Developing brain stimulation as a treatment for chronic pain in opiate dependent individuals Save

Date Added
July 3rd, 2018
PRO Number
Pro00078668
Researcher
Colleen Hanlon

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Keywords
Brain, Drug Studies, Pain, Psychiatry
Summary

The purpose of this study is to develop transcranial magnetic stimulation (TMS) as a novel, non-pharmacologic approach to decreasing pain in individuals with chronic pain. This study will test whether rTMS over the prefrontal cortex can produce a reduction in your perception of pain, your desire to use opiates, and your brain's response to opiate cues. The results of this study will be used to design and develop a large clinical trial of rTMS as an innovative, new treatment option for chronic lower back pain in individuals that have used chronic opiates.

Institution
MUSC
Recruitment Contact
Julia Imperatore
843-792-5560
imperato@musc.edu

A Phase 2B, 8-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of the Fatty Acid Amide Hydrolase (FAAH) Inhibitor PF-04457845 in Adults with DSM-5 Current Cannabis Use Disorder (CUD) Save

Date Added
July 3rd, 2018
PRO Number
Pro00079439
Researcher
Aimee Mc Rae

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Keywords
Drug Studies, Substance Use
Summary

This study will examine whether the investigational medication PF-0447845 is safe and effective in reducing cannabis use among people who frequently use cannabis. This is a 12-week, randomized, double-blind, placebo-controlled outpatient clinical trial that will be conducted at 4 research sites in the eastern U.S.

Institution
MUSC
Recruitment Contact
Amanda Wagner
843-792-0484
wagne@musc.edu

A Phase III Study of BBI-608 plus nab-Paclitaxel with Gemcitabine in Adult Patients with Metastatic Pancreatic Adenocarcinoma Save

Date Added
June 28th, 2018
PRO Number
Pro00073638
Researcher
Carolyn Britten

Silhouette
Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies, Pancreas
Summary

The purpose of this study is to find out whether patients with pancreatic cancer will live longer when receiving treatment with nab-Paclitaxel and Gemcitabine, a standard chemotherapy regimen, given in combination with a new drug, BBI-608, or live longer when receiving treatment with nab-Paclitaxel and Gemcitabine alone for pancreatic cancer. The length of participation for this study will continue until your doctor feels you are no longer benefitting from your treatment. This study is expected to take 2-3 years to complete. This research is being done to improve on existing treatments for pancreatic cancer.

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

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination With Cabozantinib (CB-Cabo) vs. Placebo With Cabozantinib (Pbo-Cabo) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC) Save

Date Added
June 12th, 2018
PRO Number
Pro00077321
Researcher
Theodore Gourdin

Silhouette
Keywords
Cancer/Genitourinary, Drug Studies
Summary

The purpose of this study is to determine if CB-839 (an "investigational" drug), given together with cabozantinib (an "approved" drug) is able to stop or reduce the rate of cancer growth in patients with advanced or metastatic renal cell carcinoma better than cabozantinib alone. This study will also look at any possible effect that CB-839 in combination with cabozantinib may have on your cancer.

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

A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of CDX-3379 in Combination with Cetuximab in Patients with Advanced Head and Neck Squamous Cell Carcinoma Save

Date Added
June 12th, 2018
PRO Number
Pro00076144
Researcher
Paul O'brien

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

The purpose of this study is to see whether an investigational drug called CDX-3379 combined with cetuximab, a monoclonal antibody that targets a protein called EGFR, will shrink tumors for subjects with head and neck squamous cell carcinoma (HNSCC). This study is for patients who have been diagnosed with HNSCC and who have previously received cetuximab but who have since experienced progression. Both the investigational drug, CDX-3379, and cetuximab are administered intravenously (into a vein). Subjects can expect to participate in the study for 2 years or longer.

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

Enhancing self-regulation by altering memories that increase risk of relapse among smokers: A translational clinical neuroscience study of a novel medication Save

Date Added
June 5th, 2018
PRO Number
Pro00076669
Researcher
Michael Saladin

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Keywords
Drug Studies, Smoking
Summary

The proposed study is looking to recruit smokers over the age of 18 to complete a four visit study. Participants will be randomized to receive either rapamycin (sirolimus) or a placebo at the second visit to assess potential effects on craving and relapse. Four study visits will be completed over the course of about three weeks.

Institution
MUSC
Recruitment Contact
Emily Burns
843-792-6984
burnsemi@musc.edu

A PHASE Ib STUDY OF THE SAFETY AND PHARMACOKINETICS OF ATEZOLIZUMAB (ANTI?PD-L1 ANTIBODY) ALONE OR IN COMBINATION WITH AN IMMUNOMODULATORY DRUG AND/OR DARATUMUMAB IN PATIENTS WITH MULTIPLE MYELOMA (RELAPSED/REFRACTORY AND POST-AUTOLOGOUS STEM CELL TRANSPLANTATION) Save

Date Added
May 22nd, 2018
PRO Number
Pro00075616
Researcher
Amarendra Neppalli

Silhouette
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects that have been diagnosed with multiple myeloma. The investigational drug in this study is atezolizumab.The purpose of this study is to test the safety of various combinations of an experimental (not yet approved by the U.S. Food and Drug Administration [FDA] or any other regulatory authority outside the United States) drug called atezolizumab given with daratumumab, lenalidomide, and/or pomalidomide with or without dexamethasone (all approved by the FDA for the treatment of multiple myeloma) at different dose levels and to find out what effects, good or bad, the combination of these drugs has on you. Participants can expect to be in this study for 36 months.

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

Effect and safety of semaglutide 2.4 mg once-weekly in subjects with overweight or obesity Save

Date Added
May 22nd, 2018
PRO Number
Pro00077418
Researcher
Patrick O'neil

Silhouette
Keywords
Drug Studies, Obesity, Weight Control
Summary

The study seeks to determine how well semaglutide, the study medication, works in people suffering from overweight or obesity over a period of 68 weeks along with a 7-week follow-up period. Participants will be randomly assigned to receive semaglutide or an inactive placebo. All participants will receive diet and physical activity counseling. Participants will inject themselves once-weekly with study medication. The primary measure of the study will be weight change.

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

Scleroderma Lung Study III (SLS III): Combining the anti-fibrotic effects of pirfenidone (PFD) with mycophenolate (MMF) for treating scleroderma-related interstitial lung disease Save

Date Added
May 8th, 2018
PRO Number
Pro00077568
Researcher
Richard Silver

Silhouette
Keywords
Autoimmune disease, Drug Studies, Lung, Scleroderma, Shortness of Breath
Summary

This study will assess how 18 months of oral mycophenolate will compare to 18 months of mycophenolate plus pirfenidone, in the treatment of Systemic Sclerosis related Interstitial Lung Disease. Tolerability and toxicity will also be assessed, during this study.
This research is designed to test whether combining pirfenidone and mycophenolate will result in a more rapid and possibly greater improvement in lung function than occurs when mycophenolate is used alone. While both of these drugs have been approved by the U.S. Food and Drug Administration (FDA) to treat other medical conditions, neither drug has been FDA-approved for the treatment of scleroderma related lung disease. This research is being funded by the drug company, Genentech.

Institution
MUSC
Recruitment Contact
Kelley Kajdasz
843-792-5290
gibsonke@musc.edu

A Phase III Randomized, Double-Blind Clinical Study of Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo as a Treatment for Recurrent or Progressive Metastatic Urothelial Carcinoma in Patients who have Failed a First-Line Platinum-Containing Chemotherapy Regimen for Advanced/Metastatic Disease (KEYNOTE-698/ECHO-303) Save

Date Added
May 7th, 2018
PRO Number
Pro00077046
Researcher
Theodore Gourdin

Silhouette
Keywords
Cancer/Genitourinary, Drug Studies, Men's Health, Urinary, Women's Health
Summary

This study evaluates the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease.

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

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