The Watch the Spot Trial Save

Date Added
June 10th, 2016
PRO Number
Pro00044920
Researcher
Gerard Silvestri

Silhouette
Keywords
Cancer, Lung, Pulmonary
Summary

The study will compare two sets of professionally-recommended guidelines for follow-up of patients with small lung nodules. The two guidelines are different in the frequency and timing of follow-up; one is more frequent and the one is less frequent. All patients who have a small lung nodule detected on a chest scan will have a recommended follow-up schedule automatically inserted into their imaging report so that their health care provider may follow the guideline-recommended intervals for follow-up chest scans. Patients and their physicians may choose not to follow the recommendations, depending on preference or the physician's clinical judgment. As part of this research study, information from patients with a small lung nodule who are seen at MUSC will be collected from the electronic medical record. This will include characteristics of the patient (such as age, smoking history), basic information about the lung nodule (such as nodule size, nodule density), and the medical care received.

Institution
MUSC
Recruitment Contact
Katherine Taylor
843-792-2297
taylkat@musc.edu

Evaluating N-acetylcysteine as a pharmacotherapy for tobacco use disorder Save

Date Added
March 1st, 2016
PRO Number
Pro00052793
Researcher
Erin Mcclure

Silhouette
Keywords
Drug Studies, Smoking
Summary

The purpose of this study is to assess the effects of N-Acetylcysteine (NAC), an over-the-counter antioxidant, to assist adult cigarette smokers with quitting and preventing relapse to smoking. This medication may help people quit smoking by reducing withdrawal symptoms, craving, and preventing relapse, but we do not know if NAC helps smokers early in their quit attempt or after they have already quit.

Institution
MUSC
Recruitment Contact
Intake Team
843-792-4097
smokingstudy@musc.edu

Translational Neuropsychopharmacology Research of Nicotine Addiction Save

Date Added
October 20th, 2015
PRO Number
Pro00048152
Researcher
Brett Froeliger

Silhouette
Keywords
Smoking
Summary

This study is investigating the effects of combining 2 medications, Varenicline (commonly known as Chantix®) and N-acetylcysteine, on smoking behavior in daily cigarette smokers who are interested in quitting smoking. The study consists of 10 visits over 6 weeks. Compensation is available for those that qualify. Smokers must be between the ages of 18 and 55.

Institution
MUSC
Recruitment Contact
Aaron Haas
843-882-7196
haas@musc.edu

CAROTID REVASCULARIZATION AND MEDICAL MANAGEMENT FOR ASYMPTOMATIC CAROTID STENOSIS TRIAL Save

Date Added
July 6th, 2015
PRO Number
Pro00043906
Researcher
Christine Holmstedt

Silhouette
Keywords
Stroke
Summary

CREST-2 is two parallel multi-center randomized, observer-blinded endpoint clinical trials. One trial will assess treatment differences between intensive medical management alone compared to carotid endarterectomy procedure plus intensive medical management. The parallel trial will assess treatment differences between intensive medical management alone compared to carotid artery stenting plus intensive medical management. Intensive medical management will involve control of blood pressure, LDL cholesterol, cigarette smoking, and other vascular risk factors.

Institution
MUSC
Recruitment Contact
Robert Burfeind
843-792-8606
burfeind@musc.edu

Theta Burst TMS as a Tool to Change Smoking Behavior Save

Date Added
May 5th, 2015
PRO Number
Pro00042165
Researcher
Colleen Hanlon

Silhouette
Keywords
Brain, Drug Studies, Psychiatry, Smoking
Summary

The goal of this study is to determine whether transcranial magnetic stimulation (TMS) is an effective treatment in decreasing craving in individuals who habitually smoke cigarettes. The study consists of six total visits to MUSC; one for the consent process, two that will include MRI scans, and five that will include TMS administration. Compensation will be provided for each visit.

Institution
MUSC
Recruitment Contact
Oliver Mithoefer
843-792-6402
mithoefe@musc.edu

Novel Treatment to Enhance Smoking Cessation before Cancer Surgery Save

Date Added
April 21st, 2015
PRO Number
Pro00043340
Researcher
Benjamin Toll

Silhouette
Keywords
Cancer
Summary

This is a smoking cessation treatment study. Patients who have a cancer or a suspected cancer who will undergo surgical removal of their cancer are eligible to participate in this study. A novel smoking cessation treatment will be provided to half of the participants in the study. All study participants will receive standard smoking cessation therapy including counseling and the nicotine patch.

Institution
MUSC
Recruitment Contact
Alana Rojewski
unknown
rojewski@musc.edu

RNA Biomarkers in the Progression of Oropharyngeal Squamous Cell Carcinoma: A Prospective Non-Randomized Study by the Head and Neck Oncology Group (HNOG) at the Medical University of South Carolina Save

Date Added
January 6th, 2015
PRO Number
Pro00033992
Researcher
Terrence Day

Silhouette
Keywords
Cancer, Cancer/Head & Neck
Summary

This study seeks to assess the evolving biomarkers identifiied in head and neck cancers including smoking related and human papillomavirus related markers and their correlation with clinical outcomes, quality of life, survivorship and cancer control.

Head and neck cancer patients will be offered the opportunity to participate in HeadNOG which includes survey information about cancer diagnosis, signs and symptoms, demographics, cancer site, stage and histology and long term outcomes.

This analysis will then assess RNA/DNA biomarkers and lipid profiles, and their role in the etiopathogenesis, treatment and outcomes for head and neck cancer.

It is the goal of HeadNOG to provide a date resource that results in strategies for personalized care of head and neck cancer patients in South Carolina for the future.

Ultimately, it is hoped that biomarkers will direct patient care and improve quality of life and cancer control.

Institution
MUSC
Recruitment Contact
Terrence Day
843=792-0719
dayt@musc.edu

Synchronized-EEG Method for Automatically-delivered Real Time (SMART) Transcranial Magnetic Stimulation (TMS) for Nicotine Addiction Save

Date Added
October 7th, 2014
PRO Number
Pro00034876
Researcher
Xingbao Li

Silhouette
Keywords
Healthy Volunteer Studies, Smoking
Summary

Nicotine dependence remains a significant public health concern. Nicotine can affect brain neural oscillations. A magnetic field applied to the outside of the skull can produce electrical activity in the brain without significant pain or the need for anesthesia. In this proposal, we will build an individual brain signal-driven transcranial magnetic stimulation loop, and then test whether this stimulation loop can modulate neural oscillations and reduce cue-induced craving, including nicotine craving. This research will build an innovative brain stimulation method for neuroscientific research and develop a potential efficacy therapy for nicotine dependence as well other neuropsychiatric disorders.

Institution
MUSC
Recruitment Contact
John Henderson
843 792 5560
henderjs@musc.edu

A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the Deep Transcranial Magnetic Stimulation (DTMS) (with the H-ADD Coil) intended as an aid to Smoking Cessation Save

Date Added
April 8th, 2014
PRO Number
Pro00033326
Researcher
Mark George

Silhouette
Keywords
Pulmonary, Smoking
Summary

This research is being conducted at the Medical University of South Carolina Institute of Psychiatry Brain Stimulation Lab by Dr. Mark George to see if deep repetitive transcranial magnetic stimulation (dTMS) is effective in assisting participants to quit smoking. TMS is a noninvasive medical procedure that uses magnetic fields to stimulate nerve cells in the brain to act as an aid to smoking cessation. The treatment period will involve 18 active/sham treatments to be given daily for 3 weeks then weekly treatments in week 4, 5, and 6. A follow up visit will be scheduled about 2 1/2 months after week 6. The entire study is four months in duration. Participants who may be recruited into the study would include the following: men and women 22-70 years of age, chronic; heavy smokers who have smoked for more than 1 year, with no period of abstinence greater than 3 months during the past year; subjects who are motivated to quit smoking; subjects who have negative answers on the TASS; and those who are able to sign an informed consent.

Institution
MUSC
Recruitment Contact
Jkeonye Moss
843-876-5141
mosjk@musc.edu

Repetitive TMS Modulates Dorsal Lateral Prefrontal-Ventral Medial Prefrontal Pathway to Decrease Craving in Smokers Save

Date Added
March 4th, 2014
PRO Number
Pro00032649
Researcher
Xingbao Li

Silhouette
Keywords
Brain, Smoking
Summary

Cigarette smoking causes significant morbidity and mortality in the United States. Smoking cessation is difficult, with the average smoker attempting to quit five times before permanent success. Moreover, the majority of smoking quit attempts result in relapse. Brain stimulation for smoke cessation is an exciting new area that builds on advancing neuroscience knowledge concerning the functional neurocircuitry of addiction. Cortical stimulation can now be performed non-invasively by transcranial magnetic stimulation (TMS). Several studies have shown that TMS can reduce cue-elicited craving in smokers. Previous research by our group has shown that a single session of 15 minutes high frequency (10 Hz) repetitive TMS (rTMS) at 100% motor threshold over the left dorsal lateral prefrontal cortex (DLPFC) can reduce cue-induced craving compared to sham TMS. However, the mechanism by which craving is reduced by rTMS is poorly understood both at behavioral and neural levels. Neuroimaging studies in nicotine dependence have revealed cue-related responses in numerous brain areas, including frontal, parietal cortices and subcortical areas. Recently functional magnetic resonance imaging (fMRI) studies by our group have shown that cue-induced craving induced brain activation in ventral medial prefrontal cortex (VMPFC), including medial frontal, orbital frontal and anterior cingulate. This Chair Research Development Fund (CRDF) pilot proposal will integrate two new techniques- TMS and fMRI to investigate DLPFC-VMPFC pathway in smokers. Using double-masked methods we hypothesize that cue-induced exposure will induce brain activity in VMPFC, and 15 minutes rTMS over DLPFC will reduce cue-induced craving through modulating DLPFC-VMPFC pathway (increased activity DLPFC and decreased activity VMPFC). In the one year of project, we plan to recruit 10 non-treatment-seeking nicotine-dependent cigarette smokers and 20 non-smoking participants, both males and females of all ethnic and racial groups between the ages of 18 and 60 to participate in the study. The participants will randomly receive two different types of brain stimulation: active rTMS or sham rTMS over the left DLPFC with a 1 week interval between treatments. MRI scans will be completed pre and post rTMS. The data from this pilot will provide the information needed for submitting a larger-scale investigation (R01) to investigate cue craving neutral pathway and develop a potential clinical applications of TMS in smoke cessation.

Institution
MUSC
Recruitment Contact
William DeVries
843 7925729
devriesw@musc.edu

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