Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts Substudy Enrollment Protocol for Analysis of Biomarkers to Predict Disease Progression in the Emergency Department (ePAPER)

Date Added
November 15th, 2024
PRO Number
Pro00140608
Researcher
Gary Headden

List of Studies


Keywords
Immune System
Summary

If a person has symptoms of an upper respiratory infection, the sponsor is developing a blood test to help decide if it is bacterial or viral infection. Using a blood sample, the test will give a score of 0-100 to help decide along with your symptoms if antibiotics are necessary for treatment.

Substudy: Subjects with suspected infection will give a blood sample for the evaluation of certain biomarkers to help determine if the biomarkers can predict the disease progression to severe disease.

Institution
MUSC
Recruitment Contact
Paige Hall
843 792 7944
hallpai@musc.edu

Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts Substudy Enrollment Protocol for Analysis of Biomarkers to Predict Disease Progression in the Emergency Department (ePAPER)

Date Added
November 15th, 2024
PRO Number
Pro00140608
Researcher
Gary Headden

List of Studies


Keywords
Immune System
Summary

If a person has symptoms of an upper respiratory infection, the sponsor is developing a blood test to help decide if it is bacterial or viral infection. Using a blood sample, the test will give a score of 0-100 to help decide along with your symptoms if antibiotics are necessary for treatment.

Substudy: Subjects with suspected infection will give a blood sample for the evaluation of certain biomarkers to help determine if the biomarkers can predict the disease progression to severe disease.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Paige Hall
843 792 7944
hallpai@musc.edu

Pilot Test of an Innovative Implementation Strategy to Improve Reach, Quality, and Equity in Child Maltreatment Prevention

Date Added
November 14th, 2024
PRO Number
Pro00141218
Researcher
Hannah Espeleta

List of Studies

Keywords
Disease Prevention, Healthy Volunteer Studies, Infant
Summary

Millions of children are victims of maltreatment each year in the United States. Research on home visiting programs show that child maltreatment can be prevented; however, these programs struggle to reach families in need and provide high quality care. SafeCare is a sustainable and effective home visiting child maltreatment prevention program, serving over 8,000 families each year. This study will examine the feasibility and implementation of a hybrid in-person/virtual delivery model for SafeCare with 12 home visiting providers and 40 caregivers to inform how home visiting programs are delivered to maximize reach to families, improve family outcomes, and decrease harm to children.

Institution
MUSC
Recruitment Contact
Gabriela Becerra
(843) 792-4202
becerra@musc.edu

A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer.

Date Added
November 14th, 2024
PRO Number
Pro00138977
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer, Cancer/Breast
Summary

This study is for women with inflammatory breast cancer. This study is being done to see if by adding the drug olaparib to the usual radiation therapy will lower the chance of their cancer returning.

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

COVID and Diabetes Assessment: CODA Study Protocol

Date Added
November 14th, 2024
PRO Number
Pro00136948
Researcher
Harsha Karanchi

List of Studies


Keywords
Coronavirus, Diabetes, SARS-CoV-2
Summary

The COVID and Diabetes Assessment (CODA) study is for adults who have been diagnosed with type 1 diabetes or type 2 diabetes within the last 90 days. This study will examine if having a recent COVID-19 infection may impact the course of diabetes. We will gather information about both diabetes and COVID-19 infection. Participants will be followed for 2 years and asked to complete surveys and provide blood samples. No treatment or medications are involved in the study.

Institution
MUSC
Recruitment Contact
Ebony Dawkins Mikell
843-792-4675
Panacceb@musc.edu

Cryoablation for Monomorphic Ventricular Tachycardia

Date Added
November 12th, 2024
PRO Number
Pro00140469
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Heart, Surgery
Summary

This study is enrolling subjects who are referred for a ventricular tachycardia (VT) ablation. VT is an abnormal heart rhythm that comes from the lower chambers of the heart. An ablation is a procedure to treat abnormal heart rhythms by identifying where the abnormal heart rhythm is starting and then scarring the tissue as a way to stop them. In this study the scars are being made by freezing the tissue. This is called cryoablation. This study will use the Adagio VT Cryoablation System (vCLAS™ Catheter and Console) to perform the cryoablation. This system is considered investigational meaning it has not been approved for use outside of this study by the Food and Drug Administration (FDA). Study participation will last about one year and include the following visits: screening/baseline, procedure, pre discharge, 1, 3, 6 and 12 months. There will also be a telephone call at day 7 post ablation procedure. The study will also collect data including medical history and medications, physical exam findings, data from the procedure, echocardiogram (ultrasound test of the heart, electrocardiogram or ECG (test that captures the electrical activity of the heart) and cardiac MRI. The primary study risks are those related to the ablation procedure including pain, abnormal heart rhythms, low or high blood pressure, and blood vessel or heart muscle damage. There is potential benefit as the procedure may eliminate the abnormal heart rhythm and the information gained may help others with this condition in the future.

Institution
MUSC
Recruitment Contact
Chandler Schwede
873-792-5998
schwede@musc.edu

Prospective, Multi-site Safety and Effectiveness Post-Approval Study of FARAPULSE Pulsed Field Ablation in Paroxysmal Atrial Fibrillation ADVENT PAS

Date Added
November 12th, 2024
PRO Number
Pro00140425
Researcher
Rachel Kaplan

List of Studies

Keywords
Heart
Summary

This study is enrolling subjects who are undergoing an atrial fibrillation ablation. Atrial fibrillation (AF) is a condition where the heart beats rapidly and irregularly. An ablation procedure can destroy the tissue in the heart that transmits the irregular electrical signals that cause the AF. The ablation procedure will use the FARAPULSE™ Pulsed Field Ablation System which is approved by the Food and Drug Administration (FDA) and uses pulsed field energy (a specific type of electrical energy) to destroy the heart tissue.

This study will last about 3 years and include up to 10 visits, some of which can be done remotely. Study procedures include blood work, electrocardiogram (ECG) which is a tracing of the heart's electrical activity, and collection of medical history and images.

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

A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination with Durvalumab compared With Durvalumab as Maintenance Therapy in Subjects with Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following First-Line Induction Therapy with Platinum, Etoposide and Durvalumab

Date Added
November 12th, 2024
PRO Number
Pro00136512
Researcher
Mariam Alexander

List of Studies

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

Researchers are investigating a new way to treat a type of lung cancer called small-cell lung cancer, which is very aggressive and often doesn't respond well to treatment. They're studying a drug called Tarlatamab, which targets a specific protein found on the cancer cells. This drug has already shown some promise when used alone, but now they're testing whether it works even better when combined with another type of cancer treatment called anti-PD-L1 therapy. This combination treatment might help the body's immune system fight the cancer more effectively. The hope is that by using these two treatments together, they can improve outcomes for people with small-cell lung cancer and give them a better chance of survival.

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

A Randomized Phase II Study of Tepotinib with or without Ramucirumab in Participants with MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)

Date Added
November 7th, 2024
PRO Number
Pro00140795
Researcher
Christopher Rangel

List of Studies

Keywords
Cancer/Lung
Summary

This phase II Expanded Lung-MAP treatment trial tests tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after a period of improvement (recurrent). Tepotinib is used in patients whose cancer has a mutated (changed) form of a gene called MET. It is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal MET protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving tepotinib with ramucirumab may lower the chance of the cancer from growing or spreading in patients with stage IV or recurrent non-small cell lung cancer.

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

Identification of proinflammatory biomarkers in episodic recurrent vertigo to differentiate Meniere's disease from Vestibular Migraine

Date Added
November 7th, 2024
PRO Number
Pro00140623
Researcher
Habib Rizk

List of Studies


Keywords
Ears, Genetics, Hearing, Inflammation
Summary

We are interested in seeing which biomarkers are involved in the pathophysiological pathways of vestibular migraine and Meniere's disease. To this end, we will have eligible patients undergo peripheral blood draws to establish a biobank. The blood samples collected will undergo in vitro testing to determine the cytokine profiles of the immune cells and will also undergo genetic testing. Data and samples collected will be used for future studies as well.

Institution
MUSC
Recruitment Contact
Habib Rizk
843 876-0112
rizkh@musc.edu



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