Phase II Trial of Response-Adapted Therapy Based on Positron Emission Tomography (PET) for Bulky Stage I and Stage II Classical Hodgkin Lymphoma (HL) Save

Date Added
May 21st, 2015
PRO Number
Pro00044587
Researcher
Robert Siegel
Keywords
Cancer, Cancer/Lymphoma, Drug Studies
Summary

This phase II clinical trial is studying how well response-based therapy assessed by PET scan works in treating patients with bulky stage I and stage II Hodgkin lymphoma. PET scans will be obtained during the course of therapy. Researchers will evaluate the usefulness of this PET scan to determine whether radiation may be left out in the treatment of disease if the PET scan shows a response to chemotherapy alone. In addition, a small percentage of patients may have disease that is not adequately treated with ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) and radiotherapy. Researchers hope to identify this group of patients using early PET scans and will change to a chemotherapy treatment called BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone).

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-864-603-6201
kristina_stoeppler-biege@bshsi.org

Theta Burst TMS as a Tool to Change Smoking Behavior Save

Date Added
May 5th, 2015
PRO Number
Pro00042165
Researcher
Colleen Hanlon
Keywords
Brain, Drug Studies, Psychiatry, Smoking
Summary

The goal of this study is to determine whether transcranial magnetic stimulation (TMS) is an effective treatment in decreasing craving in individuals who habitually smoke cigarettes. The study consists of six total visits to MUSC; one for the consent process, two that will include MRI scans, and five that will include TMS administration. Compensation will be provided for each visit.

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

A Phase 3, Randomized, Double-Blind,Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive Save

Date Added
April 14th, 2015
PRO Number
Pro00043283
Researcher
Patrick Flume
Keywords
Adolescents, Cystic Fibrosis, Drug Studies, Lung, Pulmonary
Summary

This study will evaluate the safety of VX-661 in combination with ivacaftor over 3 months in subjects with Cystic Fibroisis 12-years-old and older who are heterozygous for the F508del mutation and a second CFTR Allele.This study has 2 treatment periods: an Ivacaftor Run-in Period for 4 weeks, followed by a treatment period for 8 weeks.

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

rTMS as a Tool to Decrease Pain and Opiate Craving Save

Date Added
April 7th, 2015
PRO Number
Pro00042186
Researcher
Colleen Hanlon
Keywords
Brain, Drug Studies, Psychiatry, Substance Use
Summary

The purpose of this study is to develop repetitive transcranial magnetic stimulation (rTMS) as a potential treatment for opiate dependence addiction. Repetitive TMS is a non-invasive technique that uses magnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). 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. TMS has been approved by the FDA as an investigational tool as well a therapy for depression.

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

A Randomized, Double-Blind, Placebo-Controlled, Phase 4, Relapse Prevention Study Evaluating the Efficacy and Safety of Vortioxetine (5, 10 and 20 mg) in Adults With Major Depressive Disorder Save

Date Added
March 24th, 2015
PRO Number
Pro00042473
Researcher
Olga Brawman-mintzer
Keywords
Depression, Drug Studies, Mental Health
Summary

Major depressive disorder (MDD) is a mental illness in which affected individuals have low mood with low self-esteem, and loss of interest or pleasure in normally enjoyable activities. It is a long-term illness for many subjects and maintenance therapy is recommended to prevent relapse in subjects with recurrent depression.
The purpose of this study is to test the efficacy and safety of doses of vortioxetine capsules (5, 10 or 20 mg/day) compared with placebo (a non-active capsule/ ?dummy drug?) in preventing relapse in people with acute recurrent MDD.

Institution
MUSC
Recruitment Contact
Olga Brawman-Mintzer
843-724-2945
mintzero@musc.edu

A Phase 2, Multi-Center, Randomized, Placebo-Controlled Study of IV Gallium Nitrate in Patients with Cystic Fibrosis ?The IGNITE Study? Save

Date Added
February 17th, 2015
PRO Number
Pro00039080
Researcher
Patrick Flume
Keywords
Cystic Fibrosis, Drug Studies, Pulmonary
Summary

People with Cystic Fibrosis (CF) often have thick mucus in the airways of the lungs that is hard to cough up. The mucus can build up and eventually lead to a chronic cough. The mucus is also a good environment for bacteria (germs) to live and grow, rapidly leading to infections. One bacteria, Pseudomonas aeruginosa (Pa) is particularly good at living in the CF lung. People with CF who agree to take part in this study would be those who have had Pa in their lungs for at least 1 year.

The purpose of this research study is to test the effect of an infusion (through a vein) of a drug called gallium nitrate in patients with CF. Laboratory tests suggest that this drug may be able to fight Pa infections. Gallium nitrate is an FDA approved drug that is used to treat high calcium in the blood caused by cancer. The drug also works in other bone diseases and has been used to treat certain cancers.

If the study shows that the drug is safe and may be helpful in treating CF, additional studies with gallium nitrate may be done in patients with CF in the future.

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

Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis Save

Date Added
February 17th, 2015
PRO Number
Pro00040298
Researcher
Diane Kamen
Keywords
Autoimmune disease, Drug Studies, Lupus
Summary

The primary objective of the study is to assess the safety of Belimumab following treatment with Rituximab and Cyclophosphamide in patients with Lupus Nephritis. The study will last for about 2 years and will involve 20 study visits. Patients who meet criteria will be assigned to one of two groups: Group 1 will have Rituximab plus Cyclophosphamide followed by Belimumab infusions, and Group 2 will have Rituximab plus Cyclophosphamide, but will not have the Belimumab infusions. This study is not blinded, so patients will know what group they are assigned to. Patients will be followed closely by the study doctors to determine their lupus activity levels over the course of 2 years.

Institution
MUSC
Recruitment Contact
Margaret Lindemuth
843-792-8613
hardinm@musc.edu

A Randomized, Double-blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) Save

Date Added
February 17th, 2015
PRO Number
Pro00038310
Researcher
Rahul Argula
Keywords
Autoimmune disease, Drug Studies, Immune System, Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH), Sarcoidosis, Scleroderma
Summary

Systemic sclerosis (SSc) or scleroderma is an autoimmune disease in which a person?s own immune cells attack his/her skin and internal organs, including the joints, lungs, heart, intestinal tract, and kidneys. The effects on the lungs, including pulmonary arterial hypertension (PAH), are among the most serious complications of SSc. In general, PAH is defined as an increase in pressure in the pulmonary arteries (the main blood vessels that lead from the heart to the lungs). Treatments for PAH have focused on symptom management rather than curing the disease.

This study has been designed to look at a new approach to treating the cause of the disease, rather than the symptoms of the disease. Recent research suggests that SSc-PAH may be the result of an ?attack? by immune cells. This study will look at the effect of the drug rituximab on the immune system and the immune ?attack? on the lungs. Rituximab is an immunosuppressive drug that eliminates the B cells for a few months, and therefore may halt the B cell attack on the lungs thought to be associated with this disease.The recovery of your B cells will be closely monitored throughout the study by blood testing.

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

Neural substrates of emotion: Impact of cocaine dependence Save

Date Added
December 2nd, 2014
PRO Number
Pro00039699
Researcher
Aimee Mc Rae
Keywords
Drug Studies, Psychiatry, Stress Disorders, Substance Use
Summary

Social stress often leads to drug craving and relapse in cocaine-dependent populations. Currently there are no FDA approved medications for the treatment of cocaine dependence. Therefore, biomedical research studies aimed at investigating the brain mechanisms responsible for controlling emotional responses to social stress could have a significant impact on the development of effective therapeutic treatment strategies for cocaine-dependent individuals.

Institution
MUSC
Recruitment Contact
Lisa Nunn
792-0476
jenkinli@musc.edu

A Phase II Randomized, Double-Blind Study of Dalantercept plus Axitinib Compared to Placebo plus Axitinib in Patients with Advanced Renal Cell Carcinoma Save

Date Added
May 13th, 2014
PRO Number
Pro00033034
Researcher
Theodore Gourdin
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Kidney, Men's Health, Women's Health
Summary

This study is for individuals with renal cell carcinoma (RCC). The purpose of this study is:

?To find out whether the study treatment can stop your RCC from growing, or prevent it from growing as fast as it would without dalantercept.
?To evaluate the safety of the study treatment in subjects with RCC.
?To find out if the study treatment has an effect on biomarkers (molecules that indicate how well you respond to study treatment) in your blood and/or tissue.

Participants will receive a dose of dalantercept or placebo (a substance with inactive drug that looks the same as dalantercept) plus axitinib. It is expected that a participant will be on this study for a variation of time (total duration will vary per subject).

Institution
MUSC
Recruitment Contact
Seth Price
843-792-1918
pricesr@musc.edu

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