Benefits of Cochlear Implantation and Hearing Preservation for Children With Preoperative Functional Hearing: A Prospective Clinical Trial.

Objectives: This study was designed to (1) compare preactivation and postactivation performance with a cochlear implant for children with functional preoperative low-frequency hearing, (2) compare outcomes of electric-acoustic stimulation (EAS) versus electric-only stimulation (ES) for children with versus without hearing preservation to understand the benefits of low-frequency acoustic cues, and (3) to investigate the relationship between postoperative acoustic hearing thresholds and performance.

Design: This was a prospective, 12-month between-subjects trial including 24 pediatric cochlear implant recipients with preoperative low-frequency functional hearing. Participant ages ranged from 5 to 17 years old.

Improvement in vision-related quality-of-life using the NEI-VFQ-9 over 1-year in the Manhattan Vision Screening and Follow-up Study (NYC-SIGHT).

Purpose: To examine the nine-item National Eye Institute Vision Function Questionnaire (NEI-VFQ-9) scores at baseline and 12 months in participants enrolled in the Manhattan Vision Screening and Follow-up Study (NYC-SIGHT) and determine factors associated with improvements in vision-related quality-of-life (VRQOL).

Methods: Retrospective review of NEI-VFQ-9 scores at baseline and 12-month follow-up in a community-based eye health screening study conducted in Upper Manhattan, New York. Participants were age ≥ 40 years and older, living independently in public/affordable housing developments and able to provide informed consent.

Factors Influencing Pediatric Cochlear Implant Use.

Purpose: Cochlear implant device use, quantified by hearing hours percentage (HHP), is a known variable that impacts pediatric spoken language outcomes. Isolating specific factors that impact HHP could help clinicians intervene to reduce the implications of barriers and amplify the positive facets. The aim of this study is to identify variables that predict HHP in children.

In vivo CAR T-cell generation in nonhuman primates using lentiviral vectors displaying a multidomain fusion ligand.

Chimeric antigen receptor (CAR) T-cell therapies have demonstrated transformative efficacy in treating B-cell malignancies. However, high costs and manufacturing complexities hinder their widespread use. To overcome these hurdles, we have developed the VivoVec platform, a lentiviral vector capable of generating CAR T cells in vivo.

Effect of Age and Unaided Acoustic Hearing on Pediatric Cochlear Implant Users' Ability to Distinguish Yes/No Statements and Questions.

Purpose: The purpose of this study was to evaluate the ability to discriminate yes/no questions from statements in three groups of children: bilateral cochlear implant (CI) users, nontraditional CI users with aidable hearing preoperatively in the ear to be implanted, and controls with normal hearing. Half of the nontraditional CI users had sufficient postoperative acoustic hearing in the implanted ear to use electric-acoustic stimulation, and half used a CI alone.

Method: Participants heard recorded sentences that were produced either as yes/no questions or as statements by three male and three female talkers.

Manhattan Vision Screening and Follow-up Study (NYC-SIGHT): a nested cross-sectional assessment of falls risk within a cluster randomised trial.

Background: To investigate the feasibility of using the Stopping Elderly Accidents, Deaths and Injuries (STEADI) Falls Risk Tool Kit during community-based eye health screenings to assess falls risk of participants enrolled in the Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT).

Methods: Cross-sectional analysis of data from a 5-year prospective, cluster-randomised clinical trial conducted in affordable housing developments in New York City in adults age 40 years and older. Prescreening questions determined whether participants were at risk of falling.

Manhattan Vision Screening and Follow-up Study (NYC-SIGHT): Vision and refractive error results.

Clinical Relevance: Optometrists can play a key role in providing access to eye care in underserved populations by organising community-based eye health screenings that include optometric exams to detect vision impairment and uncorrected refractive error.

Background: Community-based eye health screenings and optometric exams were conducted in the NYC-SIGHT Study.

Methods: A sub-analysis of vision impairment and refractive error results within a 5-year prospective, cluster-randomised clinical trial.

Survival analysis on subchondral bone length for total knee replacement.

Objective: Use subchondral bone length (SBL), a new MRI-derived measure that reflects the extent of cartilage loss and bone flattening, to predict the risk of progression to total knee replacement (TKR).

Methods: We employed baseline MRI data from the Osteoarthritis Initiative (OAI), focusing on 760 men and 1214 women with bone marrow lesions (BMLs) and joint space narrowing (JSN) scores, to predict the progression to TKR. To minimize bias from analyzing both knees of a participant, only the knee with a higher Kellgren-Lawrence (KL) grade was considered, given its greater potential need for TKR.

Factors that influence performance in pediatric cochlear implant recipients with cochlear nerve deficiency.

Objectives: Children with cochlear nerve deficiency (CND) have wide variability in outcomes with cochlear implant (CI) use. The current study aims to report a large cohort of pediatric CI recipients with CND and to evaluate for factors that may predict improved performance.

Methods: The current study is a retrospective review of pediatric CI recipients with CND at a tertiary academic hospital.

Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT): optometric exam improves access and utilization of eye care services.

Purpose: To describe the benefits of optometric evaluation for detection of vision-affecting conditions in the context of community-based eye health screenings and identify factors associated with having a recent dilated eye exam.

Methods: Enrolled participants were age 40 and older, living independently in affordable housing developments in New York City. Eye health screening failure and criteria for seeing the on-site study optometrist were defined as visual acuity 20/40 or worse in either eye, intraocular pressure 23-29 mmHg, or an unreadable fundus image.

Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT): Subanalysis of Referral to Ophthalmology.

Purpose: The Manhattan Vision Screening and Follow-up Study aims to provide access to eye care for underserved populations, detect native rates of ocular pathology, and refer participants with eye disease to ophthalmology. This subanalysis describes the reasons for referral to ophthalmology and identifies risk factors associated with being referred.

Methods: Enrolled participants were aged ≥40 years, living independently in public housing developments and able to provide consent for eye health screenings.

Manhattan Vision Screening and Follow-Up Study: (NYC-SIGHT)Tele-Retinal Image Findings and Importance of Photography.

To describe tele-retinal abnormality image findings from the Manhattan Vision Screening and Follow-up Study (NYC-SIGHT), which aims to investigate whether community-based eye health outreach strategies using telemedicine can improve visual outcomes among at-risk populations in Upper Manhattan. A 5-year prospective, cluster-randomized clinical trial was conducted. Eligible individuals aged 40 years and older were recruited from affordable housing developments and senior centers in New York City.

Long-Term Perceived Benefit of Pediatric Cochlear Implant Users with Unilateral Hearing Loss.

Objective: To assess the perceived benefit of cochlear implant (CI) use for children with unilateral hearing loss (UHL) and evaluate whether perceived abilities are associated with performance on measures of speech recognition and spatial hearing.

Method: Nineteen children with moderate-to-profound UHL underwent cochlear implantation. The Speech Spatial and Qualities of Hearing Questionnaire modified for children (SSQ-C) were completed by parental proxy pre-operatively and at 3, 6, 9, 12, 18, and 24 months post-activation.

Factors that influence outcomes and device use for pediatric cochlear implant recipients with unilateral hearing loss.

Introduction: Candidacy criteria for cochlear implantation in the United States has expanded to include children with single-sided deafness (SSD) who are at least 5 years of age. Pediatric cochlear implant (CI) users with SSD experience improved speech recognition with increased daily device use. There are few studies that report the hearing hour percentage (HHP) or the incidence of non-use for pediatric CI recipients with SSD.

Two-Year Outcomes of Cochlear Implant Use for Children With Unilateral Hearing Loss: Benefits and Comparison to Children With Normal Hearing.

Objectives: Children with severe-to-profound unilateral hearing loss, including cases of single-sided deafness (SSD), lack access to binaural cues that support spatial hearing, such as recognizing speech in complex multisource environments and sound source localization. Listening in a monaural condition negatively impacts communication, learning, and quality of life for children with SSD. Cochlear implant (CI) use may restore binaural hearing abilities and improve outcomes as compared to alternative treatments or no treatment.

Manhattan Vision Screening and Follow-up Study (NYC-SIGHT): Baseline Results and Costs of a Cluster-Randomized Trial.

Purpose: To describe the 15-month baseline results and costs of the Manhattan Vision Screening and Follow-up Study, which aims to investigate whether innovative community-based eye health screening can improve early detection and management of glaucoma and other eye diseases among high-risk populations.

Design: Five-year prospective, cluster-randomized controlled trial.

Methods: Individuals aged 40+ years were recruited from public housing buildings in New York City for an eye health screening (visual acuity (VA) with correction, intraocular pressure measurements (IOP), and fundus photography).

Younger Age at Cochlear Implant Activation Results in Improved Auditory Skill Development for Children With Congenital Deafness.

Purpose: The U.S. Food and Drug Administration indications for cochlear implantation in children is currently 9 months of age and older for children with bilateral profound sensorineural hearing loss (SNHL).

Cochlear Nerve Deficiency in Pediatric Unilateral Hearing Loss and Asymmetric Hearing Loss.

Introduction: The rates of cochlear nerve abnormalities and cochlear malformations in pediatric unilateral hearing loss (UHL) are conflicting in the literature, with important implications on management. The aim of this study was to investigate the incidence of cochlear nerve deficiency (CND) in pediatric subjects with UHL or asymmetric hearing loss (AHL).

Methods: A retrospective chart review of pediatric subjects <18 years of age evaluated for UHL or AHL with fine-cut heavily T2-weighted magnetic resonance imaging (MRI) between January 2014 and October 2019 (n = 291) at a tertiary referral center was conducted.

American Cochlear Implant Alliance Task Force Guidelines for Clinical Assessment and Management of Cochlear Implantation in Children With Single-Sided Deafness.

More children with single-sided deafness (SSD) are receiving cochlear implants (CIs) due to the expansion of CI indications. This unique group of pediatric patients has different needs than the typical recipient with bilateral deafness and requires special consideration and care. The goal of cochlear implantation in these children is to provide bilateral input to encourage the development of binaural hearing.

A Single-Center Comparative Study of Open Transabdominal and Laparoscopic Transanal Ileal Pouch-Anal Anastomosis with Total Mesorectal Excision. Has the Bar Been Raised?

Background: Most ulcerative colitis (UC) patients requiring surgery undergo transabdominal ileal pouch-anal anastomosis (IPAA) performed minimally invasively or open. Although one multicenter study demonstrated acceptably low morbidity after transanal pouch, our initial single-center experience with transanal IPAA (ta-IPAA) was associated with an unacceptably high rate of anastomotic leak. The aim of this study was to compare the short-term outcomes of ta-IPAA and transabdominal IPAA with growing experience of transanal proctectomy and determine whether one approach offered any advantage or benefit over the other.

The Limitations of FDA Criteria: Inconsistencies with Clinical Practice, Findings, and Adult Criteria as a Barrier to Pediatric Implantation.

Children require greater access to sound than adults as they are learning to communicate using hearing and spoken language. Yet when it comes to cochlear implant candidacy, currently approved Food and Drug Administration (FDA) criteria for adults are much less restrictive than those for children, allowing for greater levels of residual hearing and aided speech recognition in adults. Cochlear implant guidelines for children have changed very little in the 30 years since cochlear implants have been approved for pediatrics, and this lack of change has proven to be a barrier to implantation.

A randomized phase I study comparing the pharmacokinetics of a bevacizumab (HD204) biosimilar to European Union- and United States of America-sourced bevacizumab.

Purpose: This first-in-human study was designed to evaluate the pharmacokinetic (PK) equivalence between HD204 and the European Union (EU)-sourced bevacizumab, between HD204 and the United States of America (US)-sourced bevacizumab, and between EU-sourced and US-sourced bevacizumab (NCT03390673).

Methods: In this randomized, double-blind, 3-way parallel group, single-dose comparative PK study, healthy male subjects were randomized to receive a single 1 mg/kg intravenous dose of HD204, EU-sourced bevacizumab or US-sourced bevacizumab. PK parameters were calculated using non-compartmental methods.