Evaluation of Low- and High-Nicotine Tobacco-Free Nicotine Pouches as a Harm Reducing Substitute for Combustible Cigarettes

Date Added
October 15th, 2024
PRO Number
Pro00139710
Researcher
Amanda Palmer

List of Studies

Keywords
Smoking
Summary

Tobacco-free oral nicotine pouches (such as Zyn brand) are a less harmful alternative to combustible tobacco (cigarette/cigarillo/little cigar) smoking. Pouches, however, contain nicotine, and addictive substance that is not risk-free. The present study is evaluating how well nicotine pouches, at different nicotine levels, help people switch away from smoking combustible tobacco. People who smoke will be asked to answer questions about their tobacco product use and provide breath samples and cheek swab samples at an in-person visit to MUSC Charleston. Participants will then be provided with a 28-day supply of nicotine pouches, and will be asked to switch from smoking to pouches over the course of 4 weeks. Finally, participants will complete a final visit at MUSC, and will answer more questions about their tobacco use 1-month later.

Institution
MUSC
Recruitment Contact
Talia Ogretmen
843-259-8111
ogretmet@musc.edu

A Randomized Phase III Trial of Doxorubicin +Pembrolizumab Versus Doxorubicin Alone for the Treatment of Undifferentiated Pleomorphic Sarcoma (UPS) and Related Poorly Differentiated Sarcomas

Date Added
October 25th, 2024
PRO Number
Pro00139599
Researcher
Christopher Rangel

List of Studies

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

This study if for patients with undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma that has spread from where it first started to other places in the body or it cannot be removed by surgery. This study compares the effect of pembrolizumab plus doxorubicin to doxorubicin alone in treating patients. Doxorubicin damages the cell's DNA and may kill tumor cells. Doxorubicin also blocks a certain enzyme needed for cell division and DNA repair. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attach the cancer and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to the standard chemotherapy, doxorubicin, may help patients with UPS or a related poorly differentiated sarcoma live longer without having disease progression. The duration of the study will be about 12 years, with 6 months of active treatment for those receiving doxorubicin alone and 2 years active treatment for those receiving doxorubicin and pembrolizumab. Each participant will be in follow up for 10 years. Some of the main side effects are nausea, vomiting, low blood count, fatigue and mild diarrhea.

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

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to evaluate Dostarlimab as Sequential Therapy after Chemoradiation in Participants with Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

Date Added
October 25th, 2024
PRO Number
Pro00136526
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Drug Studies
Summary

This phase III study evaluates whether a new drug, dostarlimab, can delay or reduce the risk of cancer returning when administered for a year, shortly after receiving a combination of radiotherapy and chemotherapy (CRT). This study will enroll adults diagnosed with head and neck cancer who are treated with CRT. This study is divided into three parts: the screening period begins shortly after CRT and lasting 4-6 weeks where tests will be conducted to determine eligibility, followed by a 12-month treatment period where participants will receive either dostarlimab or an inactive substance (salt solution) with no effect on your body (placebo), and a follow up period when they will continue to be assessed to see if their cancer has returned or gotten worse. Participants may be on the study for approximately up to 5 years in total. The main risks are anaemia, nausea, vomiting, and diarrhea. Alternatives to this treatment is standard of care CRT because for this type of head and neck cancer, at the present time, there are no other approved therapies administered shortly after CRT that may prevent or delay the return of the cancer. The study benefit is dostarlimab may help slow or stop the growth of your cancer.

Institution
MUSC
Recruitment Contact
HCC clinical trails office
843-792-9321
hcc-clinicaltrials@musc.edu

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

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

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

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 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

Technology-Enhanced Therapy vs. Medication Monitoring for Buprenorphine Retention in Pregnant Persons

Date Added
December 3rd, 2024
PRO Number
Pro00141060
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, skill building intervention is for pregnant people prescribed buprenorphine for the treatment of opioid use disorder, compared to medication monitoring. Participants are randomized to one of the conditions. Participants randomized to receive the skill building intervention will attend three 60-90-minute therapy appointments during pregnancy with an additional 30-minute therapy session towards the end of pregnancy, and 3 additional monthly postpartum (after childbirth) sessions (0-6 months postpartum). As part of the program, participants will receive access to a mobile application, which will be accessible for the duration of the study. Participants randomized to medication monitoring will be asked to log each time the medication is taken for a two month period. All participants will also be asked to complete questionnaires at enrollment, at the end of pregnancy, 3-month postpartum, and 6-months postpartum, be contacted randomly throughout the study to perform a medication count, and complete a urine drug screen at 6-months postpartum. The total duration of the study is between 9-13 months depending on when enrollment occurs (early second trimester-mid third trimester). Compensation up to $500 is provided.

Institution
MUSC
Recruitment Contact
Morgan Thomas
843-988-4211
thomamor@musc.edu



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