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

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-escalation, Proof-of-Concept Study Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics of INT-787 in Subjects with Severe Alcohol-Associated Hepatitis

Date Added
April 6th, 2023
PRO Number
Pro00124137
Researcher
Don Rockey

List of Studies


Keywords
Alcohol, Liver
Summary

To evaluate the efficacy of an investigational medication (INT-787) as assessed by disease progression in severe alcohol-associated hepatitis (sAH).

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
843-876-8439
blanke@musc.edu

A Stepped Wedge Cluster Randomized Trial Comparing a Navigation-Based Multilevel Intervention With Treatment as Usual to Improve Initiation of Timely Postoperative Radiation Therapy in Adults with Locally Advanced Head and Neck Squamous Cell Carcinoma (The ENDURE Trial)

Date Added
April 6th, 2023
PRO Number
Pro00123953
Researcher
Evan Graboyes

List of Studies


Keywords
Cancer/Head & Neck
Summary

For patients with head and neck cancer, delays starting adjuvant radiation therapy are common, disproportionately burden racial minorities, and contribute to poor survival and racial disparities in mortality. However, effective therapies to improve the delivery of timely, equitable, guideline-adherent adjuvant radiation therapy are lacking. We have developed a navigation-based multilevel intervention to enhance care coordination, communication, and key cancer care delivery processes that could provide the first effective treatment in this population, thereby improving survival, decreasing racial disparities in outcomes, and developing new standards of clinical care.

Institution
MUSC
Recruitment Contact
Jessica McCay
843-791-0719
mccayj@musc.edu

Advancing Couple and Family Alcohol Treatment through Patient-Oriented Research and Mentorship

Date Added
April 4th, 2023
PRO Number
Pro00127577
Researcher
Julianne Flanagan

List of Studies


Keywords
Alcohol
Summary

Intimate partner violence (IPV) is a serious public health problem that results in significant health and economic burdens including mortality, morbidity, and poor treatment outcomes. A well-developed field of research suggests that alcohol misuse and posttraumatic stress disorder (PTSD) can lead to IPV. Individuals with PTSD and/or problematic drinking behaviors are at risk for IPV because of several factors that are common symptoms of PTSD. Because individuals with PTSD often drink alcohol to "self-medicate" or cope with distressing PTSD symptoms, PTSD co-occurs with alcohol misuse and alcohol use disorder at extraordinarily high rates. However, few studies have examined the combined effects of alcohol misuse and PTSD on any form of violence.

This study will examine the effects of alcohol misuse and posttraumatic stress disorder (PTSD) on alcohol-related intimate partner violence (IPV). We will examine these associations among couples (N=70) in a controlled laboratory setting using validated, standardized methods in a 'real-world' settings using 28 days of ecological momentary assessment (EMA). EMA includes very short surveys (5 minutes or less) that participants respond to on a smartphone application. Participants will be asked to respond to these surveys in the morning and three additional times throughout the day.

Institution
MUSC
Recruitment Contact
Stacey Sellers
843-792-5807
sellersst@musc.edu

Self-Management for Youth Living with Sickle Cell Disease: SMYLS Multi-site Trial

Date Added
April 4th, 2023
PRO Number
Pro00127137
Researcher
Shannon Phillips

List of Studies


Keywords
Adolescents, Blood Disorders, Minorities, Pain, Pediatrics, Rare Diseases
Summary

The purpose of this study is to find out whether a web-based intervention using a mobile app is helpful for teens and young adults with sickle cell disease (SCD) in learning how to care for and manage their symptoms. 272 teens and adults with SCD will be enrolled in this study which is being conducted at the Medical University of South Carolina in Charleston SC., East Carolina University in Greenville NC., University of Miami in Miami FL., and the University of Alabama in Birmingham AL.

Institution
MUSC
Recruitment Contact
Shannon Phillips
843-792-9379
phillipss@musc.edu

Impact of Systemic Tetracyclines in Adolescence on Metabolism, Adiposity, and Skeletal Maturation

Date Added
April 4th, 2023
PRO Number
Pro00120674
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Skin
Summary

In clinical practice, standard of care for treatment of adolescent acne includes extended courses, i.e., 3 months or longer, of systemic tetracyclines, a type of antibiotic.The gut is home to many bacteria. Administration of antibiotics kills these bacteria and prevents them from repopulating during critical developmental periods. The lack of these bacteria has effects on metabolism, fat, and bone mass
accrual in adolescent mice. Given what we have observed in mouse studies,
we are interested to observe the impact of systemic tetracycline acne therapy in adolescents on fat deposition and the skeleton.

Institution
MUSC
Recruitment Contact
Courtney Linkous
8435662453
linkousc@musc.edu

A multicenter randomized controlled trial to establish the impact of MeMed BV® on management of patients with suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("BV: JUPITER" TRIAL)

Date Added
March 29th, 2023
PRO Number
Pro00126966
Researcher
Gary Headden

List of Studies


Keywords
Pulmonary
Summary

1) You will be asked to provide a blood sample; up to two tubes for a total of up to 10mL (less than 2 teaspoons).
2) Samples will be processed and tested on the MeMed BV device.
3) You will be asked about your medical history, medications, and current illness, as well as demographic information (i.e. date of birth) and a contact phone number.
4) If eligible, it will be decided by chance, using a computer, if you will be put into one of two arms: the MeMed BV arm or the control arm. You have an equal chance of being placed in each group. You cannot choose your study group.
a. The MeMed BV arm: your clinician will receive the BV result, this will include a recommendation regarding antibiotic treatment
b. The control arm: your clinician will not receive the MeMed BV results and will treat you according to standard of care.
5) You will be contacted by a member of the study team at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness

Institution
MUSC
Recruitment Contact
Robert Houck
18436931860
houckr@musc.edu



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