Tulane Research - Clinical Translational Unit

The Allergen Reduction and Child Health Study (ARCHS) is a 12-month, two group randomized control trial of children with asthma and who are exposed to cockroaches. Children ages 5 - 17 living in the Greater New Orleans area will be recruited from a variety of clinic and community settings. The overall goal of the study is to improve patient-centered asthma outcomes (asthma symptom days, health care utilization, asthma control and quality of life) by targeting one key allergen - cockroach exposure in the child's home. The investigators propose a simple intervention of insecticidal bait that is low cost, simple to implement, and which is lower toxicity than other forms of pest control. The reduction in the number of cockroaches in the home is an environmental outcome that is patient-centered and is likely to add to its acceptance by families of children with asthma.

Type: Interventional

Start Date: Nov 2020

open study

This is a Phase 2b, randomized, open label study to assess the safety and efficacy of DPX-Survivac and pembrolizumab, with and without low-dose cyclophosphamide (CPA) in subjects with relapsed or refractory DLBCL.

Type: Interventional

Start Date: Jun 2021

open study

The purpose of this study is to evaluate the efficacy of muvalaplin in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke.

Type: Interventional

Start Date: Sep 2025

open study

The primary purpose of this study is to evaluate the safety and efficacy of larsucosterol, as determined by transplant-free survival through Day 90 in participants with severe alcohol-associated hepatitis (AH) with pre-treatment Maddrey Discriminant Function (MDF) score greater than or equal to (>=) 32 and Model for End-stage Liver Disease (MELD) scores 21-30, inclusive.

Type: Interventional

Start Date: Jan 2026

open study

V-INTERVENTION will evaluate the effectiveness of inclisiran in preventing major cardiovascular and limb events in patients receiving percutaneous coronary or peripheral arterial revascularization. Inclisiran is a subcutaneous, twice-yearly injection that is FDA-approved as an adjunct with statin therapy and on the market to lower LDL-C in high-risk populations.

Type: Interventional

Start Date: Jul 2025

open study

Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of etentamig (ABBV-383) in adult participants with relapsed/refractory (R/R) MM. Etentamig (ABBV-383) is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study is broken into 4 Arms; Arm A (Parts 1 and 2), Arm B and Arms C & D. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of etentamig (ABBV-383). In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of etentamig (ABBV-383). In Arm B a flat dose of etentamig (ABBV-383) will be tested. In Arms C & D, the step-up dose identified in Arm A will be used followed by the target dose of etentamig (ABBV-383) to investigate outpatient administration of etentamig (ABBV-383). Around 210 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 50 sites across the world. Participants will receive etentamig (ABBV-383) as an infusion into the vein in 28 day cycles for approximately 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Type: Interventional

Start Date: Mar 2023

open study

CAPTAIN-T2D will take place in two parts. Part 1 (Screening) will evaluate patients with type 2 diabetes and elevated cortisol risk factors for trial eligibility and the presence of elevated cortisol. Participants deemed eligible from Part 1 will be randomized to either clofutriben or placebo in the double-blind (participant and investigator), dose-ranging, interventional Part 2 (Treatment).

Type: Interventional

Start Date: Nov 2025

open study

The purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177Lu) vipivotide tetraxetan also known as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter referred to as AAA617. The study also seeks to further characterize (as possible) any other AAA617 causally related serious adverse event(s) in the long-term in adults with prostate cancer who received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials.

Type: Interventional

Start Date: Aug 2023

open study

The study aims to evaluate and compare the incidence of atrial arrhythmias (including Post-Operative Atrial Fibrillation (POAF), atrial flutter, and atrial tachycardia) stratified by baseline Utah fibrosis stages and overall fibrosis (%) of the left atrial wall area. The investigators hypothesize that patients with a higher baseline Utah fibrosis staging will experience a higher incidence of POAF. The study also aims to evaluate and compare the in-hospital mortality, length-of-stay (LOS), complication rates (strokes, pneumonia, respiratory failure etc.) of the different Utah fibrosis stage cohorts. Perform cost analysis and compare between patients with POAF and patients without POAF. The investigators hypothesize that patients experiencing POAF will have a higher mortality rate, longer LOS, greater complications, and therefore, additional hospital costs.

Type: Observational

Start Date: Nov 2021

open study

Collection of SARS-COV-2 Secretions and Serum for Countermeasure Development (aka ClinSeqSer) is an observational study to understand natural history of SARS-COV-2 infections among special populations and characterise post-covid morbidity through immune response, virus genome sequencing, cytokine response, and virus shedding. Given the descriptions of infection course of patients over the outbreak of 2003 (SARS-Cov01) and since January 2019 in China and Europe, and now worldwide: 1. Acutely infected patients shed virus that could be of major interest to characterize (viral quantification, characterization of virus shedding -of infective and of non-infective virus) the former reflecting/predictive of severity of disease and the latter reflecting extent/source of contagiosity. 2. Convalescent infected patients develop a specific anti-virus antibody response that is (likely) protective and therefore suits the preliminary requirement for the potential benefits of the convalescent patient plasma therapeutic infusion approach. In addition, long term effects of COVID-19 commonly known as long-haulers remains clinically unclear. Thousands of patients have now been diagnosed with COVID-19 in Louisiana (444,000 cases, 10,122 deaths, 2.2% mortality in Louisiana (LA), as of March 2021), and numerous patients are now also complaining of post-acute sequelae of SARS-CoV-2 (PASC). The investigators want to further clarify questions surrounding rational confinement duration and therapeutic approach by collecting plasma of convalescent patients to identify optimal antibody titer by ELISA, specificity of naturally occurring inflammatory (protein/antibody and RNA) response, and possibly test in vitro antibody neutralization activity.

Type: Observational

Start Date: Mar 2020

open study

The main purpose of this study is to look at the effect (efficacy) and safety of efgartigimod IV in participants with primary immune thrombocytopenia (ITP). After an up to 2 weeks screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod IV or placebo IV, respectively during the double-blinded treatment period (DBTP). At the end of the treatment period (up to 24 weeks), all participants will receive efgartigimod IV during the first 52-week open-label treatment period (OLTP1). At the end of the first OLTP1, participants may begin a second 52-week OLTP2. After the OLTP2, the participants will enter a follow-up period (approximately 8 weeks) while off study drug. The participants will be in the study for up to 138 weeks. More information can be found here: https://clinicaltrials.argenx.com/advancenext

Type: Interventional

Start Date: Oct 2024

open study

This is a 10-year multi-center, prospective, longitudinal, single arm study evaluating immunologic, inflammatory and laboratory parameters associated with long-term Palynziq treatment in subjects with phenylketonuria (PKU) in the United States (US). Subjects in the US for whom a clinical decision has been made that they will receive pegvaliase to treat their PKU within 30 days following the date of enrollment in Study 165-501 (incident-users) or who have previously started treatment with pegvaliase at the date of enrollment in Study 165-501 (prevalent-users) are eligible for participation in Study 165-503.

Type: Observational

Start Date: Jan 2024

open study

The investigators are aiming to investigate the association between ejection fraction (EF) determined by echocardiography and signals obtained from Photoplethysmography (PPG) in the general population. The investigators are also aiming to investigate the association between blood pressure and signals obtained from PPG in the general population. Finally, the investigators are also aiming to investigate the association between signals obtained from PPG in the general population to cardioechographic findings such as, valvular heart disease, structural heart diseases, cardiomyopathies, pericardial disease etc.

Type: Observational

Start Date: Aug 2021

open study

Disasters have negative effects in the short term (physical trauma, adverse environmental exposures, and unstable housing) and the long term (relocation, changes in family functioning, and negative economic effects), which interact with social determinants to worsen health among the most vulnerable women, infants, and communities. Trauma and severe stress are directly linked to pregnancy complications, and raise blood pressure during pregnancy, alter stress hormones, and increase vulnerability to infection, all of which predispose to reduced fetal growth and preterm birth. Disasters also worsen mental health, and depression during pregnancy and postpartum, for instance, is associated with worse physical health during pregnancy, maternal impairment, poorer quality parenting, negative child behavior, and poorer infant cognitive development.The goal of this intervention is to improve mental health in pregnant women living in a disaster-affected region. The main questions this intervention aims to answer are: - Assess the implementation outcomes (acceptability, adaptation, adoption, feasibility, fidelity, and sustainability) of a pilot intervention in a disaster recovery environment. - Assess the effectiveness of the M-O-M-S pilot intervention in a disaster recovery environment. The study will recruit pregnant women in areas that have experienced a natural disaster. Women will be recruited in early pregnancy and attend a series of classes on the cognitive and relationship changes of pregnancy and motherhood, and mental preparation for labor, led by a "mentor," a mother who has experienced pregnancy, labor, and motherhood.

Type: Interventional

Start Date: Nov 2023

open study

The primary objective of the STRIVE study is to compare two implementation strategies for Diabetes Prevention Program delivery: an in-person health coach strategy (standard 24 in-person sessions at WIC clinics) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions at WIC clinics supplemented by technology support) on implementation and health-related outcomes in postpartum women.

Type: Interventional

Start Date: Dec 2023

open study

This study is a quasi-experimental design, specifically a non-randomized controlled trial (NCT) designed to test the effects of gun violence reduction intervention including MI for youth ages 16-24 years old who present to the Emergency Department or ICU Spirit of Charity Trauma Center (SCTC) at University Medical Centers or another area hospital in New Orleans, Louisiana following a gunshot injury or stab wound. The study will utilize an enrollment strategy that involves alternating, across recruitment days, the assigned study condition. Thus, Day 1 participants would be enrolled into TAU, Day 2 participants would be enrolled in MI-case management condition, Day 3 participants would be enrolled in TAU, etc. This proposed design will minimize any confounds associated with self-selection while possibly increasing enrollment rate. Research questions include: 1. Will youth allocated to the MI prevention condition have safer firearm related behaviors and beliefs compared to the TAU control condition at 6 months post- enrollment? 2. Will youth allocated to the MI prevention condition have reduced gun violence recidivism compared to the TAU control condition at 18 months post-enrollment. 3. How do youth's social and normative environments influence their gun behaviors and attitudes? Researchers will compare intervention and TAU arms to see if there are any differences in outcome measures. Participants will: 1. complete study eligibility assessment, be assigned to one of two conditions depending on the date of assessment, consent, and enroll in the Emergency Department (ED) or inpatient unit of hospital by a study team member, 2. participate in one of two conditions: MI administered by a licensed clinical social worker, or treatment as usual control group (TAU) administered by a study team member (n=170 per condition) 3. complete three surveys (baseline, 3-month, and 6-month) conducted by a study team member 4. 18-month post examination of participant hospital records 5. have the option to complete a 1-1.5 hour interview, 1-3 months after the 6-month survey is completed (n=50)

Type: Interventional

Start Date: Aug 2022

open study

The burden of hypertension and related cardiovascular diseases, stroke, and end-stage kidney disease is disproportionately high in Black populations, especially in the South. The Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED) cluster randomized trial aims to test the effectiveness, implementation, and sustainability of a community health worker (CHW)-led multifaceted intervention compared to enhanced usual care for hypertension control in Black communities. In the BLESSED trial, the investigators plan to recruit 1,176 adults with hypertension (approximately 28 per church) from 42 predominantly Black churches in the Greater New Orleans area. The multifaceted intervention will last for 18 months, followed by a post-intervention follow-up visit at 24 months. The BLESSED trial aims to generate evidence regarding the effectiveness, implementation, and sustainability of this CHW-led church-based multifaceted intervention in eliminating hypertension disparities in the United States (US) general population.

Type: Interventional

Start Date: Nov 2023

open study