PHASE III TRIAL OF SALVAGE STEREOTACTIC RADIOSURGERY (SRS) OR SRS + HIPPOCAMPALAVOIDANT WHOLE BRAIN RADIOTHERAPY (HA-WBRT) FOR FIRST OR SECOND DISTANT BRAIN RELAPSE AFTER UPFRONT SRS WITH BRAIN METASTASIS VELOCITY ≥4 BRAIN METASTASES/YEAR

Date Added
August 4th, 2022
PRO Number
Pro00122545
Researcher
Charlotte Rivers

List of Studies


Keywords
Cancer/Brain
Summary

This study is for men or women who received stereotactic radiosurgery to treat cancer that spread to their brain, and now the cancer has returned in other areas of the brain. This study is being done to see if by adding radiation therapy called whole-brain radiation therapy that avoids the hippocampus to preserver memory plus medication approved to treat dementia can extend these patients lives.

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

Syntactic Bootstrapping in Toddlers

Date Added
August 2nd, 2022
PRO Number
Pro00122285
Researcher
Sabrina Horvath

List of Studies

Keywords
Language, Pediatrics, Speech Disorders
Summary

Learning new words is challenging for all toddlers, and it may be particularly challenging for toddlers who are late talkers. In this study, we ask whether late talkers use the same cues to figure out the meanings of new words as do their typically developing peers. Toddlers ages 2.0-2.5 will watch videos of people doing new actions and hear made-up words. An eye-tracking device will capture their face and their gaze patterns, and we will use this data to determine how they are making sense of the new words they are hearing. Results will provide insights into how toddlers learn new words and whether this process relates to toddlers' current language abilities.

Institution
MUSC
Recruitment Contact
Sabrina Horvath
843-792-9363
horvaths@musc.edu

A multi methods study to explore the feasibility of assessing the bereavement needs of parent-child dyads following sibling death.

Date Added
August 2nd, 2022
PRO Number
Pro00121605
Researcher
Shannon D'Alton

List of Studies


Keywords
Adolescents, Children's Health, Pediatrics
Summary

In the United States, nearly 62,000 children and adolescents are bereaved by the death of a sibling each year. Bereaved siblings and parents are at a lifelong risk for negative physical and psychological outcomes, yet little is known about the support and resource needs in the first 6 months following death. The purpose of this study is to determine the best ways to identify bereavement needs and barriers to grief support for parents and children following sibling death and to assess how bereavement needs impact parental distress and child quality of life and grief.

This study is for children between 8 and 17 years of age who have experienced the death of a sibling in the past 24 months. Children must have a parent or primary care giver actively take part in the study with them as a parent-child dyad. Information from this study will be used to help understand how to improve the care and support of parents and siblings that have experienced a loss.

Institution
MUSC
Recruitment Contact
Shannon D'Alton
843-518-3500
vaillan@musc.edu

A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy With or Without SBRT for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer

Date Added
August 2nd, 2022
PRO Number
Pro00121443
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients who have been diagnosed with advanced non-small cell lung cancer. The purpose of this study is to compare the usual treatment alone to using SBRT plus the usual treatment. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the addition of SBRT increases the life of patients by 6 months or more compared to the usual approach. The study drugs are nivolumab and ipilimumab. Participants can expect to be on this study for up to 2 years.

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

PK Papyrus Covered Coronary Stent System

Date Added
July 26th, 2022
PRO Number
Pro00119783
Researcher
Michael Foster

List of Studies

Keywords
Cardiovascular
Summary

The PK Papyrus Covered Coronary Stent System is a Humanitarian Use device (HUD) approved for the use of acute perforation in native coronary vessels or coronary bypass grafts in vessels 2.4-5.0mm in diameter. In an emergency situation, PK Papyrus may be used emergently outside its' approved indications if a patient has a life threatening condition that needs immediate treatment and no generally acceptable alternative treatment for the condition exists.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Jacqueline Sheriod-Scott
803-255-2927
sheriods@musc.edu

A Phase II Open-Label, Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1/PD-L1 Based Immunotherapy

Date Added
July 26th, 2022
PRO Number
Pro00118909
Researcher
Theodore Gourdin

List of Studies


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

This study is for subjects that have metastatic urothelial cancer (mUC). Metastatic means your cancer has spread outside the area where it started and has spread to distant parts or organs of the body. This study is testing an "investigational" (not yet Food and Drug Administration, FDA, approved drug) study drug called sacituzumab govitecan. Sacituzumab govitecan is given intravenously, through IV. The primary purpose of this study is to evaluate treatment with sacituzumab govitecan alone and in combination with other treatments namely cisplatin, avelumab and pembrolizumab improves tumor shrinkage. They are antibodies made in a laboratory that blocks signals that the cancer sends to quiet your immune system. By blocking that signal your immune system can see the cancer as foreign and fight it. The subject may remain in the study for 18 months. They may receive additional treatment beyond 18 months if they are tolerating and showing benefit form the treatment.

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

Glycemic Profile in At Risk Women Without Diabetes and Macrosomic Fetuses

Date Added
July 19th, 2022
PRO Number
Pro00121993
Researcher
Matthew Finneran

List of Studies


Keywords
Obstetrics and Gynecology
Summary

This study is to collect data to assess the benefit of 3rd trimester glucose surveillance in non-diabetic women with big babies.

Institution
MUSC
Recruitment Contact
Jesslyn Payne
843-792-7525
paynej@musc.edu

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-PART STUDY OF HIGH AND LOW DOSE BPN14770 IN MALE ADOLESCENTS (AGED 12 TO <18 YEARS) WITH FRAGILE X SYNDROME

Date Added
July 19th, 2022
PRO Number
Pro00121660
Researcher
Caroline Buchanan

List of Studies

Keywords
Genetics, Rare Diseases
Summary

This is a 3-part study, with each part having a unique set of objectives for male
adolescents aged 12 to < 18 years with fragile X syndrome (FXS). Part 1 is an openlabel,
single-dose, pharmacokinetics (PK) assessment of BPN14770 25 mg and
50 mg; Part 2 is double-blind (DB) and randomized; and Part 3 is an open-label
extension (OLE) for patients who complete Part 2.

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

Combining noninvasive brain stimulation and functional neuroimaging in patients with stroke

Date Added
July 19th, 2022
PRO Number
Pro00120319
Researcher
Nathan Rowland

List of Studies


Keywords
Rehabilitation Studies, Stroke, Stroke Recovery
Summary

Transcranial direct current stimulation (tDCS) can be an effective therapy for stroke recovery patients. However, the extent to which patients show improvements with tDCS is highly variable. This variability may arise due to the differences of stroke location in the brain and because of differences in brain damage, all of which may differ between patients. If the relationship between these factors and tDCS efficacy were known, recovery from stroke using tDCS might become more predictable. Our overall objective is to understand potential measures of tDCS efficacy that may someday allow for optimization of clinical outcomes and patient care.

Institution
MUSC
Recruitment Contact
Brenna Baker-Vogel
843-792-0651
bakebren@musc.edu; salazarc@musc.edu



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