5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder
This study will be a multi-site, double-blind, randomized clinical trial of the 5-HT2A receptor agonist psilocybin for smoking cessation. The current trial will be conducted across three sites with experience in conducting psilocybin research: Johns Hopkins University (JHU), the University of Alabama at Birmingham (UAB), and New York University Grossman School of Medicine (NYU). The proposed double-blind study will treat 66 participants (22 at each site), randomized to receive either: 1) oral psilocybin; 30 mg in session 1 and either 30 mg or 40 mg in session 2, with sessions 1 week apart (total 2 drug exposures separated by approximately one week); or 2) oral niacin; 150 mg in session 1 and either 150 mg or 200 mg in session 2, with sessions 1 week apart (total 2 drug exposures separated by approximately one week).
<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 Multicenter Randomized Blinded Active-Controlled Phase 2 Study to Sequentially Evaluate the Safety and Efficacy of BIIB091 Monotherapy and BIIB091 Combination Therapy With Diroximel Fumarate in Participants With Relapsing Forms of Multiple Sclerosis
The purpose of this research study is to determine how effective the study treatment BIIB091 is in treating patients with Multiple Sclerosis (MS) alone and in conjunction with Diroximel Fumarate.
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 clinical study to assess whether the gut microbiome affects the response of children with short stature (SS) to growth hormone (GH) therapy
Title of ProtocolA clinical study to assess whether the gut microbiome affects the response of children with short stature (SS) to GH therapy Research questions: • Does the composition of the gut microbiome of SS children differ from their “normal” siblings or age/sex-matched controls (with normal height 10-90%) ? • Does the composition of the gut microbiome change in response to GH therapy? • Can the initial composition of the gut microbiome predict response to therapy? Background and significance:Short stature (SS) is defined as a standing height below 2 SDS for sex/age matched controls of a well-nourished subject. Short stature can be due to various causes such as growth hormone deficiency (GHD), syndromes or idiopathic short stature (ISS). The Utah Growth Study (1), which is the largest population-based survey of growth in nearly 115,000 American children, found that approximately 44,000 children in the US have SS (2).SS children can be treated with rhGH till attainment of final adult height prediction. The response to GH therapy usually assessed every 3-4 months during therapy (3). GH usually improves growth velocity and final height in SS children, however the response varies greatly (4). In the past few years there is an increasing rate of poor or unsatisfactory response to GH treatment among SS subjects (i.e., not leading to significant catch-up growth) (5). The reasons for the variable response are not clear. GH dosing is weight based and monitoring and dose adjustments are based on blood tests and growth. Using data from the Genentech National Cooperative Growth Study (NCGS), collected over a 25-year period, to examine the responsiveness to rhGH in1,186 SS patients it was found that during the first year, lower BMI SDS predicted worse response to GH therapy (6).This data are in line with a previous report showing that children with SS have lower BMI than children in the normal population (7).
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 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.
A First-in-Human Phase 1a/1b Trial to Assess the Safety Tolerability and Preliminary Efficacy of LY4170156 an Antibody-Drug Conjugate Targeting Folate Receptor a Expressing Tumor Cells in Participants with Selected Advanced Solid Tumors
This study will test a new drug called LY4170156, an antibody drug conjugate (ADC) to see how it works in the body, and if it helps patients with different types of cancer, like ovarian, endometrial, cervical, lung, breast, pancreatic, and colorectal cancers. The study has two phases. In Phase 1a, doctors will find the best dose of LY4170156 by giving it to patients and checking for side effects and how well it works. If needed, they will try different doses to see which one is the safest and most effective. In Phase 1b, the best dose from Phase 1a will be given to more patients to see how well it works as a single treatment. Patients will be divided into groups based on the type of cancer and a specific antigen in their tumors to which the ADC binds, which will be tested in a lab. The study will make sure that the drug is given at the right dose and checks how patients feel during the treatment.