A Single-Center Phase 3 Study of RELAXaHEAD: A Behavioral Approach to Remote Migraine Management in Primary Care
Migraine is the second most disabling condition worldwide. We know that it can be hard for patients to access migraine care. Thus, we are conducting a study for patients of NYU Langone Health who have migraine. Specifically, NYU patients who have visited primary care, have a diagnosis of migraine, and are ages 16+ with 4+ headache days per month will be asked to take part in a smartphone-based migraine self- management program to determine if it will improve migraine-related disability, quality of life and headache days. In this study you will be asked to keep track of your headaches using a headache diary app called RELAXaHEAD. This app will allow you to keep track of your headache days, pain level, sleep, medications, cycle, and notes. Participation time for this intervention can be up to 15 minutes a day for 6 weeks. We will also continue to track use for up to 6 months to see if you think the management program is helpful beyond the initial 6 weeks.
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 Single Dose Study to Evaluate the Pharmacokinetics of LY3209590 in Pediatric Participants with Type 2 Diabetes Mellitus Protocol Number: I8H-MC-BDDB
The purpose of this research study is find out about the safety and tolerability of an experimental drug (LY3209590) for the treatment of pediatric type 2 diabetes mellitus (T2DM) which is a once weekly treatment option. This study will last about 100 days and will involve about 8 visits. Participants will be administered a single dose of a study drug as an injection their belly. Participants will be asked to monitor their glucose levels using a glucose meter provided by the study team.
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 Study to Evaluate PF-06823859 in People With Active Idiopathic Inflammatory Myopathies (Including Dermatomyositis or Polymyositis)
The purpose of this research study is to learn about the effects of the study drug PF-06823859 for treating dermatomyositis (DM) or polymyositis (PM).
A Transdiagnostic Study of Emotional Impulsivity in Suicidal Ideation and Behavior
The purpose of this research study is to understand and learn more about why some people with schizophrenia or depression are more likely to think about or attempt suicide than others. One way to study this issue is by comparing people with schizophrenia or depression with high and low levels of suicidal thoughts and attempts. This study will involve clinical interviews, questionnaires, cognitive testing, and MRI scanning.
A022104 The Janus Rectal Cancer Trial: A Randomized Phase II Trial Testing the Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients with Locally Advanced Rectal Cancer
This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.