A PHASE 2, OPEN-LABEL, RANDOMIZED STUDY OF N-803, A FUSION PROTEIN ACTIVATOR OF NATURAL KILLER AND T CELLS, IN COMBINATION WITH PEMBROLIZUMAB VS PEMBROLIZUMAB ALONE AS FIRST-LINE TREATMENT FOR PATIENTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) Save

Date Added
September 25th, 2018
PRO Number
Pro00080330
Researcher
John Wrangle

List of Studies

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

This study is for patients who have been diagnosed with metastatic, non-small cell lung cancer (NSCLC), have not received any prior chemotherapy for metastatic disease, and are eligible to receive pembrolizumab, a FDA approved standard therapy for NSCLC. The investigational drug in this study is ALT-803. In this research study, participants will be selected by chance to receive either the study drug ALT-803 in combination with pembrolizumab or will receive pembrolizumab alone. The purpose of this research study is to test the effectiveness of the study drug, ALT-803, in combination with pembrolizumab compared to pembrolizumab alone. Participants can expect to be in this study for 24 months.

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

A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer Save

Date Added
September 25th, 2018
PRO Number
Pro00080886
Researcher
Michael Lilly

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Prostate
Summary

The purpose of this research study is to determine the effectiveness and safety of niraparib used in combination with JNJ-63723283 in the treatment of subjects with advanced prostate cancer. The study medication, niraparib and JNJ-63723283 are given in cycles, with each cycle lasting 28 days. You will continue study medication for as long as your disease does not appear to be getting worse based on assessments by your doctor.

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

A Phase I/II Study of Pomalidomide, Dexamethasone and Ixazomib VS. Pomalidomide and Dexamethasone for Patients with Multiple Myeloma Relapsing on Lenalidomide as Part of First Line Therapy Save

Date Added
September 20th, 2018
PRO Number
Pro00082054
Researcher
Tondre Buck

List of Studies

Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to compare the effects, good and/or bad, of the study drugs pomalidomide, ixazomib and dexamethasone, or the study drugs pomalidomide and dexamethasone, on participants and their multiple myeloma to find out which is better. In this study, participants will get either the study drugs pomalidomide, ixazomib and dexamethasone or the study drugs pomalidomide and dexamethasone. If participants are assigned to the study drugs pomalidomide and dexamethasone and experience progression of their multiple myeloma, they will have the option to receive the study drug ixazomib in combination with the study drugs pomalidomide and dexamethasone.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

Impact of lofexidine on stress, craving and opioid use Save

Date Added
September 4th, 2018
PRO Number
Pro00081381
Researcher
Kathleen Brady

List of Studies


Profiles_link
Keywords
Drug Studies, Psychiatry
Summary

The purpose of this study is to determine if the medication lofexidine, taken together with buprenorphine or methadone, is more effective at reducing opioid craving, use and stress response than buprenorphine or methadone alone, and to see if this effect is different for men and women. Participants are randomly assigned to add either lofexidine or placebo to their buprenorphine or methadone treatment for five weeks. They return at the end of five weeks to participate in an opioid imagery task and stress task. Throughout the study, participants complete "CREMA" sessions (Cue Reactivity Ecologic Momentary Assessment) using an iPhone app three times a day. These sessions include looking at stressful and neutral pictures and rating stress and craving.

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

Impact of progesterone on stress reactivity and cannabis use Save

Date Added
September 4th, 2018
PRO Number
Pro00081360
Researcher
Aimee Mc Rae

List of Studies


Profiles_link
Keywords
Drug Studies, Psychiatry
Summary

The purpose of the study is to determine if the hormone progesterone affects marijuana users' stress response and marijuana use. Participation lasts approximately three weeks. During the first week, participants are randomly assigned to take either progesterone or placebo and remain abstinent from marijuana. They return at the end of the week to participate in a stress task. Throughout the three weeks, participants complete "CREMA" sessions (Cue Reactivity Ecologic Momentary Assessment) three times a day. These sessions include looking at stressful and neutral pictures and rating stress and craving.

Institution
MUSC
Recruitment Contact
Lisa Nunn
843-792-0476
jenkinli@musc.edu

A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF QPI-1002 FOR THE PREVENTION OF MAJOR ADVERSE KIDNEY EVENTS (MAKE) IN SUBJECTS AT HIGH RISK FOR ACUTE KIDNEY INJURY (AKI) FOLLOWING CARDIAC SURGERY Save

Date Added
September 4th, 2018
PRO Number
Pro00080148
Researcher
Marc Katz

List of Studies

Silhouette
Keywords
Drug Studies, Heart, Kidney, Surgery
Summary

The purpose of this study is to test whether the study drug (QPI-1002) prevents Major Adverse Kidney Events (MAKE) after heart surgery in adult patients who are at high risk of developing Acute Kidney Injuries (AKI). This study is a one-time infusion of the study drug (QPI-1002) with follow-up visits lasting for one year.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis Save

Date Added
August 28th, 2018
PRO Number
Pro00076525
Researcher
John Huggins

List of Studies


Profiles_link
Keywords
Drug Studies, Lung, Pulmonary
Summary

This is a research study to find out the safety and efficacy of a drug called BG00011 and to find the best dosage. The study drug will be given by an injection under the skin, also called subcutaneously (SC), once a week during the treatment period. Study treatment will be given to you and you will be trained on how to inject yourself with the study drug/placebo in a prefilled syringe. You can ask for re-training at any time during the study. You will be in the study for up to 65 weeks (including a Screening visit, a Study Treatment Period of 52 weeks, and a Safety Follow-Up visit). This study is a randomized, double blind, placebo controlled study.

Institution
MUSC
Recruitment Contact
Allison Patterson
(843) 792-5168
patteallmusc.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

List of Studies


Profiles_link
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 14-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

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

List of Studies


Profiles_link
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 may have used chronic opiates.

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

List of Studies


Profiles_link
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
Brittany Frasier
843-792-6984
frasibri@musc.edu

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