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 Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen) for the Treatment of Adults with Systemic Sclerosis

Date Added
August 11th, 2020
PRO Number
Pro00101903
Researcher
Richard Silver

List of Studies

Keywords
Autoimmune disease, Drug Studies, Immune System, Rare Diseases, Scleroderma
Summary

The purpose of this research study is to see if IgPro10 (the study medication) is effective and tolerated when administered to adults with diffuse cutaneous systemic sclerosis (dcSSc) who have skin thickness involvement throughout their body. The study medication is administered intravenously through an IV. There are approximately 22 scheduled visits to the study site to complete assessments, in addition to a Follow-Up phone call. Your participation will last for approximately 80 weeks.

Institution
MUSC
Recruitment Contact
Jordan Fash
843-792-8997
fash@musc.edu

A Phase 2a, Open-label, Single-arm, 2-Part Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX‐147 in Adults with APOL1-mediated Focal Segmental Glomerulosclerosis

Date Added
July 21st, 2020
PRO Number
Pro00099956
Researcher
Roberto Pisoni

List of Studies

Keywords
Drug Studies, Genetics, Kidney, Minorities, Rare Diseases
Summary

The study is an open-label study to determine the safety and efficacy of VX-147-101 in subjects who have APOLI dependent FSGS. The study comprises three periods: screening, treatment, and follow-up. The study includes a screening visit to determine if you have the APOLI gene. Participation in this study will last approximately 17 weeks. Participants may choose to participate in an off-treatment observation for up to 12 additional weeks.

Institution
MUSC
Recruitment Contact
Linda Walker
843-792-6109
walkerlp@musc.edu

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation

Date Added
May 28th, 2020
PRO Number
Pro00096416
Researcher
John Wrangle

List of Studies

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

This study is for patients who have been diagnosed with solid tumor malignancy with KRAS G12C mutation. The investigational drug used in this study is MRTX849. The purpose of this study is to see if patients with cancer with a KRAS G12C mutation will benefit from treatment with MRTX849, what side effects occur and how often they occur and to see how quickly MRTX849 is absorbed into the blood stream and how fast it is removed by the body. Participants can expect to be in this study for as long as the disease does not get worse.

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

A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Date Added
April 28th, 2020
PRO Number
Pro00096818
Researcher
John Kaczmar

List of Studies

Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with PD-L1 Positive Head and Neck Squamous Cell Carcinoma (HNSCC). Specifically, for people with this type of cancer that cannot be treated with surgery or radiation treatment and has not been treated for cancer that spread to sites distant from the head and neck region (metastatic) or for cancer that returned or got worse after being treated (recurrent).The investigational drug (not approved by the FDA) in this study is GSK3359609. The purpose of this research study is to find out if GSK3359609 combined with pembrolizumab works better than the single drug pembrolizumab. Participants can expect to receive treatment for about 3 years and be in follow-up for the rest of their life.

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

Topical treatment for superficial disseminated actinic porokeratosis: A Single-Blinded Comparison Between Lovastatin/Cholesterol and Lovastatin

Date Added
April 7th, 2020
PRO Number
Pro00096259
Researcher
Dirk Elston

List of Studies

Keywords
Drug Studies, Genetics, Inflammation, Pain, Rare Diseases, Skin
Summary

The purpose of this research is to treat disseminated actinic porokeratosis (DSAP) with cholesterol/lovastatin or lovastatin alone. The goal of treatment is to decrease (DSAP) lesions after 12 weeks of treatment and compare which treatment is best.

The study is single-blinded and randomized, meaning the patients will not be told of which treatment they will receive, and the decision of which treatment they will receive will be completely random. The patient will also agree to close up photographs and clinical photographs taken of their disseminated actinic porokeratosis at the initial visit. At weeks 4, 8, and 12, the patients will complete a virtual visit. The subject will take a picture (phone camera/digital camera) of their lesions/skin markings with a measuring instrument. These photos will be shared with the investigators. Physical exam, photographs, and a review of of the subjects medical records will occur in the study. Changes in size, appearance, and pain will be monitored throughout the study.

The possible benefit of joining this study is that the treatment received may be more effective than the other study treatment or than other available treatments for DSAP, although this cannot be guaranteed.

Institution
MUSC
Recruitment Contact
Alan Snyder
9106195832
snydeala@musc.edu

Efficacy and Safety of Tirzepatide Once Weekly in Participants without Type 2 Diabetes Who Have Obesity or are Overweight with Weight- Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)

Date Added
March 10th, 2020
PRO Number
Pro00095068
Researcher
Patrick O'Neil

List of Studies

Keywords
Drug Studies, Obesity, Weight Control
Summary

Tirzepatide is an investigational medication that has been studied for the treatment of diabetes when administered once a week by self-injection. In these trials people who received the medication also lost some weight. This study is being done to see how safe tirzepatide is and how well it will work to help people who are obese or overweight to lose weight, when it is used along with a reduced-calorie diet and increased physical activity.

Participants will be randomly assigned to one of three doses of tirzepatide or to a placebo (inactive look-alike drug). They will be followed for either 72 or 176 weeks depending on the results of an initial test of blood sugar control.

Institution
MUSC
Recruitment Contact
Mary Harley
843-792-5428
harleyma@musc.edu

A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate Cancer

Date Added
March 10th, 2020
PRO Number
Pro00095193
Researcher
Michael Lilly

List of Studies

Keywords
Cancer, Cancer/Lymphoma, Drug Studies, Men's Health, Prostate
Summary

This study is for patients who are 18 years and older that have been diagnosed with metastatic castration-resistant prostate cancer (mCRPC).The investigational drugs in this study are Nivolumab and Ipilimumab.The purpose of this research study is to test the effectiveness (how well the drug works), safety, and tolerability of different dosing regimens containing nivolumab plus ipilimumab, ipilimumab alone, or cabazitaxel plus prednisone or prednisolone in participants with metastatic castration-resistant prostate cancer (mCRPC).Duration of this study will take approximately 24 months.

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

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Who are Candidates for Radical Prostatectomy

Date Added
March 9th, 2020
PRO Number
Pro00095232
Researcher
Thomas Keane

List of Studies

Keywords
Cancer, Drug Studies, Men's Health
Summary

This study is for patients who have been diagnosed with localized and locally advanced high-risk prostate cancer who are planned for radical prostatectomy (surgical removal of the whole prostate and surrounding tissue). This is a research study to find out if experimental medication called apalutamide (also known as JNJ-56021927) plus androgen deprivation therapy (ADT) , also known as hormone therapy, is safe and could improve the results of surgery and delay the time to when prostate cancer tumors spread to other parts of the body.

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

Protocol RR3 (CP-03-001), Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine Plus Nab-Paclitaxel Following Induction With Sequential IV Gemcitabine Plus Nab-Paclitaxel and Radiotherapy for Unresectable Locally Advanced Pancreatic Cancer (TIGeR-PaC)

Date Added
March 2nd, 2020
PRO Number
Pro00093024
Researcher
D. Thor Johnson

List of Studies

Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

The purpose of this study is to find out if we can prolong your survival by delivering the chemotherapy drug through an artery that goes directly into your pancreas and to find out if this experimental approach is better or worse than the usual approach for your pancreatic cancer. All subjects will receive induction therapy of IV gemcitabine plus nab-paclitaxel, as well as radiation therapy for approximately four months. Subjects who remain eligible will then be randomized to receive either intra-arterial chemotherapy with gemcitabine; or to continue gemcitabine plus nab-paclitaxel. Subjects will receive the randomized treatments for up to 16 weeks or until progression. Both groups will receive either IV gemcitabine and nab-paclitaxel or oral capecitabine following the 16 week treatment course until disease progression at the discretion of the Investigator.

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



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