PULMONARY EMBOLISM – THROMBUS REMOVAL WITH CATHETER-DIRECTED THERAPY: THE PE-TRACT TRIAL

Date Added
May 10th, 2023
PRO Number
Pro00127854
Researcher
Kevin Dickey

List of Studies

Keywords
Lung, Pulmonary
Summary

This is a study to determine effectiveness of using catheter directed therapy along with medical directed therapy when treating pulmonary embolism versus using medical directed therapy alone.

Institution
MUSC
Recruitment Contact
Samuel Bidwell
843-792-2305
bidwells@musc.edu

A Randomized Trial of Cryoprobe Versus Forceps for Transbronchial Biopsy (FROSTBITE-2)

Date Added
May 9th, 2023
PRO Number
Pro00124571
Researcher
Christopher Gilbert

List of Studies

Keywords
Cancer, Lung, Pulmonary
Summary

This study is for patients scheduled for a bronchoscopy procedure for evaluation of lung transplantation, lung disease, and lung nodules. Those who give consent to participate in this study will be randomized into one of two lung biopsy sampling method groups: Group 1) 1.1 mm single-use Cryoprobe or Group 2) conventional 2.0 mm forceps. These devices are used with a bronchoscope to obtain lung tissue biopsy samples and are being evaluated to determine which is better for confirming a diagnosis. All procedures will be done via standard of care and screening will be accomplished via medical chart review. Subjects will have two in-person appointments and one follow-up telephone call. The first of which is their standard of care office visit with the doctor to go over their plan of care. The second visit is for the standard of care bronchoscopy procedure to obtain biopsy samples. Thirty days following the procedure, a member of the study team will call the subject to assess whether any adverse events may have occurred since the procedure.

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

A multicenter randomized controlled trial to establish the impact of MeMed BV® on management of patients with suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("BV: JUPITER" TRIAL)

Date Added
March 29th, 2023
PRO Number
Pro00126966
Researcher
Gary Headden

List of Studies


Keywords
Pulmonary
Summary

1) You will be asked to provide a blood sample; up to two tubes for a total of up to 10mL (less than 2 teaspoons).
2) Samples will be processed and tested on the MeMed BV device.
3) You will be asked about your medical history, medications, and current illness, as well as demographic information (i.e. date of birth) and a contact phone number.
4) If eligible, it will be decided by chance, using a computer, if you will be put into one of two arms: the MeMed BV arm or the control arm. You have an equal chance of being placed in each group. You cannot choose your study group.
a. The MeMed BV arm: your clinician will receive the BV result, this will include a recommendation regarding antibiotic treatment
b. The control arm: your clinician will not receive the MeMed BV results and will treat you according to standard of care.
5) You will be contacted by a member of the study team at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness

Institution
MUSC
Recruitment Contact
Robert Houck
18436931860
houckr@musc.edu

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency–Associated Liver Disease With METAVIR Stage F2 to F4 Fibrosis

Date Added
January 10th, 2023
PRO Number
Pro00125124
Researcher
Charlie Strange

List of Studies


Keywords
Pulmonary
Summary

This study will evaluate the safety and effectiveness of fazirsiran (investigational drug) compared with placebo (an inactive substance) in patients with alpha-1 antitrypsin deficiency associated liver disease (AATD-LD). If eligible, subjects will be randomized (assigned to a group by chance) to receive either fazirsiran or placebo to be administered subcutaneously (an injection under the skin). Subjects will be treated on Day 1, at Week 4, and then every 12 weeks for 196 weeks. Subjects will be followed for 6 months after their last dose of study drug or placebo for a total study duration of approximately 230 weeks (including 10 weeks of the screening period which is the time needed to assess if a subject is eligible for the study).

Institution
MUSC
Recruitment Contact
Mary Hayden
843-792-8438
blantonm@musc.edu