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

Comparing compression wrap to compression plus longitudinal elastic netting in leg wounds.

Date Added
August 15th, 2023
PRO Number
Pro00129952
Researcher
Joshua Visserman

List of Studies

Keywords
Skin
Summary

This study's purpose is to research the effect that a compression bandage application has on the skin when applied over an area that has a wound. To better understand the healing process, special cameras and other devices will be used to measure the change in the wound and limb size, temperature of the skin around the wound, amount of oxygen in the tissue around the wound, and the amount of water in the skin before and after a compression bandage is applied. This research will involve two different compression bandage applications, both of which are standard of care.

Institution
MUSC
Recruitment Contact
Travita Lee
(843) 792-2927
leetrav@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

Medical University of South Carolina Interstitial and Connective Tissue Associated Lung Disease Biobank (MUSICAL)

Date Added
August 9th, 2023
PRO Number
Pro00127647
Researcher
Aravind Menon

List of Studies

Keywords
Interstitial Lung Disease (ILD), Lung
Summary

The purpose of this study is to learn more about interstitial lung disease through collection of information and blood samples to be used in future research projects. Basic information and a blood sample will be collected in conjunction with clinical care for this study, approximately every 3 months.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
843-792-0965
recruitment@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

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Patients with Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein (a)

Date Added
August 8th, 2023
PRO Number
Pro00130428
Researcher
Ashley Waring

List of Studies

Keywords
Cardiovascular, Cholesterol, Drug Studies
Summary

This study is enrolling participants with elevated lipoprotein (a) levels, a cholesterol like substance, to test an investigational study medication called olpasiran. Investigational means it has not yet been approved by the US Food and Drug Administration (FDA) for commercial use but has been approved for use in this study. Olpasiran is a subcutaneous injection given every 12 weeks. This study is randomized, which means participants are randomly assigned, like the flip of a coin, to either receive olpasiran or placebo. Placebo looks like the study medication but has no active ingredients. Neither the participants nor the study doctor or study team will know if you are getting study medication or placebo. Participation in this study will last up to 4 1/2 years and include about 14-24 study visits. Study procedures include physical exams, medical history and medication review, electrocardiograms (tracing of the electrical activity of your heart), blood work, questionnaires and medication administration.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

An Open-Label Phase 1b Study of E7386 in Combination With Other Anticancer Drug(s) in Subjects With Solid Tumors

Date Added
August 8th, 2023
PRO Number
Pro00127767
Researcher
Toros Dincman

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

A Phase III, Multicenter, Open-label Study of Ribociclib vs. Palbociclib in Patients With Advanced Hormone Receptor-positive/HER2-negative/HER2-Enriched Breast Cancer - HARMONIA Trial

Date Added
August 2nd, 2023
PRO Number
Pro00128890
Researcher
Frank Brescia

List of Studies


Keywords
Cancer, Cancer/Breast, Drug Studies, Men's Health, Women's Health
Summary

The study is for patients that have been diagnosed with with a certain type of breast cancer, characterized as HER2 (Human Epidermal Growth Factor Receptor 2)-negative and hormonal receptor (HR)-positive, and with a specific characteristic (molecular subtype) called HeER2-Enriched. The investigational drugs used in this study are Ribociclib and Palbociclib. The main purpose of this study is to learn determine if participants with the specific HER2-Enriched subtype will have delayed progression of the disease when treated with ribociclib compared to palbociclib. Participants can expect to be in this study for up to 5 years.

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

A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Prurigo Nodularis

Date Added
August 2nd, 2023
PRO Number
Pro00128776
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

The purpose of this research study is to determine if an investigational cream, ruxolitinib 1.5% cream, is safe and effective to treat adults with prurigo nodularis. In this study, ruxolitinib cream will be compared to a "vehicle cream." The vehicle cream looks like the ruxolitinib cream but contains no ruxolitinib. This study can last up to 60 weeks, including up to 4 weeks for screening, up to 52 weeks for treatment, and 30 days for safety follow-up. Eligible participants will be randomized 1:1 to receive ruxolitinib 1.5% cream or vehicle cream for the first 12 weeks. For the following 40 weeks all participants will receive the ruxolitinib cream.

Institution
MUSC
Recruitment Contact
Tiffany Vereen
843-792-6882
vereent@musc.edu



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