First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGF-β Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients with EGFR-Driven Advanced Solid Tumors

Date Added
July 27th, 2021
PRO Number
Pro00111442
Researcher
John Kaczmar

List of Studies


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

This study is for patients who have advanced cancers, such as head and neck cancer, colorectal cancer, breast cancer, and others. This study is testing a new treatment for these types of cancer. The new test drug is called ficerafusp alfa. Pembrolizumab is an approved drug by the United States Food and Drug Administration (FDA) for the diseases described in this study and will be used as approved. The type of cancer a patient has will determine whether he/she will get ficerafusp alfa alone or ficerafusp alfa in combination with pembrolizumab. Participants will receive either ficerafusp alfa alone, ficerafusp alfa in combination with pembrolizumab or ficerafusp alfa, depending on your cancer until the cancer gets worse, they experience bad side effects, or until they withdraw consent, or until the Investigator considers it is in his/her best interest to discontinue the study drug.

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

Testing a Novel Dry Electrode Headset for Electroencephalography Telehealth

Date Added
October 19th, 2021
PRO Number
Pro00113242
Researcher
Jonathan Halford

List of Studies

Keywords
Epilepsy
Summary

This study aims to improve access of Veterans with epilepsy living in rural areas to the most important diagnostic procedure for the care of patients with epilepsy: the routine electroencephalogram (EEG). We will test a new method for recording EEG which uses a novel dry electrode system headset that does not require an EEG technologist to operate. The headset integrates the EEG electrodes and amplifier into a compact system which is easily placed on the head. This approach could make it possible for a nurse or nurse assistant with minimal training to record an EEG in a rural community based outpatient clinic (CBOC) as part of an epilepsy telemedicine outreach program along with clinical interviews. We will compare performance of this dry electrode system to standard EEG when it is used by EEG technologists in three VA medical centers. This project has the potential to improve access of Veterans to the EEG procedure and decrease cost to the Veterans Health Care System.

Institution
MUSC
Recruitment Contact
to be decided
843-789-7428
jonathan.halford@va.gov

Assessment of Potential Biomarkers of Seizure Susceptibility Using Novel NextSense EEG Earbuds

Date Added
February 8th, 2022
PRO Number
Pro00118031
Researcher
Ekrem Kutluay

List of Studies


Keywords
Epilepsy
Summary

The purpose of this study is to understand whether there may be certain characteristics or patterns that might predict seizure events in patients undergoing EEG monitoring and at home. Researchers will also be assessing the comfort and usability of a new device called NextSense EEG earbud device at the same time as routine inpatient epilepsy monitoring unit (EMU) admissions, as well as device use in the home environment. In order to enroll in the at-home extension, the participant must be enrolled in the inpatient EMU admission portion of the study. Participants will be asked to assess their mood, sleep quality, and the comfort and usability of the device during their inpatient admission at regular intervals. If participating in the at-home extension, these same assessment questionnaires, in addition to a seizure diary, will be completed by participants at regular intervals.

Institution
MUSC
Recruitment Contact
Lindsey Weissman
843-792-2330
weissmal@musc.edu

Pediatric Acute Leukemia (PedAL) Screening Trial Developing New Therapies for Relapsed Leukemias

Date Added
March 11th, 2022
PRO Number
Pro00118800
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Leukemia, Pediatrics
Summary

This study is for patients that have been diagnosed with leukemia. This study is called a screening study and we are doing this study to find better ways to diagnose and treat leukemia in children, adolescents and young adults. Bone marrow, blood, and medical information about participant's cancer and treatment will be collected. Participants can expect to be on this study for 5 years.

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

Community use of wearable wrist stimulation device

Date Added
April 5th, 2022
PRO Number
Pro00118317
Researcher
Na Jin Seo

List of Studies


Keywords
Cerebral Palsey, Stroke, Stroke Recovery
Summary

Sensory stimulation has been shown to enhance rehabilitation outcomes. However, most sensory stimulation devices interfere with natural hand tasks. Thus, a new wearable stimulation device has been developed to deliver imperceptible vibration to wrist skin. This study is to evaluate the community use of the device for patients with neurologic movement disorders. Participation will include wearing the provided device and charging the device every night. The knowledge regarding community use of the device may contribute to improving the device functionality and usability for future users of the device.

Institution
MUSC
Recruitment Contact
Na Jin Seo
8437920084
seon@musc.edu

Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥65 Year-olds (PRIMARY)

Date Added
May 17th, 2022
PRO Number
Pro00119787
Researcher
Marc Katz

List of Studies


Keywords
Heart, Surgery
Summary

The purpose of this research is to compare the risks and benefits of two different procedures used to help patients with mitral valve regurgitation (also known as MR). MR is a condition where the valve does not close fully when it is supposed to, and some blood can then leak back into the left atrium instead of circulating to the rest of the body. The treatment options this study will compare are: (1) transcatheter edge-to-edge repair (abbreviated as TEER; which is a catheter procedure for repairing the mitral valve that doesn't require surgery to open up the heart) and (2) mitral valve repair surgery, which is an open-heart surgical procedure. There are no new or "experimental" procedures being tested in this study: both treatment options are well-established treatments and are regularly performed in patients who have MR.

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

A Multi-Site Randomized Clinical Trial Comparing a Brief Tele-Cognitive Behavioral Therapy Intervention (BRIGHT) with Attention Control for the Management of Body Image-Related Distress Among Head and Neck Cancer Survivors

Date Added
August 2nd, 2022
PRO Number
Pro00110248
Researcher
Evan Graboyes

List of Studies


Keywords
Cancer/Head & Neck
Summary

Because head and neck cancer arises in cosmetically and functionally critical areas, head and neck cancer survivors suffer high rates of body image-related distress. Body image-related distress is a source of significant morbidity, contributing to stigmatization, social isolation, and worse quality of life. Unfortunately, effective therapies exist to manage body image-related distress among head and neck cancer survivors are lacking. We have developed a novel, scalable, tele-cognitive behavioral therapy intervention for head and neck cancer survivors with body image disturbance that could provide the first effective treatment in this population, thereby minimizing psychosocial morbidity, improving quality of life, and developing new standards of clinical care.

Institution
MUSC
Recruitment Contact
Evan Graboyes
843-791-0719
graboyes@musc.edu

Evaluating the specific role of endogenous opioids as the mechanism underlying tAN-based analgesia in healthy individuals

Date Added
September 6th, 2022
PRO Number
Pro00122762
Researcher
Jeffrey Borckardt

List of Studies


Keywords
Healthy Volunteer Studies
Summary

This study is attempting to understand whether 30-minutes of a new ear stimulation technology can reduce pain in healthy individuals. Participants in this trial will attend two experimental visits, during which they will receive ear stimulation during the intravenous administration (I.V.) of either saline or naloxone. During each visit, the amount of thermal pain participants can tolerate will be determined before and after ear stimulation. Brain scans will also be collected before and after ear stimulation. Each visit should last about 3 hours.

Institution
MUSC
Recruitment Contact
Falon Sutton
843-792-9502
suttonf@musc.edu

Evaluating the Efficacy of Telehealth-Delivered Brief Family Involved Treatment (B-FIT) for Alcohol Use Disorder among Veterans

Date Added
September 6th, 2022
PRO Number
Pro00121552
Researcher
Julianne Flanagan

List of Studies


Keywords
Alcohol, Military, Stage II
Summary

Improving alcohol use disorder (AUD) treatment among Veterans is a national public health problem. The rate of AUD among Veterans is twice that of civilians, with up to 50% of Veterans having AUD. Family-based AUD programs are rarely undertaken in busy treatment clinics, and Veterans with problem drinking behavior or AUD are commonly excluded from couple therapies. As a result, there is a need to develop effective family AUD treatments that are both brief and highly accessible to Veterans.

The purpose of this study is to evaluate a new treatment add-on called Brief Family-Involved Treatment (B-FIT), which will be delivered via telehealth among Veterans engaged in alcohol-based treatment/therapy.

This study is an 12-week, Stage-II, open randomized controlled trial examining B-FIT in combination with treatment as usual, TAU (i.e., B-FIT + CBT treatment) as compared to TAU alone (i.e., CBT treatment). Veterans and their treatment companion (family member, partner, friend) will complete weekly assessments during the treatment phase in addition to 3 & 6 month follow-up assessments, all via telehealth.

Institution
MUSC
Recruitment Contact
Alexander Hannegan
843-7920608
alh324@musc.edu

REAL Answers (Registry Expansion Analysis to Learn Answers)

Date Added
November 16th, 2022
PRO Number
Pro00124358
Researcher
Hermes Florez

List of Studies

Keywords
Anxiety, Blood Disorders, Cardiovascular, Genetics, Hypertension/ High Blood Pressure, Pain, Stroke, Stroke Recovery
Summary

Over 2400 people who have sickle cell disease and are between the ages of 15 and 45 have been enrolled into the National Registry (SCDIC-I) of patients with Sickle Cell Disease (SCD). A rich resource of natural history data, the SCDIC-I Registry has longitudinal data collected yearly since 2016 from patient surveys (e.g. self reported pain incidences, sleep, barriers to care, experiences during and after pregnancy), medical record abstraction (e.g. medications, transfusion history, co-morbidities) and laboratory results. The 150 patients (or 1200 among the 8 sites) will be selected from both MUSC adult and pediatric SCD clinics starting at 12 years of age; those not previously enrolled in the SCDIC National Registry will be offered the possibility to enroll in SCDIC-II.
We will look at the following:
1- Compare the effect of new SCD medications – crizanlizumab, voxelotor, and L-glutamine – on clinical outcomes in individuals with SCD.
2 - Identify genetic and genomic predictors of response to crizanlizumab, voxelotor, and L-glutamine
3 - Integrate study data into the CureSCi metadata catalog (MDC) to enhance future cross-study analyses.

Institution
MUSC
Recruitment Contact
Jayla Moss
843-792-4653
mossjay@musc.edu



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