Pediatrics Biorepository for Nephrology Clinical Research

Date Added
April 20th, 2023
PRO Number
Pro00124386
Researcher
Katherine Twombley

List of Studies


Keywords
Bladder, Children's Health, Kidney, Urinary
Summary

The goal of this study is to develop a biorepository to store pediatric biospecimens from nephrology cohorts for on-going and future research studies. These studies plan to advance the state of science in the hopes to find more information that potentially leads to developing novel diagnostic approaches and identify therapeutic targets to prevent and/or treat pediatric disease involving the kidneys.

Institution
MUSC
Recruitment Contact
Katherine Twombley
843-792-8904
twombley@musc.edu

A Prospective, Single-arm, Multi-center, Open-label Trial Evaluating the Continuous Application of Prevena™ Therapy for up to 14 days

Date Added
April 20th, 2023
PRO Number
Pro00124286
Researcher
Thomas Curran

List of Studies


Keywords
Surgery
Summary

The purpose of this study is to demonstrate that the continuous use of negative pressure dressings for up to 14 days has similar benefits and risks to the continuous use for up to 7 days. The 3M study product being used in this study includes the PREVENA Plus Incision Management System with PREVENA Dressings (Peel & Place, Customizable and ARTHRO●FORM). The study product is considered investigational because it has not been approved by the FDA for continuous use for up to 14 days. It is currently approved for use for up to 7 days.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
(843) 792-8896
(843) 792-8896

Multifaceted Intervention To Improve Graft outcome disparities in African American Kidney Transplants

Date Added
April 18th, 2023
PRO Number
Pro00127666
Researcher
David Taber

List of Studies


Keywords
Transplant
Summary

This is a randomized study to test a smartphone app that a pharmacist will use to help kidney transplant patients track their medications, blood pressures, and blood sugars if they have diabetes. The goal of this study is to improve care and outcomes in kidney transplant patients and, in particular, help African American patients have better outcomes after transplant.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

Phase II Trial of Sparing the Urethra, Pudendal Artery and Rectum During Stereotactic Ablative Body Radiotherapy (SUPR-SABR) for Low and Intermediate Risk Prostate Cancer

Date Added
April 18th, 2023
PRO Number
Pro00125210
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer, Cancer/Genitourinary, Cancer/Other, Men's Health, Prostate
Summary

This study is for subjects that have been diagnosed with prostate cancer, and their doctor has recommended external beam radiation therapy. The purpose of the study is to evaluate the side effects of a shorter course of radiation called stereotactic ablative body radiotherapy (SABR). The expected duration of the study is up to 28 months including one to four months prior to radiation therapy for treatment preparation, two weeks during radiation therapy, and 24 months after radiation therapy.

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

A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)

Date Added
April 17th, 2023
PRO Number
Pro00128249
Researcher
Stephen Savage

List of Studies


Keywords
Bladder, Cancer/Genitourinary
Summary

This study is for patients with bladder cancer. The study is being done to see if by using one type of chemotherapy instilled in the bladder, Gemcitabine and Docetaxel, instead of the usual BCG therapy can lower the chance of the patient's bladder cancer from growing or spreading.

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

A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)

Date Added
April 17th, 2023
PRO Number
Pro00128249
Researcher
Stephen Savage

List of Studies


Keywords
Bladder, Cancer/Genitourinary
Summary

This study is for patients with bladder cancer. The study is being done to see if by using one type of chemotherapy instilled in the bladder, Gemcitabine and Docetaxel, instead of the usual BCG therapy can lower the chance of the patient's bladder cancer from growing or spreading.

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

A Multicenter, Adaptive, Randomized, Controlled Trial Platform To Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections

Date Added
April 12th, 2023
PRO Number
Pro00126098
Researcher
Andrew Goodwin

List of Studies


Keywords
Coronavirus, Critical Care
Summary

The protocol aims to improve standard of care, by ensuring an agile research infrastructure, with an ability to rapidly assess interventions during epidemic transmission of one or more respiratory pathogens adversely affecting public health.

Trials within this protocol can be adaptive, will be randomized, and will have superiority as the primary objective. Comparisons in the trials may be between an unlicensed agent to a blinded placebo plus standard of care (SOC), between an approved off-label agent to a blinded placebo plus SOC, among several active interventions (blinded or non-blinded; i.e., a comparative effectiveness study), or among different treatment strategies.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

BIO-CONDUCT Study BIOTRONIK Conduction System Pacing with the Solia Lead

Date Added
April 11th, 2023
PRO Number
Pro00127714
Researcher
Anne Kroman

List of Studies

Keywords
Cardiovascular, Heart
Summary

This study is enrolling subjects who need a pacemaker implant for a heart rhythm disorder. A pacemaker is a device implanted under the skin in the upper chest, and is designed to send electrical signals to tell the heart to squeeze (contract) through wires called leads. A conventional pacemaker has a lead placed in the right ventricle (lower chamber of the heart) which is referred to as ventricular pacing. This study will investigate conduction system pacing which is pacing from the part of the ventricle that normally carries electricity through the heart. The specific name for this part of the ventricle is the left bundle branch block area. The heart's conduction system initiates impulses that tells the heart muscle to contract in a coordinated fashion. This study will use the Solia S lead, which is considered investigational, meaning it is not yet approved by the Food and Drug Administration (FDA) for conduction system pacing. The Solia S lead is approved for ventricular pacing.

Participation in this study will last about one year and include 4-5 visits, some of which may be done virtually. The study involves collecting data from your pacemaker implant, Solia S placement, completing questionnaires, electrocardiogram, medical history and medications.

Risks include those associated with the pacemaker implant procedure such as potentially longer implant time, a tear in the interventricular septum (the wall separating the lower chambers of the heart) or unsuccessful lead placement. Other study related risks may include the risk of loss of confidentiality, risks of answering a questionnaire or unknown risks. There may be no benefit to you but the information learned may benefit others in the future who need conduction system pacing.

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

Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved EF Heart Failure

Date Added
April 11th, 2023
PRO Number
Pro00126551
Researcher
Sheldon Litwin

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure, Shortness of Breath
Summary

The purpose of this study is to evaluate the potential effectiveness, outcomes, and safety (before, during, and after study procedures) of the Inter Atrial Shunt Device (IASD) in the treatment of subjects with heart failure symptoms and relatively normal pumping of the heart. This study involves the use of an investigational medical device called the Corvia Atrial Shunt (CAS) System. The CAS is permanently implanted in the heart to reduce the increased pressure in the left side of the heart by creating a small opening between the two upper chambers of the heart. Participants will have a 50% chance of being in either group A having the CAS placed or group B and not receiving the device. Subjects will have 7 research clinic visits, and multiple telephone calls for a total of 5 years of follow-up. The research clinic visits will include medical exams, health questionnaires, ECG and echocardiogram of the heart and 6 minute hall walk tests.

Institution
MUSC
Recruitment Contact
Elhaam Borhanian
843-792-5873
borhania@musc.edu

Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved EF Heart Failure

Date Added
April 11th, 2023
PRO Number
Pro00126551
Researcher
Sheldon Litwin

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure, Shortness of Breath
Summary

The purpose of this study is to evaluate the potential effectiveness, outcomes, and safety (before, during, and after study procedures) of the Inter Atrial Shunt Device (IASD) in the treatment of subjects with heart failure symptoms and relatively normal pumping of the heart. This study involves the use of an investigational medical device called the Corvia Atrial Shunt (CAS) System. The CAS is permanently implanted in the heart to reduce the increased pressure in the left side of the heart by creating a small opening between the two upper chambers of the heart. Participants will have a 50% chance of being in either group A having the CAS placed or group B and not receiving the device. Subjects will have 7 research clinic visits, and multiple telephone calls for a total of 5 years of follow-up. The research clinic visits will include medical exams, health questionnaires, ECG and echocardiogram of the heart and 6 minute hall walk tests.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Elhaam Borhanian
843-792-5873
borhania@musc.edu



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