AN EIGHTEEN MONTH OBSERVATIONAL INVESTIGATION OF PARTICIPANTS WITH OPEN ANGLE GLAUCOMA AND A DOCUMENTED HISTORY OF PROGRESSIVE VISUAL FIELD LOSS: ASSESSING THE REPRODUCIBILITY AND RESPONSIVENESS OF OUTCOME MEASURES OF GLAUCOMA PROGRESSION
This is a 18 month observational study in individuals who have any form of open angle glaucoma with Humphrey visual field (HVF) 24-2 SITA standard MD of -2.0 to -10 dB and slope of -0.5 to -1.0 dB/year in 4 visual fields performed in the last 24 months. The study will evaluate several common clinical measures used in the management of glaucoma (RNFL OCT, GCIPL OCT, OCTA, HVF 24-2 MD, HVF 10-2 MD, Mars contrast sensitivity) for test-retest reproducibility and responsiveness to glaucoma progression. Each participant completes 11 visits in 18 months.
An Evaluation of Home Urinalysis Testing for Systemic Lupus Erythematosus (SLE) Patients at Elevated Risk for Developing Lupus Nephritis: A Pilot Stage and Randomized Controlled Study
Pilot Study: Feasibility, acceptability, and adaptation. We will produce a teaching video for home-based proteinuria testing that will instruct patients on how to collect a sample and evaluate the home colorimetric dipsticks (only protein, Siemens Albutrix).The urinalysis video planned, which will simply instruct the patients how to line up the dipsticks with the single protein color chart and match the color most closely corresponding to their urine. A scoring system will be explained, such that the color matching will be assigned as follows: negative = 1, trace = 2, +300 (.300g/l) = 3, 1.000g/l = 4, 3.000g/l = 5, 10.000g/l = 6.Following informed consent at their clinic visit, 18 participating patients will view the educational video, with available subtitles in all three languages (i.e., English, Spanish and Mandarin. The patient will have sufficient dipsticks to test the first morning void once weekly for a year (with weekly reminders via a text protocol) unless earlier intervention is required. For reporting the weekly score, the patient will be instructed to respond to the text they receive on the morning of the weekly dipstick check and enter the number corresponding to the color matching the dipstick, and indicate “period” if menstruating. If the score provided by the patient is 3 or greater for two consecutive weeks, the texting program will be programmed to alert the coordinator to call the patient and ask the patient come to the local laboratory for a formal UPCR. A UPCR of 0.5 or greater would trigger an immediate SOC visit with Drs. Buyon, Saxena, Belmont, or Izmirly. We will be using the HIPAA-compliant texting platform, SlickText, for patient communication. Participants will be able to send STOP message to opt out, and the only information included is their phone number. Additionally, they will be able to send TEAM message to receive a call from the coordinator if they encounter any difficulties. Each participant will receive texts in their preferred language. Feasibility for Stage 1 will be assessed quantitatively by the number of patients approached for the evaluation versus number willing to participate, with 70% participating as considered feasible. Acceptability will be determined if =80% of participants respond that they are at least moderately satisfied, using a brief Client Satisfaction Questionnaire. Data on adherence and implementation feasibility will be captured via SlickText (number of weeks returning a dipstick value divided by overall weeks, accommodating menstruation when urinalysis may not be completed, although patients will be instructed to collect the urine and record their period). Adherence of 75% will be considered successful. Further, we will aim to clinically validate the scores reported by patients who have a scheduled standard-of-care visit preferably on the same day as the weekly morning dipstick scoring is done; we will attempt to assure that patient score readings of 1 or 2 correspond to UPCR < 0.3. If we find errors, we will coach the patient and check their supply of dipsticks for deterioration. At the middle and end of the first year of the protocol, we will conduct debriefing interviews to evaluate the personal experiences and satisfaction with the intervention and modify the protocol accordingly. Clinical Trial To Follow: Implement a larger randomized controlled trial (RCT) among all eligible in the NYU Lupus Cohort (160 participating patients). Patients will be enrolled and randomized (1:1) to home testing intervention in addition to standard of care or standard of care only. Patients who have a scheduled standard-of-care visit preferably on the same day as the weekly morning dipstick scoring is done; we will attempt to assure that patient score readings of 1 or 2 correspond to UPCR < 0.3. The primary outcome will be that has a clinical indication for a kidney biopsy (UPCR 0.5 regardless of either de novo or relapsed disease), whether or not the patient actually undergoes the procedure.
An Open-label Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety Tolerability Pharmacokinetics Pharmacodynamics and Preliminary Antitumor Activit of TAK-500 a Novel Stimulator of Interferon Genes Agonist as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Select Locally Advanced or Metastatic Solid Tumors
This study is about a new medicine called TAK-500. We want to see if it is safe and if it works well by itself or with another medicine called pembrolizumab. The study has two parts. First, we will try different amounts of TAK-500 to see which one has the fewest side effects and still works well. Then, we will give this amount to people who have certain types of cancer. People with serious cancers, like those in the throat, stomach, pancreas, liver, lungs, head, neck, and kidney, as well as a type of breast cancer and a cancer called mesothelioma, will join the study. We want to see if the medicine doesn't make people feel too sick, how it works in the body, and if it helps fight the cancer.
An Open Label Multi-Center Retrospective and Prospective Evaluation of Equinoxe Proximal Humerus Fracture Plates Clinical and Radiographic Outcomes
The primary objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data to better understand the safety and performance of Equinoxe Proximal Humerus Fracture Plates over time.
AN OPEN-LABEL MULTICENTER PHASE 1/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF AB-2100 IN PATIENTS WITH RECURRENT ADVANCED OR METASTATIC CLEAR-CELL RENAL CELL CARCINOMA (CCRCC)
This is a study seeing if a new cellular medicine called AB-2100, a logic-gated CAR T cell targeting PSMA and Ca-IX, is effective for adult patients with a specific type of advanced kidney cancer called clear-cell renal cell carcinoma (ccRCC). The study team wants to the safety and anti-cancer effectiveness of this medicine. Patients will try different doses of AB-2100 in the first part of the study, and once they figure out the right amount that has tolerable side effects, more patients will receive the treatment in the second part. The study is split into different steps for each patient, like checking if they're a good fit for the study, getting cell samples from the patient, preparing the body for treatment, receiving the medicine, and then seeing how things go afterward concerning treatment.
AN OPEN-LABEL MULTICENTER PHASE 2 STUDY EVALUATING THE EFFICACY AND SAFETY OF CRG-022 A CD22-DIRECTED AUTOLOGOUS CHIMERIC ANTIGEN RECEPTOR (CAR) T-CELL THERAPY IN PARTICIPANTS WITH RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA AFTER CD19-DIRECTED CAR T-CELL THERAPY
CD19-directed autologous CAR T-cell therapy has changed the treatment landscape for patients withrelapsed/refractory (R/R) large B-cell lymphoma (LBCL). Nonetheless, up to 60% of patients undergoingautologous CD19-directed CAR T-cell therapy experience disease progression due to treatment resistance, includingCD19-negative relapse; outcomes for these patients are poor. Therapy directed at an alternative B-cell-specificantigen may be able to overcome resistance to CD19-directed therapy.CRG-022 is an autologous CAR T-cell product targeting CD22, a common B-cell antigen widely expressed inLBCL. This study aims to evaluate the safety and the efficacy of CRG-022 in the treatment of participants with R/RLBCL that has progressed after CD19-directed CAR T-cell therapy, an area of high unmet need.
AN OPEN-LABEL MULTICENTER STUDY OF LOXO-435 (LY3866288) IN ADVANCED SOLID TUMOR MALIGNANCIES WITH FGFR3 ALTERATIONS
This is a study of a drug called LOXO-435 for patients with advanced solid tumors, specifically focusing on metastatic urothelial cancer (mUC) that has a change in a gene called FGFR3. The study will be conducted in two phases. Phase 1a is the first part and will test different doses of LOXO-435 to determine its safety, how well it is accepted by the patient's body, how the body processes it (pharmacokinetics), and its initial effectiveness. This phase will include patients with any type of solid tumor that has an alteration in the FGFR3 gene or its related proteins. The goal is to find the recommended dose for the next phase. Phase 1b is the second part and will involve four groups of patients receiving the recommended dose from Phase 1a. These groups will include patients with urothelial cancer, either as a single treatment or in combination with pembrolizumab (another drug), as well as patients with other types of advanced solid tumors who will receive LOXO-435 alone. The purpose is to evaluate the effectiveness and safety of LOXO-435 in these specific patient groups.
An open-label phase I dose escalation expansion study of MGY825 in adult patients with advanced non-small cell lung cancer
This study wants to figure out if a new medicine called MGY825 is safe and helpful for patients with advanced non-small cell lung cancer. They also want to learn how the body handles this medicine and if it can shrink tumors. The main aim is to make sure it's safe and useful for future treatments. They'll watch closely for any side effects, adjust the doses as needed, and see how it affects the patients overall. The study has two parts: first, they'll find the safest and most effective dose, and then they'll test it on different groups of patients. They're especially interested in patients with specific genetic changes (NFE2L2/KEAP1/CUL3) and certain enzyme levels because these things might affect how well the medicine works. The ultimate goal is to offer better treatments for those with advanced lung cancer who have already tried other options.
Andrew W. Brotman, MD | NYU Langone Health
Dr. Andrew W. Brotman is NYU Langone’s executive vice president and vice dean for clinical affairs and strategy, chief clinical officer.
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