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 Prospective Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients with End-stage Renal Disease (ESRD)
Each year, only about 27,000 kidney transplants are performed in the United States, leaving over 90,000 people with end stage renal disease (ESRD) waiting for a kidney transplant. Central to the problem of prolonged wait-times is the fact that there are not enough donor organs available for all the ESRD patients who need them. However, over the past 5 years there have been exciting developments in a new type of transplant called kidney xenotransplantation, which may help people with ESRD who are struggling with long wait-times. In kidney xenotransplantation, a kidney from a genetically modified pig is transplanted into a person with ESRD. Special medicines, similar to those used in regular human-to-human transplants, help prevent the body from rejecting the new kidney. These pig kidneys can perform the same important functions as human kidneys, allowing the body to stay balanced and healthy. One big advantage of xenotransplantation is that it can drastically reduce wait-times since there is a more plentiful and easily available supply of pig kidneys compared to human donor kidneys. Patients who have received these pig kidneys have seen encouraging results— all the kidneys have started working right away, and patients have been able to stop dialysis after the transplant. NYU is excited to start a clinical trial, offering this pioneering treatment to ESRD patients who rely on dialysis. If you are interested in learning more about this trial, please reach out to our team for more information.
A QUALITATIVE STUDY OF THE EXPERIENCE OF BLACK/ AFRICAN AMERICANS (AA) PARTICIPATING IN ALZHEIMER S DISEASE RESEARCH
The purpose of the study is to improve the understanding of the experience of Black/African Americans in Alzheimer’s disease and related dementias (ADRD) clinical research and to explore how race and culture might influence research participation.
A Randomised Open-Label Phase III Study of Saruparib (AZD5305) Plus Camizestrant compared with Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1 BRCA2 or PALB2 Mutations and Hormone Receptor Positive HER2-Negative (IHC 0 1+ 2+/ ISH non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)
This study is testing how well a new medicine, saruparib (AZD5305), works when combined with camizestrant compared to other common treatments for advanced breast cancer. The patients in the study have a specific type of cancer that is hormone receptor (HR) positive, HER2 negative, and caused by mutations in BRCA1, BRCA2, or PALB2 genes. Patients will be randomly assigned to one of three groups: saruparib with camizestrant, a doctor’s choice of CDK4/6 inhibitor plus endocrine therapy (ET), or a CDK4/6 inhibitor with camizestrant. The study has four parts: testing for specific genetic markers, screening to see who qualifies, treatment, and follow-up to check progress. Treatment will continue as long as the cancer is under control, side effects are manageable, or the patient chooses to stop. After treatment, doctors will monitor safety, survival, and cancer growth.
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 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 Double-blind Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated with Bipolar I or Bipolar II disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 Years
The purpose of this study is to investigate how “CAPLYTA (Lumaterperone)” works on symptoms of Major Depressive Episodes (MDEs) associated with Bipolar Disorder in young people (10-17 years of age). This study will last about 9 weeks and will involve 9 visits to our center over this period.
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 to Evaluate the Efficacy and Safety of Fazirsiranin the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease with METAVIR Stage F2 to F4 Fibrosis
This is a phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of fazirsiran (TAK-999, previously called ARO-AAT) in the treatment of subjects aged 12 to 75 years (inclusive) with AATD-LD moderate to advanced fibrosis and compensated cirrhosis.The study will enroll subjects with PiZZ AATD-LD with METAVIR stage F2, F3, or F4 liver fibrosis. Approximately 126 up to 140 subjects are planned to be randomized 1:1 to receive either placebo or fazirsiran administered subcutaneously (SC). Subject randomization will be stratified according to METAVIR stage (F2 or F3 vs F4). The F4cc population will be capped at 25% of the total subjects with the remaining 75% being comprised of F2 and F3 subjects.
A RANDOMIZED DOUBLE BLIND PLACEBO-CONTROLLED STUDY OF THE EFFECTS OF STELLATE GANGLION BLOCK ON NEURAL ACTIVITY AND SYMPTOMS IN PARTICIPANTS WITH POST-TRAUMATIC STRESS DISORDER
We are doing this research study to learn more about how a Stellate Ganglion Block (SGB) procedure changes activity in the brain in subjects with Post-traumatic Stress Disorder (PTSD). PTSD is a mental health disorder that some people develop after witnessing or experiencing a traumatic event. People who have PTSD re-experience the traumatic event and feel the same fear and discomfort that they associated with the trauma long after the danger has gone.