An Open-Label Extension Study of BPN14770 in Subjects with Fragile X Syndrome

Date Added
May 1st, 2023
PRO Number
Pro00125951
Researcher
Caroline Buchanan

List of Studies

Keywords
Genetics, Pediatrics, Rare Diseases
Summary

This is an OLE study for subjects completing from one of two double-blind clinical
trials. Subjects must have completed the Week 13 visit from one of these two parent
clinical trials to be eligible for this OLE.

Institution
Self Regional Healthcare
Recruitment Contact
Caleb Hinzman
864-672-6912
chinzman@ggc.org

Neoadjuvant Screening Trial: LCMC4 Evaluation of Actionable Drivers in Early Stage Lung Cancer

Date Added
April 25th, 2023
PRO Number
Pro00127146
Researcher
Kathryn Engelhardt

List of Studies

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

This collaborative study was developed by the Lung Cancer Mutation Consortium (LCMC) and supported by the Thoracic Surgery Oncology Group (TSOG). The purpose of this study is to determine if it is possible to identify genetic changes in the tumors or blood of patients with early-stage lung cancers using both blood-based and tumor-based testing when cancer is suspected or first diagnosed. In this trial, participants will be asked to provide blood samples at three different time points. They will also be asked for permission for tumor tissue to be sent to the researchers. Tumor tissue will be collected if there is a leftover sample from a participant's surgery. These samples will be sent to the researchers to be analyzed for genetic changes. The researchers hope that in the future, genetic changes can help doctors determine what the best treatment is for patients with early-stage lung cancer.

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

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

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

Pediatrics Biorepository to Support Cardiology Clinical Research

Date Added
April 9th, 2023
PRO Number
Pro00124741
Researcher
Eric Graham

List of Studies


Keywords
Cardiovascular, Heart
Summary

This proposal is to contribute to data registry and sample bank called Pediatrics Biorepository for Cardiology Clinical Research. Samples collected in this study may be used for future research which plan to advance the state of science in the hopes to develop new ways to diagnose and treat children affected with heart conditions.

Institution
MUSC
Recruitment Contact
Eric Graham
843-792-9570
grahamem@musc.edu

RANDOMIZED PHASE III TRIAL OF MFOLFIRINOX +/- NIVOLUMAB VS. FOLFOX +/- NIVOLUMAB FOR FIRST-LINE TREATMENT OF METASTATIC HER2-NEGATIVE GASTROESOPHAGEAL ADENOCARCINOMA

Date Added
April 6th, 2023
PRO Number
Pro00128202
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer/Gastrointestinal
Summary

This study is for patients with cancer in the stomach, esophagus, or gastroesophogeal junction. The study is being done to see if by adding a third chemotherapy drug to the usual combination of two chemotherapy drugs is better or worse than the usual approach for treatment.

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



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