A Phase 1/2a, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Date Added
August 24th, 2020
PRO Number
Pro00096015
Researcher
John Wrangle

List of Studies


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

This study is for patients that have been diagnosed with Non-Small Cell Lung Cancer (NSCLC).The investigational drug used in this study is CLN-081.

This study has 3 parts; Phase 1 Dose Escalation, Phase 1 Dose Expansion, and Phase 2a Dose Expansion:
-Phase 1 Dose Escalation: The main aim of this part of the study is to find a maximum tolerated dose for CLN-081. This will be done by slowly increasing the dose given to each participant or to small groups of participants until certain adverse effects are seen. All participants will be closely monitored by the study doctor and team. When the maximum tolerated dose has been found, it will be used in the subsequent parts of the study.
-Phase 1 Dose Expansion: In this part of the study more participants will receive the maximum tolerated dose to confirm the safety of this dose of the study medicine and to explore different dosing schedules, for example, taking the study medicine once a day versus twice a day.
-Phase 2a Dose Expansion: The main aim of this part of the study will be to see how well the study medicine works in reducing tumor size.

Participants can expect to be on this study for about 3 years.

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

Proactive and reactive perturbation training to reduce falls and improve gait stability in people with chronic stroke

Date Added
August 4th, 2020
PRO Number
Pro00101810
Researcher
Jesse Dean

List of Studies


Keywords
Stroke
Summary

Following a stroke, many individuals have a high risk of falls, which can negatively influence quality of life. Unfortunately, current treatments have not effectively addressed this problem. This study investigates whether two methods of delivering mechanical perturbations during walking have the potential to improve post-stroke walking balance and reduce real-world fall incidence.

Institution
MUSC
Recruitment Contact
Alyssa Chesnutt
843-792-8171
hydar@musc.edu

Ovarian Cancer Survival in African-American Women

Date Added
July 28th, 2020
PRO Number
Pro00102103
Researcher
Andrew Lawson

List of Studies


Keywords
Cancer
Summary

Epithelial ovarian cancer (EOC) is the 5th leading cause of cancer death in women in the U.S. African-American (AA) women have the lowest survival of any racial/ethnic group,1 yet little is known about factors affecting survival among AAs. The African American Cancer Epidemiology Study (AACES) is a multi-site epidemiologic study of AA women in diverse geographic regions. AACES has enrolled an unprecedented number of AA participants during a previous funding period, 593 AA women with invasive EOC and 752 controls, making AACES the largest study of ovarian cancer in AA women to date. Prior to AACES, no epidemiologic study of ovarian cancer had enrolled more than 150 AA cases and 150 AA controls. Due to comprehensive data collection, pathology assessment and length of follow-up, AACES is uniquely positioned to evaluate factors influencing the survival of EOC in AA women. The causes of the poor outcomes in AA women are likely multifactorial and need to be examined from multiple levels, including factors affecting both the neighborhood social environment and individual level factors.

Institution
MUSC
Recruitment Contact
Andrew Lawson
843-876-1865
lawsonab@musc.edu

Early measurement of ST2 as a prognostic biomarker for future occurrence of acute GVHD II-IV in a prospective multisite study

Date Added
July 17th, 2020
PRO Number
Pro00100472
Researcher
Sophie Paczesny

List of Studies

Keywords
Cancer
Summary

The purpose of this study is to collect two blood specimens and information about participants who are receiving a standard of care bone marrow or stem cell transplant to use and help better understand graft-versus-host disease (GVHD). One potential new way to help researchers better understand GVHD is through a biomarker (a substance found in your blood/tissue) called ST2. The new information learned from this study could then be used in future research for patients undergoing stem cell transplants. This is a non-interventional study (no drugs involved).

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
843-792-9321

Down syndrome biomarker project

Date Added
June 25th, 2020
PRO Number
Pro00090922
Researcher
Eric Hamlett

List of Studies


Keywords
Alzheimers, Blood Disorders, Brain, Children's Health, Dementia, Inflammation, Vascular
Summary

Alzheimer's disease and Epilepsy may affect over 80% of individuals that have Down syndrome by the age of 60. Biomarkers found in the blood can enhance our understanding of the earliest changes linked to disease and may enhance clinical detection and healthy aging for individuals with Down syndrome.

The purpose of this study is to discover early neurobiological processes underlying the transition from healthy aging to disease. Our research team has developed technology that allows detection of small changes in the brain that get transferred to the blood.

We are recruiting individuals that either have or do not have Down syndrome for this biomarker study. Participants should be between the ages of 6 months and 85 years old and may include mothers and siblings of a child with Down syndrome. Infants and children will require consent form a parental or legal guardian.

Each participant will provide a blood sample for research purposes. We will also gather some basic health information about senses, habits, exercise level and smoking/vaping exposures.

Institution
MUSC
Recruitment Contact
Eric Hamlett
919 357 7543
hamlette@musc.edu

Prospective tReatment EffiCacy in IPF uSIng genOtype for Nac Selection (PRECISIONS) trial

Date Added
June 17th, 2020
PRO Number
Pro00097636
Researcher
Timothy Whelan

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

This is a multi-center, randomized, double-blind, placebo-controlled trial of 200 participants to receive N-acetyl cysteine (NAC) or placebo for a 24 month duration. The purpose of this study is to see if n-acetylcysteine (NAC) can help people with idiopathic pulmonary fibrosis (IPF) who have a specific gene type and to see if NAC is safe to take without causing too many side effects.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Umbilical Cord-derived Mesenchymal Stem Cells (MSC) for Cellular Therapy

Date Added
June 16th, 2020
PRO Number
Pro00099509
Researcher
Hongjun Wang

List of Studies


Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The objective of this study is to obtain viable mesenchymal stem cells (MSCs) from umbilical cords in uncomplicated planned cesarean deliveries. Potential donors will be screened prior to donation of umbilical cords to confirm no infectious disease, viruses and/or diseases. The overall goal is to obtain MSCs from healthy donors for eventual transfusion into patients for potential treatment of diseases, such as chronic pancreatitis, systemic sclerosis, type 1 diabetes, COVID 19, acute respiratory distress syndrome (ARDS), and other diseases in studies approved by the IRB. We also want to store the cells as repository for other potential therapy.

Institution
MUSC
Recruitment Contact
Leah Benn
843-792-2813
bennle@musc.edu

Molecular links between Alzheimer's Disease and Cardiomyopathy

Date Added
June 16th, 2020
PRO Number
Pro00071077
Researcher
Federica del Monte

List of Studies


Keywords
Alzheimers, Dementia, Genetics, Heart
Summary

Patients with Alzheimer Disease and patients with Heart failure (and a control group free from both the previous mentioned conditions) will be evaluated with cardiac and neuropsychological assessments, in order to investigate the relationship between the two conditions. The study consists of two initial visits, and a 4- and 8-year follow-up visit.

Institution
MUSC
Recruitment Contact
Camilla Bacchin
843-442-6981
bacchin@musc.edu

SUPERIOR VENA CAVAL OCCLUSION IN SUBJECTS WITH ACUTE DECOMPENSATED HEART FAILURE - AN EARLY FEASIBILITY STUDY

Date Added
June 9th, 2020
PRO Number
Pro00096629
Researcher
Ryan Tedford

List of Studies


Keywords
Cardiovascular
Summary

This study is an early feasibility study which typically consist of evaluating innovative devices or innovative uses of approved devices. The purpose of this study is to see if an investigational device called preCARDIA Intermittent Balloon Device can limit fluid overload in congested patients with advanced heart failure. This investigational device is a catheter which has been approved by the U.S. Food and Drug Administration (FDA) to occlude large vessels but not for the treatment of advanced heart failure. Currently, there are no device-based approaches that are FDA-approved for advanced heart failure. This study will help find out if this device-based approach can improve symptoms and heart function in congested patients with advanced heart failure

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
8437920464
panneeer@musc.edu

The Randomised Controlled Trial of Frontal and Temporal Electroconvulsive Therapy (ECT) for Severe Depression (The RAFT ECT Study)

Date Added
June 2nd, 2020
PRO Number
Pro00098725
Researcher
Mark George

List of Studies


Keywords
Depression, Mental Health
Summary

This is a research study to find out if a new form of electroconvulsive therapy (ECT) is as effective and safe as a current form. The new form of ECT is called Frontal (Ultrabrief Right Unilateral) ECT. If enrolled in this this study, participants will be randomly assigned (like flipping a coin) to receiving Frontal ECT or the current standard form of ECT called Temporal (Ultrabrief Right Unilateral) ECT.

Institution
MUSC
Recruitment Contact
Morgan Dancy
843-876-5141
maddoxm@musc.edu



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