80202135SJS3001/DAFFODIL - A Randomized Placebo-controlled Double-blind Multicenter Phase 3 Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults with Moderate to Severe Sj gren's Disease (SjD)
The purpose of this study is to see if nipocalimab is safe and useful for treating patients with Sjögren’s disease. Available treatment options for Sjögren’s disease are limited to symptomatic management. Nipocalimab is a drug that lowers the level of a group of proteins in the blood called IgG (immunoglobulin G). IgG is a type of antibody involved in Sjögren’s disease and other autoimmune illnesses.
<strong>Adolescents:</strong> A Prospective Single Arm Open Label Trial to Confirm Safety and Effectiveness of Prism as an Adjunct to Standard of Care in Adolescents with Post-Traumatic Stress Disorder (PTSD)
The purpose of this research study is to is to establish if the FDA-approved Prism device, currently used for treating adult PTSD patients can also be safely used to help adolescents. For more information, please email TeenPTSDTxStudy@nyulangone.org.
A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized Double-Blind Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants with Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus with or without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)
This is a 2-part seamless, randomized, double-blind, placebo-controlled, multicenter, Phase 2/3 study designed to evaluate the efficacy and safety of BIIB059 for the treatment of participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarial therapy. The study includes a Part A (Phase 2) and a Part B (Phase 3 registrational). The study comprises a 24-week DBPC treatment period followed by a 28-week ETP; the total treatment duration of 52 weeks.Participants who successfully complete the 52-week treatment period will be offered the opportunity to participate in an LTE study under a separate protocol. The LTE study will evaluate the long-term safety profile of BIIB059 in the treatment of CLE.Participants will be randomly assigned in a 2:1 ratio to receive either BIIB059 or placebo SC Q4W, respectively, from Week 0 to Week 20, with an additional loading dose at Week 2 during the DBPC period.During the ETP, all participants will receive BIIB059 from Week 24 to Week 48. At Week 26, participants will receive a loading dose where all participants who were randomly assigned to BIIB059 during the DBPC period will receive the placebo and all participants who were randomly assigned to placebo during the DBPC period will receive BIIB059.
A Community-Based Intervention To Address Health-Related Social Needs For Patients On LAI-PrEP
The purpose of this study is to evaluate the effect of addressing health-related social needs for people taking long-acting injectable HIVprevention medication (LAI-PrEP). We are particularly interested inrecruiting people that are most vulnerable to HIV infection and least likelyto be prescribed PrEP, including cisgender women of color and genderdiverse persons (transgender or non-binary individuals). If you are eligible and agree to participate, you would start LAI-PrEP aspart of your standard of care and would have 5 research study visits. Atthe study visits, you would be asked to complete various surveys and 1interview. If you decide to participate in this study, you would be asked to come to 5in-person study visits over a period of approximately 1 year. You would be compensated for each in-person study visit.
A Comparison of NeuroSpan Bridge NeuraGen Nerve Guide and Nerve Autograft for Peripheral Nerve Repair (NeuroSpan-1)
The purpose of this research study is to compare three treatments for nerve injuries in the arms or legs: the NeuroSpan Bridge, the NeuraGen Nerve Guide, and using a person’s own nerve (nerve autograft). These treatments help repair damaged nerves and restore movement or feeling.
A computational approach to optimal deactivation of cochlear implant electrodes
The goal of the present study is to use computationally driven models of speech understanding in CI users to guide the search for which combination of active electrodes can yield the best speech understanding for a specific patient. It is hypothesized that model-recommended settings will result in significantly better speech understanding than standard-of-care settings.
A double blind randomised placebo-controlled trial evaluating the efficacy and safety of nerandomilast over 26 weeks in patients with Systemic Autoimmune Rheumatic Diseases associated Interstitial Lung Diseases (SARD-ILD)
The purpose of this research study is to test a new drug called nerandomilast in participants with Systemic Auto-immune Rheumatic Diseases associated Interstitial Lung Diseases (SARD-ILD) to see how it affects the lungs, how it impacts breathing and coughing, and how it affects the risk for infections.
A Double-Blind Randomized Multicenter Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults with Focal Seizures (POWER 1)
The main purpose of this research is to find out how well PRAX-628 works and how safe it is when used to treat focal seizures compared to placebo (inactive drug). The study also looks at the side effects of taking PRAX-628 compared with placebo and how the body processes it. The active study drug or placebo will be taken in addition to your regular anti-seizure medications.
A DOUBLE-BLIND RANDOMIZED PLACEBO-CONTROLLED MULTICENTER OUTPATIENT PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF STACCATO ALPRAZOLAM IN PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH EPILEPSY WITH A PREDICTABLE SEIZURE PATTERN.
Staccato alprazolam is being developed for the indication of rapid cessation of a prolonged focal or generalized seizure that has not progressed to status epilepticus in patients with epilepsy 12 years of age and older. After completing the study, eligible study participants will be allowed to enroll in an open-label extension (OLE) study.
A Feasibility Pilot Study of Home-Based Intermittent 60Hz Light Therapy for the Treatment of Depression
The purpose of this study is to see how easy it is to use an intermittent light therapy device in adults with a major depressive episode (MDE), and to see how mood is impacted by the light therapy. Participants will complete 15 non-invasive light stimulation sessions, online surveys, and assessments.