A Single-Center Observational Study of the Pre-Operative and Post-Operative Corneal Endothelial Cell Density of Patients Undergoing Glaucoma Surgery
This study aims to investigate corneal endothelial cell migration and healing after glaucoma surgery using non-contact specular microscopy and tomography. Eighty patients undergoing glaucoma surgery will have corneal imaging taken pre-operatively, one month, three months, and six months post-operatively, and lastly at 1 year. Endothelial cell density and corneal thickness will be correlated and analyzed pre- and post-operatively. The focus of our study will be on tube-shunt surgery; other forms of glaucoma surgery such as MIGS may be included for comparison.
A Single Center Observational Study of Vascular Health and Hemodynamics in Heart Failure
Heart failure is associated with marked morbidity and mortality and yet role of vascular health in the pathogenesis of this disease remains poorly understood with limited therapeutic options. Examination of the vascular endothelium via brachial vein endovascular cell phenotyping in patients undergoing routine right heart catheterization offers a unique opportunity to examine the relationship between vascular endophenotypes and hemodynamics.
A SINGLE-CENTER OBSERVATIONAL STUDY ON THE ABILITY OF DYNAMIC VASCULAR OPTICAL SPECTROSCOPY TO MONITOR THE HEALTH OF THE CAROTID ARTERY
To validate the use of dynamic vascular optical spectroscopy (DVOS) for monitoring oxygen saturation in the carotid artery, we will enroll 20 subjects ages 18-40 with no history of vascular disease and no history of neck radiation treatment. Subjects will be non-smokers, non-hypertensive, non-diabetic and have no history of neck trauma and no history of high cholesterol. This study is non-interventional and DVOS measurements collected at the carotid artery will be compared to DVOS measurements at the radial artery on the same subject for calibration of the system.
A Single-Center Observational Study to Develop EEG Biomarkers of Transition from Acute to Chronic Pain
We will enroll acute and chronic low back pain and control subjects. We will record high density EEG in these subjects, along with pain and mood questionnaires. Those with acute pain will be followed longitudinally with additional visits at 1, 3, and 6 months. We will use machine learning to develop and validate a biomarker for the transition from acute to chronic pain.
A SINGLE CENTER PILOT STUDY ESTABLISHING TEST-RETEST RELIABILITY OF SWALLOWING PRESSURES COLLECTED WITH HIGH RESOLUTION PHARYNGEAL MANOMETRY (HRPM)
Difficulty swallowing (known as dysphagia) can have devastating consequences for health and quality of life. The current gold-standard assessment tool, videofluoroscopy (VF), allows real time visualization of swallowing via a video x-ray. Unfortunately, VF exposes the patient to radiation and therefore is limited in its use. A relatively new technique for quantifying swallowing physiology is called High Resolution Pharyngeal Manometry (HRPM) - it registers the pressures generated by the swallowing muscles on a catheter passed through the nose to the esophagus. Our team (speech pathology, otolaryngology, gastroenterology) recently acquired an HRPM system and is eager to employ it in our research grants with a focus on aging, disease progression, and treatment for swallowing disorders. However, at this time, very little is known about the test-retest reliability of this tool which leaves us unable to conduct realistic power calculations in these proposals. Therefore, we will plan to collect VF/HRPM test-retest data in 20 older adults two weeks apart.
A Single Center Pilot Study on the Use of a Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
This study aims to gather initial data on the potential effectiveness of a transcutaneous auricular vagal nerve stimulation device in patients diagnosed with chronic kidney disease. The study participants will receive a 15-minute session of transcutaneous auricular vagal nerve stimulation at one of two specified doses, assigned alternatively. Prior to and after the stimulation, vital signs, heart rate variability, and autonomic function will be monitored. Our primary aims are to investigate the feasibility of the protocol and generate preliminary signals of efficacy and tolerability for two different doses of vagal nerve stimulation. The pilot estimates will be used to design a larger scale study that may lead to potentially targeted interventions to reduce CV mortality in the CKD population.
A single-center prospective observational study of post-discharge outcomes and function among patients treated for severe COVID-19 disease
This is a single-center observational study that aims to examine physical and mental function of patients treated for severe COVID-19 disease at NYU Langone Health one month post-discharge. We will use telephone interviews with patients to characterize their overall health state, physical function, breathlessness, mood, social support and post-discharge challenges. We will use chart review to identify patient demographics, comorbidities, and clinical condition, and to identify treatments received. Our target enrollment is 500 patients.
A single-center randomized clinical trial to test the efficacy of pharyngeal swallowing exercises (with or without protein supplementation) to build pharyngeal muscular reserve in pre-frail older adults
The swallowing muscles are prone to decreased strength and function as part of the natural aging process which can lead to difficulty swallowing, malnutrition, and frailty. Exercise and nutrition are powerful stimulators of muscular change. The proposed research will investigate the effectiveness of a 12-week proactive regimen of swallowing exercises (with or without daily protein supplement drinks) to improve the composition, force, and physiology of the swallowing muscles and explore the relationship to overall health and physical function in 80 community-dwelling older adults. Each participant will serve as their own control for 12 weeks before being randomized to complete swallowing exercises alone or swallowing exercises with protein drinks.
A Study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With Non-Muscle Invasive Bladder Cancer
This study is examining how well a new treatment called N-803, combined with a standard treatment called BCG, works compared to just using BCG alone in patients who haven't had BCG before and have a specific type of bladder cancer that hasn't spread into the muscle. There are two groups of patients in the study: one group has a more serious form of the cancer, and the other group has a less serious form. Every patient in the study will get either N-803 and BCG or just BCG through a tube into the bladder for six weeks. After that, the doctors will check how well the treatment is working. If it's going well, some patients will keep getting more treatments to help keep the cancer from coming back. The study will follow patients for about three years to see how they're doing.
A two-part randomized placebo controlled double blind multicenter Phase 3 study to evaluate the efficacy and safety of linerixibat for the treatment of cholestatic pruritus in participants with primary biliary cholangitis (PBC).
This study is a Phase 3, multicenter, 2-part (Part A and Part B), randomized, double-blind, placebo-controlled study in PBC patients with moderate to severe pruritus. Part A will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo over 24 weeks, while Part B will assess the return of itch over 8 weeks after withdrawal of linerixibat. In both Part A and Part B, participants may be treatment naïve, have had prior itch therapy and/or may take stable background itch therapy at the discretion of the physician in the best interest of the patient or rescue medication where applicable.This study consists of four Periods (Screening, Intervention (Part A and Part B) and Follow-up)