UAB - Center for Clinical and Translational Science

The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.

Type: Interventional

Start Date: Jul 2020

open study

Smoking remains the single most preventable cause of morbidity and mortality in the United States, accounting for approximately half a million deaths every year. The current study will investigate the efficacy and mechanisms of change of a novel smoking cessation intervention. The current study will thus provide essential information regarding a treatment that has the potential to enhance the efficacy of existing smoking cessation interventions, thereby having a beneficial impact on the public health of the United States.

Type: Interventional

Start Date: Aug 2019

open study

The human epidermal growth factor receptor 2 (HER2) regulates cell growth and survival. Approximately 15-20% of all breast cancers are HER2-positive, which are an aggressive and fast-growing subtype of breast cancer. This study will evaluate a new treatment using a potent Poly polymerase (PARP) inhibitor known as Niraparib. Niraparib will be combined with trastuzumab, a HER2-targeted agent, to evaluate the safety and tolerability in patients with metastatic HER2 positive breast cancer. It is anticipated that the combination of drugs will improve survival and have few side effects.

Type: Interventional

Start Date: Sep 2019

open study

The purpose of this study is to learn about using the imaging to make images of the lungs and nose with the long-term goal of the research leading to potential treatments and new therapies for patients with cystic fibrosis.

Type: Observational

Start Date: Apr 2016

open study

The purpose of this study is to test the performance of the AID-P across 21 sites in the Parkinson Study Group. Each site will perform imaging, clinical scales, diagnosis, and will upload the data to the web-based software tool. The clinical diagnosis will be blinded to the diagnostic algorithm and the imaging diagnosis will be compared to the movement disorders trained neurologist diagnosis.

Type: Observational

Start Date: Jul 2021

open study

This is a phase II interventional study evaluating the use of minimal residual disease by next generation sequencing to defer autologous hematopoietic stem cell transplantation (AHCT) in patients with newly diagnosed multiple myeloma.

Type: Interventional

Start Date: Sep 2021

open study

The purpose of this study is to investigate the brain activity associated with non-motor symptoms of movement disorders, including Parkinson's disease and essential tremor. These movement disorders commonly have significant non-motor features also, including depression, cognitive impairment, decreased attention, and slower processing speeds. The investigators are interested in the brain activity associated with these symptoms, and perform recordings of the surface of the brain, in addition to the typical recordings the investigators perform, during routine deep brain stimulation (DBS) surgery.

Type: Interventional

Start Date: Apr 2021

open study

The main objective of this randomized trial comparing vision therapy to observation is to determine the short-term effectiveness of vision therapy on distance intermittent exotropia control. The results will help determine whether to proceed to a full-scale, long-term randomized trial.

Type: Interventional

Start Date: Oct 2021

open study

Many of the 2.8 million family caregivers (FCGs) of persons with advanced cancer are underserved, particularly African-Americans and rural-dwellers in the Southern U.S.. Most have poor access and awareness of community-based palliative care services and have received no formal support or training despite providing assistance to their relatives an average of 8 hrs/day. Providing intense care and witnessing a close friend or family member struggle with advanced cancer can result in FCGs experiencing marked distress, particularly as their care recipients near end of life (EOL). Reports from NCI and NINR caregiving summits, systematic reviews, and the National Academy of Medicine have highlighted major limitations of cancer caregiver interventions, including a lack of attention to underserved populations and cost, poor scalability, over reliance on highly-trained professionals (e.g., nurses, psychologists, behavioral therapists), lengthy sessions over a short duration, and a lack of demonstrated impact on patient outcomes and healthcare utilization. To address this gap, the investigators have developed and tested feasibility and acceptability of a lay navigator-led early palliative care intervention called ENABLE Cornerstone for rural and minority family caregivers of persons with advanced cancer in the Southern U.S.. Evolving out of the team's prior trials and community stakeholder formative evaluation work, this multicomponent intervention is based on Pearlin's Stress-Health Process Model where lay navigators, overseen by an interdisciplinary outpatient palliative care team, employ health coaching techniques and caregiver distress screening to behaviorally activate and reinforce psychoeducation on managing stress and coping, getting and asking for help, improving caregiving skills, and decision-making/advance care planning over 6 brief in-person/telephonic sessions plus monthly follow-up from diagnosis through early bereavement. This proposed hybrid type I randomized effectiveness-implementation trial will determine whether ENABLE Cornerstone compared to usual care can improve family caregiver (Aim 1) and patient outcomes (Aim 2) and will evaluate implementation costs, cost effectiveness and healthcare utilization (Aim 3), over 24 weeks with 294 family caregivers and their patients with newly-diagnosed advanced cancer. To maximize recruitment, the investigators will recruit from two community cancer centers in Birmingham, AL and Mobile, AL. Our theory-driven, standardized approach is innovative because it uses lay navigators in collaboration with a palliative care interdisciplinary team to promote caregiver activation, skills and knowledge enhancement, as opposed to other difficult-to-implement intervention models that rely mostly on delivery of services by advanced practice professionals providing lengthy sessions over a short duration. If effectiveness is established, the ENABLE Cornerstone intervention offers a highly scalable and reproducible model of formal caregiver support that would be primed for dissemination and implementation.

Type: Interventional

Start Date: Jan 2020

open study

The main purpose of this study is to create a longitudinal cohort of those with Sickle Cell Trait (SCT) to better understand the hematologic phenotype for those that carry HbS, assess for differences in those with varying quantities of HbS and assess for potential clinical complications of SCT.

Type: Observational

Start Date: Apr 2023

open study

The Investigators will recruit 50 participants with acute SCI (within 72 hours of injury) Fasting blood collection and bowel function survey will be conducted 4 times: at baseline [the time of first stool sample, within 72 hours of injury] and 1, 6, and 12 months after SCI. Stool will be collected for gut microbiome analysis 4 times

Type: Observational

Start Date: Oct 2023

open study

Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including safety questions.

Type: Observational [Patient Registry]

Start Date: Jul 2015

open study

In the present study, the investigators aim to investigate feasibility of utilizing noninvasive neuromodulation, specifically taVNS, as a nonpharmacologic approach to address insomnia in patients with stage I-IV breast cancer.

Type: Interventional

Start Date: Sep 2023

open study

The purpose of this research is to better understand how emotion processing unfolds in the brain using stereoelectroencephalography (sEEG) and direct brain stimulation. This study will use standard behavioral emotion processing tasks combined with neural recording and direct brain stimulation to assess different aspects of emotion processing. Stimulation pulses during pre and post-test periods will assess the effects of stimulation before and after conditioning, the results of which will be combined with results from the activity of each electrode during the emotion tasks to inform us of the nature of emotion processing in the brain and allow us to devise brain modulation protocols in the future.

Type: Interventional

Start Date: Mar 2023

open study

For this current phase of the larger project, the investigators will survey transplant candidates as well as the participants family and friends to understand the barriers to volunteering and evaluation. This project will examine how network characteristics are associated with eventual living donor kidney transplant outcomes and test the efficacy of evidence-based interventions designed to assist kidney transplant candidates in participant donor search on a multi-center scale.

Type: Interventional

Start Date: Oct 2021

open study

The investigator aims to assess the extent to which a brief exercise intervention improves systemic growth factor concentrations, reverses loss of systemic vascular networks and hypertension, and by extension, improves neurocognition. To test the investigator's hypothesis that increased cardiovascular fitness will correlate with improved vascular density, the investigator proposes the innovative use of retinal density scans.

Type: Interventional

Start Date: Oct 2021

open study

The treatment of patients with major burns requires resuscitation with massive amounts of fluid, typically a type of salt water that is given by vein. This frequently results in injury to vital organs, especially the lungs and kidneys, and even in death. In this study, the investigators propose to use plasma, a specially prepared blood product made from the liquid part of blood, that has undergone special treatment to reduce the risk of disease transmission. The aims include 1) reduce the amount of fluid given during the first 24 hours after a burn 2) reduce the incidence of lung injury and other complications related to the administration of funds and 3) determine if the blood product has any effect on inflammation. An overall decrease the amount of fluids that burn patients receive should decrease the potential for lung injury, decrease days in the hospital, and improve survival.

Type: Interventional

Start Date: Aug 2022

open study

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).

Type: Interventional

Start Date: Oct 2021

open study

This is a 3-arm study stratified by plasma ctDNA. Patients with residual TNBC disease after pre-operative therapy will be assigned to 1 of 3 Arms based on plasma ctDNA positivity and genomic marker(s).

Type: Interventional

Start Date: Aug 2021

open study

This is a pilot feasibility trial among older adults (≥60y) scheduled to undergo Autologous Stem Cell transplantation at UAB. Participants will be randomized into either a prehabilitation program or an attention control group before their transplant. The primary outcomes will be feasibility and secondary outcomes include changes in physical function at the time of transplant and at 12 weeks follow up.

Type: Interventional

Start Date: Jul 2023

open study

The objective is to compare the efficacy and safety of masitinib in combination with riluzole versus matched placebo in combination with riluzole for the treatment of Amyotrophic Lateral Sclerosis (ALS).

Type: Interventional

Start Date: Feb 2021

open study

This study will be conducted to assess the safety and tolerability of ferric citrate in pediatric participants with hyperphosphatemia related to chronic kidney disease (CKD).

Type: Interventional

Start Date: Jun 2023

open study

The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.

Type: Observational

Start Date: Jan 1987

open study

A prospective, non blinded, single arm, multicenter study designed to assess the safety and effectiveness of the bioprosthetic, VenoValve, which is surgically implanted into the deep venous system for treatment of patients with deep venous valvular insufficiency ( C4b-C6 patients).

Type: Interventional

Start Date: Aug 2021

open study

This study is evaluating how ruxolitinib affects premalignant breast cells. One half of the study participants will receive ruxolitinib for approximately 15 days, and the other half will receive a placebo (sugar pill) for approximately 15 days. Once study participants have completed their ruxolitinib or placebo, participants will undergo surgery to remove the premalignant breast tissue.

Type: Interventional

Start Date: May 2018

open study