Randomized Evaluation of Bromocriptine in Myocardial Recovery Therapy (REBIRTH) for Peripartum Cardiomyopathy
The purpose of the study is to test the use of a drug called bromocriptine for women who have a condition called “Peripartum cardiomyopathy” or PPCM. PPCM means you have heart failure at the end of pregnancy or after giving birth. The study will look at how the heart muscle improves in women taking bromocriptine compared to a group of women given a placebo or inactive pill.
Randomized Phase II/III Trial of 2nd Line Nivolumab + Paclitaxel + Ramucirumab versus Paclitaxel + Ramucirumab in Patients with PD-L1 CPS = 1 Advanced Gastric and Esophageal Adenocarcinoma (PARAMUNE)
A randomized Phase II/III Trial of 2nd Line Nivolumab + Paclitaxel + Ramucirumab versus Paclitaxel + Ramucirumab in Patients with PD-L1 CPS = 1 Advanced Gastric and Esophageal Adenocarcinoma
RANDOMIZED PHASE II/III TRIAL OF SENTINEL LYMPH NODE BIOPSY VERSUS ELECTIVE NECK DISSECTION FOR EARLY-STAGE ORAL CAVITY CANCER
This study is designed as a randomized, phase II/III trial aiming at comparing Elective Neck Dissection (END) and Sentinel Lymph Node (SLN) Biopsy in terms of shoulder related-quality of life (QOL) and disease-free survival (DFS) in patients with early-stage oral cavity squamous cell carcinoma (OCSCC) (cT1-2N0). The phase II uses a superiority design with shoulder-related quality of life (QOL), as measured by the Neck Dissection Impairment Index (NDII), as the primary endpoint. The phase III portion is a non-inferiority trial with DFS as the primary endpoint. The NDII is a hierarchical co-primary endpoint for the phase III. Patients enrolled to the phase II will be included in the primary endpoint analysis of the phase III based on 618 randomized patients. In phase II, 194 randomized patients are required for the analysis after accounting for QOL non-compliance, so 228 patients will be randomized.With this trial, the difference in 6-month NDII scores between arms in the phase II will determine if the study should proceed to a phase III study (“Go/No-Go” decision) to evaluate DFS and NDII. The phase II portion will also determine the feasibility for conducting a SLN biopsy-related study in the NCTN setting. While sufficient DFS events will not be available during the phase II portion of the study, evaluation of the NDII scores between arms in the intermediate (6 month) period, will allow for moving into a phase III study based upon shoulder-related QOL for patients treated with SLN biopsy compared to END, potentially shortening the overall duration of the study if no shoulder-related QOL difference between the surgical arms is detectable.Enrolled OCSCC patients with FDG PET/CT negative result will be stratified by clinical and radiographic T-stage (T1 vs. T2) and Zubrod performance status (0 vs 1-2) before being randomized to receive either SLN biopsy or END in a 1:1 ratio. Enrolled OCSCC patients with FDG PET/CT positive result will go off study and their pathology findings will be collected into a neck registry.This trial implements a permuted block randomization to randomize patients within each strata cell.
Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin Versus Docetaxel Versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck
This study will therefore address the question whether docetaxel alone is as active as docetaxel and cetuximab combination and whether either taxane-based regimen is better than cisplatin monotherapy given to this high-risk group of patients with concurrent radiation. The less toxic weekly cisplatin regimen is selected to enhance compliance in the control arm and to parallel to weekly regimen proposed for the 2 experimental arms. If positive, this study will provide a new standard of care with a non-cisplatin regimen for patients with high-risk head and neck squamous cell carcinoma in the postop setting.
Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-Adapted Treatment Versus Standard-of-Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma
This study is testing whether receiving medicine called cemiplimab (PD-L1 antibody), before surgery (neoadjuvant immunotherapy), is more effective than standard surgery for patients with resectable stage III/IV cutaneous squamous cell carcinoma. Patients will be divided into two groups. The first group will receive standard surgery followed by radiation. The second group will receive an immunotherapy medicine called cemiplimab before the surgery, followed by radiation. The study team will take blood samples from all patients to see if the blood counts are within acceptable ranges and the patients are doing well. Patients will have special scans taken at different times during the study to see how the study medicine is changing their tumor size. All patients will be closely monitored for side effects and discomfort throughout the study. Patients will be followed up to 2 years after the end of treatment.
Randomized placebo controlled trial to determine the biological signature of cannabidiol as a treatment for social anxiety disorder
The goals of these two phased studies (“R61” followed by “R33”) are to establish a biological signature of CBD’s putative therapeutic effects in SAD and its link to core SAD symptoms, to provide estimates of clinical effect sizes, and to provide safety and feasibility data to guide a future definitive RCT of CBD for SAD.
Rapid Motion-Robust and Easy-to-Use Dynamic Contrast-Enhanced MRI for Liver Perfusion Quantification (Non-treatment cohort)
We propose to develop new rapid MRI techniques combining novel motion-robust sampling strategies and advanced reconstruction models to address these challenges.
Reach Out Stay Strong Essentials for mothers of newborns (ROSE) Adaptation for Chinese American mothers
We are conducting a cultural adaptation and pilot study of a postpartum depression prevention intervention among pregnant Chinese American women. Once we establish feasibility and acceptability of the adapted intervention, we will conduct a pilot study. The study consists of focus groups, key-informant interviews, pre-intervention and post-inervetnion questionnaires, a debrief session, and a 7 session intervention.
Real Estate, Development & Facilities Design Guidelines | NYU Langone Health
NYU Langone has design guidelines for project managers, architects, and engineering teams.
Real Estate, Development & Facilities Procurement Opportunities | NYU Langone Health
NYU Langone offers procurement opportunities for various types of projects.