This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 versus placebo on top of standard of care in subjects with Progressive Pulmonary Fibrosis (PPF) over 52 weeks. Subjects will participate in the study for up to 58 weeks, inclusive of a Screening Period of up to 4 weeks, a 52-week Treatment Period, and a 2-week Follow-up Period that includes a Follow-up telephone call (TC) 2 weeks post final dose. Up to 300 eligible subjects will be randomized in a 2:1:2 ratio to 1 of 3 treatment arms: AP01 100 mg twice daily (BID), AP01 50 mg BID, or placebo BID (8 mL; two 4 mL blow-fill-seal [BFS] ampoules BID).
This is a prospective, longitudinal, multicenter, nonrandomized observational study to obtain research quality data across key outcome measures in people with Cystic Fibrosis who are ineligible and/or not taking a approved CFTR modulator and who are not receiving an investigational therapy.
Participants will be seen at study sites for research visits to include spirometry, patient reported outcomes (PROs), and blood collections on Day 0, Day 90 (3 months), Day 180 (6 months), and Day 360 (12 months). Participants will complete home spirometry as well during this period.
The COVID and Diabetes Assessment (CODA) study is for adults who have been diagnosed with type 1 diabetes or type 2 diabetes within the last 90 days. This study will examine if having a recent COVID-19 infection may impact the course of diabetes. We will gather information about both diabetes and COVID-19 infection. Participants will be followed for 2 years and asked to complete surveys and provide blood samples. No treatment or medications are involved in the study.
This study is investigating the drug, called mosliciguat, for the treatment of PH-ILD. Participation in the study may last for about 4 ½ years, although the actual time of participation may be shorter or longer. Part 1 of the study will take about 6 months. Part 2 of the study could last up to about 4 years. During the study, participants will be required to make clinic visits in person and at times will need to meet with study staff over the phone/video. At some of the clinic visits, participants will have blood drawn and have procedures to test their lungs and heart function. Participants will be randomly assigned to get mosliciguat or placebo in Part 1. In Part 2, all participants will get mosliciguat. Approximately 120 people will participate in this study.
This clinical research study is enrolling adults with diabetes, prediabetes or metabolic syndrome. The purpose of the study is to learn more about preventing cardiovascular disease. A heart CT scan will be done at screening and then 2 years later. Qualified participants will be randomly assigned to one of two groups. Participants in the usual care group, will continue to receive care from usual health care provider. In the personalized care group, participants will receive additional health care from a remote cardiologist led team which will individualize treatment based on Cleerly CAD staging results of the heart CT scan. Study is expected to last 3 1/2 years on average but could be 2 - 5 years. Participation is free.
The EPACRA- AKI study is a multicenter observational, non- interventional study, to determine actionable cut-off(s) for ProNephro AKITM (NGAL) assay to predict patients at risk for AKI in the general adult ICU population and subgroups of particular interest, such as sepsis or cardiac surgery patients.
Subject enrollment duration is anticipated for 12 months but might be extended or shortened depending on enrollment.
This study is to evaluate an investigational study drug, itepekimab, for the treatment of bronchiectasis. The main purpose for this study is to assess the safety, efficacy, and tolerability of itepekimab in bronchiectasis in addition to the current background treatment you are receiving which may include bronchodilators, inhaled corticosteroids, mucolytics, and/or maintenance antibiotics. You will receive either the study drug or a placebo if you participate in this research. This study will include about 300 participants with bronchiectasis across approximately 20 countries worldwide.
IgAN is a progressive condition that causes chronic kidney disease. Over time, some patients develop end-stage kidney disease (ESKD) requiring dialysis or kidney transplant.
The purpose of this study is to see if an investigational medication is safe and effective in the treatment of IgA nephropathy.
If you are eligible for the study and decide to participate, you will come to MUSC for study visits for about 3 years. These visits will involve blood and urine samples, questions about your health, EKGs, and physical exams. Participants will be randomized in a 1:1 ratio to receive either a weight-based IV infusion of ravulizumab or placebo for 106 weeks. Depending on your response to initial treatment, there is a possibility of additional treatment. An exploratory, open-label cohort of approximately 20 participants with eGFR 20-29 mL/min/1.73m2 may also be enrolled to expand the evidence of ravulizumab in participants with advanced kidney impairment at high risk for ESKD progression.
There is no guarantee that being in this study will help you. There is no cost to participate and compensation is available for the study visits.
This study is designed to help doctors understand how to safely - and at what dose – to give the study drug to patients suffering from acute kidney injury with accompanying acute hypoxic respiratory failure (AHRF). The study is testing Auxora (study drug) against placebo (a substance that has no medical effect).
Your chance of receiving a dose is 50% (for every 1 who receives placebo, 1 receives a dose of Auxora). This selection process is called randomization (like a ‘flip of a coin') and neither you nor your study doctor will know to which group you have been assigned. Every patient in the study will receive his/her dose of Auxora or placebo once a day, for 5 days in a row.
The purpose of the study is to evaluate if formoterol fumarate is effective in treating patients with diabetic kidney disease. Study participants will be randomly assigned to either receive formoterol fumarate (in addition to their current standard of care treatment) or standard of care treatment only. Study participants will have a 50% chance of receiving formoterol fumarate and a 50% chance of not receiving formoterol fumarate. Both groups will continue their standard of care treatment during the study.