Contingency Management to Promote Smoking Abstinence in Cancer Patients

Date Added
May 29th, 2020
PRO Number
Pro00099446
Researcher
Benjamin Toll

List of Studies


Keywords
Cancer, Smoking
Summary

This is a smoking cessation treatment study. Patients who have a cancer or a suspected cancer who will undergo surgical removal of their cancer are eligible to participate in this study. A novel smoking cessation treatment will be provided to half of the participants in the study. All study participants will receive standard smoking cessation therapy including counseling and the nicotine patch.

Institution
MUSC
Recruitment Contact
Rachel Christian
843-737-1516
chrisrac@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

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

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

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

MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience

Date Added
September 1st, 2020
PRO Number
Pro00102709
Researcher
Lisa McTeague

List of Studies


Keywords
Alcohol, Brain, Drug Studies, Psychiatry, Substance Use
Summary

The purpose of this study is to develop transcranial magnetic stimulation (TMS), specifically TMS at a frequency known as theta burst stimulation (TBS), to see how it affects the brain and changes the brain's response to alcohol-related pictures. TMS and TBS are stimulation techniques that use magnetic pulses to temporarily excite specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). TBS, which is a form of TMS, will be applied over the medial prefrontal cortex, (MPFC), which has been shown to be involved with drinking patterns and alcohol consumption. This study will test whether TBS can be used as an alternative tool to reduce the desire to use alcohol and reducing the brain's response to alcohol-related pictures.

Institution
MUSC
Recruitment Contact
Charleston Alcohol Research Center
(843) 792-1222
alcoholstudy@musc.edu

A Phase II Study of Metronomic and Targeted Anti-Angiogenesis Therapy for Children With Recurrent/Progressive Medulloblastoma

Date Added
September 1st, 2020
PRO Number
Pro00091939
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Brain, Brain Tumor, Cancer, Central Nervous System, Children's Health, Drug Studies, Pediatrics, Spinal Cord
Summary

This study is for patients with recurrent/progressive medulloblastoma, which is a type of childhood brain tumor. Participants in this study will receive intravenous (IV, into the veins) bevacizumab and intrathecal (into the spinal fluid) or intraventricular (into the fluid surrounding the brain) etoposide and cytarabine in combination with five oral (taken by mouth) chemotherapy drugs as a possible treatment for recurrent/progressive medulloblastoma. Total study duration is about 1 year and depending on how well a participant tolerates the medications and the response of the disease, the patient may continue the treatment after the first year.

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

Advanced Cardiac Therapies Improving Outcomes Network to Improve the Health of Pediatric and Congenital Heart Disease Patients with Heart Failure

Date Added
September 21st, 2020
PRO Number
Pro00096494
Researcher
Heather Henderson

List of Studies


Keywords
Cardiovascular, Heart, Pediatrics
Summary

The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) is a distributed network-based learning health system (LHS) of care centers, clinicians, researchers and industry representatives partnering with patients who have heart failure and their caregivers with the ultimate aim of achieving health, longevity and quality of life equivalent to the general population. See https://www.actionlearningnetwork.org for more information. The initial focus will be to apply structured quality improvement methods, advanced information technology systems, and sharing of best practices to track and continuously improve health-related outcomes for children with heart failure requiring advanced therapies. In the future, we plan to collaborate with other established registries and learning network (i.e. UNOS, PHTS and Cardiac Networks United) to create an integrated network that improves care throughout all phases of a patient's illness including chronic heart failure, acute decompensated heart failure, ventricular assist device support and transplant.

Institution
MUSC
Recruitment Contact
Heather Henderson
8437929570
hendhea@musc.edu

A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations

Date Added
September 25th, 2020
PRO Number
Pro00104024
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with Acute Myelogenous Leukemia (AML). This study will compare standard chemotherapy using daunorubicin, cytarabine and gemtuzumab ozogamicin (GO) to chemotherapy using an experimental drug called CPX-351. CPX-351 is made up of daunorubicin and cytarabine. CPX-351 is made in a way that makes the drugs stay in the bone marrow longer and may be more effective. CPX-351 has been shown to be well-tolerated and effective against leukemia in adults and children. Participants can expect to receive treatment on this study for 6 months and followed for up to 10 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
HCC Clinical Trials Office843-792-9321
hcc-clinical-trials@musc.edu

Alcohol Research Center. Shared clinical assessment core for the Alcohol Research Center clinical projects.

Date Added
October 6th, 2020
PRO Number
Pro00103760
Researcher
Konstantin Voronin

List of Studies


Keywords
Alcohol, Drug Studies
Summary

The purpose of this research study is to determine potential subjects eligibility for participation in the Alcohol Research Center clinical projects based on the results of the screening assessments, which they will complete during this protocol.
Participants will undergo 1-2 days screening procedures. Subjects will be asked to fill out questionnaires, they will be interviewed, will need to provide medical history and have physical exam done and provide a blood sample. Total study consists 1-2 visits which will be completed within approximately one-week period.

Institution
MUSC
Recruitment Contact
Konstantin Voronin
843-792-4887
voronin@musc.edu



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