A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants Save

Date Added
September 26th, 2017
PRO Number
Pro00066901
Researcher
Andrew Atz

Silhouette
Keywords
Children's Health, Drug Studies, Infant, Infectious Diseases, Lung, Pediatrics
Summary

This is a Randomized , Double blinded study to evaluate how effective a single dose of experimental drug called MEDI8897 is at preventing lung disease caused by RSV disease in healthy preterm infants born between 29 weeks 0 days and 34 weeks 6 days.This study also evaluate safety, tolerability and pharmacokinetics (PK) of MEDI8897 in healthy preterm infants compared with placebo.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
834-792-1213
choudhar@musc.edu

Communicating & disseminating research findings to study participants Save

Date Added
June 16th, 2017
PRO Number
Pro00067659
Researcher
Teresa Kelechi

Silhouette
Keywords
Adolescents, Cancer, Diabetes, Healthy Volunteer Studies, Infectious Diseases, Lung, Men's Health, Mental Health, Obesity, Rehabilitation Studies, Stroke, Women's Health
Summary

Many individuals who volunteer to participate in research studies are never informed about the results of those studies, and what the researchers learned from having conducted them. We believe that if researchers share results of studies with those who participated in them as volunteers, these past participants may be more likely to feel positively that they have contributed to improving the health in their communities, be more likely to enroll in other studies in the future, share their experience with others, encourage others to participate in research, and experience other positive outcomes. We want to know people's feelings about the importance of receiving study findings and how they would prefer to receive such information (what channels/formats, what kinds of messages, etc). In this study, we are looking to get the feedback of adolescents (ages 15 through 24) and older adults (50 and over) who completed their participated in an MUSC study between January 1, 2010 and present. We are also looking for MUSC researchers whose research studies have included adolescents and older adults between January 1, 2010 and the present, to get their feedback on their current strategies of sharing findings and what they believe might be best practices for doing so. Participation in our study will involve surveys and focus groups interviews.

Institution
MUSC
Recruitment Contact
Dana Burshell
843-792-1497
burshell@musc.edu

Early Intrapleural TPA Instillation Versus Late (ELEVATE) Save

Date Added
February 17th, 2017
PRO Number
Pro00058518
Researcher
Rohan Arya
Keywords
Cancer/Lung, Drug Studies, Infectious Diseases, Lung, Pulmonary, Shortness of Breath
Summary

When a chest tube is placed, it can be hard for the fluid to drain. Tissue plasminogen activator and DNase are given through the chest tube to help with draining the fluid. We are doing this research to see if early addition of tPA-DNase will help with better fluid draining.

Institution
Palmetto
Recruitment Contact
Rohan Mankikar
803-352-1237
rohan.mankikar@palmettohealth.org

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients with Cytomegalovirus (CMV) Infections that are Refractory or Resistant to Treatment with Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir. Save

Date Added
November 8th, 2016
PRO Number
Pro00058351
Researcher
Vinayak Rohan

Silhouette
Keywords
Drug Studies, Infectious Diseases, Transplant
Summary

This study is for patients who have received a kidney, liver, or pancreas transplant and who have developed resistant Cytomegalovirus infection. There will be two treatment groups to compare the improvement or resolution of Cytomegalovirus infection. Subjects will be randomized to receive 8 weeks of either the investigational drug, Maribavir, or physician assigned standard of care treatment.

Institution
MUSC
Recruitment Contact
Caitlin Schaffner
843-792-7558
schaffne@musc.edu

Bronchiectasis and Nontuberculous Mycobacterium Patient Registry Save

Date Added
November 19th, 2015
PRO Number
Pro00045254
Researcher
Patrick Flume

Silhouette
Keywords
Infectious Diseases, Lung, Pulmonary
Summary

Non-cystic fibrosis (CF) bronchiectasis is a lung disease characterized by dilation of the airways. Patients often suffer from chronic airways infection. One such associated infection is non-tuberculosis mycobacterium (NTM) lung disease, which is 50 to 75 times more common in patients with bronchiectasis than those without it. The decision to initiate treatment (for NTM pulmonary disease) is not straightforward, hinging on how the patient feels and excluding other causes for their symptoms. Symptoms patients frequently report are pulmonary related (e.g. cough, sputum production, and coughing up blood) and constitutional symptoms (e.g. fevers, weight loss and body aches). When treatment is started for NTM lung disease, it can be for many months to years and has many potential side effects. The scientific literature rarely reports outcomes of treatment from a patient's perspective, which could aid a physician's decision to initiate treatment and/or response to treatment of the patient's NTM disease. This study will 1) create a Patient Registry for patients with bronchiectasis and/or NTM disease with an emphasis on patient reported outcomes (PRO) using questionnaires and 2) prospectively collect and analyze the clinical data for patients seen in the MUSC Bronchiectasis and/or NTM clinic

Institution
MUSC
Recruitment Contact
Amy Chamberlain
843-792-3162
chambeam@musc.edu

Immune response to pneumococcal vaccination in aging HIV positive adults Save

Date Added
November 17th, 2015
PRO Number
Pro00046749
Researcher
Maria anna Westerink

Silhouette
Keywords
Aging, Blood Disorders, Healthy Volunteer Studies, HIV / AIDS, Infectious Diseases, Vaccine
Summary

We are doing this study to find out what practice, one dose PPV23 or one dose PCV13 followed by one dose PPV23, protects better against pneumonia in older HIV-positive.

Institution
MUSC
Recruitment Contact
Myroslawa Soloshchenko
8437922218
soloshch@musc.edu

Incisional negative pressure wound therapy for preoperatively irradiated lower extremity soft tissue sarcoma wounds. A prospective randomized clinical trial. Save

Date Added
August 18th, 2015
PRO Number
Pro00028423
Researcher
Lee Leddy

Silhouette
Keywords
Cancer, Cancer/Sarcoma, Infectious Diseases
Summary

This is a study comparing two methods of dressing a post operative wound that are currently in practice. One method is a traditional dry gauze dressing. The other method is using a negative pressure dressing that provides gentle suction on the wound.

We will attempt to determine how well the use of post-operative negative pressure dressing reduces wound healing problems in patients who have surgery after radiation for a sarcoma in the thigh or leg.

Institution
MUSC
Recruitment Contact
Jennifer Philp
843 8462210
Philp, Jennifer (philpj@musc.edu)

Elucidating Mechanisms of Treatment Relapse for Interferon-Free HCV Therapy Save

Date Added
August 18th, 2015
PRO Number
Pro00046669
Researcher
Eric Meissner

Silhouette
Keywords
Digestive System, HIV / AIDS, Immune System, Infectious Diseases, Liver
Summary

Treatment of chronic hepatitis C virus (HCV) infection is now possible with all oral medications. While most patients achieve a sustained virologic response (SVR) after treatment, synonymous with cure, some patients relapse after treatment for reasons that are unclear. The goal of this research is to understand how a person's immune system changes during treatment of HCV infection with all oral therapy, and how these changes might impact the chances of relapse after treatment. To address these questions, blood and clinical information will be collected from study participants over the course of receiving standard of care treatment for HCV infection. This blood and clinical information will be used to conduct laboratory research focused on the immune system.

Institution
MUSC
Recruitment Contact
Stephanie Warth
843-792-5491
warth@musc.edu

Randomized Trial to Prevent Vascular Events in HIV ? REPRIEVE (A5332) Save

Date Added
June 16th, 2015
PRO Number
Pro00042920
Researcher
Allison Eckard

Silhouette
Keywords
Cardiovascular, Cholesterol, Disease Prevention, Drug Studies, Heart, HIV / AIDS, Infectious Diseases
Summary

Pitavastatin lowers high cholesterol and triglyceride levels in the blood. The primary purpose of this study is to determine the effects of pitavastatin on lowering the traditional risk factors for cardiological events in patients who have HIV.

Institution
MUSC
Recruitment Contact
Stephanie Warth
843-792-5491
warth@musc.edu

Physician Order for Scope of Treatment (POST): PILOT STUDY Save

Date Added
August 6th, 2013
PRO Number
Pro00022252
Researcher
Walter Limehouse

Silhouette
Keywords
Aging, Alzheimers, Cancer, Dementia, Ethnicity and Disease, Geriatrics, Heart, HIV / AIDS, Infectious Diseases, Kidney, Liver, Men's Health, Minorities, Nervous System, Pulmonary, Rare Diseases, Women's Health
Summary

South Carolina Coalition for Care of Serious Illness (SCC CSI) sponsors development of Physician Orders for Scope of Treatment (POST) in South Carolina. The SC POST follows the national POLST (www. polst.org) paradigm creating an advance treatment planning physician order that migrates as valid across institutional boundaries: from physician office, to home/nursing home/hospice to EMS to hospital emergency/inpatient services. The POST form encourages a conversation between a physician and the patient regarding treatment options available to seriously ill patients for whom death within a year would not be a surprise. These choices primarily include whether to attempt cardiopulmonary resuscitation in the event of cardiac or pulmonary arrest or not (a "DNR" or "Allow Natural Death" order) and whether during acute illness to provide full treatment including endotracheal intubation and intensive care, supportive treatment such as noninvasive ventilation and no intensive care, or comfort care only. The Charleston and Greenville areas will pilot POST. Investigators by area will survey providers completing POST documents for patients or treating patients with POST about the utility of this form and how use of the form affected their patient's treatment. A chart reviews of patients presenting with a POST form to a hospital emergency or inpatient unit will address whether providers respected patient treatment choices. SCC CSI plans to publish the results of the pilot in appropriate journals and present the results at medical meetings and to interested persons. The results of the study may provide the supporting documentation for subsequent legislation supporting POST. POST represents a coordinated statement of a seriously ill patient's treatment choices to be honored across multiple treatment settings.

Institution
MUSC
Recruitment Contact
Walter Limehouse
792-9705
limehouw@musc.edu

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