A phase 1/2 study of ALT-803 in patients with relapse/refractory indolent B cell non-Hodgkin lymphoma in conjunction with rituximab Save

Date Added
October 13th, 2015
PRO Number
Pro00047808
Researcher
Saurabh Chhabra
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with indolent B cell non-Hodgkin lymphoma and your disease returned or did not improve at all after receiving one or more treatments containing rituximab.The investigational drug in this study is ALT-803. The purpose of this research study is to test standard rituximab with different doses of the study drug, ALT-803, to see which dose is safer in people. Participants can expect to be in this study for 36 weeks and have evaluations of your disease for up to 5 years.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects with Advanced Hematologic Malignancies with an IDH1 Mutation Save

Date Added
October 13th, 2015
PRO Number
Pro00048303
Researcher
Robert Stuart
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with acute myelogenous leukemia (AML) . The investigational drug in this study is AG-120. The purpose of this study is to identify and test the highest dose of AG-120 that can be given safely. Participants can expect to be in the study for as long as the study doctor feels it is in the participants best interest.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

10 days of medial prefrontal cortex theta burst stimulation (MPFC cTBS) as a tool to improve clinical outcomes and decrease frontal-striatal reactivity to cues among treatment-engaged cocaine users Save

Date Added
October 6th, 2015
PRO Number
Pro00046438
Researcher
Colleen Hanlon
Keywords
Brain, Drug Studies, Psychiatry, Substance Use
Summary

The goal of this pilot study is to determine if, in treatment-seeking substance dependent individuals, ten sessions of continuous theta burst transcranial magnetic brain stimulation (cTBS) over a brain region involved in craving (medial prefrontal cortex) can lower an individual's craving and brain response to drug-related cues. This study involves a screening visit, followed by one MRI visit, followed by ten cTBS treatment visits on consecutive days. There will be three follow-up MRI visits: the first will immediately follow completion of a 28-day outpatient treatment program, while the second and third will be one month and two months post-treatment.

Institution
MUSC
Recruitment Contact
Oliver Mithoefer
843-792-6402
mithoefe@musc.edu

Effect of approach bias modification on cue-reactivity in individuals with cannabis use disorder. Save

Date Added
October 6th, 2015
PRO Number
Pro00048215
Researcher
Brian Sherman
Keywords
Drug Studies, Psychiatry, Substance Use
Summary

Biases in cognitive processing of drug-related stimuli are central to the maintenance of addiction and contribute to poor treatment outcome. This study will evaluate how people who frequently use marijuana respond to marijuana cues, and if a computerized task affects this response. During the two week study period participants will engage in four computer task sessions, and response to marijuana cues will be assessed directly before and after the two-week study period. Two weeks after the last study visit, marijuana cue response and computer task performance will again be assessed. Marijuana use will be tracked throughout the study and follow-up periods.

You may be eligible if you:
Are between the ages of 18 and 65.
Smoke marijuana.
Are willing to provide informed consent.

Eligible participants may receive compensation.

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

Enhancing disrupted reconsolidation: Impact on cocaine craving, reactivity & use Save

Date Added
October 6th, 2015
PRO Number
Pro00021392
Researcher
Michael Saladin
Keywords
Drug Studies, Mental Health, Psychiatry, Substance Use
Summary

Our recently completed study has provided the first evidence that administration of the medication propranolol, following exposure to cocaine cues, can alter drug-associated memories and reduce craving and other drug cue-elicited responses in cocaine addicted persons. The proposed research will use two methods to increase the memory altering effects of propranolol observed in our recently completed study, and document lasting effects not only on craving and cue-elicited reactions, but also on cocaine use. Positive findings will set the stage for a formal clinical trial that could lead to significantly improved treatment outcomes for this treatment-resistant addiction.

Institution
MUSC
Recruitment Contact
Amanda Smith
843-792-6984
smitham@musc.edu

A CLINICAL AND MOLECULAR RISK-DIRECTED THERAPY FOR NEWLY DIAGNOSED MEDULLOBLASTOMA (SJMB12) Save

Date Added
October 6th, 2015
PRO Number
Pro00025554
Researcher
Amy-lee Bredlau
Keywords
Brain Tumor, Cancer/Brain, Drug Studies, Pediatrics
Summary

Treatment of children ? 3 and < 22 years for newly diagnosed medulloblastoma with clinical and molecular risk directed therapy. Innovations to contemporary medulloblastoma therapy include reduced dose cyclophosphamide, reduced dose radiation therapy for low risk medulloblastoma, and use of novel therapies targeted toward the specific molecular subgroups of the disease.

Institution
MUSC
Recruitment Contact
Kate McCormack
843-876-8481
mccormk@musc.edu

An Open Label study to examine the effects of DAS181 administered by Nebulized formulation in Immunocompromised subjects with Parainfluenza (PIV) Infection post study participation in PIV protocol DAS181-2-05 Save

Date Added
October 5th, 2015
PRO Number
Pro00029144
Researcher
Michelle Hudspeth
Keywords
Drug Studies, Immune System, Pediatrics, Pulmonary
Summary

The purpose of this research study is to test the safety, effectiveness and tolerability of an investigational drug called DAS181 on subjects with a very weak immune system who are diagnosed with PIV. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA). DAS181 can be administered as a reconstituted dry powder that is breathed into the respiratory tract (nose, throat and lungs) using a liquid aerosol spray administered using a nebulizer. A nebulizer is an electrically powered machine that turns liquid medication into a mist so that it can be breathed directly into the lungs through a face mask or mouthpiece.

Institution
MUSC
Recruitment Contact
Mohammed Al Gadban
843-792-4837
algadban@musc.edu

Phase 2, Multi-center, Randomized, Double-blind, Placebocontrolled Study to Evaluate the Efficacy and Safety of Brilacidin Oral Rinse Administered Daily for 7 Weeks in Attenuating Oral Mucositis in Patients with Head and Neck Cancer Receiving Concurrent Chemotherapy and Radiotherapy Save

Date Added
September 22nd, 2015
PRO Number
Pro00046620
Researcher
Anand Sharma
Keywords
Cancer, Cancer/Head & Neck, Drug Studies
Summary

This study is for subjects who have been diagnosed with head and neck cancer and are being treated with radiation therapy and chemotherapy. This treatment is expected to irritate the mouth and throat and cause a condition called oral mucositis, which may cause pain and difficulty swallowing. The investigational drug in this study is an oral rinse called BRILACIDIN. It is being studied to see if it can prevent or decrease the occurrence of oral mucositis. The purpose of this study is to see if BRILACIDIN can prevent or decrease the occurrence of oral mucositis. Participants can expect to be in this study for 14-15 weeks.

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

A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis and Resultant Portal Hypertension in Patients with NASH Cirrhosis. Save

Date Added
September 22nd, 2015
PRO Number
Pro00045478
Researcher
Don Rockey
Keywords
Drug Studies, Liver
Summary

Non-alcoholic steatohepatitis (NASH) is a chronic inflammatory disease that progressively leads to fibrosis and eventually cirrhosis (scarring of the liver). Currently, there are no medical therapies for NASH or liver fibrosis. The purpose of this study is to determine if an investigational drug, GR-MD-02, can reverse the scarring in the liver and heal cirrhosis.

Institution
MUSC
Recruitment Contact
Mary Hart
843-876-8439
hartmm@musc.edu

A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Save

Date Added
September 9th, 2015
PRO Number
Pro00046751
Researcher
Patrick Flume
Keywords
Cystic Fibrosis, Drug Studies, Lung, Pulmonary
Summary

This is an open-label rollover study for subjects who have participated in 661-103, 661-106 or 661-109

This study will evaluate the long term safety and effects of treatment with VX-661 in combination with ivacaftor over 100 weeks in subjects with Cystic Fibroisis 12-years-old and older who are heterozygous or homeozygous for the F508del-CFTR mutation.

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

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