UAB - Center for Clinical and Translational Science

The purpose of this study is to assess the safety, tolerability and preliminary effectiveness of CC-92480 (BMS-986348) in novel therapeutic combinations for the treatment of Relapsed or Refractory Multiple Myeloma (RRMM).

Type: Interventional

Start Date: Oct 2022

open study

The TRIPS study is a prospective, multi-center, double-blind, adaptively randomized, placebo-controlled clinical trial of the drug anakinra for reversal of moderate to severe hyperinflammation in children with sepsis-induced multiple organ dysfunction syndrome (MODS).

Type: Interventional

Start Date: Jun 2022

open study

This is a Phase 1/2 multicenter, open-label, single dose trial of 4D-710 investigational gene therapy in adults with cystic fibrosis.

Type: Interventional

Start Date: Mar 2022

open study

This is a multicenter, randomized, double-blind study of two treatment regimens for invasive candidiasis included candidemia. Subjects will receive intravenous echinocandin followed by oral ibrexafungerp (SCY-078) vs intravenous echinocandin followed by oral fluconazole.

Type: Interventional

Start Date: Aug 2022

open study

This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out if it is safe for participants with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). It will study SEA-CD70 to find out what its side effects are and if it works for AML and MDS. A side effect is anything the drug does besides treating cancer. This study will have seven groups or "parts." - Part A will find out how much SEA-CD70 should be given to participants - Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants with MDS. - Part C will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants with AML. - Part D will find out how much SEA-CD70 with azacitidine should be given to participants - Part E will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat participants with MDS or MDS/AML that has not been treated. - Part F will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat participants with MDS or MDS/AML. - Part G will find out how much SEA-CD70 with azacitidine and with venetoclax should be given to participants with AML. Also, to evaluate safety and tolerability of PF-08046040 in combination with azacitidine and venetoclax in participants with previously untreated AML who are unfit for standard induction chemotherapy.

Type: Interventional

Start Date: Aug 2020

open study

Registry study to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices.

Type: Observational [Patient Registry]

Start Date: Apr 2014

open study

This is a randomized, double-blind, placebo-controlled, multicenter study in participants with Parkinson's disease (PD) with motor fluctuations. Participants will be randomized to receive once-daily oral doses of either 75 milligrams (mg) CVN424 or 150 mg CVN424, or a matching placebo for 12 weeks. Participants who successfully complete this study and retain eligibility/suitability will be invited to participate in a future open-label extension (OLE) study.

Type: Interventional

Start Date: Sep 2024

open study

The goal of this clinical trial is to compare 2 different timepoints for clamping the umbilical cord at birth for term-born infants with a prenatal diagnosis of congenital heart disease (CHD). The main questions it aims to answer are: - Does Delayed Cord Clamping at 120 seconds (DCC-120) or Delayed Cord Clamping at 30 seconds (DCC-30) after birth lead to better health outcomes? - Does DCC-120 seconds or DCC-30 seconds after birth lead to better neuromotor outcomes at 22-26 months of infant age (postnatal)? Participants will be asked to do the following: - Participate in either DCC-120 or DCC-30 at birth (randomized assignment). - Complete General Movements Assessment (GMA) at 3-4 months of infant age (postnatal), complete questionnaires / surveys at this time. - Complete questionnaires / surveys at 9-12 months of infant age (postnatal). - Complete Hammersmith Infant Neurological Examination (HINE), Developmental Assessment of Young Children 2 Edition (DAYC-2), and questionnaires / surveys at 22-26 months of infant age (postnatal). - Permit data collection from electronic medical records for both the mother and infant study participants. Investigators will compare DCC-120 vs. DCC-30 to see which approach is more beneficial to both the mother and baby with CHD.

Type: Interventional

Start Date: Dec 2023

open study

Knee osteoarthritis (OA) is the most prevalent form of arthritis, a significant cause of disability in the U.S. With an aging population and the rise in obesity rates, the prevalence of knee OA is expected to climb, significantly reducing quality of life (QOL) for those suffering from this debilitating condition. Current national efforts to reduce analgesic utilization highlight the critical need for safe, effective, and accessible alternatives for pain relief. Low-carbohydrate diets (LCDs) reduce inflammation and pain independent of weight loss, indicating that diet interventions offer a non-pharmacological complementary treatment. However, differences exist in metabolism that are rarely addressed in diet intervention studies. Thus, it is important to assess the potential of different diets in a broad population of chronic pain sufferers to determine the potential of diets to reduce knee OA pain. We have shown that a LCD was associated with reduced evoked knee OA pain, daily pain and oxidative stress when compared to either a USDA diet or a diet-as-usual control. Both experimental diets reduced weight to a similar degree, arguing that diet quality was likely the key factor in pain reduction, as opposed to weight loss. However, previous studies comparing diets have utilized diet prescriptions with less control for adherence to the diets. To overcome this obstacle, and in line with our recent work, we will provide all snacks and meals during the diet intervention to increase adherence and retention in the study, allowing for better control over diet interventions and consistency of foods within each study group. We will recruit adults with knee OA (N=200) to complete our two-phase protocol. Phase 1 will involve a 1-week diet run-up that will allow for quantification of pain measures, psychosocial variables (socioeconomic status, nutritional knowledge, proximity to grocery stores, food insecurity), and diet quality to provide a baseline for comparison. Phase 2 will be a 6-week randomized diet intervention (LCD or USDA diet) in which both groups will be provided with all meals at the direction of study personnel and input from participants. Evoked pain tasks, measures of pain disability, severity, catastrophizing, and interference will be assessed every 3 weeks in addition to QOL measures, mood, and depression. Physiological variables will be assessed through blood draws (inflammatory profile) and dual-energy X-ray absorptiometry scans (DXA; body composition, visceral fat) at the end of Phases 1 and 2. This will be the first study to examine the efficacy of these diets to reduce knee OA pain with an emphasis on interactions with biopsychosocial variables. Changes in all pain measures following Phase 2 will be assessed with respect to published measures of clinically-meaningful differences in pain and disability, as well as for statistical significance. The central hypothesis is that the LCD will improve pain and QOL in participants with knee OA more than the USDA diet, but that both will be beneficial. Specific Aim 1: To investigate the efficacy of the diets to reduce pain and improve QOL. Hypothesis 1: The LCD group will show significantly greater reductions in: a) self-reported pain (>1.7 in pain intensity) and, b) evoked pain (>30%) when compared to the USDA diet. Hypothesis 2: The LCD group will show greater improvements in: a) QOL, b) mood, and c) self-reported improvement (>50% participants reporting "much improved" or "very much improved"). Hypothesis 3 (secondary): Both diets will result in improved pain disability, severity, catastrophizing and pain related fear; the LCD will outperform the USDA diet. Specific Aim 2: To explore individual differences in diet and baseline measures. Hypothesis 1: Baseline diet quality will be negatively associated with baseline pain sensitivity Hypothesis 2: Those reporting greater a) food insecurity and/ or b) proximity to grocery stores will report poorer-quality diets. Specific Aim 3: To determine whether physiological variables contribute to diet effects or lack thereof. Hypothesis 1: Baseline physiological measures (inflammatory profile) will predict: a) pain sensitivity, and b) reductions in pain. Hypothesis 2: Change in physiological measures (inflammatory profile, adiposity, leptin) will be related to: a) change in pain measures, b) change in QOL, c) self-reported improvement and, d) mood.

Type: Interventional

Start Date: Feb 2023

open study

This is a Phase 3, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma. Participants randomized to the pembrolizumab monotherapy arm who subsequently have a blinded independent central review- verified confirmed progressive disease (PD) will be offered lifileucel monotherapy in an optional crossover period.

Type: Interventional

Start Date: Mar 2023

open study

The goal of this clinical trial is to test the effectiveness of an integrated infectious disease/substance use disorder (SUD) clinical team intervention approach in patients hospitalized with severe injection-related infections (SIRI) who use drugs. The main question this study aims to answer is whether this intervention approach will be associated with lower mortality and fewer hospital readmissions. Participants will participate in the integrated SUD/ID care team intervention (SIRI Team). Researchers will compare this intervention to treatment as usual (TUA) to see if there are any differences in health outcomes.

Type: Interventional

Start Date: Jan 2024

open study

CLN-619-001 is a Phase 1, open-label, multi-center study of CLN-619 alone and in combination with pembrolizumab in patients with advanced solid tumors.

Type: Interventional

Start Date: Oct 2021

open study

The proposed clinical study is intended to evaluate oral P5P for the treatment of patients confirmed to have Pyridox(am)ine 5'-Phosphate Oxidase (PNPO) deficiency via genetic analysis. There is an unmet clinical need for pharmaceutical grade P5P, as to date none has been made commercially available. Patients will receive pharmaceutical grade P5P according to their normal oral P5P dosing regimen, as previously established by their physicians.

Type: Interventional

Start Date: Feb 2024

open study

Although extensively studied, the cause of preeclampsia remains uncertain other than it is thought that the placenta plays a critical role in the development of preeclampsia. Recent data revealed that exosomes released from the placenta could cause preeclampsia by transporting specific cargo responsible for the pathophysiological changes associated with the systemic disease. By isolating these exosomes from maternal blood and placental tissue in patients diagnosed with preeclampsia and studying their biochemical, cellular and molecular mechanism in an animal model, the investigators hope to elucidate the critical role that exosomal cargo plays in the development of preeclampsia and cardiovascular remodeling. This will be accomplished by obtaining patient samples from volunteers delivering at the Women and Infants Center and taking the samples to the lab for quantification, characterization, and identification of key functional roles through in/ex vivo, in vitro, and profiling studies. The investigators believe this work will be valuable as hope exists to define the functional role exosomes play in the development of preeclampsia that leads to cardiovascular remodeling. Data from this study will shed more light on the functional role of exosomal cargo in normal and pathological pregnancies and point towards novel therapeutic intervention strategies for preeclampsia associated with cardiovascular disease.

Type: Observational

Start Date: Dec 2019

open study

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 adult psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no correlated epileptiform activity). 19 years and older participants diagnosed with PNES who are treated at UAB FND clinic will engage in twelve sessions of ReACT. Participants will be randomly assigned to one of three conditions: no wait, 3-month waiting period, 6-month waiting period. 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 (PCS), pain tolerance (time with hand in water) and cortisol response. Target assessments occur 7 days before treatment and 7 days after the 12th treatment session. Participants randomized to the 3-month and 6-month waiting period will also complete these measures one additional time immediately before the beginning of their waiting period. Long term follow-up assessments will occur at 2 months, 6 months and 12 months after the 12th treatment session. PNES frequency will be measured from 30 days before to 12 months after treatment. Participants randomized to the 3-month or 6-month waiting period conditions will log weekly PNES episodes until the start of therapy.

Type: Interventional

Start Date: Apr 2025

open study

This is a pediatric kidney transplant study comparing the safety and efficacy of an immunosuppressive regimen of belatacept and sirolimus to tacrolimus and Mycophenolate Mofetil (MMF). Two hundred participants will be randomized (1:1) to one of two groups within 24 hours following the transplant procedure. The duration of the study from time of transplant to the primary endpoint is 12-24 months.

Type: Interventional

Start Date: May 2024

open study

The goal of this clinical trial is to test the effects of 10 weeks of exercise on overall brain health, reduction in blood pressure, and the number of blood vessels in the back of the eyes in patients with hypertension and have a body mass index ≥ 25 kg/m2. The main question[s] it aims to answer are: - To test the effect of moderate vs intensive exercise on Brain Care Score outcomes. - To ascertain the differential impact of moderate vs high intensity exercise in reducing hypertension and its downstream effects.

Type: Interventional

Start Date: Jan 2024

open study

The purpose of this study is to evaluate whether the use of the Detection of Elder Mistreatment Through Emergency Care Technicians-Revised for Primary Care (DETECT-RPC) screening tool increases the average reporting of elder mistreatment (EM) by homebased primary care (HBPC) clinicians.

Type: Interventional

Start Date: Feb 2025

open study

In 2014, a team of parents, nurses, and physicians created Patient and Family Centered I-PASS (PFC I-PASS), a bundle of communication interventions to improve the quality of information exchange between physicians, nurses, and families, and to better integrate families into all aspects of daily decision making in hospitals. PFC I-PASS changed how doctors and nurses talk to patients and families on rounds when they're admitted to the hospital. (Rounds are when a team of doctors visit patients every morning to do a checkup and make a plan for the day.) Rounds used to happen in a way that left out patients and families. Doctors talked at, not with patients, used big words and medical talk, and left nurses out. PFC I-PASS changed rounds by including families and nurses, using simple non-medical words, and talking in an organized way so nothing is left out. When PFC I-PASS was put in place in 7 hospitals, patients had fewer adverse events and better hospital experience. But it didn't focus on how to talk with patients with language barriers. This project builds upon upon PFC I-PASS to make it better and focus on the special needs of patients who speak languages other than English. This new intervention is known as PFC I-PASS+. PFC I-PASS+ includes all parts of PFC I-PASS plus having interpreters on and after rounds and training doctors about communication and cultural humility. The study team will now conduct a stepped-wedge cluster randomized trial to compare the effectiveness of PFC I-PASS+ and PFC I-PASS to usual care at 8 hospitals.

Type: Interventional

Start Date: Mar 2024

open study

Vorasidenib in combination with pembrolizumab in participants with recurrent or progressive isocitrate dehydrogenase-1 (IDH-1) mutant Glioma.

Type: Interventional

Start Date: Jan 2023

open study

The choice of autograft for ACL reconstruction continues to be debated. To date, there has only be one completed randomized controlled trial with quad tendon to BTB and the tendon included a bone plug. There has been no study to date comparing an all soft tissue quad tendon to patellar tendon in a randomized controlled trial for ACL reconstruction.

Type: Interventional

Start Date: Sep 2023

open study

Advancements in prenatal genetic screening have significantly improved the identification of chromosomal abnormalities and heritable conditions during pregnancy, yet current standards for patient education in this domain are largely ineffective. The most effective approach to education about prenatal screening is one-on-one genetic counseling, but due to the limited number of counselors this is not feasible, especially in rural and frontier areas. The investigators will address this national problem using a novel education game that can more effectively address this gap in healthcare decision-making.

Type: Interventional

Start Date: Mar 2023

open study

The goal of the current pilot clinical trial is to evaluate the safety and tolerability of pirfenidone in patients with predicted moderately severe and severe acute pancreatitis. Pirfenidone is currently approved by FDA for the treatment of idiopathic pulmonary fibrosis. Now, over 5 years of data has accumulated demonstrating safety of its use in humans. The investigators' preclinical data suggest that pirfenidone is very effective in reducing the severity of acute pancreatitis in animal models. Following are the objectives of the proposed clinical trial: Primary Objective: - To evaluate the safety and tolerability of pirfenidone, compared to placebo, in patients predicted to have moderately severe or severe AP. - To evaluate the efficacy of pirfenidone in reducing the laboratory markers of inflammation and improving patient reported outcome measures. Secondary Objective: - To evaluate the efficacy of pirfenidone in reducing the severity of acute pancreatitis, as measured by well-defined endpoints.

Type: Interventional

Start Date: Aug 2023

open study

The purpose of this study is to determine how effective a 6-week exercise program is for improving memory compared to a no-intervention control group, investigate the brain changes that may be responsible for memory improvements, and determine if the memory benefits and brain changes are retained 6 weeks after completing the exercise intervention in people with Idiopathic generalized epilepsy (IGE).

Type: Interventional

Start Date: Jul 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 206 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