Supplementations of industrial multichamber parenteral nutrition bags in critically ill children: safety of the practice

Parenteral nutrition (PN) is sometimes required in critically ill children because of contraindication or intolerance to full enteral nutrition. European guidelines recommend favoring multichamber bag PN (MCB PN), when possible, for quality purposes and ease of use. The prescribers may adjust the MCB PN through supplementations to better fulfill patient needs. The objective of this study is to investigate the use and supplementations of MCB PN. This observational, single-center, retrospective study was conducted in a pediatric intensive care unit (PICU). We collected prescriptions of MCB PNs and their supplementations added directly into PN bags. A descriptive analysis and a comparison of electrolyte supplementations with the manufacturer's recommendations were undertaken. One hundred thirty-five children (median age 39.2 months [7.0-118.8]) were included, 1449 MCB PNs were administered, and 1652 supplementations were carried out in 736 PN bags. Thirty-two percent of supplementations were vitamins, 32.2% were trace elements, and 35.8% were electrolytes. Around 10% of electrolyte supplementations in PN bags were outside the manufacturer's recommendations. These nonconformities primarily concerned phosphate. This study showed the real-world clinical use of MCB PN in the PICU. Proper attention should be paid to septic risks and physicochemical risks to ensure efficient practice and safety of MCB PN use. [Abstract copyright: © 2022 The Authors. Nutrition in Clinical Practice published by Wiley Periodicals LLC on behalf of American Society for Parenteral and Enteral Nutrition.

Solutions for global marine litter pollution

Since the 1950s the amount of plastics in the marine environment has increased dramatically. Worldwide there is a growing concern about the risks and possible adverse effects of (micro) plastics. This paper reflects on the sources and effects of marine litter and the effects of policies and other actions taken worldwide. Current knowledge offers a solid basis for effective action. Yet, so far the effects of policies and other initiatives are still largely insufficient. The search for appropriate responses could be based on possible interventions and profound understanding of the context specific factors for success. Moreover, the scope, timeframe and dynamics of all initiatives are distinctly different and orchestration at all levels, in close cooperation with one another is currently lacking

Process development and validation of expanded regulatory T cells for prospective applications: an example of manufacturing a personalized advanced therapy medicinal product

Background: A growing number of clinical trials have shown that regulatory T (Treg) cell transfer may have a favorable effect on the maintenance of self-tolerance and immune homeostasis in different conditions such as graft-versus-host disease (GvHD), solid organ transplantation, type 1 diabetes, and others. In this context, the availability of a robust manufacturing protocol that is able to produce a sufficient number of functional Treg cells represents a fundamental prerequisite for the success of a cell therapy clinical protocol. However, extended workflow guidelines for nonprofit manufacturers are currently lacking. Despite the fact that different successful manufacturing procedures and cell products with excellent safety profiles have been reported from early clinical trials, the selection and expansion protocols for Treg cells vary a lot. The objective of this study was to validate a Good Manufacturing Practice (GMP)-compliant protocol for the production of Treg cells that approaches the whole process with a risk-management methodology, from process design to completion of final product development. High emphasis was given to the description of the quality control (QC) methodologies used for the in-process and release tests (sterility, endotoxin test, mycoplasma, and immunophenotype). Results: The GMP-compliant protocol defined in this work allows at least 4.11 7 109 Treg cells to be obtained with an average purity of 95.75 \ub1 4.38% and can be used in different clinical settings to exploit Treg cell immunomodulatory function. Conclusions: These results could be of great use for facilities implementing GMP-compliant cell therapy protocols of these cells for different conditions aimed at restoring the Treg cell number and function, which may slow the progression of certain diseases

The new Checklist of the Italian Fauna: marine Mollusca.

The mollusc fauna of the Mediterranean Sea is still considered as the best-known marine mollusc fauna in the world. The previous modern checklists of marine Mollusca were produced by joint teams of amateurs and professionals. During the last years the Italian Society of Malacology (Società Italiana di Malacologia – S.I.M.) maintained an updated version of the Mediterranean checklist, that served as the backbone for the development of the new Italian checklist. According to the current version (updated on April 1st, 2021), 1,777 recognised species of marine molluscs are present in the Italian Economic Exclusive Zone, including also the Tyrrhenian coasts of Corsica and the continental shelf of the Maltese archipelago. The new checklist shows an increase of 17% of the species reported in the 1995 Checklist. This is largely (yet not solely) due to the new wave of studies based on Integrative Taxonomy approaches. A total of 135 species (7.6%) are strictly endemic to the Italian waters; 44 species (2.5%) are alien and correspond to the 28% of the Mediterranean alien marine molluscs. All eight extant molluscan classes are represented. The families represented in the Italian fauna are 307, an increase of 14.6% from the first checklist, partly due to new records and partly to new phylogenetic systematics. Compared with the whole Mediterranean malacofauna, the Italian component represents 71% in species and 61% in families, which makes it a very remarkable part of the Mediterranean fauna

Imaging in gynecological disease (17): ultrasound features of malignant ovarian yolk sac tumors (endodermal sinus tumors)

Objective To describe the clinical and sonographic characteristics of malignant ovarian yolk sac tumors (YSTs). Methods In this retrospective multicenter study, we included 21 patients with a histological diagnosis of ovarian YST and available transvaginal ultrasound images and/or videoclips and/or a detailed ultrasound report. Ten patients identified from the International Results All cases were pure YSTs, except for one that was a mixed tumor (80% YST and 20% embryonal carcinoma). Median age at diagnosis was 25 (interquartile range (IQR), 19.5–30.5) years. Seventy-six percent (16/21) of women had an International Federation of Gynecology and Obstetrics (FIGO) Stage I–II tumor at diagnosis. Fifty-eight percent (11/19) of women felt pain during the ultrasound examination and one presented with ovarian torsion. Median serum α-fetoprotein (S-AFP) level was 4755 (IQR, 1071–25 303) μg/L and median serum CA 125 level was 126 (IQR, 35–227) kU/L. On ultrasound assessment, 95% (20/21) of tumors were unilateral. The median maximum tumor diameter was 157 (IQR, 107–181) mm and the largest solid component was 110 (IQR, 66–159) mm. Tumors were classified as either multilocular-solid (10/21; 48%) or solid (11/21; 52%). Papillary projections were found in 10% (2/21) of cases. Most (20/21; 95%) tumors were well vascularized (color score, 3–4) and none had acoustic shadowing. Malignancy was suspected in all cases, except in the patient with ovarian torsion, who presented a tumor with a color score of 1, which was classified as probably benign. Image and videoclip quality was considered as adequate in 18/21 cases. On review of the images and videoclips, we found that all tumors contained both solid components and cystic spaces, and that 89% (16/18) had irregular, still fine-textured and slightly hyperechoic solid tissue, giving them a characteristic appearance. Conclusion Malignant ovarian YSTs are often detected at an early stage, in young women usually in the second or third decade of life, presenting with pain and markedly elevated S-AFP. On ultrasound, malignant ovarian YSTs are mostly unilateral, large and multilocular-solid or solid, with fine-textured slightly hyperechoic solid tissue and rich vascularization. © 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of the International Society of Ultrasound in Obstetrics and Gynecology

Evaluating the risk of ovarian cancer before surgery using the ADNEX model to differentiate between benign, borderline, early and advanced stage invasive, and secondary metastatic tumours: prospective multicentre diagnostic study

Objectives To develop a risk prediction model to preoperatively discriminate between benign, borderline, stage I invasive, stage II-IV invasive, and secondary metastatic ovarian tumours. Design Observational diagnostic study using prospectively collected clinical and ultrasound data. Setting 24 ultrasound centres in 10 countries. Participants Women with an ovarian (including para-ovarian and tubal) mass and who underwent a standardised ultrasound examination before surgery. The model was developed on 3506 patients recruited between 1999 and 2007, temporally validated on 2403 patients recruited between 2009 and 2012, and then updated on all 5909 patients. Main outcome measures Histological classification and surgical staging of the mass. Results The Assessment of Different NEoplasias in the adneXa (ADNEX) model contains three clinical and six ultrasound predictors: age, serum CA-125 level, type of centre (oncology centres v other hospitals), maximum diameter of lesion, proportion of solid tissue, more than 10 cyst locules, number of papillary projections, acoustic shadows, and ascites. The area under the receiver operating characteristic curve (AUC) for the classic discrimination between benign and malignant tumours was 0.94 (0.93 to 0.95) on temporal validation. The AUC was 0.85 for benign versus borderline, 0.92 for benign versus stage I cancer, 0.99 for benign versus stage II-IV cancer, and 0.95 for benign versus secondary metastatic. AUCs between malignant subtypes varied between 0.71 and 0.95, with an AUC of 0.75 for borderline versus stage I cancer and 0.82 for stage II-IV versus secondary metastatic. Calibration curves showed that the estimated risks were accurate. Conclusions The ADNEX model discriminates well between benign and malignant tumours and offers fair to excellent discrimination between four types of ovarian malignancy. The use of ADNEX has the potential to improve triage and management decisions and so reduce morbidity and mortality associated with adnexal pathology

Ecological and socioeconomic aspects of meliponiculture in the Yucatan Peninsula, Mexico

Objective: Describe the main economic and ecological characteristics in the production of crops of native stingless bees (NSB) in the Yucatan peninsula (YP), Mexico. Design/methodology/approach: Through the snowball method, an exhaustive search for references on meliponiculture was carried out, using keywords individually or in combination, such as meliponiculture, Melipona, native stingless bee, Mayan meliponiculture, Yucatan peninsula, etc. Results: In Campeche and Yucatán there are a total of 216 producers who have a total of 3362 jobones destined for meliponiculture. However, economic and ecological studies are scarce and do not allow to know in depth the benefits of NSB in the YP, that is, information on production costs and economic spillover that would be obtained with the preservation of the NSB. Limitations on study/implications: This study describes the socioeconomic and ecological aspects of native stingless bees in the Yucatán peninsula, México. Findings/conclusions: Meliponiculture is an important activity from the cultural aspect, therefore its rescue and conservation is urgent; on the other hand, the selling cost of Melipona honey is higher compared to honey from the bee Apis mellifera L., being an economic alternative for producers in rural communities.Objective: To describe the main economic and ecological characteristics in the production of native stingless bees (NSBs) in the Yucatan Peninsula (YP), Mexico. Design/Methodology/Approach: Through the snowball method, an exhaustive search for references about meliponiculture was conducted, using keywords individually or combined, such as meliponiculture, Melipona, native stingless bees, Mayan meliponiculture, Yucatan Peninsula, etc. Results: In Campeche and Yucatán there is a total of N=216 producers who own a total of 3,362 “jobones” destined to meliponiculture. However, economic and ecological studies are scarce and do not allow deeply understanding the benefits of NSBs in the YP; that is, information about production costs and economic benefits that would be obtained with the conservation of NSBs. Study Limitations/Implications: This study describes the socioeconomic and ecological aspects of native stingless bees in the Yucatan Peninsula. Findings/Conclusions: Meliponiculture is an important activity from the cultural aspect, therefore, its rescue and conservation is urgent; on the other hand, the sale cost of Melipona honey is higher compared to honey from the Apis melifera L. bee, representing an economic alternative for the producers of rural communities