UAB - Center for Clinical and Translational Science

The purpose of this study is to assess sense of control and catastrophic symptom expectations as targets for Retraining and Control Therapy (ReACT- an intervention focused on changing behaviors and thoughts) for treatment of pediatric psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no medical explanation). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of ReACT. Sense of control over actions will be measured by the magic and turbulence task, a well-validated measure of sense of control. Participants will complete the cold pressor test (CPT) in which participants hold their hand in cool water for as long as possible up to 3 minutes. Catastrophic symptom expectations in response to the CPT will be measured by Pain Catastrophizing Scale for Children (PCS-C) pain tolerance (time with hand in water) and cortisol response. Target assessments will occur 7 days before treatment, 7 days after 8th treatment session and 7 days after 12th treatment session. Participants will also complete long term follow-up visits via HIPAA-compliant Zoom at 6 months and 12 months after the 12th treatment session where participants will complete questionnaires. PNES frequency will be measured from 30 days before to 12 months after treatment.

Type: Interventional

Start Date: Oct 2021

open study

This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 (NBTXR3) / radiation therapy (RT)±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

Type: Interventional

Start Date: Dec 2021

open study

The primary objective of this substudy is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET ligand [18F]DPA-714 in participants enrolled in the UAB Innate and Adaptive Immunity in Parkinson's Disease (Clinical Research Core) and Longitudinal [18F]DPA-714 Imaging in a Parkinson Disease Cohort studies. The PET tracer [18F]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The amount and distribution of [18F]DPA-714 in the brain will be correlated to clinical data acquired through the separate ongoing UAB Innate and Adaptive Immunity in Parkinson Disease (Clinical Research Core) and Longitudinal [18F]DPA-714 Imaging in a Parkinson Disease Cohort studies. The primary objective of this study is to determine if patients with PD have higher levels of neuroinflammation than healthy controls as measured with [18F]DPA-714-PET/MRI.

Type: Interventional

Start Date: Mar 2018

open study

The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact TAPUR@asco.org, or if a patient, your nearest participating TAPUR site (see participating centers). ******************************************************************** Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ********************************************************************

Type: Interventional

Start Date: Mar 2016

open study

This is formative evaluation trial guided by the Values Clarification Theory25 and the Cultural Values Theory26, with specific aims to: Aim 1. Develop a culturally appropriate version of the PPC Approach for older AAs with CVCs by assembling a community advisory group of 3 primary care clinicians, 3 older AA patients with CVCs, and 3 AA persons who care for AA patients with CVCs to solicit feedback on the PPC Approach. Aim 2. Determine the acceptability (e.g., program appraisal interviews) and feasibility (e.g., avg. length of program sessions, program participation rate, study completion rate) of the PPC Approach among a sample 20 of under-resourced older southern AA patients with CVCs receiving primary care at Cooper Green Mercy Health Services Authority. Aim 3. Examine the ability of participants to complete pre- and post-test (8 weeks post-baseline) measures of perception of care, treatment burden, shared decision-making, and patient-clinician communication exchange.

Type: Observational

Start Date: May 2026

open study

In this study, individuals living with diabetes in the Birmingham area will participate in a free, 3-month DSMES program hosted by MedsPLUS Consulting, a local independent pharmacy and wellness center, at a local faith-based organization. DSMES sessions meet twice a month and typically address topics including physical activity, nutrition, coping, and reducing risk and complications. Prior to beginning the program, participants will complete a questionnaire that assesses diabetes self-management behaviors (such as diet, physical activity, and medication adherence) and diabetes knowledge. Additionally, they will participate in a biometric screening where clinical data such as blood A1C, blood pressure, blood cholesterol, and BMI are collected. This data will also be collected again after the completion of the program. In this program, participants will be assigned a community health worker who will contact them outside of scheduled DSMES sessions to provide support. Participants will also be randomly assigned to one of two cohorts, the Traditional cohort and the Remote Patient Monitoring (RPM) cohort. The traditional cohort will use paper trackers to track blood pressure and blood sugar outside of DSMES sessions while the RPM cohort will utilize an RPM platform to track this data.

Type: Interventional

Start Date: Jul 2026

open study

This is an open label, non-randomized, multicenter, pilot, dose expansion study of low dose post-transplant cyclophosphamide (25 mg/kg on Days +3 and +4)/tacrolimus/ruxolitinib in the setting of myeloablative conditioning (MAC) allogeneic peripheral blood stem cell transplantation (PBSCT).

Type: Interventional

Start Date: Jan 2026

open study

The purpose of this study is to evaluate the safety and tolerability of mRNA-2808 in participants with relapsed or refractory multiple myeloma (RRMM).

Type: Interventional

Start Date: Sep 2025

open study

The goal of this clinical trial is to compare Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and standard ureteroscopy (URS) with laser lithotripsy for the treatment of urolithiasis. This is a prospective, randomized (1:1), multi-center study.

Type: Interventional

Start Date: May 2026

open study

This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer. Standard of care therapy includes chemotherapy before surgery (neoadjuvant) to shrink or get rid of the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator. The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. Giving pembrolizumab in combination with radiation therapy after neoadjuvant chemotherapy may help prevent surgical removal of the bladder in patients with muscle invasive bladder cancer.

Type: Interventional

Start Date: Nov 2025

open study

This study is recruiting participants who are experiencing a first episode of psychosis and who have certain genetic factors that may make them respond better to certain medications that are used to treat people with psychosis.

Type: Interventional

Start Date: Sep 2024

open study

This project will compare the health effects of public housing renovation, neighborhood built and social environment improvements, and indoor air purification, alone and in combination, as well as the cost effectiveness of each approach. STUDY 1: The study will assess the effects of public housing and neighborhood environment (built and social) improvements on health-related behaviors, psychosocial and physiologic stress, and self-reported and physiological markers of lung health and chronic disease. STUDY 2: The study will determine whether indoor air purification can positively impact lung health in public housing sites not undergoing housing renovation, comparing a site near industrial pollution vs one less contaminated.

Type: Interventional

Start Date: Jun 2025

open study

Radiosurgery is the use of a focal high dose of radiation therapy to ablate or kill a tumor. This trial will enroll patients with brain metastases 4 cm or less in greatest diameter and will compare 0mm margin to a 2mm margin for treatment.

Type: Interventional

Start Date: Apr 2025

open study

The purpose of this study is to find out if the investigational drug called omecamtiv mecarbil can reduce the risk of the effects of heart failure, like hospitalization, transplantation, or death in patients with heart failure and severely reduced ejection fraction.

Type: Interventional

Start Date: Dec 2024

open study

This is a multicenter randomized controlled trial that assesses the efficacy of a decisional intervention [University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL)] compared to an attention control.

Type: Interventional

Start Date: Jul 2025

open study

The goal of this clinical trial is to learn about the effect of breast-pumping frequency on breast milk supply/ volume in mothers of preterm infants. The main question it aims to answer is: - What effect does pumping frequency have on breast milk supply. Researchers will compare breastmilk supply of mothers who pump every 2 hours to the supply of those who pump every 3 hours to see if there is a difference in the amount of breastmilk they produce. Participants will be assigned to either pump every 2 hours or every 3 hours and record how many milliliters of breastmilk they produce daily for the first 28 days of their baby's life.

Type: Interventional

Start Date: Jun 2025

open study

High blood pressure (hypertension) is a known side effect of the treatment with fruquintinib. Current research does not provide a clear answer whether minority groups such as Black/African American and/or Hispanic/Latino with refractory metastatic colorectal cancer (mCRC) have a bigger risk of higher blood pressure after treatment with fruquintinib. The main aim of this study is to learn how often adults of a minority group experience hypertension after they have been treated with fruquintinib for refractory mCRC. Other aims are to learn how safe fruquintinib is and how well it is tolerated by participants. Participants will receive fruquintinib in 4-week treatment cycles until their condition worsens, they do no longer tolerate the treatment or stop the treatment for other reasons. After the last treatment, participants will be checked upon every 3 months until study completion.

Type: Interventional

Start Date: Jan 2025

open study

The trial will be an open label, single arm, phase 2 study to assess the tolerability and efficacy of HLX-1502 in participants with NF1 that are 16 years or older in age with progressive and/or symptomatic PN. This study will also investigate the safety and efficacy of HLX-1502 in a small cohort of 12 to 15 year olds.

Type: Interventional

Start Date: Feb 2025

open study

Colorectal cancer (CRC) once predominantly affected older individuals, but in recent years has witnessed a progressive increase in incidence among young adults. Once rare, early-onset colorectal cancer (EOCRC, that is, a CRC diagnosed before the age of 50) now constitutes 10-15% of all newly diagnosed CRC cases and it stands as the first cause of cancer-related death in young men and the second for young women. This study aims to detect EOCRC with a non-invasive test, using a blood-based molecular assay based on microRNA (ribonucleic acid)

Type: Observational

Start Date: Apr 2023

open study

CAPTIVA-MRI is an observational multimodal MR imaging study that is ancillary to the CAPTIVA trial [a 3-arm, double-blind Phase III trial conducted at approximately 115 StrokeNet sites randomizing patients with stroke attributed to 70-99% intracranial atherosclerotic stenosis (ICAS) to aspirin plus ticagrelor, clopidogrel, or rivaroxaban.] The primary goal of this ancillary study is to determine if MRI biomarkers can potentially identify ICAS patients who fail best medical management. The CAPTIVA-MRI study leverages the CAPTIVA trial design and implementation to capture information that will inform and facilitate the next generation of ICAS trials and the management of patients with ICAS.

Type: Observational

Start Date: Jun 2024

open study

A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been deemed by their responsible physicians or by their own decision to be unsuitable for oral anticoagulation therapy.

Type: Interventional

Start Date: Dec 2022

open study

The over-arching goal of the Contrast-Enhanced Spectral Mammography Imaging Screening Trial (CMIST) is to determine if dual-energy contrast-enhanced spectral mammography (CESM) can detect more cancers with fewer false positives than digital breast tomosynthesis (DBT) in women with dense breasts. Aim 1: To evaluate the performance of CESM compared to DBT at baseline for breast-cancer screening in women with dense breasts. Aim 2: To evaluate the performance of CESM compared to DBT at the 1-year follow up for breast-cancer screening in women with dense breasts.

Type: Interventional

Start Date: Mar 2023

open study

This study is dedicated to help identify biomarkers for depression and suicide. The purpose of the study is to better understand these links to improve medical and psychiatric care in the future. This research is also to test the effects of standard treatment of depression on improvement in depressive and suicidal behavior and on biomarkers (e.g. miRNA) for these disorders.

Type: Interventional

Start Date: Oct 2022

open study

This study is being conducted to determine the relationship between early childhood exposures, such as Adverse Childhood Experiences, Social Determinants of Health and nutrition/breastfeeding, among children with sickle cell disease, and behavioral interventions aimed to reshape psychological resilience and lifestyle factors towards positive health outcomes.

Type: Interventional

Start Date: Aug 2026

open study

DALY II USA is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and/or refractory B cell lymphoma (BCL). Cohorts include subjects with diffuse large B-cell lymphoma (DLBCL) after receiving at least 2 lines of therapy, primary or secondary central nervous system (CNS) lymphoma (PCNSL) and (SCNSL) after receiving at least one line of therapy, mantle cell lymphoma (MCL) and Richter's transformation (RT) after receiving at least one line of therapy, and DLBCL transplant-ineligible after receiving at least one line of therapy.

Type: Interventional

Start Date: May 2021

open study