Part A of this study will compare the effects of Clofazimine Inhalation Suspension to placebo. The purpose of this study is to find out if Clofazimine Inhalation Suspension can treat NTM lung disease by getting rid of the bacteria from the lungs and to make sure that Clofazimine Inhalation Suspension is safe for use. The participant will continue with current treatment for NTM lung disease in this study. To test if the bacteria are gone from the lungs, sputum will be tested on a regular basis (every month) to see if the culture changes from positive to negative. Participants will be randomly assigned by chance (like drawing numbers from a hat) to either Clofazimine Inhalation Suspension or placebo.
After the participant completes the study treatment in Part A, they will be eligible to receive Clofazimine Inhalation Suspension in Part B.
Approximately 234 participants will take part in the study at approximately 120 sites globally.
This is a randomized, double-blind, multicenter, parallel-group Phase IIIb study with a fixed treatment period of 52 weeks. The purpose of this study is to compare BDA MDI with AS MDI on severe asthma exacerbations in adolescent participants aged 12 to < 18 years with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year. Participants will administer randomized IMP as needed as they normally would with their own prescribed rescue inhaler.
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.
This study is for subjects that have been diagnosed with cancer in their
arm, leg, or trunk (the part of the body that involves the chest, abdomen,
and pelvis). The purpose of this research study is to preserve healthy
tissue around the cancer on the arm(s) and/or leg(s) using
hypofractionated radiotherapy, while treating the cancer and preventing
it from spreading to other areas of the body. This study will look at early side effects and effectiveness of preoperative 5-day hypofractionated radiotherapy. Active participation in the study will take about 12 visits and are completed once the participant has a 6-month post-operation visit.
The purpose of this study is to better understand how practicing a new skill builds a stable memory and how this memory is maintained over time as one gets older. A better understanding how memories are controlled in healthy aging may help to develop better treatments for memory problems.
The study's main question is how the different brain regions communicate with each other when one is retrieving memories of a well-practiced skill. Specifically, when and where the brain waves that are related to skill memory are produced. The brief changes in the brain will be recorded with functional magnetic resonance imaging (fMRI), a medical technology that looks at blood flow in the brain. To assess electrical changes in the brain, the brain waves, electroencephalography (EEG) will be used. Combining EEG and fMRI will allow the precise detection of the exact location where the brain is active at any moment in time.
This study is conducted at the Medical University of South Carolina (MUSC). The study will take about one to two weeks and involves two visits to MUSC including an interview and combined brain recording and brain scan during task practice (EEG-fMRI) and up to 7 days of online skill practice at home. Volunteers in this research study must be free of any brain disease or brain injuries and have to be in good health status. Approximately 40 volunteers will take part in this study.
This is a retrospective chart review study looking at the assessment of the clinical performance of single gene non-invasive prenatal screening and comparison to standard of care.
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.
The research study determines if remibrutinib (study treatment) with two doses, dose A (10 mg b.i.d.) and dose B (25 mg b.i.d)., is safe and effective and can help adult patients with moderate to severe hidradenitis suppurativa (HS).
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.
Stroke survivors routinely report disabling emotional health challenges and inability to find emotional wellness support. This project will increase emotional support within a stroke rehabilitation occupational therapy (OT) and/or speech therapy (ST) rehabilitation program. OT and/or ST provided via telerehabilitation will be enhanced with a type of emotional wellness therapy that teaches stroke survivors various strategies to better address anxiety, worry and dread.