Oculoplastic Surgery Doctors | NYU Langone Health
Find a doctor at the Oculoplastic Surgery at NYU Langone.
Older Adult Services at Family Health Centers at NYU Langone | NYU Langone Health
Older adult services are provided through Family Health Centers at NYU Langone’s Community-Based Programs.
Open-Label Multicenter Phase 1 Study to Assess the Safety of P-CD19CD20-ALLO1 in Subjects with Selected Relapsed/Refractory B cell Malignancies
This Phase 1, multi-center, open-label, dose escalation study will enroll and treat approximately 120 adult subjects with relapsed/refractory DLBCL NOS (including DLBCL arising from indolent lymphomas), HGBL, PMBCL, and tFL or follicular lymphoma Grade 3B.This study consists of 2 parts: dose escalation (Part 1) and expansion at a selected dose (= MTD or RDE) and LD regimen (Part 2).Only sites that are experienced in managing oncology subjects and stem-cell/bone marrow transplant and have the resources to manage the types of acute emergent events expected with CAR-T cell administration will be selected to participate in this study. A Safety Committee will meet regularly to review safety data throughout the study.Part 1 (Dose Escalation)During Part 1, dose levels shown in Table 1 will be evaluated using a 3+3 escalation design.Subjects and cohorts will be staggered as follows:• The dosing of the first 3 subjects in all cohorts in Arm S will be staggered by a minimum of 28 days.• There will be a minimum 28-day stagger period between dose escalation cohorts in Arm S.• Dosing in Arms LD 750 and LD 1000 will be = the maximum cleared P-CD19CD20-ALLO1 dose level in Arm S and may enroll concurrently.• The first 2 subjects in Arms LD 750 and LD 1000 at each P-CD19CD20-ALLO1 dose level will be staggered by a minimum of 14 days.The Safety Committee will review the data for each dose cohort to determine progression to the next dose cohort. The Safety Committee may recommend enrollment of additional subjects in a dose cohort of an Arm to further evaluate the outcomes observed at that dose level.The first 3 subjects in each cohort in Arm S must be admitted to the hospital for P-CD19CD20-ALLO1 administration for 7 days. Subjects should remain within 2 hours driving distance from the hospital through 28 days after administration of P-CD19CD20-ALLO1 to attend clinic visits.Dose Escalation GuidelinesThe 3+3 dose escalation will be conducted per Table 2, with the Safety Committee reviewing the data from each dose cohort to determine the outcome. Beginning with Cohort 1 of Arm S (LD regimen of cyclophosphamide (500 mg/m2) and fludarabine (30 mg/m2) and P-CD19CD20-ALLO1 dose of 0.75 × 106 cells/kg), at least 3 subjects will be dosed in the cohort. If no DLT through Day 28 is observed in the first 3 subjects, then dose escalation may proceed to Cohort 2 of Arm S (LD regimen of cyclophosphamide (500 mg/m2) and fludarabine (30 mg/m2) and P-CD19CD20-ALLO1 dose of 2 × 106 cells/kg). Concurrently, Arm LD 750 and Arm LD 1000 may begin enrolling at the cleared Cohort 1 P-CD19CD20-ALLO1 dose of 0.75 × 106 cells/kg.If a DLT is observed in 1 of the first 3 subjects in any Cohort of Arm S, then at least 3 additional subjects will be treated at this dose level. If no further DLT is observed, dose escalation may proceed. If DLTs are observed in 2 or more of 6 subjects, the MTD will be considered to be at the next lower dose level and further enrollment may take place at a lower dose level, or an intermediate dose level may be tested at the discretion of the Safety Committee. If 2 or more subjects experience DLTs in Cohort 1, the Safety Committee, after reviewing available data, may elect to dose 3 subjects in either Cohort minus 1 or Cohort minus 2 with the same 3+3 expansion rules. If 2 or more subjects experience DLTs in Cohort minus 1, the Safety Committee, based on the consideration of safety and efficacy data to assess risk vs. benefit, may elect to dose 3 subjects at a lower dose (Cohort minus 2) with the same 3+3 expansion rules or recommend study discontinuation.If a DLT is observed in 1 of the first 3 subjects in any Cohort of Arm LD 750 or Arm LD 1000, then at least 3 additional subjects will be treated at this dose level and LD regimen. If no further DLT is observed, dose escalation may proceed as P-CD19CD20-ALLO1 dose levels are cleared in Arm S. If DLTs are observed in 2 or more of 6 subjects, the MTD will be considered to be at the next lower P-CD19CD20-ALLO1 dose level and further enrollment may take place at a lower dose level, or an intermediate dose level may be tested at the discretion of the Safety Committee. If 2 or more subjects experience DLTs in Cohort 1, the Safety Committee, after reviewing available data, may elect to dose 3 subjects in either Cohort minus 1 or Cohort minus 2 with the same 3+3 expansion rules. If 2 or more subjects experience DLTs in Cohort minus 1, the Safety Committee, based on the consideration of safety and efficacy data to assess risk vs. benefit, may elect to dose 3 subjects at a lower dose (Cohort minus 2) with the same 3+3 expansion rules or recommend discontinuation of the study Arm.If Cohort 5 is completed in any Arm without identifying an MTD, the Safety Committee may elect to select recommended dose(s) for expansion (RDE) based on established safe doses in Part 1. The Safety Committee may also assess further dose escalation cohorts in increments of 5 to 10 × 106 P-CD19CD20-ALLO1 cells/kg beyond the Cohort 5 dose level. Dose escalation beyond Cohort 5 will proceed only following protocol amendment.Part 2 (Expansion)In Part 2, safety and efficacy data will be monitored at regular intervals throughout the study by the Sponsor medical monitor and Safety Committee to ensure subjects safety.Part 2 will include a population of subjects with B cell malignancies selected based on results from Part 1 and may include one or more of the histologic subtypes of Part 1. Criteria for tumor selection will be based on safety and emerging efficacy observed in Part 1.Subjects in Part 2 will receive P-CD19CD20-ALLO1 at selected dose(s) and LD chemotherapy regimen(s) from Part 1 that were deemed safe based on the safety data, and available PK data, as well as available response data, as determined by the Sponsor. Up to 2 dose levels may be identified from Part 1 for the Part 2 dose expansion. A dose level where no more than 1 of 6 subjects experienced DLTs in Part 1 may continue evaluation with additional subject enrollment for Part 2 if the review of safety, PK, and available response data warrants its expansion. This additional subject enrollment may proceed, while other subjects are undergoing the DLT evaluation period at higher dose levels in Part 1.The Safety Committee and the Sponsor will review all available safety, PK, and/or response data to evaluate the dose(s) in the expansion cohort for selection of the recommended Phase 2 dose (RP2D). An additional 10 subjects may be enrolled at the selected RP2D. In addition, based on discussion with the Safety Committee, other B cell malignancies, such as indolent lymphomas or chronic lymphocytic leukemia (CLL), may also be considered to be evaluated in a separate cohort at documented safe dose(s) from Part 1; up to 20 subjects may be enrolled.
Optimization and evaluation of accelerated MRI for prostate imaging
In this study will evaluate and optimize rapid or accelerated magnetic resonance imaging of the prostate. Scanning will be performed upon the existing clinical MRI scanner systems in the Department of Radiology. The novelty of our work lies in modifying clinical sequences or acquisitions in order to acquire less data (and hence faster imaging) and use novel reconstruction methods to produce diagnostic images. Our methods will result in accelerated MRI as less scanning data will be required when compared to conventional imaging
Optimized sodium MR imaging at clinical field strength to study in vivo sodium signal in mild traumatic brain injury
The overall goal of this project is to detect and quantify changes in brain sodium MRI (NaMRI) signal after Mild Traumatic Brain Injury (MTBI).
Optimizing exercise for the treatment of anxiety
Anxiety disorders are impairing and amongst the most common psychiatric conditions; yet, many impacted individuals do not receive or respond to evidence-based care. There is thus a great need to develop and optimize additional first-line, more accessible interventions for anxiety disorders. Exercise has benefits for anxiety and physical health, without many of the side effects, accessibility issues, or costs of medications or psychotherapy. However, adherence to exercise recommendations is low, and even worse for high intensity exercise (HIE) in individuals with anxiety disorders. This may be due to high anxiety sensitivity (AS), or fear of anxiety-related physiological sensations, as HIE may induce similar sensations. There are, however, no formal guidelines for optimal intensity or titration of exercise for any mental health condition, and it remains unclear whether exercise requires slower titration for optimal tolerability and response for anxiety.In order to develop exercise as a formally prescribed intervention for anxiety disorders in a way that enhances engagement and adherence, research is needed to guide optimal titration of exercise prescriptions, and to establish mechanisms that should be targeted to optimize outcomes in practice. Addressing these gaps, this study will examine the impact of exercise titration on AS/anxiety symptom severity as well as engagement and adherence. Specifically, 90 sedentary adults with a primary anxiety disorder and high AS will be randomized to either 8 weeks of 1) low intensity exercise, or 2) flexible titration to HIE. Blinded, validated clinician-rated and patient-rated outcomes will be assessed over treatment and at 1- and 3-month follow-up. To better understand what mechanisms influence decisions to exercise in the real-world, and novel to this research and key training goals, are the use of heart rate (HR) as an objective mechanistic target for exercise intensity, examining changes in valuation of exercise through a neuroeconomics task, examining changes in interoceptive sensitivity, and the integration of ecological momentary assessment (EMA) to measure effects of immediate changes in mood with exercise on anxiety outcomes and adherence. We hypothesize that those in the T-HIE condition will evidence lower levels of AS at post-treatment (Week 8; primary endpoint). Additionally, we hypothesize that T-HIE and LIE will have similar rates of engagement and adherence.
Optimizing Recruitment and Retention of Communities Underrepresented in Research: A Pilot Study
This study aims to illustrate the depth and breadth of existing research methods that have been used to increase recruitment and retention of understudied health disparity communities. Results from semi-structured interviews will provide empirical evidence on best research practices pertaining to the recruitment and retention of diverse communities.
Oral & Injected Medication for Psoriasis | NYU Langone Health
Dermatologists at NYU Langone may prescribe oral or injected medications to manage the symptoms of psoriasis.
Oral Cancer | NYU Langone Health
Perlmutter Cancer Center doctors use surgery, radiation therapy, and medication to manage oral cancer in adults.
Oral Medication for Rosacea | NYU Langone Health
NYU Langone doctors may manage rosacea with oral medications, including prescription antibiotics and retinoids.