Birmingham, AL Paid Clinical Trials

This is a Phase 1/2 multicenter, open-label, single dose trial of 4D-710 investigational gene therapy in adults with CF who are ineligible for or unable to tolerate CFTR modulator therapy. Read Less

This is a single-center study to evaluate the safety and effectiveness of three investigational devices, the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and the Surgeon-Modified Endografts in the treatment of aortic pathologies involving the visceral vessels. The three investigational devices offer an endovascular approach to treat complex aortic pathologies that cannot be treated with commercially available devices. This customized, endovascular approach has the potential to decrease hospital length of stay, pulmonary complications, and in-hospital mortality. Read Less

The purpose of this basic research study is to determine the contribution of endogenous ascorbic acid (AA) turnover to urinary oxalate excretion in both normal BMI and obese adult non-stone formers and calcium oxalate stone formers. The studies proposed will use diets of known nutrient composition, a stable isotope of ascorbic acid (13C6-AA) and mass spectrometric techniques to quantify ascorbic acid turnover to oxalate. Read Less

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis Read Less

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. Read Less

Cognitive aging in people with HIV (PWH) is of increasing concern for several reasons: 1) between 52%-59% of PWH experience cognitive impairment known as HIV-Associated Neurocognitive Disorder (HAND) which impacts everyday functioning and quality of life; 2) HAND increases in severity and prevalence with age; and 3) 70% of PWH in the United States will be 50 and older by 2030. Fortunately, cognitive training programs can individually target specific cognitive impairments in PWH and possibly reduce the severity and prevalence of HAND and improve everyday functioning and quality of life. This approach is based around the underlying concept of intra-individual variability as controlled through higher level allocation of cognitive resources, known as executive functioning. This feasibility study will use a two-group pre-post experimental design of adults with HAND including: 1) a 20-hours of Executive Functioning Training group (enroll 60, n=48 with attrition), and 2) a no-contact control (enroll 60, n=48 with attrition). Aim 1 - Feasibility: To determine feasibility and acceptability of the intervention (i.e., attrition, feedback). Exploratory Aim 1 - Cognition: Compare adults who receive Executive Functioning Training to those who receive no training to determine whether they improve in global cognitive ability and overall cognitive IIV. This high impact study is innovative in the following ways: 1) This is the first study aimed to reduce cognitive IIV in PWH. 2) This is the first study to use IIV as a guide to target solely executive functioning training to improve global cognitive ability, which may reduce the severity and prevalence of HAND. 3) Over the last decade, the epicenter of HIV has emerged in the Deep South where this study will occur. Most participants in this study will be older PWH who identify as lower social economic status (SES) and/or African Americans and experience HAND symptoms. Read Less

Study is a phase I study to determine the maximum tolerated dose of adding Loncastuximab Tesirine to Aclabrutinib in the treatment of chronic lymphocytic leukemia. Read Less

The purpose of the study is to see if a new group of imaging tests can help identify response to stage IV HER2+ breast cancer before treatment. Read Less

This study will evaluate the use of siltuximab to decrease the severity of cytokine release syndrome (CRS) and immune effector cell-associated neurological syndrome (ICANS) in patients who will receive chimeric antigen receptor (CAR) T-cell therapy for the treatment of hematological malignancies. Read Less

The primary purpose of this study is to see if people with HIV who had a significant weight gain after starting INSTI (integrase strand transfer inhibitor)+TAF/FTC (tenofovir alafenamide/emtricitabine) (TAF/3TC (lamivudine)) regimen could either slow their rate of weight gain or lose weight within about 1 year if they switch to a regimen containing doravirine (DOR; a newer, non-nucleoside reverse transcriptase inhibitor medication). The study will also try to see if participants changing from TAF/FTC (or TAF/3TC) to TDF/FTC (or TDF/3TC) will experience less additional weight gain or a reduction in overall body weight at 48 weeks compared to persons continued on an INSTI + TAF/FTC (or TAF/3TC) combination. INSTINs assessed in A5391 include bictegravir (BIC), dolutegravir (DTG), or raltegravir (RAL). Additionally, the study will see whether a change in ART can affect things like waist circumference, metabolic and cardiovascular health, fat and lean mass body composition, bone health, and maintenance of virologic suppression. Finally, the study will look at the safety and tolerability of DOR plus either TAF/FTC (or TAF/3TC) versus TDF/FTC (or TDF/3TC). Read Less

The goal of this Clinical Study is to understand the outcomes by informing therapy choice for adjuvant treatment in clear cell renal cell carcinoma by using molecular residual disease. The main question[s] it aims to answer are: what is the progression free survival of a cohort of high risk resected RCC patients when treated based on MRD what is the overall survival of high risk resected RCC patients when treated based on MRD Participants will forgo adjuvant therapy with pembrolizumab if they have no detectable molecular residual disease. Participants will continue on with standard of care pembrolizumab if they do appear to have molecular residual disease. Read Less

Multiple sclerosis (MS) is an inflammatory autoimmune disease associated with an imbalance between pro- and anti-inflammatory markers (cytokines) resulting in a demyelinating and neurodegenerative disease. There is early evidence that spinal manipulation (chiropractic care) is better than control in influencing immune (cytokine) activity in asymptomatic participants, but few studies have been completed in participants with chronic inflammatory conditions, such as MS. The purpose of this project is to examine the immediate (after a single thoracic spinal manipulation treatment) and summative impact (after 8 thoracic spinal manipulation treatments occurring over 4 weeks) on pro-inflammatory (interleukin (IL) IL-1ß, IL-2, IL-6, Tumor necrosis factor-alpha) and anti-inflammatory (IL-4, IL-10) plasma cytokines 20 minutes and 2 hours after thoracic spinal manipulation in participants diagnosed with neuroinflammatory relapsing-remitting MS (RR-MS). Spinal manipulation treatment will be limited to the thoracic spine. Secondary outcomes will include determining the impact of 8 thoracic spinal manipulations on fatigue, cognitive processing speed, pain, depression, sleep, and motor function through questionnaires and performance of various in assessments such as the timed 25 foot walk test. Read Less