Neoadjuvant Screening Trial: LCMC4 Evaluation of Actionable Drivers in Early Stage Lung Cancer

Date Added
April 25th, 2023
PRO Number
Pro00127146
Researcher
Ian Bostock Rosenzweig

List of Studies

Keywords
Cancer/Lung, Lung, Men's Health, Women's Health
Summary

This collaborative study was developed by the Lung Cancer Mutation Consortium (LCMC) and supported by the Thoracic Surgery Oncology Group (TSOG). The purpose of this study is to determine if it is possible to identify genetic changes in the tumors or blood of patients with early-stage lung cancers using both blood-based and tumor-based testing when cancer is suspected or first diagnosed. In this trial, participants will be asked to provide blood samples at three different time points. They will also be asked for permission for tumor tissue to be sent to the researchers. Tumor tissue will be collected if there is a leftover sample from a participant's surgery. These samples will be sent to the researchers to be analyzed for genetic changes. The researchers hope that in the future, genetic changes can help doctors determine what the best treatment is for patients with early-stage lung cancer.

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

GORE® CARDIOFORM Septal Occluder Migraine Clinical Study: A Study to evaluate the safety and efficacy of transcatheter closure of patent foramen ovale for relief of migraine headaches

Date Added
April 26th, 2023
PRO Number
Pro00121438
Researcher
John Rhodes

List of Studies


Keywords
Cardiovascular, Nervous System
Summary

The GORE RELIEF Clinical study is evaluating if anti-clotting medications and/ or closure of Patent foramen ovale (PFO) using the GOREĀ® CARDIOFORM Septal Occluder device in the heart will reduce migraine headaches in adults. The purpose of the study is to investigate whether patients who take a certain type of medication and have a decrease in migraine headaches will also have a decrease in migraine headaches after closure of the PFO, without having to take the medication long-term. It will also look at how safe the study device is (safety) in closing the PFO. The study is randomized and blinded; subjects will have an equal chance of being assigned study medication or placebo pills.

Institution
MUSC
Recruitment Contact
Terry Headley
843-792-4629
johme@musc.edu

A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

Date Added
April 27th, 2023
PRO Number
Pro00127453
Researcher
Erin Forster

List of Studies


Keywords
Ulcerative colitis
Summary

This study is being done to learn more about a study drug called efavaleukin alfa in people with moderately to severely active ulcerative colitis. The purpose of the study is to evaluate if efavaleukin alfa is effective and safe in improving this condition. The study drug, efavaleukin alfa, will be compared to placebo. Efavaleukin alfa is being developed by Amgen Inc., a for-profit biopharmaceutical company. Efavaleukin alfa is still experimental and is not approved by any regulatory health agency (like the Food and Drug Administration [FDA] or European Medicines Agency [EMA]).

Institution
MUSC
Recruitment Contact
Zerlinna Teague
843-792-0965
recruitment@musc.edu

Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after CABG (PACeS)

Date Added
May 1st, 2023
PRO Number
Pro00127835
Researcher
Arman Kilic

List of Studies

Keywords
Heart, Surgery
Summary

There are two classes of drugs for preventing blood clots in patients with atrial fibrillation (AF), an irregular heartbeat, after cardiac surgery: antiplatelet drugs (like aspirin) and anticoagulants (blood thinners). This study aims to determine whether the addition of blood thinners to antiplatelet drugs will improve treatment outcomes in patients who develop AF after coronary artery bypass grafting (CABG) surgery.

In this study, you will be randomized (assigned to a group by chance--like flipping a coin) into one of 2 study groups; the assignment to receive the antiplatelet drug alone or the antiplatelet drug plus a blood thinner.

Before discharge from the hospital, you will undergo an electrocardiogram (ECG), which examines the electrical activity of your heart. At 1 and 2 months after randomization, you will receive a phone call from the study staff. At 3 months after randomization, you will return to the institution where you received your surgery for an in-person visit. At 6 months, you will receive a phone call from the study staff. Your total participation will be about 6 months.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
(843) 792-8896
overstrm@musc.edu

An Open-Label Extension Study of BPN14770 in Subjects with Fragile X Syndrome

Date Added
May 1st, 2023
PRO Number
Pro00125951
Researcher
Caroline Buchanan

List of Studies

Keywords
Genetics, Pediatrics, Rare Diseases
Summary

This is an OLE study for subjects completing from one of two double-blind clinical
trials. Subjects must have completed the Week 13 visit from one of these two parent
clinical trials to be eligible for this OLE.

Institution
Self Regional Healthcare
Recruitment Contact
Caleb Hinzman
864-672-6912
chinzman@ggc.org

Utility and Histologic Effects of the J-Tip Device in Dermatologic Conditions Requiring Local Anesthesia

Date Added
May 2nd, 2023
PRO Number
Pro00107787
Researcher
Lara Wine Lee

List of Studies


Keywords
Cancer/Skin, Skin
Summary

This project is a pilot study to determine if use of the J-Tip Needle-Free Injection System, used to administer local anesthesia, has any effects on the appearance of skin samples when viewed under a microscope compared with skin samples that have been injected with local anesthesia using a needle. If use of the J-Tip device for local anesthesia delivery is shown not to alter the microscopic appearance of skin, anesthesia for skin biopsies in the future may potentially be performed without a needle, allowing for less fear and pain.

Institution
MUSC
Recruitment Contact
Lara Wine Lee
(843) 792-3021
winelee@musc.edu

Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

Date Added
May 2nd, 2023
PRO Number
Pro00125254
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Brain, Pediatrics
Summary

This study is for patients that have been diagnosed with relapsed/refractory neuroblastoma. The investigational drug given is eflornithine (DFMO) along with etoposide. DFMO is the investigational drug being used along with etoposide for treatment of neuroblastoma. Participants will undergo a number of standard tests and research-related procedures before being able to enroll in this study. Some risks include but are not limited to: fewer red and white blood cells, diarrhea, abdominal pain, loss of appetite, skin rash, seizure, difficulty swallowing and blurred vision. Participants can expect to be on this study for approximately 2 years. Participants will then be followed for up to 5 years after study completion.

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

Sex Differences in the Interface between Cannabis Use and Stress among Emerging Adults

Date Added
May 2nd, 2023
PRO Number
Pro00127995
Researcher
Kevin Gray

List of Studies


Keywords
Adolescents, Drug Studies, Psychiatry, Substance Use
Summary

This study is enrolling emerging adults (ages 18-25) with cannabis use disorder (CUD) to examine sex differences in (a) cannabis withdrawal symptoms during short-term cannabis abstinence, (b) cannabidiol (CBD) versus placebo effects on stress reactivity during short-term cannabis abstinence, and (c) the relationship between stress reactivity and time to cannabis relapse after short-term cannabis abstinence. The proposed study is designed to reveal sex differences and guide the development of tailored treatments that address factors disproportionately affecting emerging adult females with CUD.

Participants will complete an assessment visit to determine eligibility. Eligible participants will be scheduled for their next visit and will be instructed to abstain from cannabis use for 3 days. Participants will be set up with a phone application (app) and given instructions on its use. This app will send twice daily, random surveys everyday throughout study participation with questions about cannabis use, cravings, and overall mood. Participants will also complete twice daily saliva samples.

At the end of the 3 days, participants will return to the clinic for their second visit. Participants will complete a urine and blood sample at each visit. After eating a snack, participants will receive one dose of CBD (800mg) or placebo and then participate in a stress task. Upon completion of the stress task, participants will complete 3 saliva samples and then be discharged after evaluation by research staff. After the completion of Visit 2, participants will continue to complete twice daily surveys for 10 days. The study will last approximately 14 days.

There are risks involved with participating in this study, including risks associated with CBD, risks associated with the stress task and study procedures, emotional distress from answering personal questions, and loss of confidentiality. There is a risk of experiencing cannabis withdrawal symptoms during the 3-day period of cannabis abstinence. Some potential risks related to CBD include dry mouth, diarrhea, reduced appetite, drowsiness, and fatigue. There is a risk of loss of confidentiality, but the researchers will code the samples and research information to protect privacy. There are no direct benefits to the participant, but we hope the knowledge gained will help us inform future clinical strategies to address cannabis use in emerging adults.

Institution
MUSC
Recruitment Contact
Sarah Bourne
843-792-5239
bourne@musc.edu

A randomized controlled trial of smell training and trigeminal nerve stimulation in the treatment of COVID-related persistent smell loss

Date Added
May 2nd, 2023
PRO Number
Pro00127790
Researcher
Bernadette Cortese

List of Studies


Keywords
Coronavirus, Nervous System, Nose, Psychiatry
Summary

Persistent smell loss that can include diminished or distorted smell function is a common symptom of long COVID syndrome. There are limited treatment options for long COVID-related smell loss. Our study aims to determine the efficacy of two at-home treatments, smell training and non-invasive trigeminal nerve stimulation. This study requires participants to conduct daily at-home treatment sessions, attend three in-person study visits at the MUSC Department of Psychiatry and Behavioral Sciences, and complete electronic questionnaires over the 12-week trial, and again at the six-month timepoint. Participants in this trial may benefit directly with an improvement in sense of smell. However, participation may also help society more generally, as this study will provide new information about long COVID-related smell loss and its treatment.

Substudy

Long COVID syndrome has been associated with cognitive impairment and may be related to affected emotional regulation. This study will use a electroencephalography (EEG) to examine how the body and brain responses to emotional cues in participants who are currently undergoing treatment for COVID-related smell loss. Participation will aid in the understanding of how emotional processing in long COVID is impacted by treatment for related smell loss.

Institution
MUSC
Recruitment Contact
Mary Clare Koebel
843-790-3449
scent-4-longcovid@musc.edu

Targeting the Shared Substrates of Alcohol Misuse and Cognitive Impairment: Accelerated rTMS for Older Adults with Alcohol Use Disorder

Date Added
May 2nd, 2023
PRO Number
Pro00127570
Researcher
Lisa McTeague

List of Studies


Keywords
Alcohol, Brain, Psychiatry, Substance Use
Summary

Alcohol misuse is a risk factor for early onset cognitive impairment, contributing to 10% of early onset dementia, with risk corresponding to consumption. Additionally, continued drinking risks worsening cognitive decline and dementia progression, while worsening cognitive impairment contributes to drinking escalation. Repetitive transcranial magnetic stimulation (rTMS) has been shown to improve cognition in Alzheimer's Disease and Related Dimentias (ADRD) and separately reduce heavy drinking in alcohol use disorder. Our objective is to optimize rTMS for simultaneous mitigation of both drinking and cognitive dysfunction in older adults.

Institution
MUSC
Recruitment Contact
Charleston Alcohol Research Center
843-792-1222
alcoholstudy@musc.edu



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