan 2016

open study

This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).

Type: Interventional

Start Date: Sep 2022

open study

This research study is evaluating whether primary palliative care is an alternative strategy to specialty palliative care for improving quality of life, symptoms, mood, coping, and end of life outcomes in patients with acute myeloid leukemia (AML).

Type: Interventional

Start Date: Jun 2022

open study

This study is to compare the two techniques to achieve change in the tissue quality at areas of lack of Keratinized Tissue (KT) using soft tissue grafting with autogenous graft material (Free Gingival Graft)(FGG) vs Strip gingival graft with acellular dermal matrix (ADM) (SGG+ADM).

Type: Interventional

Start Date: Sep 2021

open study

The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.

Type: Observational

Start Date: Oct 2020

open study

The purpose of the study is to see if imaging with fluorine-18 Fluorodeoxyglucose ([18F] FDG) and fluorine-18 Displacement Per Atom ([18F]DPA-714) using positron emission tomography and computed tomography (PET/CT) will show lung inflammation and fibrosis in patients diagnosed with idiopathic pulmonary fibrosis (IPF). This study may help physicians and researchers better understand how best to treat patients with IPF in the future.

Type: Interventional

Start Date: Dec 2020

open study

The Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry started recruiting in 2014 with the objective of studying Idiopathic Pulmonary Fibrosis. In 2018, the registry expanded to include recruitment of participants with other chronic fibrosing interstitial lung diseases (ILDs) with progressive phenotype also referred to as progressive fibrosing interstitial lung diseases in the Chronic Fibrosis Interstitial Lung Disease with Progressive Phenotype (ILD-PRO) Registry. When the third phase of the registry begins, the IPF-PRO registry will enroll additional patients with idiopathic pulmonary fibrosis. This IPF-PRO registry is a prospective registry that will collect information regarding the natural history, health care interactions, participant reported questionnaire data to assess quality of life, and the methods of treatment of participants with a diagnosis of idiopathic pulmonary fibrosis (IPF) or of another chronic fibrosing interstitial lung disease (ILD) with progressive phenotype established at the enrolling centers. In addition, blood samples and chest image studies will be collected and banked for future research projects.

Type: Observational [Patient Registry]

Start Date: Jun 2014

open study