Radioactive Iodine Therapy for Thyroid Nodules & Cancers | NYU Langone Health
NYU Langone doctors may use radioactive iodine therapy to manage some toxic nodules and thyroid cancers.
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.
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 Multicenter Phase 3 Study to Evaluate the Safety Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in adult subjects diagnosed with FOSs who are taking 1 to 3 ASMs. Eligible subjects will be randomized 1:1:1 (XEN1101 25 mg: 15 mg: placebo) and stratified according to use of background CYP 3A4-inducer ASMs.
RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED PHASE 2 STUDY OF VE202 IN PATIENTS WITH MILD-TO-MODERATE ULCERATIVE COLITIS
VE202 is a rationally designed, live biotherapeutic product (LBP) for oral (po) administration that consists of 16 well-characterized, clonally-derived, nonpathogenic, nontoxigenic, commensal strains of Clostridia species. VE202 includes 12 strains from Clostridium cluster XIVa, 2 strains from cluster IV, and 2 strains from cluster XVIII. These bacteria, which were originally derived from the stool of a single healthy human, are obligate anaerobes that were selected for inclusion in the LBP based on individual strain- and consortia-specific properties that include association with healthy human gut microbiomes, promotion of colonic regulatory T (Treg) cells, production of beneficial and immunoregulatory metabolites, and lack of overt pathogenic or toxigenic features. The goal of treatment with VE202 is to restore the gut microbiome to a healthy and anti-inflammatory state in patients with UC via induction of immunoregulatory cells in the intestine, production of epithelium-protective metabolites, suppression of potentially inflammatory organisms, and maintenance of homeostatic signaling.
Randomized Double-Blind Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects with Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
EP-547-201 is a randomized, double-blind, placebo-controlled study to evaluate the effects of EP547 on pruritus over 6 weeks in subjects with cholestatic pruritus due to primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC).The study includes a Screening Period of up to 4 weeks to assess subject eligibility; a 6-week Double-Blind Treatment Period; a 6-week Open-Label Extension Period; and a 2-week Safety Follow-Up Period after administration of the last dose of study drug (EP547 or placebo). Approximately 58 subjects will be randomized to receive either 100 mg doses of EP547 or placebo orally (PO) once daily (QD) in a 1:1 ratio. In the Open-Label Extension Period, all subjects will receive 100 mg doses of EP547.
Randomized multicenter open-label phase 3 study of mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with FRa-positive recurrent platinum-sensitive epithelial ovarian fallopian tube or primary peritoneal cancers who have not progressed after second line platinum-based chemotherapy plus bevacizumab(GOG 3078)
The purposes of this study are: • To determine if mirvetuximab soravtansine (MIRV) plus BEV is effective at managing subjects' type of cancer in a maintenance setting, meaning to assess if it helps to prevent their cancer from returning or delaying their cancer’s return. • To determine if mirvetuximab soravtansine (MIRV) plus BEV is more effective at managing subjects' type of cancer in a maintenance setting than treatment with BEV alone.• To find out what effects, both good and/or bad, MIRV plus BEV may have on subjects and their type of cancer. • To assess if taking MIRV and BEV affects quality of life, both good and/or bad.
Randomized Open-label Multicenter Phase 3 Trial of Repotrectinib Versus Crizotinib in Participants with Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-na ve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)
This is a study to compare two medicines (repotrectinib and crizotinib) for patients with a type of lung cancer called ROS1-positive NSCLC (Non-small Cell Lung Cancer). The study team wants to see which treatment works better for patients whose cancer hasn't been treated before with targeted treatment. Some patients with specific types of spread of cancer (NS metastases or leptomeningeal disease) in their brain can join too. Patients who fit the rules will be put into two groups randomly. One group will get repotrectinib (Arm A), and the other will get crizotinib (Arm B). The patients will take these medicines by mouth. The study has three parts: first checking if people can join, then getting the treatment, and finally keeping an eye on them to make sure there are few side effects and how they're doing after the treatment stops.
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.