This study gives people who were part of an earlier Avalyn research protocol with inhaled pirfenidone versus placebo an opportunity to convert to open label or active investigational drug treatment. The goal is to continue learning additional safety and efficacy information in patients over a longer period of treatment time. Pulmonary fibrosis is a disorder with a poor prognosis that is often far worse than many cancers with limited treatment options. While this medication has yet to be proven effective, the safety profile currently is acceptable and the risks versus benefits favor offering this opportunity to patients with informed consent.
This will be a study in the home care setting to further validate the concept of Simeox 200 in a cohort of patients with bronchiectasis and overproduction of mucous as an alternative to other methods of ACT(airway clearance techniques). Bronchiectasis is a chronic lung disease where airways become permanently damaged, widened, and lose their ability to clear mucus, leading to a buildup of bacteria, recurrent infections, and symptoms like a daily cough, thick, discolored phlegm, shortness of breath, and fatigue. The device is a 510(k) FDA cleared device that works using by air and vibration to help clear mucous from the lungs. There are 4 visits and an at home usage period. The study will be running approximately a year or until the cohort is filled. The data from this study will be used to power a future randomized controlled pivotal clinical study comparing Simeox 200 against other ACTs such as High Frequency Chest Wall Oscillation (HFCWO).
BTX-302-001 is a research study investigating the safety (how many side effects participants may have) and tolerability (how tolerable the side effects are) of BEAM-302 for individuals with Alpha-1 Antitrypsin Deficiency (AATD)-associated lung and/or liver disease. This study also aims to gather additional information regarding how BEAM-302 moves through the participant's body, how long it stays, and how long it takes to eliminate it - which is defined as the study drug's pharmacokinetics or "PK". Researchers would like to determine through this research study how BEAM-302 impacts the disease course (progression) of AATD in terms of AATD blood biomarkers, which are substances in blood that the body normally makes and will help show if an individual's AATD is improving, staying the same, or getting worse, along with lung and liver function testing results and the quality of life of participants.
This research study will be split into two main parts, Part A (which is for individuals with AATD-associated lung disease with no clear evidence of AATD-associated liver disease) and Part B (which is for individuals with AATD-associated liver disease). Additionally, each Part will be split into two separate cohorts, where one cohort will receive a single intravenous (IV) infusion of BEAM-302 (single-dose cohort) and the other will receive two IV infusions of BEAM-302 approximately 8 weeks apart (multi-dose cohort). Within these cohorts (single-dose and multi-dose), there are also separate smaller cohorts that will vary by the dose of BEAM-302 administered to participants, so a participant in this study could receive any of the following dosages - 15mg, 30mg, 60mg, 75mg, or 90mg. Overall, the research study will last up to around 29 months for each participant, depending on which cohort they are in, and their participation will be split into three main study periods - Screening, Dose and Dose-limiting toxicity (DLT), and Follow-up. It is also important to note that when a participant is receives their infusion(s) of BEAM-302 during the Dose and DLT period, the administration of the study drug will be done as a part of an in-patient hospital stay that will last up to 48 hours so that they can be closely monitored by the study team.
The key eligibility criteria for this study are that individuals (male or female) must be 18 to 70 years old, possess the PiZZ type of AATD, and have either AATD-associated lung disease with no clear evidence of AATD-associated liver disease or AATD-associated liver disease. There are additional eligibility criteria that must be met in order to be able to participate in the study, which will be assessed across up to 2 study visits that will occur during the Screening period.
This study will enroll patients and collect blood samples from those who are either in lung cancer screening, have a lung nodule that is suspicious for malignancy, a newly diagnosed cancer, or healthy control subjects. These samples that are being collected and banked will be used for future development of blood tests to detect lung cancer in future patients at the earliest stages.
This study will enroll patients and collect blood samples from those who are either in lung cancer screening, have a lung nodule that is suspicious for malignancy, a newly diagnosed cancer, or healthy control subjects. These samples that are being collected and banked will be used for future development of blood tests to detect lung cancer in future patients at the earliest stages.
This study will enroll patients and collect blood samples from those who are either in lung cancer screening, have a lung nodule that is suspicious for malignancy, a newly diagnosed cancer, or healthy control subjects. These samples that are being collected and banked will be used for future development of blood tests to detect lung cancer in future patients at the earliest stages.
This study will enroll patients and collect blood samples from those who are either in lung cancer screening, have a lung nodule that is suspicious for malignancy, a newly diagnosed cancer, or healthy control subjects. These samples that are being collected and banked will be used for future development of blood tests to detect lung cancer in future patients at the earliest stages.
This is a non-invasive, observational study aiming to collect data on the impact chest tubes have on inpatients during their hospitalizations. Sleep and activity patterns, as well as select vital signs will be tracked using an MUSC-owned Apple Watch, which subjects will wear, and an MUSC-owned iPhone, for up to seven days during admission to the hospital. Each day, a study coordinator will visit subjects to collect a brief sleep survey. Participation may last up to 7 days while subjects are admitted and have a chest tube in place. Upon completion of the study, a study coordinator will collect the Apple Watch and iPhone for data analysis.
This pilot data will provide initial information on the feasibility of collecting and performing a larger study on the inpatient mobility, activity, and sleep.
This study is for patients scheduled for a bronchoscopy, a procedure that allows doctors to examine lungs and airways for evaluation of suspicious lung nodules. Those who give consent to participate in this study will be randomized into one of two lung biopsy sampling method groups based on the Rapid On Site Evaluation of the initial sample obtained by the doctor performing the bronchoscopy as part of the standard of care procedure for the patient. the potential groups the subject will be randomized into are: Cryoprobe or transbronchial biopsy needle. 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. 7 days following the procedure, a member of the study team will check the subjects medical chart to assess whether any adverse events have occurred.
The study includes both a retrospective cross-sectional and prospective longitudinal cohort study design. Demographic and clinical data will be obtained through medical record review. 3-4 blood draws will be collected over the course of the study. If participants were also in the MAC2v3 or NTM PRO Cohort study, data collected for that study will be used in this study. About 450 subjects are expected to participate in this study at 7 research sites in the United States. Participation in this study is expected to last up to 12 months. During that time, participants will have about 3-4 study visits.