Advancing Cath Lab Results with FFRangio Coronary Physiology Assessment: The ALL-RISE Study
The primary objective of this trial is to test whether FFRangio®-guided treatment is noninferior to conventional pressure wire-guided treatment in patients with coronary artery disease being evaluated for percutaneous coronary intervention (PCI) with respect to major adverse cardiac events (MACE) at one year.
AERODIGESTIVE DISEASE IN THE WORLD TRADE CENTER EXPOSED FDNY COHORT: A Single Center Observational Study of Biomarkers of Airway Disease Barrett s and Underdiagnosed Reflux Noninvasively
The destruction of the World Trade Center (WTC) led to the exposure of thousands of first responders and inhabitants of New York City to WTC-particulate matter (WTC-PM). WTC-PM exposure in our Fire Department of New York (FDNY) cohort is associated with the development of obstructive airways disease (OAD), gastroesophageal reflux disease (GERD) and Barrett’s Esophagus (BE). GERD is a well-known risk factor of the metaplastic changes of BE, which can subsequently lead to adenocarcinoma. GERD is also associated with occupational or environmental exposure related OAD. Overall, WTC-exposed firefighters with OAD had a three times higher risk of developing GERD. At least 40% of WTC rescue and recovery workers have developed GERD symptoms, which is 8.2 times its pre-9/11 prevalence. It is in the context of these findings that we propose to study Aerodigestive Disease in the World Trade Center Exposed FDNY Cohort: Validation of Biomarkers and Defining Risk to Tailor Therapy. Research that will further define, phenotype aerodigestive/gastrointestinal health biomarkers, determine impact on lung health to improve care fulfill the mandate of the James Zadroga 9/11 Health and Compensation Act and are in line with PAR-16-098.GERD diminishes health-related quality of life and productivity. Complications of GERD can further extend beyond BE; extra-esophageal reflux can incite or exacerbate allergies, sinusitis, chronic bronchitis, and asthma. Management of reflux is challenging and often refractory to proton pump inhibitor (PPI) therapy, with associated significant health costs. WTC-PM exposure associated asthma more often had, persistent GERD. Although many studies have suggested interdependence between airway and digestive diseases, the causative factors and specific mechanisms remain unclear. There is no gold standard of GERD diagnosis and few disease specific biomarkers. We have successfully identified metabolic, vascular and inflammatory biomarkers of WTC-airway hyperreactivity (WTC-AHR). We have identify biomarkers of GERD/BE in our WTC exposed population with respiratory disease, facilitating identification of biologically relevant immune pathways. In addition, we now present data that GERD increases the odds of developing WTC-AHR, independent of exposure intensity. We propose 2 AIMs to explore the HYPOTHESIS that serum biomarkers will be different in FDNY rescue and recovery workers who proceed to develop GERD/BE. Noninvasive biomarkers will identify subjects that may require improved treatment. We are requesting funding of our translational research to leverage the longitudinally phenotyped FDNY-WTC cohort and identify Biomarkers of Airway Disease, Barrett’s and Underdiagnosed Reflux Noninvasively (BAD-BURN). We will validate biomarkers of GERD and BE (AIM 1), and phenotype subgroups with aerodigestive disease to identify noninvasive biomarkers of under-diagnosis/treatment efficacy to inform future biologically plausible therapies to improve care (AIM 2).
AFFIRM: A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
This is a Phase 4 multicenter evaluation of seladelpar, administered as a once-daily oral capsule, in a randomized, double-blind, placebo-controlled, parallel-group study in patients with PBC. This fixed-duration study (156 weeks) will randomize approximately 192 subjects across approximately 150 sites worldwide. The population to be studied is patients with PBC and compensated cirrhosis restricted to CP-A or CP-B.Key inclusion criteria include confirmed diagnosis of PBC as defined by having any 2 of the following 3 diagnostic criteria: 1) history of elevated ALP, GGT, or conjugated bilirubin of at least 6 months; 2) positive AMA titer or other PBC-specific antibodies; or 3) documented liver biopsy results consistent with PBC. Eligible subjects must have compensated CP-A or CP-B cirrhosis based on prespecified histologic, radiographic, biochemical, and/or clinical criteria.Current UDCA therapy is not a requirement for this study. However, if a subject is not taking UDCA, the subject should have a history of an inadequate response or intolerance to UDCA per Investigator assessment. If subjects are taking UDCA, the dose should be stable for at least 12 weeks prior to Screening.Key exclusion criteria include ALP =10×ULN, ALT or AST =5×ULN, and TB =5×ULN. Subjects are also excluded for history of, or listed for, liver transplant (unless on a transplant list despite relatively early-stage disease per region guidelines); presence or history of decompensated cirrhosis; CP-C cirrhosis; overlapping AIH; hepatitis A, B, or C; or hepatocellular carcinoma (diagnosed or suspected). Use of OCA or fibrates within 6 weeks prior to Screening is also exclusionary.The study includes a 5-week screening, a 156-week treatment period, and a 2-week safety follow-up period.
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AGCT1531: A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs.Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors
The aim of this study for low and standard risk germ cell tumor (GCT) patients is to minimize toxicity by reducing therapy while maintaining current survival rates. The trial will eliminate chemotherapy for low risk patients who are likely cured with surgery and will observe the salvage rates among those who recur.Low risk patients are defined as Stage I patients, ages 0 – 50 years old. Since the trial is enrolling patients from pediatric oncology, gynecologic oncology and genito-urinary oncology (testicular cancer) the relevant staging criteria can be found in Appendices II (COG), III (FIGO), IV (AJCC) and V (IGCCC [International Germ Cell Consensus Classification]). The low risk arm will have two strata. One strata will includepatients with an ovarian pure immature teratoma: COG Stage I (FIGO Stage IA and IB), Grade 2 or 3 with a maximum alpha fetoprotein (a-FP) of 1,000 ng/mL. The other low risk strata will be comprised of patients with COG Stage I (FIGO Stage IA and B; AJCC Stage IA and B) germ cell tumors at any extracranial site (testes, ovary, extragonadal) that have at least one malignant histology, defined as embryonal carcinoma, choriocarcinoma or yolk sac tumor. Patients with pure seminoma or dysgerminoma are excluded from this trial. Low risk patients who recur may receive treatment, if eligible, on the appropriate standard risk arm.Among standard risk patients the trial will evaluate whether cisplatin, which is the standard-of-care in COG, can be replaced with a less toxic alternative platin analogue, carboplatin. The standard risk arm will be divided into 2 age-based strata: (1) Standard Risk 1 (SR1) arm, which includes patients up to 11 years of age with COG Stage II - IV ovarian, testicular or extragonadal GCT and (2) Standard Risk 2 (SR2) arm, which includes patients between 11 and 25 years of age with COG Stage II – III (FIGO Stage IC, II and III) ovarian, COG Stage II extragonadal and testicular, COG Stage II – IV with IGCCC good risk disease.SR1 patients will be randomized to receive either 4 cycles of PEb (cisplatin, etoposide and bleomycin) or 4 cycles of CEb (carboplatin, etoposide and bleomycin). SR2 patients will be randomized to receive either 3 cycles of BEP (cisplatin, etoposide and bleomycin) or 3 cycles of BEC (carboplatin, etoposide and bleomycin). Bleomycin will be administered once per cycle for a total of 4 doses in SR1 patients versusweekly for a total of 9 doses in SR2 patients.Several corollary studies, including evaluation of toxicities (including patient-reported outcomes), pharmacogenetic analysis of adverse events, evaluation of a new miRNA diagnostic and prognostic test and molecular pathway analysis of pediatric, adolescent and young adult GCT are important components of this clinical trial.
AGCT1532: Phase 3 Accelerated BEP Trial: A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours
Bleomycin, Etoposide, Cisplatin (BEP) administered 3-weekly x 4 remains standard 1st line chemotherapy for intermediate- and poor-risk metastatic germ cell tumours (GCTs). Cure rates are over 90% for good-risk disease, 85% with intermediate-risk, and about 70% for poor-risk disease. Previous strategies to improve first-line chemotherapy have failed to improve cure rates and were more toxic than BEP. New strategies are needed for patients with intermediate and poor-risk disease. BEP is accelerated by cycling Cisplatin and etoposide 2-weekly instead of 3-weekly. The Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) is conducting a trial comparing accelerated BEP with standard BEP. The aim of this study is to determine if accelerated BEP is superior to standard BEP as first-line chemotherapy for intermediate and poor risk metastatic GCTs.
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AHCRN Registry: Characterizing Patient Populations in the Adult Hydrocephalus Clinical Research Network (AHCRN)
The AHCRN Registry has been developed to obtain data about hydrocephalus patientevents, treatments and outcomes from the network Clinical Centers, and to create a database to be used by AHCRN investigators. The ongoing maintenance of the Registry serves two main purposes: (1) it will help investigators understand the variability, progression, and current treatment practices for hydrocephalus in adults, with an ultimate goal of better guiding and assessing therapeutic intervention and providing recommendations on patient care and; (2) it will provide pilot and descriptive data necessary for hypothesis generation and study design (e.g., preliminary power analyses, recruitment projections) for studies under development by the AHCRN. This multi-institutional database will be useful for tracking trends in hydrocephalus over time. The Registry will be an invaluable resource to the AHCRN and will help stimulate new research protocols, identify potential need for future expansion of the network to incorporate additional patient populations, and provide a descriptive understanding of adults with hydrocephalus cared for within the network.