This study will recruit 2,634 participants,50 years of age or older, who have sustained a primary fragility fracture of the hip, femur, pelvis, clinical spine, humerus, or wrist in the last 12 months. Participants will be recruited from approximately 20 sites around the United States. Patients will be randomized to either continue treatment with "Augmented Fracture Liaison Service" or to continue with "Enhanced Usual Care." Both pathways incorporate patient education about the high risk of future fractures and available treatment approaches for fracture risk reduction. Patient education materials, in English or Spanish, will include information about fractures, bone health and osteoporosis, and will refer participants to resources to provide additional education on ways to reduce the risk of another fracture. Both arms of the study will be mailed education materials after enrollment. Study participation will consist of surveys over the course of 2 years, and a visit to a bone health specialist.
This is a Phase 3, open-label, follow-up study to evaluate the long-term safety,
tolerability, and efficacy of sotatercept when added to background PAH therapy for the treatment of PAH. Participants enrolled in this study are from the following parent studies: PULSAR, SPECTRA, STELLAR, HYPERION, and ZENITH. Participants eligible to enroll in this study will have participated in and completed the requirements of the MK-7962-004 study (Amendment 07 or later). In this study, participants will receive open-label sotatercept . The duration of participation for each participant will vary based on their enrollment date, but it is anticipated to be up to 3 years.
The purpose of the study is to find out if mosliciguat, the investigational drug that is being studied, with treprostinil, is safe and effective in treating adults who live with PH-ILD. Approximately 20 participants diagnosed with PH-ILD who are currently on a stable dose of inhaled treprostinil who meet all inclusion and no exclusion criteria will be enrolled. Part 1 of the study will take about 5 ½ months. Part 2 of the study is optional if you choose to participate in the extension period. Part 2 does not have a set end date and your participation in Part 2 will end if you or your study doctor decide to stop your participation or the Sponsor ends the study.
The overall objective of this proposal is to identify patients with Rheumatoid Arthritis-Interstitial Lung Disease (RA-ILD) that are at the highest risk for progressive disease at the time of diagnosis. Our central hypothesis is that novel quantitative imaging and specific blood markers will be associated with progressive RA-ILD. Approximately 80 subjects will be enrolled from MUSC and participation with last up to 2 years.
This observational study will systematically pursue ADA (American Diabetes Association)
recommended screening for diabetic microvascular complications and macrovascular surrogates in patients with CFRD (Cystic Fibrosis Related Diabetes). The study will enroll approximately 200 subjects, each of which will participate for 4 weeks. Each subject will be asked to fill in questionnaires related to their complications.
The purpose of the Re-Spire Study is to help researchers learn more about the efficacy and long-term safety and tolerability of the research drug L606 in participants with PH-ILD.
There are two phases of the Re-Spire Study participants can potentially join with the second phase starting directly after the first phase ends. The first phase is called the "Blinded Treatment Phase" (BTP). This is the "double-blind," assigned by chance portion of the study and will last approximately 28 weeks (a 30-day Screening period followed by a 24-week study period). The second phase of the Re-Spire Study is called the "Open Label Extension Phase" (OLEP). This phase is optional. It is called "open-label" because there is no placebo and everyone who joins will take the active study drug, L606.
About 350 participants will take part in this research study from around 120 study centers or research sites in various countries or regions.
DROP-FPF is a clinical study that will assess whether an investigational medication called nerandomilast can reduce the risk of interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) getting worse over time. By learning more about people with early lung abnormalities, it may inform researchers how to reduce the risk of developing progressive pulmonary fibrosis.
OBSERVE-ARDS is a prospective, multi-center, observational human subjects research study designed to collect longitudinal clinical data and remnant biological specimens from adults with clinically defined ARDS. The study is non-interventional and does not introduce, modify, or recommend any diagnostic, therapeutic, or management decisions. All participant care is determined solely by the treating clinical teams in accordance with routine clinical practice and dictated by any other clinical studies in which they are enrolled. The study is conducted to support efforts to improve understanding of biological heterogeneity in ARDS and to enable the development and evaluation of biomarker-driven endotyping and treatment-prediction algorithms.