This is a prospective, multicenter, observational study in an international setting (North America, Europe, and Israel) to follow clinical outcomes for patients with complex fistulizing conditions for 24 months after undergoing surgical intervention to treat the index fistula. During participation, standardized data on exposure and outcomes (clinical, patient reported outcomes (PROs), and Healthcare Resource Utilization (HCRU)) will be collected from electronic data capture forms (EDCs). Following the surgical intervention for the fistulizing condition (index date), outcomes will be assessed at 3 months, 6 months, 12 months, and 24 months post-surgery (post-index).

This is a phase 4, prospective, multicenter, single-arm, open-label study designed
to evaluate the effect of early and rapid treprostinil therapy on mean pulmonary artery pressure (mPAP) reduction to improve Right ventricular (RV) function and reverse RV remodeling in patients with PAH. This study will use the CardioMEMS™ HF System (CardioMEMS) to measure and monitor mPAP, but may allow mPAP monitoring via RHC (right heart catheterization), if CardioMEMS is NOT available at a subject's Baseline Visit (Day 1) or if the CardioMEMS™ PA Sensor implantation is unsuccessful.

Participation is expected to be up to 37 months and will include about 10 office visits to the study doctor. This will be divided up into a 30-day Screening Period, a 12-month Treatment Period, and a 24-month Extended Treatment Period.

This study is a multicenter, randomized, double-blinded, placebo-controlled trial to evaluate the safety and efficacy of ExoFlo for the treatment of moderate-to-severe ARDS (Acute Respiratory Distress Syndrome). The purpose of this study is to research and evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles, ExoFlo, as treatment for Moderate-to-Severe ARDS. Bone Marrow Mesenchymal Stem Cell (bmMSC)-Derived Extracellular Vesicles is an investigational drug created from human bone marrow being studied for the treatment of moderate-to-severe ARDS. This is a research study that will involve monitoring oxygen and inflammation levels after taking the investigational product and assessing the safety of the investigational product. The experimental treatment is a biologic product called Bone Marrow Mesenchymal Stem Cell (bmMSC)-Derived Extracellular Vesicles Allograft Product ExoFlo, which is purified from the bone marrow of a healthy well-screened individual. Participants will receive either 15mL of the investigational product with 85 mL of normal saline or 100 mL of normal saline only (placebo). The expected duration of participation in the study is a maximum of 61 days, which includes 1-day screening prior to treatment and 60 days following the first treatment.

This multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical
study is designed to evaluate the safety and tolerability of 3 dose levels of TTI-101 vs placebo in participants with idiopathic pulmonary fibrosis (IPF). a screening period of up to 28 days, 100 participants will be randomly assigned to receive 1 of 3 dose levels of TTI-101 (25 participants per dose level) or matching placebo (25 participants). Enrollment will be stratified by current use of nintedanib. The assigned study drug will be self-administered orally in tablet form twice daily (BID) with a glass of water after a meal. Once randomized, each participant will maintain their current standard of care supportive medications, including cough treatment, medications for symptom relief or quality of life improvements, oxygen therapy where indicated, respiratory physiotherapy, and treatment of comorbidities. Following randomization, all participants will enter the 12-week, double-blind treatment period.

This Phase 3 study, comprising a double-blind, placebo-controlled treatment period of up to 48 weeks, will assess the efficacy and safety of seralutinib versus placebo when added to background PAH disease-specific medication in adult PAH subjects who are WHO FC II or III. The primary objective of the study is to assess the efficacy of seralutinib relative to placebo with a primary endpoint of change from baseline to Week 24 in 6MWD.

The study will test OATD-01, an experimental medicine, for the first time in patients with pulmonary sarcoidosis (swollen tissue in the lungs). The study goal is to evaluate OATD-01 in the reduction of inflammation and assessing OATD-01 safety.

Everyone who participates in this study will receive OATD-01 or matching placebo (inactive mock tablet). Subjects will be randomly assigned to receive either OATD-01 or placebo for 12 weeks.

The study will run in several hospitals or outpatient clinics, in different countries in Europe and in the USA. In this study, there will be about 98 study subjects in total.

For all patients whether taking OATD-01 or matching placebo, there will be a screening period, a treatment period which will commence after randomization has taken place and will last for 12 weeks and then a follow up visit approximately 4 weeks post last dose of OATD-01.

The total duration of the study is 18 weeks.

This is a double-blind, randomized, placebo-controlled study of CMTX-101 in pwCF who are 18 years of age or older and chronically infected with P. aeruginosa. This study will evaluate the safety and tolerability, PK, immunogenicity, reduction of pulmonary P. aeruginosa burden, and exploratory endpoints of CMTX-101 in up to 41 participants. This study has 2 parts.

Study LTI-401 is an open-label, multicenter study which will evaluate the safety and tolerability of LIQ861, the study drug, in subjects who have World Health Organization (WHO) Group 1 & 3 Pulmonary Hypertension. The purpose of this research study is to evaluate the long-term safety and tolerability of LIQ861 in patients with WHO Group 3 Pulmonary Hypertension associated with interstitial lung disease (PH-ILD). The investigational form of Treprostinil in this study is called LIQ861, it is delivered to your lungs using a hand-held device called a dry powder inhaler (DPI). Dose levels may be adjusted by the Study Doctor between 26.5 micrograms to 318 micrograms based on your PH-ILD symptoms. The study will include approximately 60 subjects and participation will last 52 weeks.

This is a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study. This study will be conducted in approximately 20 centers globally, in subjects with IPF. Participation will last for about 18 weeks and include about 12 study clinic visits with the Study Doctor and/or study staff. This study will take place over approximately a year. The study will investigate a single dose level of GRI-0621 of 4.5mg compared with placebo, following once daily oral administration for 12 weeks. Approximately 36 subjects with IPF will be randomized in a 2:1 ratio for GRI-0621 4.5mg or Placebo. The study consists of a Screening Period, a Treatment Period and a Safety Follow-Up Period. The Screening Period will be conducted within 4 weeks prior to randomization, and is comprised of at least two separate in-clinic visits to assess eligibility.
Concurrently, a BAL Sub-Study will be conducted, for up to 12 eligible subjects (across various centers). The objective of the Sub-Study is to examine the role of NKT cells in fibrotic lung disease.

Nontuberculous mycobacteria (NTM) cause a chronic pulmonary infection associated with cough, fatigue, and shortness of breath. Our primary objectives are to better understand the trajectory of patient-reported outcomes (PROs), e.g.
respiratory symptoms and health-related quality of life (HRQoL), across the entire disease course and measure toxicity and tolerability using patient-reported symptomatic adverse events in treated patients with nontuberculous mycobacterial pulmonary disease (NTM-PD).