A Prospective Randomized Open-label Phase 4 Study of the Immunology and Safety of Maternal RSV Vaccination (ABRYSVOTM) Infant Nirsevimab (BEYFORTUSTM) Immunization or Both Products During the First Year of Life
At the NYU Langone Vaccine Center, we are conducting an NIH sponsored clinical trial on two FDA-approved products that protect against RSV (Respiratory Syncytial Virus): the Maternal RSV Vaccine (ABRYSVOTM) and the Infant RSV Immunization (BEYFORTUSTM). RSV infection can be fatal to infants. Thus, protection against this virus is strongly recommended by the CDC. The standard single protection approach is either the Maternal RSV Vaccine (ABRYSVOTM) during pregnancy or the Infant RSV Immunization (BEYFORTUSTM) after birth. Given the danger of RSV, researchers are conducting this clinical trial to compare the safety and effectiveness of a new double protection approach versus the standard single protection approach using these FDA-approved products. The new double protection approach includes both the Maternal RSV Vaccine (ABRYSVOTM) during pregnancy and the Infant RSV Immunization (BEYFORTUSTM). If you are eligible and agree to participate, you will be randomly assigned to 1 of 4 study groups: New Approach: Double protection Group 1 Mother gets the RSV vaccine (ABRYSVOTM) at 32 to 36 weeks of pregnancy Infant gets the RSV immunization (BEYFORTUSTM) at birth Group 2 Mother gets the RSV vaccine (ABRYSVOTM) at 32-36 weeks of pregnancy Infant gets the RSV immunization (BEYFORTUSTM) at 3 months old Standard Approach: Single protection Group 3 Mother gets the RSV vaccine (ABRYSVOTM) at 32 to 36 weeks of pregnancy Group 4 Infant gets the RSV immunization (BEYFORTUSTM) at birth If you are interested in participating, you will be asked to provide informed consent for yourself and your infant to be part of this study. In this study, you will be asked to complete 6 to 7 in-person visits and 2 phone visits. Your infant will have 5 in-person study visits, which will coincide with your study visits. Participation in this study would begin between 20 to 32 weeks of pregnancy and last until 12 months after your delivery.
A Prospective Randomized Study of a Novel EEG Neurofeedback System for the Treatment of PTSD Using Machine Learning-Based Amygdala Biomarkers
The main purpose of this study is to confirm Prism training can help U.S. Veterans and civilians with post-traumatic stress disorder (PTSD). We will do this by running a large-scale study where some participants get actual neurofeedback treatment and others receive a pretend (sham) treatment.
A Randomized Comparative Effectiveness Study of Staged Complete Revascularization with Percutaneous Coronary Intervention to Treat Coronary Artery Disease vs Medical Management Alone in Patients with Symptomatic Aortic Valve Stenosis undergoing Elective Transfemoral Transcatheter Aortic Valve Replacement: The COMPLETE TAVR Study
This study is being conducted in Aortic Stenosis patients who have undergone successful TAVR with a balloon expandable heart valve who also have coronary artery disease (CAD) or narrowing of the heart arteries.The study will compare:1. opening all suitable stenosis or blockages with an additional procedure (either during the same hospitalization as the TAVR or as a separate procedure) called percutaneous coronary intervention (PCI). This procedure opens or widens the stenosis with a stent thereby allowing blood to flow to the heart muscle. This procedure will happen within 45 days of your TAVR procedure. You will also receive optimal medical therapy.OR2. treating these additional stenosis or blockages with medication only and not opening them with an additional PCI procedure.
A randomized control trial to study the effects of automated physician directed messaging on patient engagement in the digital diabetes prevention program
This study aims to understand the effects of automated physician directed messaging on patient engagement in the digital diabetes prevention program (dDPP). The messages are tailored to patient engagement levels based on established engagement thresholds, which are based on the patient’s use of the dDPP application. The system is designed to minimize work for providers by sending automated targeted messages to patients to potentially increase engagement, prevent onset of diabetes and improve clinical outcomes. The patients in the study are automatically nudged using a combination of text messaging and mychart messaging. Using a mixed-methods design, this study will be completed in three phases. The first phase was a quality improvement project to observe user engagement behavior in the dDPP program, and user test messages to potentially impact their behavior. Phase 2 will be recruiting up to 40 prediabetic patients from two sites within NYU Langone Health to adapt and iterate on the workflow to refine the study intervention. In addition, we will be conducting interviews with providers to build a provider-facing dashboard to report their patients’ engagement behaviors and health outcomes. For Phase 3, we aim to conduct a randomized control trial with 400 pre-diabetic patients, all of whom will be using the dDPP application, and half of them will be randomized to the intervention group and receive automated targeted messaging.
A Randomized controlled study of a health literacy-informed technology-based approach to support safe medication use by parents after discharge of infants from the neonatal intensive care unit
This is a randomized controlled study of parents of children to be discharged from the neonatal intensive care unit at Bellevue and Elmhurst hospitals. A total of 425 subjects will be recruited across two sites over preparatory phases and two primary study phases. Subjects will be assigned to 1 of 3 intervention groups: usual care, HELPix (health literacy-informed written materials and verbal counseling in addition to usual care), or HELPix + TECH (a health literacy-informed web application in addition to HELPix and usual care). Phase A is a pilot study, in which 120 parents will be enrolled at Bellevue Hospital and randomly assigned to usual care or HELPix + TECH. Phase B will take place at both Bellevue and Elmhurst Hospitals, and 225 subjects will be randomly assigned to usual care, HELPix, or HELPix + TECH. Parents will be screened and recruited, written informed consent will be obtained, and a brief survey will be administered on the day of the child’s expected discharge from the neonatal intensive care unit Subjects will then receive usual care followed by the intervention if randomized to one of those groups (Visit 1, Day 0). Medication knowledge, dosing, and adherence will be assessed in-person at a subsequent follow-up visit (Visit 2, Day ~1-7). Adverse events will be assessed via phone call (Visit 3, Day ~30-45). Additional data will be assessed using a chart review. There will be a preparatory phase before each of the 2 phases. For the preparatory phase before Phase A: 10 cognitive interviews will be conducted to assess parent comprehension/ acceptability of HELPix followed by 20 parent interviews focused on HELPix app usability.For the preparatory phase before Phase B: 12 cognitive interviews will be conducted to assess parent comprehension/ acceptability of HELPix. In addition to the cognitive interviews, 3 rounds of feedback with 6 parents per round will be conducted to iteratively refine the HELPix digital app. Once adapted, 20 parents will be asked about HELPix app usability.
A RANDOMIZED CONTROLLED TRIAL OF MAGNESIUM SULFATE AS AN ADJUNCTIVE ANALGESIC IN PROSTATE SURGERY
We will randomize prostate surgery patients to receive magnesium sulfate or not in the context of a standardized anesthetic. Postoperative pain scores and analgesic dose will be measured, in addition to the presence of shivering, quantitative neuromuscular blockade monitoring, drugs administered during anesthesia, and postoperative disposition (home or admission to hospital). We anticipate 110 subjects will give us 90% power to detect a 2 point difference in a 10 point pain score 30 minutes after awakening.
A randomized double-blind double-dummy parallel-group study comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis followed by extended treatment with open-label remibrutinib
The purpose of this research study is to compare remibrutinib and teriflunomide safety and efficacy in patients with relapsing forms of Multiple Sclerosis (RMS).
A randomized double-blind placebo controlled 2-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sj gren s syndrome (NEPTUNUS-1)
The aim of this study is to find out how well treatment with ianalumab works in people with active Sjögren’s syndrome.
A Randomized Double-Blind Placebo-Controlled Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Subjects with Progressive Pulmonary Fibrosis (PPF)
The purpose of this study is to evaluate the safety and efficacy of multiple doses of AP01 compared with placebo (a study treatment containing no active ingredients), over 52 weeks in participants with Progressive Pulmonary Fibrosis (PPF). During the study, you will continue your current PPF treatment regimen; the study drug will be added to your current treatment regimen.
A Randomized Double-Blind Placebo-Controlled Phase 3 Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients with Severe Hypertriglyceridemia
The purpose of this study is to determine the safety, tolerability, and efficacy of the study drug, olezarsen. Apolipoprotein C-III (apoC-III) is a protein found in blood that increases triglyceride levels. The study drug, olezarsen (ISIS 678354), is designed to reduce the amount of apoC-III in the blood. This may help lower the risk of developing pancreatitis and to improve other symptoms of severe hypertriglyceridemia.