Portable Transcranial Magnetic Stimulation (TMS) in a Van for Treatment-Resistant Depression

Date Added
December 3rd, 2024
PRO Number
Pro00139739
Researcher
Mark George

List of Studies


Keywords
Anxiety, Depression
Summary

In this pilot study we will assemble a portable TMS(transcranial magnetic stimulation) unit, in a van, and then test out delivering TMS in Medical University of South Carolina (MUSC)-affiliated facilities in South Carolina, all within 90 minutes of driving from Charleston, SC. This work will hopefully open up access to TMS for millions of patients with treatment-resistant depression who cannot be treated in the current model.
We will recruit up to 30 treatment-resistant depression patients who live near one of the MUSC-affiliated clinics. We will treat these patients, open-label, with FDA-approved accelerated TMS (6 sessions each day, over 2 hours, for 5 days, spread over one or two weeks). We will measure TMS effectiveness using standard depression rating scales.

Institution
MUSC
Recruitment Contact
Alexandra Herron
843 876 9004
herronal@musc.edu

Portable Transcranial Magnetic Stimulation (TMS) in a Van for Treatment-Resistant Depression

Date Added
December 3rd, 2024
PRO Number
Pro00139739
Researcher
Mark George

List of Studies


Keywords
Anxiety, Depression
Summary

In this pilot study we will assemble a portable TMS(transcranial magnetic stimulation) unit, in a van, and then test out delivering TMS in Medical University of South Carolina (MUSC)-affiliated facilities in South Carolina, all within 90 minutes of driving from Charleston, SC. This work will hopefully open up access to TMS for millions of patients with treatment-resistant depression who cannot be treated in the current model.
We will recruit up to 30 treatment-resistant depression patients who live near one of the MUSC-affiliated clinics. We will treat these patients, open-label, with FDA-approved accelerated TMS (6 sessions each day, over 2 hours, for 5 days, spread over one or two weeks). We will measure TMS effectiveness using standard depression rating scales.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Alexandra Herron
843 876 9004
herronal@musc.edu

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Post-Operative Steroids after Sleep Surgery

Date Added
December 3rd, 2024
PRO Number
Pro00138969
Researcher
Mohamed Abdelwahab

List of Studies

Keywords
Pain, Sleep Disorders, Surgery
Summary

The purpose of this study is to study the effectiveness of steroids after sleep surgery in improving pain, reducing difficulties in swallowing, and reducing the amount of narcotic pain medication after surgery. This study also want to see what dosage of steroids, whether intravenous or oral, are more effective at reducing these symptoms and providing a more effective surgical procedure for your sleep apnea. Anyone planning to undergo sleep surgery for your obstructive sleep apnea at the recommendation of the Sleep Surgery Division here at MUSC is invited to participate in this study. The study will be using both intravenous and oral dexamethasone, a very common and widely used steroid. This steroid has been FDA approved for many medical indications.

Institution
MUSC
Recruitment Contact
Nicolas Poupore
843-792-8299
poupore@musc.edu

A first-in-human, non-significant risk study of the ViewFlex X ICE system

Date Added
November 26th, 2024
PRO Number
Pro00140797
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Heart
Summary

This study involves collecting data and physician feedback while using the ViewFlex X System during a routine electrophysiology (EP) procedure. An electrophysiology procedure is done to correct an electrical abnormality in the heart. The ViewFlex X System is considered investigational meaning it has not been approved for commercial use by the Food and Drug Administration (FDA). The ViewFlex System will obtain and integrate heart images with the mapping information obtained during your procedure. There is also an option to have the procedure videotaped. Study participation lasts until hospital discharge post procedure. Study related risks include risks associated with using the ViewFlex X System, loss of confidentiality and unknown risks.

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

Evaluating INClisiran as a soLUtion to improve LDL-C management and cloSe care gaps in an Inclusive ASCVD and ASCVD risk equivalent populatiON (VICTORION-INCLUSION)

Date Added
November 26th, 2024
PRO Number
Pro00139806
Researcher
Ashley Waring

List of Studies

Keywords
Cholesterol, Drug Studies, Heart, Men's Health, Women's Health
Summary

This study is enrolling participants with heart disease or at high risk of developing heart disease who are already taking a cholesterol lowering medication referred to as a statin. This study is specifically seeking participants who are historically underrepresented in cardiovascular clinical trials including females, and racial/ethnic minorities, as well as those living in rural areas. This study involves the medication inclisiran which is an approved medication to help lower "bad" cholesterol. In this study participants will be randomized meaning assigned by chance to receive inclisiran along with usual care or not receive inclisiran and will continue usual care for the first 360 days. You will have a 50:50 chance, like flipping a coin, to receive inclisiran. Those participants who are randomized to not receive inclisiran initially will then receive it after day 360 and continue in the study for another 360 days so up to day 720. Participation will take up to 7 study visits.

Study related procedures include collecting medical history, demographics, questionnaires and blood work, as well as receive inclisiran as a shot just under the skin every 4 months. Study related risks include injection site reactions, joint pain or stiffness, bronchitis or an allergic reaction. There is also a risk of loss of confidentiality.

Institution
MUSC
Recruitment Contact
Olivia Washington
843-792-5863
washoliv@musc.edu

Morbidity of locally recurrent cutaneous squamous cell carcinoma – a comparative case-control study

Date Added
November 25th, 2024
PRO Number
Pro00140037
Researcher
Joel Cook

List of Studies


Keywords
Cancer/Skin
Summary

To determine if locally recurrent cutaneous squamous cell carcinoma (cSCC) leads to increased patient morbidity, and, if so, to what extent. The main outcome will be the margin required to clear locally recurrent cSCC versus that of similar primary cSCC. Secondary outcomes will analyze number of mohs micrographic surgery (MMS) layers, the difference in area between the clinical lesion and the defect size, closure types and sizes, loss of function, and referrals (radiation, oncology, reconstruction, etc.) required for treatment.

Institution
MUSC
Recruitment Contact
Siddharth Srikakolapu
8438765074
srikakol@musc.edu

A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of denifanstat in patients with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and F2/F3 fibrosis (FASCINATE-3)

Date Added
November 25th, 2024
PRO Number
Pro00138888
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

To evaluate the effect of denifanstat 50 mg compared to placebo in reducing the risk of liver-related composite clinical outcome.
To evaluate the effect of denifanstat 50 mg compared to placebo after 52 weeks of treatment on achieving:
- MASH resolution without worsening of fibrosis,
OR
- Fibrosis regression without worsening of steatohepatitis.

Institution
MUSC
Recruitment Contact
Joshua Inman
843-876-8439
inmanj@musc.edu

A Non-randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-Oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCk]

Date Added
November 22nd, 2024
PRO Number
Pro00140162
Researcher
Maggie Westfal

List of Studies

Keywords
Cancer, Cancer/Gynecological, Women's Health
Summary

BRCA1 mutations are errors in genes that can be inherited and may predispose you to ovarian cancer. This study is for women who have a BRCA1 mutation and have elected to undergo a surgical intervention. Surgical intervention is to compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among individuals with deleterious BRCA1 germline mutations.

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

ABSORBABLE ANTIBACTERIAL SOFT TISSUE SUPPORT IN BREAST RECONSTRUCTION WITH INFECTION OUTCOMES ASSESSMENT

Date Added
November 22nd, 2024
PRO Number
Pro00139591
Researcher
Gabriel Klein

List of Studies

Keywords
Surgery
Summary

This study is being conducted in women who are at least 22 years old,+ and will be undergoing either a unilateral or bilateral mastectomy with immediate two-stage post-mastectomy alloplastic prepectoral breast reconstruction (initial insertion of a tissue expander on top of the chest wall muscle followed by change-over to a breast implant after a period of tissue expander inflation).

The purpose of this research study is to evaluate the safety and effectiveness of the Melodi Matrix. .

The Melodi Matrix is an absorbable mesh that contains antibacterial agents (medicines that fight infections caused by bacteria) and is wrapped around tissue expanders before being implanted. After approximately 9 weeks, the mesh will fully absorb into the body.

Institution
MUSC
Recruitment Contact
Deanna DeHoff
843-792-8522
dehoff@musc.edu

A Pilot Study of a Remote Attention-Deficit/Hyperactivity Disorder Monitoring Program for Children in Rural Areas

Date Added
November 22nd, 2024
PRO Number
Pro00137796
Researcher
Claire MacGeorge

List of Studies


Keywords
ADD/ADHD
Summary

For this pilot study, children diagnosed with ADHD starting stimulant treatment for the first time, or have not received stimulant treatment in the prior 6 months, in rural settings will be the focus of efforts to improve time to optimal symptom control, in an effort to maximize the treatment benefit for the academic year. We anticipate that more frequent provision of information by families and teachers to medical providers, enabled by technology and remote monitoring tools, will encourage more rapid improvement in symptom burden. This would be achieved through timely, even weekly, titration of medication per the current treatment guidelines, which is only possible with symptom reports.

The goals of this pilot study are 2-fold:
• Evaluate caregiver and teacher utilization of the RAMP platform early in the treatment course of ADHD
• Evaluate provider utilization of the RAMP platform in everyday practice and management of children early in the treatment course of ADHD

Institution
MUSC
Recruitment Contact
Shannon Cabaniss
843-732-1839
smw207@musc.edu



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