This is a prospective, observational research study for patients with IBD under the care of a gastroenterologist provider. The objective of the Corrona Inflammatory Bowel Diseases (IBD) Registry is to create a national cohort of patients with IBD.The diseases under study include Crohn's Disease (CD), Ulcerative Colitis (UC) and Indeterminate Colitis (IC). Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of IBD .Approximately 10,000 patients and 150 clinical sites in North America will be recruited to participate with no defined upper limit for either target. The Corrona IBD Registry is a long-term observational study; therefore, the duration of the registry has no pre-determined stop date.

Nontuberculous mycobacteria (NTM) cause a chronic pulmonary infection associated with cough, fatigue, and shortness of breath. We seek to develop and test a disease-specific patient-reported outcome measure (PROM) in well-characterized populations of patients with NTM pulmonary disease. Ultimately, a validated PROM for individuals with NTM pulmonary disease will fill a critical need for effective NTM treatments by improving clinical trial design and identifying a meaningful endpoint that can guide therapeutic development.

The primary objective of this study is to evaluate the efficacy of namilumab in subjects with chronic pulmonary sarcoidosis (CPS). This study will include adult subjects who have been diagnosed with CPS for more than 6 months who are not well controlled by OCS and/or immunosuppressive therapy (IST). 100 total subjects are planned for this study. There will be a Double-blind treatment period of this study lasting approximately 26 weeks as well as an optional Open-Label Extension (OLE) Treatment Period which will extend the length of the study to approximately 64 weeks.

This is a prospective, multicenter open-label study in adults with CF who are colonized with NTM. Subjects will receive two 5-day infusion cycles of IV gallium. The study will evaluate the safety and antimycobacterial effect of two 5-day infusions of IV gallium. Subjects will be on study for up to 148 days, with a screening period of up to 7 days and active study period up to 20 days. About 40 people with CF who are 18 years of age or older will take part in this study at about 10 hospitals and clinics around the country.

This is a multicenter, randomized, double-blind, placebo-controlled, study comparing the efficacy and safety of intravenous (IV) efzofitimod 3 mg/kg and 5 mg/kg versus placebo after 48 weeks of treatment. This study will enroll adults with histologically confirmed pulmonary sarcoidosis receiving stable treatment with oral corticosteroid (OCS), with or without immunosuppressant therapy. The duration of patient participation is up to 56 weeks, including a Screening period (up to 4 weeks), a Treatment period (48 weeks), and a Follow-up period (4 weeks).

The primary objective of this platform trial is to evaluate the efficacy and safety of differing treatments in CF pulmonary exacerbations during a planned 14 day course of IV antimicrobials. Primary efficacy will be evaluated as the difference in mean ppFEV1 (pulmonary function testing) changes from Visit 1 to Visit 2 (Day 28 ± 2 days) between intervention arms. The study will compare treatment of an intravenous aminoglycoside and β-lactams (AG) versus intravenous β-lactams only (non-AG) in people with CF diagnosed with a pulmonary exacerbation who will be treated for Pa.

This is a cross-sectional, multi-center study comparing stool-based testing (multi-target DNA-based test and quantitative FIT test) to standard of care colonoscopy for CRC screening in PwCF. The study includes an enrollment visit, two stool samples completed at home, a clinical screening colonoscopy, and three participant surveys which will be completed at enrollment and remotely.
The total duration of participant participation will be 3-12 months, depending on the timing of the completion of the stool sample and the participant's colonoscopy. The targeted participant timeline is 3 months from enrollment to the completion of a clinical screening colonoscopy. To allow for varying site-specific clinical colonoscopy scheduling delays and COVID delays in scheduling, the duration of time between stool sampling and screening colonoscopy may extend up to 12 months for inclusion of data in the study. However, greater than 3 months duration between stool-based testing and colonoscopy will be considered a protocol deviation.

This is a pivotal Phase 2/3, double-blind, placebo-controlled study of oral study drug epetraborole + OBR (Optimized background regimen) versus placebo + OBR in patients with treatment-refractory MAC lung disease. A total of approximately 314 patients will be enrolled in this Phase 2/3 study. For the Phase 2 and Phase 3 parts of the study, the duration of study participation for each patient, not including
Screening, will be up to approximately 19 months. During the conduct of the study, an independent Data and Safety Monitoring Board (DSMB) will be responsible for periodic review of unblinded study safety data by performing a qualitative and quantitative safety assessment.

Following the study Entry Visit, subjects will return at Week 4,
Week 12, and every 12 weeks thereafter. Study visits will continue
for up to 6 years or until the subject prematurely discontinues study
treatment due to an adverse event or other reason, inhaled treprostinil
becomes commercially available for IPF in the region in which the
study is conducted, or the study is discontinued by the Sponsor
(whichever is sooner). Subjects will also be contacted by telephone or
email at least weekly until Week 12 and monthly thereafter in
between study visits to discuss study drug titration, assess study drug
tolerability, monitor adverse event, document changes to concomitant
medications, and remind subjects to bring in all study drug and a
device to their next clinic visit.

The study will be an open-label, randomized, parallel arm study that will include a
treatment arm and control arm. Participants will have clinic visits at screening, randomization (day 1) and weeks 4, 12, 18, and 24. After week 24, participants will have clinic visits at weeks 32, 40, and 48. Participants will also have a telehealth visit on day 2 and phone calls to assess adverse events (AEs), serious adverse events (SAEs), and review patient education will occur during weeks 5, 8, 36, and 44. The phone calls may be converted to telehealth visits or clinic visits and / or followed by clinic visits, if the study team deems it necessary. Pulmonary function testing, quality of life survey (St. George's Respiratory Questionnaire (SGRQ)), and blood draw will occur at each clinic visit.