A Multicenter, Randomized Trial of Photodynamic Therapy versus Argon Plasma Coagulation for Lung Cancer with Endobronchial Obstruction Save

Date Added
April 29th, 2019
PRO Number
Pro00081628
Researcher
Nicholas Pastis

List of Studies


Profiles_link
Keywords
Cancer, Lung, Pulmonary
Summary

Other than Nd:YAG laser, no other comparative studies of thermal ablative therapies with PDT for malignant airway obstruction have been performed. Little has been published about need for additional therapies and changes in quality of life following airway de-obstruction procedures in a randomized fashion comparing different modalities. The aim of this multicenter, prospective, randomized clinical study is to evaluate the efficacy of PDT vs APC.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis Save

Date Added
April 23rd, 2019
PRO Number
Pro00087417
Researcher
Bryan Garcia

List of Studies

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Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

The purpose of this study is to learn more about the effectiveness and safety of VX-561 used in patients with cystic fibrosis. Patients who have cystic fibrosis and are currently taking a stable dose of ivacaftor (IVA) are invited to take part in this research study. VX-561 is a form of IVA, an approved medication for some types of CF, that lasts longer in the body, allowing the medicine to be taken once a day instead of twice a day. Participation could last for approximately 20 weeks. There will be approximately 88 people participating in this study.

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

A Phase 3, randomized, double-blind, parallel-group, placebo-controlled multicenter study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Save

Date Added
April 9th, 2019
PRO Number
Pro00075953
Researcher
Timothy Whelan

List of Studies


Profiles_link
Keywords
Lung, Pulmonary
Summary

The main purpose of this study is to investigate how well GLPG1690, an experimental drug being investigated for the treatment of Idiopathic Pulmonary Fibrosis (IPF), is tolerated and to see how well GLPG1690 works together with your current treatment of pirfenidone or nintedanib. Approximately 750 participants will take part in the study. It has been described that patients with IPF have increased levels of autotaxin which leads to inflammation of the lungs. It is being investigated whether GLPG1690 can, by decreasing the activity of autotaxin, reduce safely the inflammation in the lungs that occurs in people with IPF, and therefore affect the progression of the disease.

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

A Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study of Intravenous ATYR1923 in Patients with Pulmonary Sarcoidosis Save

Date Added
January 22nd, 2019
PRO Number
Pro00084946
Researcher
Walter James

List of Studies

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Keywords
Lung, Pulmonary, Sarcoidosis
Summary

This study is being done to learn more about the safety of the drug ATYR1923, to see if taking this drug ATYR1923 will allow you to reduce your steroid dose, and to find out more about the effects of different doses of this drug on the lungs of people who have pulmonary sarcoidosis. This study will also look at how the body responds to the drug. These things will be measured by taking samples of your blood, through medical examinations performed by your study doctor, by lung function tests and by reviewing images of your lungs. This study also includes taking blood samples for biomarkers, antibodies, and tryptase and complement levels. A skin lesion biopsy portion of the study is optional. Participation will last up to 28 weeks. You will have a total of 7 study site clinic visits and 8 telephone contacts during the treatment period.

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) Save

Date Added
January 8th, 2019
PRO Number
Pro00083949
Researcher
Rahul Argula

List of Studies


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

This is a Phase 2 study to determine the efficacy and safety of an experimental study drug called sotatercept. Enrolled patients will receive either sotatercept or placebo (substance that is made to resemble drugs but does not contain an active drug) in combination with your current Pulmonary arterial hypertension (PAH) medication(s), which falls within currently accepted standard of care (SOC) for PAH. There are 4 parts to this research study, a screening period (28 days), a 6-month double-blind treatment period, an 18-month extension period, and an 8-week follow up period. If qualified to continue with treatment, the subject will receive subcutaneous (under the skin) injection(s) of the study treatment through a needle at each dosing visit (multiple injections may be required).

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

Post-treatment Long-term Follow-up Study of ADVM-043 Gene Therapy in Alpha-1 Antitrypsin Deficiency Save

Date Added
December 11th, 2018
PRO Number
Pro00083818
Researcher
Charlie Strange

List of Studies


Profiles_link
Keywords
Genetics, Lung, Pulmonary, Rare Diseases
Summary

This study is designed to follow individuals who participated in "Phase 1/2 Study of Intravenous or Intrapleural Administration of a Serotype rh.10 Replication Deficient Adeno-associated Virus Gene Transfer Vector Expressing the Human Alpha-1 Antitrypsin cDNA to Individuals with Alpha-1 Antitrypsin Deficiency" for 5 years after receiving treatment.

Institution
MUSC
Recruitment Contact
Danielle Woodford
843-792-6280
woodfordd@musc.edu

Prospective study of peripherally inserted venous catheters in CF patients Save

Date Added
November 20th, 2018
PRO Number
Pro00083486
Researcher
Patrick Flume

List of Studies


Profiles_link
Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

The main purpose of this study is to see if important factors can be identified in each of the three categories (patient, catheter, and catheter management) that are linked to blood clotting complications. This is a multicenter, prospective observational study to evaluate risk factors associated with complications of peripherally inserted central catheter (PICCs) and midline catheters. Both adult and pediatric patients with CF who receive care at participating centers will be eligible for participation. This study can last for 2 weeks.

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

Vitamin C, Thiamine and Steroids in Sepsis A multi-center, randomized, placebo-controlled, double-blind, adaptive clinical trial of vitamin C, thiamine and steroids as combination therapy in patients with sepsis. Save

Date Added
October 18th, 2018
PRO Number
Pro00078768
Researcher
Andrew Goodwin

List of Studies


Profiles_link
Keywords
Lung, Pulmonary
Summary

Sepsis is an acute life-threatening illness. Specific aims of this study are to demonstrate the efficacy of combination therapy using vitamin C, thiamine and corticosteroids to reduce the duration of cardiovascular and respiratory organ dysfunction in critically ill patients with sepsis. Additionally, this research study aims to demonstrate the efficacy of combination therapy using vitamin C, thiamine and corticosteroids to reduce 30-day mortality in critically ill patients with sepsis.

Institution
MUSC
Recruitment Contact
Abbi Reed
843-792-1820
reedab@musc.edu

A Multicenter, Open-Label Study To Estimate The Effect Sizes Of HRCT Endpoints In Response To Glucocorticoid Induction Therapy In Subjects With Pulmonary Sarcoidosis Save

Date Added
September 25th, 2018
PRO Number
Pro00081796
Researcher
Walter James

List of Studies

Silhouette
Keywords
Lung, Pulmonary, Sarcoidosis
Summary

The purpose of this study is to compare an imaging procedure called high-resolution computed tomography (HRCT) against the standard pulmonary function tests (PFTs) to see if HRCT is better at showing if the standard glucocorticoid treatment is working. This study also includes testing of blood samples for biomarkers which are measurable indicators of the severity or presence of some disease state. The maximum time you will be in the study is 3 months. During this time, you will need to visit the study site 6 times for 6 site study visits. This study will enroll subjects with a diagnosis of pulmonary sarcoidosis at stage II or III who have shortness of breath (dyspnea) and have not received prednisone or prednisolone (glucocorticoids) treatment or other sarcoidosis therapy within the last three months.

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

A trial to evaluate the safety of long term treatment with nintedanib in patients with scleroderma related lung fibrosis. Save

Date Added
September 25th, 2018
PRO Number
Pro00081735
Researcher
John Huggins

List of Studies


Profiles_link
Keywords
Lung, Pulmonary
Summary

The purpose of this research study is to evaluate the long-term safety and tolerability of the study drug called nintedanib in subjects with Systemic Sclerosis and associated Interstitial Lung Disease. Patients who have completed (did not prematurely discontinue trial medication) SENSCISTM (1199.214) can participate in this study. Unlike 1199.214, patients will will know the dose of the study drug. Treatment duration for each patient will be variable. Treatment will be stopped if a reason for withdrawal is met The patient will be in this study about 3 years and have about 26 visits to the study center. These visits include physical exams, blood and urine samples, urine pregnancy testing, collection of unused study drug, and receiving the study drug supply at the reduced dose.

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

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