The effect of transcutaneous auricular vagal nerve stimulation on pupillary response and perceptual learning.
Study 1: We will observe the use of taVNS versus sham setting(s) on healthy human subjects and observe pupillary response in a passive study session. All subjects will receive taVNS and two sham settings (lobe stimulation and ulnar wrist stimulation) and no stimulation at all. Study 2: We will evaluate behavior on a perceptual learning in a go/no-go task paradigm where healthy human subjects will receive either taVNS, sham, or no intervention. We will also record pupil dilation on task performance to index overall effort and cognitive demand.
The effects of Gender-Affirming Hormone Therapy (GAHT) on blood pressure of transgender adolescents as measured by ambulatory blood pressure monitoring (ABPM) over the first year of therapy
The goal of this study is to inform regarding effects of GAHT on blood pressure, to help improve clinical practice guidelines regarding screening and treatment of transgender adolescents, in order to provide more comprehensive counsel to patients regarding the possible risks.
The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) Study Trial
To assess the safety and effectiveness of the Hancock Jaffe VenoValve for the treatment of patients with deep venous valvular insufficiencyA prospective, non-blinded, single-arm multi-center pivotal study of the Hancock Jaffe VenoValve. All patients will receive optimized care (e.g., appropriate medications, compression therapy) throughout the study.The study will be conducted in accordance with the 2020 Standard ISO 14155 (Clinical investigation of medical devices for human patients - Good clinical practice), and other regulatory and legal requirements.
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The HistoSonics Edison System for treatment of primary solid renal tumors using histotripsy (#HOPE4KIDNEY US)
This trial is a prospective, multi-center, single-arm pivotal trial designed to evaluate the effectiveness and safety of the HistoSonics Edison System for the destruction of kidney tissue by treating primary solid renal tumors. Data through 90 days for all enrolled subjects will be summarized in a primary analysis to be submitted for Regulatory Submission to the FDA. Additionally, subjects will be followed for five (5) years post-index procedure, with evaluations at the 14-day, 30-day, 90-day, 180-day and annual time points.
The New York City Study of Fertility and Environmental Exposures (NYC FREE): A single-center observational study of environmental and lifestyle influences on health and reproduction
NYC FREE is a reproductive health study that will enroll people of reproductive age who have the potential to become pregnant in the near future and partners of these individuals. The overall aim of this project is to create a biobank that will facilitate future studies on the relation of environmental and lifestyle factors with reproductive health and human fecundity.
THE NEW YORK MOVEMENT DISORDER STUDY
Movement disorders represent a major public health crisis. Large longitudinal clinicopathological studies form the basis for studying the symptomatology, epidemiology, progression and pathogenesis of these diseases. In addition, by studying blood and brain tissue for biomarker and genetic studies has the potential to pave the way towards new diagnostics and uncover underlying pathogenic mechanisms that can be targeted for therapeutic development. The goal of this project is to perform a clinicopathological study of a large cohort of patients with movement and related disorders drawn from the patients at the Robert and John M. Bendheim (RJB) Parkinson and Movement Disorders Center and at The NYU Langone Health The Marlene and Paolo Fresco Institute for Parkinson’s and Movement Disorders (Fresco Institute). Movement disorders represent a large group of related diseases that include Parkinson’s disease, dystonia, essential tremor, myoclonus, chorea, and others. Here, volunteers will be assessed for clinical and neuroradiological features in an ongoing way during their disease course. Blood will be collected for genetic and biomarker studies. In addition, we will recruit healthy adult volunteers who will serve as controls to test the specificity of our findings. Finally, patients will be offered the opportunity to serve as brain tissue donors. These clinical and neuropathological variables will stored using the secure Research Electronic Data Capture (REDCap) web-based software and correlative studies will be performed.
The PROP-RD Study: A Prospective Registry for the Study of Outcomes and Predictors in Pouchitis and Pouch-Related Disorders
Purpose: Create a prospective registry of patients with pouch-related conditions to allow for longitudinal assessment of outcomes.Participants: 320 patients from 8 centers who are diagnosed with acute pouchitis, CADP, CARP, or CD of the pouch.Procedures (methods): Following the enrollment data collection during a standard of care clinic visit, patients will complete online questionnaires at 3, 6, and 12 months following enrollment.These questionnaires will include standardized follow-up assessments of disease activity and detailed questions regarding patient-reported response to initial therapies.We will prospectively collect serial stool samples from 90 patients with acute pouchitis (a subset of the 320 patients enrolled in the registry). Samples will be collected at the time of diagnosis (day 0 in clinic) and the end of antibiotic therapy (day 14).
THE PROSPECTIVE NATURAL HISTORY OF FAMILIAL DYSAUTONOMIA
Our ultimate goal is to develop new treatments for patients with familial dysautonomia (FD, OMIM 223900). We also want to learn which specific nerve populations are affected by the disease-causing mutation, whether these features are progressive, and how best to measure them in clinical trials. FD is caused by a founder mutation in the IKBKAP gene that is carried by 1:30 people of European Jewish ancestry. Over 99% of affected patients have two copies of the identical founder mutation. This affects the development of the sensory nervous system, which relays information to the brain. FD is both developmental and progressive. Current drug treatments are supportive and none specifically target the on-going neurological decline. Partnership between academic centers, advocacy groups and federal agencies has allowed the creation of a pipeline for drug development and an infrastructure for translational research. The first aim of this project will be to enroll patients with FD from around the world in a non-interventional natural history study. We will score the severity of their clinical features and follow how they evolve over time. The natural history will focus on establishing disease-specific milestones to use as outcome measures in future clinical trials. We will find ways to measure the progressive neurological aspects of the disease including blindness and gait ataxia, which are intrinsically related and most devastating to the patient’s quality of life overtime. We will also explore other potential biomarkers that quantify renal, cardiovascular, respiratory, orthopedic and cognitive aspects of the disease, which will help us monitor adverse events. The second aim of this project will address one of the most intriguing questions about the disease; why some patients are more severely affected than others. The study will include genomic sequencing from patients with FD, to find specific modifier genes that influence the severity of traits as possible targets for future drug development. Some of these genes may be important in the general population, but discovering them could be easier in FD patients due to >99% being homozygous for the founder mutation.
The Psorcast Study: A Validation Study of a Smartphone Sensor-Based Patient-Driven Detection of Psoriatic Disease
Smartphone-based and physician-assessed measures will be collected at baseline and 12 weeks after initiating a new therapy for psoriatic disease. Weekly digital assessments will also be performed.