Recovery & Support for Myasthenia Gravis | NYU Langone Health
NYU Langone specialists develop an ongoing care plan to help you improve muscle strength after treatment for myasthenia gravis.
Support for Autonomic Disorders | NYU Langone Health
NYU Langone experts provide support services for people with autonomic disorders through our Dysautonomia Center.
Surgery for Osteoarthritis of the Knee | NYU Langone Health
If medication and physical therapy don’t relieve pain due to osteoarthritis of the knee, NYU Langone doctors may recommend surgery.
A Multi-Center Observational Study Assessing the Utility of an Immune Cell Function Assay in a Cardiac Sarcoid Population
Sarcoid is an autoimmune disease that can be found in any and every organ system. The greatest degree of morbidity and mortality comes from cardiac involvement where it can lead to sudden cardiac death, heart block, and heart failure. The basics of the treatment for cardiac sarcoid include appropriate preventative treatment for ventricular arrhythmias, guideline directed medical treatment for heart failure, and immunosuppression to decrease active cardiac inflammation. The amount of immunosuppression and with which medication is of expert opinion. Using PET scan, we can help assess for successful suppression of the disease, but often 2nd or 3rd line treatments are required after initial therapy strategy is deemed insufficient. As of now, there are no predictors of who will fail initial treatment. For this study, there are three different hypotheses. First, we suspect the baseline Immuknow tertile (low, medium, high) will correlate with the rate of response to first line immunosuppression with low being more likely than the combined medium/high grouping to be responsive on first clinically indicated PET follow up. Second, that a subsequent decrease in ImmuKnow grade, for those that start in the medium or high range, will be predictive of resolution of inflammation on cardiac PET. Lastly, we would like to assess whether an intermediate ImmuKnow assay, drawn at 1 month, would be predictive of response at 3 month follow up.The study population will include adults with a clinical or histological diagnosis of cardiac sarcoidosis found to have active inflammation on cardiac PET scan who are not currently on immunosuppressive therapy. This should be their first time undergoing treatment for cardiac sarcoid (i.e. not with disease recurrence). This will give us a uniform patient population that will not have effects of prior immunosuppression as to their response to current treatment, and not possibly already have treatment failure. We will also be storing biologic samples for future analysis. We believe that a change in the immunophenotype of an individual in response to treatment will be the hallmark of successful immunosuppression. We will be using these samples to assess this in the future.
A Phase 1/2a Open-label Study of VS-7375 a KRAS G12D (ON/OFF) Inhibitor as Monotherapy and in Combination in Patients with Advanced KRAS G12D-Mutant Solid Tumors
VS-7375 is a highly selective oral, non-covalent, small molecule KRAS G12D inhibitor. VS-7375 demonstrated potent inhibition of KRAS G12D-mutated-dependent signal transduction and cancer cell viability in vitro, as well as anticancer activity in human CRC and PDAC xenograft models alone and in combination with cetuximab. Collectively, the significant unmet medical need for treating tumors that harbor KRAS G12D mutations and the nonclinical results with VS-7375 strongly support a rationale for its development in patients with KRAS G12D-mutated cancers.VS-7375 is currently in clinical development in China under the name GFH375 by GenFleet Therapeutics Technology Co., Ltd (Shanghai, China). A first-in-human (FIH) clinical study of VS-7375 (Study GFH375X1101; NCT06500676) is ongoing as a multiphase study in China targeting patients with advanced KRAS G12D-mutated solid tumors, including NSCLC, PDAC, and CRC. The Phase 1 portion of that study involves dose escalation using a Bayesian optimal interval (BOIN) design to evaluate safety, tolerability, and pharmacokinetics (PK) across a range of doses, with initial endpoints focused on evaluating adverse events (AEs) and dose-limiting toxicities (DLTs). As of 17 January 2025, the 750 mg daily dose has been cleared for DLTs, and Study GFH375X1101 remains ongoing in the dose finding stage for patients with KRAS G12D-mutated cancers in China.This study is designed to evaluate the safety, tolerability, preliminary anticancer activity, and PK of VS-7375 in participants with advanced solid tumors harboring a KRAS G12D mutation outside China. The study will be conducted in 4 parts: Part A (single-agent dose escalation),Part B (single-agent dose expansion), Part C (VS-7375 combination dose escalation), and Part D (VS-7375 combination dose expansion).
Biomarkers for preterm births using non-invasive samples
Preterm delivery is a leading cause of neonatal mortality and continues to be a major public health concern. Although some pregnant women will present with preterm labor (uterine contractions), most will not progress to actual preterm delivery (birth). Identifying which pregnant women presenting with preterm labor that will actually progress to preterm delivery is a challenge for clinicians. Studies have demonstrated that measuring biomarkers (inflammatory mediators, microRNA and cytokines) in intra-uterine tissues (placenta, amniotic membranes and amniotic fluids) can predict preterm labor progression to delivery. However obtaining such samples are invasive and can be dangerous. The overall goal of this study is to identify biomarkers from samples from non-invasive sites that will increase the clinician’s ability to identify patients who present with second trimester preterm labor (uterine contractions) that will progress to preterm delivery. Specifically, we will measure biomarkers from non-invasive samples (blood, urine, vaginal secretions and saliva) in pregnant women (at less than 34 weeks gestation) presenting to NYU Winthrop Hospital with preterm labor (contractions). We will compare two groups; 1) pregnant women with preterm labor that deliver within 3 days after admission to the hospital vs. 2) women with preterm labor that deliver more than 3 days after admission. We will need 60 samples from group 1. Since approximately 25% of pregnant women presenting with preterm labor will actually end with preterm delivery, we will enroll a total of 240 subjects. After consent is obtained, samples (blood, urine, vaginal secretions and saliva) will be collected at the time of the hospital admission. If the patient did not progress to preterm delivery and was discharged home, no more samples will be obtained. If the patient continued to be admitted in the hospital for observation, weekly samples will be obtained whenever possible. When subjects progress to active labor and delivery, samples will be collected (blood, urine, vaginal secretions and saliva) as well as placenta/fetal membranes after delivery. The collected samples will be transported, processed and stored at the PI lab at NYU Winthrop Hospital. Biomarkers (such as inflammatory mediators, cytokines and microRNA) will be evaluated to predict preterm delivery in these pregnant women. A secondary objective is to correlate the inflammatory biomarkers obtained during pregnancy with the neonatal outcome (obtained by review of the neonatal medical records).
Investigating the Temperature Dependence of Age-related Tau Pathology Relevant to Early Alzheimer's Disease
This is a cross-sectional study in 100 older adults (n = 100, 50 female, 60–80 years) who are cognitively normal (n = 70) or have mild cognitive impairment (n = 30). The purpose is to test whether features of body temperature (Tb), measured with ingestible telemetry, are associated with tau pathology, measured with [18-F]-MK-6240 tau PET-MR and plasma P-tau. Participant involvement includes 6 study visits over a period of 4 months. The duration of the project is 5 years. Briefly, subjects who express interest and are eligible for screening based on a pre-screening call will undergo in-person medical screening and complete several intake questionnaires at Visit 1, followed by a blood draw at CTSI, a clinical interview and neuropsychological testing at Visit 2. A 7-day at-home sleep assessment and actigraphy data, after Visit 2, will help us determine sleep-wake cycles and screen for Obstructive Sleep Apnea which is exclusionary for our study, if severe. At Visits 3 & 4, subjects will undergo body temperature measurements with ingestible telemetric thermometry over 48 hours, commencing on Night 1 of a 48 hour visit to the MSCIC sleep lab. Sleep EEG characteristics will be assessed with polysomnography on Nights 1 and 2 of this 48 hour period. During the day between these nights, subjects will be free to return home. After sleep study data is analyzed, the Eligibility Checklist can be completed. At Visit 5 which will take place at least 7 days after the sleep study completion, subjects will undergo a Tau PET/MR scan at the Center for Biomedical Imaging. At Visit 6, at least 7 days after the sleep study (but not on the same day as the Tau PET/MR) subjects will undergo an amyloid PET/MR scan. The purpose of the PET/MR scans is to control for tau and amyloid burden in the central nervous system.This cross-sectional study will lay the ground work for future prospective studies to determine whether Tb based interventions can prevent the progression of NFT pathology toward reducing Alzheimer’s Disease burden.
Medication for Fibromyalgia | NYU Langone Health
NYU Langone doctors prescribe medication to manage the symptoms of fibromyalgia, such as chronic pain and difficulty sleeping.
NYU Langone Outpatient Surgery Center | NYU Langone Health
The NYU Langone Outpatient Surgery Center specializes in orthopedic procedures.
Support for Primary Central Nervous System Lymphoma | NYU Langone Health
NYU Langone specialists offer pain management, counseling, and rehabilitation for people with primary central nervous system lymphoma.