Developing brain imaging biomarkers to quantify the effects of at-home taVNS treatment in ASD

Date Added
November 5th, 2024
PRO Number
Pro00140411
Researcher
Xiaolong Peng

List of Studies


Keywords
Adolescents, Anxiety, Autism
Summary

The purpose of this study is to explore whether a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) can manage symptoms in patients with autism spectrum disorder (ASD). Additionally, this study also uses magnetic resonance imaging (MRI) to capture images of participants' brains and apply an image processing method called INSCAPE to track brain state changes during taVNS treatment in ASD. We will recruit up to 16 participants with ASD.

Institution
MUSC
Recruitment Contact
Nicole Cash
843-792-9502
cashni@musc.edu

Prospective Placebo-Controlled Trial of Intramuscular Steroid Administration for the Treatment of Unexplained Chronic Cough

Date Added
November 5th, 2024
PRO Number
Pro00140403
Researcher
Lauren Howser

List of Studies

Keywords
Throat
Summary

This study is being done to see if injections in different locations can help to minimize chronic cough. This is done through the injection of an anti-inflammatory medication (steroid) into your upper arm muscle. The procedure takes less than 5 minutes. There has not yet been a study completed using arm muscle injections. The safety profile of arm muscle injections is expected to be the same as the superior laryngeal nerve (SLN) injection which is in the neck is already used at MUSC in regular practice. This is the same medication and the same dosage as the arm injection in this study. By better understanding if this treatment helps improve chronic cough, an additional treatment option could be utilized for this patient population. SLN injections are usually only performed by fellowship trained laryngologists (an extra specialized year of training after ENT residency). However, if arm muscle injections are found to be equivalent in treating chronic cough, general ENT physicians could likely provide this treatment to their patients without the need to see a specialized laryngologist. This study will evaluate safety and effectiveness of the arm muscle injection. Steroids are investigational for the purpose of this study.

Institution
MUSC
Recruitment Contact
Kirsten Meenan
843-792-6755
meenan@musc.edu

A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY EVALUATING GLOFITAMAB AS A SINGLE AGENT VERSUS INVESTIGATOR'S CHOICE IN PATIENTS WITH RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA

Date Added
November 6th, 2024
PRO Number
Pro00135996
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 mantle cell lymphoma that has spread and has not responded to treatment. This study is testing an "investigational" (not yet FDA approved) study drug called glofitamab. The purpose of this study is to compare the effects, good or bad, of glofitamab (experimental arm) versus bendamustine plus rituximab (BR) or rituximab plus lenalidomide (R-Len;the control arm) on subjects with relapsed/refractory mantle cell lymphoma. Your total time in the study and the number of assessments in the follow up visits, will depend on how your MCL responds to study treatment. This could range from 1 day to more than 24 months. The screening period may last up to 28 days (4 weeks) and may involve more than one visit to the clinic.

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

Cryoablation for Monomorphic Ventricular Tachycardia

Date Added
November 12th, 2024
PRO Number
Pro00140469
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Heart, Surgery
Summary

This study is enrolling subjects who are referred for a ventricular tachycardia (VT) ablation. VT is an abnormal heart rhythm that comes from the lower chambers of the heart. An ablation is a procedure to treat abnormal heart rhythms by identifying where the abnormal heart rhythm is starting and then scarring the tissue as a way to stop them. In this study the scars are being made by freezing the tissue. This is called cryoablation. This study will use the Adagio VT Cryoablation System (vCLAS™ Catheter and Console) to perform the cryoablation. This system is considered investigational meaning it has not been approved for use outside of this study by the Food and Drug Administration (FDA). Study participation will last about one year and include the following visits: screening/baseline, procedure, pre discharge, 1, 3, 6 and 12 months. There will also be a telephone call at day 7 post ablation procedure. The study will also collect data including medical history and medications, physical exam findings, data from the procedure, echocardiogram (ultrasound test of the heart, electrocardiogram or ECG (test that captures the electrical activity of the heart) and cardiac MRI. The primary study risks are those related to the ablation procedure including pain, abnormal heart rhythms, low or high blood pressure, and blood vessel or heart muscle damage. There is potential benefit as the procedure may eliminate the abnormal heart rhythm and the information gained may help others with this condition in the future.

Institution
MUSC
Recruitment Contact
Chandler Schwede
873-792-5998
schwede@musc.edu

Prospective, Multi-site Safety and Effectiveness Post-Approval Study of FARAPULSE Pulsed Field Ablation in Paroxysmal Atrial Fibrillation ADVENT PAS

Date Added
November 12th, 2024
PRO Number
Pro00140425
Researcher
Rachel Kaplan

List of Studies

Keywords
Heart
Summary

This study is enrolling subjects who are undergoing an atrial fibrillation ablation. Atrial fibrillation (AF) is a condition where the heart beats rapidly and irregularly. An ablation procedure can destroy the tissue in the heart that transmits the irregular electrical signals that cause the AF. The ablation procedure will use the FARAPULSE™ Pulsed Field Ablation System which is approved by the Food and Drug Administration (FDA) and uses pulsed field energy (a specific type of electrical energy) to destroy the heart tissue.

This study will last about 3 years and include up to 10 visits, some of which can be done remotely. Study procedures include blood work, electrocardiogram (ECG) which is a tracing of the heart's electrical activity, and collection of medical history and images.

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

Pilot Test of an Innovative Implementation Strategy to Improve Reach, Quality, and Equity in Child Maltreatment Prevention

Date Added
November 14th, 2024
PRO Number
Pro00141218
Researcher
Hannah Espeleta

List of Studies

Keywords
Disease Prevention, Healthy Volunteer Studies, Infant
Summary

Millions of children are victims of maltreatment each year in the United States. Research on home visiting programs show that child maltreatment can be prevented; however, these programs struggle to reach families in need and provide high quality care. SafeCare is a sustainable and effective home visiting child maltreatment prevention program, serving over 8,000 families each year. This study will examine the feasibility and implementation of a hybrid in-person/virtual delivery model for SafeCare with 12 home visiting providers and 40 caregivers to inform how home visiting programs are delivered to maximize reach to families, improve family outcomes, and decrease harm to children.

Institution
MUSC
Recruitment Contact
Gabriela Becerra
(843) 792-4202
becerra@musc.edu

Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts Substudy Enrollment Protocol for Analysis of Biomarkers to Predict Disease Progression in the Emergency Department (ePAPER)

Date Added
November 15th, 2024
PRO Number
Pro00140608
Researcher
Gary Headden

List of Studies


Keywords
Immune System
Summary

If a person has symptoms of an upper respiratory infection, the sponsor is developing a blood test to help decide if it is bacterial or viral infection. Using a blood sample, the test will give a score of 0-100 to help decide along with your symptoms if antibiotics are necessary for treatment.

Substudy: Subjects with suspected infection will give a blood sample for the evaluation of certain biomarkers to help determine if the biomarkers can predict the disease progression to severe disease.

Institution
MUSC
Recruitment Contact
Paige Hall
843 792 7944
hallpai@musc.edu

Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts Substudy Enrollment Protocol for Analysis of Biomarkers to Predict Disease Progression in the Emergency Department (ePAPER)

Date Added
November 15th, 2024
PRO Number
Pro00140608
Researcher
Gary Headden

List of Studies


Keywords
Immune System
Summary

If a person has symptoms of an upper respiratory infection, the sponsor is developing a blood test to help decide if it is bacterial or viral infection. Using a blood sample, the test will give a score of 0-100 to help decide along with your symptoms if antibiotics are necessary for treatment.

Substudy: Subjects with suspected infection will give a blood sample for the evaluation of certain biomarkers to help determine if the biomarkers can predict the disease progression to severe disease.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Paige Hall
843 792 7944
hallpai@musc.edu

A Phase 3, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multinational, multicenter study to evaluate the efficacy and safety of amlitelimab by subcutaneous injection in participants aged 12 years and older with moderate to-severe atopic dermatitis (AD) who are on background topical corticosteroids and have had an inadequate response to prior biologic therapy or oral Janus Kinase (JAK) inhibitor treatment

Date Added
November 21st, 2024
PRO Number
Pro00138920
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Pediatrics, Skin
Summary

This is a Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multiple dose level study to investigate the efficacy and safety of subcutaneous injections of amlitelimab in participants aged 12 years and older with moderate-to-severe AD who are on background topical corticosteroids or calcineurin inhibitors and have had an inadequate response to prior biologic or oral JAKi therapy. There will be up to 13 visits including up to a 4-week screening period, a 36 week treatment period, and a post-treatment safety follow up period or a long-term Safety Study for 16 weeks. Subjects will be randomized in a 1:1:1 ratio to the following study arms: amlitelimab Q4W, amlitelimab Q12W, and placebo Q4W.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@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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