Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis
The purpose of this study is to use different measures to evaluate pain levels and pain responses in subjects with chronic pancreatitis to develop a biomarker that can help to better predict the response to medical and interventional therapies for pain. Biomarkers are measurable indicators of changes in the body (for example: pain, disease progression, treatment response).
Anomalous Aortic Origin of a Coronary Artery (AAOCA): Establishing a Multi-Institutional Registry
This is a retrospective and longitudinal cohort study. Subjects will be enrolled either when identified from medical records or when diagnosed with AAOCA. Baseline demographics, diagnoses, and test results will be obtained through retrospective chart review. Follow-up health-related information will be obtained through annual questionnaire. The project will be carried out at several participating CHSS member institutions, with the data stored and analyzed at the CHSS Data Center.
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.
REBYOTA for the Prevention of Recurrence of Clostridioides Difficile Infection (CDI) in Adult Patients: An Observational Study
This is a prospective observational cohort study designed to collect data on patients who received REBYOTA for the prevention of rCDI in the routine care setting. As all data collected for this study are observational, the decision to prescribe REBYOTA is at the treating physician’s discretion and independent from the decision to enroll the patient in the study. Adult patients who receive a prescription for REBYOTA to prevent rCDI are eligible to enroll according to the inclusion and exclusion criteria described below. Patients must enroll in the study between prescription and administration. This allows time for patients to enroll while still conducting the baseline measurement of patient-reported outcomes (CDI-DaySyms™) prior to administration. REBYOTAFor each patient, the current or presenting rCDI episode will be defined as the CDI episode just prior to receiving REBYOTA. If a patient receives REBYOTA more than once, the first dose will be used to define the presenting rCDI and to assess REBYOTA effectiveness.Baseline period will be defined as the time period between the date REBYOTA is prescribed and the date REBYOTA is administered.Data will be collected from patients’ medical records after obtaining informed consent. Data about clinical history, CDI events (primary and recurrent: severity, treatment), CDI-related symptoms, treatments, medical procedures, AEs, and healthcare resource utilization (i.e., hospitalizations and re-admissions) will be collected through 6 months of follow-up from the date of REBYOTA administration.
Non-invasive biomarkers for neonatal outcomes in preterm infants
Despite modern advances that have greatly improved the health outcomes for preterm infants, the field of neonatology still lacks reliable prognostic tools for many disorders. Noninvasively-obtained samples (such as blood, trach aspirate, urine, saliva and stool samples) contain a wealth of biologic information in the form of DNA, RNA, proteins, and metabolites that can predict neonatal outcomes. Exosomes are small, membrane-bound extracellular vesicles (EVs) that are released by a variety of cells and involved in several cell-to-cell communication pathways. A proposed mechanism by which exosomes mediate cell signaling is via microRNAs (miRNAs), which are small, non-coding RNA segments that silence complementary messenger RNA (mRNA) segments. While exosomes have been characterized in biofluids from adults, few studies have examined the diagnostic value of biofluid exosomes.The objective of this study is to determine whether exosomes can be isolated from neonatal blood, urine, trach aspirate, saliva and stool samples, and if so, whether specific biomarkers (such as exosomal miRNAs) are associated with distinct neonatal pathologies such as chronic lung disease of prematurity (BPD: Bronchopulmonary dysplasia) or other neonatal inflammatory conditions. This is significant because findings could revolutionize the way preterm infants in neonatal intensive care units (NICUs) are monitored at the bedside. This exploratory, prospective study will be conducted with samples collected from the NYU Winthrop Hospital NICU. Specifically, we will measure biomarkers from non-invasive samples (Blood, urine, saliva and stool samples) in two groups; 1) preterm infants
Innovative NeurovaScular Product surveIllance REgistry (INSPIRE)
The purpose of this study is to collect information over time about how the approved Pipeline™ Shield Device is working and/or the outcome of the treatment. The study will be used to support post-market surveillance activities and post-approval studies (e.g., to collect safety and performance information). In addition, it will be used to obtain clinical evidence for the development and improvement of medical devices, therapies, device guidelines, patient services/solutions and provide clinical data to support health economics and clinical outcomes research. The Pipeline™ Shield Device is not investigational and the procedures being performed are not experimental.
Monitoring and Prediction of Treatment Response in Crohn s Disease with Dual-Energy CT Enterography
This will be a quantitative, prospective study. Patients with small bowel Crohn’s will be enrolled in the study. Patients will undergo an initial DECTE prior to starting a new therapy as is already performed by standard of care. Following implementation of medical therapy, patients will undergo a follow-up DECTE 4 to 8 months later as is performed by standard of care. Medical therapies are at the discretion of the gastroenterologist caring for the patient as per standard of care. The iodine density will be determined and 3D iodine density maps will be created for each patient at the time of both DECTE examinations. We will be required to record patient name, MRN, accession number of each CT, patient age, gender, and clinical data including the Crohn’s disease activity index (CDAI), which is a calculated score based on a combination of clinical and laboratory values that do not involve PHI. PHI (MRN, accession number, name, dates of scans) will be used to identify patients for inclusion in the study and for comparison with follow-up imaging. All PHI will be removed at the earliest opportunity. The age, gender and initial clinical information will be recorded while first identifying patients. Clinical information will also be recorded at the time of follow-up CT. Following the 2nd DECTE, all PHI including MRN and accession number will be discarded. Each patient will be assigned a random identification number for anonymous image review. No link to PHI will be maintained.
Our Locations | NYU Langone Health
NYU Langone Heart has locations in New York City and on Long Island, as well as in Westchester County and Florida.
The Prospective Natural History of Congenital Insensitivity to Pain with the Anhidrosis (CIPA)
The purpose of this study is to create a database of clinical information collected from you/your child’s medical chart on a yearly basis from patients with Congenital Insensitivity to Pain with Anhidrosis (CIPA). The study will document the clinical features of patients with CIPA overtime by storing their routine clinical test results in a central database. The study will involve collaborators at other specialist clinics around the world who follow/evaluate patients annually. Providing blood for future use is optional.
School Health Program—Family Health Centers at NYU Langone | NYU Langone Health
The School Health Program—Family Health Centers at NYU Langone brings healthcare into schools where it is convenient for children to access.