Actelion Protocol AC-055-205: A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Macitentan in Patients with Pulmonary Hypertension After Left Ventricular Assist Device Implantation Save

Date Added
August 5th, 2016
PRO Number
Pro00053983
Researcher
Patrick Mccann

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart, Pulmonary Arterial Hypertension (PAH), Vascular
Summary

The Actelion SOPRANO study is a prospective, multicenter, double-blind, randomized, placebo-controlled, parallel-group Phase II study to evaluate the safety and effect of macitentan on pulmonary vascular resistance in subjects with pulmonary hypertension after left ventricular assist device (LVAD) implantation. Male and female patients 18 years of age or older who have had surgical implantation of LVAD may be eligible to participate in this study.

Study Site:
Palmetto Heart
8 Richland Medical Park
Columbia, SC 29203

Study Site Principal Investigator Contact Information:
Patrick McCann, MD at 803-434-3800

Institution
Palmetto
Recruitment Contact
Patrick McCann
803-434-3800
ClinicalTrialSurvey@PalmettoHealth.org

A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease Save

Date Added
July 26th, 2016
PRO Number
Pro00057087
Researcher
Rahul Argula

List of Studies


Profiles_link
Keywords
Drug Studies, Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

The purpose of this study is to investigate the safety and how well inhaled treprostinil works in subjects with pulmonary hypertension associated with interstitial lung disease or combined pulmonary fibrosis and emphysema. Adults over the age of 18 are eligible. Study requires at least 6 separate clinic visits over approximately a 20 week period.

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

A Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy STELLAR Study Save

Date Added
July 12th, 2016
PRO Number
Pro00056376
Researcher
Scott Lindhorst

List of Studies


Profiles_link
Keywords
Brain, Brain Tumor, Cancer, Cancer/Brain, Drug Studies
Summary

Subjects are being asked to volunteer for a research study because they have their first anaplastic astrocytoma (AA) tumor progression (worsening) or recurrence.

The purpose of this study is to measure how well and how safe eflornithine is in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has come back after radiation and chemotherapy. Eflornithine is an experimental drug that the United States Food and Drug Administration (FDA) has not approved it for use by the general public. Lomustine has been approved by the FDA in the United States for this patient population.

Institution
MUSC
Recruitment Contact
Michele DeCandio
843-792-9016
decandio@musc.edu

Regression of fibrosis and reversal of diastolic dysfunction in HFpEF patients treated with allogenic CDCs Save

Date Added
June 21st, 2016
PRO Number
Pro00054823
Researcher
Michael Zile

List of Studies


Profiles_link
Keywords
Drug Studies, Heart
Summary

This study is evaluating an investigational product called CAP-1002 Allogenic Cardiosphere ?Derived Cells. Allogenic means tissue or cells that come from another person. CAP-1002 is a product consisting of cells grown from donated heart muscle tissue. The purpose of this study is to look at the safety and feasibility of delivery of allogenic human cardiosphere derived stem cells (CDC's) through the arteries of the heart in participants with heart failure. The study will also determine if CAP-1002 might reduce clinically-meaningful adverse events, meaning some of the symptoms you are experiencing relating to your heart failure may go away and you may feel better. In this study, we will be investigating whether CAP-1002 is safe and begin to look at effectiveness in repairing heart tissue in comparison to placebo (inactive substance) control.

Institution
MUSC
Recruitment Contact
Lindsey Stewart
843-792-1238
stew@musc.edu

Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs. Placebo in Combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma (HER2CLIMB) Save

Date Added
May 24th, 2016
PRO Number
Pro00054909
Researcher
Sara Giordano

List of Studies

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

The purpose of this study is to test study treatments that combine an investigational drug (ONT-380) with two approved drugs (capecitabine and trastuzumab) in subjects with advanced breast cancer to find out what effects, good or bad, it may have on you and your disease.

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

A Randomized, Phase 2, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) Save

Date Added
May 10th, 2016
PRO Number
Pro00054206
Researcher
Timothy Whelan

List of Studies


Profiles_link
Keywords
Drug Studies, Lung, Pulmonary
Summary

This research study includes adults (18 years of age or older) with Idiopathic Pulmonary Fibrosis (IPF). The study is being conducted to find out if KD025 is a safe and effective treatment. Participants will be put on the study drug, KD025, for about 24 weeks (followed by another 24 weeks on KD025 if tolerated well). They will be on a daily dose of 400mg (by mouth) and in previous tests have shown to reduce IPF and inflammation.

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

Effects of Oxytocin on Alcohol Craving and Intimate Partner Aggression Save

Date Added
May 3rd, 2016
PRO Number
Pro00054689
Researcher
Julianne Hellmuth

List of Studies


Profiles_link
Keywords
Alcohol, Drug Studies, Healthy Volunteer Studies, Mental Health, Psychiatry
Summary

Alcohol use disorders (AUD) and intimate partner aggression (IPA) frequently co-occur. There are significant health and economic burdens associated with AUD and co-occurring IPA, and little empirical data to guide treatment efforts. The neuropeptide oxytocin may help mitigate both AUD and IPA. However, clinical data examining oxytocin's effects on human aggression is scant. The proposed study is designed to address these gaps in the literature by utilizing a human laboratory paradigm to test the effects of oxytocin on craving and aggression among couples with AUD and co-occurring IPA.

Institution
MUSC
Recruitment Contact
Charli Kirby
843-300-9577
Kirbych@musc.edu

Comparative Effectiveness of Pulmonary Embolism Prevention after Hip and Knee Replacement: Balancing Safety and Effectiveness Save

Date Added
April 19th, 2016
PRO Number
Pro00053742
Researcher
Vincent Pellegrini

List of Studies


Profiles_link
Keywords
Drug Studies, Joint
Summary

PEPPER is a randomized study comparing the three most commonly used blood thinners in North America in patients who have elected to undergo primary or revision hip or knee joint replacement surgery. The blood thinners being compared are enteric coated aspirin plus air pump compression, low intensity warfarin, and rivaroxaban.

Institution
MUSC
Recruitment Contact
Monica Baczko
843-792-8169
baczko@gmail.com

Alcohol Research Center. Shared clinical assessment core for the Alcohol Research Center clinical projects. Save

Date Added
December 1st, 2015
PRO Number
Pro00050179
Researcher
Konstantin Voronin

List of Studies


Profiles_link
Keywords
Alcohol, Drug Studies, Genetics
Summary

This research protocol will be using for initial screening and assessment potential study subjects for their farther participation in the other specific research protocols/components. These research components are part of larger research protocol - Alcohol Center Grant.

Institution
MUSC
Recruitment Contact
Mark Ghent
843-792-1222
ghent@musc.edu

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
Brian Hess

List of Studies

Silhouette
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

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