A Phase 3, 28-week, multicentre, randomised, double-blind, placebo-controlled trial (OA-10) to evaluate the efficacy and safety of a single injection of lorecivivint in the target knee joint of moderately to severely symptomatic osteoarthritis patients.

Objectives: To assess the efficacy and safety of an intra-articular (IA) CLK/DYRK inhibitor, lorecivivint (LOR), for the treatment of moderate to severe symptomatic knee osteoarthritis (OA).

Methods: This was a Phase 3, 28-week, multicentre, double-blind, placebo-controlled study evaluating the efficacy and safety of a single IA injection of LOR. Patients with ACR-defined knee OA, Kellgren-Lawrence (KL) grades 2-3, and pain Numeric Rating Scale (NRS) ≥4 and ≤8 in the target knee were randomised (1:1) to receive LOR 0.

Phase 3, 56-week, randomised, double-blind, placebo-controlled study utilising patient-reported and radiographic outcomes evaluating the efficacy and safety of a lorecivivint injection in patients with moderate to severe knee osteoarthritis: OA-11 Study.

Objectives: To determine the efficacy, safety, and tolerability of intraarticular (IA) lorecivivint (LOR) in the treatment of knee osteoarthritis (OA).

Methods: Patients with American College of Rheumatology criteria-defined knee OA, Kellgren-Lawrence (KL) grades 2-3, and medial Joint Space Width (JSW) by radiograph between 1.5 and 4 mm in the target knee were enrolled in this phase 3, 56-week, multicentre, double-blind, placebo-controlled study.

Assessment of community readiness to address malnutrition in rural southwest Guatemala.

Background: Malnutrition is prevalent throughout southwest Guatemala, where >40% of children suffer from chronic undernutrition. Evidence supports that assessing a community's awareness and readiness to address malnutrition is a critical first step in improving the success of a nutrition intervention program. The objective of this study was to apply the community readiness model (CRM) to assess community readiness to address childhood malnutrition in a rural southwest region of Guatemala.

Indications and Outcomes of Laser Retinopexy in Eyes With High-Risk Lattice Degeneration.

To examine the characteristics of eyes with high-risk lattice degeneration treated with laser retinopexy and determine the indications, safety, and outcomes of the treatment. This interventional single-surgeon consecutive retrospective study was conducted at Wills Eye Hospital between 2014 and 2021. The series included eyes with lattice degeneration with high-risk lesions.

Sexual assault and the matrix of harm: Sexual assault survivors narrate their whole lives in more negative ways.

This paper uses data from the American Voices Project, an interview study based on a random population sample, to explore the relationship between assault experiences and how people narrate their lives. Using quantitative sentiment analysis, we find that survivors of assault express significantly greater negative sentiment when asked to tell their life stories. These negative sentiments are observable throughout the entire interview, including before questions of assault are asked.

Forward and Back is Not Enough: Applying Best Practices for Translation of Pediatric Sleep Questionnaires.

Cultural differences in the experience of sleep warrant consideration in the measurement of sleep across populations. This requires careful attention to both language and culture when translating survey measures. While forward and back translation is the most commonly used approach, it has numerous limitations if used as an isolated method.

Safety, Tolerability, and Pharmacokinetics of Same-Knee Intra-Articular Injection of Corticosteroid and Lorecivivint Within 7 Days: An Open-Label, Randomized, Parallel-Arm Study.

Introduction: Knee osteoarthritis (OA) is a common painful disorder. Intra-articular (IA) corticosteroid injections are frequently prescribed to treat knee pain. Lorecivivint (LOR), a novel IA cdc2-Like Kinase (CLK)/Dual-Specificity Tyrosine Phosphorylation-Regulated Kinase (DYRK) inhibitor thought to modulate Wnt and inflammatory pathways, has appeared safe and demonstrated improved patient-reported outcomes compared with placebo.

First-in-human study of a pharmacological duodenal exclusion therapy shows reduced postprandial glucose and insulin and increased bile acid and gut hormone concentrations.

Aims: To address the need for noninvasive alternatives to metabolic surgery or duodenal exclusion devices for the management of type 2 diabetes (T2D) and obesity by developing an orally administered therapeutic polymer, GLY-200, designed to bind to and enhance the barrier function of mucus in the gastrointestinal tract to establish duodenal exclusion noninvasively.

Materials And Methods: A Phase 1, randomized, double-blind, placebo-controlled, single- (SAD) and multiple-ascending-dose (MAD) healthy volunteer study was conducted. In the SAD arm, four cohorts received a single dose of 0.

VITRECTOMY FOR VITREOUS HEMORRHAGE ASSOCIATED WITH RETINAL VEIN OCCLUSION: Visual Outcomes, Prognostic Factors, and Sequelae.

Purpose: To report the outcomes of pars plana vitrectomy for vitreous hemorrhage (VH) associated with retinal vein occlusion and to identify prognostic indicators.

Methods: Interventional, retrospective consecutive case series between 2015 and 2021.

Results: The study included 138 eyes of 138 patients (64 female and 74 male); 81 patients had branch retinal vein occlusion and 57 had central retinal vein occlusion.

Clinical and Economic Impact of COVID-19 on Agricultural Workers, Guatemala.

We evaluated clinical and socioeconomic burdens of respiratory disease in banana farm workers in Guatemala. We offered all eligible workers enrollment during June 15-December 30, 2020, and annually, then tracked them for influenza-like illnesses (ILI) through self-reporting to study nurses, sentinel surveillance at health posts, and absenteeism. Workers who had ILI submitted nasopharyngeal swab specimens for testing for influenza virus, respiratory syncytial virus, and SARS-CoV-2, then completed surveys at days 0, 7, and 28.

NODULAR EPIRETINAL MÜLLER CELL GLIOSIS IN THE FOVEA.

Purpose: The purpose of this study was to report the findings of a hyperreflective nodular epiretinal gliosis observed with optical coherence tomography presumed to be due to subclinical hyaloidal traction causing Mϋller cell cone gliosis.

Methods: Retrospective, observational case series.

Results: Six eyes of six patients (mean age: 57 years, range 35-81 years) presented with a nodular epiretinal gliosis and had an average follow-up interval of 26 months (range 1-82 months).

Clinical and Economic Impact of COVID-19 on Plantation Workers: Preliminary Results from the Guatemala Agricultural Workers and Respiratory Illness Impact (AGRI) Study.

We evaluated the clinical and socioeconomic burdens of respiratory disease in a cohort of Guatemalan banana plantation workers. All eligible workers were offered enrollment from June 15-December 30, 2020, and annually, then followed for influenza-like illnesses (ILI) through: 1) self-reporting to study nurses, 2) sentinel surveillance at health posts, and 3) absenteeism. Workers with ILI submitted nasopharyngeal swabs for influenza, RSV, and SARS-CoV-2 testing, then completed surveys at days 0, 7, and 28.

Phase 1 Dose-Escalation Study of Plasma Kallikrein Inhibitor THR-149 for the Treatment of Diabetic Macular Edema.

Purpose: The purpose of this study was to evaluate the safety and preliminary efficacy of a single intravitreal injection of 3 dose levels of THR-149 in adults with center-involved diabetic macular edema (DME).

Methods: A phase 1, open-label, multicenter 3 + 3 dose-esclation study with 3-month follow-up. The primary endpoint was the incidence of dose-limiting toxicities (DLTs) up to and including the Day 14 visit.

Retrospective Study of Ellipsoid Zone Integrity Following Treatment with Intravitreal Ocriplasmin (OZONE Study).

Purpose: To assess generalized (GD) and focal ellipsoid zone disruption (FD) in patients with symptomatic vitreomacular adhesion (sVMA) using spectral domain optical coherence tomography (SD-OCT) following ocriplasmin.

Patients And Methods: OZONE was a Phase 4, retrospective study of patients with sVMA treated with a single intravitreal injection of ocriplasmin (0.125 mg).

Endophthalmitis following Intravitreal Anti-Vascular Endothelial Growth Factor Therapy: Changes in Incidence and Outcomes over a 9-Year Period.

: To evaluate whether the incidence, microbial spectrum, and visual outcomes of endophthalmitis following intravitreal injections have changed over time.: Retrospective cohort study of endophthalmitis in eyes receiving intravitreal injection of anti-vascular endothelial growth factor between 2009-2012 and 2016-2017 at a single, large retina practice.: A total of 283,315 injections resulted in 96 suspected infectious endophthalmitis cases.

Resolution of Pseudophakic Cystoid Macular Edema: 2 mg Intravitreal Triamcinolone Acetonide versus 40 mg Posterior Sub-Tenon Triamcinolone Acetonide.

Purpose: To compare 2 mg intravitreal triamcinolone (IVT) versus 40 mg posterior sub-Tenon triamcinolone acetonide (STT) for the treatment of eyes with pseudophakic cystoid macular edema.

Methods: A retrospective, single-center review of eyes receiving 2 mg IVT between 3/1/2012-3/1/2017 and 40 mg STT between 1/1/2015-3/1/2017. Visual acuity (VA) and central macular thickness (CMT) were recorded at baseline, 1-, 3-, and 6-month follow-up visits.

Vulnerability in Law and Bioethics.

Understanding universal vulnerability as inherent in human beings raises questions about the use of differentiating and stigmatizing terms such as vulnerable populations, by which individuals are grouped together based on perceived dissimilarity, deviance, or victimhood. Understanding human vulnerability also calls into question concepts, such as individual responsibility and consent, currently relied upon to resolve ethical and legal dilemmas. When normalized, vulnerability provides a powerful and inclusive conceptual tool that can help us define individual, professional, and institutional responsibility in situations of inherent inequality, such as that of researcher/research subject or doctor/patient.

PATIENT-REPORTED VISUAL FUNCTION FROM THE OCRIPLASMIN FOR TREATMENT FOR SYMPTOMATIC VITREOMACULAR ADHESION, INCLUDING MACULAR HOLE (OASIS) STUDY.

Purpose: To evaluate patient-reported visual function after ocriplasmin through the 25-item National Eye Institute Visual Function Questionnaire (VFQ-25) in patients with symptomatic vitreomacular adhesion/vitreomacular traction including macular hole.

Methods: This was a prespecified analysis of a secondary endpoint from the OASIS trial. Patients received a single intravitreal injection of ocriplasmin (0.

Improved glycemic control with minimal systemic metformin exposure: Effects of Metformin Delayed-Release (Metformin DR) targeting the lower bowel over 16 weeks in a randomized trial in subjects with type 2 diabetes.

Objective: Metformin use is restricted in patients with renal impairment due to potential excess systemic accumulation. This study evaluated the glycemic effects and safety of metformin delayed-release (Metformin DR), which targets metformin delivery to the ileum to leverage its gut-based mechanisms of action while minimizing systemic exposure.

Research Designs And Methods: Participants (T2DM [HbA1c 7-10.

Outcomes of Eyes Lost to Follow-up with Proliferative Diabetic Retinopathy That Received Panretinal Photocoagulation versus Intravitreal Anti-Vascular Endothelial Growth Factor.

Purpose: To compare anatomic and functional outcomes in eyes with proliferative diabetic retinopathy (PDR) that were lost to follow-up (LTFU) for more than 6 months after treatment with either intravitreal injection (IVI) of anti-vascular endothelial growth factor (VEGF) agents or panretinal photocoagulation (PRP).

Design: Retrospective cohort study.

Participants: Fifty-nine patients who were LTFU immediately after treatment for more than 6 months between September 2013 and September 2016.