Phase I open-label trial evaluating BI 1810631 as monotherapy in the treatment of patients with advanced or metastatic solid tumors with HER2 aberrations (BEAMION-Lung 1)
This is a Phase I, open-label, multicentre trial of BI 1810631 administered orally as a singleagent. The trial has two parts; Phase Ia, which is the dose escalation part (non-randomised),and Phase Ib which is the dose expansion part. The dose expansion part will consist of 3cohorts. If needed, the expansion part will include a randomised dose optimization in Cohort1
Preparing for Your Visit as an International Patient | NYU Langone Health
NYU Langone Health provides information on how to prepare for your visit as an international patient traveling from abroad.
Randomized placebo controlled trial to determine the biological signature of cannabidiol as a treatment for social anxiety disorder
The goals of these two phased studies (“R61” followed by “R33”) are to establish a biological signature of CBD’s putative therapeutic effects in SAD and its link to core SAD symptoms, to provide estimates of clinical effect sizes, and to provide safety and feasibility data to guide a future definitive RCT of CBD for SAD.
Reduction in spread of excitation as predictor of multi-channel spectral resolution
Despite the impoverished information provided by a cochlear implant (CI), patients are unable to use all of the information provided by the CI speech processor. With a CI, pitch is presented by the location in the cochlea in which electric stimulation is presented. Typically, the cochlear location (and therefore the pitch) corresponds to the physical electrode locations. Unfortunately the electric fields provided by stimulation on a single electrode are broad and as a result, adjacent electrodes typically stimulate overlapping neural populations in the cochlea. Therefore, even with 12 to 22 electrodes in a modern implant, CI users typically perform as if they only have approximately 8 electrodes. A technique known as "current focusing" involves simultaneously stimulating on multiple electrodes out of phase, resulting in a reduction in electrical spread within the cochlea. Current focusing may reduce channel interaction and thereby increase the amount of independent information perceived from electrical stimulation. Depending on patient-related factors (e.g., neuronal health, location of electrodes, etc.), individual CI users may or may not benefit from current focusing. The overall goals of this research are to improve CI users' performance via current focusing and to identify CI users that may benefit from focused stimulation. We hypothesize that if current focusing can reduce the spread of excitation, then channel interaction will be reduced and the spectral resolution will be increased, thereby CI performance in challenging listening conditions (e.g., speech in noise, music perception). If current focusing is applied to "current steered" virtual channels, the spectral resolution may be further increased. Ultimately, current shaping (steering and focusing) can be optimized for individual CI users, allowing for efficient transmission of the maximum amount of spectral cues for each patient.In order to achieve the goals of the study, we will conducting a number of speech and hearing tests.
Sarcopenia as a Risk Factor for Adverse Postoperative Outcomes in IBD
We will conduct a prospective cohort study of 120 patients at NYU Langone. Patients who have a biopsy confirmed diagnosis of IBD, who are = 18 years-old, who are undergoing disease-related intestinal resection at NYU Langone Health, and have had CT imaging within 90 days of surgery, will be eligible for study inclusion. Patients who are seen at our outpatient NYU IBD surgical clinics or preoperatively in the hospital, and are planned for intestinal resection, will be approached by their physician to gauge interest in study participation. Sarcopenia Measures: In accordance with guidelines from the EWGSOP and FNIH Sarcopenia Project, our prospective assessment of sarcopenia will include both measures of muscle strength and mass. Muscle strength will be evaluated through grip strength using a standardized Jamar dynamometer, whereby three measurements will be taken from each hand and with a chair stand. Muscle mass will be determined using the cross-sectional imaging measure found to be most predictive of postoperative outcomes. Cognitive assessment will also be performed using a MOCA questionnaire upon initial assessment. On initial study visit, participants will be asked relevant demographic information including age, sex, smoking status (never, former, current), prior abdominal surgery, as well as race and ethnicity. Body mass index (BMI) will be taken at the time of visit, and comorbidities from the Charlson Comorbidity Index will be obtained from the EHR with patients categorized as having 0, 1, =2 comorbidities. IBD-specific variables including: (1) preoperative use of corticosteroids, immunomodulators (IMM) and/or biologics, (2) presence of preoperative infection/abscess, (3) preoperative use of exclusive enteral or parenteral nutrition, and (4) elective or emergent status of the procedure will be extracted from the EHR. Disease severity will be obtained at the time of initial study visit, using validated questionnaires for both CD and UC. For CD, severity will obtained using the validated Harvey Bradshaw Index with scores 16 severe disease. For UC, disease severity will be obtained using the validated Mayo score, with 10 severe disease. Primary Outcome: 30-day composite of postoperative mortality and major complications, including infection, bleeding (requiring blood transfusion or requiring intervention), cardiac event (myocardial infarction, arrhythmia, and cardiac arrest), stroke, acute kidney injury (increase in serum creatinine of =0.3 mg/dL from baseline or =1.5 times baseline), venous thromboembolism, reoperation, readmission, and need for ICU-level care. Outcome measures will be obtained from the electronic health record (HER).We plan to reach enrollment over two years given preliminary surgical numbers from NYU IBD surgical clinic (620 unique patient surgeres over prior 5 years).
Study of newly identified natriuretic protein haptoglobin related protein without signal peptide as biomarker for renal salt wasting and new syndrome of renal salt wasting in Alzheimer s disease: Study to identify protein that alters brain cell function in Alzheimer s disease
This study is being done to better understand hyponatremia (low blood sodium). We have now identified a protein that may be used to diagnose a cause of hyponatremia, cerebral/renal salt wasting (C/RSW). C/RSW is the loss of excessive amounts of salt and water in the urine and is what causes dehydration or too little salt and water in your body. The dehydration can be severe enough to cause low blood pressure, weakness, loss of appetite, dizziness, confusion, trouble walking and even fainting, especially when you stand up. We have also identified that the same protein is present in the blood of subjects with C/RSW and with Alzheimer’s disease (AD). We have also shown that the brain cells of subjects with Alzheimer’s disease are altered. The major aims of this study are to: Develop the protein to help diagnose C/RSW. Use the protein to identify a new syndrome of C/RSW in subjects with Alzheimer’s disease and Identify the protein in the blood of subjects with Alzheimer’s disease that causes their brains cell to alter their function. We can then inhibit the function of this protein to possibly prevent the dementia of Alzheimer disease.
Transcranial Photobiomodulation as a Potential Modulator for Sleepiness
The purpose of this research study is to investigate a potential treatment for residual sleepiness in those who are treating their sleep apnea. Specifically, this clinical trial aims to treat residual sleepiness in those with sleep apnea who have already been treated with CPAP and are stillexperiencing tiredness. The study will use a non-invasive treatment called transcranial photobiomodulation which is intended to help people feel more awake.
invoice-submission-guide-vendors.pdf
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Microsoft Word - prep_FGP FA Application 07.2021 - Spanish.docx
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policy-145-ils-program.pdf
... Safety Policy Manual Policy 145 Policy: Interim Life Safety (ILS) Program Page 1 of 15 Revised ... Section Title Page 1.0 Application ...