Butler, New Jersey

Speech Performance and Clinic Efficiency With Remote Care Compared With Standard of Care in Adults With a Cochlear Implant in the First 12 Months Post-activation

A Clinical Trial of Study Medicine (Marstacimab) in Pediatric Patients With Hemophilia A or Hemophilia B

Acute Optic Neuritis Network: an International Study That Invesitages Subjects With a First-ever Episode of Acute Inflammation of the Optic Nerve

The Acute Optic Neuritis Network (ACON) is a global cooperation of currently 26 academic centers longitudinally investigating subjects with inaugural acute optic neuritis (ON). ON often occurs at presentation of multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD) and myelin-oligodendrocyte-glycoprotein (MOG) antibody-associated disease (MOGAD). The recommended treatment of high-dose corticosteroids for ON is based on a North-American study population, which did not address treatment timing, or antibody serostatus. The ACON study is primarily designed to investigate the effect of time to high-dose corticosteroid treatment on 6-month visual outcomes in ON. All patients presenting within 30 days of inaugural ON will be enrolled. For primary analysis, patients will subsequently be assigned either into the MS-ON, aquaporin-4-IgG positive ON (AQP4-IgG+ON) or MOG-IgG positive ON (MOG-IgG+ON) group and then further sub-stratified according to the number of days from onset of visual loss to high-dose corticosteroids. The primary outcome measure will be high-contrast best-corrected visual acuity (HC-BCVA) at 6 months. Additionally, multimodal data will be collected in subjects with any ON (CIS-ON, MS-ON, AQP4-IgG+ON or MOG-IgG+ON and seronegative non-MS-ON), excluding infectious and granulomatous ON. Secondary outcomes include: optical coherence tomography (OCT) and magnetic resonance imaging (MRI) measurements, serum and cerebrospinal fluid (CSF) biomarkers (AQP4- and MOG-IgG levels; neurofilament; glial fibrillary protein), questionnaires (headache, visual function in daily routine, depression, and quality of life) at presentation, at 6- and 12-months follow-up. Data will be collected from 22 academic hospitals from Africa, Asia, the Middle East, Europe, North America, South America, Australia and Europe. Planned recruitment consists of 100 MS-ON, 50 AQP4-IgG+ON and 50 MOG-IgG+ON. This prospective, multimodal data collection will assess the potential value of early high-dose corticosteroid treatment, investigate the interrelations between functional impairments and structural changes, and evaluate the diagnostic yield of laboratory biomarkers. This analysis has the ability to substantially improve treatment strategies and accuracy of diagnostic stratification in acute demyelinating ON.

Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma

Five years after randomization, participants who have received axicabtagene ciloleucel will transition to a separate long-term follow-up study (study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.

Study of ARO-MMP7 Inhalation Solution in Healthy Subjects and Patients With Idiopathic Pulmonary Fibrosis

Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors

A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age

The study will be conducted in 2 parts: Part 1 Dose-Ranging and Part 2 Safety Expansion.

Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason®

Observational Study of Acalabrutinib in Patients With Chronic Lymphocytic Leukaemia in the United Kingdom

1. Primary Objectives: a. To estimate real-world progression-free survival in patients with CLL who received acalabrutinib in the first-line. 2. Secondary Objectives: 1. To estimate real-world overall survival in patients with CLL who received acalabrutinib in the first-line. 2. To describe real-world response rate to acalabrutinib in patients with CLL who received acalabrutinib in the first-line. 3. To describe the healthcare resource utilisation in patients with CLL who received acalabrutinib in the first-line. 4. To describe post-progression treatment patterns in patients with CLL who progressed from first-line acalabrutinib. 5. To describe real-world clinical progression free survival in patients with CLL who received acalabrutinib in the first-line and progressed during acalabrutinib treatment. 6. To describe acalabrutinib treatment patterns in patients with CLL who received acalabrutinib in the first-line. 7. To describe baseline clinical and demographic characteristics in patients with CLL who received acalabrutinib in the first-line.

A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease