3D Free-Breathing Fat and Iron Corrected T1 Mapping
This study proposes a novel 3D liver T1 mapping technique that will enable water-specific T1 mapping (or fat/iron-corrected T1 mapping) to remove the influence of both fat and iron, two confounding factors that have typically been neglected in standard T1 mapping. In a pilot study, we will test the performance of the proposed method for evaluating nonalcoholic steatohepatitis (NASH).
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 12-week randomized double-blind placebo-controlled trial investigating the effects of Levetiracetam in early psychosis
This is a 12-week study of levetiracetam in conjunction with a second generation antipsychotic in early psychosis patients with treatment-resistant symptoms. Treatment with antipsychotics has been shown to be associated with loss of volume in the hippocampus. Brain chemicals, called neurotransmitters, that might be associated with this loss are glutamate and dopamine. The drug levetiracetam reduces excessive amounts of these neurotransmitters, which may help protect against this loss when taken with antipsychotics. Participants will complete screening and baseline visits before being randomized in a 2:1 ratio of levetiracetam or placebo. They will complete weekly study visits for the first 4 weeks (Baseline, Weeks 2-4) and then additional visits at Week 6, 8, and 12. Participants will be studied both by assessing change in symptom severity and cognitive performance over the 12 weeks as well as using a measure of Hippocampal Volume Integrity at baseline and week 12. After completing Week 12 or decision to withdraw prematurely from the study, participants will complete a 9 day medication tapering regimen.
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.