The Challenges and Opportunities in Pediatric Medical Device Innovation: Monitoring Devices.

Background: Medical device innovation and development for pediatric care lags behind that of adults. With higher technical risks, challenges in accumulating data, smaller market sizes, and limited return on investment, there is less incentive for pediatric device development. Consequently, translation of medical devices specifically designed to improve pediatric care is limited.

ICU care through NGS - Based identification of infectious agents: A comparative study.

Background: Sepsis claims 1 in 5 lives annually as per global statistics. Sepsis incidence in recent studies represents at least 35 % of all ICU admissions and has a high mortality rate, especially in the presence of co-existing morbidities. The challenge has been to accurately diagnose the causative organism, considering factors such as possible polymicrobial infections, commensals and environmental contaminants.

Pediatric Device Clinical Trials Activity: 1999-2022.

Objectives: This study assessed the state of pediatric medical device (PMD) development by comparing PMD clinical trials to pediatric trials evaluating drugs and biologics, from 1999 to 2022.

Methods: The site www.clinicaltrials.

Fine-scale monitoring of insecticide resistance in Aedes aegypti (Diptera: Culicidae) from Sri Lanka and modeling the phenotypic resistance using rational approximation.

Background: The unplanned and intensified use of insecticides to control mosquito-borne diseases has led to an upsurge of resistance to commonly used insecticides. Aedes aegypti, the main vector of dengue, chikungunya, and Zika virus, is primarily controlled through the application of adulticides (pyrethroid insecticides) and larvicides (temephos). Fine spatial-scale analysis of resistance may reveal important resistance-related patterns, and the application of mathematical models to determine the phenotypic resistance status lessens the cost and usage of resources, thus resulting in an enhanced and successful control program.

Lung Cancer Survival in Sri Lanka.

Nuradh Joseph  Lung cancer is the second commonest cancer among males in Sri Lanka. Real-world survival data are scarce, and we conducted a retrospective survival analysis among patients treated for lung cancer.  All patients with primary lung cancer treated at three selected units during 2015-2016 were included in the study.

Outcomes of patients with esophageal and gastric cancer in Sri Lanka: A retrospective survival analysis.

Introduction: Esophageal carcinoma is the fourth most common cancer among males and sixth most common cancer among females in Sri Lanka. Gastric cancer is less common, but its incidence is gradually rising. We conducted a retrospective analysis of survival of esophageal and gastric cancer patients treated at National Cancer Institute, Maharagama, Sri Lanka.

Heterogeneity in treatment effects across diverse populations.

Differences in patient characteristics, including age, sex, and race influence the safety and effectiveness of drugs, biologic products, and medical devices. Here we provide a summary of the topics discussed during the opening panel at the 2018 Johns Hopkins Center for Excellence in Regulatory Science and Innovation symposium on Assessing and Communicating Heterogeneity of Treatment Effects for Patient Subpopulations: Challenges and Opportunities. The goal of this session was to provide a brief overview of FDA-regulated therapeutics, including drugs, biologics and medical devices, and some of the major sources of heterogeneity of treatment effects (HTE) related to patient demographics, such as age, sex and race.

Regulatory Science, and How Device Regulation Will Shape Our Future.

Pediatric medical device approvals lag behind adult approvals. Historically, medical devices have rarely been designed specifically for children, but use in children has most often borrowed from adult or general use applications. While a variety of social, economic, and clinical factors have contributed to this phenomenon, the regulatory process remains a fundamental aspect of pediatric device development and commercialization.

The landscape of cardiovascular care in pediatric cancer patients and survivors: a survey by the ACC Pediatric Cardio-Oncology Work Group.

Objective: To enhance the understanding of cardiovascular care delivery in childhood cancer patients and survivors.

Study Design: A 20-question survey was created by the Pediatric Cardio-oncology Work Group of the American College of Cardiology (ACC) Cardio-oncology Section to assess the care, management, and surveillance tools utilized to manage pediatric/young adult cardio-oncology patients. The survey distribution was a collaborative effort between Cardio-oncology Section and membership of the Adult Congenital and Pediatric Cardiology Section (ACPC) of the ACC.

Children and Adults With Rare Diseases Need Innovative Medical Devices.

Rare diseases (RD) affect approximately 30 million Americans, half of whom are children. This study is the first to comprehensively evaluate their medical device needs via a survey of physicians. The study sought to identify and document the presumed unmet diagnostic and therapeutic device needs for RD management; clarify the magnitude of the potential unmet need; and generate meaningful data to inform medical device stakeholders.

Predictors in breast cancer screening behaviors of South Asian women.

Aim: Screening is important in minimizing breast cancer-related morbidity. It is prudent to identify the factors that affect women's choice in participation in mammographic screening. Our objective was to identify the factors that influence the breast screening behaviors in Sri Lankan women.

Helicase-like transcription factor (Hltf) regulates G2/M transition, Wt1/Gata4/Hif-1a cardiac transcription networks, and collagen biogenesis.

HLTF/Hltf regulates transcription, remodels chromatin, and coordinates DNA damage repair. Hltf is expressed in mouse brain and heart during embryonic and postnatal development. Silencing Hltf is semilethal.

Association of socioeconomic position and medical insurance with fetal diagnosis of critical congenital heart disease.

Background: Access to beneficial novel healthcare technology has been inequitable in the United States. Fetal echocardiography, used with increasing frequency for prenatal diagnosis (PD) of congenital heart disease, allows for optimal neonatal management and possible improved outcomes. We sought to evaluate whether PD of critical congenital heart disease is related to socioeconomic (SE) position, medical insurance, and race.

Discussions about end-of-life care in nursing homes.

Objective: To measure the frequency with which nursing home residents and their surrogates discuss with clinicians the resident's wishes concerning future treatment and to assess the influence of the Patient Self Determination Act (PSDA) on the frequency and nature of such discussions.

Design: Retrospective cohort study of residents admitted to nursing homes before and after the PSDA.

Setting: Six large (at least 120 licensed chronic care beds), randomly selected nursing homes in Connecticut.

Quantization effects in digitally behaving circuit implementations of Kohonen networks.

Implementing a neural network on a digital or mixed analog and digital chip yields the quantization of the synaptic weights dynamics. This paper addresses this topic in the case of Kohonen's self-organizing maps. We first study qualitatively how the quantization affects the convergence and the properties, and deduce from this analysis the way to choose the parameters of the network (adaptation gain and neighborhood).

Antimicrobial activity of cytotoxic drugs may influence isolation of bacteria and fungi from blood cultures.

The potential antimicrobial activity of cyclophosphamide, vincristine, and adriamycin against Gram positive and negative bacteria and Candida albicans was examined. The time taken for different microbial inocula to turn a simulated blood culture positive in the presence of different concentrations of these drugs was measured. Doxorubicin retarded the growth of Staphylococcus aureus, Staphylococcus epidermidis, and Streptococcus sanguis in a concentration dependent manner.

Legionnaires' disease in elderly people: the first sign of an outbreak in the community?

Legionella pneumophila is responsible for up to 5% of cases of community-acquired pneumonia and mainly affects people aged over 50 years. The confirmation of legionellosis in two elderly patients living close to each other prompted a search for other cases. A total of eleven subjects with legionnaires' disease was recognized.

Rapid method for differentiating strains of Branhamella catarrhalis.

The ability of Branhamella catarrhalis to cause nosocomial infections is a matter of some controversy. The API ZYM research kit for detecting 89 enzymes was used on 49 isolates of B catarrhalis to select enzymes of potential use in differentiating clinical isolates. Twenty nine enzymes were produced by all isolates (13 strongly positive) and many of these were esterases; 16 enzymes were not detected in any isolate (40 if a more stringent criterion was used).