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policy-133-medical-gas-outlets.pdf
... Safety Policy Manual Policy No. 133 Policy: Medical Gas Outlets and Piping Page 1 of 4 Revised ... -Index Safety System (DISS) Medigas Policy No. 133 Policy: Medical Gas Outlets and Piping Page 2 of 5 ...
<strong>Adolescents:</strong> A Prospective Single Arm Open Label Trial to Confirm Safety and Effectiveness of Prism as an Adjunct to Standard of Care in Adolescents with Post-Traumatic Stress Disorder (PTSD)
The purpose of this research study is to is to establish if the FDA-approved Prism device, currently used for treating adult PTSD patients can also be safely used to help adolescents. For more information, please email TeenPTSDTxStudy@nyulangone.org.
A Phase 1 Study of MOMA-313 Given as Monotherapy or in Combination With a PARP Inhibitor in Participants With Advanced or Metastatic Solid Tumors
This is a study testing MOMA-313, a drug that blocks a protein called DNA polymerase theta (Pol?) for prostate cancer with a genetic feature called homologous repair deficiency, most commonly with mutation in the gene BRCA2. The drug is being tested by itself or combined with another drug called olaparib, which blocks a different protein (PARP). There are two groups of patients: one group will get MOMA-313 alone, and the other group will get both MOMA-313 and olaparib. In the first group, doctors will test different doses to find the best amount that is effective and with the least amount of side effects to give patients. If patients do well but don't have a strong response to MOMA-313 alone, they may be switched to get both drugs together. The study will also look at how food ate by a patient affects MOMA-313 and how it interacts with olaparib.
A Phase 1/2 open label first-in-human dose escalation and expansion study for the evaluation of safety pharmacokinetics pharmacodynamics and anti-tumor activity of SAR445877 administered as monotherapy or in combination with other anticancer therapies in adults with advanced solid tumors
This is an open-label, multi-center study testing whether the study medicine, SAR445877, (new fusion protein combining anti-programmed cell death 1 (PD1) antibody with modified interleukin (IL)15) is safe and has fewer side effects as a treatment alone or when given with other medicines for adult patients with solid tumors that have spread from their primary location. This study has two parts- For part 1, patients with solid tumors that have spread to other parts of their body and who have no alternative treatment options for their cancer will receive the study medicine every 2 weeks or weekly, together with other medicines decided by the study doctor. For part 2, patients will be divided into nine groups based on the type of their cancer. This group of patients will receive the study medicine at the dose that was found to be most effective and with fewer side effects in part 1 of the study, along with the medicine called cetuximab (EGFR antibody). All patients will have their blood samples taken to see how their bodies are handling the study medicine and to check if they are doing well. All patients will have special scans taken to see how the study medicine is changing their cancer. All patients will be closely monitored for safety and side effects.
A Phase 1/2 Open-Label Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of TNG260 as Single Agent and in Combination with an anti-PD-1 Antibody in Patients with STK11-Mutated Advanced Solid Tumors
This is a first-in-human Phase 1/2, open-label, multicenter, dose-escalation and -expansionstudy designed to determine the MTD of TNG260 as single agent and in combination withpembrolizumab, to determine the RP2D(s) of the combination, and to evaluate the safety andtolerability, PK, and antineoplastic activity of escalating oral doses of TNG260 whenadministered alone and with a standard dose of pembrolizumab in participants with locallyadvanced or metastatic STK11-mutated solid tumors who have progressed on at least 1 lineof standard therapy or are ineligible for standard therapies.In Phase 1 (dose escalation), at least 3 DLT-evaluable participants will be enrolled insequentially escalating dose cohorts to determine the MTD of single agent TNG260, theMTD of the combination of TNG260 and pembrolizumab, and the RP2D(s) of TNG260 incombination with a standard dose of pembrolizumab. The dose escalation of TNG260 will beguided by two BLRMs based on any DLTs observed in the first cycle (ie, the first 21 days) ofthe single agent therapy and the second cycle for the combination therapy.Participants in Phase 2 (dose expansion) will be dosed at the RP2D(s) determined fromPhase 1 based on demonstrated tolerability, together with available PK data and results oftarget engagement studied during Phase 1 (or other measures including PD and efficacy), asapplicable. Three Phase 2 combination expansion arms (TNG260 in combination withpembrolizumab) will enroll up to approximately 30 participants each.
A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS
This is a first-in-human, open-label, Phase 1a/b master protocol to evaluate safety,tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinicalactivity of PF-07799544 (also known as ARRY-134) as a single agent and in combinationwith other targeted agents in participants with advanced solid tumors.The mitogen activated protein kinase (MAPK) pathway plays a role in several key signalingand phosphorylation events that contribute to tumorigenesis. Inhibition of mitogen activatedextracellular kinase (MEK), along with rapidly accelerating fibrosarcoma (RAF) kinases, hasproven to be a successful transformative strategy for melanoma and other MAPKpathway-altered tumors. However, the duration of clinical benefit is limited by a narrowtherapeutic index, de novo and acquired resistance and poor brain penetration. PF-07799544is a next-generation, fully brain penetrant MEK inhibitor. Therefore, there is strong scientificrationale for PF-07799544 as a backbone for targeted therapy combination regimens.Phase 1a will be a monotherapy dose escalation of PF-07799544 to identify the maximumtolerated dose (MTDM) or recommended dose for expansion (RDEM) in participants withadvanced solid tumors whose disease has progressed on standard therapy.Phase 1b will be based on a master protocol design and will be comprised of multiplesubstudies, evaluating PF-07799544 with different combinatorial agents in participants withadvanced B-Raf protein kinase (BRAF) mutated melanoma or other solid tumors. Additional substudies may be added through amendment, and may include other study drugcombinations in other patient populations. Each substudy testing a new combination of drugswill be comprised of 2 parts: Part 1 to evaluate safety, tolerability, PK, and PD of thecombination of escalating doses of PF-07799544 with that of other targeted agents and Part 2to evaluate anti-tumor activity, safety, PK, and PD.
A PHASE 1B/2 MULTICENTER OPEN-LABEL STUDY OF IFINATAMAB DERUXTECAN (I-DXd) A B7-H3 ANTIBODY-DRUG CONJUGATE (ADC) IN COMBINATION WITH ATEZOLIZUMAB WITH OR WITHOUT CARBOPLATIN AS FIRST-LINE INDUCTION OR MAINTENANCE IN SUBJECTS WITH EXTENSIVE-STAGE SMALL CELL LUNG CANCER (ES-SCLC) (IDeate-Lung03)
This global study is designed to test how safe and effective the drug I-DXd is when combined with atezolizumab, with or without carboplatin. The treatment will be used either as ongoing maintenance therapy or as part of a short initial treatment followed by maintenance. The study will take place at multiple locations in the United States, Europe, and Japan. It has two main parts: Part A focuses on checking safety, while Part B adjusts the doses to find the best amount to use. Patients must be able to perform normal daily activities and can join even if they have brain metastases that don’t cause symptoms. A type of radiation therapy called prophylactic cranial irradiation (PCI) is allowed if the patient’s cancer responds well to the treatment. The study will start by testing one group to see if thedoses are safe before adding more groups and eventually randomizing patients. Previous studies suggest that combining I-DXd and atezolizumab should have manageable side effects. Researchers may add new treatment options to the study later if needed.
A Phase 1b/2 Study of AZD0120 (also known as GC012F) a Chimeric Antigen Receptor T Cell Therapy Targeting CD19 and B cell Maturation Antigen in Participants with Relapsed or Refractory AL Amyloidosis
Open-label Phase 1b/2 study with primary objective of this study is to evaluate the safety, tolerability and efficacy of AZD0120 in participants with light chain (AL) amyloidosis.
A Phase 3 Open-label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant HR+ HER2- Locally Advanced or Metastatic Breast Cancer
This is a Phase 3 study testing whether the study medicine RLY-2608 (selective inhibitors of PI3Ka) along with fulvestrant (standard hormone therapy) is more effective and safer than other medicines, such as capivasertib (AKT inhibitor) and fulvestrant combination for patients with HR+/HER2- advanced breast cancer, whose cancer has come back after prior treatment with a CDK4/6 inhibitor and shows changes in the PIK3CA gene. Patients will be randomly divided into two groups. Group 1 will receive the RLY-2608 and fulvestrant, and Group 2 will receive capivasertib and fulvestrant. The study team will monitor all patients for the time interval it takes for the cancer to come back or worsen (PFS) for both groups, as well as the overall survival of patients. Blood samples will be collected from all patients to see how their bodies are handling the study medicine and to check their overall well-being. Specialized testing known as ctDNA testing will be done for all patients to learn about their cancer. All patients will undergo special scans to check how their tumors are responding to the medication. All patients will be closely monitored for potential side effects and safety concerns.