Cystic Fibrosis Patient Registry

Date Added
December 9th, 2002
PRO Number
Pro00120872
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis
Summary

The CF Patient Registry is an observational study. It does not involve medical treatments and serves only as an epidemiologic record of demographics, characteristics of disease and treatment, utilization patterns, and clinical outcomes.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry (IPF-PRO)

Date Added
May 13th, 2014
PRO Number
Pro00033910
Researcher
Timothy Whelan

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

The purpose of this research registry is to better understand the natural history of Idiopathic Pulmonary Fibrosis and current practice patterns. The IPF-PRO registry will be used to collect data and biological samples that will support future research studies by identifying disease biomarkers for IPF. Through these studies, researchers hope to find new ways to detect, treat, and maybe prevent or cure health problems. Some of these studies may be about how genes affect health and disease, or how a person's genes affect their response to a treatment. Some of these studies may lead to new products, such as drugs or tests for diseases. We are asking you to let us collect and store some of your blood and health information so they might be used in these kinds of future studies.

If you are newly diagnosed with IPF and are eligible for participation in IPF-PRO, you will be asked to sign a consent form to become enrolled if you agree to be in this registry. At enrollment a member of MUSC research staff will collect information from you and about your medical history and medical care, as well as information about the types of health insurance (public or private) that you have. As part of your participation in this registry, you will be required to sign a medical release form giving permission for your medical records to be reviewed for the purposes of data collection for the registry. This is an observational registry which means you will not receive any investigational treatments or investigational drugs, and only minimally invasive procedures will be performed (blood draws) at scheduled clinic visits. In addition to the face to face visits for self-administered participant reported questionnaires and blood collection, at roughly 6-month intervals, sites will review the participant's medical records. Your disease management and treatment decisions will be determined by you and your health care professional. Subjects will be followed until the last enrolled subject has been followed for 3 years up to a maximum of 5 years.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Multiple Patient Program for Lamprene® (clofazimine) for the treatment of Non-Tuberculous Mycobacterial (NTM) Infections

Date Added
March 21st, 2017
PRO Number
Pro00065207
Researcher
Patrick Flume

List of Studies


Keywords
Nontuberculous mycobacteria (NTM)
Summary

Lamprene®/Clofazimine, is a product of the pharmaceutical company named Novartis Pharmaceuticals Corporation. Lamprene®/Clofazimine is approved by FDA (the U.S Food and Drug Administration) for the treatment of leprosy. It is being tested in non-Novartis clinical studies for drug resistant tuberculosis and non-tuberculous mycobacteria (NTM).

If you have been diagnosed with NTM, then your doctor may decide that this infection can be treated with Lamprene®/Clofazimine. This medicine is provided to you in an expanded access program. This means that this medicine is not registered for the treatment of NTM, but it can be used in special situations where there are no other possible treatments. For example, this may be because you have a type of Mycobacterial infection that is resistant or failed to respond optimally to other drugs, or because you have had side effects that prevent the use of other drugs.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Phase 2, Randomized, Double-Blind,Placebo-Controlled Study To Evaluate The Safety and Efficacy of SPI-1005 Capsules in Cystic Fibrosis Patients with Acute Pulmonary Exacerbation receiving IV Tobramycin at risk for Ototoxicity

Date Added
August 8th, 2017
PRO Number
Pro00067873
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis
Summary

This study has two parts and will assess your hearing and the potential effects of antibiotic-induced ototoxicity. Ototoxicity is a potential effect of drugs used to treat your lung infections, and its effect on your ears (oto=ears), particularly structures in your inner ear that enable hearing and balance. Part One of the study will assess your inner ear function that may be associated with hearing loss and / or loss of balance in cystic fibrosis patients taking tobramycin. Part Two is looking to determine if SPI-1005, an investigational drug, influences hearing loss, due to mediations (tobramycin).

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

The CHEC-SC Cohort Study: CHaractErizing CFTR Modulated Changes in Sweat Chloride and their Association with Clinical Outcomes

Date Added
January 10th, 2018
PRO Number
Pro00073414
Researcher
Sylvia Szentpetery

List of Studies


Keywords
Cystic Fibrosis
Summary

This is an observational study which will collect sweat chloride values from approximately 1000 cystic fibrosis subjects who are currently on cystic fibrosis transmembrane conductance regulator (CFTR) modulators. This study will require one visit to an MUSC clinic which will last approximately 2 hours. Compensation is provided.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Study to Understand Disease Course Inflammation and Endotype of South Carolinians with Nontuberculous Mycobacteria

Date Added
June 18th, 2019
PRO Number
Pro00089284
Researcher
Patrick Flume

List of Studies


Keywords
Non-interventional, Nontuberculous mycobacteria (NTM)
Summary

The goal of this cohort and biorepository is to collect data and blood specimens on individuals with Nontuberculous Mycobacteria (NTM), pulmonary disease, and healthy adults to better understand the illness and ultimately improve the care and survival of those with these conditions.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Multicenter Randomized Pragmatic Clinical Trial Comparing Two-versus-Three Antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease

Date Added
July 16th, 2019
PRO Number
Pro00089685
Researcher
Patrick Flume

List of Studies


Keywords
Nontuberculous mycobacteria (NTM)
Summary

The purpose of this study is to better understand treatment practices for Mycobacterium avium complex (MAC) disease. This study is comparing the effectiveness and tolerability of taking 2 drugs compared to 3 drugs in people with MAC disease.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Routine Cardiac Screening in Sarcoidosis Patients

Date Added
August 20th, 2019
PRO Number
Pro00090373
Researcher
Walter James

List of Studies


Keywords
Sarcoidosis
Summary

This is a trial for cardiac sarcoidosis in patients seen during routine clinical care who have not been clinically suspected to have cardiac sarcoidosis according to conventional criteria. The addition of echocardiogram and ambulatory ECG to usual clinical follow-up will be compared. This is a multicenter study, coordinated by the Foundation for Sarcoidosis Research. Up to 12 sites in the US and Europe will participate. Each site will enroll 50 consecutive consenting individuals to a total of 600 enrolled subjects in a randomized trial of additional screening versus usual care.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Pulmonary Hypertension Association Registry (PHAR)

Date Added
March 18th, 2020
PRO Number
Pro00097483
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

The PHAR is a multicenter, prospective registry of newly evaluated patients at PHCCs in the United States who have either PAH or CTEPH. Baseline information will be collected at the time of initial evaluation at the PHCC (within six months of the initial outpatient PHCC visit) with follow-up data collected at approximately 6-month intervals. This study will determine how patients with PH are evaluated, tested, and treated, and will observe how well patients do. The goal of the project is to see if patients with PH are treated according to recommended guidelines and to see if there are certain factors which lead to better or worse outcomes in patients with PH. There is no intervention or study medication used and there is no limitation to how a patient is treated in this study.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Prospective tReatment EffiCacy in IPF uSIng genOtype for Nac Selection (PRECISIONS) trial

Date Added
June 17th, 2020
PRO Number
Pro00097636
Researcher
Timothy Whelan

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

This is a multi-center, randomized, double-blind, placebo-controlled trial of 200 participants to receive N-acetyl cysteine (NAC) or placebo for a 24 month duration. The purpose of this study is to see if n-acetylcysteine (NAC) can help people with idiopathic pulmonary fibrosis (IPF) who have a specific gene type and to see if NAC is safe to take without causing too many side effects.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu



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