The Global Paradise® System US Post Approval Study (US GPS)

Date Added
August 13th, 2024
PRO Number
Pro00138696
Researcher
Thomas Todoran

List of Studies


Keywords
Hypertension/ High Blood Pressure
Summary

This study will enroll two groups of participants. The first group are those who participated in the RADIANCE CAP study, so have already undergone the renal denervation procedure. Those participants can enroll in this post approval study which will entail yearly follow up visits or telephone calls, blood pressure monitoring and questionnaires. The second group of participants are those scheduled to undergo a procedure called renal denervation for the treatment of high blood pressure that has not responded adequately to medications and lifestyle changes. Renal denervation is a procedure which uses a catheter (thin hollow tube) placed in the renal arteries (blood vessels that go to the kidneys) to deliver ultrasound energy. This energy will heat up a small area of tissue around the renal arteries to disable nerves that are surrounding the blood vessels as a way to help reduce blood pressure. Study visits include screening, procedure, discharge, months 1, 3, 6 and 12 then yearly for up to 5 years. Study procedures for this group includes blood work and urine studies, blood pressure monitoring, questionnaires, a follow up ultrasound of your kidneys and the blood vessels around the kidneys. Study related risks include loss of confidentiality, blood draw risks and unknown risks.

Institution
MUSC
Recruitment Contact
Anthony Awkar
843-876-5009
awkar@musc.edu

A phase 2, adaptive, double-blinded, placebo controlled, randomized, multi-center trial to evaluate the efficacy, safety and tolerability of intracoronary infusion of AB-1002 in adult subjects with New York Heart Association (NYHA) Class III heart failure and non-ischemic cardiomyopathy (GenePHIT)

Date Added
August 13th, 2024
PRO Number
Pro00138528
Researcher
Adrian Van Bakel

List of Studies


Keywords
Cardiovascular, Genetics, Heart
Summary

This study is evaluating the safety and effectiveness of the experimental treatment named AB-1002. The purpose of this study is to look at the safety and feasibility of delivery of adeno-associated virus (AAV) through the coronary arteries into the heart in participants with heart failure and non-ischemic cardiomyopathy. An experimental treatment is another option for care for your disease that is still being tested and is not yet approved by the Food and Drug Administration (FDA).

Participation in this study is expected to last one year and include up to 18 visits. Study related procedures include the following heart related testing: study drug infusion, electrocardiograms (ECG), a test to show the heart's electrical activity, echocardiogram (Echo), a test that uses ultrasound to capture moving images of the heart, cardiopulmonary stress test, sample collection including blood, urine, tissue, nasal mucus, saliva, semen, and stool, questionnaires, physical exams, and at least an overnight stay in the hospital. You will also need to take medications to suppress your immune system.

There are risks associated with this study. Risks associated with gene therapy include an immune response that may cause inflammation in the liver, heart or other organs. It may damage your red blood cells, cause a low platelet count or cause the formation of small blood clots. There are also risks related to the study procedures including bleeding associated with the heart biopsy, risks related to drawing blood, risks of radiation, and loss of confidentiality. There may be no benefit to you but knowledge gained from this study may benefit others with heart failure and non-ischemic cardiomyopathy in the future.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
8438765783
shr37@musc.edu

Health Outcomes of Parents with Cystic Fibrosis (HOPe:CF) Aim 2

Date Added
August 13th, 2024
PRO Number
Pro00136818
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis
Summary

We will follow 146 new parents of children <5 years of age at 18 participating US
adult CF centers to assess the primary outcome of ppFEV1 up to 5 years after
becoming a parent. A prospective approach will capture the immediate and longterm impact of the use of the highly effective CFTR modulator ETI by ~90% of US
adults with CF. By combining objective health measures and participant surveys,
we can comprehensively assess the psychosocial impacts of parenthood and
explore the interplay between the parenting role and physical and mental health.
We anticipate identifying modifiable factors that may ameliorate negative health
impacts of parenthood.

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

A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)

Date Added
August 9th, 2024
PRO Number
Pro00133370
Researcher
Brian Hess

List of Studies


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

This study is for subjects that have been diagnosed with Follicular Lymphoma.
This study is testing an investigational drug(s) called Epcoritamab that is not approved by the FDA (Food and Drug Administration). The purpose of this study is to see if the combination of the study drug epcoritamab with rituximab and lenalidomide has a better response rate than standard of care chemoimmunotherapy in the treatment of follicular lymphoma. The total study treatment duration is up to 2.5 years. You may stop the study treatment early if you do not respond after 6 months, your disease worsens, you no longer tolerate the study drug(s), or you withdraw from the study.

Once you finish the study treatment or discontinued study treatment early, you will continue to the Post-Study Treatment Follow Up Period, you will come back to the study clinic every 6 months for the first 3 years and then yearly to have imaging scans and blood work to check if your disease is in remission or worsen.

If your disease worsens or if you start a new FL treatment, you will enter the Long-term Follow Up Period, you will be called by telephone or your health record will be reviewed to check on your well-being and to see what your next treatment plan will be. This follow-up may last up to 15 years.

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

A Phase II Study of Naxitamab Added to Induction Therapy for Subjects With Newly Diagnosed High-Risk Neuroblastoma

Date Added
August 8th, 2024
PRO Number
Pro00134887
Researcher
Jacqueline Kraveka

List of Studies


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

This study is for patient that have been diagnosed with High Risk Neuroblastoma. The investigational drug in this study is naxitamab. The purpose of this study is to test the safety of adding an Anti-GD2 Immunotherapy agent (naxitamab) to your standard therapy during the induction phase of care. Read the sections on risks and benefits carefully and be sure you understand them. This study will also look at the effectiveness of this treatment.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinicaltrials@musc.edu

Black and African Americans Connections to Parkinson's Disease (BLAAC PD) A Project of the Global Parkinson's Genetics Program (GP2)

Date Added
August 7th, 2024
PRO Number
Pro00135539
Researcher
Vanessa Hinson

List of Studies


Keywords
Healthy Volunteer Studies, Parkinsons
Summary

Your participation in this study will help researchers understand genetic information about Parkinson's disease in Black and African Americans. BLAAC PD aims to generate genetic data on PD and non-PD Black and African American participants. To join this study, you must be over 18 years of age and identify as Black or African American. Subjects must have a diagnosis of PD or not have PD or any other neurological condition. The study will consist of one visit, at this visit you will be asked to answer a few questions and give a blood sample. You will not receive your genetic results.

Institution
MUSC
Recruitment Contact
Magdaline Volcy
843-792-1022
volcy@musc.edu

The Effects of Adolescents Alcohol Use on Oral Microbiota and the Brain.

Date Added
August 6th, 2024
PRO Number
Pro00138324
Researcher
Anna Kirkland

List of Studies

Keywords
Adolescents, Alcohol, Brain, Drug Studies, Pediatrics, Psychiatry, Substance Use
Summary

Adolescence is a time of development in the brain and microbiome, including the microbiome present in the mouth called the oral microbiome. Alcohol use often begins and escalates during adolescence, which can cause changes to the oral microbiome leading to changes in the brain. The alcohol specific changes to the oral microbiome and the brain may make adolescents more vulnerable to a lifelong struggle with alcohol use disorder. This study will collect (1) saliva to assess the composition of the oral microbiome and (2) brain measurements using magnetic resonance imaging (MRI) across adolescents who may or may not use alcohol. Findings from this study will help form a more thorough understanding of the biological consequences of adolescent alcohol use, with the long-term goal of informing novel prevention and intervention efforts.

Institution
MUSC
Recruitment Contact
Anna Kirkland
(843) 792-5453
kirklaan@musc.edu

Tracking Brain Imaging Changes in Depression over Clinical Accelerated TMS Therapy at the Individual Level

Date Added
August 6th, 2024
PRO Number
Pro00138260
Researcher
Xiaolong Peng

List of Studies


Keywords
Brain, Depression
Summary

The aim of this study is to use magnetic resonance imaging (MRI) to capture images of participants' brains and apply an image processing method called INSCAPE to assess brain states. This study will recruit participants who are scheduled to receive accelerated Transcranial Magnetic Stimulation (TMS) therapy for Major Depressive Disorder (MDD). Participation in this study involves two visits, each including a 30-minute MRI scan. The interval between each visit is about one week. Depressed participants will also complete mood assessments at various intervals while they are receiving accelerated TMS for depression.

Institution
MUSC
Recruitment Contact
Katherine Tucker
843-792-9502
tuckekat@musc.edu

Out-of-State, At-Home, Transcutaneous Auricular Neuromodulation for Hypermobile Ehlers Danlos Syndrome

Date Added
August 6th, 2024
PRO Number
Pro00138254
Researcher
Jeffrey Borckardt

List of Studies


Keywords
Brain
Summary

Hypermobile EDS and hypermobile spectrum disorder (collectively referred to as hEDS) are estimated to affect 1 in 500 individuals worldwide. This study will enroll hEDS patients to test a new ear stimulation system to help reduce symptoms associated with hEDS, including pain and GI problems. Ear stimulation will be applied twice daily, for four weeks at home, and we will collect electronic behavioral data to track progress.

Institution
MUSC
Recruitment Contact
Katherine Tucker
843-792-9502
tuckekat@musc.edu

EMPWR Pilot Trial: Treatment Retention in Medication for Opioid Use Disorder Among Pregnant and Postpartum Women

Date Added
August 6th, 2024
PRO Number
Pro00137982
Researcher
Sara Witcraft

List of Studies

Keywords
Anxiety, Mental Health, Pregnancy, Psychiatry, Sleep Disorders, Substance Use, Women's Health
Summary

This study involves testing how useful a technology-enhanced intervention is for pregnant people prescribed buprenorphine for the management of opioid use disorder. The intervention being studied is a brief skill building protocol and a mobile application. Participation involves three 60-90-minute skill building appointments during pregnancy, and four 30-minute check-in visits at the end of pregnancy through 3 months postpartum. The mobile application will be accessible for at least the duration of the study. Participants will also be asked to complete questionnaires at enrollment and again at 1-month postpartum and 3-months postpartum, will send monthly photos of their prescription bottle/box, and will be contacted randomly throughout the study to perform a medication count. The total duration of the study is between 5-9 months depending on when you enroll. Compensation is provided.

Institution
MUSC
Recruitment Contact
Maham Dilawar
843-214-4496
dilawarm@musc.edu



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