Clinical Evaluation of the Thin TCP-EBUS Bronchoscopy System

Date Added
January 28th, 2020
PRO Number
Pro00083498
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Lung, Pulmonary
Summary

This is a single-center pilot study at the Medical University of South Carolina (MUSC) to evaluate the safety and efficacy of the TCP-EBUS scope (Thin EBUS). This study will consist of a standard of care bronchoscopy and will be followed for approximately 3 months. While the device is not FDA approved, it is the same technology but a thinner version of the SCP-EBUS bronchoscope.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

A Phase 3 Trial Investigating Blinatumomab ( NSC# 765986) in Combination With Chemotherapy in Patients With Newly Diagnosed Standard Risk or Down Syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients With Localized B-Lymphoblastic Lymphoma (B-LLy)

Date Added
January 22nd, 2020
PRO Number
Pro00095606
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with B-Lymphoblastic Leukemia (B-ALL) or Localized B-Lymphoblastic Lymphoma (B-LLy). The investigational drug used is Blinatumomab. The purpose of this study is to determine in a randomized manner if the addition of 2 cycles of blinatumomab to standard therapy improves disease-free survival (DFS) in patients with SR B-ALL and higher risk features (SR-High), and patients with standard-risk average (SR-Avg) B-ALL who are negative for minimal residual disease (MRD) by flow cytometry but have detectable or indeterminate MRD as measured by high-throughput sequencing (HTS) at end of Induction (EOI). Participants can expect to receive treatment on this study for about 2 years. After treatment, participants will be followed-up with every year for about 10 years.

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

GBM AGILE Trial

Date Added
January 21st, 2020
PRO Number
Pro00089802
Researcher
Scott Lindhorst

List of Studies


Keywords
Brain Tumor, Glioblastoma
Summary

Glioblastoma adaptive, global, innovative learning environment or GBM AGILE trial is to identify effective therapies and improve survival for a type of brian cancer called glioblastoma (GBM) and to match effective therapies with adult patients with newly diagnosed or recurring glioblastoma. Eligible participants will have a 50/50 chance of taking either standard therapy medications or a medication not yet approved by the FDA called regorafenib during their standard of care treatment for GBM.

Institution
MUSC
Recruitment Contact
John Keller
843-792-2209
Kellej@musc.edu

Speech entrainment for Aphasia Recovery

Date Added
January 6th, 2020
PRO Number
Pro00091924
Researcher
Leonardo Bonilha

List of Studies

Keywords
Language, Speech Disorders, Stroke, Stroke Recovery
Summary

After a stroke, many people experience a language impairment called aphasia. One of the most debilitating types of aphasia is non-fluent aphasia. Non-fluent aphasia is defined by significantly reduced speech production, with the speaker producing only a few words or even less. Speech entrainment therapy (SET) is a treatment that has been shown to increase fluency in people with non-fluent aphasia. Our study looks to define the best dose of SET that leads to sustained improvements in spontaneous speech production.
Participants who are eligible will undergo baseline language testing, an MRI, and will be randomized into one of 4 treatment groups: SET for 3 weeks, SET for 4.5 weeks, SET for 6 weeks, and no treatment (control group).

Institution
MUSC
Recruitment Contact
Stephanie Cute
843-876-8581
cute@musc.edu

EVALUATION OF PATIENT OUTCOMES FROM THE KIDNEY ALLOGRAFT OUTCOMES ALLOSURE REGISTRY (KOAR)

Date Added
December 18th, 2019
PRO Number
Pro00093140
Researcher
David Taber

List of Studies


Keywords
Transplant
Summary

This study will monitor for kidney rejection using the Allosure and AlloMap test. Subjects will be followed for 3 years post transplant.

Institution
MUSC
Recruitment Contact
Kandace Taylor
843-792-7082
taylokan@musc.edu

PROSPECTIVE STUDY OF ACUTE FLACCID MYELITIS (AFM) TO DEFINE NATURAL HISTORY, RISK FACTORS, AND PATHOGENETIC MECHANISMS

Date Added
December 11th, 2019
PRO Number
Pro00094024
Researcher
Stephen Thacker

List of Studies

Keywords
Brain, Infectious Diseases, Nerve, Nervous System, Spinal Cord
Summary

This study is designed to gain a better understanding and natural history of acute flaccid myelitis (AFM).

This study will include reviewing medical records to record information about the medications taken to treat AFM and your social history (smoking, alcohol and drug use). The results of lab tests, imaging studies and tests will also be collected to determine if you have any damage to your nerves that are done by your clinical care team to diagnose your AFM.

Samples from Mouth, nose, stool and blood will be collected as a part of this study. Any remaining spinal fluid that is in the lab from the spinal tap from clinical labs will also be collected. A neurological exam and tests to determine issues with muscles, functionality and strength after being diagnosed with AFM will also be performed as a part of this study.

Institution
MUSC
Recruitment Contact
Sandra Fowler
8437922385
fowlersl@musc.edu

A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin Conditions

Date Added
December 3rd, 2019
PRO Number
Pro00093832
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a 5-year, longitudinal, observational study of adult and pediatric patients (all ages) being treated for Immune-Mediated Inflammatory Skin Conditions. In addition to the study database, a biospecimen repository will be included in order to perform studies on biomarkers of response.

Patients being prescribed medical therapy for IMISC will be eligible for enrollment. Treatment algorithms will follow each site's local standard of care and no specific treatments, assessments, and/or laboratory tests will be dictated by enrollment in the main TARGET-DERM Program. Patients will be screened and enrolled at a regularly scheduled clinic visit. Up to three years of retrospective
medical records from patients who provide consent/assent and meet all inclusion and exclusion criteria will be obtained by the research site. Records will include but will not be limited to: hospitalizations, laboratory reports, clinic notes, telephone contact reports, medication lists, reasons for medication initiation and/or discontinuation, biopsy results, and imaging. Patients may
also be linked to external databases (such as patient support programs). Patients will also be asked to provide biological samples and complete patient reported outcome (PRO) surveys, although participation in these two portions is optional.

During the follow-up period, the research site will prospectively submit the research subjects' medical records approximately every 6 to 12 months, for up to 5 years. Patients/legal representatives ("parent proxy") will be asked to complete PRO surveys at regular intervals during this follow-up period.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@musc.edu

Characterization of physiological changes induced through motor-evoked potential conditioning in people with spinal cord injury

Date Added
December 3rd, 2019
PRO Number
Pro00091457
Researcher
Aiko Thompson

List of Studies


Keywords
Central Nervous System, Nervous System, Rehabilitation Studies, Spinal Cord
Summary

We are currently recruiting volunteers who are interested in participating in a brain-spinal cord-muscle response training study that aims to better understand the changes that take place in the nervous system as a result of this type of training. After spinal cord injury, brain-to-muscle connections are often interrupted. Because these connections are important in movement control, when they are not working well, movements may be disturbed. Researchers have found that people can learn to strengthen these connections through training. Strengthening these connections may be able to improve movement control and recovery after injuries.

Research participants will be asked to stand, sit, and walk during the study sessions. Electrodes are placed on the skin over leg muscles for monitoring muscle activity. For examining brain-to-muscle connections, we use transcranial magnetic stimulation. The stimulation is applied over the head and will indirectly stimulate brain cells with little or no discomfort.

Participation in this study requires approximately three sessions per week for four months, followed by two to three sessions over another three months. Each session lasts approximately 1 hour. Participants will receive a mileage reimbursement.

Institution
MUSC
Recruitment Contact
Blair Dellenbach
843-792-6313
stecb@musc.edu

Treatment of Drug-resistant Adult and Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 System

Date Added
November 26th, 2019
PRO Number
Pro00089025
Researcher
Milos Budisavljevic

List of Studies


Keywords
Blood Disorders, Kidney
Summary

A device called the "Liposorber LA-15 System" has been approved by the
United States Food and Drug Administration for treating kids with focal
segmental glomerulosclerosis (FSGS). The "Liposorber LA-15 System" can only be used if other treatment options, like drugs, don't work or can't be used,
but the kidneys are still working okay. It can also be used if the subject
has had a kidney transplant and the FSGS comes back after the
transplant. Although the Liposorber System can be used for FSGS, we
are not sure how well the Liposorber System works. So, we are doing this
study to find out how well the treatment works in adults.
In this research study, there will be up to 5 adults who have FSGS
enrolled at MUSC. Subjects will come back for up to 12 treatments over 9
weeks and then 5 visits to their study doctor over the next 2 years.

Institution
MUSC
Recruitment Contact
Linda Walker
843-792-6109
walkerlp@musc.edu

A randomized trial of low versus moderate exposure busulfan for infants with severe combined immunodeficiency (SCID) receiving TCRαβ+/CD19+ depleted transplantation: A Phase II study by the Primary Immune Deficiency Treatment Consortium (PIDTC) and Pediatric Transplantation & Cellular Therapy Consortium (PTCTC) PIDTC "CSIDE" Protocol (Conditioning SCID Infants Diagnosed Early) PTCTC NMD 1801

Date Added
November 5th, 2019
PRO Number
Pro00091878
Researcher
Michelle Hudspeth

List of Studies


Keywords
Cancer, Infant, Pediatrics
Summary

This study is for children age 0-2 who have been diagnosed with severe combined immunodeficiency (SCID). In this study, participants will be randomized (select by chance) into groups that will decide the dose of chemotherapy they will receive, receive chemotherapy prior to a blood stem cell transplant, and have blood drawn for research tests. The purpose of this research study is to find out if lower doses of a chemotherapy drug called busulfan before stem cell transplant can help patients with SCID, and to see if the device the CliniMACS® is effective in preparing donor stem cells before the transplant. Participants can expect to be in this study for up to 3 years.

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



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