Mechanisms of New-Onset Autoimmunity/Longitudinal Immune Systems Analysis (MONA-LISA)

Date Added
June 14th, 2023
PRO Number
Pro00127526
Researcher
Diane Kamen

List of Studies


Keywords
Autoimmune disease, Lupus, Non-interventional
Summary

This is an observational non-medication study. The purpose of this study is to understand the immune system in people who are at risk for developing systemic lupus erythematosus ("lupus" or "SLE"). The investigators hope to develop better ways to predict who will get lupus and possibly come up with ideas for new treatments that can prevent or treat the disease.

Participants will be asked to complete 4 annual study visits and monthly telephone contacts with the study team over the course of 3 years. Visits will include a physical exam, collection of blood and urine, and the completion of some surveys/questionnaires about your health and wellbeing. The monthly phone calls will be a brief contact to check on any changes in your health and should take no longer than 15 minutes to complete.

Compensation is available for participation.

Institution
MUSC
Recruitment Contact
Lusawasra King
843-792-7645
kinglu@musc.edu

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Date Added
July 5th, 2023
PRO Number
Pro00126590
Researcher
Marc Katz

List of Studies


Keywords
Cardiovascular, Surgery
Summary

This is an Investigational Device Exemption (IDE) clinical research trial (referred to also as a trial or a research trial) sponsored by AtriCure, Inc (the Sponsor) to learn whether the use of the AtriClip® LAA Exclusion System to close off your left atrial appendage (LAA) during your heart surgery will reduce the risk of stroke. The AtriClip has not been well studied or approved by the FDA for stroke prevention; therefore, this procedure is considered investigational.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
8437928896
overstrm@musc.edu

Novel Cellular Therapy for the Treatment of Pain Associated with Chronic Pancreatitis

Date Added
July 18th, 2023
PRO Number
Pro00127525
Researcher
Hongjun Wang

List of Studies


Keywords
Pain
Summary

Patients with chronic pancreatitis often suffer from severe abdominal pain that reduce their quality of life. The major purpose of this study is evaluate the safety and efficacy of an infusion of the patient's own stem cells to relieve chronic pain. The stem cells will be isolated from the patient's bone marrow and grown in the clean lab to be used for treatment. After infusion into the vein, the participant will be followed for 12 months to evaluate their pain and other outcomes.

Institution
MUSC
Recruitment Contact
Leah Benn
843-792-2813
bennle@musc.edu

Randomized Phase II/III Trial of First Line Platinum/Etoposide with or without Atezolizumab (NSC #783608) in Patients with Advanced or Metastatic Poorly Differentiated Extrapulmonary Neuroendocrine Carcinomas (NEC)

Date Added
July 30th, 2023
PRO Number
Pro00129939
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer/Gastrointestinal, Cancer/Genitourinary
Summary

This study is for patients with neuroendocrine carcinoma (NEC) originating outside of the lung. This study is being done to see if the combination of atezolizumab, an immunotherapy drug, with a platinum drug (cisplatin or carboplatin) and etoposide better or worse than a platinum drug and etoposide for patients with advance or metastatic neuroendocrine carcinoma originating outside the lung

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

REBYOTA™ for the Prevention of Recurrence of Clostridioides Difficile Infection (CDI) in Adult Patients: An Observational Study

Date Added
August 8th, 2023
PRO Number
Pro00130739
Researcher
Scott Curry

List of Studies


Keywords
Bowel, Infectious Diseases
Summary

This is a prospective observational cohort study that will create a patient registry by collecting data on patients who receive REBYOTA to prevent recurrence of Clostridioides difficile infection (CDI). The registry will include data about CDI episodes, CDI related symptoms, healthcare resource utilization (i.e., hospitalizations and re-admissions) and this data will be collected up to 6-months after receiving REBYOTAâ„¢.

Institution
MUSC
Recruitment Contact
Alicia Hartley
843-792-4100
hartleal@musc.edu

An Open-Label Study of E7386 in Combination With Other Anticancer Drug(s) in Subjects With Solid Tumors

Date Added
August 8th, 2023
PRO Number
Pro00127767
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to learn about the effects of an experimental treatment called E7386. This study is for patients with hepatocellular carcinoma, colorectal cancer, endometrial cancer, or other solid tumors. E7386 in combination with levantinib fight tumors by decreasing tumor density. The purpose of this study is to learn about the effects of an experimental treatment called E7386. E7386 is considered "experimental" because it has not been approved by the U.S. Food & Drug Administration (FDA) for the treatment of any disease. Levantinib is FDA approved and has been previously used to treat cancer, however, it is considered experimental in combination with E7386.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Randomized Evaluation of Bromocriptine in Myocardial Recovery Therapy for Peripartum Cardiomyopathy

Date Added
August 14th, 2023
PRO Number
Pro00122591
Researcher
Stephanie Gaydos

List of Studies

Keywords
Heart
Summary

The study is being done to test the use of a drug called bromocriptine for women who have a condition called Peripartum cardiomyopathy or PPCM. PPCM means you have a weak heart after giving birth. The study will look at how the heart muscle improves in women taking bromocriptine compared to a group of women given a placebo or inactive pill. Bromocriptine is approved by the United States Food and Drug Administration (FDA) to treat irregular periods and other symptoms that result from having high blood levels of a substance called prolactin. It is not approved for use in usual care to treat PPCM. The follow up period will be about 3 years. The study will have an initial visit and then the follow -up visits will take place at one, three, six, and 12 months in the first year and visits by phone at 24 months and 36 months.

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
843-792-0464
panneeer@musc.edu

LIBREXIA - AF A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants with Atrial Fibrillation

Date Added
August 15th, 2023
PRO Number
Pro00130569
Researcher
James Phillips

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart, Vascular
Summary

This is a study comparing the new class anticoagulants factor XIa to the FDA approved Apixaban. The study is to determine if Milvexian is as effective and safe with preventing clots for patients with A-fib and to determine if Milvexian is better at reducing the chances of bleeding.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Jacqueline Sheriod-Scott
1-803-255-2927
sheriods@musc.edu

LIBREXIA - AF A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants with Atrial Fibrillation

Date Added
August 15th, 2023
PRO Number
Pro00130569
Researcher
James Phillips

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart, Vascular
Summary

This is a study comparing the new class anticoagulants factor XIa to the FDA approved Apixaban. The study is to determine if Milvexian is as effective and safe with preventing clots for patients with A-fib and to determine if Milvexian is better at reducing the chances of bleeding.

Institution
MUSC Heart and Vascular Institute
Recruitment Contact
Jacqueline Sheriod-Scott
1-803-255-2927
sheriods@musc.edu

Health Education Approach to Lung Screening (HEALS)

Date Added
August 29th, 2023
PRO Number
Pro00130682
Researcher
Marvella Ford

List of Studies


Keywords
Cancer, Lung, Minorities
Summary

The Southeastern Consortium for Lung Cancer Health Equity (SC3), led by Dr. Robert A. Winn, assembles an outstanding interdisciplinary team of translational researchers positioned in the heart of the historical and current tobacco-producing region within the southeast. Collectively, SC3's investigative team has unparalleled experience in lung cancer screening, translational research in lung cancer health disparities, community outreach and engagement, and recruiting and retaining racial and ethnic minorities and individuals from other medically underserved groups using evidence-based strategies. As NCI-designated cancer centers, all three centers report high enrollment of underserved minorities onto interventional trials and are committed to reducing the substantial disparities found in lung cancer outcomes in their collective Black/African American and rural communities.

Institution
MUSC
Recruitment Contact
Ellen Gomez
8438762428
gomezel@musc.edu



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