Radiofrequency Ablation for Neck Pain | NYU Langone Health
Doctors at NYU Langone may recommend radiofrequency ablation to relieve neck pain.
Radiosurgery & Radiation Therapy for Pituitary Tumors | NYU Langone Health
NYU Langone doctors may use radiosurgery or radiation therapy to manage some pituitary tumors.
Ralinepag -ROR-PH-301 (APD811-301) - A Phase 3 randomized double-blind placebo-controlled study to evaluate the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH
Site for Phase 3 studies evaluating the efficacy and safety of ralinepag in patients with WHO Group 1 pulmonary arterial hypertension
Randomized Clinical Evaluation of the AccuCinch Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)
The purpose of this research study is to assess the safety and effectiveness of the AccuCinch Ventricular Restoration System and compare it to standardized heart failure medications.The AccuCinch Ventricular Restoration System is an investigational (experimental) device intended to treat patients who are experiencing symptoms of heart failure due to a dilated left ventricle (heart chamber that pumps blood).
Randomized Controlled Open-Label Parallel Group Multi-Center Prospective Phase 4 Study Comparing the Efficacy of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2 3 and 4 Pressure Injuries
This post-marketing study is being performed to assess the effectiveness of Altrazeal® Transforming Powder Dressing (“Altrazeal®” or “TPD”) manufactured by ULURU Inc. in patients with pressure injuries (sometimes also referred to as pressure sores or decubitus ulcers) compared to the current Standard of Care (SOC) therapies. TPD is manufactured, marketed, and used in the United States of America (US). ULURU Inc. is registered with the US Food and Drug Administration (FDA) and Altrazeal® is listed as a Class I 510(k) exempt medical device: “dressing, wound, hydrogel without drug and/or biologic.” (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=410757&lpcd=NAE) Under the supervision of a health care professional, TPD may be used in surgical, acute or chronic wounds including pressure injuries.Objectives:Primary: To compare the efficacy of TPD in reducing primary dressing changes in the treatment of non-infected Stage 2, 3 and 4 pressure injuries (PrIs).Secondary: Evaluate: 1) wound healing trajectories2) safety in the form of adverse events3) subject pain for sensate patientsExploratory: Evaluate: 1) resource utilization of TPD relative to SOC2) cost-effectiveness of TPD versus SOC3) budget impact analysis of adopting TPD4) wound quality of life5) research subject satisfaction6) other ad-hoc analyses as warranted
Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Participants with Cholestatic Pruritus (EXPAND)
The purpose of this clinical research study is to learn more about the use of the study drug, maralixibat, for the treatment of cholestatic pruritus (itch due to liver disease).
Randomized Double-Blind Placebo-controlled Safety Study of Glial Cell Line-Derived Neurotrophic Factor Gene Transfer (AAV2-GDNF) in Multiple System Atrophy
In this clinical trial, we are testing a drug called glial cell line-derived neurotrophic factor (GDNF) gene transfer to see if it helps people with Multiple System Atrophy (MSA). GDNF gene is delivered to a part of the brain involved in MSA. This study will evaluate the safety of this study drug, and see whether it can improve the course of MSA.
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.