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
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

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

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

Impact of progesterone on stress reactivity and cannabis use Save

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

Silhouette
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 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

Silhouette
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 Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients with Prostate Cancer and Cardiovascular Disease Receiving Degarelix (GnRH Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist) Save

Date Added
August 21st, 2018
PRO Number
Pro00075705
Researcher
Thomas Keane

Silhouette
Keywords
Cancer, Cancer/Genitourinary, Cardiovascular, Drug Studies, Prostate
Summary

The purpose of this trial is to test if a marketed drug for advanced prostate cancer (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another marketed drug for advanced prostate cancer (LUPRON DEPOT) in patients with prostate cancer and cardiovascular disease.

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

A Phase 1b Study of SAR650984 (isatuximab) in Combination with Pomalidomide and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma Save

Date Added
August 14th, 2018
PRO Number
Pro00078384
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 Relapsed/Refractory
Multiple Myeloma. The investigational drug in this study is SAR650984 (isatuximab), administered via infusion.The main purpose of of this study is to evaluate the possible risks and the effectiveness of SAR650984 when given together with pomalidomide and dexamethasone (the combination being called the study treatment) in patients with multiple myeloma. Your participation in this study may last up to 8 weeks, or possibly longer if you are responding well to treatment.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-9321
hcc-clinical-trials@musc.edu

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis Save

Date Added
July 10th, 2018
PRO Number
Pro00079009
Researcher
Edwin Smith

Silhouette
Keywords
Autoimmune disease, Drug Studies, Inflammation, Scleroderma, Skin, Stage III
Summary

SSc, which also can be called scleroderma, is a rare autoimmune disease. Autoimmune diseases such as SSc make your immune system over-active which causes chronic inflammation. This chronic inflammation leads to scar tissue, or fibrosis, of the skin and some internal organs.

The skin and involved internal organs with chronic inflammation from SSc become scarred over time, which makes them not work as well as they should. Lenabasum may help stop chronic inflammation, and stop scarring from getting worse without lowering the immune system.

This study is currently enrolling subjects who have scleroderma and are 18 years or older. Participation in the study will require you to complete 13 scheduled visits over the course of one year. After the completion of each visit, subjects will be compensated.

Institution
MUSC
Recruitment Contact
Trevor Faith
843-792-4844
faitht@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

Silhouette
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

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

Silhouette
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

Effect and safety of semaglutide 2.4 mg once-weekly as adjunct to intensive behavioural therapy in subjects with overweight or obesity Save

Date Added
June 26th, 2018
PRO Number
Pro00078980
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 intensive lifestyle change counseling including a low-calorie diet. 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

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