Colonizing Microbiome as a Determinant of COVID-19 Outcome

Date Added
August 4th, 2020
PRO Number
Pro00102644
Researcher
Alexander Alekseyenko

List of Studies


Keywords
Coronavirus, Immune System, Infectious Diseases, Non-interventional, SARS-CoV-2
Summary

COVID-19 testing involves collection of swabs from nasopharyngeal cavities where the SARS-CoV-2 virus replicates. Many other commensal and pathogenic microbes may be found in the same host niche. Collectively, these microbes are called the microbiome. We hypothesize that the colonizing microbiome at the time of diagnosis may provide leads for early stratification of cases into risk categories, future clinical manifestations of the disease, and insights into treatment strategies.

Institution
MUSC
Recruitment Contact
Bashir Hamidi
843-792-8657
hamidib@musc.edu

REDUCING THE SARS-COV-2 VIRAL LOAD BY HARNESSING THE POWER OF T-CELLS

Date Added
June 25th, 2020
PRO Number
Pro00100487
Researcher
Besim Ogretmen

List of Studies


Keywords
Coronavirus, Immune System
Summary

This protocol is designed to identify donors who recovered from COVID 19 to isolate their PBMCs and T cells for ex vivo reprogramming and expansion in the presence of SARS-CoV-2 spike protein.

Institution
MUSC
Recruitment Contact
Besim Ogretmen
843-792-0940
ogretmen@musc.edu

Innovative Dermatology Real World Data and Research Collaborative

Date Added
June 23rd, 2020
PRO Number
Pro00100084
Researcher
Lara Wine Lee

List of Studies


Keywords
Immune System, Skin
Summary

This is a 2-year, longitudinal, observational study of adult patients (ages 18 and above) being treated for moderate to severe plaque psoriasis.

Patients being prescribed or initiating medical therapy with a new biologic drug (such as risankizumab, guselkumab, brodalumab, tildrakizumab, ixekizumab, adalimumab, etanercept, ustekinumab, secukinumab, certilizumab pegol, infliximab, or apremilast) for the treatment of plaque psoriasis will be eligible for enrollment. The study will be conducted to gather data from enrolled patients' electronic health records, prospective physician-reported information provided by the patients' dermatologists, and information collected from questionnaires and surveys completed by the enrolled patients.

Patients will be screened and enrolled at a regularly scheduled clinic visit. Retrospective medical records from patients who provide consent/assent and meet all inclusion and exclusion criteria will be obtained by the research site. Records will include but will not be limited to: hospitalizations, emergency room visits, procedures, and medical costs. Physician reported outcomes will be recorded at regularly scheduled visits. Patients will also be asked to complete patient reported outcome (PRO) surveys and questionnaires to record data regarding demographics, clinical characteristics of psoriatic disease, comorbidities, family history, occupation and lifestyle factors, use of PsO support programs, contact information, concomitant medication use, medication side effects, and symptom characteristics.

During the follow-up period, the research site will prospectively submit the research subjects' medical records approximately every 3 to 12 months, for up to 2 years. Patients will be asked to complete PRO surveys electronically at regular intervals during this follow-up period.

Institution
MUSC
Recruitment Contact
Virginia Barton
843-876-0110
bartonv@musc.edu

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study Evaluating the Safety and Efficacy of Intravenous Iloprost in Subjects With Systemic Sclerosis Experiencing Symptomatic Digital Ischemic Episodes (AURORA Study)

Date Added
November 12th, 2019
PRO Number
Pro00092860
Researcher
Edwin Smith

List of Studies


Keywords
Autoimmune disease, Drug Studies, Immune System, Rare Diseases, Scleroderma, Stage III
Summary

The purpose of this study is to find out more information about the study drug iloprost for the treatment of symptomatic Raynaud's phenomenon (RP) attacks in people with scleroderma. A Raynaud's attack is defined as one where you notice at least one color change of your finger(s) (blue, white, or red) associated with at least one symptom (pain, numbness, tingling, and/or discomfort of the finger[s]). Your participation in this study will last approximately 9 weeks and will include 8 visits to the study center and 1 phone call from the study staff.

Institution
MUSC
Recruitment Contact
Brittany Frasier
843-792-8613
Frasibri@musc.edu

Identifying functional regulatory marks underlying monocyte dysfunction in scleroderma

Date Added
February 19th, 2019
PRO Number
Pro00085936
Researcher
Paula Ramos

List of Studies


Keywords
Autoimmune disease, Ethnicity and Disease, Genetics, Healthy Volunteer Studies, Immune System, Inflammation, Minorities, Scleroderma, Women's Health
Summary

Scleroderma (systemic sclerosis) is a chronic autoimmune disease, characterized by dysregulation of immune cells in the blood and subsequent fibrosis and vascular dysfunction, associated with significant mortality and morbidity, disproportionately affecting women and African Americans, and without satisfactory treatments. Monocytes, a type of blood immune cells, are critically involved, but the mechanisms responsible for their deregulation in scleroderma remain largely unknown. The goal of this project is to understand how the regulation of monocytes differs between scleroderma and healthy individuals. Volunteers will be asked to provide a blood sample, for which modest compensation will be provided. This is not a drug study.

Institution
MUSC
Recruitment Contact
Tyler Malone
843-792-5935
malonety@musc.edu

Role of microbiota-TLR7/8 Interaction in systemic lupus erythematosus

Date Added
September 5th, 2018
PRO Number
Pro00079851
Researcher
Chenthamarakshan Vasu

List of Studies


Keywords
Autoimmune disease, Immune System, Inflammation, Lupus
Summary

The goal of this study is to learn more about lupus (Systemic Lupus Erythematosus; SLE), which affect African-Americans more than other groups. The purpose of this study is to understand what role microbes living in the intestine (called microbiota) have in causing lupus. This study will include males and females of all ethnic backgrounds who have SLE, individuals who have immediate family members with SLE, and unrelated healthy volunteers. For subject recruitment, CCCR/MCRC databases including the longitudinal SLE in Gullah Health (SLEIGH) study as well as the chart review will be used to screen for eligibility. The study is sponsored by the National Institutes of Health.

Institution
MUSC
Recruitment Contact
Tyler Malone
843-792-5935
malonety@musc.edu

Evaluating Precision Medicine among Male Primary Care Patients

Date Added
February 9th, 2018
PRO Number
Pro00074274
Researcher
Chanita Hughes-Halbert

List of Studies


Keywords
Immune System, Inflammation, Men's Health
Summary

It is important to understand multiple personal-level factors that impact disease risks and outcomes to determine the most effective ways to establish precise medical strategies to prevent, diagnose, and treat chronic health conditions and diseases. This is especially important among minority and underserved populations that would benefit from more tailored healthcare approaches. This study will develop and assess strategies for circulating evidence about precision medicine and improving precision medicine approaches.

Institution
MUSC
Recruitment Contact
Melanie Jefferson
843-876-2430
sweatma@musc.edu

IDENTIFICATION OF PERIPHERAL BLOOD CELL SUBSETS DYSREGULATED IN LUPUS AND SCLERODERMA

Date Added
October 17th, 2017
PRO Number
Pro00069048
Researcher
Paula Ramos

List of Studies


Keywords
Autoimmune disease, Immune System, Lupus, Scleroderma
Summary

Often considered as related diseases, systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) are severe autoimmune disorders characterized, among other, by dysregulation of immune cells in the blood. The roles of different immune cells in SLE and SSc remain unclear. It is of increasing importance to characterize specific immune cells and define their impact on autoimmune disease, which may lead to new therapies. The goal of this study is to identify blood immune cells associated with SLE and SSc.

Institution
MUSC
Recruitment Contact
Daniel Melcher
843-792-2509
melcher@musc.edu

Pathogen Identification in Pediatric Hematopoietic Stem Cell Transplant Patients with Suspected Lower Respiratory Tract Infection

Date Added
December 6th, 2016
PRO Number
Pro00060294
Researcher
Michelle Hudspeth

List of Studies


Keywords
Adolescents, Children's Health, Immune System, Lung, Pediatrics, Transplant
Summary

This study is for patient that have been diagnosed with suspected lower respiratory tract infection. The purpose of this study is to evaluate a new test that may be able to find more lung infections than current tests can. This new test is called next-generation sequencing and looks in respiratory secretions for bacteria, viruses, fungi, and other organisms that may cause infection. We hope to learn more about the usefulness of this new test in identifying infections.

Institution
MUSC
Recruitment Contact
Thomas Hortman
864-792-9579
hortman@musc.edu

Elucidating Mechanisms of Treatment Relapse for Interferon-Free HCV Therapy

Date Added
August 18th, 2015
PRO Number
Pro00046669
Researcher
Eric Meissner

List of Studies


Keywords
Digestive System, HIV / AIDS, Immune System, Infectious Diseases, Liver
Summary

Treatment of chronic hepatitis C virus (HCV) infection is now possible with all oral medications. While most patients achieve a sustained virologic response (SVR) after treatment, synonymous with cure, some patients relapse after treatment for reasons that are unclear. The goal of this research is to understand how a person's immune system changes during treatment of HCV infection with all oral therapy, and how these changes might impact the chances of relapse after treatment. To address these questions, blood and clinical information will be collected from study participants over the course of receiving standard of care treatment for HCV infection. This blood and clinical information will be used to conduct laboratory research focused on the immune system.

Institution
MUSC
Recruitment Contact
Lisa Martin
843-876-5699
martinl@musc.edu



-- OR --