Umbrella Long-Term Follow-Up Protocol

Date Added
July 10th, 2008
PRO Number
Pro00143020
Researcher
Jacqueline Kraveka

List of Studies


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

This study is for patients enrolled on COG protocols.. The main purpose of this study is to develop a mechanism for tracking and retaining patients enrolled on COG
protocols. Participants can expect to be in the study for life or until requested by participant.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinicaltrials@musc.edu

ACNS0831: Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years

Date Added
June 25th, 2013
PRO Number
Pro00024678
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

Ependymoma is a type of rare childhood cancer that occurs in the brain and spinal cord. Survival statistics are generally disappointing with a 5-year survival of 50-64%. The standard of care for ependymoma is maximal surgical resection followed by radiation therapy directed at the primary site of disease.

Radiation therapy is associated with immediate and long-term toxicities in children, especially young children. For this reason, it has been the practice of some doctors not to give radiation therapy to children with ependymoma when the tumor has been completely surgically removed. The investigators who designed this study have created strict measures to choose those who will not receive additional treatment after surgery and careful follow-up to minimize the risks to those who are assigned to observation only.

Institution
MUSC
Recruitment Contact
Jacqueline Kraveka
843-792-2957
kravekjm@musc.edu

Enroll-HD: A Prospective Study in a Global Huntington's Disease Cohort

Date Added
September 10th, 2015
PRO Number
Pro00048038
Researcher
Miroslav Cuturic

List of Studies

Keywords
Genetics, Movement Disorders
Summary

The primary objective of Enroll-HD is to develop a comprehensive repository of prospective and systematically collected clinical research data (demography, clinical features, family history, genetic characteristics) and biological specimens (blood) from individuals with manifest HD, unaffected individuals known to carry the HD mutation or at risk of carrying the HD mutation, and control research participants (e.g., spouses, siblings or offspring of HD mutation carriers known not to carry the HD mutation). Enroll-HD is conceived as a broad-based and long-term project to maximize the efficiencies of non-clinical research and participation in clinical research while ensuring privacy and protections for consenting research participants.

Institution
USC
Recruitment Contact
Alyson Grant
803-545-6104
alyson.grant@uscmed.sc.edu

A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects with Advanced Hematologic Malignancies with an IDH1 Mutation

Date Added
October 13th, 2015
PRO Number
Pro00048303
Researcher
Praneeth Baratam

List of Studies

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

This study is for patients that have been diagnosed with acute myelogenous leukemia (AML) . The investigational drug in this study is AG-120. The purpose of this study is to identify and test the highest dose of AG-120 that can be given safely. Participants can expect to be in the study for as long as the study doctor feels it is in the participants best interest.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

Quantitative Neuroimaging Assessment of White Matter Integrity in the Context of Aging and AD

Date Added
December 19th, 2017
PRO Number
Pro00073604
Researcher
Andreana Benitez

List of Studies


Keywords
Aging, Alzheimers, Brain, Healthy Volunteer Studies
Summary

The purpose of this study is to use neuroimaging to understand how networks in the brain change over time. Although the single most significant risk factor for developing Alzheimer's disease (AD) is age, the neurobiological processes underlying the transition from normal aging to AD are not well understood. Our group of researchers has developed ways to use MRI to detect small changes in certain parts of the brain. We will use neuroimaging to understand how the connections in the brain change over time in healthy aging. The goal is to discover which brain changes are present in healthy aging.

Participants will have two study visits (about 2 years apart) where they will undergo tests to assess mental function, fill out questionnaires, and undergo a blood draw, brain MRI and PET scan and provide a saliva sample. At the second visit, participants will not repeat PET scan. Participants will continue to be followed longitudinally every two years as long as the study is funded.

Participants are required to have a Co-Participant accompany them for the first portion of each visit. This individual must be a reliable informant that has contact with the participant at least once per week.

Institution
MUSC
Recruitment Contact
Katrina Madden
843-792-9186
IAMstudy@musc.edu

A Phase 2b, Multicenter, Randomized, Open-label, Two-Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 Compared to Standard Neonatal Care for the Prevention of Bronchopulmonary Dysplasia, the Most Common Cause of Chronic Lung Disease of Prematurity

Date Added
December 10th, 2019
PRO Number
Pro00091762
Researcher
Carol Wagner

List of Studies


Keywords
Children's Health, Infant, Pediatrics
Summary

Babies that are born extremely prematurely are at higher risk of developing chronic (long term) lung disease (CLD) and other complications (problems). The purpose of this study is to test the safety and effectiveness of an investigational drug called mecasermin rinfabate (rhIGF-1/rhIGTBP-3) or OHB-607. The researchers want to find out if OHB-607 can help reduce the risk of chronic lung disease in babies born prematurely and if it can help reduce the risk of other complications.

Institution
MUSC
Recruitment Contact
Della MacNicholas
843-792-8385
macnichd@musc.edu

Priming the rehabilitation engine: aerobic exercise as the fuel to spark behavioral improvements in stroke

Date Added
February 2nd, 2021
PRO Number
Pro00105988
Researcher
Ryan Ross

List of Studies

Keywords
Exercise, Rehabilitation Studies, Stroke, Stroke Recovery
Summary

Stroke is a leading cause of disability in the U.S. and many Veteran stroke survivors live with severe disability. Despite recent advances in rehabilitation treatments many stroke survivors have persistent physical and mental difficulties such as reduced arm and leg function, difficulty thinking, and depression.
Developing treatments that address these problems is necessary to improve long-term recovery for stroke survivors. Aerobic exercise (AEx) can improve physical and mental function, and reduce depression. Additionally, AEx may enhance physical rehabilitation by making the brain more receptive to, and consequently improving the response to a rehabilitation treatment. Therefore, combining AEx with physical rehabilitation has the potential to improve multiple parts of stroke recovery. This study will examine the effect of combining AEx with physical rehabilitation on physical and mental function in stroke survivors. By gaining a better understanding of the effects of this combined intervention we aim to advance the rehabilitative care of Veteran stroke survivors.

Institution
MUSC
Recruitment Contact
Ryan Ross
843-792-3477
rossre@musc.edu

Pilot Trial of Belimumab in Early Lupus

Date Added
February 9th, 2021
PRO Number
Pro00104939
Researcher
Melissa Cunningham

List of Studies


Keywords
Drug Studies, Lupus
Summary

This is a study looking at the effects of Belimumab, a medication approved by the FDA to treat lupus, in people who have been recently diagnosed with lupus. It proposes that the early use of Belimumab may prevent long-term tissue damage from the disease. The study will last 2 years with clinic visits every 4 weeks.

Institution
MUSC
Recruitment Contact
Emma Hatch
843-792-4296
hatchem@musc.edu

Improving the Collaborative Health of Minority COVID-19 Survivor and Carepartner Dyads Through Interventions Targeting Social and Structural Health Inequities.

Date Added
May 6th, 2021
PRO Number
Pro00110062
Researcher
Martina Mueller

List of Studies


Keywords
Cardiovascular, Coronavirus, Diabetes, Hypertension/ High Blood Pressure, Minorities, Stroke
Summary

Underserved, racial and ethnic minority communities are experiencing higher rates of COVID-19 cases and associated mortality compared to whites due to long standing social and structural inequities that also drive disparities in chronic diseases such as stroke, cardiovascular disease, diabetes, and hypertension. Patients with underlying chronic diseases who are recovering from COVID-19 depend on the support of family and friends (informal caregivers/care partners) who are being exposed to the same pandemic and racial stressors, exposure that can affect the health and quality of life of both partners. The primary goal of this study is to test the efficacy of an adapted, telehealth-enhanced intervention that targets barriers impacting family illness management behaviors of Black/African American (AA) adult COVID-19 survivors and carepartner dyads for improved quality of life and COVID/chronic illness health related outcomes.

Institution
MUSC
Recruitment Contact
Gayenell Magwood
8437920685
magwoodg@musc.edu

A Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with Fragile X Syndrome

Date Added
June 25th, 2021
PRO Number
Pro00112028
Researcher
Caroline Buchanan

List of Studies

Keywords
Genetics
Summary

The Drug Product ZYN002 is a transdermal CBD gel. CBD is the primary non-euphoric cannabinoid contained in the Cannabis sativa L. plant. The CBD contained within ZYN002 is a pharmaceutically produced Active Pharmaceutical Ingredient (API) that is chemically identical to the CBD present in Cannabis. ZYN002 is currently being evaluated in clinical trials in children and adolescents with Fragile X Syndrome (FXS), autism spectrum disorder, 22q11.2 deletion syndrome, and developmental and epileptic encephalopathies. The safety and efficacy of ZYN002 in the treatment of behavioral symptoms in children and adolescents with FXS has been evaluated in three studies: Study ZYN2-CL-009, a completed open-label, multiple-center, multiple-dose study (n=20); Study ZYN2-CL-016, a completed randomized, double-blind, placebo-controlled, multiple-center study (n=212 randomized); and Study ZYN2-CL-017, an ongoing open-label extension and expanded access study to assess the long-term safety and tolerability of ZYN002 (n=240). The present protocol for ZYN2-CL-033 (RECONNECT) is designed to evaluate the efficacy and safety of ZYN002 for the treatment and behavioral symptoms in children and adolescents with genetic evidence of full mutation FXS. Qualified subjects that complete ZYN2-CL-033 will have the opportunity to roll over to the open label ZYN2-CL-017 study.

Institution
Self Regional Healthcare
Recruitment Contact
Sarah English
8646726912
senglish@ggc.org



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