Mount Edgecombe

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

Researchers are evaluating the safety and effectiveness of pramipexole extended release (ER) compared to escitalopram for treating major depressive disorder (MDD) and MDD with mild neurocognitive disorder (MND) in people living with HIV. This phase II, randomized, open-label trial includes an optional sub-study with 36 participants to assess treatment effects on cerebrospinal fluid (CSF) profiles. Participants will be carefully monitored to track treatment response and any side effects. Participants will take either pramipexole ER tablets or escitalopram tablets, both taken orally. The study includes scheduled visits for detailed and brief assessments throughout treatment to check for toxicity, response, and dose adjustments as needed. The sub-study for CSF evaluation is optional and involves a smaller group of participants. During the study, participants will undergo evaluations including the Beck Depression Inventory-II to measure changes in depression symptoms from the start to week 24. Researchers will also monitor for any severe or neuropsychiatric adverse events related to the study drugs throughout the 24 weeks. Participants will be assessed regularly to ensure safety and to observe treatment effects over the study period.

This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months. Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.