Environmental monitoring of current good manufacturing practices cleanroom facilities for manufacturing of cellular therapy products in an academic hospital setting.

As the field of cell and gene therapy (CGT) continues to grow, so too must the infrastructure and regulatory guidance supporting the manufacture of these potentially life-saving products-especially early-phase products manufactured at an increasing number of academic or hospital-based facilities providing decentralized (or point of care) manufacturing. An important component of current good manufacturing practices, including those regulating cell and gene therapies, is the establishment of an effective environmental monitoring (EM) program. While several guidelines for establishing an EM program are available, these guidelines do not specifically address the unique aspects of manufacturing CGT products and they do not provide real-world evidence demonstrating the effectiveness of the program.

First Report of Fusarium annulatum Associated with Young Vine Decline in California.

From 2018 to 2021 a decline was detected in young vineyards of both wine and table grape (Vitis vinifera L.) in seven counties across California (Kern, Monterey, Napa, Sonoma, Tulare, Yolo, and Yuba). Affected vines showed poor or no growth throughout the season, dieback, sap exudation and internal cankers around the graft union.

Assessment of Nymphal Ecology and Adult Xylella fastidiosa Transmission Biology of Aphrophora nr. permutata (Hemiptera: Aphrophoridae) in California Vineyards.

Although Aphrophora nr. permutata (Hemiptera: Aphrophoridae) is a reported vector of the plant pathogen Xylella fastidiosa (Wells) (Xanthomonadales: Xanthomonadaceae), its ecology and role in Pierce's disease dynamics in coastal California vineyards are poorly understood. From 2016 to 2020, we surveyed the abundance of A.

The impact of grapevine red blotch disease on Vitis vinifera L. Chardonnay grape and wine composition and sensory attributes over three seasons.

Background: Grapevine red blotch virus (GRBV) is a recently discovered DNA virus, which was demonstrated to be responsible for grapevine red blotch disease (GRBD). Its presence has been confirmed in the United States, Canada, Mexico, and South Korea in white and red Vitis vinifera cultivars, including Chardonnay. It has been shown that the three-cornered alfalfa treehopper (Spissistilus festinus) was able to both acquire the GRBV from a grapevine infected and transmit it to healthy grapevines in glasshouse conditions.

Impact of Grapevine Red Blotch Disease on Grape Composition of Vitis vinifera Cabernet Sauvignon, Merlot, and Chardonnay.

Grapevine red blotch disease (GRBD) is a recently recognized viral disease that affects grapevines ( Vitis vinifera L.). Currently little is known about its impact on grape composition.

Grapevine Red Blotch Virus May Reduce Carbon Translocation Leading to Impaired Grape Berry Ripening.

Grapevine red blotch virus (GRBV) is suspected to alter berry ripening and chemistry. This study performed a physiological characterization of GRBV infected grapevines with attention to the factors leading to chemical changes during ripening of Cabernet Sauvignon in two rootstocks, 110R and 420A. RB(+) grapevines had transiently lower net photosynthesis; however, berry total soluble solids (TSS) accumulation was consistently reduced in the two years of study.

Characterization of grapevine leafroll-associated virus 3 genetic variants and application towards RT-qPCR assay design.

Grapevine leafroll-associated virus 3 (GLRaV-3) is the most widely prevalent and economically important of the complex of RNA viruses associated with grapevine leafroll disease (GLD). Phylogenetic studies have grouped GLRaV-3 isolates into nine different monophyletic groups and four supergroups, making GLRaV-3 a genetically highly diverse virus species. In addition, new divergent variants have been discovered recently around the world.

Concurrent validity and sensitivity to change of Direct Behavior Rating Single-Item Scales (DBR-SIS) within an elementary sample.

The purpose of this study was to evaluate the concurrent validity, sensitivity to change, and teacher acceptability of Direct Behavior Rating single-item scales (DBR-SIS), a brief progress monitoring measure designed to assess student behavioral change in response to intervention. Twenty-four elementary teacher-student dyads implemented a daily report card intervention to promote positive student behavior during prespecified classroom activities. During both baseline and intervention, teachers completed DBR-SIS ratings of 2 target behaviors (i.

Red blotch disease alters grape berry development and metabolism by interfering with the transcriptional and hormonal regulation of ripening.

Grapevine red blotch-associated virus (GRBaV) is a major threat to the wine industry in the USA. GRBaV infections (aka red blotch disease) compromise crop yield and berry chemical composition, affecting the flavor and aroma properties of must and wine. In this study, we combined genome-wide transcriptional profiling with targeted metabolite analyses and biochemical assays to characterize the impact of the disease on red-skinned berry ripening and metabolism.

Closed-reference metatranscriptomics enables in planta profiling of putative virulence activities in the grapevine trunk disease complex.

Grapevines, like other perennial crops, are affected by so-called 'trunk diseases', which damage the trunk and other woody tissues. Mature grapevines typically contract more than one trunk disease and often multiple grapevine trunk pathogens (GTPs) are recovered from infected tissues. The co-existence of different GTP species in complex and dynamic microbial communities complicates the study of the molecular mechanisms underlying disease development, especially under vineyard conditions.

Got milk? Effects of early enteral feedings in patients with gastroschisis.

Background: Initiating early enteral intake post-surgical gastroschisis repair may result in better patient outcomes. However, there is lack of evidence and consistency in clinical practice regarding the timing of initiation of feedings, and few studies have determined best practices for post-operative nutritional management.

Purpose: To determine whether early nutritional management using a standardized advancement protocol improves outcomes for patients with gastroschisis.

White button mushrooms increase microbial diversity and accelerate the resolution of Citrobacter rodentium infection in mice.

The effect of feeding C57BL/6 mice white button (WB) mushrooms or control (CTRL) diets for 6 wk was determined on the bacterial microflora, urinary metabolome, and resistance to a gastrointestinal (GI) pathogen. Feeding mice a diet containing 1 g WB mushrooms/100 g diet resulted in changes in the microflora that were evident at 2 wk and stabilized after 4 wk of WB feeding. Compared with CTRL-fed mice, WB feeding (1 g/100 g diet) increased the diversity of the microflora and reduced potentially pathogenic (e.

Implementation of evidence-based practices for surgical site infection prophylaxis: results of a pre- and postintervention study.

Background: Although evidence-based guidelines for best practices pertaining to surgical site infection (SSI) prophylaxis exist, the feasibility of implementing such practices remains to be demonstrated outside of a controlled clinical trial. This study was designed to assess the safety and feasibility of implementing evidence-based care practices to prevent SSIs.

Study Design: A prospective, double-cohort (pre- and postintervention) trial in elective, general surgery patients was conducted.

How we will produce the evidence-based EURRECA toolkit to support nutrition and food policy.

Background: There is considerable variation in the recommended micronutrient intakes used by countries within Europe, partly due to different methodologies and concepts used to determine requirements and different approaches used to express the recommendations. As populations become more mobile and multi-national, and more traditional foods become available internationally, harmonised recommendations based on up to date science are needed. This was recognised by the European Commission's (EC) Directorate-General (DG) Research in their 2005 call for proposals for a Network of Excellence (NoE) on 'nutrient status and requirements of specific vulnerable population groups'.

Creating windows of opportunity for policy change: Incorporating evidence into decentralized planning in Kenya.

Problem: Because researchers and policy-makers work in different spheres, policy decisions in the health arena are often not based on available scientific evidence.

Approach: We describe a model that illustrates the policy process and how to work strategically to translate knowledge into policy actions. Several types of activity--agenda-setting, coalition building and policy learning--together can create a window of opportunity for policy change.

How does fast track affect quality of care in the emergency department?

Study Objectives: Use of fast track has been shown to improve the emergency department flow of less urgent patients. It has been speculated, however, that this could negatively affect the care of urgent patients. The objective of this study was to determine whether a dedicated fast track for less urgent patients [Canadian Triage and Acuity scale category 4/5 (CTAS 4/5)] affected (1) the time to assessment for urgent patients (CTAS 3), (2) the length of stay for less urgent patients (CTAS 4 and 5), and (3) the left-without-being-seen rate.

Priority risk factors for back injury in agricultural field work: vineyard ergonomics.

With support of a NIOSH Community Partners grant, the authors reviewed data from three cooperating vineyard companies in Napa and Sonoma Counties, finding both high rates of evidence of musculoskeletal disorders (MSDs) and identifying priority MSD hazards for intervention. Data from OSHA 200 injury report logs identified 29 reported MSDs and 435 lost workdays in a working population of 194 in a 30-month period. The majority of these (20) involved backstrain.