Investigating Bias from Missing Data in an Electronic Health Records-Based Study of Weight Loss After Bariatric Surgery.

Purpose: Missing data is common in electronic health records (EHR)-based obesity research. To avoid bias, it is critical to understand mechanisms that underpin missingness. We conducted a survey among bariatric surgery patients in three integrated health systems to (i) investigate predictors of disenrollment and (ii) examine differences in weight between disenrollees and enrollees at 5 years.

Using the monocyte activation test as a stand-alone release test for medical devices.

Monocyte activation tests (MAT) are widely available but rarely used in place of animal-based pyrogen tests for safety assessment of medical devices. To address this issue, the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods and the PETA International Science Consortium Ltd. convened a workshop at the National Institutes of Health on September 18-19, 2018.

Monitoring genome-wide replication fork directionality by Okazaki fragment sequencing in mammalian cells.

The ability to monitor DNA replication fork directionality at the genome-wide scale is paramount for a greater understanding of how genetic and environmental perturbations can impact replication dynamics in human cells. Here we describe a detailed protocol for isolating and sequencing Okazaki fragments from asynchronously growing mammalian cells, termed Okazaki fragment sequencing (Ok-seq), for the purpose of quantitatively determining replication initiation and termination frequencies around specific genomic loci by meta-analyses. Briefly, cells are pulsed with 5-ethynyl-2'-deoxyuridine (EdU) to label newly synthesized DNA, and collected for DNA extraction.

Potential Beneficial Effects of Dietary Protein Supplementation and Exercise on Functional Capacity in a Pilot Study of Individuals with Heart Failure with Preserved Ejection Fraction.

Approximately half of heart failure patients in the US have heart failure with preserved ejection fraction (HFpEF). HFpEF impairs physical performance and thus reduces quality of life. Increasing dietary protein intake can increase lean body mass and physical performance in healthy elderly individuals, but the effect of a high-quality protein supplement, with or without a structured exercise program, has not been investigated in HFpEF patients.

The relationship between kidney function and body mass index before and after bariatric surgery in patients with chronic kidney disease.

Background: Improvements in kidney function post-bariatric surgery may be related to weight loss-independent effects.

Objectives: To characterize the dynamic relationship between body mass index (BMI) and estimated glomerular filtration rate (eGFR) before and after bariatric surgery in patients with chronic kidney disease (CKD).

Setting: Kaiser Permanente Southern California (KPSC) health system.

Pre-validation of SENS-IS assay for in vitro skin sensitization of medical devices.

According to ISO 10993-1:2018, the skin sensitization potential of all medical devices must be evaluated, and for this endpoint ISO 10993-10:2010 recommends the use of in vivo assays. The goal of the present study was to determine if the in vitro SENS-IS assay could be a suitable alternative to the current in vivo assays. The SENS-IS assay uses the Episkin Large and SkinEthic RHE reconstructed human epidermis models to evaluate marker genes.

Effect of bacterial contamination in bile on pancreatic cancer cell survival.

Background: Introduction of gut flora into the biliary system is common owing to biliary stenting in patients with obstructing pancreatic head cancer. We hypothesize that alteration of biliary microbiome modifies bile content that modulates pancreatic cancer cell survival.

Methods: Human bile samples were collected during pancreaticoduodenectomy.

Prevalence of Adeno-Associated Virus 3 Capsid Binding and Neutralizing Antibodies in Healthy and Hemophilia B Individuals from India.

Adeno-associated virus (AAV) vector-based gene therapy offers a new treatment option for individuals with hemophilia. Pre-existing anti-AAV antibodies significantly impact the use of AAV vectors. Even relatively low titers of AAV neutralizing antibodies (NAb) from natural AAV infections against the capsid have been shown to inhibit the transduction of intravenously administered AAV in animal models and were associated with limited efficacy in human trials.

Infant isoflurane exposure affects social behaviours, but does not impair specific cognitive domains in juvenile non-human primates.

Background: Clinical studies show that children exposed to anaesthetics for short times at young age perform normally on intelligence tests, but display altered social behaviours. In non-human primates (NHPs), infant anaesthesia exposure for several hours causes neurobehavioural impairments, including delayed motor reflex development and increased anxiety-related behaviours assessed by provoked response testing. However, the effects of anaesthesia on spontaneous social behaviours in juvenile NHPs have not been investigated.

The Bariatric Experience Long Term (BELONG): Factors Related to Having Bariatric Surgery in a Large Integrated Healthcare System.

Purpose: Bariatric surgery is the most effective treatment for severe obesity, but currently, only 1-2% of all eligible patients undergo surgery each year. This study examined which factors were associated with a patient receiving bariatric surgery after referral in a real-world healthcare setting.

Materials And Methods: The current study used the baseline survey and electronic medical record (EMR) data from the Bariatric Experience Long Term (BELONG) study (n = 1975).

Model-based optimisation of agricultural profitability and nutrient management: a practical approach for dealing with issues of scale.

To manage agricultural landscapes more sustainably, we must understand and quantify the synergies and trade-offs between environmental impact, production, and other ecosystem services. Models play an important role in this type of analysis as generally it is infeasible to test multiple scenarios by experiment. These models can be linked with algorithms that optimise for multiple objectives by searching a space of allowable management interventions (the control variables).

A Roadmap for Institutionalizing Collaborative Care for Depression in a Large Integrated Healthcare System.

Background: Collaborative models for depression have not been widely adopted throughout the USA, possibly because there are no successful roadmaps for implementing these types of models.

Objective: To provide such a roadmap through a case study of the institutionalization of a depression care management (DCM) initiative for adult depression in a large healthcare system serving over 300,000 adults with depression.

Design: A retrospective observational program evaluation.

Intracardiac echocardiography guided nonocclusive balloon cryothermal applications to achieve antral isolation during pulmonary vein isolation.

Objective: Ablation for atrial fibrillation (AF) requires electrical isolation of the pulmonary veins (PV) by wide-area circumferential PV antral isolation (PVAI). Cryoballoon ablation delivers cryoenergy circumferentially after occlusion of the PV by the cryoballoon; thus, it is likely that the level of isolation, determined by adequate balloon-tissue contact, depends on PV anatomy. We sought to examine the need for nonocclusive segmental cryoballoon ablation in achieving antral isolation, describe methods of accurate visualization of the cryoballoon using intracardiac echocardiography (ICE), and provide data on biophysical characteristics of an effective nonocclusive cryothermal lesion.

DOT Diary: Developing a Novel Mobile App Using Artificial Intelligence and an Electronic Sexual Diary to Measure and Support PrEP Adherence Among Young Men Who Have Sex with Men.

Young men who have sex with men (YMSM) are highly vulnerable to HIV. While pre-exposure prophylaxis (PrEP) has demonstrated effectiveness, adherence has been low among YMSM and difficult to measure accurately. In collaboration with a healthcare company, we configured an automated directly-observed therapy (aDOT) platform for monitoring and supporting PrEP use.

Update on Nonfacial Fat Transplantation.

Background: Fat transplantation is becoming increasingly popular for off-face rejuvenation.

Objective: To provide an update in the literature of current knowledge and emerging concepts in the use of fat transplantation for nonfacial applications.

Materials And Methods: This update includes the potential benefits and risks of using fat transfer techniques on the body.

Neural effects of oxytocin and mimicry in frontotemporal dementia: A randomized crossover study.

Objective: To determine whether intranasal oxytocin, alone or in combination with instructed mimicry of facial expressions, would augment neural activity in patients with frontotemporal dementia (FTD) in brain regions associated with empathy, emotion processing, and the simulation network, as indexed by blood oxygen-level dependent (BOLD) signal during fMRI.

Methods: In a placebo-controlled, randomized crossover design, 28 patients with FTD received 72 IU intranasal oxytocin or placebo and then completed an fMRI facial expression mimicry task.

Results: Oxytocin alone and in combination with instructed mimicry increased activity in regions of the simulation network and in limbic regions associated with emotional expression processing.

Environmental and Aerosolized Severe Acute Respiratory Syndrome Coronavirus 2 Among Hospitalized Coronavirus Disease 2019 Patients.

During April and May 2020, we studied 20 patients hospitalized with coronavirus disease 2019 (COVID-19), their hospital rooms (fomites and aerosols), and their close contacts for molecular and culture evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Among >400 samples, we found molecular evidence of virus in most sample types, especially the nasopharyngeal (NP), saliva, and fecal samples, but the prevalence of molecular positivity among fomites and aerosols was low. The agreement between NP swab and saliva positivity was high (89.

The suitability of reconstructed human epidermis models for medical device irritation assessment: A comparison of In Vitro and In Vivo testing results.

The ISO 10993 standards on biocompatibility assessment of medical devices discourage the use of animal tests when reliable and validated in vitro methods are available. A round robin validation study of in vitro reconstructed human epidermis (RhE) assays was performed as potential replacements for rabbit skin irritation testing. The RhE assays were able to accurately identify strong irritants in dilute medical device extracts.

A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines: A Focus on Safety From the SAKURA 3 Study.

Background: SAKURA 3 was a Phase 3, open-label, repeat-dose safety study of DaxibotulinumtoxinA for Injection (DAXI); a component of the largest Phase 3 clinical development program of an aesthetic neuromodulator in glabellar lines.

Objective: To evaluate the use of DAXI (40U) up to 3 treatments for moderate or severe glabellar lines.

Methods: Eligible subjects rolled over from the placebo-controlled trials (n = 477) or were de novo (n = 2,214) and received 1 to 3 treatments over a maximum of 84 weeks.

Early symptoms in symptomatic and preclinical genetic frontotemporal lobar degeneration.

Objectives: The clinical heterogeneity of frontotemporal dementia (FTD) complicates identification of biomarkers for clinical trials that may be sensitive during the prediagnostic stage. It is not known whether cognitive or behavioural changes during the preclinical period are predictive of genetic status or conversion to clinical FTD. The first objective was to evaluate the most frequent initial symptoms in patients with genetic FTD.

An Exploration of the Relationships Among Facial Dimensions, Age, Sex, Dominance Status, and Personality in Rhesus Macaques ().

Aspects of personality in nonhuman primates have been linked to health, social relationships, and life history outcomes. In humans as well as nonhuman primates, facial morphology is associated with assertiveness, aggression, and measures of dominance status. In this study we aimed to examine the relationship among facial morphology, age, sex, dominance status, and ratings on the personality dimensions Confidence, Openness, Assertiveness, Friendliness, Activity, and Anxiety in rhesus macaques ().

Transmission modes of severe acute respiratory syndrome coronavirus 2 and implications for infection control: a review.

The complete picture regarding transmission modes of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is unknown. This review summarises the available evidence on its transmission modes, our preliminary research findings and implications for infection control policy, and outlines future research directions. Environmental contamination has been reported in hospital settings occupied by infected patients, and is higher in the first week of illness.