EXPANDED ACCESS PROTOCOL (EAP) FOR SUBJECTS RECEIVING LISOCABTAGENE MARALEUCEL THAT IS NONCONFORMING FOR COMMERCIAL RELEASE
This study is an expanded access protocol (EAP), meaning it is testing the safety and effectiveness of a medicine called nonconforming lisocabtagene maraleucel (a batch of CAR-T-cell therapy or treatment that is suitable for EAP’s clinical use but not suitable for commercial release) in blood cancer patients who have been prescribed it as part of their routine care. The patients will first receive a medicine called lymphodepleting chemotherapy and then will be treated with the study medicine. The study team will check how the patients are doing and monitor all the patients for side effects and discomforts throughout the study. All patients will have their blood samples taken during the treatment to see if their blood counts are within acceptable ranges. Doctors will follow up with all patients for up to 3 months after they receive the study medicine to check for safety and to see how the study medicine is changing their cancer. Subjects will first receive a lymphodepleting chemotherapy regimen and then be treated with nonconforming lisocabtagene maraleucel as the treatment plan.
Expanded Access Treatment of Neladalkib (NVL-655) in Patients with Advanced ALK+ NSCLC or Other ALK+ Solid Tumors
This is a study testing a medicine called Neladalkib (a type of ALK blocker) for patients who have ALK-positive non-small cell lung cancer (NSCLC) that has spread or is hard to treat. This Expanded Access Program gives patients with ALK-positive solid tumors another way to get the medicine Neladalkib if they cannot join a clinical trial or do not have any other good treatment options. Neladalkib works by blocking a protein made by the ALK gene. This protein helps the cancer cells grow and survive. By blocking it, Neladalkib may help stop the cancer from getting worse. Patients will take Neladalkib by mouth, once daily. All patients will have frequent medical check ups and blood samples taken to see how their bodies are handling the study medicine. The study team will have special scans done for all patients to see how the cancer is responding to the study medicines.The study team will be monitoring the patients for potential side effects and safety concerns.
EXpanding Prenatal cell free DNA screening Across moNogenic Disorders (EXPAND)
The purpose of this research is to develop and validate a single gene Non-Invasive Prenatal Test. The development of this investigational single-gene noninvasive prenatal testing (sgNIPT) for conditions such as cystic fibrosis (CF), spinal muscular atrophy (SMA), Sickle cell disease, alpha thalassemia (a-thalassemia) and beta thalassemia (ß-thalassemia) could provide information about the possibility that a child will be born with a serious health condition, in some cases in the absence of paternal screening.
EXpanding Prenatal cell free DNA screening Across moNogenic Disorders (EXPAND)
The purpose of this study is to develop an investigational non-invasive prenatal geneticscreening test that will assess a baby’s risk of being affected by an inherited genetic condition. Enrolled participants will be asked to provide a blood sample, a cheek swab from their newborn if needed, andhealth information related to their pregnancy and delivery. The aim of this study is to collect information to aid in the development of a blood test that can beperformed during pregnancy to determine if a baby is at risk for an inherited condition.
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Exploring spectral and temporal resolution in the apex for speech processor optimization
Two unique attributes of the Med-El cochlear implant system are a long electrode array allowing for apical stimulation of the cochlea and a speech processing strategy (FSP) which specifically provides fine temporal cues in the apex. The deep insertion of the Med-El array allows for encoding place pitch for a greater cochlear extent than the Nucleus and Advanced Bionics arrays. Additionally, the deep insertion allows for temporal encoding in apex where presumably temporal resolution is greatest. However, despite the advantages of the deeply inserted electrode array and the FSP speech processing strategy, there has been little evidence that apical stimulation has provided a consistent clinical benefit (e.g. Magnusson, 2011; Lorens et al., 2010; Riss et al., 2009; Riss et al., 2008). One potential limitation in clinical performance could come from individual variability in both spectral and temporal sensitivities in the apex such that some (but not all) patients benefit greatly from apical stimulation resulting in unimpressive improvements averaged across all subjects while truthfully some patients are receiving large benefits. Another potential limitation in performance could be a non-optimal implementation of temporal coding in FSP.In the following proposal, we will psychophysically explore the temporal and spectral parameter space in the apex to gain an understanding of the potential capabilities and limitations of apical stimulation. Additionally, we will correlate performance on our psychophysical tasks with performance on a speech in noise task and musical pitch task to determine how temporal and spectral cues relate to clinical performance. A correlation between either temporal or spectral resolution in the apex and clinical performance could be used to both guide future refinements of speech processing strategies as well as clinically predict who would benefit from specific processing strategies.
Exploring the Association Between the Caregiver-Child Relationship and Cardiovascular Health
This is an observational study that seeks to collect data (survey, medical record, semi-structured interview, and biospecimen data) from adults who are caregivers of young children (ages 3-10 years) recruited through pediatric and internal medicine clinical sites (NYU Langone and Bellevue Hospital) and two ongoing NYU studies (s19-01964, s16-01104) along with patients seen at the NYU Center for the Prevention of Cardiovascular Disease (CVD), to explore associations between aspects of caregiving for a child (the caregiving role, environment (e.g., potential sources of stress), and relationship with the child) and adult cardiovascular health (CVH), as scored using criteria defined by the American Heart Association. The associations will be explored cross-sectionally (at one point in time), and longitudinally (change in cardiovascular health over time using 3, 6 and 12-month follow-up timepoints).
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