Clinical Feasibility of Low Intensity Focused Ultrasound Pulsation for the Treatment of Generalized Anxiety Disorder

Date Added
July 6th, 2021
PRO Number
Pro00109178
Researcher
Mark George

List of Studies


Keywords
Anxiety
Summary

The purpose of this research is to test out a new way of treating generalized anxiety disorder (GAD) with low intensity focused ultrasound pulsation (LIFUP). If the subject agree to participate in the research study, the participation will last approximately 10.5 hours over seven (7) days. The visits are as follows: 1- consent and MRI, 2- and 3- focused ultrasound will be delivered outside of the MRI environment, 4- MRI plus focused ultrasound, 5- assessments 1 week post focused ultrasound, and 6- one month follow-up assessments. Research studies are voluntary and include only people who agree to take part.

Institution
MUSC
Recruitment Contact
Sarah Huffman
843-792-8672
huffmans@musc.edu

Optimal Perioperative Therapy for Incidental Gallbladder Cancer (OPT-IN)- A Randomized Phase II/III Trial

Date Added
July 5th, 2021
PRO Number
Pro00112123
Researcher
Katherine Morgan

List of Studies


Keywords
Cancer/Gastrointestinal, Gall Bladder
Summary

This study is for patients with gallbladder cancer. The purpose of this study is to compare the usual treatment (surgery plus chemotherapy after) to using chemotherapy both before and after surgery.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
(843) 792-9321
hcc-clinical-trials@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

Olfactory Dysfunction in Aging Adults

Date Added
June 25th, 2021
PRO Number
Pro00111776
Researcher
Rodney Schlosser

List of Studies


Keywords
Aging, Non-interventional, Nose
Summary

Smell loss has been reported in more than 50% of older adults. Currently there are no validated methods for classifying patients with smell loss in aging based on either disease site or process. This study aims to better understand how age affects the sense of smell. This study will involve those 50 and older and will take up to 5 years, with 5 follow up annual visits, or can be done remotely.

Institution
MUSC
Recruitment Contact
Charn Pitiranggon
843-792-9496
pitirach@musc.edu

Adequacy for molecular analysis in EBUS-TBNA specimens vs. liquid biopsies in patients with NSCLC, aka, "The Liquid Trial"

Date Added
June 16th, 2021
PRO Number
Pro00105097
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study will be looking at biopsies taken from mediastinal lymph nodes and a blood sample from patients who have known or suspected metastatic lung cancer. These two samples will be compared using next-gen sequencing to explore if either sampling method offers better results.

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

Autologous BM-MSCs and Islet Co-transplantation to Enhance Islet Survival and Function in TP-IAT Patients

Date Added
June 15th, 2021
PRO Number
Pro00099487
Researcher
Hongjun Wang

List of Studies


Keywords
Diabetes, Pancreas, Transplant
Summary

Islet transplantation is a clinical procedure to treat patients with chronic pancreatitis after removal of their pancreases. Islet survival is influenced by several factors, including but not limited to triggering an inflammatory response. The loss of islet cells during transplantation can cause surgical diabetes, in which the patient will need insulin injections to regulate their blood sugar. The goal of this study is to test whether co-transplantation of the patient's stem cells, called mesenchymal stromal cells (MSCs), along with their islet cells, will protect transplanted islet cells from death, therefore reducing the patient's chances of getting surgical diabetes. MSCs can modulate immune cells and are a promising resource for cell-based therapy.

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

Determination and Validation of Lung EpiCheck®: A Multianalyte Assay for Lung Cancer Prediction

Date Added
June 14th, 2021
PRO Number
Pro00109559
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study aims to create a test that will detect changes in the genes found in the patient's blood very soon after he/she develops lung cancer. Detecting lung cancer at an early stage can significantly reduce the chance that the patient will die from lung cancer. This test is expected to perform better than any other tests that are currently available.

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

Determination and Validation of Lung EpiCheck®: A Multianalyte Assay for Lung Cancer Prediction

Date Added
June 14th, 2021
PRO Number
Pro00109559
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study aims to create a test that will detect changes in the genes found in the patient's blood very soon after he/she develops lung cancer. Detecting lung cancer at an early stage can significantly reduce the chance that the patient will die from lung cancer. This test is expected to perform better than any other tests that are currently available.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

Determination and Validation of Lung EpiCheck®: A Multianalyte Assay for Lung Cancer Prediction

Date Added
June 14th, 2021
PRO Number
Pro00109559
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study aims to create a test that will detect changes in the genes found in the patient's blood very soon after he/she develops lung cancer. Detecting lung cancer at an early stage can significantly reduce the chance that the patient will die from lung cancer. This test is expected to perform better than any other tests that are currently available.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

Determination and Validation of Lung EpiCheck®: A Multianalyte Assay for Lung Cancer Prediction

Date Added
June 14th, 2021
PRO Number
Pro00109559
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study aims to create a test that will detect changes in the genes found in the patient's blood very soon after he/she develops lung cancer. Detecting lung cancer at an early stage can significantly reduce the chance that the patient will die from lung cancer. This test is expected to perform better than any other tests that are currently available.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu



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