The study is researching an experimental drug called REGN7544. The study is focused on adult patients (18 to 85 years old) hospitalized due to a serious infection (called "sepsis" in this form) and receiving standard-of-care medications for low blood pressure (called "vasopressors" in this form) due to sepsis. The aim of the study is to see if REGN7544 is safe, tolerable and effective when compared to placebo, by observing the effects on blood pressure and the total amount of vasopressor dose received. The general procedures include collection of information from medical records, some additional testing, such as electrocardiogram, collection of blood, and having blood pressure and heart rate measured .There will also be a screening visit, two telephone visits, and one additional in-person visit. It is expected that taking part in this research will last about 13 weeks (3 months).
The purpose of this study is to observe and capture demographic characteristics,
treatment patterns, and clinical outcomes of interest for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) to further clinical understanding of the epidemiological landscape and outcomes of the disease and treatment. This study will follow patients for up to 5 years after enrollment.
Subjects prescribed with the LibAirty system will be instructed to perform daily therapy sessions per standard device use recommendations. During the study period, subjects will be followed according to standard of care procedures and timelines for Bronchiectasis management. Clinical outcomes and healthcare resource utilization during the study period will be collected and compared to the 12-month period prior to study enrollment. Adherence to therapy will be evaluated by device recorded logs. Health related quality of life and subject satisfaction with the system will be evaluated by designated questionnaires, collected during clinic visits. Subjects will be followed for 12 months after starting therapy. Each subject will be required to complete a screening and enrollment visit, and any scheduled follow up visits according to standard of care timelines through 12 months (with data expected to be collected at 6 and 12 (±1m) months at minimum). Up to one hundred (100) subjects older than 21 years of age, with bronchiectasis who meet the entry criteria will be enrolled to the study, in up to ten (10) sites.
This study is the first time the drug PF-07868489 will be tested in humans. The goal is to see if the drug is safe and how the body reacts to it. In the first part, healthy adults will receive a single dose to check for any side effects and how the drug moves through the body. In the second part, patients with a specific lung condition called Pulmonary Arterial Hypertension (PAH) will receive multiple doses to see if the drug helps their condition and to further check its safety and effects.
This is a Phase 2 platform research study that is assessing three different investigational medications (versus placebo) for hospitalized adults who have Acute Respiratory Distress Syndrome (ARDS). As a platform study, each of the three treatment groups will receive a different investigational drug (or placebo) depending on the severity of their ARDS. Participants will also receive standard treatment as determined by the treating physician.
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).
The goal is to evaluate how well etrasimod helps reduce symptoms by week 12 of treatment. This involves determining whether patients experience enough improvement to be considered in remission. The focus is on how the medication performs in everyday, real-world conditions.
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 study will see if the experimental medicine MTX-463 can slow or stop idiopathic pulmonary fibrosis (IPF) from worsening in people at least 40 years of age or older. Participants will receive either MTX-463 or a placebo (which contains no active drug) through an intravenous infusion once every 4 weeks, for a total of 6 infusions. Overall, participants will attend a total of 9 visits over the course of approximately 32 weeks, or roughly 8 months.
The purpose of this research study is to determine the best treatment goals for patients with active CD. Researchers are investigating how treating and monitoring CD to meet specific treatment goals will keep your disease under control (remission) and decrease complications such as hospitalizations and surgeries. Group 1 treatment goals include IUS response (if the drug is improving your CD) and IUS assessed transmural healing (healing of all bowel layers), clinical remission (normalization of CD symptoms), and biomarker remission (improvement in stool and blood tests that show inflammation). Group 2 treatment goals include clinical remission and biomarker remission. Comparing the treatment goals in these groups may inform doctors how best to manage CD in the future. Approximately 304 people will be enrolled in this study. This research study will involve receiving 300 mg of vedolizumab as an intravenous (IV) infusion into your arm at Weeks 0, 2, 6, 10, and 14, then every 4 or 8 weeks thereafter.