A Phase 1, Open-Label, Dose-Escalation and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Activity and Pharmacokinetics of REGN3767 (anti-LAG-3 mAb) Administered Alone or in Combination with REGN2810 (anti-PD-1 mAb) in Patients with Advanced Malignancies

Date Added
November 14th, 2017
PRO Number
Pro00067774
Researcher
John Kaczmar

List of Studies


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

The purpose of this first in human study is to find a safe dose level of the investigational drug REGN3767 alone or in combination with REGN2810. Other purposes of this study are to measure the levels of REGN3767 and REGN2810 in the subject's blood and to collect any evidence of tumor shrinkage when given alone or in combination with REGN2810.
REGN3767 and REGN2810 are both a type of drug called a monoclonal antibody. Antibodies are proteins that are naturally found in your blood stream that fight infections. A monoclonal antibody is a special kind of antibody that is manufactured as a medication to target a specific protein in the body that may be involved in the subject's cancer.
In this part of the study each participant will receive 1 of 3 different doses of REGN3767 alone or in combination with one dose of REGN2810. There will be a total of 6 different groups of participants the study team plans to study based on what dose of REGN3767 they receive and whether they receive it alone or with REGN2810.
The study is sponsored by Regeneron. The investigator in charge of this study at MUSC is Carolyn Britten, MD. Part 1 of this study is being done at 4-5 sites. Approximately24-48 people will take part study-wide.

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

Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

Date Added
December 21st, 2017
PRO Number
Pro00073365
Researcher
Sarah Marrison

List of Studies


Keywords
Cancer/Breast
Summary

This study is for women being screened for breast cancer. The main purpose of this study is to determine whether screening for breast cancer with tomosynthesis mammography is superior to digital mammography for breast cancer screening.

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

An Open Label Study to Assess the Feasibility and Tolerability of Accelerated Theta Burst Repetitive Transcranial Magnetic Stimulation (iTBS-rTMS) for the Treatment of Post-Partum Depression

Date Added
January 2nd, 2018
PRO Number
Pro00073886
Researcher
Lisa McTeague

List of Studies


Keywords
Depression, Post Partum Depression
Summary

This is an open-label study designed to investigate the feasibility and tolerability of a novel TMS treatment protocol to treat depression in women with post-partum depression. It is known that TMS can effectively treat depression. The FDA approved protocol lasts 6 weeks and is not feasible for many women with post-partum depression. We are investigating a 6 day treatment for depression which may be more acceptable for this population. We further hope to characterize the anti-depressant effect and durability of this protocol in order to design a larger trial.

Institution
MUSC
Recruitment Contact
Samantha LaPorta
843-792-8274
laporta@musc.edu

The CHEC-SC Cohort Study: CHaractErizing CFTR Modulated Changes in Sweat Chloride and their Association with Clinical Outcomes

Date Added
January 10th, 2018
PRO Number
Pro00073414
Researcher
Sylvia Szentpetery

List of Studies


Keywords
Cystic Fibrosis
Summary

This is an observational study which will collect sweat chloride values from approximately 1000 cystic fibrosis subjects who are currently on cystic fibrosis transmembrane conductance regulator (CFTR) modulators. This study will require one visit to an MUSC clinic which will last approximately 2 hours. Compensation is provided.

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

Carotid Revascularization and Medical Management for Asymptomatic Carotid stenosis - Hemodynamics (CREST-H)

Date Added
January 31st, 2018
PRO Number
Pro00073070
Researcher
Christine Holmstedt

List of Studies


Keywords
Cardiovascular, Heart, Stroke
Summary

This is an ancillary study on the Phase 3 parent trial (CREST-2) in which patients with asymptomatic high grade carotid artery stenosis have enrolled to receive either a novel intensive medical management plan alone, or in combination with either Carotid Endarterectomy (CEA) or Carotid artery stenting (CAS). Patients enrolled in CREST-H will undergo a baseline MRI and some patients will also undergo a followup MRI at 1 year. The purpose is to determine whether cognition can be improved by revascularization among the subset of CREST-2 patients with hemodynamic impairment and mild cognitive impairment at baseline.

Institution
MUSC
Recruitment Contact
Vicki Streets
843-792-8606
streetsv@musc.edu

A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway–Mutant Acute Lymphoblastic Leukemia

Date Added
February 13th, 2018
PRO Number
Pro00071934
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Cancer, Cancer/Leukemia, Pediatrics
Summary

This study is for patients that have been diagnosed with High Risk B-Lymphoblastic Leukemia (HR B-ALL). The investigational drug in this study is Ruxolitinib. The purpose of this study is to find out if the study drug, ruxolitinib, in combination with standard HR B-ALL treatment is safe and effective in children, adolescents, and young adults with HR B-ALL. Participants can expect to be in this study for the treatment period of approximately 26 months (females) or 38 months (males) plus the post-treatment follow-up. Subjects are considered on study during the post-treatment follow-up period until the subject is deceased, lost to follow-up, or until the study is completed. Subjects in this study will be followed until all enrolled subjects have been followed for 3 years from Day 1 or are deceased or lost to follow-up.

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

The reversibility of liver fibrosis after HCV eradication

Date Added
March 15th, 2018
PRO Number
Pro00076212
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

This an observational study that aims to assess the outcome of patients with advanced fibrosis and cirrhosis recurrence in patients with hepatitis C virus (HCV) infection after HCV eradication. We aim to describe this unique group of patients as well as determine whether any particular variables are significant predictors of fibrosis/cirrhosis resolution. A multivariate analysis will be conducted to determine risk factors independently related to fibrosis/cirrhosis resolution and clinical outcome.

Institution
MUSC
Recruitment Contact
Shaurya Prakash
843-860-8059
prakash@musc.edu

Integrated Analysis of Vision Quality with Aberrometry

Date Added
March 27th, 2018
PRO Number
Pro00074857
Researcher
Karolinne Rocha

List of Studies


Keywords
Vision/ Eye
Summary

The purpose of this study is to identify and measure refractive errors of the eye as well as visual symptoms after cataract surgery.

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@musc.edu

SpHincterotomy for Acute Recurrent Pancreatitis Trial

Date Added
May 15th, 2018
PRO Number
Pro00078002
Researcher
Valerie Durkalski

List of Studies


Keywords
Pancreas
Summary

The purpose of this study is to determine if a procedure called Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincterotomy reduces the risk of pancreatitis or the number of recurrent pancreatitis episodes in patients with pancreas divisum. ERCP with sphincterotomy is a procedure where doctors used a combination of x-rays and an endoscope (a long flexible lighted tube) to find the opening of the duct where fluid drains out of the pancreas. People who have been diagnosed with pancreas divisum, have had at least two episodes of pancreatitis, and are candidates for the ERCP with sphincterotomy procedure may be eligible to participate. Participants will be will be randomly assigned to either have the ERCP with sphincterotomy procedure, or to have a "sham" procedure, meaning that you will be treated as if you are having the ERCP with sphincterotomy procedure but the procedure will not really be performed. Participants will have follow up visits 30 days after the procedure, 6 months after the procedure, and continuing every 6 months until the study ends.

Institution
MUSC
Recruitment Contact
April Williams
(843) 792-3316
williamsa@musc.edu



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