A Phase 2, Prospective, Randomized, Open-label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus- Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplant Save

Date Added
February 27th, 2018
PRO Number
Pro00072922
Researcher
Michelle Hudspeth

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Leukemia, Children's Health, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects who have been diagnosed with acute leukemia or myelodysplastic syndrome (MDS) and are a candidate for allogeneic hematopoietic stem cell transplant (HSCT). The study is being done to learn if adding defibrotide to the standard medicines for prevention of acute Graft-versus-Host Disease (aGvHD), which is called immunoprophylaxis, will help to prevent aGvHD better than using the usual immunoprophylaxis medicines alone. The investigational drug in this study is called Defibrotide. The duration of participation for each patient is approximately 6 months.

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

Feasibility of an Electronic Geriatric Assessment (EGA) for Older Adults with Cancer Save

Date Added
February 15th, 2018
PRO Number
Pro00075247
Researcher
Amarinthia Curtis

List of Studies

Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to learn more about older adults (age 65 and older) with cancer and their overall health by completing a survey called a "geriatric assessment" (GA). A GA is designed to gather information about a patient's nutritional status, mental health, spiritual health, social support, and memory. In addition, it informs health care providers about how well you carry out your daily activities and collects information on the other health problems you may have.

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

Altering memories that increase risk of relapse in alcohol use disorders: A translational clinical neuroscience pilot investigation of a novel pharmacological agent. Save

Date Added
February 6th, 2018
PRO Number
Pro00073523
Researcher
Michael Saladin

List of Studies


Profiles_link
Keywords
Alcohol, Drug Studies, Stage II
Summary

The proposed study will employ treatment-seeking AUD individuals who will be randomly assigned to receive either 15 mg of rapamycin (sirolimus) or placebo immediately after the first of two alcohol cue exposure sessions scheduled to occur on consecutive days. Subjective responses (i.e., craving) and physiological (heart rate & skin conductance) reactivity will be obtained before, during and after cue presentations in both sessions. The durability of any observed treatment effects will be assessed in a Follow-up session performed approximately 10 days following completion of the second session. Treatment effects on self-report measures of drinking behavior during the approximately 10 days preceding the Follow-up session will also be assessed.

Institution
MUSC
Recruitment Contact
Brittany Frasier
843-792-6984
frasibri@musc.edu

A Randomized, Double-Blind, Placebo-Controlled, Phase IIa, Parallel Group, Two-Cohort Study to Define the Safety, Tolerability, Clinical and Exploratory Biological Activity of the Chronic Administration of Nilotinib in Participants with Parkinson's Disease (PD) Save

Date Added
December 19th, 2017
PRO Number
Pro00069638
Researcher
Vanessa Hinson

List of Studies


Profiles_link
Keywords
Drug Studies, Movement Disorders, Parkinsons
Summary

The purpose of this study is to determine if a drug called Nilotinib is safe, if it can be tolerated by patients with PD and to learn if Nilotinib has the possibility of effectively treating PD symptoms. Nilotinib has been approved by the Food and Drug Administration (FDA) to treat certain types of cancer (leukemia) but is considered investigational in this study because it has not been approved for treating PD.

In this study, we are comparing two doses (150mg or 300mg) of Nilotinib to placebo (a pill that looks like the study drug but does not have any active medication in it, like a sugar pill). If you are eligible and choose to be in the study you will be randomly assigned to one of three groups, either:

? 150mg Nilotinib
or
? 300mg Nilotinib
or
? Placebo

All three groups will take two pills of the assigned type each day by mouth. ?Randomly' means that the group you are placed in is determined by chance (like tossing a coin). You will have a 2:1 chance of receiving Nilotinib. Neither you nor the researchers will know whether you are taking Nilotinib or placebo.

About 100 individuals will be interviewed and assessed, and 75 people will be asked to participate in this study at 25 clinics across the United States. Approximately 6 participants will be asked to participate in the study at MUSC.

Institution
MUSC
Recruitment Contact
Shonna Fletes
843-792-9115
jenkisho@musc.edu

A Dose-Escalation and Dose-Expansion Study of Enfortumab Vedotin (ASG-22CE) in Combination with pembrolizumab and/or chemotherapy for Treatment of Patients with Locally Advanced or Metastatic Urothelial Cancer Save

Date Added
December 12th, 2017
PRO Number
Pro00072223
Researcher
Theodore Gourdin

List of Studies

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

This is a study that will test how an experimental drug (enfortumab vedotin) combined with a kind of anticancer drug called an immune checkpoint inhibitor (CPI) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body.

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

A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants with Advanced Renal Cell Carcinoma (FRACTION-RCC) Save

Date Added
December 12th, 2017
PRO Number
Pro00070527
Researcher
Theodore Gourdin

List of Studies

Silhouette
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Kidney
Summary

The purpose of this study is to determine whether nivolumab in combination with other therapies is more effective than nivolumab in combination with ipilimumab in treating patients/subjects with advanced renal cell carcinoma.

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

Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis: A Phase 1/2 Multicenter Randomized, Double Blinded, Safety Study Save

Date Added
October 17th, 2017
PRO Number
Pro00070403
Researcher
Richard Silver

List of Studies


Profiles_link
Keywords
Autoimmune disease, Drug Studies, Scleroderma, Skin
Summary

This study is being conducted in order to test the safety of Brentuximab Vedotin in subjects with Diffuse Cutaneous Systemic Sclerosis. The study involves a Screening visit, a Baseline visit and 12 study visits occurring every 3 to 4 weeks, with enrollment lasting approximately 52 weeks, during which enrolled subjects will receive either the study compound or placebo.

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

Aneurysmal Subarachnoid Hemorrhage Trial RandOmizing Heparin Save

Date Added
September 26th, 2017
PRO Number
Pro00051279
Researcher
Alejandro Spiotta

List of Studies


Profiles_link
Keywords
Adolescents, Brain, Drug Studies, Men's Health, Minorities, Obesity, Pain, Stroke, Women's Health
Summary

The purpose of this study is to determine if giving the medicine "heparin" intravenously (through the veins) continuously for up to 14 days to subjects after a brain aneurysm has burst will help improve the chances of subjects having a good recovery after the bleed compared to subjects who get routine brain aneurysm care (standard of care). Patients who get routine care would also get heparin, but they would typically get an overall lower dose and the heparin would be injected under the skin (heparin shot) instead of in the veins.

Institution
MUSC
Recruitment Contact
Amora Mayo-Perez
843-792-1737
mayoaper@musc.edu

An Open-label Phase 1/2A Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of TRC253, an Androgen Receptor Antagonist, in Patients With Metastatic Castration-resistant Prostate Cancer Save

Date Added
September 26th, 2017
PRO Number
Pro00067101
Researcher
Michael Lilly

List of Studies


Profiles_link
Keywords
Cancer/Genitourinary, Drug Studies
Summary

This is a multi-center, first-in-human, open-label, Phase 1/2A dose-escalation study in which eligible patients with metastatic castration-resistant prostate carcinoma (mCRPC) will receive oral doses of TRC253. The estimated completion date is September 2018.

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

Effect of GET73 on magnetic resonance spectroscopy measures of central glutamate and GABA and alcohol cue-elicited brain activation in recently abstinent non-treatment-seeking individuals with Alcohol Use Disorder Save

Date Added
September 26th, 2017
PRO Number
Pro00069862
Researcher
Raymond Anton

List of Studies


Profiles_link
Keywords
Alcohol, Brain, Drug Studies, Substance Use
Summary

The purpose of this study is to evaluate the potential mechanism of action and the safety of GET73, a new drug under development for the reduction of craving and drinking in alcohol dependent individuals. The study involves five to six visits over a three to four week period, including one to two assessment visits and two visits during which participants will be assigned to take, in a double-blinded fashion, both GET73 and a placebo (two visits during each condition). During three of these visits, participants will undergo a one-hour MRI scan. Compensation is available for qualified participants.

Institution
MUSC
Recruitment Contact
Katy Fuqua
(843) 792-1452
fuquama@musc.edu

Change_preferences

-- OR --

Create_login