Pilot RCT of Remote Mental Health and Substance Use Screening, Brief Intervention and Referral to Treatment (SBIRT), Compared to In-Person SBIRT for Peripartum Women.

Date Added
November 3rd, 2020
PRO Number
Pro00103742
Researcher
Constance Guille

List of Studies


Keywords
Mental Health, Pregnancy, Psychiatry, Women's Health
Summary

This is a research study to compare a text message based mental health and substance use screening and referral to treatment program, called Listening to Women (LTW), to standard of care mental health and substance use screening. Pregnant women ages 18-41 who are receiving prenatal care within the MUSC Health system are invited to participate.

Institution
MUSC
Recruitment Contact
Edie Douglas
843-792-0403
douglaed@musc.edu

A Phase 1/2a, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Date Added
August 24th, 2020
PRO Number
Pro00096015
Researcher
John Wrangle

List of Studies


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

This study is for patients that have been diagnosed with Non-Small Cell Lung Cancer (NSCLC).The investigational drug used in this study is CLN-081.

This study has 3 parts; Phase 1 Dose Escalation, Phase 1 Dose Expansion, and Phase 2a Dose Expansion:
-Phase 1 Dose Escalation: The main aim of this part of the study is to find a maximum tolerated dose for CLN-081. This will be done by slowly increasing the dose given to each participant or to small groups of participants until certain adverse effects are seen. All participants will be closely monitored by the study doctor and team. When the maximum tolerated dose has been found, it will be used in the subsequent parts of the study.
-Phase 1 Dose Expansion: In this part of the study more participants will receive the maximum tolerated dose to confirm the safety of this dose of the study medicine and to explore different dosing schedules, for example, taking the study medicine once a day versus twice a day.
-Phase 2a Dose Expansion: The main aim of this part of the study will be to see how well the study medicine works in reducing tumor size.

Participants can expect to be on this study for about 3 years.

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

Racial/ethnic disparities in systemic lupus erythematosus (SLE) among women: examination of clinical factors and genetics

Date Added
August 11th, 2020
PRO Number
Pro00098592
Researcher
Mara Lennard Richard

List of Studies


Keywords
Autoimmune disease, Ethnicity and Disease, Genetics, Kidney, Lupus, Women's Health
Summary

Systemic lupus erythematosus (SLE) also known as lupus is a complex autoimmune disorder where the immune system attacks itself instead of external pathogens that can cause disease like bacteria or viruses. The large majority of SLE patients are women. The purpose of this study is to better understand how SLE affects overall patient health in women and expression of genes linked to the development of SLE. Part of this study involves collection of a blood sample at a single visit to test expression of genes linked to SLE. This study will compare demographic and clinical characteristics and genetic differences among women with SLE from three racial/ethnic groups. Better understanding of racial/ethnic differences in health and genetic expression of SLE could help reduce poor disease outcomes such as kidney or heart disease. Results will help us learn more about differences in SLE health across different racial/ethnic backgrounds and will guide medical care.

Institution
MUSC
Recruitment Contact
Jonathan Flume
843-792-3926
jof63@musc.edu

A Mixed Methods Approach to Symptom Clusters in Black Women with Heart Failure Preserved Ejection Fraction: A Feasibility Study

Date Added
August 7th, 2020
PRO Number
Pro00101261
Researcher
Alexandra Ruppe

List of Studies

Keywords
Cardiovascular, Ethnicity and Disease, Heart, Minorities, Non-interventional, Shortness of Breath, Women's Health
Summary

This study aims to explore symptoms for Black women with heart failure using surveys and interviews. Black women have not been included in the majority of heart failure research. It is important that Black women have a voice and the ability to share their symptom experience. The goal of this research is to study clusters of heart failure symptoms in Black women to eventually improve symptom education, monitoring, and treatments.

Institution
MUSC
Recruitment Contact
Alexandra Ruppe
8034176635
moseleal@musc.edu

An Open-label, Randomized Phase 3 Study of MK-6482 Versus Everolimus in Participants with Advanced Renal Cell Carcinoma That Has Progressed After Prior PD-1/L1 and VEGF-Targeted Therapies

Date Added
July 30th, 2020
PRO Number
Pro00097539
Researcher
Theodore Gourdin

List of Studies


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

This study is for a patient that have received previous treatment for renal cell carcinoma. During this study, patients will be randomized to get the investigational drug, MK-6482, or a standard of care drug, everolimus. This is a study to test if MK-6482 or the standard of care drug works better for patientsr type of prostate cancer. MK-6482 is considered experimental. "Experimental" means that the study drug is currently being tested for patientsr type of cancer. It has not been approved by certain health authorities, such as the United States (U.S.) Food and Drug Administration (FDA) to treat prostate cancer. Where as, everolimus, has been an approved standard of care chemotherapy by the FDA.
Participants can expect to be in this study for 4 years.

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

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus-Host Disease in Subjects Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Date Added
July 1st, 2020
PRO Number
Pro00095489
Researcher
Michelle Hudspeth

List of Studies


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

This study is for patients that are getting an allogeneic hematopoietic stem cell transplantation (allo-HSCT) from an unrelated donor for a hematologic malignancy, (cancers that affect the blood and/or lymphatic system). The investigational drug in this study is Vedolizumab. This purpose of this study is to investigate the safety and effectiveness of Vedolizumab compared to placebo (dummy drug), for prevention of intestinal acute graft versus-host disease (aGvHD) in patients undergoing allo-HSCT. GvHD occurs when particular types of white blood cell (T cells) in the donated cells (the graft) attack patients own body cells.

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

Umbilical Cord-derived Mesenchymal Stem Cells (MSC) for Cellular Therapy

Date Added
June 16th, 2020
PRO Number
Pro00099509
Researcher
Hongjun Wang

List of Studies


Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The objective of this study is to obtain viable mesenchymal stem cells (MSCs) from umbilical cords in uncomplicated planned cesarean deliveries. Potential donors will be screened prior to donation of umbilical cords to confirm no infectious disease, viruses and/or diseases. The overall goal is to obtain MSCs from healthy donors for eventual transfusion into patients for potential treatment of diseases, such as chronic pancreatitis, systemic sclerosis, type 1 diabetes, COVID 19, acute respiratory distress syndrome (ARDS), and other diseases in studies approved by the IRB. We also want to store the cells as repository for other potential therapy.

Institution
MUSC
Recruitment Contact
Meghan Blalock
843-792-1800
schneidm@musc.edu

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation

Date Added
May 28th, 2020
PRO Number
Pro00096416
Researcher
John Wrangle

List of Studies


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

This study is for patients who have been diagnosed with solid tumor malignancy with KRAS G12C mutation. The investigational drug used in this study is MRTX849. The purpose of this study is to see if patients with cancer with a KRAS G12C mutation will benefit from treatment with MRTX849, what side effects occur and how often they occur and to see how quickly MRTX849 is absorbed into the blood stream and how fast it is removed by the body. Participants can expect to be in this study for as long as the disease does not get worse.

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

Integrated Early Intervention for Alcohol Use Disorder and Posttraumatic Stress Disorder Following Sexual Assault

Date Added
May 5th, 2020
PRO Number
Pro00099114
Researcher
Christine Hahn

List of Studies


Keywords
Women's Health
Summary

This study is for women who have experienced a sexual assault in the past six weeks and use alcohol. The research involves completing a five week behavioral treatment for stress and alcohol use. Participants will complete surveys during visits. Participants may also be asked to complete brief daily assessments on their smart phones.

Institution
MUSC
Recruitment Contact
Christine Hahn
8437923386
hahnc@musc.edu

A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Date Added
April 28th, 2020
PRO Number
Pro00096818
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with PD-L1 Positive Head and Neck Squamous Cell Carcinoma (HNSCC). Specifically, for people with this type of cancer that cannot be treated with surgery or radiation treatment and has not been treated for cancer that spread to sites distant from the head and neck region (metastatic) or for cancer that returned or got worse after being treated (recurrent).The investigational drug (not approved by the FDA) in this study is GSK3359609. The purpose of this research study is to find out if GSK3359609 combined with pembrolizumab works better than the single drug pembrolizumab. Participants can expect to receive treatment for about 3 years and be in follow-up for the rest of their life.

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



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