Molecular Assessment and Profiling of Liver transplant rEcipients: The MAPLE Study

Date Added
December 23rd, 2021
PRO Number
Pro00115748
Researcher
Jared White

List of Studies


Keywords
Liver, Transplant
Summary

The primary purpose of this registry is to evaluate the feasibility and clinical validation of LiverCare in liver transplant recipients, as part of post-transplant surveillance. LiverCare is an investigational panel test that includes 6 components: 1. AlloSure Liver 2. AlloMap Liver 3. AlloHeme Liver 4. iBox Liver 5. HistoMap Liver 6. AlloID. AlloSure Liver is a research test used to measure donor-derived cell free DNA in Liver transplant recipients. AlloMap Liver is a research gene expression profile test using peripheral blood to establish immune activity and is currently undergoing clinical evaluation and development. iBox Liver is an analytic platform that predicts organ outcomes after transplant using a software algorithm based on information from your medical records and is currently undergoing clinical evaluation and development. AlloHeme Liver is a diagnostic test to measure donor and recipient DNA in the blood. HistoMap Liver is a tissue-based gene expression test using tissue collected from standard of care biopsies to establish immune profiles within the organ and is currently undergoing clinical evaluation and development. AlloID is a blood test that will quantify the presence of more than 100 pathogens including standard post-transplant infectious disease screening such as Cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus, Human Herpesvirus 6 (HHV-6) and viral hepatitis.

Institution
MUSC
Recruitment Contact
Deanna DeHoff
843-792-8522
dehoff@musc.edu

A Long-term Safety Study to Assess the Potential for Chronic Liver Injury in Participants Treated with Epidiolex® Cannabidiol Oral Solution

Date Added
December 15th, 2021
PRO Number
Pro00111927
Researcher
Jonathan Halford

List of Studies


Keywords
Epilepsy
Summary

This is a study designed to assess whether there will be injury to the liver in participants who are already being treated Epidiolex or who are about to begin treatment with Epidiolex
Participants ages 4 and above on existing Epidiolex treatment for FDA-approved indications and participants with no previous experience of Epidiolex and who are about to be prescribed Epidiolex for an FDA-approved indication will be recruited from multiple sites in the US.
This study will include a screening period of up to 21 (± 7) days to assess participant eligibility. A physical exam, blood/serum laboratory tests and laboratory
scoring.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
843 792-1115
bulgarino@musc.edu

A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination with Other Anti-cancer Agents in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

Date Added
December 14th, 2021
PRO Number
Pro00116496
Researcher
Brian Hess

List of Studies


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

This study is for subjects with Diffuse large B-cell lymphoma (DLBCL) that has gotten worse or come back after two or more treatments. This study is testing an "investigational" (not yet FDA approved drug) study drug called loncastuximab tesirine (ADCT-402). Treatment will be administered intravenously or via tablet depending on the subject's assigned treatment. The primary purpose of this study is to test whether the investigational drug combination of loncastuximab tesirine in combination with one of four other anti-cancer agents is a safe and effective treatment for relapsed or refractory B-cell Non-Hodgkin Lymphoma. Treatment will be assigned by a system in a sequence unless the subject has received the combination drug (the drug that is not locastuximab). This means the first enrolled subject will be assigned to arm C, the second to arm E, and so on. The subject will be seen approximately once a week during treatment, and may remain in the study for up to 3 years.

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

A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Heart Valve System in the Treatment of High Surgical Risk Patients with Symptomatic, Severe Aortic Regurgitation (AR)

Date Added
December 14th, 2021
PRO Number
Pro00116082
Researcher
Nicholas Amoroso

List of Studies


Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System in a patient population with symptomatic severe Aortic regurgitation ( a condition where the heart's aortic valve does not close tightly and allows some blood to leak back into the heart chamber) requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR).

Your involvement in this study will last approximately 5 years from the time of your procedure. The visits include: Screening/Baseline, Procedure, Pre-Discharge, 1 month, 6 months and annualy for 5 years

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

Tele-PCIT: Internet Delivered PCIT for Young Children with Neurodevelopmental Disorders

Date Added
December 11th, 2021
PRO Number
Pro00114624
Researcher
Rosmary Ros-Demarize

List of Studies


Keywords
ADD/ADHD, Autism, Pediatrics
Summary

The purpose of this research study is to evaluate Parent Child Interaction Therapy (PCIT) delivered via tele-health for young children with a developmental diagnosis (ex. suspected or diagnosed autism, ADHD, global developmental delay, etc.) and disruptive behavior problems. Participants will go through a screening to determine eligibility. Once screening is complete, participants will complete a pre-therapy assessment in clinic, followed by 10 telehealth sessions one time per week, at no cost. Participants will then be asked to complete an in-person post-therapy assessment and follow-up questionnaires will be re-administered 3 months following the completion of therapy. Families will be compensated for their time.

Institution
MUSC
Recruitment Contact
Jessie Montezuma
843-714-1352
autismresearch@musc.edu

Validation of Early Prognostic Data for Recovery Outcome after Stroke for Future, Higher Yield Trials

Date Added
December 8th, 2021
PRO Number
Pro00116137
Researcher
Kirstin-Friederike Heise

List of Studies

Keywords
Rehabilitation Studies, Stroke, Stroke Recovery
Summary

VERIFY will validate biomarkers of upper extremity (UE) motor outcome in the acute ischemic stroke window for immediate use in clinical trials, and explore these biomarkers in acute intracerebral hemorrhage. The central hypothesis is that patients have different UE outcomes depending on corticomotor system (CMS) function, measured as motor evoked potential (MEP) status with TMS, and on CMS structure, measured as acute lesion load with MRI. VERIFY will create the first multicenter, large-scale, prospective dataset of clinical, TMS, and MRI measures in the acute stroke time window.

Institution
MUSC
Recruitment Contact
Patricia Finetto
843-792-8533
piersonp@musc.edu

THRIVE-ASD: Telehealth Rapid Intervention for Externalizing Behaviors in ASD

Date Added
December 3rd, 2021
PRO Number
Pro00114600
Researcher
Rosmary Ros-Demarize

List of Studies


Keywords
Autism, Children's Health, Pediatrics
Summary

The purpose of this research study is to evaluate Parent Child Interaction Therapy (PCIT) delivered via telehealth for young children with autism spectrum disorder (ASD) and disruptive behavior problems. Participants will go through a screening to determine eligibility. Eligible families who choose to participate will complete 3 in-person visits at MUSC and may receive 10 telehealth therapy sessions, at no cost. Families will be compensated for their time.

Institution
MUSC
Recruitment Contact
Jessie Montezuma
843-714-1352
autismresearch@musc.edu

A Prospective Study Evaluating Maternal and FetaL Outcomes in the ERa of ModulatorS (MAYFLOWERS)

Date Added
December 1st, 2021
PRO Number
Pro00116448
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis
Summary

This is a prospective, multi-center, observational study in pregnant women with cystic fibrosis (CF) to characterize forced expiratory volume in 1 second (FEV1) changes based on exposure to highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators. The key factors contributing to the change in lung function during pregnancy and for 2 years post-delivery will be evaluated along with assessment of fetal and maternal outcomes.
The total duration of participation for each participant is expected to be about 3 years (up to 35 months). Women will be enrolled in the first trimester of pregnancy and assessed every 3 months during pregnancy and during the first year after delivery, then every 6 months for an additional year. Over the course of the study, CF clinical data, patient-reported outcomes, questionnaires, obstetrical outcomes, infant growth, child development outcomes, baseline CF-related therapies and co-morbidities will be collected to enable evaluation of changes from before pregnancy to during pregnancy and post-delivery.
MAYFLOWERS participants will be provided an opportunity to participate in an optional continuous glucose monitoring (CGM) sub-study to evaluate glucose control in pregnancy. Participants will undergo CGM sensor placement and data collection as part of the MAYFLOWERS study.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
shannonz@musc.edu

Care Retention and Engagement of Veterans Living with HIV during the COVID-19 Pandemic

Date Added
December 1st, 2021
PRO Number
Pro00113239
Researcher
Ruth Adekunle

List of Studies

Keywords
Coronavirus, HIV / AIDS, Minorities
Summary

The COVID-19 pandemic has affected all persons, though disadvantaged populations such as persons living with HIV are likely to be disproportionally impacted by the physical, economic, and psychological toll of the global pandemic. This study aims to better understand how COVID-19 has impacted care for veterans living with HIV.

Institution
MUSC
Recruitment Contact
Ruth Adekunle
843-876-3092
adekunle@musc.edu

Immunobiology of Influenza Critical Illness in Young People (PICFLU2)

Date Added
November 24th, 2021
PRO Number
Pro00112536
Researcher
Sara Rhodes Proctor Short

List of Studies

Keywords
Infectious Diseases, Pediatrics
Summary

The Pediatric Intensive Care Influenza Study #2 (PICFLU2) is a multiyear, multicenter prospective observational study in patients aged ≤ 21 years hospitalized in pediatric Intensive Care Units (PICUs) and Stepdown (or intermediate) Care Units (SDUs) in the US designed to evaluate of the immunobiology of influenza virus-related critical illness in young hosts.

Institution
MUSC
Recruitment Contact
Lauren Wakefield
843-792-0603
wakefila@musc.edu



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